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Telemedicine in cancer care: Not all patients can access
CHICAGO – for patients with cancer, but uptake of telemedicine was plagued by inequities, a retrospective study suggests.
Before March 2020, only a very small percentage of patients with cancer used telemedicine services.
By November 2021, nearly 16% of patients initiating cancer treatment were using this approach.
However, certain groups were less likely to use telemedicine, in particular, patients who were Black, uninsured, did not live in cities, and were less affluent, noted lead author Jenny S. Guadamuz, PhD, a quantitative scientist at Flatiron Health and a postdoctoral research associate at the University of Southern California, Los Angeles.
The results are concerning because they suggest that telemedicine expansion could widen cancer care disparities, Dr. Guadamuz said. Previous studies found racial disparities in care access and outcomes early on in the pandemic.
“These findings are critically important considering recent efforts to make coverage of telemedicine services permanent, instead of tied to the [Health and Human Services] public health emergency declaration,” she said. “There are also efforts to increase reimbursement rates for telemedicine services by Medicare, several Medicaid programs, and private insurers.”
This study was highlighted at a press briefing held in advance of the American Society of Clinical Oncology annual meeting, where it will be presented at a poster session (abstract 6511).
ASCO President Everett E. Vokes, MD, said telemedicine is “an important tool to communicate with patients” but that it is important to consider the “digital divide.”
He also emphasized the need “to expand and learn to use telehealth not in a crisis but as part of our regular care moving forward.” In July 2021, as telemedicine services were expanding, ASCO released practice recommendations specific to telehealth and oncology.
“Telemedicine can improve access to timely cancer care, but, as this study points out, telemedicine must be available equitably, so that every patient can access the care they need and deserve,” he said in a press statement.
Study details
For the study, Dr. Guadamuz and colleagues assessed telemedicine uptake by nearly 27,000 patients in a Flatiron electronic health record–derived deidentified database of patients who initiated treatment for any of 21 common cancers at about 280 community oncology clinics between March 2020 and November 2021.
They found that Black patients were significantly less likely than were White patients to use telemedicine (13.2% vs. 15.6%; odds ratio [OR], 0.82), as were patients without documented insurance, compared with those who were well insured (11.6% vs. 16.4%; OR, 0.68).
Those in rural and suburban areas were less likely than were those in urban areas to use telemedicine (9.7% and 13.0% vs. 17.7%; ORs, 0.50 and 0.69, respectively), and those in less affluent vs. more affluent areas were also less likely to use telemedicine (10.6% vs. 23.6%, OR, 0.39).
Dr. Guadamuz noted that the differences remained statistically significant after adjustment for clinical characteristics and that racial inequities were seen across cancer types and over time.
Future work should assess other potential characteristics associated with telemedicine inequities, evaluate whether health care delivered via telemedicine is of similar quality as in-person services, and determine the types of practice that are providing telemedicine more equitably to their patients, she concluded.
A version of this article first appeared on Medscape.com.
CHICAGO – for patients with cancer, but uptake of telemedicine was plagued by inequities, a retrospective study suggests.
Before March 2020, only a very small percentage of patients with cancer used telemedicine services.
By November 2021, nearly 16% of patients initiating cancer treatment were using this approach.
However, certain groups were less likely to use telemedicine, in particular, patients who were Black, uninsured, did not live in cities, and were less affluent, noted lead author Jenny S. Guadamuz, PhD, a quantitative scientist at Flatiron Health and a postdoctoral research associate at the University of Southern California, Los Angeles.
The results are concerning because they suggest that telemedicine expansion could widen cancer care disparities, Dr. Guadamuz said. Previous studies found racial disparities in care access and outcomes early on in the pandemic.
“These findings are critically important considering recent efforts to make coverage of telemedicine services permanent, instead of tied to the [Health and Human Services] public health emergency declaration,” she said. “There are also efforts to increase reimbursement rates for telemedicine services by Medicare, several Medicaid programs, and private insurers.”
This study was highlighted at a press briefing held in advance of the American Society of Clinical Oncology annual meeting, where it will be presented at a poster session (abstract 6511).
ASCO President Everett E. Vokes, MD, said telemedicine is “an important tool to communicate with patients” but that it is important to consider the “digital divide.”
He also emphasized the need “to expand and learn to use telehealth not in a crisis but as part of our regular care moving forward.” In July 2021, as telemedicine services were expanding, ASCO released practice recommendations specific to telehealth and oncology.
“Telemedicine can improve access to timely cancer care, but, as this study points out, telemedicine must be available equitably, so that every patient can access the care they need and deserve,” he said in a press statement.
Study details
For the study, Dr. Guadamuz and colleagues assessed telemedicine uptake by nearly 27,000 patients in a Flatiron electronic health record–derived deidentified database of patients who initiated treatment for any of 21 common cancers at about 280 community oncology clinics between March 2020 and November 2021.
They found that Black patients were significantly less likely than were White patients to use telemedicine (13.2% vs. 15.6%; odds ratio [OR], 0.82), as were patients without documented insurance, compared with those who were well insured (11.6% vs. 16.4%; OR, 0.68).
Those in rural and suburban areas were less likely than were those in urban areas to use telemedicine (9.7% and 13.0% vs. 17.7%; ORs, 0.50 and 0.69, respectively), and those in less affluent vs. more affluent areas were also less likely to use telemedicine (10.6% vs. 23.6%, OR, 0.39).
Dr. Guadamuz noted that the differences remained statistically significant after adjustment for clinical characteristics and that racial inequities were seen across cancer types and over time.
Future work should assess other potential characteristics associated with telemedicine inequities, evaluate whether health care delivered via telemedicine is of similar quality as in-person services, and determine the types of practice that are providing telemedicine more equitably to their patients, she concluded.
A version of this article first appeared on Medscape.com.
CHICAGO – for patients with cancer, but uptake of telemedicine was plagued by inequities, a retrospective study suggests.
Before March 2020, only a very small percentage of patients with cancer used telemedicine services.
By November 2021, nearly 16% of patients initiating cancer treatment were using this approach.
However, certain groups were less likely to use telemedicine, in particular, patients who were Black, uninsured, did not live in cities, and were less affluent, noted lead author Jenny S. Guadamuz, PhD, a quantitative scientist at Flatiron Health and a postdoctoral research associate at the University of Southern California, Los Angeles.
The results are concerning because they suggest that telemedicine expansion could widen cancer care disparities, Dr. Guadamuz said. Previous studies found racial disparities in care access and outcomes early on in the pandemic.
“These findings are critically important considering recent efforts to make coverage of telemedicine services permanent, instead of tied to the [Health and Human Services] public health emergency declaration,” she said. “There are also efforts to increase reimbursement rates for telemedicine services by Medicare, several Medicaid programs, and private insurers.”
This study was highlighted at a press briefing held in advance of the American Society of Clinical Oncology annual meeting, where it will be presented at a poster session (abstract 6511).
ASCO President Everett E. Vokes, MD, said telemedicine is “an important tool to communicate with patients” but that it is important to consider the “digital divide.”
He also emphasized the need “to expand and learn to use telehealth not in a crisis but as part of our regular care moving forward.” In July 2021, as telemedicine services were expanding, ASCO released practice recommendations specific to telehealth and oncology.
“Telemedicine can improve access to timely cancer care, but, as this study points out, telemedicine must be available equitably, so that every patient can access the care they need and deserve,” he said in a press statement.
Study details
For the study, Dr. Guadamuz and colleagues assessed telemedicine uptake by nearly 27,000 patients in a Flatiron electronic health record–derived deidentified database of patients who initiated treatment for any of 21 common cancers at about 280 community oncology clinics between March 2020 and November 2021.
They found that Black patients were significantly less likely than were White patients to use telemedicine (13.2% vs. 15.6%; odds ratio [OR], 0.82), as were patients without documented insurance, compared with those who were well insured (11.6% vs. 16.4%; OR, 0.68).
Those in rural and suburban areas were less likely than were those in urban areas to use telemedicine (9.7% and 13.0% vs. 17.7%; ORs, 0.50 and 0.69, respectively), and those in less affluent vs. more affluent areas were also less likely to use telemedicine (10.6% vs. 23.6%, OR, 0.39).
Dr. Guadamuz noted that the differences remained statistically significant after adjustment for clinical characteristics and that racial inequities were seen across cancer types and over time.
Future work should assess other potential characteristics associated with telemedicine inequities, evaluate whether health care delivered via telemedicine is of similar quality as in-person services, and determine the types of practice that are providing telemedicine more equitably to their patients, she concluded.
A version of this article first appeared on Medscape.com.
AT ASCO 2022
Increased social services spending ups cancer survival of Blacks
Five-year overall survival increased among non-Hispanic Black patients by 2.02% in conjunction with a 10% increase in spending. In addition, there was a decrease in racial disparities in survival between non-Hispanic Black patients and White patients for many types of cancers.
However, public welfare spending had no real impact on the overall 5-year survival for the entire cohort (0.25 % per 10% increase in spending; P = .78) or for non-Hispanic White patients (0.52% per 10% increase in spending, P = .58).
“We know from prior research that outcomes are worse for minorities,” said lead author Justin Michael Barnes, MD, from the department of radiation oncology at Washington University in St. Louis, Mo. “It’s thought that some of the differences are related to impaired access to health care for minorities, which is related to social determinants of health. This includes socioeconomic factors, educational attainment, place of residence, as well as environmental stressors.
“Our data show that greater state welfare expenditures were associated with greater 5-year survival among Black patients and decreased Black–White disparities,” said Dr. Barnes. “I think these data are thought provoking, but they certainly aren’t the end. I see these data as a proof-of-concept project.”
Dr. Barnes reported the findings at a press conference held in advance of the annual meeting of the American Society of Clinical Oncology, during which the study will be presented (Abstract 6509).
Improved 5-year survival in Black patients
For the study, Dr. Barnes and colleagues evaluated the association of 5-year overall survival and public welfare spending in 2,925,550 individuals aged 18 years and older who were diagnosed with cancer during the period 2007-2016. The cohort was drawn from the Surveillance, Epidemiology, and End Results Program. In addition, annual state spending data were obtained from the U.S. Census Bureau. The team examined survival outcomes by race and ethnicity as well as by cancer site. The investigators accounted for factors such as age, sex, metropolitan residence, state, county-level income and education, insurance status, cancer site, stage at diagnosis, and year of diagnosis.
Much of public welfare spending was related to Medicaid but also included programs that provide subsidy assistance for individuals, such as Supplemental Security Income.
As compared with White patients, the 5-year overall survival rate was 10.8% lower among non-Hispanic Black patients. But there was a 4.46% (P for interaction <.001) narrowing of the 5-year overall survival disparity in non-Hispanic Black patients in comparison with White patients per 10% increase in spending, or a 42% closure of the 10.8% disparity.
Regarding specific cancer types, increased public welfare spending was associated with a narrowing of the 5-year overall survival disparity between Black patients and non-Hispanic White patients for the following cancers: breast (a 6.15% survival increase for Black patients led to a 39% closing of the disparity), cervix (a 11.9% survival increase led to a 46% closing of the disparity), colorectum (a 4.42% survival increase led to a 48% closing of the disparity), head and neck (a 9.41% survival increase led to a 38% closing of the disparity), liver (a 7.02% survival increase led to a 49% closing of the disparity), ovary (an 8.95% survival increase led to a 41% closing of the disparity), bladder (an 8.18% survival increase led to a 44% closing of the disparity), and uterus (a 14.1% survival increase led to a 40% closing of the disparity).
“Some type of public welfare seems to be helping improve oncologic outcomes for some of our most socioeconomically at-risk patients, but we don’t know the specifics,” Dr. Barnes concluded. “Additional work is needed to identify the most influential public health expenditures. If we can do this, we can more rigorously evaluate state-level policies and their association with cancer outcomes.”
Public welfare improves outcomes
Weighing in on the data, Sarah P. Cate, MD, director, Special Surveillance and Breast Program, Mount Sinai Health System, New York, noted that racial disparities have been identified in many areas of health care and with respect to many diseases. “In the world of oncology, time to diagnosis and treatment significantly impacts overall survival,” she told this news organization. “Many studies are currently underway to investigate why certain ethnic groups have worse cancer outcomes.”
This study is important, she noted, in that it “highlights a discrete source of correcting these disparities in a large group of patients. Obviously there are multiple barriers to care, but increased public welfare spending in oncology should decrease some of these disparities.”
Julie R. Gralow, MD, ASCO’s chief medical officer and executive vice president, commented that it is known that state public welfare spending can mitigate structural racism and at least partially address social determinants of health, such as financial stability, education, place of residence, and insurance status. “This research found that states that increased their public health spending improved overall survival in Black patients with a variety of solid tumors and also resulted in a decrease in racial disparities in survival,” she said. “This important data provides clear support for the benefits of investment in public welfare spending at the state level, including Medicaid expansion.”
The study did not receive funding. Dr. Barnes and Dr. Cate have disclosed no relevant financial relationships. Dr. Gralow has relationships with Genentech, AstraZeneca Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
Five-year overall survival increased among non-Hispanic Black patients by 2.02% in conjunction with a 10% increase in spending. In addition, there was a decrease in racial disparities in survival between non-Hispanic Black patients and White patients for many types of cancers.
However, public welfare spending had no real impact on the overall 5-year survival for the entire cohort (0.25 % per 10% increase in spending; P = .78) or for non-Hispanic White patients (0.52% per 10% increase in spending, P = .58).
“We know from prior research that outcomes are worse for minorities,” said lead author Justin Michael Barnes, MD, from the department of radiation oncology at Washington University in St. Louis, Mo. “It’s thought that some of the differences are related to impaired access to health care for minorities, which is related to social determinants of health. This includes socioeconomic factors, educational attainment, place of residence, as well as environmental stressors.
“Our data show that greater state welfare expenditures were associated with greater 5-year survival among Black patients and decreased Black–White disparities,” said Dr. Barnes. “I think these data are thought provoking, but they certainly aren’t the end. I see these data as a proof-of-concept project.”
Dr. Barnes reported the findings at a press conference held in advance of the annual meeting of the American Society of Clinical Oncology, during which the study will be presented (Abstract 6509).
Improved 5-year survival in Black patients
For the study, Dr. Barnes and colleagues evaluated the association of 5-year overall survival and public welfare spending in 2,925,550 individuals aged 18 years and older who were diagnosed with cancer during the period 2007-2016. The cohort was drawn from the Surveillance, Epidemiology, and End Results Program. In addition, annual state spending data were obtained from the U.S. Census Bureau. The team examined survival outcomes by race and ethnicity as well as by cancer site. The investigators accounted for factors such as age, sex, metropolitan residence, state, county-level income and education, insurance status, cancer site, stage at diagnosis, and year of diagnosis.
Much of public welfare spending was related to Medicaid but also included programs that provide subsidy assistance for individuals, such as Supplemental Security Income.
As compared with White patients, the 5-year overall survival rate was 10.8% lower among non-Hispanic Black patients. But there was a 4.46% (P for interaction <.001) narrowing of the 5-year overall survival disparity in non-Hispanic Black patients in comparison with White patients per 10% increase in spending, or a 42% closure of the 10.8% disparity.
Regarding specific cancer types, increased public welfare spending was associated with a narrowing of the 5-year overall survival disparity between Black patients and non-Hispanic White patients for the following cancers: breast (a 6.15% survival increase for Black patients led to a 39% closing of the disparity), cervix (a 11.9% survival increase led to a 46% closing of the disparity), colorectum (a 4.42% survival increase led to a 48% closing of the disparity), head and neck (a 9.41% survival increase led to a 38% closing of the disparity), liver (a 7.02% survival increase led to a 49% closing of the disparity), ovary (an 8.95% survival increase led to a 41% closing of the disparity), bladder (an 8.18% survival increase led to a 44% closing of the disparity), and uterus (a 14.1% survival increase led to a 40% closing of the disparity).
“Some type of public welfare seems to be helping improve oncologic outcomes for some of our most socioeconomically at-risk patients, but we don’t know the specifics,” Dr. Barnes concluded. “Additional work is needed to identify the most influential public health expenditures. If we can do this, we can more rigorously evaluate state-level policies and their association with cancer outcomes.”
Public welfare improves outcomes
Weighing in on the data, Sarah P. Cate, MD, director, Special Surveillance and Breast Program, Mount Sinai Health System, New York, noted that racial disparities have been identified in many areas of health care and with respect to many diseases. “In the world of oncology, time to diagnosis and treatment significantly impacts overall survival,” she told this news organization. “Many studies are currently underway to investigate why certain ethnic groups have worse cancer outcomes.”
This study is important, she noted, in that it “highlights a discrete source of correcting these disparities in a large group of patients. Obviously there are multiple barriers to care, but increased public welfare spending in oncology should decrease some of these disparities.”
Julie R. Gralow, MD, ASCO’s chief medical officer and executive vice president, commented that it is known that state public welfare spending can mitigate structural racism and at least partially address social determinants of health, such as financial stability, education, place of residence, and insurance status. “This research found that states that increased their public health spending improved overall survival in Black patients with a variety of solid tumors and also resulted in a decrease in racial disparities in survival,” she said. “This important data provides clear support for the benefits of investment in public welfare spending at the state level, including Medicaid expansion.”
The study did not receive funding. Dr. Barnes and Dr. Cate have disclosed no relevant financial relationships. Dr. Gralow has relationships with Genentech, AstraZeneca Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
Five-year overall survival increased among non-Hispanic Black patients by 2.02% in conjunction with a 10% increase in spending. In addition, there was a decrease in racial disparities in survival between non-Hispanic Black patients and White patients for many types of cancers.
However, public welfare spending had no real impact on the overall 5-year survival for the entire cohort (0.25 % per 10% increase in spending; P = .78) or for non-Hispanic White patients (0.52% per 10% increase in spending, P = .58).
“We know from prior research that outcomes are worse for minorities,” said lead author Justin Michael Barnes, MD, from the department of radiation oncology at Washington University in St. Louis, Mo. “It’s thought that some of the differences are related to impaired access to health care for minorities, which is related to social determinants of health. This includes socioeconomic factors, educational attainment, place of residence, as well as environmental stressors.
“Our data show that greater state welfare expenditures were associated with greater 5-year survival among Black patients and decreased Black–White disparities,” said Dr. Barnes. “I think these data are thought provoking, but they certainly aren’t the end. I see these data as a proof-of-concept project.”
Dr. Barnes reported the findings at a press conference held in advance of the annual meeting of the American Society of Clinical Oncology, during which the study will be presented (Abstract 6509).
Improved 5-year survival in Black patients
For the study, Dr. Barnes and colleagues evaluated the association of 5-year overall survival and public welfare spending in 2,925,550 individuals aged 18 years and older who were diagnosed with cancer during the period 2007-2016. The cohort was drawn from the Surveillance, Epidemiology, and End Results Program. In addition, annual state spending data were obtained from the U.S. Census Bureau. The team examined survival outcomes by race and ethnicity as well as by cancer site. The investigators accounted for factors such as age, sex, metropolitan residence, state, county-level income and education, insurance status, cancer site, stage at diagnosis, and year of diagnosis.
Much of public welfare spending was related to Medicaid but also included programs that provide subsidy assistance for individuals, such as Supplemental Security Income.
As compared with White patients, the 5-year overall survival rate was 10.8% lower among non-Hispanic Black patients. But there was a 4.46% (P for interaction <.001) narrowing of the 5-year overall survival disparity in non-Hispanic Black patients in comparison with White patients per 10% increase in spending, or a 42% closure of the 10.8% disparity.
Regarding specific cancer types, increased public welfare spending was associated with a narrowing of the 5-year overall survival disparity between Black patients and non-Hispanic White patients for the following cancers: breast (a 6.15% survival increase for Black patients led to a 39% closing of the disparity), cervix (a 11.9% survival increase led to a 46% closing of the disparity), colorectum (a 4.42% survival increase led to a 48% closing of the disparity), head and neck (a 9.41% survival increase led to a 38% closing of the disparity), liver (a 7.02% survival increase led to a 49% closing of the disparity), ovary (an 8.95% survival increase led to a 41% closing of the disparity), bladder (an 8.18% survival increase led to a 44% closing of the disparity), and uterus (a 14.1% survival increase led to a 40% closing of the disparity).
“Some type of public welfare seems to be helping improve oncologic outcomes for some of our most socioeconomically at-risk patients, but we don’t know the specifics,” Dr. Barnes concluded. “Additional work is needed to identify the most influential public health expenditures. If we can do this, we can more rigorously evaluate state-level policies and their association with cancer outcomes.”
Public welfare improves outcomes
Weighing in on the data, Sarah P. Cate, MD, director, Special Surveillance and Breast Program, Mount Sinai Health System, New York, noted that racial disparities have been identified in many areas of health care and with respect to many diseases. “In the world of oncology, time to diagnosis and treatment significantly impacts overall survival,” she told this news organization. “Many studies are currently underway to investigate why certain ethnic groups have worse cancer outcomes.”
This study is important, she noted, in that it “highlights a discrete source of correcting these disparities in a large group of patients. Obviously there are multiple barriers to care, but increased public welfare spending in oncology should decrease some of these disparities.”
Julie R. Gralow, MD, ASCO’s chief medical officer and executive vice president, commented that it is known that state public welfare spending can mitigate structural racism and at least partially address social determinants of health, such as financial stability, education, place of residence, and insurance status. “This research found that states that increased their public health spending improved overall survival in Black patients with a variety of solid tumors and also resulted in a decrease in racial disparities in survival,” she said. “This important data provides clear support for the benefits of investment in public welfare spending at the state level, including Medicaid expansion.”
The study did not receive funding. Dr. Barnes and Dr. Cate have disclosed no relevant financial relationships. Dr. Gralow has relationships with Genentech, AstraZeneca Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
FROM ASCO 2022
'New benchmark' set in phase-3 blood cancer study
The phase 3 SHINE study was conducted in 520 older patients (aged ≥ 65 years) with newly diagnosed mantle cell lymphoma who were randomized to receive ibrutinib or placebo plus bendamustine-rituximab (BR) and rituximab maintenance.
After 7 years of follow-up, median PFS was 80.6 months with the ibrutinib combination versus 52.9 years with placebo, offering patients an additional 2.3 years of disease-free life.
Complete response rates were higher with ibrutinib versus placebo, and importantly, there were no new safety signals with the combination.
“We believe this phase 3 clinical trial sets a new benchmark for patients with newly diagnosed mantle cell lymphoma and the elderly,” commented lead investigator Dr. Michael Wang, department of lymphoma & myeloma, University of Texas MD Anderson Cancer Center, Houston.
He was speaking during a press briefing at the annual meeting of the American Society of Clinical Oncology, where the study was presented. It was also simultaneously published in the New England Journal of Medicine.
These results “bring new hope to newly diagnosed, older patients with this rare cancer, who have had too few treatment options” and are “generally underrepresented in clinical trials,” commented Dr. Julie R. Gralow, ASCO chief medical officer.
She described the difference in PFS between the two treatment groups as “profound” and “clinically meaningful,” and said the combination can be considered a “new standard of care as initial treatment of older patients with mantle cell lymphoma.”
Some lymphoma experts not impressed
The study got pushback from several lymphoma experts commenting on Twitter.
Lymphoma specialist and consultant hematologist Toby Eyre, MBChB, from Oxford University, London, highlighted the fact that although there was a PFS benefit, there was no overall survival benefit and more toxicity.
“I hope no one implements this regimen,” replied “Papa Heme” Dr. Aaron Goodman, a hematologist at UC San Diego Health, California.
“The authors should be congratulated on completing a large RCT in this space. As far as the result adding ibrutinib added about 28 mos to PFS. This is actually the median DoR of BTK inhibitors in the 2nd line. So big question is, whether the extra tox is worth it,” commented another lymphoma specialist, Dr. Tim Fenske, MD, of the Medical College of Wisconsin, Milwaukee, replying in the same Twitter thread.
“I don’t see a benefit in adding continuous ibrutinib upfront to BR, based on these results. Added toxicity + less treatment free interval make this a tough pill to swallow (pun intended),” commented Dr. Alan Skarbnik, MD, of Novant Health, Charlotte, N.C.
Potential for first-line use
Ibrutinib is already approved for use in mantle cell lymphoma, but in patients who have received at least one prior therapy; this is an accelerated approval, based on overall response rate.
These new data could lead to approval for first-line use of the drug.
“There is an urgent need to improve outcomes for older patients with mantle cell lymphoma,” Dr. Wang commented in a company press release. “Given the median progression-free survival of 6.7 years, the ibrutinib combination demonstrated the potential to be a first-line treatment in this population.”
Mantle cell lymphoma, a form of non-Hodgkin’s lymphoma, affects men more than women and is more common in people aged over 65 years. Older patients often cannot tolerate intensive chemotherapy or stem cell transplants, so they often have poor outcomes, Dr. Wang explained during the press briefing.
He noted that SHINE is the first phase 3 study to examine ibrutinib plus BR as a first-line therapy in mantle cell lymphoma and involved patients with previously untreated stage II-IV disease aged ≥ 65 years not planning to undergo stem cell transplant.
Participants were a median age of 71 years, and 68%-71% were male. Most were White (76%-79%), and median time from initial diagnosis to randomization was 1.4-1.5 months.
At the data cut-off of June 30, 2021, median follow-up was 84.7 months. Disease progression or death had occurred in 44.4% of patients given ibrutinib and 58.0% of those given placebo.
Dr. Wang noted that the PFS curves “separated early, indicating the benefit that was achieved early within the first year and also that those benefits remained durable” throughout follow-up.
The percentage of patients with a complete response was 65.5% among patients treated with ibrutinib and 57.6% among those in the placebo group.
At the current analysis, there was no significant difference in overall survival between the two treatment arms, with a hazard ratio of 1.07 (P = .06).
Dr. Wang explained that “even though the study has been going on for 10 years, we don’t have enough deaths ... to evaluate overall survival yet.”
Furthermore, the median age of patients at enrollment was 71 years and is currently 78 years, with “half of them over 80 years,” so they are more likely to die of “other causes” than from mantle cell lymphoma, he commented.
He added that if the study had been designed to assess overall survival, it would have been “very different,” requiring 1,500 patients and a follow-up of 15-20 years.
The safety profile of the novel combination was “no surprise,” Dr. Wang said, and “consistent with what we’re seeing in daily practice.”
Grade 3/4 treatment-related adverse events were seen in 81.5% of patients treated with ibrutinib and 77.3% of those given placebo, and 47.1% and 48.1%, respectively, experienced grade 3/4 neutropenia.
In the post-presentation discussion, Dr. Wang said that approximately 40% of the patients in the placebo group received a BTK inhibitor at progression, and most were given ibrutinib.
He cautioned that the current results cannot be generalized to “other subtypes of lymphoma,” as they are “very different,” with different prognostic factors and different underlying biologies.
The study was funded by Janssen Pharmaceuticals and Pharmacyclics, an AbbVie Company. Dr. Wang has reported relationships with multiple companies, as listed in the article. Dr. Gralow has reported relationships with Genentech, AstraZeneca, Hexal, Puma Biotechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
The phase 3 SHINE study was conducted in 520 older patients (aged ≥ 65 years) with newly diagnosed mantle cell lymphoma who were randomized to receive ibrutinib or placebo plus bendamustine-rituximab (BR) and rituximab maintenance.
After 7 years of follow-up, median PFS was 80.6 months with the ibrutinib combination versus 52.9 years with placebo, offering patients an additional 2.3 years of disease-free life.
Complete response rates were higher with ibrutinib versus placebo, and importantly, there were no new safety signals with the combination.
“We believe this phase 3 clinical trial sets a new benchmark for patients with newly diagnosed mantle cell lymphoma and the elderly,” commented lead investigator Dr. Michael Wang, department of lymphoma & myeloma, University of Texas MD Anderson Cancer Center, Houston.
He was speaking during a press briefing at the annual meeting of the American Society of Clinical Oncology, where the study was presented. It was also simultaneously published in the New England Journal of Medicine.
These results “bring new hope to newly diagnosed, older patients with this rare cancer, who have had too few treatment options” and are “generally underrepresented in clinical trials,” commented Dr. Julie R. Gralow, ASCO chief medical officer.
She described the difference in PFS between the two treatment groups as “profound” and “clinically meaningful,” and said the combination can be considered a “new standard of care as initial treatment of older patients with mantle cell lymphoma.”
Some lymphoma experts not impressed
The study got pushback from several lymphoma experts commenting on Twitter.
Lymphoma specialist and consultant hematologist Toby Eyre, MBChB, from Oxford University, London, highlighted the fact that although there was a PFS benefit, there was no overall survival benefit and more toxicity.
“I hope no one implements this regimen,” replied “Papa Heme” Dr. Aaron Goodman, a hematologist at UC San Diego Health, California.
“The authors should be congratulated on completing a large RCT in this space. As far as the result adding ibrutinib added about 28 mos to PFS. This is actually the median DoR of BTK inhibitors in the 2nd line. So big question is, whether the extra tox is worth it,” commented another lymphoma specialist, Dr. Tim Fenske, MD, of the Medical College of Wisconsin, Milwaukee, replying in the same Twitter thread.
“I don’t see a benefit in adding continuous ibrutinib upfront to BR, based on these results. Added toxicity + less treatment free interval make this a tough pill to swallow (pun intended),” commented Dr. Alan Skarbnik, MD, of Novant Health, Charlotte, N.C.
Potential for first-line use
Ibrutinib is already approved for use in mantle cell lymphoma, but in patients who have received at least one prior therapy; this is an accelerated approval, based on overall response rate.
These new data could lead to approval for first-line use of the drug.
“There is an urgent need to improve outcomes for older patients with mantle cell lymphoma,” Dr. Wang commented in a company press release. “Given the median progression-free survival of 6.7 years, the ibrutinib combination demonstrated the potential to be a first-line treatment in this population.”
Mantle cell lymphoma, a form of non-Hodgkin’s lymphoma, affects men more than women and is more common in people aged over 65 years. Older patients often cannot tolerate intensive chemotherapy or stem cell transplants, so they often have poor outcomes, Dr. Wang explained during the press briefing.
He noted that SHINE is the first phase 3 study to examine ibrutinib plus BR as a first-line therapy in mantle cell lymphoma and involved patients with previously untreated stage II-IV disease aged ≥ 65 years not planning to undergo stem cell transplant.
Participants were a median age of 71 years, and 68%-71% were male. Most were White (76%-79%), and median time from initial diagnosis to randomization was 1.4-1.5 months.
At the data cut-off of June 30, 2021, median follow-up was 84.7 months. Disease progression or death had occurred in 44.4% of patients given ibrutinib and 58.0% of those given placebo.
Dr. Wang noted that the PFS curves “separated early, indicating the benefit that was achieved early within the first year and also that those benefits remained durable” throughout follow-up.
The percentage of patients with a complete response was 65.5% among patients treated with ibrutinib and 57.6% among those in the placebo group.
At the current analysis, there was no significant difference in overall survival between the two treatment arms, with a hazard ratio of 1.07 (P = .06).
Dr. Wang explained that “even though the study has been going on for 10 years, we don’t have enough deaths ... to evaluate overall survival yet.”
Furthermore, the median age of patients at enrollment was 71 years and is currently 78 years, with “half of them over 80 years,” so they are more likely to die of “other causes” than from mantle cell lymphoma, he commented.
He added that if the study had been designed to assess overall survival, it would have been “very different,” requiring 1,500 patients and a follow-up of 15-20 years.
The safety profile of the novel combination was “no surprise,” Dr. Wang said, and “consistent with what we’re seeing in daily practice.”
Grade 3/4 treatment-related adverse events were seen in 81.5% of patients treated with ibrutinib and 77.3% of those given placebo, and 47.1% and 48.1%, respectively, experienced grade 3/4 neutropenia.
In the post-presentation discussion, Dr. Wang said that approximately 40% of the patients in the placebo group received a BTK inhibitor at progression, and most were given ibrutinib.
He cautioned that the current results cannot be generalized to “other subtypes of lymphoma,” as they are “very different,” with different prognostic factors and different underlying biologies.
The study was funded by Janssen Pharmaceuticals and Pharmacyclics, an AbbVie Company. Dr. Wang has reported relationships with multiple companies, as listed in the article. Dr. Gralow has reported relationships with Genentech, AstraZeneca, Hexal, Puma Biotechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
The phase 3 SHINE study was conducted in 520 older patients (aged ≥ 65 years) with newly diagnosed mantle cell lymphoma who were randomized to receive ibrutinib or placebo plus bendamustine-rituximab (BR) and rituximab maintenance.
After 7 years of follow-up, median PFS was 80.6 months with the ibrutinib combination versus 52.9 years with placebo, offering patients an additional 2.3 years of disease-free life.
Complete response rates were higher with ibrutinib versus placebo, and importantly, there were no new safety signals with the combination.
“We believe this phase 3 clinical trial sets a new benchmark for patients with newly diagnosed mantle cell lymphoma and the elderly,” commented lead investigator Dr. Michael Wang, department of lymphoma & myeloma, University of Texas MD Anderson Cancer Center, Houston.
He was speaking during a press briefing at the annual meeting of the American Society of Clinical Oncology, where the study was presented. It was also simultaneously published in the New England Journal of Medicine.
These results “bring new hope to newly diagnosed, older patients with this rare cancer, who have had too few treatment options” and are “generally underrepresented in clinical trials,” commented Dr. Julie R. Gralow, ASCO chief medical officer.
She described the difference in PFS between the two treatment groups as “profound” and “clinically meaningful,” and said the combination can be considered a “new standard of care as initial treatment of older patients with mantle cell lymphoma.”
Some lymphoma experts not impressed
The study got pushback from several lymphoma experts commenting on Twitter.
Lymphoma specialist and consultant hematologist Toby Eyre, MBChB, from Oxford University, London, highlighted the fact that although there was a PFS benefit, there was no overall survival benefit and more toxicity.
“I hope no one implements this regimen,” replied “Papa Heme” Dr. Aaron Goodman, a hematologist at UC San Diego Health, California.
“The authors should be congratulated on completing a large RCT in this space. As far as the result adding ibrutinib added about 28 mos to PFS. This is actually the median DoR of BTK inhibitors in the 2nd line. So big question is, whether the extra tox is worth it,” commented another lymphoma specialist, Dr. Tim Fenske, MD, of the Medical College of Wisconsin, Milwaukee, replying in the same Twitter thread.
“I don’t see a benefit in adding continuous ibrutinib upfront to BR, based on these results. Added toxicity + less treatment free interval make this a tough pill to swallow (pun intended),” commented Dr. Alan Skarbnik, MD, of Novant Health, Charlotte, N.C.
Potential for first-line use
Ibrutinib is already approved for use in mantle cell lymphoma, but in patients who have received at least one prior therapy; this is an accelerated approval, based on overall response rate.
These new data could lead to approval for first-line use of the drug.
“There is an urgent need to improve outcomes for older patients with mantle cell lymphoma,” Dr. Wang commented in a company press release. “Given the median progression-free survival of 6.7 years, the ibrutinib combination demonstrated the potential to be a first-line treatment in this population.”
Mantle cell lymphoma, a form of non-Hodgkin’s lymphoma, affects men more than women and is more common in people aged over 65 years. Older patients often cannot tolerate intensive chemotherapy or stem cell transplants, so they often have poor outcomes, Dr. Wang explained during the press briefing.
He noted that SHINE is the first phase 3 study to examine ibrutinib plus BR as a first-line therapy in mantle cell lymphoma and involved patients with previously untreated stage II-IV disease aged ≥ 65 years not planning to undergo stem cell transplant.
Participants were a median age of 71 years, and 68%-71% were male. Most were White (76%-79%), and median time from initial diagnosis to randomization was 1.4-1.5 months.
At the data cut-off of June 30, 2021, median follow-up was 84.7 months. Disease progression or death had occurred in 44.4% of patients given ibrutinib and 58.0% of those given placebo.
Dr. Wang noted that the PFS curves “separated early, indicating the benefit that was achieved early within the first year and also that those benefits remained durable” throughout follow-up.
The percentage of patients with a complete response was 65.5% among patients treated with ibrutinib and 57.6% among those in the placebo group.
At the current analysis, there was no significant difference in overall survival between the two treatment arms, with a hazard ratio of 1.07 (P = .06).
Dr. Wang explained that “even though the study has been going on for 10 years, we don’t have enough deaths ... to evaluate overall survival yet.”
Furthermore, the median age of patients at enrollment was 71 years and is currently 78 years, with “half of them over 80 years,” so they are more likely to die of “other causes” than from mantle cell lymphoma, he commented.
He added that if the study had been designed to assess overall survival, it would have been “very different,” requiring 1,500 patients and a follow-up of 15-20 years.
The safety profile of the novel combination was “no surprise,” Dr. Wang said, and “consistent with what we’re seeing in daily practice.”
Grade 3/4 treatment-related adverse events were seen in 81.5% of patients treated with ibrutinib and 77.3% of those given placebo, and 47.1% and 48.1%, respectively, experienced grade 3/4 neutropenia.
In the post-presentation discussion, Dr. Wang said that approximately 40% of the patients in the placebo group received a BTK inhibitor at progression, and most were given ibrutinib.
He cautioned that the current results cannot be generalized to “other subtypes of lymphoma,” as they are “very different,” with different prognostic factors and different underlying biologies.
The study was funded by Janssen Pharmaceuticals and Pharmacyclics, an AbbVie Company. Dr. Wang has reported relationships with multiple companies, as listed in the article. Dr. Gralow has reported relationships with Genentech, AstraZeneca, Hexal, Puma Biotechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
FROM ASCO 2022