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Don’t let FOMI lead to antibiotic overuse
Is fear of missing an infection – call it “FOMI” – leading you to overprescribe antibiotics to your patients?
Inappropriate use of antibiotics can result in adverse events and toxicity, superinfections such as Clostridioides difficile and Methicillin-resistant Staphylococcus aureus, excess mortality and costs, and resistance to the drugs.
All that has been well-known for years, and antibiotic resistance has become a leading public health concern. So why are physicians continuing to overprescribe the drugs?
Speaking at the 2022 annual Internal Medicine Meeting of the American College of Physicians, James “Brad” Cutrell, MD, medical director of antimicrobial stewardship, University of Texas Southwestern Medical Center, Dallas, said clinicians in the United States and elsewhere appear to be falling into a three-part fallacy when it comes to using the drugs: fear of “missing an infection,” coupled with patient expectations that they will leave the office with a prescription and combined with an overemphasis on the potential benefit to the individual at the expense of the risk to society of antibiotic resistance.
Antibiotics are the only drugs that lose their efficacy for all patients over time the more they are used. “For example, if I give a beta blocker to a patient, it’s not going to affect other patients down the road,” Dr. Cutrell said. “It’s not going to lose its efficacy.”
“What we need in medicine is a new culture around antibiotic use,” Dr. Cutrell added. “We need more respect for the dangers of antibiotic misuse and to have confidence in [their] benefits and when they can be used wisely.”
Rampant misuse
Outpatient prescriptions account for at least 60% of antibiotic use in the United States. The rate is even higher in other countries, Dr. Cutrell said during a presentation at the 2022 annual Internal Medicine Meeting of the American College of Physicians.
“About 10% of adult visits and 20% of pediatric visits will result in an antibiotic prescription,” said Dr. Cutrell, noting that prescribing patterns vary widely across the country, with as much as a three-fold difference in some locations. But at least 30% of outpatient antibiotic prescriptions are inappropriately ordered, he said.
“When we look at acute respiratory infections, upwards of 50% are not indicated at all,” he said. Imagine, he added, if the same error rate applied to other medical practices: “What if surgeons were only right 50% of the time, or if the oncologist was only giving the right treatment 50% of the time?”
The most recent Antibiotic Threats Report from the U.S. Centers for Disease Control and Prevention estimated that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and about 36,000 deaths annually in the United States alone.
How to be a better steward
The core elements for antimicrobial stewardship in the outpatient setting, according to Dr. Cutrell, include making a commitment to optimize prescribing, implementing at least one policy or practice to improve prescribing, monitoring prescribing practices and offering feedback to clinicians, and educating both patients and clinicians.
All that is similar to in-patient stewardship, he said, but outpatient clinicians face a few unique challenges. “Patients are lower acuity, and there is less diagnostic data, and program resources and time are more limited,” he said. Patient satisfaction is also a major driver, and it is also more difficult to measure and track ambulatory antibiotic use.
Interventions have been identified, however, that can help improve stewardship. One is auditing and feedback with peers. “Another [is] commitment posters, which can be placed around the clinic, and that helps set the culture,” he said. “Clinical education and practice guidelines are also important.”
Clinicians should also:
- Observe antibiotic best practices
- Optimize antibiotic selection and dosing
- Practice effective diagnostic stewardship
- Use the shortest duration of therapy necessary
- Avoid antibiotics for inappropriate indications
- Educate patients on when antibiotics are needed
- Follow and become good antibiotic stewardship mentors
“Multiple antibiotic stewardship interventions are effective, particularly those focused on behavioral interventions,” Dr. Cutrell said. “Every provider should follow antibiotic ‘best practices’ and other simple steps to prescribe antibiotics more wisely and to improve patient care.”
Dr. Cutrell reported financial relationships with Gilead Sciences and Regeneron Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Is fear of missing an infection – call it “FOMI” – leading you to overprescribe antibiotics to your patients?
Inappropriate use of antibiotics can result in adverse events and toxicity, superinfections such as Clostridioides difficile and Methicillin-resistant Staphylococcus aureus, excess mortality and costs, and resistance to the drugs.
All that has been well-known for years, and antibiotic resistance has become a leading public health concern. So why are physicians continuing to overprescribe the drugs?
Speaking at the 2022 annual Internal Medicine Meeting of the American College of Physicians, James “Brad” Cutrell, MD, medical director of antimicrobial stewardship, University of Texas Southwestern Medical Center, Dallas, said clinicians in the United States and elsewhere appear to be falling into a three-part fallacy when it comes to using the drugs: fear of “missing an infection,” coupled with patient expectations that they will leave the office with a prescription and combined with an overemphasis on the potential benefit to the individual at the expense of the risk to society of antibiotic resistance.
Antibiotics are the only drugs that lose their efficacy for all patients over time the more they are used. “For example, if I give a beta blocker to a patient, it’s not going to affect other patients down the road,” Dr. Cutrell said. “It’s not going to lose its efficacy.”
“What we need in medicine is a new culture around antibiotic use,” Dr. Cutrell added. “We need more respect for the dangers of antibiotic misuse and to have confidence in [their] benefits and when they can be used wisely.”
Rampant misuse
Outpatient prescriptions account for at least 60% of antibiotic use in the United States. The rate is even higher in other countries, Dr. Cutrell said during a presentation at the 2022 annual Internal Medicine Meeting of the American College of Physicians.
“About 10% of adult visits and 20% of pediatric visits will result in an antibiotic prescription,” said Dr. Cutrell, noting that prescribing patterns vary widely across the country, with as much as a three-fold difference in some locations. But at least 30% of outpatient antibiotic prescriptions are inappropriately ordered, he said.
“When we look at acute respiratory infections, upwards of 50% are not indicated at all,” he said. Imagine, he added, if the same error rate applied to other medical practices: “What if surgeons were only right 50% of the time, or if the oncologist was only giving the right treatment 50% of the time?”
The most recent Antibiotic Threats Report from the U.S. Centers for Disease Control and Prevention estimated that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and about 36,000 deaths annually in the United States alone.
How to be a better steward
The core elements for antimicrobial stewardship in the outpatient setting, according to Dr. Cutrell, include making a commitment to optimize prescribing, implementing at least one policy or practice to improve prescribing, monitoring prescribing practices and offering feedback to clinicians, and educating both patients and clinicians.
All that is similar to in-patient stewardship, he said, but outpatient clinicians face a few unique challenges. “Patients are lower acuity, and there is less diagnostic data, and program resources and time are more limited,” he said. Patient satisfaction is also a major driver, and it is also more difficult to measure and track ambulatory antibiotic use.
Interventions have been identified, however, that can help improve stewardship. One is auditing and feedback with peers. “Another [is] commitment posters, which can be placed around the clinic, and that helps set the culture,” he said. “Clinical education and practice guidelines are also important.”
Clinicians should also:
- Observe antibiotic best practices
- Optimize antibiotic selection and dosing
- Practice effective diagnostic stewardship
- Use the shortest duration of therapy necessary
- Avoid antibiotics for inappropriate indications
- Educate patients on when antibiotics are needed
- Follow and become good antibiotic stewardship mentors
“Multiple antibiotic stewardship interventions are effective, particularly those focused on behavioral interventions,” Dr. Cutrell said. “Every provider should follow antibiotic ‘best practices’ and other simple steps to prescribe antibiotics more wisely and to improve patient care.”
Dr. Cutrell reported financial relationships with Gilead Sciences and Regeneron Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Is fear of missing an infection – call it “FOMI” – leading you to overprescribe antibiotics to your patients?
Inappropriate use of antibiotics can result in adverse events and toxicity, superinfections such as Clostridioides difficile and Methicillin-resistant Staphylococcus aureus, excess mortality and costs, and resistance to the drugs.
All that has been well-known for years, and antibiotic resistance has become a leading public health concern. So why are physicians continuing to overprescribe the drugs?
Speaking at the 2022 annual Internal Medicine Meeting of the American College of Physicians, James “Brad” Cutrell, MD, medical director of antimicrobial stewardship, University of Texas Southwestern Medical Center, Dallas, said clinicians in the United States and elsewhere appear to be falling into a three-part fallacy when it comes to using the drugs: fear of “missing an infection,” coupled with patient expectations that they will leave the office with a prescription and combined with an overemphasis on the potential benefit to the individual at the expense of the risk to society of antibiotic resistance.
Antibiotics are the only drugs that lose their efficacy for all patients over time the more they are used. “For example, if I give a beta blocker to a patient, it’s not going to affect other patients down the road,” Dr. Cutrell said. “It’s not going to lose its efficacy.”
“What we need in medicine is a new culture around antibiotic use,” Dr. Cutrell added. “We need more respect for the dangers of antibiotic misuse and to have confidence in [their] benefits and when they can be used wisely.”
Rampant misuse
Outpatient prescriptions account for at least 60% of antibiotic use in the United States. The rate is even higher in other countries, Dr. Cutrell said during a presentation at the 2022 annual Internal Medicine Meeting of the American College of Physicians.
“About 10% of adult visits and 20% of pediatric visits will result in an antibiotic prescription,” said Dr. Cutrell, noting that prescribing patterns vary widely across the country, with as much as a three-fold difference in some locations. But at least 30% of outpatient antibiotic prescriptions are inappropriately ordered, he said.
“When we look at acute respiratory infections, upwards of 50% are not indicated at all,” he said. Imagine, he added, if the same error rate applied to other medical practices: “What if surgeons were only right 50% of the time, or if the oncologist was only giving the right treatment 50% of the time?”
The most recent Antibiotic Threats Report from the U.S. Centers for Disease Control and Prevention estimated that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and about 36,000 deaths annually in the United States alone.
How to be a better steward
The core elements for antimicrobial stewardship in the outpatient setting, according to Dr. Cutrell, include making a commitment to optimize prescribing, implementing at least one policy or practice to improve prescribing, monitoring prescribing practices and offering feedback to clinicians, and educating both patients and clinicians.
All that is similar to in-patient stewardship, he said, but outpatient clinicians face a few unique challenges. “Patients are lower acuity, and there is less diagnostic data, and program resources and time are more limited,” he said. Patient satisfaction is also a major driver, and it is also more difficult to measure and track ambulatory antibiotic use.
Interventions have been identified, however, that can help improve stewardship. One is auditing and feedback with peers. “Another [is] commitment posters, which can be placed around the clinic, and that helps set the culture,” he said. “Clinical education and practice guidelines are also important.”
Clinicians should also:
- Observe antibiotic best practices
- Optimize antibiotic selection and dosing
- Practice effective diagnostic stewardship
- Use the shortest duration of therapy necessary
- Avoid antibiotics for inappropriate indications
- Educate patients on when antibiotics are needed
- Follow and become good antibiotic stewardship mentors
“Multiple antibiotic stewardship interventions are effective, particularly those focused on behavioral interventions,” Dr. Cutrell said. “Every provider should follow antibiotic ‘best practices’ and other simple steps to prescribe antibiotics more wisely and to improve patient care.”
Dr. Cutrell reported financial relationships with Gilead Sciences and Regeneron Pharmaceuticals.
A version of this article first appeared on Medscape.com.
FROM INTERNAL MEDICINE 2022
Treating frail patients requires ‘precision gerontology’
An estimated 15% of Americans over age 65 years who aren’t living in institutions are considered frail – a complex geriatric syndrome that raises the odds of disability, hospitalization, the need for nursing care, and death.
But while the word frailty may conjure images of wizened and weakened men and women, the clinical picture is far less clear.
“We’ve made a lot of progress in some ways, but still a lot of work to be done in others,” George A. Kuchel, MD, CM, the chair in geriatrics and gerontology and director of the UConn Center on Aging in Farmington, Conn., said at the annual meeting of the American College of Physicians.
“You have to be very careful about generalizations,” Dr. Kuchel said. “This is very important when you are thinking about managing it.”
One of the key take-home messages, Dr. Kuchel said, “and one of the first things I learned as a geriatrics fellow, is that when you have seen one older person, all you have seen is one older person.”
The second major take-home is that frailty is multifactorial – a critical consideration when it comes to managing elderly patients.
“Unlike other conditions, there is no single medication, there is no one single thing you can do – it is really multifactorial,” he said. “What it means is to match the components to target unique needs, and that is something that we are calling ‘precision gerontology,’ as opposed to precision medicine.”
The definitions of frailty vary but can involve increased vulnerability; enhanced risk of declining function, disability, and death; and a decline in functioning across multiple physiologic systems, accompanied by an increased vulnerability to stressors.
Key features that clinicians should emphasize include multifactorial etiology with each risk factor contributing only modestly:
- Multidimensional nature, with physical and psychosocial factors playing a part.
- Frailty represents an extreme consequence of the normal aging process.
- The process is dynamic, and individuals can fluctuate between frailty states.
Diagnosing frailty
Diagnosing frailty in the average clinical setting can be a challenge. Unlike other disorders, no single test or assessment tool exists for the condition. Most settings or patients, for example, do not even have the device to measure hand grip strength, Dr. Kuchel said. Other obstacles include a lack of time and reimbursement.
However, clinicians can quickly and easily assess patients for several warning signs, including the presence of multimorbidity (>5 diseases), slow walking speed (<1 m/sec), inability to climb a flight of stairs, and/or walk a block or rise from chair five times with arms folded.
“These are simple questions that can be asked by a medical assistant or even over the phone ahead of time,” he said.
Frailty and sarcopenia are closely linked but are not equivalent. As a result, dual-energy x-ray absorptiometry (DXA), which can measure both bone mineral density and muscle mass, is not a good assessment of frailty because muscle mass by itself is not necessarily tied to weakness. Instead, Dr. Kuchel said, measuring muscle function and quality is much more effective at identifying frail patients.
“Gait velocity is potentially the greatest single measure, and if there is one thing you should do with your patient, it is to check gait velocity,” Dr. Kuchel said. Researchers at his facility are working on radio technology identification-based device that allows for measuring gait when a patient walks down the hallway.
“Measuring gait should be the sixth vital sign, and you need to have that information in front of you when working with older patients,” he said. “We are working on integrating it into our system.”
Managing frailty
Although no single intervention for frailty exists, physical activity has been shown to delay its onset. Still, Dr. Kuchel said, clinicians can try a range of approaches, both biologic and social, to address the condition.
Assessing for and treating depression, for example, may help reduce frailty fatigue, as can stopping medications – including benzodiazepines, and corticosteroids – that might be worsening the condition. Another step is to check for low vitamin D levels and hypothyroidism, he said.
Some patients have unexplained anemia that could be corrected, as well as correcting basal and orthostatic hypotension, which can arise from overtreatment, Dr. Kuchel added.
People with HIV can experience accelerated aging, as can adults who were treated with chemotherapy and radiation as children. “We are also beginning to see some of this with long COVID, so there seems to be some overlap,” he said.
Finally, socioeconomic considerations include the possibility of elder neglect and/or abuse, and the effects of poverty on nutrition and the ability to pay for needed medications.
The bottom line, Dr. Kuchel said, is that managing frailty is possible, but doing so effectively may require stops and starts.
“Correct what is correctable, such as nutrition, vitamin D, depression, and stopping offending meds,” he said. “Match multicomponent interventions with deficits and interventions targeting health care systems will include better care coordination. A comprehensive geriatric assessment is important in the care of this geriatric syndrome.
Dr. Kuchel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An estimated 15% of Americans over age 65 years who aren’t living in institutions are considered frail – a complex geriatric syndrome that raises the odds of disability, hospitalization, the need for nursing care, and death.
But while the word frailty may conjure images of wizened and weakened men and women, the clinical picture is far less clear.
“We’ve made a lot of progress in some ways, but still a lot of work to be done in others,” George A. Kuchel, MD, CM, the chair in geriatrics and gerontology and director of the UConn Center on Aging in Farmington, Conn., said at the annual meeting of the American College of Physicians.
“You have to be very careful about generalizations,” Dr. Kuchel said. “This is very important when you are thinking about managing it.”
One of the key take-home messages, Dr. Kuchel said, “and one of the first things I learned as a geriatrics fellow, is that when you have seen one older person, all you have seen is one older person.”
The second major take-home is that frailty is multifactorial – a critical consideration when it comes to managing elderly patients.
“Unlike other conditions, there is no single medication, there is no one single thing you can do – it is really multifactorial,” he said. “What it means is to match the components to target unique needs, and that is something that we are calling ‘precision gerontology,’ as opposed to precision medicine.”
The definitions of frailty vary but can involve increased vulnerability; enhanced risk of declining function, disability, and death; and a decline in functioning across multiple physiologic systems, accompanied by an increased vulnerability to stressors.
Key features that clinicians should emphasize include multifactorial etiology with each risk factor contributing only modestly:
- Multidimensional nature, with physical and psychosocial factors playing a part.
- Frailty represents an extreme consequence of the normal aging process.
- The process is dynamic, and individuals can fluctuate between frailty states.
Diagnosing frailty
Diagnosing frailty in the average clinical setting can be a challenge. Unlike other disorders, no single test or assessment tool exists for the condition. Most settings or patients, for example, do not even have the device to measure hand grip strength, Dr. Kuchel said. Other obstacles include a lack of time and reimbursement.
However, clinicians can quickly and easily assess patients for several warning signs, including the presence of multimorbidity (>5 diseases), slow walking speed (<1 m/sec), inability to climb a flight of stairs, and/or walk a block or rise from chair five times with arms folded.
“These are simple questions that can be asked by a medical assistant or even over the phone ahead of time,” he said.
Frailty and sarcopenia are closely linked but are not equivalent. As a result, dual-energy x-ray absorptiometry (DXA), which can measure both bone mineral density and muscle mass, is not a good assessment of frailty because muscle mass by itself is not necessarily tied to weakness. Instead, Dr. Kuchel said, measuring muscle function and quality is much more effective at identifying frail patients.
“Gait velocity is potentially the greatest single measure, and if there is one thing you should do with your patient, it is to check gait velocity,” Dr. Kuchel said. Researchers at his facility are working on radio technology identification-based device that allows for measuring gait when a patient walks down the hallway.
“Measuring gait should be the sixth vital sign, and you need to have that information in front of you when working with older patients,” he said. “We are working on integrating it into our system.”
Managing frailty
Although no single intervention for frailty exists, physical activity has been shown to delay its onset. Still, Dr. Kuchel said, clinicians can try a range of approaches, both biologic and social, to address the condition.
Assessing for and treating depression, for example, may help reduce frailty fatigue, as can stopping medications – including benzodiazepines, and corticosteroids – that might be worsening the condition. Another step is to check for low vitamin D levels and hypothyroidism, he said.
Some patients have unexplained anemia that could be corrected, as well as correcting basal and orthostatic hypotension, which can arise from overtreatment, Dr. Kuchel added.
People with HIV can experience accelerated aging, as can adults who were treated with chemotherapy and radiation as children. “We are also beginning to see some of this with long COVID, so there seems to be some overlap,” he said.
Finally, socioeconomic considerations include the possibility of elder neglect and/or abuse, and the effects of poverty on nutrition and the ability to pay for needed medications.
The bottom line, Dr. Kuchel said, is that managing frailty is possible, but doing so effectively may require stops and starts.
“Correct what is correctable, such as nutrition, vitamin D, depression, and stopping offending meds,” he said. “Match multicomponent interventions with deficits and interventions targeting health care systems will include better care coordination. A comprehensive geriatric assessment is important in the care of this geriatric syndrome.
Dr. Kuchel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An estimated 15% of Americans over age 65 years who aren’t living in institutions are considered frail – a complex geriatric syndrome that raises the odds of disability, hospitalization, the need for nursing care, and death.
But while the word frailty may conjure images of wizened and weakened men and women, the clinical picture is far less clear.
“We’ve made a lot of progress in some ways, but still a lot of work to be done in others,” George A. Kuchel, MD, CM, the chair in geriatrics and gerontology and director of the UConn Center on Aging in Farmington, Conn., said at the annual meeting of the American College of Physicians.
“You have to be very careful about generalizations,” Dr. Kuchel said. “This is very important when you are thinking about managing it.”
One of the key take-home messages, Dr. Kuchel said, “and one of the first things I learned as a geriatrics fellow, is that when you have seen one older person, all you have seen is one older person.”
The second major take-home is that frailty is multifactorial – a critical consideration when it comes to managing elderly patients.
“Unlike other conditions, there is no single medication, there is no one single thing you can do – it is really multifactorial,” he said. “What it means is to match the components to target unique needs, and that is something that we are calling ‘precision gerontology,’ as opposed to precision medicine.”
The definitions of frailty vary but can involve increased vulnerability; enhanced risk of declining function, disability, and death; and a decline in functioning across multiple physiologic systems, accompanied by an increased vulnerability to stressors.
Key features that clinicians should emphasize include multifactorial etiology with each risk factor contributing only modestly:
- Multidimensional nature, with physical and psychosocial factors playing a part.
- Frailty represents an extreme consequence of the normal aging process.
- The process is dynamic, and individuals can fluctuate between frailty states.
Diagnosing frailty
Diagnosing frailty in the average clinical setting can be a challenge. Unlike other disorders, no single test or assessment tool exists for the condition. Most settings or patients, for example, do not even have the device to measure hand grip strength, Dr. Kuchel said. Other obstacles include a lack of time and reimbursement.
However, clinicians can quickly and easily assess patients for several warning signs, including the presence of multimorbidity (>5 diseases), slow walking speed (<1 m/sec), inability to climb a flight of stairs, and/or walk a block or rise from chair five times with arms folded.
“These are simple questions that can be asked by a medical assistant or even over the phone ahead of time,” he said.
Frailty and sarcopenia are closely linked but are not equivalent. As a result, dual-energy x-ray absorptiometry (DXA), which can measure both bone mineral density and muscle mass, is not a good assessment of frailty because muscle mass by itself is not necessarily tied to weakness. Instead, Dr. Kuchel said, measuring muscle function and quality is much more effective at identifying frail patients.
“Gait velocity is potentially the greatest single measure, and if there is one thing you should do with your patient, it is to check gait velocity,” Dr. Kuchel said. Researchers at his facility are working on radio technology identification-based device that allows for measuring gait when a patient walks down the hallway.
“Measuring gait should be the sixth vital sign, and you need to have that information in front of you when working with older patients,” he said. “We are working on integrating it into our system.”
Managing frailty
Although no single intervention for frailty exists, physical activity has been shown to delay its onset. Still, Dr. Kuchel said, clinicians can try a range of approaches, both biologic and social, to address the condition.
Assessing for and treating depression, for example, may help reduce frailty fatigue, as can stopping medications – including benzodiazepines, and corticosteroids – that might be worsening the condition. Another step is to check for low vitamin D levels and hypothyroidism, he said.
Some patients have unexplained anemia that could be corrected, as well as correcting basal and orthostatic hypotension, which can arise from overtreatment, Dr. Kuchel added.
People with HIV can experience accelerated aging, as can adults who were treated with chemotherapy and radiation as children. “We are also beginning to see some of this with long COVID, so there seems to be some overlap,” he said.
Finally, socioeconomic considerations include the possibility of elder neglect and/or abuse, and the effects of poverty on nutrition and the ability to pay for needed medications.
The bottom line, Dr. Kuchel said, is that managing frailty is possible, but doing so effectively may require stops and starts.
“Correct what is correctable, such as nutrition, vitamin D, depression, and stopping offending meds,” he said. “Match multicomponent interventions with deficits and interventions targeting health care systems will include better care coordination. A comprehensive geriatric assessment is important in the care of this geriatric syndrome.
Dr. Kuchel has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM INTERNAL MEDICINE 2022
EU approves new blood and lung cancer drugs
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the two products at its April meeting.
New drug for certain lung cancer patients
Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and is indicated for the treatment of patients with advanced NSCLC harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping. Patients must have already been treated with immunotherapy and/or platinum-based chemotherapy.
The product is approved in the United States, and the Food and Drug Administration noted that it is the first approved treatment for NSCLC with MET exon 14-skipping mutations.
The FDA granted the drug an accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, which included a cohort of previously treated and treatment-naive patients. The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months.
The most common side effects were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
Conditional approval for lymphoma
Mosunetuzumab is an investigational bispecific antibody targeting CD20 and CD3, and redirects T cells to engage and eliminate malignant B cells.
The CHMP recommended a conditional approval for this drug for use as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
Mosunetuzumab was reviewed under EMA’s accelerated access program, which usually takes 150 evaluation days as opposed to 210, and it was designated as an orphan medicine during its development.
The EMA stated that the benefits of this product are the high proportion of patients with a complete response and the durability of the treatment response.
As previously reported by this news organization, results from a phase 2 expansion study showed that when used as monotherapy, it induced high response rates and long-duration responses in patients with heavily pretreated, relapsed, or refractory follicular lymphoma.
At a median follow-up of 18.3 months, 54 of 90 patients (60%) had a complete response, and 18 (20%) had a partial response after treatment with mosunetuzumab.
The most common reported side effects were cytokine release syndrome, neutropenia, pyrexia (fever), hypophosphatemia, and headache.
Mosunetuzumab is awaiting FDA approval in the United States.
A conditional marketing authorization from CHMP is granted to products that meet an unmet medical need, and when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorization holder is expected to provide comprehensive clinical data at a later stage.
Detailed recommendations for the use of both products will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.
A version of this article first appeared on Medscape.com.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the two products at its April meeting.
New drug for certain lung cancer patients
Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and is indicated for the treatment of patients with advanced NSCLC harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping. Patients must have already been treated with immunotherapy and/or platinum-based chemotherapy.
The product is approved in the United States, and the Food and Drug Administration noted that it is the first approved treatment for NSCLC with MET exon 14-skipping mutations.
The FDA granted the drug an accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, which included a cohort of previously treated and treatment-naive patients. The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months.
The most common side effects were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
Conditional approval for lymphoma
Mosunetuzumab is an investigational bispecific antibody targeting CD20 and CD3, and redirects T cells to engage and eliminate malignant B cells.
The CHMP recommended a conditional approval for this drug for use as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
Mosunetuzumab was reviewed under EMA’s accelerated access program, which usually takes 150 evaluation days as opposed to 210, and it was designated as an orphan medicine during its development.
The EMA stated that the benefits of this product are the high proportion of patients with a complete response and the durability of the treatment response.
As previously reported by this news organization, results from a phase 2 expansion study showed that when used as monotherapy, it induced high response rates and long-duration responses in patients with heavily pretreated, relapsed, or refractory follicular lymphoma.
At a median follow-up of 18.3 months, 54 of 90 patients (60%) had a complete response, and 18 (20%) had a partial response after treatment with mosunetuzumab.
The most common reported side effects were cytokine release syndrome, neutropenia, pyrexia (fever), hypophosphatemia, and headache.
Mosunetuzumab is awaiting FDA approval in the United States.
A conditional marketing authorization from CHMP is granted to products that meet an unmet medical need, and when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorization holder is expected to provide comprehensive clinical data at a later stage.
Detailed recommendations for the use of both products will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.
A version of this article first appeared on Medscape.com.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the two products at its April meeting.
New drug for certain lung cancer patients
Capmatinib is a selective, reversible inhibitor of MET tyrosine kinase and is indicated for the treatment of patients with advanced NSCLC harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping. Patients must have already been treated with immunotherapy and/or platinum-based chemotherapy.
The product is approved in the United States, and the Food and Drug Administration noted that it is the first approved treatment for NSCLC with MET exon 14-skipping mutations.
The FDA granted the drug an accelerated approval based on overall response rate and response duration in the GEOMETRY mono-1 trial, which included a cohort of previously treated and treatment-naive patients. The overall response rate was 68% in the treatment-naive patients and 41% in the previously treated patients. The median duration of response was 12.6 months and 9.7 months.
The most common side effects were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
Conditional approval for lymphoma
Mosunetuzumab is an investigational bispecific antibody targeting CD20 and CD3, and redirects T cells to engage and eliminate malignant B cells.
The CHMP recommended a conditional approval for this drug for use as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
Mosunetuzumab was reviewed under EMA’s accelerated access program, which usually takes 150 evaluation days as opposed to 210, and it was designated as an orphan medicine during its development.
The EMA stated that the benefits of this product are the high proportion of patients with a complete response and the durability of the treatment response.
As previously reported by this news organization, results from a phase 2 expansion study showed that when used as monotherapy, it induced high response rates and long-duration responses in patients with heavily pretreated, relapsed, or refractory follicular lymphoma.
At a median follow-up of 18.3 months, 54 of 90 patients (60%) had a complete response, and 18 (20%) had a partial response after treatment with mosunetuzumab.
The most common reported side effects were cytokine release syndrome, neutropenia, pyrexia (fever), hypophosphatemia, and headache.
Mosunetuzumab is awaiting FDA approval in the United States.
A conditional marketing authorization from CHMP is granted to products that meet an unmet medical need, and when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorization holder is expected to provide comprehensive clinical data at a later stage.
Detailed recommendations for the use of both products will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.
A version of this article first appeared on Medscape.com.
Which breast cancer surgery leads to better quality of life?
Women diagnosed with early breast cancer facing surgery often have a choice of having all of their breast or only a part of the breast removed.
A new study shows that a patient’s satisfaction with their breasts at 10 years after surgery is similar for both groups of women.
However, superior psychosocial and sexual well-being at 10 years after surgery was reported by women who underwent breast-conserving surgery and adjuvant radiation therapy (RT), compared with those who underwent mastectomy and reconstruction.
“These findings may inform preference-sensitive decision-making for women with early-stage breast cancer,” write the authors, led by Benjamin D. Smith, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.
The study was published online in JAMA Surgery.
These findings have important implications for patient decision-making, given that more women eligible for breast-conserving surgery are opting for a mastectomy, say Sudheer Vemuru, MD, from the University of Colorado at Denver, Aurora, and colleagues, writing in an accompanying editorial.
“Overall, the preponderance of evidence suggests superior short-term and long-term patient-reported outcomes in patients with early-stage breast cancer undergoing breast conserving surgery compared with mastectomy,” they comment.
Study details
For their study, Dr. Smith and colleagues conducted a comparative effectiveness research study using data from the Texas Cancer Registry and identified women diagnosed with stage 0-II breast cancer and treated with breast-conserving surgery or mastectomy and reconstruction between 2006 and 2008.
A total of 647 patients were included in their analysis (40%; 356 had undergone breast-conserving surgery; 291 had undergone mastectomy and reconstruction), 551 (85.2%) confirmed treatment with breast-conserving surgery with RT (n = 315) or mastectomy and reconstruction without RT (n = 236).
The median age of the cohort was 53 years and the median time from diagnosis to survey was 10.3 years. Mastectomy and reconstruction were more common among women who were White, younger, node positive, had larger tumors, had bilateral breast cancer, received chemotherapy, and had higher income.
The primary outcome was patient satisfaction with their breasts, as measured with the BREAST-Q patient-reported outcome measure. Secondary outcomes included physical well-being, psychosocial well-being, and sexual well-being. The EuroQol Health-Related Quality of Life 5-Dimension, 3-Level gaged health utility, and local therapy decisional regret was measured via the Decisional Regret Scale.
Using breast-conserving surgery plus RT as the referent, the authors did not find any significant differences in breast satisfaction, physical well-being, health utility, or decisional regret among the study cohorts: breast satisfaction: effect size, 2.71 (P = .30); physical well-being: effect size, –1.80 (P = .36); health utility: effect size, –0.003 (P = .83); and decisional regret: effect size, 1.32 (P = .61).
However, psychosocial well-being (effect size, –8.61; P < .001) and sexual well-being (effect size, –10.68; P < .001) were significantly worse among women who had undergone mastectomy and reconstruction without RT.
They noted that interactions of race and ethnicity and age by treatment group were not significant for reported satisfaction with breast outcomes. But the findings “indicated that the burden of poor long-term QOL outcomes was greater among younger individuals, those with lower educational attainment and income, and certain racial and ethnic minority populations,” they write. “These findings suggest that opportunities exist to enhance equity in the long-term QOL of individuals with breast cancer.”
The editorialists note that previous studies have also found diminished quality of life following mastectomy compared with breast-conserving surgery. However, most of these prior studies included patients undergoing breast-conserving surgery without RT, patients undergoing mastectomy without reconstruction, and patients undergoing mastectomy with RT.
In contrast, this latest study “directly compared breast-conserving surgery with RT vs. mastectomy and reconstruction without RT to avoid those potential confounders,” they point out.
The study was supported by grants from the National Cancer Institute and other bodies. Several of the study authors disclosed relationships with industry and/or with nonprofit organizations. The full list can be found with the original article. Editorialist Clara Lee, MD, reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study.
A version of this article first appeared on Medscape.com.
Women diagnosed with early breast cancer facing surgery often have a choice of having all of their breast or only a part of the breast removed.
A new study shows that a patient’s satisfaction with their breasts at 10 years after surgery is similar for both groups of women.
However, superior psychosocial and sexual well-being at 10 years after surgery was reported by women who underwent breast-conserving surgery and adjuvant radiation therapy (RT), compared with those who underwent mastectomy and reconstruction.
“These findings may inform preference-sensitive decision-making for women with early-stage breast cancer,” write the authors, led by Benjamin D. Smith, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.
The study was published online in JAMA Surgery.
These findings have important implications for patient decision-making, given that more women eligible for breast-conserving surgery are opting for a mastectomy, say Sudheer Vemuru, MD, from the University of Colorado at Denver, Aurora, and colleagues, writing in an accompanying editorial.
“Overall, the preponderance of evidence suggests superior short-term and long-term patient-reported outcomes in patients with early-stage breast cancer undergoing breast conserving surgery compared with mastectomy,” they comment.
Study details
For their study, Dr. Smith and colleagues conducted a comparative effectiveness research study using data from the Texas Cancer Registry and identified women diagnosed with stage 0-II breast cancer and treated with breast-conserving surgery or mastectomy and reconstruction between 2006 and 2008.
A total of 647 patients were included in their analysis (40%; 356 had undergone breast-conserving surgery; 291 had undergone mastectomy and reconstruction), 551 (85.2%) confirmed treatment with breast-conserving surgery with RT (n = 315) or mastectomy and reconstruction without RT (n = 236).
The median age of the cohort was 53 years and the median time from diagnosis to survey was 10.3 years. Mastectomy and reconstruction were more common among women who were White, younger, node positive, had larger tumors, had bilateral breast cancer, received chemotherapy, and had higher income.
The primary outcome was patient satisfaction with their breasts, as measured with the BREAST-Q patient-reported outcome measure. Secondary outcomes included physical well-being, psychosocial well-being, and sexual well-being. The EuroQol Health-Related Quality of Life 5-Dimension, 3-Level gaged health utility, and local therapy decisional regret was measured via the Decisional Regret Scale.
Using breast-conserving surgery plus RT as the referent, the authors did not find any significant differences in breast satisfaction, physical well-being, health utility, or decisional regret among the study cohorts: breast satisfaction: effect size, 2.71 (P = .30); physical well-being: effect size, –1.80 (P = .36); health utility: effect size, –0.003 (P = .83); and decisional regret: effect size, 1.32 (P = .61).
However, psychosocial well-being (effect size, –8.61; P < .001) and sexual well-being (effect size, –10.68; P < .001) were significantly worse among women who had undergone mastectomy and reconstruction without RT.
They noted that interactions of race and ethnicity and age by treatment group were not significant for reported satisfaction with breast outcomes. But the findings “indicated that the burden of poor long-term QOL outcomes was greater among younger individuals, those with lower educational attainment and income, and certain racial and ethnic minority populations,” they write. “These findings suggest that opportunities exist to enhance equity in the long-term QOL of individuals with breast cancer.”
The editorialists note that previous studies have also found diminished quality of life following mastectomy compared with breast-conserving surgery. However, most of these prior studies included patients undergoing breast-conserving surgery without RT, patients undergoing mastectomy without reconstruction, and patients undergoing mastectomy with RT.
In contrast, this latest study “directly compared breast-conserving surgery with RT vs. mastectomy and reconstruction without RT to avoid those potential confounders,” they point out.
The study was supported by grants from the National Cancer Institute and other bodies. Several of the study authors disclosed relationships with industry and/or with nonprofit organizations. The full list can be found with the original article. Editorialist Clara Lee, MD, reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study.
A version of this article first appeared on Medscape.com.
Women diagnosed with early breast cancer facing surgery often have a choice of having all of their breast or only a part of the breast removed.
A new study shows that a patient’s satisfaction with their breasts at 10 years after surgery is similar for both groups of women.
However, superior psychosocial and sexual well-being at 10 years after surgery was reported by women who underwent breast-conserving surgery and adjuvant radiation therapy (RT), compared with those who underwent mastectomy and reconstruction.
“These findings may inform preference-sensitive decision-making for women with early-stage breast cancer,” write the authors, led by Benjamin D. Smith, MD, department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston.
The study was published online in JAMA Surgery.
These findings have important implications for patient decision-making, given that more women eligible for breast-conserving surgery are opting for a mastectomy, say Sudheer Vemuru, MD, from the University of Colorado at Denver, Aurora, and colleagues, writing in an accompanying editorial.
“Overall, the preponderance of evidence suggests superior short-term and long-term patient-reported outcomes in patients with early-stage breast cancer undergoing breast conserving surgery compared with mastectomy,” they comment.
Study details
For their study, Dr. Smith and colleagues conducted a comparative effectiveness research study using data from the Texas Cancer Registry and identified women diagnosed with stage 0-II breast cancer and treated with breast-conserving surgery or mastectomy and reconstruction between 2006 and 2008.
A total of 647 patients were included in their analysis (40%; 356 had undergone breast-conserving surgery; 291 had undergone mastectomy and reconstruction), 551 (85.2%) confirmed treatment with breast-conserving surgery with RT (n = 315) or mastectomy and reconstruction without RT (n = 236).
The median age of the cohort was 53 years and the median time from diagnosis to survey was 10.3 years. Mastectomy and reconstruction were more common among women who were White, younger, node positive, had larger tumors, had bilateral breast cancer, received chemotherapy, and had higher income.
The primary outcome was patient satisfaction with their breasts, as measured with the BREAST-Q patient-reported outcome measure. Secondary outcomes included physical well-being, psychosocial well-being, and sexual well-being. The EuroQol Health-Related Quality of Life 5-Dimension, 3-Level gaged health utility, and local therapy decisional regret was measured via the Decisional Regret Scale.
Using breast-conserving surgery plus RT as the referent, the authors did not find any significant differences in breast satisfaction, physical well-being, health utility, or decisional regret among the study cohorts: breast satisfaction: effect size, 2.71 (P = .30); physical well-being: effect size, –1.80 (P = .36); health utility: effect size, –0.003 (P = .83); and decisional regret: effect size, 1.32 (P = .61).
However, psychosocial well-being (effect size, –8.61; P < .001) and sexual well-being (effect size, –10.68; P < .001) were significantly worse among women who had undergone mastectomy and reconstruction without RT.
They noted that interactions of race and ethnicity and age by treatment group were not significant for reported satisfaction with breast outcomes. But the findings “indicated that the burden of poor long-term QOL outcomes was greater among younger individuals, those with lower educational attainment and income, and certain racial and ethnic minority populations,” they write. “These findings suggest that opportunities exist to enhance equity in the long-term QOL of individuals with breast cancer.”
The editorialists note that previous studies have also found diminished quality of life following mastectomy compared with breast-conserving surgery. However, most of these prior studies included patients undergoing breast-conserving surgery without RT, patients undergoing mastectomy without reconstruction, and patients undergoing mastectomy with RT.
In contrast, this latest study “directly compared breast-conserving surgery with RT vs. mastectomy and reconstruction without RT to avoid those potential confounders,” they point out.
The study was supported by grants from the National Cancer Institute and other bodies. Several of the study authors disclosed relationships with industry and/or with nonprofit organizations. The full list can be found with the original article. Editorialist Clara Lee, MD, reported receiving grants from the Agency for Healthcare Research and Quality during the conduct of the study.
A version of this article first appeared on Medscape.com.
FROM JAMA SURGERY
Overuse of surveillance in bladder cancer, despite guidelines
(NMIBC), a new study concludes.
These cancers are associated with low rates of recurrence, progression, and bladder cancer–specific death, so current clinical practice guidelines recommend against frequent monitoring and testing.
However, the study authors found that patients with a low grade Ta NMIBC diagnosis underwent a median of three cystoscopies per year, and many also received a median of two imagine scans (CT or MRI) as well as 2-3 urine-based tests.
“These data suggest a need for ongoing efforts to limit overuse of treatment and surveillance, which may in turn mitigate associated increases in the costs of care,” write the authors, led by Kelly K. Bree, MD, from the department of urology, University of Texas MD Anderson Cancer Center, Houston. Bladder cancer has the highest lifetime treatment cost of all malignancies, they point out.
The study was published online in JAMA Network Open.
Higher value and more evidence-based
The impact of increased surveillance of this patient cohort has broad implications for patients and the health care system in general, say experts writing in an accompanying editorial.
“It has been well established that workup for NMIBC can have negative consequences for the physical and psychological health of patients,” note Grayden S. Cook, BS, and Jeffrey M. Howard, MD, PhD, both from University of Texas Southwestern Medical Center, Dallas.
“Many of these patients undergo frequent CT imaging of the urinary tract, which carries a high dose of radiation as well as the potential for financial toxic effects (that is, detrimental consequences to the patient because of health care costs),” they write.
Additionally, patient distress is a factor, as they may experience preprocedural anxiety, physical discomfort during procedures, and worry about disease progression, they point out.
“The impact of these patterns is substantial and may have negative consequences for both patients and the health care system,” they conclude. “Thus, it is imperative to move forward with initiatives that provide higher value and are more evidence-based and patient-centered.”
Study finds frequent surveillance
The American Urological Association (AUA)/Society of Urologic Oncologists (SUO), the European Association of Urology, and the International Bladder Cancer Group have made an effort to de-escalate surveillance and treatment for patients with low-grade Ta disease, while at the same time maintaining appropriate surveillance for high-grade aggressive disease.
However, the new study found that in practice, such patients undergo frequent testing.
The study involved 13,054 patients with low-grade Ta NMIBC. Most of the participants were male (73.5%), with a median age of 76 years, and had no or few comorbidities (71.2%).
Most patients had undergone cystoscopy, and rates increased over time: from 79.3% of patients in 2004 to 81.5% of patients in 2013 (P = .007). Patients underwent a median of 3.0 cystoscopies per year following their diagnosis, and upper-tract imaging was performed in most patients.
The use of kidney ultrasonography also rose from 19% of patients in 2004 to 23.2% in 2013, as did retrograde pyelography (20.9% in 2004 vs. 24.2% in 2013). Conversely, the use of intravenous pyelography declined (from 14.5% in 2004 to 1.7% in 2012), but there was an increase in CT and MRI in all years except 2010 (from 30.4% of patients in 2004 to 47% of patients in 2013; P < .001). The rate of urine-based testing also significantly increased during the study period (from 44.8% in 2004 to 54.9% in 2013; P < .001), with patients undergoing between two to three tests per year.
Adherence to current guidelines remained similar during the study time frame. For example, 55.2% of patients received two cystoscopies per year in 2004-2008, compared with 53.8% in 2009-2013 (P = .11), suggesting that there was an overuse of all surveillance testing modalities.
As for treatment, 17.2% received intravesical immunotherapy with bacillus Calmette-Guérin, 6.1% were treated with intravesical chemotherapy (excluding receipt of a single perioperative dose). Disease recurrence within this cohort was 1.7%, and only 0.4% experienced disease progression.
When looking at the cost, the total median expenditures at 1 year after diagnosis increased by 60% during the study period, from $34,792 in 2004 to $53,986 in 2013. Higher costs were seen among patients who experienced a recurrence versus no recurrence ($76,669 vs. $53,909).
The study was supported by a grant from the U.S. Department of Defense Peer Reviewed Cancer Research Program. Several of the authors have disclosed relationships with industry, as noted in the original article. Editorialists Mr. Cook and Dr. Howard have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
(NMIBC), a new study concludes.
These cancers are associated with low rates of recurrence, progression, and bladder cancer–specific death, so current clinical practice guidelines recommend against frequent monitoring and testing.
However, the study authors found that patients with a low grade Ta NMIBC diagnosis underwent a median of three cystoscopies per year, and many also received a median of two imagine scans (CT or MRI) as well as 2-3 urine-based tests.
“These data suggest a need for ongoing efforts to limit overuse of treatment and surveillance, which may in turn mitigate associated increases in the costs of care,” write the authors, led by Kelly K. Bree, MD, from the department of urology, University of Texas MD Anderson Cancer Center, Houston. Bladder cancer has the highest lifetime treatment cost of all malignancies, they point out.
The study was published online in JAMA Network Open.
Higher value and more evidence-based
The impact of increased surveillance of this patient cohort has broad implications for patients and the health care system in general, say experts writing in an accompanying editorial.
“It has been well established that workup for NMIBC can have negative consequences for the physical and psychological health of patients,” note Grayden S. Cook, BS, and Jeffrey M. Howard, MD, PhD, both from University of Texas Southwestern Medical Center, Dallas.
“Many of these patients undergo frequent CT imaging of the urinary tract, which carries a high dose of radiation as well as the potential for financial toxic effects (that is, detrimental consequences to the patient because of health care costs),” they write.
Additionally, patient distress is a factor, as they may experience preprocedural anxiety, physical discomfort during procedures, and worry about disease progression, they point out.
“The impact of these patterns is substantial and may have negative consequences for both patients and the health care system,” they conclude. “Thus, it is imperative to move forward with initiatives that provide higher value and are more evidence-based and patient-centered.”
Study finds frequent surveillance
The American Urological Association (AUA)/Society of Urologic Oncologists (SUO), the European Association of Urology, and the International Bladder Cancer Group have made an effort to de-escalate surveillance and treatment for patients with low-grade Ta disease, while at the same time maintaining appropriate surveillance for high-grade aggressive disease.
However, the new study found that in practice, such patients undergo frequent testing.
The study involved 13,054 patients with low-grade Ta NMIBC. Most of the participants were male (73.5%), with a median age of 76 years, and had no or few comorbidities (71.2%).
Most patients had undergone cystoscopy, and rates increased over time: from 79.3% of patients in 2004 to 81.5% of patients in 2013 (P = .007). Patients underwent a median of 3.0 cystoscopies per year following their diagnosis, and upper-tract imaging was performed in most patients.
The use of kidney ultrasonography also rose from 19% of patients in 2004 to 23.2% in 2013, as did retrograde pyelography (20.9% in 2004 vs. 24.2% in 2013). Conversely, the use of intravenous pyelography declined (from 14.5% in 2004 to 1.7% in 2012), but there was an increase in CT and MRI in all years except 2010 (from 30.4% of patients in 2004 to 47% of patients in 2013; P < .001). The rate of urine-based testing also significantly increased during the study period (from 44.8% in 2004 to 54.9% in 2013; P < .001), with patients undergoing between two to three tests per year.
Adherence to current guidelines remained similar during the study time frame. For example, 55.2% of patients received two cystoscopies per year in 2004-2008, compared with 53.8% in 2009-2013 (P = .11), suggesting that there was an overuse of all surveillance testing modalities.
As for treatment, 17.2% received intravesical immunotherapy with bacillus Calmette-Guérin, 6.1% were treated with intravesical chemotherapy (excluding receipt of a single perioperative dose). Disease recurrence within this cohort was 1.7%, and only 0.4% experienced disease progression.
When looking at the cost, the total median expenditures at 1 year after diagnosis increased by 60% during the study period, from $34,792 in 2004 to $53,986 in 2013. Higher costs were seen among patients who experienced a recurrence versus no recurrence ($76,669 vs. $53,909).
The study was supported by a grant from the U.S. Department of Defense Peer Reviewed Cancer Research Program. Several of the authors have disclosed relationships with industry, as noted in the original article. Editorialists Mr. Cook and Dr. Howard have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
(NMIBC), a new study concludes.
These cancers are associated with low rates of recurrence, progression, and bladder cancer–specific death, so current clinical practice guidelines recommend against frequent monitoring and testing.
However, the study authors found that patients with a low grade Ta NMIBC diagnosis underwent a median of three cystoscopies per year, and many also received a median of two imagine scans (CT or MRI) as well as 2-3 urine-based tests.
“These data suggest a need for ongoing efforts to limit overuse of treatment and surveillance, which may in turn mitigate associated increases in the costs of care,” write the authors, led by Kelly K. Bree, MD, from the department of urology, University of Texas MD Anderson Cancer Center, Houston. Bladder cancer has the highest lifetime treatment cost of all malignancies, they point out.
The study was published online in JAMA Network Open.
Higher value and more evidence-based
The impact of increased surveillance of this patient cohort has broad implications for patients and the health care system in general, say experts writing in an accompanying editorial.
“It has been well established that workup for NMIBC can have negative consequences for the physical and psychological health of patients,” note Grayden S. Cook, BS, and Jeffrey M. Howard, MD, PhD, both from University of Texas Southwestern Medical Center, Dallas.
“Many of these patients undergo frequent CT imaging of the urinary tract, which carries a high dose of radiation as well as the potential for financial toxic effects (that is, detrimental consequences to the patient because of health care costs),” they write.
Additionally, patient distress is a factor, as they may experience preprocedural anxiety, physical discomfort during procedures, and worry about disease progression, they point out.
“The impact of these patterns is substantial and may have negative consequences for both patients and the health care system,” they conclude. “Thus, it is imperative to move forward with initiatives that provide higher value and are more evidence-based and patient-centered.”
Study finds frequent surveillance
The American Urological Association (AUA)/Society of Urologic Oncologists (SUO), the European Association of Urology, and the International Bladder Cancer Group have made an effort to de-escalate surveillance and treatment for patients with low-grade Ta disease, while at the same time maintaining appropriate surveillance for high-grade aggressive disease.
However, the new study found that in practice, such patients undergo frequent testing.
The study involved 13,054 patients with low-grade Ta NMIBC. Most of the participants were male (73.5%), with a median age of 76 years, and had no or few comorbidities (71.2%).
Most patients had undergone cystoscopy, and rates increased over time: from 79.3% of patients in 2004 to 81.5% of patients in 2013 (P = .007). Patients underwent a median of 3.0 cystoscopies per year following their diagnosis, and upper-tract imaging was performed in most patients.
The use of kidney ultrasonography also rose from 19% of patients in 2004 to 23.2% in 2013, as did retrograde pyelography (20.9% in 2004 vs. 24.2% in 2013). Conversely, the use of intravenous pyelography declined (from 14.5% in 2004 to 1.7% in 2012), but there was an increase in CT and MRI in all years except 2010 (from 30.4% of patients in 2004 to 47% of patients in 2013; P < .001). The rate of urine-based testing also significantly increased during the study period (from 44.8% in 2004 to 54.9% in 2013; P < .001), with patients undergoing between two to three tests per year.
Adherence to current guidelines remained similar during the study time frame. For example, 55.2% of patients received two cystoscopies per year in 2004-2008, compared with 53.8% in 2009-2013 (P = .11), suggesting that there was an overuse of all surveillance testing modalities.
As for treatment, 17.2% received intravesical immunotherapy with bacillus Calmette-Guérin, 6.1% were treated with intravesical chemotherapy (excluding receipt of a single perioperative dose). Disease recurrence within this cohort was 1.7%, and only 0.4% experienced disease progression.
When looking at the cost, the total median expenditures at 1 year after diagnosis increased by 60% during the study period, from $34,792 in 2004 to $53,986 in 2013. Higher costs were seen among patients who experienced a recurrence versus no recurrence ($76,669 vs. $53,909).
The study was supported by a grant from the U.S. Department of Defense Peer Reviewed Cancer Research Program. Several of the authors have disclosed relationships with industry, as noted in the original article. Editorialists Mr. Cook and Dr. Howard have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
No link between cell phones and brain tumors in large U.K. study
“These results support the accumulating evidence that mobile phone use under usual conditions does not increase brain tumor risk,” study author Kirstin Pirie, MSc, from the cancer epidemiology unit at Oxford (England) Population Health, said in a statement.
However, an important limitation of the study is that it involved only women who were middle-aged and older; these people generally use cell phones less than younger women or men, the authors noted. In this study’s cohort, mobile phone use was low, with only 18% of users talking on the phone for 30 minutes or more each week.
The results were published in the Journal of the National Cancer Institute.
This study is a “welcome addition to the body of knowledge looking at the risk from mobile phones, and specifically in relation to certain types of tumor genesis. It is a well-designed, prospective study that identifies no causal link,” commented Malcolm Sperrin from Oxford University Hospitals, who was not involved in the research.
“There is always a need for further research work, especially as phones, wireless, etc., become ubiquitous, but this study should allay many existing concerns,” he commented on the UK Science Media Centre.
Concerns about a cancer risk, particularly brain tumors, have been circulating for decades, and to date, there have been some 30 epidemiologic studies on this issue.
In 2011, the International Agency for Research on Cancer announced that cell phones are “possibly carcinogenic.” That conclusion was based largely on the results of the large INTERPHONE international case-control study and a series of Swedish studies led by Hardell Lennart, MD.
In the latest article, the U.K. researchers suggest that a “likely explanation for the previous positive results is that for a very slow growing tumor, there may be detection bias if cellular telephone users seek medical advice because of awareness of typical symptoms of acoustic neuroma, such as unilateral hearing problems, earlier than nonusers.
“The totality of human evidence, from observational studies, time trends, and bioassays, suggests little or no increase in the risk of cellular telephone users developing a brain tumor,” the U.K. researchers concluded.
Commenting on the U.K. study, Joachim Schüz, PhD, branch head of the section of environment and radiation at the IARC, noted that “mobile technologies are improving all the time, so that the more recent generations emit substantially lower output power.
“Nevertheless, given the lack of evidence for heavy users, advising mobile phone users to reduce unnecessary exposures remains a good precautionary approach,” Dr. Schuz said in a statement.
Details of U.K. study
The U.K. study was conducted by researchers from Oxford Population Health and IARC, who used data from the ongoing UK Million Women Study. This study began in 1996 and has recruited 1.3 million women born from 1935 to 1950 (which amounts to 1 in every 4 women) through the U.K. National Health Service Breast Screening Programme. These women complete regular postal questionnaires about sociodemographic, medical, and lifestyle factors.
Questions about cell phone use were completed by about 776,000 women in 2001 (when they were 50-65 years old). About half of these women also answered these questions about mobile phone use 10 years later, in 2011 (when they were aged 60-75).
The answers indicated that by 2011, the majority of women (75%) aged between 60 and 64 years used a mobile phone, while just under half of those aged between 75 and 79 years used one.
These women were then followed for an average of 14 years through linkage to their NHS records.
The researchers looked for any mention of brain tumors, including glioma, acoustic neuroma, meningioma, and pituitary gland tumors, as well as eye tumors.
During the 14 year follow-up period, 3,268 (0.42%) of the participants developed a brain tumor, but there was no significant difference in that risk between individuals who had never used a mobile phone and those who were mobile phone users. These included tumors in the temporal and parietal lobes, which are the most exposed areas of the brain.
There was also no difference in the risk of developing tumors between women who reported using a mobile phone daily, those who used them for at least 20 minutes a week, and those who had used a mobile phone for over 10 years.
In addition, among the individuals who did develop a tumor, the incidence of right- and left-sided tumors was similar among mobile phone users, even though mobile phone use tends to involve the right side considerably more than the left side, the researchers noted.
The study was funded by the UK Medical Research Council and Cancer Research UK.
A version of this article first appeared on Medscape.com.
“These results support the accumulating evidence that mobile phone use under usual conditions does not increase brain tumor risk,” study author Kirstin Pirie, MSc, from the cancer epidemiology unit at Oxford (England) Population Health, said in a statement.
However, an important limitation of the study is that it involved only women who were middle-aged and older; these people generally use cell phones less than younger women or men, the authors noted. In this study’s cohort, mobile phone use was low, with only 18% of users talking on the phone for 30 minutes or more each week.
The results were published in the Journal of the National Cancer Institute.
This study is a “welcome addition to the body of knowledge looking at the risk from mobile phones, and specifically in relation to certain types of tumor genesis. It is a well-designed, prospective study that identifies no causal link,” commented Malcolm Sperrin from Oxford University Hospitals, who was not involved in the research.
“There is always a need for further research work, especially as phones, wireless, etc., become ubiquitous, but this study should allay many existing concerns,” he commented on the UK Science Media Centre.
Concerns about a cancer risk, particularly brain tumors, have been circulating for decades, and to date, there have been some 30 epidemiologic studies on this issue.
In 2011, the International Agency for Research on Cancer announced that cell phones are “possibly carcinogenic.” That conclusion was based largely on the results of the large INTERPHONE international case-control study and a series of Swedish studies led by Hardell Lennart, MD.
In the latest article, the U.K. researchers suggest that a “likely explanation for the previous positive results is that for a very slow growing tumor, there may be detection bias if cellular telephone users seek medical advice because of awareness of typical symptoms of acoustic neuroma, such as unilateral hearing problems, earlier than nonusers.
“The totality of human evidence, from observational studies, time trends, and bioassays, suggests little or no increase in the risk of cellular telephone users developing a brain tumor,” the U.K. researchers concluded.
Commenting on the U.K. study, Joachim Schüz, PhD, branch head of the section of environment and radiation at the IARC, noted that “mobile technologies are improving all the time, so that the more recent generations emit substantially lower output power.
“Nevertheless, given the lack of evidence for heavy users, advising mobile phone users to reduce unnecessary exposures remains a good precautionary approach,” Dr. Schuz said in a statement.
Details of U.K. study
The U.K. study was conducted by researchers from Oxford Population Health and IARC, who used data from the ongoing UK Million Women Study. This study began in 1996 and has recruited 1.3 million women born from 1935 to 1950 (which amounts to 1 in every 4 women) through the U.K. National Health Service Breast Screening Programme. These women complete regular postal questionnaires about sociodemographic, medical, and lifestyle factors.
Questions about cell phone use were completed by about 776,000 women in 2001 (when they were 50-65 years old). About half of these women also answered these questions about mobile phone use 10 years later, in 2011 (when they were aged 60-75).
The answers indicated that by 2011, the majority of women (75%) aged between 60 and 64 years used a mobile phone, while just under half of those aged between 75 and 79 years used one.
These women were then followed for an average of 14 years through linkage to their NHS records.
The researchers looked for any mention of brain tumors, including glioma, acoustic neuroma, meningioma, and pituitary gland tumors, as well as eye tumors.
During the 14 year follow-up period, 3,268 (0.42%) of the participants developed a brain tumor, but there was no significant difference in that risk between individuals who had never used a mobile phone and those who were mobile phone users. These included tumors in the temporal and parietal lobes, which are the most exposed areas of the brain.
There was also no difference in the risk of developing tumors between women who reported using a mobile phone daily, those who used them for at least 20 minutes a week, and those who had used a mobile phone for over 10 years.
In addition, among the individuals who did develop a tumor, the incidence of right- and left-sided tumors was similar among mobile phone users, even though mobile phone use tends to involve the right side considerably more than the left side, the researchers noted.
The study was funded by the UK Medical Research Council and Cancer Research UK.
A version of this article first appeared on Medscape.com.
“These results support the accumulating evidence that mobile phone use under usual conditions does not increase brain tumor risk,” study author Kirstin Pirie, MSc, from the cancer epidemiology unit at Oxford (England) Population Health, said in a statement.
However, an important limitation of the study is that it involved only women who were middle-aged and older; these people generally use cell phones less than younger women or men, the authors noted. In this study’s cohort, mobile phone use was low, with only 18% of users talking on the phone for 30 minutes or more each week.
The results were published in the Journal of the National Cancer Institute.
This study is a “welcome addition to the body of knowledge looking at the risk from mobile phones, and specifically in relation to certain types of tumor genesis. It is a well-designed, prospective study that identifies no causal link,” commented Malcolm Sperrin from Oxford University Hospitals, who was not involved in the research.
“There is always a need for further research work, especially as phones, wireless, etc., become ubiquitous, but this study should allay many existing concerns,” he commented on the UK Science Media Centre.
Concerns about a cancer risk, particularly brain tumors, have been circulating for decades, and to date, there have been some 30 epidemiologic studies on this issue.
In 2011, the International Agency for Research on Cancer announced that cell phones are “possibly carcinogenic.” That conclusion was based largely on the results of the large INTERPHONE international case-control study and a series of Swedish studies led by Hardell Lennart, MD.
In the latest article, the U.K. researchers suggest that a “likely explanation for the previous positive results is that for a very slow growing tumor, there may be detection bias if cellular telephone users seek medical advice because of awareness of typical symptoms of acoustic neuroma, such as unilateral hearing problems, earlier than nonusers.
“The totality of human evidence, from observational studies, time trends, and bioassays, suggests little or no increase in the risk of cellular telephone users developing a brain tumor,” the U.K. researchers concluded.
Commenting on the U.K. study, Joachim Schüz, PhD, branch head of the section of environment and radiation at the IARC, noted that “mobile technologies are improving all the time, so that the more recent generations emit substantially lower output power.
“Nevertheless, given the lack of evidence for heavy users, advising mobile phone users to reduce unnecessary exposures remains a good precautionary approach,” Dr. Schuz said in a statement.
Details of U.K. study
The U.K. study was conducted by researchers from Oxford Population Health and IARC, who used data from the ongoing UK Million Women Study. This study began in 1996 and has recruited 1.3 million women born from 1935 to 1950 (which amounts to 1 in every 4 women) through the U.K. National Health Service Breast Screening Programme. These women complete regular postal questionnaires about sociodemographic, medical, and lifestyle factors.
Questions about cell phone use were completed by about 776,000 women in 2001 (when they were 50-65 years old). About half of these women also answered these questions about mobile phone use 10 years later, in 2011 (when they were aged 60-75).
The answers indicated that by 2011, the majority of women (75%) aged between 60 and 64 years used a mobile phone, while just under half of those aged between 75 and 79 years used one.
These women were then followed for an average of 14 years through linkage to their NHS records.
The researchers looked for any mention of brain tumors, including glioma, acoustic neuroma, meningioma, and pituitary gland tumors, as well as eye tumors.
During the 14 year follow-up period, 3,268 (0.42%) of the participants developed a brain tumor, but there was no significant difference in that risk between individuals who had never used a mobile phone and those who were mobile phone users. These included tumors in the temporal and parietal lobes, which are the most exposed areas of the brain.
There was also no difference in the risk of developing tumors between women who reported using a mobile phone daily, those who used them for at least 20 minutes a week, and those who had used a mobile phone for over 10 years.
In addition, among the individuals who did develop a tumor, the incidence of right- and left-sided tumors was similar among mobile phone users, even though mobile phone use tends to involve the right side considerably more than the left side, the researchers noted.
The study was funded by the UK Medical Research Council and Cancer Research UK.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE NATIONAL CANCER INSTITUTE
Drugs used for nausea/vomiting linked to stroke risk
Antidopaminergic antiemetics (ADAs) that are widely used for nausea and vomiting, including that related to chemotherapy, have been associated with an increased risk of ischemic stroke in a new study from France.
The authors found that ADA users could be at a threefold increased risk of stroke shortly after the initiation of treatment.
Further analysis showed that all three ADAs studied (domperidone, metopimazine, and metoclopramide) were associated with an increased risk, especially in the first days of use, but the highest increase was found for metopimazine and metoclopramide.
The study was published online March 23, 2022, in the BMJ.
“Our results show that the risk of ischemic stroke appears to be associated with ADA use,” wrote the authors, led by Anne Bénard-Laribière, PharmD, MS, of the University of Bordeaux (France). They emphasized, however, that this is an observational study and cannot therefore establish causation.
One important note about this study is that patients with a history of cancer were specifically excluded. The authors did not elaborate on what the ADAs were being used for, other than to say that ADAs are used for nausea and vomiting of “variable origins,” and a press release noted that these drugs are often used by patients with migraine.
Hence it is not clear what relevance these findings have for patients with cancer, suggested an expert unrelated to the study, Ian Olver, MD, PhD, professorial research fellow, faculty of health and medical sciences, University of Adelaide.
“So the best that can be said, from my viewpoint, is that the ADAs studied have been associated with an increased risk of stroke in patients other than cancer patients,” he told this news organization.
In addition, he also emphasized that an observational study cannot establish causation.
For their study, the authors used data from the nationwide reimbursement database. Hence, they “needed to make the assumption that the date of reimbursement approximated to the date of administration, and that would not be the case for drugs used prophylactically prior to chemotherapy or radiotherapy,” Dr. Olver commented.
The authors were also unable to make any statement about dose and schedule. “Certainly chemotherapy-induced nausea and vomiting would require more intermittent dosing compared to noncancer uses,” Dr. Olver said. In addition, “metoclopramide in conventional doses is not very effective for this purpose and metopimazine is mainly used in Europe.”
Most patients with cancer would not be receiving these drugs, he suggested: “These days they would be receiving 5HT3 receptor antagonists and NK1 receptor antagonists and steroids.”
Study details
The French study investigated the risk of ischemic stroke associated with ADA use in a real-world setting. The authors conducted a case-time-control study using data from the nationwide French reimbursement health care system database Système National des Données de Santé.
They identified 2,612 patients from the database who had experienced a first ischemic stroke between 2012 and 2016 and had also received at least one reimbursement for domperidone, metopimazine, or metoclopramide during the 70-day period prior to their stroke.
The frequency of reimbursements for ADAs was compared with a risk period (1-14 days before a stroke) and three matched reference periods (57-70 days, 43-56 days, and 29-42 days before stroke).
Patients who had experienced a stroke were matched to a control group of 21,859 randomly selected healthy people who also received an ADA in the same time period.
Within the stroke cohort, 1,250 patients received an ADA at least once during the designated risk period and 1,060 in the reference periods. Among the controls, 5,128 and 13,165 received an ADA at least one time in the risk and reference periods, respectively.
This yielded a case-time-control ratio of adjusted odds ratios of 3.12, of a risk of stroke among new users. Stratification by age (<70 years and ≥70 years), sex, history of dementia, and gastroenteritis epidemic periods revealed similar results, although the highest case-time-control ratio observed in men(aOR, 3.59).
The risk of stroke appeared to increase for all ADAs, but the highest was for metopimazine (3.62-fold increase) and metoclopramide (a 3.53-fold increase), which are both drugs that have the ability to cross the blood-brain barrier.
The study was funded by Agence Nationale de Sécurité du Médicament et des Produits de Santé through a partnership with the Health Product Epidemiology Scientific Interest Group. All authors had financial support from ANSM for the submitted work; one coauthor disclosed relationships with Pfizer and Roche. Dr. Olver disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Antidopaminergic antiemetics (ADAs) that are widely used for nausea and vomiting, including that related to chemotherapy, have been associated with an increased risk of ischemic stroke in a new study from France.
The authors found that ADA users could be at a threefold increased risk of stroke shortly after the initiation of treatment.
Further analysis showed that all three ADAs studied (domperidone, metopimazine, and metoclopramide) were associated with an increased risk, especially in the first days of use, but the highest increase was found for metopimazine and metoclopramide.
The study was published online March 23, 2022, in the BMJ.
“Our results show that the risk of ischemic stroke appears to be associated with ADA use,” wrote the authors, led by Anne Bénard-Laribière, PharmD, MS, of the University of Bordeaux (France). They emphasized, however, that this is an observational study and cannot therefore establish causation.
One important note about this study is that patients with a history of cancer were specifically excluded. The authors did not elaborate on what the ADAs were being used for, other than to say that ADAs are used for nausea and vomiting of “variable origins,” and a press release noted that these drugs are often used by patients with migraine.
Hence it is not clear what relevance these findings have for patients with cancer, suggested an expert unrelated to the study, Ian Olver, MD, PhD, professorial research fellow, faculty of health and medical sciences, University of Adelaide.
“So the best that can be said, from my viewpoint, is that the ADAs studied have been associated with an increased risk of stroke in patients other than cancer patients,” he told this news organization.
In addition, he also emphasized that an observational study cannot establish causation.
For their study, the authors used data from the nationwide reimbursement database. Hence, they “needed to make the assumption that the date of reimbursement approximated to the date of administration, and that would not be the case for drugs used prophylactically prior to chemotherapy or radiotherapy,” Dr. Olver commented.
The authors were also unable to make any statement about dose and schedule. “Certainly chemotherapy-induced nausea and vomiting would require more intermittent dosing compared to noncancer uses,” Dr. Olver said. In addition, “metoclopramide in conventional doses is not very effective for this purpose and metopimazine is mainly used in Europe.”
Most patients with cancer would not be receiving these drugs, he suggested: “These days they would be receiving 5HT3 receptor antagonists and NK1 receptor antagonists and steroids.”
Study details
The French study investigated the risk of ischemic stroke associated with ADA use in a real-world setting. The authors conducted a case-time-control study using data from the nationwide French reimbursement health care system database Système National des Données de Santé.
They identified 2,612 patients from the database who had experienced a first ischemic stroke between 2012 and 2016 and had also received at least one reimbursement for domperidone, metopimazine, or metoclopramide during the 70-day period prior to their stroke.
The frequency of reimbursements for ADAs was compared with a risk period (1-14 days before a stroke) and three matched reference periods (57-70 days, 43-56 days, and 29-42 days before stroke).
Patients who had experienced a stroke were matched to a control group of 21,859 randomly selected healthy people who also received an ADA in the same time period.
Within the stroke cohort, 1,250 patients received an ADA at least once during the designated risk period and 1,060 in the reference periods. Among the controls, 5,128 and 13,165 received an ADA at least one time in the risk and reference periods, respectively.
This yielded a case-time-control ratio of adjusted odds ratios of 3.12, of a risk of stroke among new users. Stratification by age (<70 years and ≥70 years), sex, history of dementia, and gastroenteritis epidemic periods revealed similar results, although the highest case-time-control ratio observed in men(aOR, 3.59).
The risk of stroke appeared to increase for all ADAs, but the highest was for metopimazine (3.62-fold increase) and metoclopramide (a 3.53-fold increase), which are both drugs that have the ability to cross the blood-brain barrier.
The study was funded by Agence Nationale de Sécurité du Médicament et des Produits de Santé through a partnership with the Health Product Epidemiology Scientific Interest Group. All authors had financial support from ANSM for the submitted work; one coauthor disclosed relationships with Pfizer and Roche. Dr. Olver disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Antidopaminergic antiemetics (ADAs) that are widely used for nausea and vomiting, including that related to chemotherapy, have been associated with an increased risk of ischemic stroke in a new study from France.
The authors found that ADA users could be at a threefold increased risk of stroke shortly after the initiation of treatment.
Further analysis showed that all three ADAs studied (domperidone, metopimazine, and metoclopramide) were associated with an increased risk, especially in the first days of use, but the highest increase was found for metopimazine and metoclopramide.
The study was published online March 23, 2022, in the BMJ.
“Our results show that the risk of ischemic stroke appears to be associated with ADA use,” wrote the authors, led by Anne Bénard-Laribière, PharmD, MS, of the University of Bordeaux (France). They emphasized, however, that this is an observational study and cannot therefore establish causation.
One important note about this study is that patients with a history of cancer were specifically excluded. The authors did not elaborate on what the ADAs were being used for, other than to say that ADAs are used for nausea and vomiting of “variable origins,” and a press release noted that these drugs are often used by patients with migraine.
Hence it is not clear what relevance these findings have for patients with cancer, suggested an expert unrelated to the study, Ian Olver, MD, PhD, professorial research fellow, faculty of health and medical sciences, University of Adelaide.
“So the best that can be said, from my viewpoint, is that the ADAs studied have been associated with an increased risk of stroke in patients other than cancer patients,” he told this news organization.
In addition, he also emphasized that an observational study cannot establish causation.
For their study, the authors used data from the nationwide reimbursement database. Hence, they “needed to make the assumption that the date of reimbursement approximated to the date of administration, and that would not be the case for drugs used prophylactically prior to chemotherapy or radiotherapy,” Dr. Olver commented.
The authors were also unable to make any statement about dose and schedule. “Certainly chemotherapy-induced nausea and vomiting would require more intermittent dosing compared to noncancer uses,” Dr. Olver said. In addition, “metoclopramide in conventional doses is not very effective for this purpose and metopimazine is mainly used in Europe.”
Most patients with cancer would not be receiving these drugs, he suggested: “These days they would be receiving 5HT3 receptor antagonists and NK1 receptor antagonists and steroids.”
Study details
The French study investigated the risk of ischemic stroke associated with ADA use in a real-world setting. The authors conducted a case-time-control study using data from the nationwide French reimbursement health care system database Système National des Données de Santé.
They identified 2,612 patients from the database who had experienced a first ischemic stroke between 2012 and 2016 and had also received at least one reimbursement for domperidone, metopimazine, or metoclopramide during the 70-day period prior to their stroke.
The frequency of reimbursements for ADAs was compared with a risk period (1-14 days before a stroke) and three matched reference periods (57-70 days, 43-56 days, and 29-42 days before stroke).
Patients who had experienced a stroke were matched to a control group of 21,859 randomly selected healthy people who also received an ADA in the same time period.
Within the stroke cohort, 1,250 patients received an ADA at least once during the designated risk period and 1,060 in the reference periods. Among the controls, 5,128 and 13,165 received an ADA at least one time in the risk and reference periods, respectively.
This yielded a case-time-control ratio of adjusted odds ratios of 3.12, of a risk of stroke among new users. Stratification by age (<70 years and ≥70 years), sex, history of dementia, and gastroenteritis epidemic periods revealed similar results, although the highest case-time-control ratio observed in men(aOR, 3.59).
The risk of stroke appeared to increase for all ADAs, but the highest was for metopimazine (3.62-fold increase) and metoclopramide (a 3.53-fold increase), which are both drugs that have the ability to cross the blood-brain barrier.
The study was funded by Agence Nationale de Sécurité du Médicament et des Produits de Santé through a partnership with the Health Product Epidemiology Scientific Interest Group. All authors had financial support from ANSM for the submitted work; one coauthor disclosed relationships with Pfizer and Roche. Dr. Olver disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE BMJ
Melanoma increasing, but is this overdiagnosis?
Melanoma has been increasing in incidence in the United States over the last few decades, but is this a true increase? Or is this a case of overdiagnosis, fueled by screening?
A new study argues the case for overdiagnosis.
commented lead author lead author Adewole Adamson, MD, an assistant professor of internal medicine, division of dermatology, at the University of Texas at Austin.
He posted this conclusion on Twitter after the study was published in JAMA Dermatology.
“The discrepancies in incidence and mortality trends found in this cohort study suggest considerable overdiagnosis of melanoma occurring among White patients in the U.S.,” the authors concluded.
They estimated that an estimated 59% of White women and 60% of White men with melanoma were overdiagnosed in 2014.
These results are similar to those from a recent study from Australia, which used a different method of assessing overdiagnosis. Those findings estimated that 54%-58% of melanoma cases represented overdiagnosis in Australia, Dr. Adamson noted.
“Our estimates shed light on the HUGE scope of this problem in the United States that we need to address,” Dr. Adamson commented on Twitter. “Calls for screening for melanoma in the general public will only push these numbers higher, and make patients out of healthy people.”
“Screening the general population for melanoma has never been shown to save lives and likely is responsible for the increase in melanoma overdiagnosis,” Dr. Adamson said in an interview. “Screening average- and/or low-risk patients is of low value and the harms may outweigh the theoretical benefits.”
Screening programs should be directed to those who may derive the most benefit. “Screening should be limited to high-risk patients such as older White men, patients with a lot of atypical nevi, heavy sun exposure, fair skin, and red hair,” he said. “Just like for other cancers, such as breast, prostate, and colorectal, there should be clear guidelines as to which populations to screen, as well as when to start and when to stop screening.”
Overdiagnosis is defined as the diagnosis of cancer that would never have caused any symptoms or problems in a patient’s lifetime. But therein lies the problem, explained Dr. Adamson. “Because we do not know which early, screen-detected skin cancers would be destined to progress, we are obligated to treat all of them.” There is evidence to suggest that melanoma in situ is not an obligate precursor lesion to invasive melanoma, similar to the situation in which not all ductal carcinoma in situ leads to invasive breast cancer. “It is possible that less aggressive management strategies could be the subject of future studies,” he said.
Patients out of healthy people
For their study, Dr. Adamson and colleagues compared rates of melanoma among White and Black patients. Melanoma is much less common among Black individuals, and they are also less likely to be screened. Additionally, screening rates among Black patients have remained more or less the same over the last decades, whereas screening has increased in White patients.
The team used trends in mortality as a result of melanoma in Black patients as a marker for improvements in medical care. From this, they estimated the expected mortality trends in White patients if medical care had not improved. This served as a marker for the change in true cancer occurrence. Overdiagnosis was calculated as the difference between observed incidence and estimated true cancer occurrence.
The incidence of melanoma rose dramatically among White patients from 1975 to 2014, increasing about fourfold in White women (incidence rate ratio, 4.01) and sixfold in White men (IRR, 5.97).
At the same time, there was much smaller increase (of less than 25%) in the incidence of melanoma in both Black women and Black men.
In that time period, melanoma-related mortality decreased approximately 25% in Black women and men; it remained stable in White women, but increased almost 50% in White men.
Had medical care not improved, estimated mortality would have increased 60% in White women and more than doubled in White men, the authors assert.
Guidelines needed
“Recognizing and addressing overdiagnosis is important,” said Anthony J. Olszanski, MD, RPh, associate professor, department of hematology/oncology at Fox Chase Cancer Center, Philadelphia, who was approached for comment on the paper.
That said, Dr. Olszanski noted that this particular study has important limitations. “It is, by nature, a retrospective study using data from the [Surveillance, Epidemiology, and End Results] database registry, limited to patients only in the U.S., and uses a control group of Black patients to estimate overdiagnosis in White patients. These important factors can certainly influence their findings. However, the paper also notes that White men have realized a true increase in diagnosis, backed by a notable increase in mortality.”
The findings should and do raise a number of provocative questions, Dr. Olszanski emphasized. “Should we curtail public screening? Should we mandate revised guidelines for biopsies or pathologic diagnosis?
“As a medical oncologist,” he continued, “I treat patients who clearly do not have benign disease and so it is easy for me to be biased toward aggressive screening. However, it is my opinion that we should develop guidelines aimed at lessening this apparent overdiagnosis.”
These guidelines should be based on prospective studies and would better define which lesions are most suspect and should be biopsied, which are rational for ongoing surveillance, and what pathologic features are most consistent with melanoma, he noted. “We also need to continue to educate the public, as all too often I see the patient who ignored a lesion that was changing over time. A changing lesion requires medical attention. Importantly, we likewise need to improve our commitment in educating the public about the risks of excessive ultraviolet radiation exposure and how to avoid it, as prevention continues to be a most prudent course.”
Screening catches disease early
Another expert approached for comment emphasized that identifying melanomas early on may prevent the need for aggressive therapy. “Many primary melanomas in the U.S. are diagnosed now at an early stage and are cured with surgery, and that hardly constitutes overdiagnosis,” said Jeffrey S. Weber, MD, PhD, deputy director of the Perlmutter Cancer Center and codirector of the melanoma research program, New York University Langone Health.
“In addition, the death rate from melanoma is likely decreased due to the advent of more effective therapies for metastatic disease, and the increasing use of adjuvant immune and targeted therapies that are highly effective at preventing relapse and undoubtedly at prolonging survival, but they have been approved only since 2017-2018,” he added.
This study was supported in part by the Robert Wood Johnson Foundation. Dr. Adamson and Dr. Olszanski disclosed no relevant financial relationships. Dr. Weber disclosed relationships with numerous pharmaceutical companies and holds equity in CytoMx, Biond, Neximmune, and Immunimax.
A version of this article first appeared on Medscape.com.
Melanoma has been increasing in incidence in the United States over the last few decades, but is this a true increase? Or is this a case of overdiagnosis, fueled by screening?
A new study argues the case for overdiagnosis.
commented lead author lead author Adewole Adamson, MD, an assistant professor of internal medicine, division of dermatology, at the University of Texas at Austin.
He posted this conclusion on Twitter after the study was published in JAMA Dermatology.
“The discrepancies in incidence and mortality trends found in this cohort study suggest considerable overdiagnosis of melanoma occurring among White patients in the U.S.,” the authors concluded.
They estimated that an estimated 59% of White women and 60% of White men with melanoma were overdiagnosed in 2014.
These results are similar to those from a recent study from Australia, which used a different method of assessing overdiagnosis. Those findings estimated that 54%-58% of melanoma cases represented overdiagnosis in Australia, Dr. Adamson noted.
“Our estimates shed light on the HUGE scope of this problem in the United States that we need to address,” Dr. Adamson commented on Twitter. “Calls for screening for melanoma in the general public will only push these numbers higher, and make patients out of healthy people.”
“Screening the general population for melanoma has never been shown to save lives and likely is responsible for the increase in melanoma overdiagnosis,” Dr. Adamson said in an interview. “Screening average- and/or low-risk patients is of low value and the harms may outweigh the theoretical benefits.”
Screening programs should be directed to those who may derive the most benefit. “Screening should be limited to high-risk patients such as older White men, patients with a lot of atypical nevi, heavy sun exposure, fair skin, and red hair,” he said. “Just like for other cancers, such as breast, prostate, and colorectal, there should be clear guidelines as to which populations to screen, as well as when to start and when to stop screening.”
Overdiagnosis is defined as the diagnosis of cancer that would never have caused any symptoms or problems in a patient’s lifetime. But therein lies the problem, explained Dr. Adamson. “Because we do not know which early, screen-detected skin cancers would be destined to progress, we are obligated to treat all of them.” There is evidence to suggest that melanoma in situ is not an obligate precursor lesion to invasive melanoma, similar to the situation in which not all ductal carcinoma in situ leads to invasive breast cancer. “It is possible that less aggressive management strategies could be the subject of future studies,” he said.
Patients out of healthy people
For their study, Dr. Adamson and colleagues compared rates of melanoma among White and Black patients. Melanoma is much less common among Black individuals, and they are also less likely to be screened. Additionally, screening rates among Black patients have remained more or less the same over the last decades, whereas screening has increased in White patients.
The team used trends in mortality as a result of melanoma in Black patients as a marker for improvements in medical care. From this, they estimated the expected mortality trends in White patients if medical care had not improved. This served as a marker for the change in true cancer occurrence. Overdiagnosis was calculated as the difference between observed incidence and estimated true cancer occurrence.
The incidence of melanoma rose dramatically among White patients from 1975 to 2014, increasing about fourfold in White women (incidence rate ratio, 4.01) and sixfold in White men (IRR, 5.97).
At the same time, there was much smaller increase (of less than 25%) in the incidence of melanoma in both Black women and Black men.
In that time period, melanoma-related mortality decreased approximately 25% in Black women and men; it remained stable in White women, but increased almost 50% in White men.
Had medical care not improved, estimated mortality would have increased 60% in White women and more than doubled in White men, the authors assert.
Guidelines needed
“Recognizing and addressing overdiagnosis is important,” said Anthony J. Olszanski, MD, RPh, associate professor, department of hematology/oncology at Fox Chase Cancer Center, Philadelphia, who was approached for comment on the paper.
That said, Dr. Olszanski noted that this particular study has important limitations. “It is, by nature, a retrospective study using data from the [Surveillance, Epidemiology, and End Results] database registry, limited to patients only in the U.S., and uses a control group of Black patients to estimate overdiagnosis in White patients. These important factors can certainly influence their findings. However, the paper also notes that White men have realized a true increase in diagnosis, backed by a notable increase in mortality.”
The findings should and do raise a number of provocative questions, Dr. Olszanski emphasized. “Should we curtail public screening? Should we mandate revised guidelines for biopsies or pathologic diagnosis?
“As a medical oncologist,” he continued, “I treat patients who clearly do not have benign disease and so it is easy for me to be biased toward aggressive screening. However, it is my opinion that we should develop guidelines aimed at lessening this apparent overdiagnosis.”
These guidelines should be based on prospective studies and would better define which lesions are most suspect and should be biopsied, which are rational for ongoing surveillance, and what pathologic features are most consistent with melanoma, he noted. “We also need to continue to educate the public, as all too often I see the patient who ignored a lesion that was changing over time. A changing lesion requires medical attention. Importantly, we likewise need to improve our commitment in educating the public about the risks of excessive ultraviolet radiation exposure and how to avoid it, as prevention continues to be a most prudent course.”
Screening catches disease early
Another expert approached for comment emphasized that identifying melanomas early on may prevent the need for aggressive therapy. “Many primary melanomas in the U.S. are diagnosed now at an early stage and are cured with surgery, and that hardly constitutes overdiagnosis,” said Jeffrey S. Weber, MD, PhD, deputy director of the Perlmutter Cancer Center and codirector of the melanoma research program, New York University Langone Health.
“In addition, the death rate from melanoma is likely decreased due to the advent of more effective therapies for metastatic disease, and the increasing use of adjuvant immune and targeted therapies that are highly effective at preventing relapse and undoubtedly at prolonging survival, but they have been approved only since 2017-2018,” he added.
This study was supported in part by the Robert Wood Johnson Foundation. Dr. Adamson and Dr. Olszanski disclosed no relevant financial relationships. Dr. Weber disclosed relationships with numerous pharmaceutical companies and holds equity in CytoMx, Biond, Neximmune, and Immunimax.
A version of this article first appeared on Medscape.com.
Melanoma has been increasing in incidence in the United States over the last few decades, but is this a true increase? Or is this a case of overdiagnosis, fueled by screening?
A new study argues the case for overdiagnosis.
commented lead author lead author Adewole Adamson, MD, an assistant professor of internal medicine, division of dermatology, at the University of Texas at Austin.
He posted this conclusion on Twitter after the study was published in JAMA Dermatology.
“The discrepancies in incidence and mortality trends found in this cohort study suggest considerable overdiagnosis of melanoma occurring among White patients in the U.S.,” the authors concluded.
They estimated that an estimated 59% of White women and 60% of White men with melanoma were overdiagnosed in 2014.
These results are similar to those from a recent study from Australia, which used a different method of assessing overdiagnosis. Those findings estimated that 54%-58% of melanoma cases represented overdiagnosis in Australia, Dr. Adamson noted.
“Our estimates shed light on the HUGE scope of this problem in the United States that we need to address,” Dr. Adamson commented on Twitter. “Calls for screening for melanoma in the general public will only push these numbers higher, and make patients out of healthy people.”
“Screening the general population for melanoma has never been shown to save lives and likely is responsible for the increase in melanoma overdiagnosis,” Dr. Adamson said in an interview. “Screening average- and/or low-risk patients is of low value and the harms may outweigh the theoretical benefits.”
Screening programs should be directed to those who may derive the most benefit. “Screening should be limited to high-risk patients such as older White men, patients with a lot of atypical nevi, heavy sun exposure, fair skin, and red hair,” he said. “Just like for other cancers, such as breast, prostate, and colorectal, there should be clear guidelines as to which populations to screen, as well as when to start and when to stop screening.”
Overdiagnosis is defined as the diagnosis of cancer that would never have caused any symptoms or problems in a patient’s lifetime. But therein lies the problem, explained Dr. Adamson. “Because we do not know which early, screen-detected skin cancers would be destined to progress, we are obligated to treat all of them.” There is evidence to suggest that melanoma in situ is not an obligate precursor lesion to invasive melanoma, similar to the situation in which not all ductal carcinoma in situ leads to invasive breast cancer. “It is possible that less aggressive management strategies could be the subject of future studies,” he said.
Patients out of healthy people
For their study, Dr. Adamson and colleagues compared rates of melanoma among White and Black patients. Melanoma is much less common among Black individuals, and they are also less likely to be screened. Additionally, screening rates among Black patients have remained more or less the same over the last decades, whereas screening has increased in White patients.
The team used trends in mortality as a result of melanoma in Black patients as a marker for improvements in medical care. From this, they estimated the expected mortality trends in White patients if medical care had not improved. This served as a marker for the change in true cancer occurrence. Overdiagnosis was calculated as the difference between observed incidence and estimated true cancer occurrence.
The incidence of melanoma rose dramatically among White patients from 1975 to 2014, increasing about fourfold in White women (incidence rate ratio, 4.01) and sixfold in White men (IRR, 5.97).
At the same time, there was much smaller increase (of less than 25%) in the incidence of melanoma in both Black women and Black men.
In that time period, melanoma-related mortality decreased approximately 25% in Black women and men; it remained stable in White women, but increased almost 50% in White men.
Had medical care not improved, estimated mortality would have increased 60% in White women and more than doubled in White men, the authors assert.
Guidelines needed
“Recognizing and addressing overdiagnosis is important,” said Anthony J. Olszanski, MD, RPh, associate professor, department of hematology/oncology at Fox Chase Cancer Center, Philadelphia, who was approached for comment on the paper.
That said, Dr. Olszanski noted that this particular study has important limitations. “It is, by nature, a retrospective study using data from the [Surveillance, Epidemiology, and End Results] database registry, limited to patients only in the U.S., and uses a control group of Black patients to estimate overdiagnosis in White patients. These important factors can certainly influence their findings. However, the paper also notes that White men have realized a true increase in diagnosis, backed by a notable increase in mortality.”
The findings should and do raise a number of provocative questions, Dr. Olszanski emphasized. “Should we curtail public screening? Should we mandate revised guidelines for biopsies or pathologic diagnosis?
“As a medical oncologist,” he continued, “I treat patients who clearly do not have benign disease and so it is easy for me to be biased toward aggressive screening. However, it is my opinion that we should develop guidelines aimed at lessening this apparent overdiagnosis.”
These guidelines should be based on prospective studies and would better define which lesions are most suspect and should be biopsied, which are rational for ongoing surveillance, and what pathologic features are most consistent with melanoma, he noted. “We also need to continue to educate the public, as all too often I see the patient who ignored a lesion that was changing over time. A changing lesion requires medical attention. Importantly, we likewise need to improve our commitment in educating the public about the risks of excessive ultraviolet radiation exposure and how to avoid it, as prevention continues to be a most prudent course.”
Screening catches disease early
Another expert approached for comment emphasized that identifying melanomas early on may prevent the need for aggressive therapy. “Many primary melanomas in the U.S. are diagnosed now at an early stage and are cured with surgery, and that hardly constitutes overdiagnosis,” said Jeffrey S. Weber, MD, PhD, deputy director of the Perlmutter Cancer Center and codirector of the melanoma research program, New York University Langone Health.
“In addition, the death rate from melanoma is likely decreased due to the advent of more effective therapies for metastatic disease, and the increasing use of adjuvant immune and targeted therapies that are highly effective at preventing relapse and undoubtedly at prolonging survival, but they have been approved only since 2017-2018,” he added.
This study was supported in part by the Robert Wood Johnson Foundation. Dr. Adamson and Dr. Olszanski disclosed no relevant financial relationships. Dr. Weber disclosed relationships with numerous pharmaceutical companies and holds equity in CytoMx, Biond, Neximmune, and Immunimax.
A version of this article first appeared on Medscape.com.
FROM JAMA DERMATOLOGY
Free now to speak, nine oncologists spill the beans over firing
Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.
The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.
The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.
At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.
AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.
The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.
They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.
“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”
AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
Triggered by cost cutting
The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”
Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”
There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”
Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”
As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.
“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”
Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”
The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).
This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”
“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.
In fact, the medical center hired seven new oncologists to replace them.
Noncompete covenant
In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.
“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”
The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.
“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “
In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.
Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.
“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”
Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.
“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
Telemedicine added to the mix
Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.
As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.
“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.
Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.
One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.
A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.
“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”
Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.
Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.
“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.
Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.
“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.
A version of this article first appeared on Medscape.com.
Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.
The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.
The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.
At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.
AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.
The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.
They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.
“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”
AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
Triggered by cost cutting
The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”
Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”
There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”
Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”
As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.
“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”
Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”
The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).
This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”
“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.
In fact, the medical center hired seven new oncologists to replace them.
Noncompete covenant
In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.
“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”
The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.
“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “
In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.
Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.
“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”
Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.
“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
Telemedicine added to the mix
Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.
As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.
“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.
Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.
One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.
A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.
“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”
Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.
Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.
“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.
Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.
“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.
A version of this article first appeared on Medscape.com.
Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.
The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.
The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.
At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.
AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.
The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.
They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.
“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”
AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
Triggered by cost cutting
The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”
Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”
There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”
Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”
As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.
“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”
Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”
The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).
This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”
“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.
In fact, the medical center hired seven new oncologists to replace them.
Noncompete covenant
In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.
“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”
The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.
“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “
In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.
Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.
“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”
Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.
“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
Telemedicine added to the mix
Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.
As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.
“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.
Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.
One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.
A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.
“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”
Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.
Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.
“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.
Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.
“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.
A version of this article first appeared on Medscape.com.
Oncology groups support Ukraine, one cuts ties with Russian docs
As many in the world react with sanctions imposed on Russia after its invasion of Ukraine, the oncology community has now stepped into the fray.
All the large cancer organizations have put out statements in support of Ukraine, but one group has gone further and cut its ties with Russia.
“The international cancer specialist network, OncoAlert, severed all cooperation with doctors in Russia as part of the Western sanctions,” the group announced on its Twitter page, which is decorated with a blue and yellow ribbon and declares that it “stands with Ukraine.”
“The OncoAlert Network is nonpolitical but we cannot stand idle and not take a stand against this aggression toward our Ukrainian friends & colleagues,” the group said. “The network will be pulling out of ALL collaborations & congresses in Russia.”
Not surprisingly, the post was inundated with a barrage of inflammatory and politically laced tweets from Russian and Chinese users. Many of them repeated the same phrase about “violating the Hippocratic oath and the Geneva convention,” used foul language, and slammed the United States for past military actions in other parts of the world.
A prominent Russian oncologist also responded, posting a video in which he discussed the situation more coherently and without mudslinging or scripted phrases. Andrey Kaprin, MD, PhD, is chief oncologist of the Russian Federation as well as director general of the Federal State Budgetary Institution, NMRCC, of the Ministry of Health of the Russian Federation. He says they continue to maintain relations with the largest and best known oncologic organizations. “We haven’t felt any deterioration in our relationship yet, and of course, we hope that this won’t happen.”
Dr. Kaprin said he believes OncoAlert will return to cooperation with Russia, and that “reason will prevail.”
“No one is protected from cancer, not even doctors, and that is why there should be no politics here,” he said.
Dr. Kaprin was speaking from Russia state-affiliated media, so it was not an independent commentary. Several of the Twitter responses to his video, primarily from non-Russians, were less than complimentary.
One user replied: “Cancer is rife in the Kremlin.”
Another post pointed out the hypocrisy of Russians being upset that OncoAlert was cutting ties with them. “What about sick Ukrainian kids, having to shelter in hospital basement, not having lifesaving surgeries because Russia decided to invade a democratic country?”
And another post was not buying the story that “reason will prevail,” in that the doctor’s talk seemed to contradict the reality of the situation. “I guess for every child #Russia murders they get cut off a little more from the civilized world?”
Cancer patients vulnerable
The war in Ukraine is an “unfolding humanitarian emergency,” said the World Health Organization, and it has called on top-level officials involved in the Russian invasion to ensure access for delivery of essential medical, surgical, and trauma supplies to help the Ukrainian people and refugees in neighboring countries. A shortage of oxygen, insulin, cancer therapies, and other essential supplies will continue to grow more dire in the weeks and months ahead, WHO officials predict.
One of the more heartbreaking reports described how pediatric cancer patients have been moved to hospital basements that are serving as temporary bomb shelters. Hospital staff continue to try to provide limited treatment when possible, even though essential supplies are dwindling.
“These children suffer more because they need to stay alive to fight with the cancer – and this fight cannot wait,” Lesia Lysytsia, MD, a doctor at Okhmatdyt, the country’s largest children’s hospital in Kyiv, said in an NBC news report.
For some children, the only treatment available is a basic form of chemotherapy, and at the Kyiv Regional Oncology Center, the situation became so dire for children in need of blood transfusions that physicians began to transfuse blood from parent to child.
“Our patients, they will die,” Dr. Lysytsia said. “We will calculate how many people or soldiers have died in attacks, but we will never calculate how many patients weren’t diagnosed of disease in time, how many patients died because they didn’t receive treatment. It’s an epic amount of people.”
Response from oncology community
Many of the large American oncology groups have issued strong statements expressing their support for Ukraine and offering assistance.
The American Cancer Society has partnered with the American Society of Clinical Oncology and the Sidney Kimmel Cancer Center–Jefferson Health to support all Ukrainian cancer patients and their families. The groups are engaging a network of oncologists and oncology nurses to provide support through the ACS Clinician Volunteer Corps.
The ACS and ASCO are making free cancer resources available in English, Ukrainian, Polish, and Russian through their patient information websites (available here and here), with additional patient education resources planned.
The ACS noted that there are more than 179,000 newly diagnosed patients with cancer among the Ukrainian people “suffering from Russia’s unprovoked aggression.”
“Disruptions to cancer treatment pose a grave risk to the survival of Ukrainian patients with cancer,” commented Karen Knudsen, PhD, CEO at the ACS.
ASCO also issued its own statement, declaring that it stands with “our Ukrainian members, the worldwide oncology community, and health care providers around the globe in condemning Russia’s unprovoked war on Ukraine.”
The society notes that it represents oncology professionals in Ukraine and neighboring countries including Poland, Romania, Moldova, Slovakia, and Hungary, which are now receiving thousands of refugees from the Russian invasion.
“We are hearing daily reports of cancer treatment interrupted by acts of war, including damage to medical facilities and shortages of critical supplies. Countless patients now need to find cancer care in new and unfamiliar surroundings with limited medical records and minimal resources,” the society commented.
The American Association for Cancer Research also issued a statement by President David A. Tuveson, MD, PhD, and CEO Margaret Foti, PhD, MD (hc). The organization has more than 50,000 members around the world, and they “stand in solidarity with the citizens of Ukraine during the Russian attack on their country.”
“This abhorrent war, which has been instigated by Russia’s leaders, is isolating and interrupting the lifesaving work of scientists and clinicians in Ukraine and Russia, threatening years of effective research collaborations and community building,” the AACR comments. “Limiting the exchange of innovative ideas, practices, and data across borders will significantly retard cancer research and have an adverse effect on public health.”
Perhaps the most subdued statement came from the European Society of Medical Oncology, in a brief release entitled: “Against Any War.” The society expressed profound sadness about the unfolding tragedy in Ukraine and the suffering of people. “We would like to confirm our solidarity and unconditioned support to all oncology professionals and cancer patients, with no geographical boundaries.”
ESMO also said that they were reviewing possibilities “to be of concrete help for our members and their patients, in collaboration with national and transnational oncology societies, as well as the International Cancer Foundation.”
A version of this article first appeared on Medscape.com.
As many in the world react with sanctions imposed on Russia after its invasion of Ukraine, the oncology community has now stepped into the fray.
All the large cancer organizations have put out statements in support of Ukraine, but one group has gone further and cut its ties with Russia.
“The international cancer specialist network, OncoAlert, severed all cooperation with doctors in Russia as part of the Western sanctions,” the group announced on its Twitter page, which is decorated with a blue and yellow ribbon and declares that it “stands with Ukraine.”
“The OncoAlert Network is nonpolitical but we cannot stand idle and not take a stand against this aggression toward our Ukrainian friends & colleagues,” the group said. “The network will be pulling out of ALL collaborations & congresses in Russia.”
Not surprisingly, the post was inundated with a barrage of inflammatory and politically laced tweets from Russian and Chinese users. Many of them repeated the same phrase about “violating the Hippocratic oath and the Geneva convention,” used foul language, and slammed the United States for past military actions in other parts of the world.
A prominent Russian oncologist also responded, posting a video in which he discussed the situation more coherently and without mudslinging or scripted phrases. Andrey Kaprin, MD, PhD, is chief oncologist of the Russian Federation as well as director general of the Federal State Budgetary Institution, NMRCC, of the Ministry of Health of the Russian Federation. He says they continue to maintain relations with the largest and best known oncologic organizations. “We haven’t felt any deterioration in our relationship yet, and of course, we hope that this won’t happen.”
Dr. Kaprin said he believes OncoAlert will return to cooperation with Russia, and that “reason will prevail.”
“No one is protected from cancer, not even doctors, and that is why there should be no politics here,” he said.
Dr. Kaprin was speaking from Russia state-affiliated media, so it was not an independent commentary. Several of the Twitter responses to his video, primarily from non-Russians, were less than complimentary.
One user replied: “Cancer is rife in the Kremlin.”
Another post pointed out the hypocrisy of Russians being upset that OncoAlert was cutting ties with them. “What about sick Ukrainian kids, having to shelter in hospital basement, not having lifesaving surgeries because Russia decided to invade a democratic country?”
And another post was not buying the story that “reason will prevail,” in that the doctor’s talk seemed to contradict the reality of the situation. “I guess for every child #Russia murders they get cut off a little more from the civilized world?”
Cancer patients vulnerable
The war in Ukraine is an “unfolding humanitarian emergency,” said the World Health Organization, and it has called on top-level officials involved in the Russian invasion to ensure access for delivery of essential medical, surgical, and trauma supplies to help the Ukrainian people and refugees in neighboring countries. A shortage of oxygen, insulin, cancer therapies, and other essential supplies will continue to grow more dire in the weeks and months ahead, WHO officials predict.
One of the more heartbreaking reports described how pediatric cancer patients have been moved to hospital basements that are serving as temporary bomb shelters. Hospital staff continue to try to provide limited treatment when possible, even though essential supplies are dwindling.
“These children suffer more because they need to stay alive to fight with the cancer – and this fight cannot wait,” Lesia Lysytsia, MD, a doctor at Okhmatdyt, the country’s largest children’s hospital in Kyiv, said in an NBC news report.
For some children, the only treatment available is a basic form of chemotherapy, and at the Kyiv Regional Oncology Center, the situation became so dire for children in need of blood transfusions that physicians began to transfuse blood from parent to child.
“Our patients, they will die,” Dr. Lysytsia said. “We will calculate how many people or soldiers have died in attacks, but we will never calculate how many patients weren’t diagnosed of disease in time, how many patients died because they didn’t receive treatment. It’s an epic amount of people.”
Response from oncology community
Many of the large American oncology groups have issued strong statements expressing their support for Ukraine and offering assistance.
The American Cancer Society has partnered with the American Society of Clinical Oncology and the Sidney Kimmel Cancer Center–Jefferson Health to support all Ukrainian cancer patients and their families. The groups are engaging a network of oncologists and oncology nurses to provide support through the ACS Clinician Volunteer Corps.
The ACS and ASCO are making free cancer resources available in English, Ukrainian, Polish, and Russian through their patient information websites (available here and here), with additional patient education resources planned.
The ACS noted that there are more than 179,000 newly diagnosed patients with cancer among the Ukrainian people “suffering from Russia’s unprovoked aggression.”
“Disruptions to cancer treatment pose a grave risk to the survival of Ukrainian patients with cancer,” commented Karen Knudsen, PhD, CEO at the ACS.
ASCO also issued its own statement, declaring that it stands with “our Ukrainian members, the worldwide oncology community, and health care providers around the globe in condemning Russia’s unprovoked war on Ukraine.”
The society notes that it represents oncology professionals in Ukraine and neighboring countries including Poland, Romania, Moldova, Slovakia, and Hungary, which are now receiving thousands of refugees from the Russian invasion.
“We are hearing daily reports of cancer treatment interrupted by acts of war, including damage to medical facilities and shortages of critical supplies. Countless patients now need to find cancer care in new and unfamiliar surroundings with limited medical records and minimal resources,” the society commented.
The American Association for Cancer Research also issued a statement by President David A. Tuveson, MD, PhD, and CEO Margaret Foti, PhD, MD (hc). The organization has more than 50,000 members around the world, and they “stand in solidarity with the citizens of Ukraine during the Russian attack on their country.”
“This abhorrent war, which has been instigated by Russia’s leaders, is isolating and interrupting the lifesaving work of scientists and clinicians in Ukraine and Russia, threatening years of effective research collaborations and community building,” the AACR comments. “Limiting the exchange of innovative ideas, practices, and data across borders will significantly retard cancer research and have an adverse effect on public health.”
Perhaps the most subdued statement came from the European Society of Medical Oncology, in a brief release entitled: “Against Any War.” The society expressed profound sadness about the unfolding tragedy in Ukraine and the suffering of people. “We would like to confirm our solidarity and unconditioned support to all oncology professionals and cancer patients, with no geographical boundaries.”
ESMO also said that they were reviewing possibilities “to be of concrete help for our members and their patients, in collaboration with national and transnational oncology societies, as well as the International Cancer Foundation.”
A version of this article first appeared on Medscape.com.
As many in the world react with sanctions imposed on Russia after its invasion of Ukraine, the oncology community has now stepped into the fray.
All the large cancer organizations have put out statements in support of Ukraine, but one group has gone further and cut its ties with Russia.
“The international cancer specialist network, OncoAlert, severed all cooperation with doctors in Russia as part of the Western sanctions,” the group announced on its Twitter page, which is decorated with a blue and yellow ribbon and declares that it “stands with Ukraine.”
“The OncoAlert Network is nonpolitical but we cannot stand idle and not take a stand against this aggression toward our Ukrainian friends & colleagues,” the group said. “The network will be pulling out of ALL collaborations & congresses in Russia.”
Not surprisingly, the post was inundated with a barrage of inflammatory and politically laced tweets from Russian and Chinese users. Many of them repeated the same phrase about “violating the Hippocratic oath and the Geneva convention,” used foul language, and slammed the United States for past military actions in other parts of the world.
A prominent Russian oncologist also responded, posting a video in which he discussed the situation more coherently and without mudslinging or scripted phrases. Andrey Kaprin, MD, PhD, is chief oncologist of the Russian Federation as well as director general of the Federal State Budgetary Institution, NMRCC, of the Ministry of Health of the Russian Federation. He says they continue to maintain relations with the largest and best known oncologic organizations. “We haven’t felt any deterioration in our relationship yet, and of course, we hope that this won’t happen.”
Dr. Kaprin said he believes OncoAlert will return to cooperation with Russia, and that “reason will prevail.”
“No one is protected from cancer, not even doctors, and that is why there should be no politics here,” he said.
Dr. Kaprin was speaking from Russia state-affiliated media, so it was not an independent commentary. Several of the Twitter responses to his video, primarily from non-Russians, were less than complimentary.
One user replied: “Cancer is rife in the Kremlin.”
Another post pointed out the hypocrisy of Russians being upset that OncoAlert was cutting ties with them. “What about sick Ukrainian kids, having to shelter in hospital basement, not having lifesaving surgeries because Russia decided to invade a democratic country?”
And another post was not buying the story that “reason will prevail,” in that the doctor’s talk seemed to contradict the reality of the situation. “I guess for every child #Russia murders they get cut off a little more from the civilized world?”
Cancer patients vulnerable
The war in Ukraine is an “unfolding humanitarian emergency,” said the World Health Organization, and it has called on top-level officials involved in the Russian invasion to ensure access for delivery of essential medical, surgical, and trauma supplies to help the Ukrainian people and refugees in neighboring countries. A shortage of oxygen, insulin, cancer therapies, and other essential supplies will continue to grow more dire in the weeks and months ahead, WHO officials predict.
One of the more heartbreaking reports described how pediatric cancer patients have been moved to hospital basements that are serving as temporary bomb shelters. Hospital staff continue to try to provide limited treatment when possible, even though essential supplies are dwindling.
“These children suffer more because they need to stay alive to fight with the cancer – and this fight cannot wait,” Lesia Lysytsia, MD, a doctor at Okhmatdyt, the country’s largest children’s hospital in Kyiv, said in an NBC news report.
For some children, the only treatment available is a basic form of chemotherapy, and at the Kyiv Regional Oncology Center, the situation became so dire for children in need of blood transfusions that physicians began to transfuse blood from parent to child.
“Our patients, they will die,” Dr. Lysytsia said. “We will calculate how many people or soldiers have died in attacks, but we will never calculate how many patients weren’t diagnosed of disease in time, how many patients died because they didn’t receive treatment. It’s an epic amount of people.”
Response from oncology community
Many of the large American oncology groups have issued strong statements expressing their support for Ukraine and offering assistance.
The American Cancer Society has partnered with the American Society of Clinical Oncology and the Sidney Kimmel Cancer Center–Jefferson Health to support all Ukrainian cancer patients and their families. The groups are engaging a network of oncologists and oncology nurses to provide support through the ACS Clinician Volunteer Corps.
The ACS and ASCO are making free cancer resources available in English, Ukrainian, Polish, and Russian through their patient information websites (available here and here), with additional patient education resources planned.
The ACS noted that there are more than 179,000 newly diagnosed patients with cancer among the Ukrainian people “suffering from Russia’s unprovoked aggression.”
“Disruptions to cancer treatment pose a grave risk to the survival of Ukrainian patients with cancer,” commented Karen Knudsen, PhD, CEO at the ACS.
ASCO also issued its own statement, declaring that it stands with “our Ukrainian members, the worldwide oncology community, and health care providers around the globe in condemning Russia’s unprovoked war on Ukraine.”
The society notes that it represents oncology professionals in Ukraine and neighboring countries including Poland, Romania, Moldova, Slovakia, and Hungary, which are now receiving thousands of refugees from the Russian invasion.
“We are hearing daily reports of cancer treatment interrupted by acts of war, including damage to medical facilities and shortages of critical supplies. Countless patients now need to find cancer care in new and unfamiliar surroundings with limited medical records and minimal resources,” the society commented.
The American Association for Cancer Research also issued a statement by President David A. Tuveson, MD, PhD, and CEO Margaret Foti, PhD, MD (hc). The organization has more than 50,000 members around the world, and they “stand in solidarity with the citizens of Ukraine during the Russian attack on their country.”
“This abhorrent war, which has been instigated by Russia’s leaders, is isolating and interrupting the lifesaving work of scientists and clinicians in Ukraine and Russia, threatening years of effective research collaborations and community building,” the AACR comments. “Limiting the exchange of innovative ideas, practices, and data across borders will significantly retard cancer research and have an adverse effect on public health.”
Perhaps the most subdued statement came from the European Society of Medical Oncology, in a brief release entitled: “Against Any War.” The society expressed profound sadness about the unfolding tragedy in Ukraine and the suffering of people. “We would like to confirm our solidarity and unconditioned support to all oncology professionals and cancer patients, with no geographical boundaries.”
ESMO also said that they were reviewing possibilities “to be of concrete help for our members and their patients, in collaboration with national and transnational oncology societies, as well as the International Cancer Foundation.”
A version of this article first appeared on Medscape.com.