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Lenalidomide may reduce risk of progression from SMM to MM
Lenalidomide can reduce the risk of progression from smoldering multiple myeloma (SMM) to multiple myeloma (MM), according to a phase 2/3 trial.
At 3 years, the rate of progression-free survival (PFS) was 91% in SMM patients randomized to lenalidomide and 66% in those randomized to observation.
However, more than half of patients randomized to lenalidomide discontinued treatment because of toxicity.
These results are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.
Sagar Lonial, MD, of Winship Cancer Institute, Emory University, Atlanta, discussed the results in a press briefing in advance of the meeting.
A prior trial suggested that lenalidomide plus dexamethasone can improve time to MM development and overall survival in patients with high-risk SMM (Mateos MV et al. NEJM 2013). However, inferior imaging was used in this trial, and the addition of dexamethasone hindered researchers’ ability to isolate the effects of lenalidomide, Dr. Lonial said.
With their trial (NCT01169337), Dr. Lonial and colleagues tested lenalidomide alone and screened patients using magnetic resonance imaging.
The trial enrolled patients with intermediate or high-risk SMM in two phases. In phase 2, all 44 patients received lenalidomide at 25 mg daily on days 1-21 of a 28-day cycle. They also received aspirin at 325 mg on days 1-28.
In the phase 3 portion of the trial, 182 patients were randomized to observation or lenalidomide and aspirin at the aforementioned dose and schedule. Patients were stratified according to time since SMM diagnosis – 1 year or less vs. more than 1 year.
Safety
Dr. Lonial said, in general, lenalidomide was “very well tolerated.” However, 80% of patients in phase 2 and 51% in phase 3 discontinued lenalidomide due to toxicity.
The rates of treatment-related adverse events (AEs) in the phase 2 portion were 34.1% for grade 3 AEs, 11.4% for grade 4, and 4.5% for grade 5. In the phase 3 portion, 35.2% of patients had grade 3 treatment-related AEs, and 5.7% had grade 4 treatment-related AEs.
Common AEs in phase 3 were grade 4 neutrophil count decrease (4.5%) and grade 3 infections (20.5%), hypertension (9.1%), fatigue (6.8%), skin AEs (5.7%), dyspnea (5.7%), and hypokalemia (3.4%).
Efficacy
“It is worth noting that about 50% of patients had an objective response to lenalidomide in both the phase 2 and the phase 3 trial,” Dr. Lonial said. “I think it’s also important to realize that, in the phase 2 portion of this study, of the 44 patients enrolled, 78% of them did not progress to myeloma with a median follow-up of over 5 years.”
In phase 2, PFS was 98% at 1 year, 87% at 3 years, and 78% at 5 years.
In phase 3, PFS was 98% in the lenalidomide arm and 89% in the observation arm at 1 year. At 2 years, PFS was 93% in the lenalidomide arm and 76% in the observation arm. At 3 years, PFS was 91% in the lenalidomide arm and 66% in the observation arm.
“What’s really quite interesting is that each [risk] group appeared to benefit almost equally from the early intervention of lenalidomide as a single agent,” Dr. Lonial said. “[W]hile the high-risk group may be the target now, this may be a fertile area for investigation in the intermediate-risk group as well.”
Dr. Lonial has relationships with AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen Oncology, Juno Therapeutics, Merck, Novartis, and Takeda. The trial was funded by the National Institutes of Health.
SOURCE: Lonial S et al. ASCO 2019. Abstract 8001.
Lenalidomide can reduce the risk of progression from smoldering multiple myeloma (SMM) to multiple myeloma (MM), according to a phase 2/3 trial.
At 3 years, the rate of progression-free survival (PFS) was 91% in SMM patients randomized to lenalidomide and 66% in those randomized to observation.
However, more than half of patients randomized to lenalidomide discontinued treatment because of toxicity.
These results are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.
Sagar Lonial, MD, of Winship Cancer Institute, Emory University, Atlanta, discussed the results in a press briefing in advance of the meeting.
A prior trial suggested that lenalidomide plus dexamethasone can improve time to MM development and overall survival in patients with high-risk SMM (Mateos MV et al. NEJM 2013). However, inferior imaging was used in this trial, and the addition of dexamethasone hindered researchers’ ability to isolate the effects of lenalidomide, Dr. Lonial said.
With their trial (NCT01169337), Dr. Lonial and colleagues tested lenalidomide alone and screened patients using magnetic resonance imaging.
The trial enrolled patients with intermediate or high-risk SMM in two phases. In phase 2, all 44 patients received lenalidomide at 25 mg daily on days 1-21 of a 28-day cycle. They also received aspirin at 325 mg on days 1-28.
In the phase 3 portion of the trial, 182 patients were randomized to observation or lenalidomide and aspirin at the aforementioned dose and schedule. Patients were stratified according to time since SMM diagnosis – 1 year or less vs. more than 1 year.
Safety
Dr. Lonial said, in general, lenalidomide was “very well tolerated.” However, 80% of patients in phase 2 and 51% in phase 3 discontinued lenalidomide due to toxicity.
The rates of treatment-related adverse events (AEs) in the phase 2 portion were 34.1% for grade 3 AEs, 11.4% for grade 4, and 4.5% for grade 5. In the phase 3 portion, 35.2% of patients had grade 3 treatment-related AEs, and 5.7% had grade 4 treatment-related AEs.
Common AEs in phase 3 were grade 4 neutrophil count decrease (4.5%) and grade 3 infections (20.5%), hypertension (9.1%), fatigue (6.8%), skin AEs (5.7%), dyspnea (5.7%), and hypokalemia (3.4%).
Efficacy
“It is worth noting that about 50% of patients had an objective response to lenalidomide in both the phase 2 and the phase 3 trial,” Dr. Lonial said. “I think it’s also important to realize that, in the phase 2 portion of this study, of the 44 patients enrolled, 78% of them did not progress to myeloma with a median follow-up of over 5 years.”
In phase 2, PFS was 98% at 1 year, 87% at 3 years, and 78% at 5 years.
In phase 3, PFS was 98% in the lenalidomide arm and 89% in the observation arm at 1 year. At 2 years, PFS was 93% in the lenalidomide arm and 76% in the observation arm. At 3 years, PFS was 91% in the lenalidomide arm and 66% in the observation arm.
“What’s really quite interesting is that each [risk] group appeared to benefit almost equally from the early intervention of lenalidomide as a single agent,” Dr. Lonial said. “[W]hile the high-risk group may be the target now, this may be a fertile area for investigation in the intermediate-risk group as well.”
Dr. Lonial has relationships with AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen Oncology, Juno Therapeutics, Merck, Novartis, and Takeda. The trial was funded by the National Institutes of Health.
SOURCE: Lonial S et al. ASCO 2019. Abstract 8001.
Lenalidomide can reduce the risk of progression from smoldering multiple myeloma (SMM) to multiple myeloma (MM), according to a phase 2/3 trial.
At 3 years, the rate of progression-free survival (PFS) was 91% in SMM patients randomized to lenalidomide and 66% in those randomized to observation.
However, more than half of patients randomized to lenalidomide discontinued treatment because of toxicity.
These results are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.
Sagar Lonial, MD, of Winship Cancer Institute, Emory University, Atlanta, discussed the results in a press briefing in advance of the meeting.
A prior trial suggested that lenalidomide plus dexamethasone can improve time to MM development and overall survival in patients with high-risk SMM (Mateos MV et al. NEJM 2013). However, inferior imaging was used in this trial, and the addition of dexamethasone hindered researchers’ ability to isolate the effects of lenalidomide, Dr. Lonial said.
With their trial (NCT01169337), Dr. Lonial and colleagues tested lenalidomide alone and screened patients using magnetic resonance imaging.
The trial enrolled patients with intermediate or high-risk SMM in two phases. In phase 2, all 44 patients received lenalidomide at 25 mg daily on days 1-21 of a 28-day cycle. They also received aspirin at 325 mg on days 1-28.
In the phase 3 portion of the trial, 182 patients were randomized to observation or lenalidomide and aspirin at the aforementioned dose and schedule. Patients were stratified according to time since SMM diagnosis – 1 year or less vs. more than 1 year.
Safety
Dr. Lonial said, in general, lenalidomide was “very well tolerated.” However, 80% of patients in phase 2 and 51% in phase 3 discontinued lenalidomide due to toxicity.
The rates of treatment-related adverse events (AEs) in the phase 2 portion were 34.1% for grade 3 AEs, 11.4% for grade 4, and 4.5% for grade 5. In the phase 3 portion, 35.2% of patients had grade 3 treatment-related AEs, and 5.7% had grade 4 treatment-related AEs.
Common AEs in phase 3 were grade 4 neutrophil count decrease (4.5%) and grade 3 infections (20.5%), hypertension (9.1%), fatigue (6.8%), skin AEs (5.7%), dyspnea (5.7%), and hypokalemia (3.4%).
Efficacy
“It is worth noting that about 50% of patients had an objective response to lenalidomide in both the phase 2 and the phase 3 trial,” Dr. Lonial said. “I think it’s also important to realize that, in the phase 2 portion of this study, of the 44 patients enrolled, 78% of them did not progress to myeloma with a median follow-up of over 5 years.”
In phase 2, PFS was 98% at 1 year, 87% at 3 years, and 78% at 5 years.
In phase 3, PFS was 98% in the lenalidomide arm and 89% in the observation arm at 1 year. At 2 years, PFS was 93% in the lenalidomide arm and 76% in the observation arm. At 3 years, PFS was 91% in the lenalidomide arm and 66% in the observation arm.
“What’s really quite interesting is that each [risk] group appeared to benefit almost equally from the early intervention of lenalidomide as a single agent,” Dr. Lonial said. “[W]hile the high-risk group may be the target now, this may be a fertile area for investigation in the intermediate-risk group as well.”
Dr. Lonial has relationships with AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen Oncology, Juno Therapeutics, Merck, Novartis, and Takeda. The trial was funded by the National Institutes of Health.
SOURCE: Lonial S et al. ASCO 2019. Abstract 8001.
REPORTING FROM ASCO 2019
High-intensity statins may cut risk of joint replacement
TORONTO – comparing nearly 180,000 statin users with an equal number of propensity-matched nonusers, Jie Wei, PhD, reported at the OARSI 2019 World Congress.
Less intensive statin therapy was associated with significantly less need for joint replacement surgery in rheumatoid arthritis patients, but not in those with osteoarthritis, she said at the meeting, sponsored by the Osteoarthritis Research Society International.
“In summary, statins may reduce the risk of joint replacement, especially when given at high strength and in people with rheumatoid arthritis,” said Dr. Wei, an epidemiologist at Massachusetts General Hospital, Boston, and Central South University in Changsha, Hunan, China.
She was quick to note that this study can’t be considered the final, definitive word on the topic, since other investigators’ studies of the relationship between statin usage and joint replacement surgery for arthritis have yielded conflicting results. However, given the thoroughly established super-favorable risk/benefit ratio of statins for the prevention of cardiovascular morbidity and mortality, the possibility of a prospective, randomized, controlled trial addressing the joint surgery issue is for ethical reasons a train that’s left the station.
Dr. Wei presented an analysis drawn from the U.K. Clinical Practice Research Datalink for the years 1989 through mid-2017. The initial sample included the medical records of 17.1 million patients, or 26% of the total U.K. population. From that massive pool, she and her coinvestigators zeroed in on 178,467 statin users and an equal number of non–statin-user controls under the care of 718 primary care physicians, with the pairs propensity score-matched on the basis of age, gender, locality, comorbid conditions, nonstatin medications, lifestyle factors, and duration of rheumatoid arthritis or osteoarthritis. The mean age of the matched pairs was 62 years, 52% were women, and the mean prospective follow-up was 6.5 years.
The use of high-intensity statin therapy – for example, atorvastatin at 40-80 mg/day or rosuvastatin (Crestor) at 20-40 mg/day – was independently associated with a 21% reduction in the risk of knee or hip replacement surgery for osteoarthritis and a 90% reduction for rheumatoid arthritis, compared with statin nonusers. Notably, joint replacement surgery for osteoarthritis was roughly 25-fold more common than for rheumatoid arthritis.
Statin therapy overall, including the more widely prescribed low- and intermediate-intensity regimens, was associated with a 23% reduction in joint replacement surgery for rheumatoid arthritis, compared with statin nonusers, but had no significant impact on surgery for the osteoarthritis population.
A couple of distinguished American rheumatologists in the audience rose to voice reluctance about drawing broad conclusions from this study.
“Bias, as you’ve said yourself, is a bit of a concern,” said David T. Felson, MD, professor of medicine and public health and director of clinical epidemiology at Boston University.
He was troubled that the study design was such that anyone who filled as few as two statin prescriptions during the more than 6-year study period was categorized as a statin user. That, he said, muddies the waters. Does the database contain information on duration of statin therapy, and whether joint replacement surgery was more likely to occur when patients were on or off statin therapy? he asked.
It does, Dr. Wei replied, adding that she will take that suggestion for additional analysis back to her international team of coinvestigators.
“It seems to me,” said Jeffrey N. Katz, MD, “that the major risk of potential bias is that people who were provided high-intensity statins were prescribed that because they were at risk for or had cardiac disease.”
That high cardiovascular risk might have curbed orthopedic surgeons’ enthusiasm to operate. Thus, it would be helpful to learn whether patients who underwent joint replacement were less likely to have undergone coronary revascularization or other cardiac interventions than were those without joint replacement, according to Dr. Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.
Dr. Wei agreed that confounding by indication is always a possibility in an observational study such as this. Identification of a plausible mechanism by which statins might reduce the risk of joint replacement surgery in rheumatoid arthritis – something that hasn’t happened yet – would help counter such concerns.
She noted that a separate recent analysis of the U.K. Clinical Practice Research Datalink by other investigators concluded that statin therapy started up to 5 years following total hip or knee replacement was associated with a significantly reduced risk of revision arthroplasty. Moreover, the benefit was treatment duration-dependent: Patients on statin therapy for more than 5 years were 26% less likely to undergo revision arthroplasty than were those on a statin for less than 1 year (J Rheumatol. 2019 Mar 15. doi: 10.3899/jrheum.180574).
On the other hand, Swedish investigators found that statin use wasn’t associated with a reduced risk of consultation or surgery for osteoarthritis in a pooled analysis of four cohort studies totaling more than 132,000 Swedes followed for 7.5 years (Osteoarthritis Cartilage. 2017 Nov;25[11]:1804-13).
Dr. Wei reported having no financial conflicts regarding the study, which was supported by the National Clinical Research Center of Geriatric Disorders in Hunan, China, and several British universities.
SOURCE: Sarmanova A et al. Osteoarthritis cartilage. 2019 Apr;27[suppl 1]:S78-S79. Abstract 77.
TORONTO – comparing nearly 180,000 statin users with an equal number of propensity-matched nonusers, Jie Wei, PhD, reported at the OARSI 2019 World Congress.
Less intensive statin therapy was associated with significantly less need for joint replacement surgery in rheumatoid arthritis patients, but not in those with osteoarthritis, she said at the meeting, sponsored by the Osteoarthritis Research Society International.
“In summary, statins may reduce the risk of joint replacement, especially when given at high strength and in people with rheumatoid arthritis,” said Dr. Wei, an epidemiologist at Massachusetts General Hospital, Boston, and Central South University in Changsha, Hunan, China.
She was quick to note that this study can’t be considered the final, definitive word on the topic, since other investigators’ studies of the relationship between statin usage and joint replacement surgery for arthritis have yielded conflicting results. However, given the thoroughly established super-favorable risk/benefit ratio of statins for the prevention of cardiovascular morbidity and mortality, the possibility of a prospective, randomized, controlled trial addressing the joint surgery issue is for ethical reasons a train that’s left the station.
Dr. Wei presented an analysis drawn from the U.K. Clinical Practice Research Datalink for the years 1989 through mid-2017. The initial sample included the medical records of 17.1 million patients, or 26% of the total U.K. population. From that massive pool, she and her coinvestigators zeroed in on 178,467 statin users and an equal number of non–statin-user controls under the care of 718 primary care physicians, with the pairs propensity score-matched on the basis of age, gender, locality, comorbid conditions, nonstatin medications, lifestyle factors, and duration of rheumatoid arthritis or osteoarthritis. The mean age of the matched pairs was 62 years, 52% were women, and the mean prospective follow-up was 6.5 years.
The use of high-intensity statin therapy – for example, atorvastatin at 40-80 mg/day or rosuvastatin (Crestor) at 20-40 mg/day – was independently associated with a 21% reduction in the risk of knee or hip replacement surgery for osteoarthritis and a 90% reduction for rheumatoid arthritis, compared with statin nonusers. Notably, joint replacement surgery for osteoarthritis was roughly 25-fold more common than for rheumatoid arthritis.
Statin therapy overall, including the more widely prescribed low- and intermediate-intensity regimens, was associated with a 23% reduction in joint replacement surgery for rheumatoid arthritis, compared with statin nonusers, but had no significant impact on surgery for the osteoarthritis population.
A couple of distinguished American rheumatologists in the audience rose to voice reluctance about drawing broad conclusions from this study.
“Bias, as you’ve said yourself, is a bit of a concern,” said David T. Felson, MD, professor of medicine and public health and director of clinical epidemiology at Boston University.
He was troubled that the study design was such that anyone who filled as few as two statin prescriptions during the more than 6-year study period was categorized as a statin user. That, he said, muddies the waters. Does the database contain information on duration of statin therapy, and whether joint replacement surgery was more likely to occur when patients were on or off statin therapy? he asked.
It does, Dr. Wei replied, adding that she will take that suggestion for additional analysis back to her international team of coinvestigators.
“It seems to me,” said Jeffrey N. Katz, MD, “that the major risk of potential bias is that people who were provided high-intensity statins were prescribed that because they were at risk for or had cardiac disease.”
That high cardiovascular risk might have curbed orthopedic surgeons’ enthusiasm to operate. Thus, it would be helpful to learn whether patients who underwent joint replacement were less likely to have undergone coronary revascularization or other cardiac interventions than were those without joint replacement, according to Dr. Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.
Dr. Wei agreed that confounding by indication is always a possibility in an observational study such as this. Identification of a plausible mechanism by which statins might reduce the risk of joint replacement surgery in rheumatoid arthritis – something that hasn’t happened yet – would help counter such concerns.
She noted that a separate recent analysis of the U.K. Clinical Practice Research Datalink by other investigators concluded that statin therapy started up to 5 years following total hip or knee replacement was associated with a significantly reduced risk of revision arthroplasty. Moreover, the benefit was treatment duration-dependent: Patients on statin therapy for more than 5 years were 26% less likely to undergo revision arthroplasty than were those on a statin for less than 1 year (J Rheumatol. 2019 Mar 15. doi: 10.3899/jrheum.180574).
On the other hand, Swedish investigators found that statin use wasn’t associated with a reduced risk of consultation or surgery for osteoarthritis in a pooled analysis of four cohort studies totaling more than 132,000 Swedes followed for 7.5 years (Osteoarthritis Cartilage. 2017 Nov;25[11]:1804-13).
Dr. Wei reported having no financial conflicts regarding the study, which was supported by the National Clinical Research Center of Geriatric Disorders in Hunan, China, and several British universities.
SOURCE: Sarmanova A et al. Osteoarthritis cartilage. 2019 Apr;27[suppl 1]:S78-S79. Abstract 77.
TORONTO – comparing nearly 180,000 statin users with an equal number of propensity-matched nonusers, Jie Wei, PhD, reported at the OARSI 2019 World Congress.
Less intensive statin therapy was associated with significantly less need for joint replacement surgery in rheumatoid arthritis patients, but not in those with osteoarthritis, she said at the meeting, sponsored by the Osteoarthritis Research Society International.
“In summary, statins may reduce the risk of joint replacement, especially when given at high strength and in people with rheumatoid arthritis,” said Dr. Wei, an epidemiologist at Massachusetts General Hospital, Boston, and Central South University in Changsha, Hunan, China.
She was quick to note that this study can’t be considered the final, definitive word on the topic, since other investigators’ studies of the relationship between statin usage and joint replacement surgery for arthritis have yielded conflicting results. However, given the thoroughly established super-favorable risk/benefit ratio of statins for the prevention of cardiovascular morbidity and mortality, the possibility of a prospective, randomized, controlled trial addressing the joint surgery issue is for ethical reasons a train that’s left the station.
Dr. Wei presented an analysis drawn from the U.K. Clinical Practice Research Datalink for the years 1989 through mid-2017. The initial sample included the medical records of 17.1 million patients, or 26% of the total U.K. population. From that massive pool, she and her coinvestigators zeroed in on 178,467 statin users and an equal number of non–statin-user controls under the care of 718 primary care physicians, with the pairs propensity score-matched on the basis of age, gender, locality, comorbid conditions, nonstatin medications, lifestyle factors, and duration of rheumatoid arthritis or osteoarthritis. The mean age of the matched pairs was 62 years, 52% were women, and the mean prospective follow-up was 6.5 years.
The use of high-intensity statin therapy – for example, atorvastatin at 40-80 mg/day or rosuvastatin (Crestor) at 20-40 mg/day – was independently associated with a 21% reduction in the risk of knee or hip replacement surgery for osteoarthritis and a 90% reduction for rheumatoid arthritis, compared with statin nonusers. Notably, joint replacement surgery for osteoarthritis was roughly 25-fold more common than for rheumatoid arthritis.
Statin therapy overall, including the more widely prescribed low- and intermediate-intensity regimens, was associated with a 23% reduction in joint replacement surgery for rheumatoid arthritis, compared with statin nonusers, but had no significant impact on surgery for the osteoarthritis population.
A couple of distinguished American rheumatologists in the audience rose to voice reluctance about drawing broad conclusions from this study.
“Bias, as you’ve said yourself, is a bit of a concern,” said David T. Felson, MD, professor of medicine and public health and director of clinical epidemiology at Boston University.
He was troubled that the study design was such that anyone who filled as few as two statin prescriptions during the more than 6-year study period was categorized as a statin user. That, he said, muddies the waters. Does the database contain information on duration of statin therapy, and whether joint replacement surgery was more likely to occur when patients were on or off statin therapy? he asked.
It does, Dr. Wei replied, adding that she will take that suggestion for additional analysis back to her international team of coinvestigators.
“It seems to me,” said Jeffrey N. Katz, MD, “that the major risk of potential bias is that people who were provided high-intensity statins were prescribed that because they were at risk for or had cardiac disease.”
That high cardiovascular risk might have curbed orthopedic surgeons’ enthusiasm to operate. Thus, it would be helpful to learn whether patients who underwent joint replacement were less likely to have undergone coronary revascularization or other cardiac interventions than were those without joint replacement, according to Dr. Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.
Dr. Wei agreed that confounding by indication is always a possibility in an observational study such as this. Identification of a plausible mechanism by which statins might reduce the risk of joint replacement surgery in rheumatoid arthritis – something that hasn’t happened yet – would help counter such concerns.
She noted that a separate recent analysis of the U.K. Clinical Practice Research Datalink by other investigators concluded that statin therapy started up to 5 years following total hip or knee replacement was associated with a significantly reduced risk of revision arthroplasty. Moreover, the benefit was treatment duration-dependent: Patients on statin therapy for more than 5 years were 26% less likely to undergo revision arthroplasty than were those on a statin for less than 1 year (J Rheumatol. 2019 Mar 15. doi: 10.3899/jrheum.180574).
On the other hand, Swedish investigators found that statin use wasn’t associated with a reduced risk of consultation or surgery for osteoarthritis in a pooled analysis of four cohort studies totaling more than 132,000 Swedes followed for 7.5 years (Osteoarthritis Cartilage. 2017 Nov;25[11]:1804-13).
Dr. Wei reported having no financial conflicts regarding the study, which was supported by the National Clinical Research Center of Geriatric Disorders in Hunan, China, and several British universities.
SOURCE: Sarmanova A et al. Osteoarthritis cartilage. 2019 Apr;27[suppl 1]:S78-S79. Abstract 77.
REPORTING FROM OARSI 2019
Key clinical point: High-intensity statin therapy may reduce need for joint replacement in arthritis.
Major finding: The risk of knee or hip replacement surgery for rheumatoid arthritis was slashed by 90%, and by 21% for osteoarthritis.
Study details: This study included nearly 180,000 statin users propensity score-matched to an equal number of nonusers and prospectively followed for a mean of 6.5 years.
Disclosures: The study was supported by the National Clinical Research Center of Geriatric Disorders at Central South University in Hunan, China, and by several British universities. The presenter reported having no financial conflicts of interest.
Source: Sarmanova A et al. Osteoarthritis Cartilage. 2019 Apr;27[suppl 1]:S78-S79. Abstract 77.
New recommendations on TB screening for health care workers
U.S. health care personnel no longer need to undergo routine tuberculosis testing in the absence of known exposure, according to new screening guidelines from the National Tuberculosis Controllers Association and CDC.
The revised guidelines on tuberculosis screening, testing, and treatment of U.S. health care personnel, published in Morbidity and Mortality Weekly Report, are the first update since 2005. The new recommendations reflect a reduction in concern about U.S. health care personnel’s risk of occupational exposure to latent and active tuberculosis infection.
Lynn E. Sosa, MD, from the Connecticut Department of Public Health and National Tuberculosis Controllers Association, and coauthors wrote that rates of tuberculosis infection in the United States have declined by 73% since 1991, from 10.4/100,000 population in 1991 to 2.8/100,000 in 2017. This has been matched by similar declines among health care workers, which the authors said raised questions about the cost-effectiveness of the previously recommended routine serial occupational testing.
“In addition, a recent retrospective cohort study of approximately 40,000 health care personnel at a tertiary U.S. medical center in a low TB-incidence state found an extremely low rate of TST conversion (0.3%) during 1998-2014, with a limited proportion attributable to occupational exposure,” they wrote.
The new guidelines recommend health care personnel undergo baseline or preplacement tuberculosis testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST), as well as individual risk assessment and symptom evaluation.
The individual risk assessment considers whether the person has lived in a country with a high tuberculosis rate, whether they are immunosuppressed, or whether they have had close contact with someone with infectious tuberculosis.
This risk assessment can help decide how to interpret an initial positive test result, the authors said.
“For example, health care personnel with a positive test who are asymptomatic, unlikely to be infected with M. [Mycobacterium] tuberculosis, and at low risk for progression on the basis of their risk assessment should have a second test (either an IGRA or a TST) as recommended in the 2017 TB diagnostic guidelines of the American Thoracic Society, Infectious Diseases Society of America, and CDC,” they wrote. “In this example, the health care personnel should be considered infected with M. tuberculosis only if both the first and second tests are positive.”
After that baseline testing, personnel do not need to undergo routine serial testing except in the case of known exposure or ongoing transmission. The guideline authors suggested serial screening might be considered for health care workers whose work puts them at greater risk – for example, pulmonologists or respiratory therapists – or for those working in settings in which transmission has happened in the past.
For personnel with latent tuberculosis infection, the guidelines recommend “encouragement of treatment” unless it is contraindicated, and annual symptom screening in those not undergoing treatment.
The guideline committee also advocated for annual tuberculosis education for all health care workers.
The new recommendations were based on a systematic review of 36 studies of tuberculosis screening and testing among health care personnel, 16 of which were performed in the United States, and all but two of which were conducted in a hospital setting.
The authors stressed that recommendations from the 2005 CDC guidelines – which do not pertain to health care personnel screening, testing, treatment and education – remain unchanged.
One author declared personal fees from the National Tuberculosis Controllers Association during the conduct of the study. Two others reported unrelated grants and personal fees from private industry. No other conflicts of interest were disclosed.
SOURCE: Sosa L et al. MMWR. 2019;68:439-43.
U.S. health care personnel no longer need to undergo routine tuberculosis testing in the absence of known exposure, according to new screening guidelines from the National Tuberculosis Controllers Association and CDC.
The revised guidelines on tuberculosis screening, testing, and treatment of U.S. health care personnel, published in Morbidity and Mortality Weekly Report, are the first update since 2005. The new recommendations reflect a reduction in concern about U.S. health care personnel’s risk of occupational exposure to latent and active tuberculosis infection.
Lynn E. Sosa, MD, from the Connecticut Department of Public Health and National Tuberculosis Controllers Association, and coauthors wrote that rates of tuberculosis infection in the United States have declined by 73% since 1991, from 10.4/100,000 population in 1991 to 2.8/100,000 in 2017. This has been matched by similar declines among health care workers, which the authors said raised questions about the cost-effectiveness of the previously recommended routine serial occupational testing.
“In addition, a recent retrospective cohort study of approximately 40,000 health care personnel at a tertiary U.S. medical center in a low TB-incidence state found an extremely low rate of TST conversion (0.3%) during 1998-2014, with a limited proportion attributable to occupational exposure,” they wrote.
The new guidelines recommend health care personnel undergo baseline or preplacement tuberculosis testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST), as well as individual risk assessment and symptom evaluation.
The individual risk assessment considers whether the person has lived in a country with a high tuberculosis rate, whether they are immunosuppressed, or whether they have had close contact with someone with infectious tuberculosis.
This risk assessment can help decide how to interpret an initial positive test result, the authors said.
“For example, health care personnel with a positive test who are asymptomatic, unlikely to be infected with M. [Mycobacterium] tuberculosis, and at low risk for progression on the basis of their risk assessment should have a second test (either an IGRA or a TST) as recommended in the 2017 TB diagnostic guidelines of the American Thoracic Society, Infectious Diseases Society of America, and CDC,” they wrote. “In this example, the health care personnel should be considered infected with M. tuberculosis only if both the first and second tests are positive.”
After that baseline testing, personnel do not need to undergo routine serial testing except in the case of known exposure or ongoing transmission. The guideline authors suggested serial screening might be considered for health care workers whose work puts them at greater risk – for example, pulmonologists or respiratory therapists – or for those working in settings in which transmission has happened in the past.
For personnel with latent tuberculosis infection, the guidelines recommend “encouragement of treatment” unless it is contraindicated, and annual symptom screening in those not undergoing treatment.
The guideline committee also advocated for annual tuberculosis education for all health care workers.
The new recommendations were based on a systematic review of 36 studies of tuberculosis screening and testing among health care personnel, 16 of which were performed in the United States, and all but two of which were conducted in a hospital setting.
The authors stressed that recommendations from the 2005 CDC guidelines – which do not pertain to health care personnel screening, testing, treatment and education – remain unchanged.
One author declared personal fees from the National Tuberculosis Controllers Association during the conduct of the study. Two others reported unrelated grants and personal fees from private industry. No other conflicts of interest were disclosed.
SOURCE: Sosa L et al. MMWR. 2019;68:439-43.
U.S. health care personnel no longer need to undergo routine tuberculosis testing in the absence of known exposure, according to new screening guidelines from the National Tuberculosis Controllers Association and CDC.
The revised guidelines on tuberculosis screening, testing, and treatment of U.S. health care personnel, published in Morbidity and Mortality Weekly Report, are the first update since 2005. The new recommendations reflect a reduction in concern about U.S. health care personnel’s risk of occupational exposure to latent and active tuberculosis infection.
Lynn E. Sosa, MD, from the Connecticut Department of Public Health and National Tuberculosis Controllers Association, and coauthors wrote that rates of tuberculosis infection in the United States have declined by 73% since 1991, from 10.4/100,000 population in 1991 to 2.8/100,000 in 2017. This has been matched by similar declines among health care workers, which the authors said raised questions about the cost-effectiveness of the previously recommended routine serial occupational testing.
“In addition, a recent retrospective cohort study of approximately 40,000 health care personnel at a tertiary U.S. medical center in a low TB-incidence state found an extremely low rate of TST conversion (0.3%) during 1998-2014, with a limited proportion attributable to occupational exposure,” they wrote.
The new guidelines recommend health care personnel undergo baseline or preplacement tuberculosis testing with an interferon-gamma release assay (IGRA) or a tuberculin skin test (TST), as well as individual risk assessment and symptom evaluation.
The individual risk assessment considers whether the person has lived in a country with a high tuberculosis rate, whether they are immunosuppressed, or whether they have had close contact with someone with infectious tuberculosis.
This risk assessment can help decide how to interpret an initial positive test result, the authors said.
“For example, health care personnel with a positive test who are asymptomatic, unlikely to be infected with M. [Mycobacterium] tuberculosis, and at low risk for progression on the basis of their risk assessment should have a second test (either an IGRA or a TST) as recommended in the 2017 TB diagnostic guidelines of the American Thoracic Society, Infectious Diseases Society of America, and CDC,” they wrote. “In this example, the health care personnel should be considered infected with M. tuberculosis only if both the first and second tests are positive.”
After that baseline testing, personnel do not need to undergo routine serial testing except in the case of known exposure or ongoing transmission. The guideline authors suggested serial screening might be considered for health care workers whose work puts them at greater risk – for example, pulmonologists or respiratory therapists – or for those working in settings in which transmission has happened in the past.
For personnel with latent tuberculosis infection, the guidelines recommend “encouragement of treatment” unless it is contraindicated, and annual symptom screening in those not undergoing treatment.
The guideline committee also advocated for annual tuberculosis education for all health care workers.
The new recommendations were based on a systematic review of 36 studies of tuberculosis screening and testing among health care personnel, 16 of which were performed in the United States, and all but two of which were conducted in a hospital setting.
The authors stressed that recommendations from the 2005 CDC guidelines – which do not pertain to health care personnel screening, testing, treatment and education – remain unchanged.
One author declared personal fees from the National Tuberculosis Controllers Association during the conduct of the study. Two others reported unrelated grants and personal fees from private industry. No other conflicts of interest were disclosed.
SOURCE: Sosa L et al. MMWR. 2019;68:439-43.
FROM MMWR
PsA Fast Facts: Symptoms
Improved records, communication drive Oncology Care Model success
Effective EHRs, supportive leadership, and robust physician-patient communication are key elements to successful implementation of the Center for Medicare & Medicaid Services’ Oncology Care Model (OCM), according to a summary of experiences published in the Journal of the National Cancer Institute.
Lead author Ronald M. Kline, MD, of the Center for Medicare and Medicaid Innovation and colleagues interviewed three practices and one network of practices that have employed the agency’s OCM, which uses an episode-based payment structure and aims to enhance care quality, boost high-value care, and reduce costs. The model uses a two-part payment approach, which includes monthly care management payments and potential retrospective, performance-based payments based on lowering episodes’ total cost of care. Institutions interviewed for the summary were the Clearview Cancer Institute, based in Huntsville, Ala.; the Lancaster General Medical Group, based in Lancaster, Pa.; the University of Texas, Dallas; and the U.S. Oncology Network – McKesson Specialty Health, which operates across 25 states. Representatives from each institution answered questions about their successes and challenges with the model, including how the OCM has impacted work flow and patient care.
A central theme that emerged during the interviews was the importance of communication improvements among health care teams and within patient relationships to effectively implement OCM. For example, the Clearview Cancer Institute reported that, from the top down, communication has been a key factor in transforming patient care under the model. Weekly and monthly feedback reports for Clearview clinical employees paired with active efforts to improve communications between administrative and clinical staff have boosted collaboration among teams and ensured that OCM requirements are met, according to the interview summary. As part of OCM, participants must enact certain communication enhancements, including physician-patient discussion of treatment risks and goals through structured communications, such as the Institute of Medicine (IOM) Care Management Plan. Clearview officials reported that, before model implementation, about 2% of its patients had their advance care status documented in the EHR, compared with more than 90% of patients who now have such information documented.
For the Lancaster General Medical Group, revamping how and what type of information was documented in its EHR vastly improved its practice work flow and allowed staff to make more informed decisions as part of its OCM efforts. For example, the model’s requirement for the IOM care plan inspired Lancaster leaders to redesign its informed consent process with a sharper focus on shared decision making, advance care planning, and anticancer treatment education for patients, according to the summary. Lancaster also changed its process for starting an office visit in its EHR so that physicians and staff must review or perform important care management tasks associated with OCM implementation. The “rooming tool” developed for this goal became so beneficial that Lancaster’s EHR vendor will soon be making the tool available nationally.
However, for the University of Texas, Dallas, technology deficiencies within its EHR have posed challenges for instituting elements of the OCM. Program administrators underestimated the effort required to tailor systems to meet OCM metrics across its two participating institutions, university officials reported in the summary. A number of key activities required for OCM transformation have been delayed as the institution attempts to align work flows with its technology, including harmonization of triage scripts, mechanisms of nurse triage documentation, consistent use of staging and oncology history modules, and implementation of a clinical pathways program. Efficient use of technology remains the university’s biggest challenge to the model, according to program administrators.
Meanwhile, the U.S. Oncology Network emphasized the value of designating physician leaders responsible for driving change at each of its OCM-participating sites. Network officials reported that physician champions at each site share information about OCM claims data with colleagues and identify opportunities for improvement. For example, data regarding outliers in hospitalization rates, ED visits, treatment plans, quality metric documentation, and advance care planning. U.S. Oncology Network leaders stressed that OCM program success cannot be achieved without strong physician leadership and engagement.
Dr. Kline and colleagues concluded that there is not a single path to patient-centered, high-value care, writing that the CMS made OCM flexible so that practices may discover their own paths to practice transformation.
“Regardless of structure, however, participation in OCM and other similar value-based models is an acknowledgment of anticipated future health system changes in the U.S. and a desire to gain experience in this new paradigm earlier in the process,” Dr. Kline wrote in the summary. “As these practices have described, the path is sometimes challenging, but is intended to ultimately lead to improved patient engagement and care.”
CMS’ Oncology Care Model started in July 2016 and the performance period ends in June 2021. Participants include 176 practices and 10 payers. For more information on the model, visit the CMS website.
Two coauthors are employees of CMS. Other coauthors are employees or partners in OCM practices or their management companies, which receive payments from CMS for their participation in OCM.
SOURCE: Kline RM et al. J Natl Cancer Inst. 2019 May 3. doi: 10.1093/jnci/djz072.
Effective EHRs, supportive leadership, and robust physician-patient communication are key elements to successful implementation of the Center for Medicare & Medicaid Services’ Oncology Care Model (OCM), according to a summary of experiences published in the Journal of the National Cancer Institute.
Lead author Ronald M. Kline, MD, of the Center for Medicare and Medicaid Innovation and colleagues interviewed three practices and one network of practices that have employed the agency’s OCM, which uses an episode-based payment structure and aims to enhance care quality, boost high-value care, and reduce costs. The model uses a two-part payment approach, which includes monthly care management payments and potential retrospective, performance-based payments based on lowering episodes’ total cost of care. Institutions interviewed for the summary were the Clearview Cancer Institute, based in Huntsville, Ala.; the Lancaster General Medical Group, based in Lancaster, Pa.; the University of Texas, Dallas; and the U.S. Oncology Network – McKesson Specialty Health, which operates across 25 states. Representatives from each institution answered questions about their successes and challenges with the model, including how the OCM has impacted work flow and patient care.
A central theme that emerged during the interviews was the importance of communication improvements among health care teams and within patient relationships to effectively implement OCM. For example, the Clearview Cancer Institute reported that, from the top down, communication has been a key factor in transforming patient care under the model. Weekly and monthly feedback reports for Clearview clinical employees paired with active efforts to improve communications between administrative and clinical staff have boosted collaboration among teams and ensured that OCM requirements are met, according to the interview summary. As part of OCM, participants must enact certain communication enhancements, including physician-patient discussion of treatment risks and goals through structured communications, such as the Institute of Medicine (IOM) Care Management Plan. Clearview officials reported that, before model implementation, about 2% of its patients had their advance care status documented in the EHR, compared with more than 90% of patients who now have such information documented.
For the Lancaster General Medical Group, revamping how and what type of information was documented in its EHR vastly improved its practice work flow and allowed staff to make more informed decisions as part of its OCM efforts. For example, the model’s requirement for the IOM care plan inspired Lancaster leaders to redesign its informed consent process with a sharper focus on shared decision making, advance care planning, and anticancer treatment education for patients, according to the summary. Lancaster also changed its process for starting an office visit in its EHR so that physicians and staff must review or perform important care management tasks associated with OCM implementation. The “rooming tool” developed for this goal became so beneficial that Lancaster’s EHR vendor will soon be making the tool available nationally.
However, for the University of Texas, Dallas, technology deficiencies within its EHR have posed challenges for instituting elements of the OCM. Program administrators underestimated the effort required to tailor systems to meet OCM metrics across its two participating institutions, university officials reported in the summary. A number of key activities required for OCM transformation have been delayed as the institution attempts to align work flows with its technology, including harmonization of triage scripts, mechanisms of nurse triage documentation, consistent use of staging and oncology history modules, and implementation of a clinical pathways program. Efficient use of technology remains the university’s biggest challenge to the model, according to program administrators.
Meanwhile, the U.S. Oncology Network emphasized the value of designating physician leaders responsible for driving change at each of its OCM-participating sites. Network officials reported that physician champions at each site share information about OCM claims data with colleagues and identify opportunities for improvement. For example, data regarding outliers in hospitalization rates, ED visits, treatment plans, quality metric documentation, and advance care planning. U.S. Oncology Network leaders stressed that OCM program success cannot be achieved without strong physician leadership and engagement.
Dr. Kline and colleagues concluded that there is not a single path to patient-centered, high-value care, writing that the CMS made OCM flexible so that practices may discover their own paths to practice transformation.
“Regardless of structure, however, participation in OCM and other similar value-based models is an acknowledgment of anticipated future health system changes in the U.S. and a desire to gain experience in this new paradigm earlier in the process,” Dr. Kline wrote in the summary. “As these practices have described, the path is sometimes challenging, but is intended to ultimately lead to improved patient engagement and care.”
CMS’ Oncology Care Model started in July 2016 and the performance period ends in June 2021. Participants include 176 practices and 10 payers. For more information on the model, visit the CMS website.
Two coauthors are employees of CMS. Other coauthors are employees or partners in OCM practices or their management companies, which receive payments from CMS for their participation in OCM.
SOURCE: Kline RM et al. J Natl Cancer Inst. 2019 May 3. doi: 10.1093/jnci/djz072.
Effective EHRs, supportive leadership, and robust physician-patient communication are key elements to successful implementation of the Center for Medicare & Medicaid Services’ Oncology Care Model (OCM), according to a summary of experiences published in the Journal of the National Cancer Institute.
Lead author Ronald M. Kline, MD, of the Center for Medicare and Medicaid Innovation and colleagues interviewed three practices and one network of practices that have employed the agency’s OCM, which uses an episode-based payment structure and aims to enhance care quality, boost high-value care, and reduce costs. The model uses a two-part payment approach, which includes monthly care management payments and potential retrospective, performance-based payments based on lowering episodes’ total cost of care. Institutions interviewed for the summary were the Clearview Cancer Institute, based in Huntsville, Ala.; the Lancaster General Medical Group, based in Lancaster, Pa.; the University of Texas, Dallas; and the U.S. Oncology Network – McKesson Specialty Health, which operates across 25 states. Representatives from each institution answered questions about their successes and challenges with the model, including how the OCM has impacted work flow and patient care.
A central theme that emerged during the interviews was the importance of communication improvements among health care teams and within patient relationships to effectively implement OCM. For example, the Clearview Cancer Institute reported that, from the top down, communication has been a key factor in transforming patient care under the model. Weekly and monthly feedback reports for Clearview clinical employees paired with active efforts to improve communications between administrative and clinical staff have boosted collaboration among teams and ensured that OCM requirements are met, according to the interview summary. As part of OCM, participants must enact certain communication enhancements, including physician-patient discussion of treatment risks and goals through structured communications, such as the Institute of Medicine (IOM) Care Management Plan. Clearview officials reported that, before model implementation, about 2% of its patients had their advance care status documented in the EHR, compared with more than 90% of patients who now have such information documented.
For the Lancaster General Medical Group, revamping how and what type of information was documented in its EHR vastly improved its practice work flow and allowed staff to make more informed decisions as part of its OCM efforts. For example, the model’s requirement for the IOM care plan inspired Lancaster leaders to redesign its informed consent process with a sharper focus on shared decision making, advance care planning, and anticancer treatment education for patients, according to the summary. Lancaster also changed its process for starting an office visit in its EHR so that physicians and staff must review or perform important care management tasks associated with OCM implementation. The “rooming tool” developed for this goal became so beneficial that Lancaster’s EHR vendor will soon be making the tool available nationally.
However, for the University of Texas, Dallas, technology deficiencies within its EHR have posed challenges for instituting elements of the OCM. Program administrators underestimated the effort required to tailor systems to meet OCM metrics across its two participating institutions, university officials reported in the summary. A number of key activities required for OCM transformation have been delayed as the institution attempts to align work flows with its technology, including harmonization of triage scripts, mechanisms of nurse triage documentation, consistent use of staging and oncology history modules, and implementation of a clinical pathways program. Efficient use of technology remains the university’s biggest challenge to the model, according to program administrators.
Meanwhile, the U.S. Oncology Network emphasized the value of designating physician leaders responsible for driving change at each of its OCM-participating sites. Network officials reported that physician champions at each site share information about OCM claims data with colleagues and identify opportunities for improvement. For example, data regarding outliers in hospitalization rates, ED visits, treatment plans, quality metric documentation, and advance care planning. U.S. Oncology Network leaders stressed that OCM program success cannot be achieved without strong physician leadership and engagement.
Dr. Kline and colleagues concluded that there is not a single path to patient-centered, high-value care, writing that the CMS made OCM flexible so that practices may discover their own paths to practice transformation.
“Regardless of structure, however, participation in OCM and other similar value-based models is an acknowledgment of anticipated future health system changes in the U.S. and a desire to gain experience in this new paradigm earlier in the process,” Dr. Kline wrote in the summary. “As these practices have described, the path is sometimes challenging, but is intended to ultimately lead to improved patient engagement and care.”
CMS’ Oncology Care Model started in July 2016 and the performance period ends in June 2021. Participants include 176 practices and 10 payers. For more information on the model, visit the CMS website.
Two coauthors are employees of CMS. Other coauthors are employees or partners in OCM practices or their management companies, which receive payments from CMS for their participation in OCM.
SOURCE: Kline RM et al. J Natl Cancer Inst. 2019 May 3. doi: 10.1093/jnci/djz072.
FROM THE JOURNAL OF THE NATIONAL CANCER INSTITUTE
Literature review shows inconsistent measurement of financial toxicity
The current body of literature lacks validated survey instruments to effectively measure financial distress in cancer patients, according to a systematic review.
“This review systematizes the methods and items that previous studies used for measuring the subjective financial distress of cancer patients,” wrote Julian Witte of Bielefeld (Germany) University and colleagues. Their report is in Annals of Oncology.
In this systematic review, the investigators searched major databases for studies that included data on perceived financial burden experienced by patients with cancer. The team collected and classified all usable validated survey tools, which are necessary to obtain high-quality data for analysis.
“We analyzed all detected instruments, items domains, and questions with regard to their wording, scales, and the domains of financial distress covered,” the researchers wrote.
After applying the search criteria, the investigators identified 40 studies that fit the inclusion criteria. Among those included, 352 unique questions have been used to describe financial distress in cancer patients.
After analysis, the researchers identified six distinct subdomains that characterized patient views and responses to financial distress. In particular, these domains were the use of passive financial resources, support seeking, coping with one’s lifestyle, coping with care, psychosocial responses, and active financial spending.
“We found an inconsistent coverage and use of these domains that makes it difficult to compare and quantify the prevalence of financial distress,” they wrote.
One key limitation of the study was the observational design, which could limit the generalizability of the findings.
“There is a need to join efforts to develop a common understanding of the concept of financial toxicity and related subjective financial distress,” they concluded.
The study was funded by IPSEN Pharma GmbH. The authors reported having no conflicts of interest.
SOURCE: Witte J et al. Ann Oncol. 2019 May 2. doi: 10.1093/annonc/mdz140.
The current body of literature lacks validated survey instruments to effectively measure financial distress in cancer patients, according to a systematic review.
“This review systematizes the methods and items that previous studies used for measuring the subjective financial distress of cancer patients,” wrote Julian Witte of Bielefeld (Germany) University and colleagues. Their report is in Annals of Oncology.
In this systematic review, the investigators searched major databases for studies that included data on perceived financial burden experienced by patients with cancer. The team collected and classified all usable validated survey tools, which are necessary to obtain high-quality data for analysis.
“We analyzed all detected instruments, items domains, and questions with regard to their wording, scales, and the domains of financial distress covered,” the researchers wrote.
After applying the search criteria, the investigators identified 40 studies that fit the inclusion criteria. Among those included, 352 unique questions have been used to describe financial distress in cancer patients.
After analysis, the researchers identified six distinct subdomains that characterized patient views and responses to financial distress. In particular, these domains were the use of passive financial resources, support seeking, coping with one’s lifestyle, coping with care, psychosocial responses, and active financial spending.
“We found an inconsistent coverage and use of these domains that makes it difficult to compare and quantify the prevalence of financial distress,” they wrote.
One key limitation of the study was the observational design, which could limit the generalizability of the findings.
“There is a need to join efforts to develop a common understanding of the concept of financial toxicity and related subjective financial distress,” they concluded.
The study was funded by IPSEN Pharma GmbH. The authors reported having no conflicts of interest.
SOURCE: Witte J et al. Ann Oncol. 2019 May 2. doi: 10.1093/annonc/mdz140.
The current body of literature lacks validated survey instruments to effectively measure financial distress in cancer patients, according to a systematic review.
“This review systematizes the methods and items that previous studies used for measuring the subjective financial distress of cancer patients,” wrote Julian Witte of Bielefeld (Germany) University and colleagues. Their report is in Annals of Oncology.
In this systematic review, the investigators searched major databases for studies that included data on perceived financial burden experienced by patients with cancer. The team collected and classified all usable validated survey tools, which are necessary to obtain high-quality data for analysis.
“We analyzed all detected instruments, items domains, and questions with regard to their wording, scales, and the domains of financial distress covered,” the researchers wrote.
After applying the search criteria, the investigators identified 40 studies that fit the inclusion criteria. Among those included, 352 unique questions have been used to describe financial distress in cancer patients.
After analysis, the researchers identified six distinct subdomains that characterized patient views and responses to financial distress. In particular, these domains were the use of passive financial resources, support seeking, coping with one’s lifestyle, coping with care, psychosocial responses, and active financial spending.
“We found an inconsistent coverage and use of these domains that makes it difficult to compare and quantify the prevalence of financial distress,” they wrote.
One key limitation of the study was the observational design, which could limit the generalizability of the findings.
“There is a need to join efforts to develop a common understanding of the concept of financial toxicity and related subjective financial distress,” they concluded.
The study was funded by IPSEN Pharma GmbH. The authors reported having no conflicts of interest.
SOURCE: Witte J et al. Ann Oncol. 2019 May 2. doi: 10.1093/annonc/mdz140.
FROM ANNALS OF ONCOLOGY
Key clinical point: Researchers found a lack of validated instruments to effectively measure the financial burden experienced by cancer patients in the current body of literature.
Major finding: After analysis, six distinct subdomains that characterized patient views and responses to financial distress were identified.
Study details: A systematic review that identified 40 studies related to financial distress in cancer patients.
Disclosures: The study was funded by IPSEN Pharma GmbH. The authors reported having no conflicts of interest.
Source: Witte J et al. Ann Oncol. 2019 May 2. doi: 10.1093/annonc/mdz140.
Diet linked to lower risk of death from breast cancer
A balanced, low-fat diet was associated with a lower risk of death from breast cancer in a large cohort of postmenopausal women who had no previous history of breast cancer.
Researchers studied nearly 49,000 postmenopausal women and found a 21% lower risk of death from breast cancer among women who followed the balanced, low-fat diet, compared with women who followed their normal diet.
This research is scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.
Rowan Chlebowski, MD, PhD, of the Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center in Torrance, Calif., discussed the research during a press briefing in advance of the meeting.
About the study
The research is part of the Woman’s Health Initiative (NCT00000611), which is focused on investigating methods for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women.
This trial enrolled 48,835 postmenopausal women, ages 50-79 years, with no history of breast cancer and normal mammograms at enrollment. From 1993 to 1998, the women were randomized to the study diet (n = 19,541) or their normal diet (n = 29,294).
With the normal diet, fat accounted for 32% or more of subjects’ daily calories. With the study diet, the goal was to reduce fat consumption to 20% or less of caloric intake. The study diet also required at least one daily serving of vegetables, fruits, and grains.
Dr. Chlebowski said the study diet is similar to DASH (Dietary Approaches to Stop Hypertension), but is slightly more focused on lowering fat intake.
Diet adherence
Subjects followed the study diet for a median of 8.5 years, and the median cumulative follow-up was 19.6 years.
Dr. Chlebowski noted that most women on the study diet were not able to reduce their daily fat consumption to the 20% goal. They did reduce fat consumption to 24.5% overall, which increased to 29% at the end of the intervention.
In the study-diet group, there was an average weight loss of 3%, significantly different from that of the normal-diet group (P less than .001).
Dr. Chlebowski said the weight loss indicates that subjects did adhere to the study diet, at least in part, as there was no change in physical activity among study participants. Furthermore, the researchers have evidence after 1 year that suggests subjects were incorporating more fruits and vegetables into their diets.
Breast cancer and death
At a median follow-up of 19.6 years, there were 3,374 cases of breast cancer, 1,011 deaths, and 383 deaths attributed to breast cancer.
The risk of death from breast cancer was significantly lower in the study-diet group than in the normal-diet group. The hazard ratio was 0.79 (95% confidence interval, 0.64-0.97; P = .025).
The risk of death (from any cause) after breast cancer was significantly lower in the study diet group as well, with a hazard ratio of 0.85 (95% confidence interval, 0.74-0.96; P = .01).
“Adoption of a low-fat dietary pattern reduces the risk of death from breast cancer in postmenopausal women,” Dr. Chlebowski said. “To our review, this is the only study providing randomized clinical trial evidence that an intervention can reduce a woman’s risk of dying from breast cancer.”
Dr. Chlebowski noted that the researchers have blood samples from all subjects enrolled in this study. The researchers plan to analyze those samples to further explore how the study diet affected the women and determine which components of the diet account for which effects.
The National Institutes of Health funded the study. The researchers disclosed relationships with Novartis, Pfizer, Amgen, AstraZeneca, Immunomedics, Metastat, Bayer, and Genentech/Roche.
SOURCE: Chlebowski R. et al. ASCO 2019. Abstract 520.
A balanced, low-fat diet was associated with a lower risk of death from breast cancer in a large cohort of postmenopausal women who had no previous history of breast cancer.
Researchers studied nearly 49,000 postmenopausal women and found a 21% lower risk of death from breast cancer among women who followed the balanced, low-fat diet, compared with women who followed their normal diet.
This research is scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.
Rowan Chlebowski, MD, PhD, of the Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center in Torrance, Calif., discussed the research during a press briefing in advance of the meeting.
About the study
The research is part of the Woman’s Health Initiative (NCT00000611), which is focused on investigating methods for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women.
This trial enrolled 48,835 postmenopausal women, ages 50-79 years, with no history of breast cancer and normal mammograms at enrollment. From 1993 to 1998, the women were randomized to the study diet (n = 19,541) or their normal diet (n = 29,294).
With the normal diet, fat accounted for 32% or more of subjects’ daily calories. With the study diet, the goal was to reduce fat consumption to 20% or less of caloric intake. The study diet also required at least one daily serving of vegetables, fruits, and grains.
Dr. Chlebowski said the study diet is similar to DASH (Dietary Approaches to Stop Hypertension), but is slightly more focused on lowering fat intake.
Diet adherence
Subjects followed the study diet for a median of 8.5 years, and the median cumulative follow-up was 19.6 years.
Dr. Chlebowski noted that most women on the study diet were not able to reduce their daily fat consumption to the 20% goal. They did reduce fat consumption to 24.5% overall, which increased to 29% at the end of the intervention.
In the study-diet group, there was an average weight loss of 3%, significantly different from that of the normal-diet group (P less than .001).
Dr. Chlebowski said the weight loss indicates that subjects did adhere to the study diet, at least in part, as there was no change in physical activity among study participants. Furthermore, the researchers have evidence after 1 year that suggests subjects were incorporating more fruits and vegetables into their diets.
Breast cancer and death
At a median follow-up of 19.6 years, there were 3,374 cases of breast cancer, 1,011 deaths, and 383 deaths attributed to breast cancer.
The risk of death from breast cancer was significantly lower in the study-diet group than in the normal-diet group. The hazard ratio was 0.79 (95% confidence interval, 0.64-0.97; P = .025).
The risk of death (from any cause) after breast cancer was significantly lower in the study diet group as well, with a hazard ratio of 0.85 (95% confidence interval, 0.74-0.96; P = .01).
“Adoption of a low-fat dietary pattern reduces the risk of death from breast cancer in postmenopausal women,” Dr. Chlebowski said. “To our review, this is the only study providing randomized clinical trial evidence that an intervention can reduce a woman’s risk of dying from breast cancer.”
Dr. Chlebowski noted that the researchers have blood samples from all subjects enrolled in this study. The researchers plan to analyze those samples to further explore how the study diet affected the women and determine which components of the diet account for which effects.
The National Institutes of Health funded the study. The researchers disclosed relationships with Novartis, Pfizer, Amgen, AstraZeneca, Immunomedics, Metastat, Bayer, and Genentech/Roche.
SOURCE: Chlebowski R. et al. ASCO 2019. Abstract 520.
A balanced, low-fat diet was associated with a lower risk of death from breast cancer in a large cohort of postmenopausal women who had no previous history of breast cancer.
Researchers studied nearly 49,000 postmenopausal women and found a 21% lower risk of death from breast cancer among women who followed the balanced, low-fat diet, compared with women who followed their normal diet.
This research is scheduled to be presented at the annual meeting of the American Society of Clinical Oncology.
Rowan Chlebowski, MD, PhD, of the Los Angeles Biomedical Research Institute at Harbor–UCLA Medical Center in Torrance, Calif., discussed the research during a press briefing in advance of the meeting.
About the study
The research is part of the Woman’s Health Initiative (NCT00000611), which is focused on investigating methods for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women.
This trial enrolled 48,835 postmenopausal women, ages 50-79 years, with no history of breast cancer and normal mammograms at enrollment. From 1993 to 1998, the women were randomized to the study diet (n = 19,541) or their normal diet (n = 29,294).
With the normal diet, fat accounted for 32% or more of subjects’ daily calories. With the study diet, the goal was to reduce fat consumption to 20% or less of caloric intake. The study diet also required at least one daily serving of vegetables, fruits, and grains.
Dr. Chlebowski said the study diet is similar to DASH (Dietary Approaches to Stop Hypertension), but is slightly more focused on lowering fat intake.
Diet adherence
Subjects followed the study diet for a median of 8.5 years, and the median cumulative follow-up was 19.6 years.
Dr. Chlebowski noted that most women on the study diet were not able to reduce their daily fat consumption to the 20% goal. They did reduce fat consumption to 24.5% overall, which increased to 29% at the end of the intervention.
In the study-diet group, there was an average weight loss of 3%, significantly different from that of the normal-diet group (P less than .001).
Dr. Chlebowski said the weight loss indicates that subjects did adhere to the study diet, at least in part, as there was no change in physical activity among study participants. Furthermore, the researchers have evidence after 1 year that suggests subjects were incorporating more fruits and vegetables into their diets.
Breast cancer and death
At a median follow-up of 19.6 years, there were 3,374 cases of breast cancer, 1,011 deaths, and 383 deaths attributed to breast cancer.
The risk of death from breast cancer was significantly lower in the study-diet group than in the normal-diet group. The hazard ratio was 0.79 (95% confidence interval, 0.64-0.97; P = .025).
The risk of death (from any cause) after breast cancer was significantly lower in the study diet group as well, with a hazard ratio of 0.85 (95% confidence interval, 0.74-0.96; P = .01).
“Adoption of a low-fat dietary pattern reduces the risk of death from breast cancer in postmenopausal women,” Dr. Chlebowski said. “To our review, this is the only study providing randomized clinical trial evidence that an intervention can reduce a woman’s risk of dying from breast cancer.”
Dr. Chlebowski noted that the researchers have blood samples from all subjects enrolled in this study. The researchers plan to analyze those samples to further explore how the study diet affected the women and determine which components of the diet account for which effects.
The National Institutes of Health funded the study. The researchers disclosed relationships with Novartis, Pfizer, Amgen, AstraZeneca, Immunomedics, Metastat, Bayer, and Genentech/Roche.
SOURCE: Chlebowski R. et al. ASCO 2019. Abstract 520.
REPORTING FROM ASCO 2019
Key clinical point: Women who followed a balanced, low-fat diet had a lower risk of death from breast cancer compared with women who followed their normal diet.
Major finding: The risk of death from breast cancer was significantly lower in the study-diet group than in the normal-diet group (hazard ratio, 0.79, 95% confidence interval, 0.64-0.97; P = .025).
Study details: A cohort from the Women’s Health Initiative, which randomized 48,835 postmenopausal women to a low-fat diet or to their normal diet.
Disclosures: The National Institutes of Health funded the study. The researchers disclosed relationships with Novartis, Pfizer, Amgen, AstraZeneca, Immunomedics, Metastat, Bayer, and Genentech/Roche.
Source: Chlebowski R. et al. ASCO 2019. Abstract 520.
Sustainable weight loss seen 5 years after endoscopic sleeve gastroplasty
The finding comes from the first long-term analysis of outcomes following endoscopic sleeve gastroplasty, a relatively new, minimally invasive weight-loss procedure that offers patients an alternative to bariatric surgery.
“Endoscopic sleeve gastrectomy is a 1-day outpatient procedure that uses a suturing device attached to an endoscope to create a series of sutures that cinch the stomach like an accordion down to roughly the size of a banana, and leaves no scars,” lead study author Reem Z. Sharaiha, MD, MSc, said during a media briefing in advance of the annual Digestive Disease Week®. “The procedure causes patients to eat less because they feel full faster. This results in weight loss.”
Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
While previous studies have tracked ESG results for 1-2 years, her research team followed 203 patients who underwent the procedure between August 2013 and October 2018. “We felt that a longer-term study was needed to make sure weight loss was sustainable with this method of treatment, because research shows that if you keep weight loss for an extended period of time, you’re more likely to keep it off permanently, which is ultimately what we want for these patients,” said Dr. Sharaiha, who is an attending physician at New York–Presbyterian/Weill Cornell Medicine, New York.
At baseline, the mean age of the 203 patients was 46 years, 67% were female, and their mean body mass index was 39 kg/m2. Dr. Sharaiha and colleagues observed that maximum weight loss was generally achieved by 24 months after the procedure, after which patients tended to regain a small amount of their lost weight. For example, at 1 year, the mean weight loss was 18.1 kg, with a total body weight loss of 15.2% (P less than .0001 for both associations). At 2 years, the mean weight loss was 17.3 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 3 years, the mean weight loss was 20.8 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 5 years, the mean weight loss was 18.7 kg (P = .0003) and the total body weight loss was 14.5% (P = .0002).
Overall, patients gained an average 2.4 kg of weight after achieving their minimum weight after ESG until the end of follow-up. The researchers also found that failure to lose at least 10% of total body weight within the first 3 months after ESG decreased the chance of subsequent significant weight loss by 80%. Fewer than 1% of patients experienced complications, an improvement over surgical procedures.
“Our study showed very sustainable, significant weight loss for our patients between the 1 and 5 year mark,” Dr. Sharaiha said. “Out to 5 years, there was an average 15% total body weight loss. This is significant, because studies have shown that when people lose at least 10% of their body weight, they see improvement in blood pressure, diabetes, and heart outcomes, which are the comorbidities associated with obesity. We hope these findings will help persuade insurance companies that ESG is not experimental, but has value over patients’ lifespans.”
Dr. Sharaiha and colleagues plan to follow the current cohort for the next 10-20 years. “It’s important to show the value of these endoscopic procedures, so we’ll be looking at improvement in comorbidities such as diabetes, high blood pressure, and cholesterol,” she said. “We’re also part of a randomized study that’s currently under way looking at ESG in combination with diet and exercise.”
She reported having no financial disclosures.
The finding comes from the first long-term analysis of outcomes following endoscopic sleeve gastroplasty, a relatively new, minimally invasive weight-loss procedure that offers patients an alternative to bariatric surgery.
“Endoscopic sleeve gastrectomy is a 1-day outpatient procedure that uses a suturing device attached to an endoscope to create a series of sutures that cinch the stomach like an accordion down to roughly the size of a banana, and leaves no scars,” lead study author Reem Z. Sharaiha, MD, MSc, said during a media briefing in advance of the annual Digestive Disease Week®. “The procedure causes patients to eat less because they feel full faster. This results in weight loss.”
Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
While previous studies have tracked ESG results for 1-2 years, her research team followed 203 patients who underwent the procedure between August 2013 and October 2018. “We felt that a longer-term study was needed to make sure weight loss was sustainable with this method of treatment, because research shows that if you keep weight loss for an extended period of time, you’re more likely to keep it off permanently, which is ultimately what we want for these patients,” said Dr. Sharaiha, who is an attending physician at New York–Presbyterian/Weill Cornell Medicine, New York.
At baseline, the mean age of the 203 patients was 46 years, 67% were female, and their mean body mass index was 39 kg/m2. Dr. Sharaiha and colleagues observed that maximum weight loss was generally achieved by 24 months after the procedure, after which patients tended to regain a small amount of their lost weight. For example, at 1 year, the mean weight loss was 18.1 kg, with a total body weight loss of 15.2% (P less than .0001 for both associations). At 2 years, the mean weight loss was 17.3 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 3 years, the mean weight loss was 20.8 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 5 years, the mean weight loss was 18.7 kg (P = .0003) and the total body weight loss was 14.5% (P = .0002).
Overall, patients gained an average 2.4 kg of weight after achieving their minimum weight after ESG until the end of follow-up. The researchers also found that failure to lose at least 10% of total body weight within the first 3 months after ESG decreased the chance of subsequent significant weight loss by 80%. Fewer than 1% of patients experienced complications, an improvement over surgical procedures.
“Our study showed very sustainable, significant weight loss for our patients between the 1 and 5 year mark,” Dr. Sharaiha said. “Out to 5 years, there was an average 15% total body weight loss. This is significant, because studies have shown that when people lose at least 10% of their body weight, they see improvement in blood pressure, diabetes, and heart outcomes, which are the comorbidities associated with obesity. We hope these findings will help persuade insurance companies that ESG is not experimental, but has value over patients’ lifespans.”
Dr. Sharaiha and colleagues plan to follow the current cohort for the next 10-20 years. “It’s important to show the value of these endoscopic procedures, so we’ll be looking at improvement in comorbidities such as diabetes, high blood pressure, and cholesterol,” she said. “We’re also part of a randomized study that’s currently under way looking at ESG in combination with diet and exercise.”
She reported having no financial disclosures.
The finding comes from the first long-term analysis of outcomes following endoscopic sleeve gastroplasty, a relatively new, minimally invasive weight-loss procedure that offers patients an alternative to bariatric surgery.
“Endoscopic sleeve gastrectomy is a 1-day outpatient procedure that uses a suturing device attached to an endoscope to create a series of sutures that cinch the stomach like an accordion down to roughly the size of a banana, and leaves no scars,” lead study author Reem Z. Sharaiha, MD, MSc, said during a media briefing in advance of the annual Digestive Disease Week®. “The procedure causes patients to eat less because they feel full faster. This results in weight loss.”
Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
While previous studies have tracked ESG results for 1-2 years, her research team followed 203 patients who underwent the procedure between August 2013 and October 2018. “We felt that a longer-term study was needed to make sure weight loss was sustainable with this method of treatment, because research shows that if you keep weight loss for an extended period of time, you’re more likely to keep it off permanently, which is ultimately what we want for these patients,” said Dr. Sharaiha, who is an attending physician at New York–Presbyterian/Weill Cornell Medicine, New York.
At baseline, the mean age of the 203 patients was 46 years, 67% were female, and their mean body mass index was 39 kg/m2. Dr. Sharaiha and colleagues observed that maximum weight loss was generally achieved by 24 months after the procedure, after which patients tended to regain a small amount of their lost weight. For example, at 1 year, the mean weight loss was 18.1 kg, with a total body weight loss of 15.2% (P less than .0001 for both associations). At 2 years, the mean weight loss was 17.3 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 3 years, the mean weight loss was 20.8 kg, with a total body weight loss of 14.5% (P less than .0001 for both associations). At 5 years, the mean weight loss was 18.7 kg (P = .0003) and the total body weight loss was 14.5% (P = .0002).
Overall, patients gained an average 2.4 kg of weight after achieving their minimum weight after ESG until the end of follow-up. The researchers also found that failure to lose at least 10% of total body weight within the first 3 months after ESG decreased the chance of subsequent significant weight loss by 80%. Fewer than 1% of patients experienced complications, an improvement over surgical procedures.
“Our study showed very sustainable, significant weight loss for our patients between the 1 and 5 year mark,” Dr. Sharaiha said. “Out to 5 years, there was an average 15% total body weight loss. This is significant, because studies have shown that when people lose at least 10% of their body weight, they see improvement in blood pressure, diabetes, and heart outcomes, which are the comorbidities associated with obesity. We hope these findings will help persuade insurance companies that ESG is not experimental, but has value over patients’ lifespans.”
Dr. Sharaiha and colleagues plan to follow the current cohort for the next 10-20 years. “It’s important to show the value of these endoscopic procedures, so we’ll be looking at improvement in comorbidities such as diabetes, high blood pressure, and cholesterol,” she said. “We’re also part of a randomized study that’s currently under way looking at ESG in combination with diet and exercise.”
She reported having no financial disclosures.
FROM DDW 2019
Key clinical point: Endoscopic sleeve gastroplasty is an effective, minimally invasive weight-loss procedure that results in significant total body weight loss.
Major finding: Between 1 and 5 years after endoscopic sleeve gastroplasty, patients lost 15%-20% of their total body weight.
Study details: A retrospective study of prospectively collected data on 203 patients.
Disclosures: Dr. Sharaiha reported having no financial disclosures.
No raised risk of cardiovascular events for COPD patients on aclidinium
, compared with placebo, in a randomized trial of more than 3,000 patients.
Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.
ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.
The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.
Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).
In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).
Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.
“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV1 [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.
“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.
The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.
SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.
, compared with placebo, in a randomized trial of more than 3,000 patients.
Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.
ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.
The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.
Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).
In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).
Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.
“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV1 [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.
“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.
The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.
SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.
, compared with placebo, in a randomized trial of more than 3,000 patients.
Aclidinium, a long-acting muscarinic antagonist (LAMA), has been shown to reduce COPD exacerbation in the short term, but long-term effectiveness has not been examined, wrote Robert A. Wise, MD, of Johns Hopkins University, Baltimore, and colleagues.
ASCENT-COPD is a multicenter, double-blind, randomized, placebo-controlled, parallel-group noninferiority study conducted at 522 sites in the United States and Canada. A paper on recent data from ASCENT-COPD, published in JAMA, supports early findings reported last year at the American Thoracic Society meeting.
The researchers randomized adults with COPD to a 400-mg dose of aclidinium bromide twice daily, or placebo. The average age of the patients was 67 years; 59% were men. The median exposure time to aclidinium or placebo was 365 days during the first year of treatment, and the median exposure overall was 495 days for aclidinium patients and 478 days for placebo patients.
Of the 2,537 patients who completed the study, 69 (3.9%) in the aclidinium group and 76 (4.2%) in the placebo group experienced a major adverse cardiovascular event (MACE, defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke).
In addition, annual rates of moderate to severe COPD exacerbations were significantly lower in the aclidinium patients compared with placebo patients (0.44 vs. 0.57, P less than .001).
In a secondary analysis with a definition of MACE expanded to include heart failure, arrhythmias, or cerebrovascular disease, results remained similar between the groups; events occurred in 168 aclidinium patients (9.4%) and 160 placebo patients (8.9%). The rate of COPD exacerbations requiring hospitalization was significantly lower in aclidinium patients, compared with placebo patients (0.07 vs. 0.10, P = .006).
Overall, the most common treatment-emergent adverse events were similar in the aclidinium and placebo groups, respectively; pneumonia (6.1% vs. 5.8%), urinary tract infections (5.2% vs. 5.0%), and upper respiratory tract infections (4.8% vs. 5.6%). The most common serious adverse events (in at least 1% of patients) were pneumonia, atrial fibrillation, heart failure, and coronary artery disease. Dry mouth and urinary retention were rare, and occurred in less than 1% of patients in each group.
“No patient subgroup demonstrated a difference in efficacy except when analyzed by baseline COPD severity, in which the treatment benefit was observed only in patients with FEV1 [forced expiratory volume in 1 second] of 50% predicted or less,” the researchers noted. “This may be explained by the lower exacerbation rate seen in the placebo group in patients with moderate airway obstruction vs. severe or very severe obstruction,” they said.
“Outcomes of this trial add data to the long-standing controversy over the safety of LAMAs in COPD” and support the need for additional research, they said.
The study findings were limited by several factors including insufficient power to detect cause-specific mortality and the use of a LAMA with low risk of systemic effects, the researchers noted.
SOURCE: Wise R et al. JAMA. 2019. 321:1693-1701.
FROM JAMA
PET imaging at diagnosis improves oropharyngeal cancer outcomes
For patients with oropharyngeal squamous cell carcinoma (OPSCC), initial staging with PET is associated with better cancer-specific survival (CSS) than staging with other imaging modalities, based on a retrospective analysis of more than 1,700 patients.
PET was associated with a better 3-year overall survival rate than either MRI without PET or CT alone, reported lead author Rustain L. Morgan, MD, of the University of Colorado at Denver, Aurora, and colleagues.
“To our knowledge, there have been no prospective, randomized, controlled trials to date to evaluate the effect of different imaging modalities at the time of initial staging on cancer-specific survival,” the investigators wrote in Cancer. “A population-based data source such as the Surveillance, Epidemiology, and End Results [SEER]–Medicare database provides an excellent opportunity to compare the impact of imaging modality differences on survival in patients with OPSCC.”
Using SEER data, the investigators identified more than 3,704 patients with oropharyngeal cancer; following exclusions, 1,765 patients were involved in the final analysis based on various factors, including survival beyond 2 months after diagnosis and squamous cell carcinoma histology. A Cox proportional hazards model was used to assess relationships between the primary outcome and 3-year CSS rate and imaging, sex, age, region, race, and education.
Results showed that most patients had PET imaging upon diagnosis (83.3%), while fewer had CT alone (11.4%) or MRI without PET (5.2%). Several underlying trends were found: Patients in the West were more likely to undergo PET than patients in the Midwest, South, or East; patients younger than 75 years were more likely to have PET than older patients; and men were more likely to be staged with PET than women. The 3-year CSS was longest for patients who underwent PET (56.8%), followed by MRI without PET (50.1%) and CT alone (47.3%). Controlling for treatment and stage of disease, multivariate analysis also suggested that PET is associated with better CSS; patients staged with MRI without PET had a hazard ratio of 1.748 (P = .0036) and those imaged with CT alone had an HR of 1.337 (P = .0491). Although the Cox proportional hazards model for overall survival revealed numerical trends, these lacked statistical significance for MRI without PET (HR, 1.365; P =.0683) and CT alone (HR, 1.213; P = .114).
“The current study demonstrated a significant difference in CSS based on initial imaging,” the investigators wrote. “These findings are consistent with a prior study that reported that PET imaging can improve the staging of patients with head and neck cancers, particularly as it relates to radiotherapy planning.
“The data from the current study suggest the need for further prospective research to evaluate whether CT or MRI should be considered adequate for the initial staging of patients with OPSCC,” the investigators concluded.
The study was funded by the University of Colorado Cancer Center. One coauthor reported relationships with the American Heart Association and the National Heart, Lung, and Blood Institute.
SOURCE: Morgan RL et al. Cancer. 2019 May 1. doi:10.1002/cncr.32148.
For patients with oropharyngeal squamous cell carcinoma (OPSCC), initial staging with PET is associated with better cancer-specific survival (CSS) than staging with other imaging modalities, based on a retrospective analysis of more than 1,700 patients.
PET was associated with a better 3-year overall survival rate than either MRI without PET or CT alone, reported lead author Rustain L. Morgan, MD, of the University of Colorado at Denver, Aurora, and colleagues.
“To our knowledge, there have been no prospective, randomized, controlled trials to date to evaluate the effect of different imaging modalities at the time of initial staging on cancer-specific survival,” the investigators wrote in Cancer. “A population-based data source such as the Surveillance, Epidemiology, and End Results [SEER]–Medicare database provides an excellent opportunity to compare the impact of imaging modality differences on survival in patients with OPSCC.”
Using SEER data, the investigators identified more than 3,704 patients with oropharyngeal cancer; following exclusions, 1,765 patients were involved in the final analysis based on various factors, including survival beyond 2 months after diagnosis and squamous cell carcinoma histology. A Cox proportional hazards model was used to assess relationships between the primary outcome and 3-year CSS rate and imaging, sex, age, region, race, and education.
Results showed that most patients had PET imaging upon diagnosis (83.3%), while fewer had CT alone (11.4%) or MRI without PET (5.2%). Several underlying trends were found: Patients in the West were more likely to undergo PET than patients in the Midwest, South, or East; patients younger than 75 years were more likely to have PET than older patients; and men were more likely to be staged with PET than women. The 3-year CSS was longest for patients who underwent PET (56.8%), followed by MRI without PET (50.1%) and CT alone (47.3%). Controlling for treatment and stage of disease, multivariate analysis also suggested that PET is associated with better CSS; patients staged with MRI without PET had a hazard ratio of 1.748 (P = .0036) and those imaged with CT alone had an HR of 1.337 (P = .0491). Although the Cox proportional hazards model for overall survival revealed numerical trends, these lacked statistical significance for MRI without PET (HR, 1.365; P =.0683) and CT alone (HR, 1.213; P = .114).
“The current study demonstrated a significant difference in CSS based on initial imaging,” the investigators wrote. “These findings are consistent with a prior study that reported that PET imaging can improve the staging of patients with head and neck cancers, particularly as it relates to radiotherapy planning.
“The data from the current study suggest the need for further prospective research to evaluate whether CT or MRI should be considered adequate for the initial staging of patients with OPSCC,” the investigators concluded.
The study was funded by the University of Colorado Cancer Center. One coauthor reported relationships with the American Heart Association and the National Heart, Lung, and Blood Institute.
SOURCE: Morgan RL et al. Cancer. 2019 May 1. doi:10.1002/cncr.32148.
For patients with oropharyngeal squamous cell carcinoma (OPSCC), initial staging with PET is associated with better cancer-specific survival (CSS) than staging with other imaging modalities, based on a retrospective analysis of more than 1,700 patients.
PET was associated with a better 3-year overall survival rate than either MRI without PET or CT alone, reported lead author Rustain L. Morgan, MD, of the University of Colorado at Denver, Aurora, and colleagues.
“To our knowledge, there have been no prospective, randomized, controlled trials to date to evaluate the effect of different imaging modalities at the time of initial staging on cancer-specific survival,” the investigators wrote in Cancer. “A population-based data source such as the Surveillance, Epidemiology, and End Results [SEER]–Medicare database provides an excellent opportunity to compare the impact of imaging modality differences on survival in patients with OPSCC.”
Using SEER data, the investigators identified more than 3,704 patients with oropharyngeal cancer; following exclusions, 1,765 patients were involved in the final analysis based on various factors, including survival beyond 2 months after diagnosis and squamous cell carcinoma histology. A Cox proportional hazards model was used to assess relationships between the primary outcome and 3-year CSS rate and imaging, sex, age, region, race, and education.
Results showed that most patients had PET imaging upon diagnosis (83.3%), while fewer had CT alone (11.4%) or MRI without PET (5.2%). Several underlying trends were found: Patients in the West were more likely to undergo PET than patients in the Midwest, South, or East; patients younger than 75 years were more likely to have PET than older patients; and men were more likely to be staged with PET than women. The 3-year CSS was longest for patients who underwent PET (56.8%), followed by MRI without PET (50.1%) and CT alone (47.3%). Controlling for treatment and stage of disease, multivariate analysis also suggested that PET is associated with better CSS; patients staged with MRI without PET had a hazard ratio of 1.748 (P = .0036) and those imaged with CT alone had an HR of 1.337 (P = .0491). Although the Cox proportional hazards model for overall survival revealed numerical trends, these lacked statistical significance for MRI without PET (HR, 1.365; P =.0683) and CT alone (HR, 1.213; P = .114).
“The current study demonstrated a significant difference in CSS based on initial imaging,” the investigators wrote. “These findings are consistent with a prior study that reported that PET imaging can improve the staging of patients with head and neck cancers, particularly as it relates to radiotherapy planning.
“The data from the current study suggest the need for further prospective research to evaluate whether CT or MRI should be considered adequate for the initial staging of patients with OPSCC,” the investigators concluded.
The study was funded by the University of Colorado Cancer Center. One coauthor reported relationships with the American Heart Association and the National Heart, Lung, and Blood Institute.
SOURCE: Morgan RL et al. Cancer. 2019 May 1. doi:10.1002/cncr.32148.
FROM CANCER
Key clinical point: For patients with oropharyngeal cancer, initial staging with PET imaging is associated with better cancer-specific survival than staging with other imaging modalities.
Major finding: Patients who underwent PET at diagnosis had a 3-year overall survival rate of 56.8%, compared with those who had MRI without PET (50.1%) or CT alone (47.3%).
Study details: A retrospective analysis of 1,765 patients with oropharyngeal cancer who had imaging performed at diagnosis.
Disclosures: The study was funded by the University of Colorado Cancer Center. One coauthor reported relationships with the American Heart Association and the National Heart, Lung, and Blood Institute.
Source: Morgan RL et al. Cancer. 2019 May 1. doi:10.1002/cncr.32148.