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FDA boxed warning leads to drop off in use of ESAs
The Food and Drug Administration’s 2007 “boxed warning” about serious adverse events associated with the use of erythropoietin-stimulating agents (ESAs) was followed by a substantial reduction in their use among patients recovering from colorectal, breast, or lung cancer, according to a new report.
Boxed warnings are considered one of the strongest mechanisms with which the FDA can communicate concerns about drug safety to the public. However, some critics have questioned the effectiveness of these warnings, and the available evidence “remains inconclusive, largely because almost all of [the data] were drawn from observational studies using pre-post designs without control groups,” said John Bian, PhD, of the University of South Carolina College of Pharmacy and Hollings Cancer Center, Columbia, and his associates.
The investigators analyzed data in the SEER cancer registry for the period immediately before and immediately after the 2007 boxed warning was issued. Their sample comprised 45,319 patients aged 66 years and older who were treated either in the “pre” warning period (January 2004-September 2006) or the “post” period (April 2007-September 2009). This included a control group of 3,375 patients with myelodysplastic syndromes. Use of ESAs in these patients was off-label and was not targeted by the boxed warning (J Clin Oncol. 2017 Apr 25. doi: 10.1200/JCO.2017.72.6273).The use of ESAs declined sharply after the boxed warning was issued, except in the control group. The proportion of breast cancer patients receiving ESAs dropped from 49%-55% before 2007 to 30% in 2007, 16% in 2008, and 9% in 2009.
Similarly, the proportion of colorectal cancer patients receiving ESAs declined from about 35%-40% before 2007 to 18% in 2007, 11% in 2008, and 9% in 2009. The proportion of lung cancer patients receiving ESAs decreased from 56%-58% before 2007 to 40% in 2007, 29% in 2008, and 24% in 2009. In contrast, the proportion of patients with myelodysplastic syndromes receiving ESAs – the control group – remained relatively stable at 39%-42% before 2007, 35% in 2007, and 32% in 2008 and 2009.
This represents a reduction of approximately 40% overall in the use of ESAs among targeted patients after the warning was issued. However, this decrease appeared to have little effect on the incidence of hospitalization for venous thromboembolism in this patient population, Dr. Bian and his associates noted.
The study was supported by the National Institutes of Health. Dr. Bian reported having no relevant financial disclosures. His associates reported ties to Quincy Bioscience, Bristol-Myers Squibb, Taiho Pharmaceutical, Mylan, Eli Lilly, Merck, Amgen, and BDI Pharma.
The Food and Drug Administration’s 2007 “boxed warning” about serious adverse events associated with the use of erythropoietin-stimulating agents (ESAs) was followed by a substantial reduction in their use among patients recovering from colorectal, breast, or lung cancer, according to a new report.
Boxed warnings are considered one of the strongest mechanisms with which the FDA can communicate concerns about drug safety to the public. However, some critics have questioned the effectiveness of these warnings, and the available evidence “remains inconclusive, largely because almost all of [the data] were drawn from observational studies using pre-post designs without control groups,” said John Bian, PhD, of the University of South Carolina College of Pharmacy and Hollings Cancer Center, Columbia, and his associates.
The investigators analyzed data in the SEER cancer registry for the period immediately before and immediately after the 2007 boxed warning was issued. Their sample comprised 45,319 patients aged 66 years and older who were treated either in the “pre” warning period (January 2004-September 2006) or the “post” period (April 2007-September 2009). This included a control group of 3,375 patients with myelodysplastic syndromes. Use of ESAs in these patients was off-label and was not targeted by the boxed warning (J Clin Oncol. 2017 Apr 25. doi: 10.1200/JCO.2017.72.6273).The use of ESAs declined sharply after the boxed warning was issued, except in the control group. The proportion of breast cancer patients receiving ESAs dropped from 49%-55% before 2007 to 30% in 2007, 16% in 2008, and 9% in 2009.
Similarly, the proportion of colorectal cancer patients receiving ESAs declined from about 35%-40% before 2007 to 18% in 2007, 11% in 2008, and 9% in 2009. The proportion of lung cancer patients receiving ESAs decreased from 56%-58% before 2007 to 40% in 2007, 29% in 2008, and 24% in 2009. In contrast, the proportion of patients with myelodysplastic syndromes receiving ESAs – the control group – remained relatively stable at 39%-42% before 2007, 35% in 2007, and 32% in 2008 and 2009.
This represents a reduction of approximately 40% overall in the use of ESAs among targeted patients after the warning was issued. However, this decrease appeared to have little effect on the incidence of hospitalization for venous thromboembolism in this patient population, Dr. Bian and his associates noted.
The study was supported by the National Institutes of Health. Dr. Bian reported having no relevant financial disclosures. His associates reported ties to Quincy Bioscience, Bristol-Myers Squibb, Taiho Pharmaceutical, Mylan, Eli Lilly, Merck, Amgen, and BDI Pharma.
The Food and Drug Administration’s 2007 “boxed warning” about serious adverse events associated with the use of erythropoietin-stimulating agents (ESAs) was followed by a substantial reduction in their use among patients recovering from colorectal, breast, or lung cancer, according to a new report.
Boxed warnings are considered one of the strongest mechanisms with which the FDA can communicate concerns about drug safety to the public. However, some critics have questioned the effectiveness of these warnings, and the available evidence “remains inconclusive, largely because almost all of [the data] were drawn from observational studies using pre-post designs without control groups,” said John Bian, PhD, of the University of South Carolina College of Pharmacy and Hollings Cancer Center, Columbia, and his associates.
The investigators analyzed data in the SEER cancer registry for the period immediately before and immediately after the 2007 boxed warning was issued. Their sample comprised 45,319 patients aged 66 years and older who were treated either in the “pre” warning period (January 2004-September 2006) or the “post” period (April 2007-September 2009). This included a control group of 3,375 patients with myelodysplastic syndromes. Use of ESAs in these patients was off-label and was not targeted by the boxed warning (J Clin Oncol. 2017 Apr 25. doi: 10.1200/JCO.2017.72.6273).The use of ESAs declined sharply after the boxed warning was issued, except in the control group. The proportion of breast cancer patients receiving ESAs dropped from 49%-55% before 2007 to 30% in 2007, 16% in 2008, and 9% in 2009.
Similarly, the proportion of colorectal cancer patients receiving ESAs declined from about 35%-40% before 2007 to 18% in 2007, 11% in 2008, and 9% in 2009. The proportion of lung cancer patients receiving ESAs decreased from 56%-58% before 2007 to 40% in 2007, 29% in 2008, and 24% in 2009. In contrast, the proportion of patients with myelodysplastic syndromes receiving ESAs – the control group – remained relatively stable at 39%-42% before 2007, 35% in 2007, and 32% in 2008 and 2009.
This represents a reduction of approximately 40% overall in the use of ESAs among targeted patients after the warning was issued. However, this decrease appeared to have little effect on the incidence of hospitalization for venous thromboembolism in this patient population, Dr. Bian and his associates noted.
The study was supported by the National Institutes of Health. Dr. Bian reported having no relevant financial disclosures. His associates reported ties to Quincy Bioscience, Bristol-Myers Squibb, Taiho Pharmaceutical, Mylan, Eli Lilly, Merck, Amgen, and BDI Pharma.
Key clinical point:
Major finding: The use of ESAs among cancer patients that were targeted by the boxed warning dropped by about 40% after the warning was issued.
Data source: A retrospective cohort study involving 45,319 cancer patients enrolled in the SEER data registry during 2004-2009.
Disclosures: The study was supported by the National Institutes of Health. Dr. Bian reported having no relevant financial disclosures. His associates reported ties to Quincy Bioscience, Bristol-Myers Squibb, Taiho Pharmaceutical, Mylan, Eli Lilly, Merck, Amgen, and BDI Pharma.
Welcome to the Annual Meeting
Welcome to Hospital Medicine 2017 (HM17), the largest meeting ever held specifically for hospital medicine. The Society of Hospital Medicine (SHM) is proud that HM17 brings together a broad range of stakeholders in hospital medicine, including physicians of many specialties, acute-care providers, administrators, pharmacists, C-suite executives, recruiters, and educators. Your decision to join your colleagues at HM17 demonstrates your commitment to not only the specialty of hospital medicine but also to the patients you serve.
This year’s renowned speakers will present important sessions addressing the rapidly evolving healthcare landscape. To open the main meeting on Tuesday, Karen DeSalvo, MD, MPH, MSc, former acting assistant secretary for health for the U.S. Department of Health & Human Services, will present her featured address, “Rethinking Health: The Vital Role of Hospitals and the Hospitalist.” On Wednesday, Patrick Conway, MD, MSc, MHM, an SHM member, the Centers for Medicare & Medicaid Services deputy administrator for innovation and quality, and director of the Center for Medicare and Medicaid Innovation, will speak about “Health Care System Transformation.”
Please make sure to download the HM17 at Hand meeting app, a wonderful resource for every HM17 attendee that puts the meeting at your fingertips. Create an individualized conference experience from your smartphone, tablet, or laptop.
Don’t miss the opportunity to meet one on one with members of SHM’s Board of Directors, who will be available in the exhibit hall in the SHM booth during scheduled visit times. Please consult the Meet the Board schedule in the HM17 at Hand app for further information.
On behalf of the SHM Board of Directors and staff, welcome to HM17 and to Las Vegas. Through this meeting’s rich selection of educational opportunities, research offerings, and networking events, SHM continues its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, continuing to transform medical care and revolutionize patient care.
Dr. Wellikson is CEO of SHM.
Welcome to Hospital Medicine 2017 (HM17), the largest meeting ever held specifically for hospital medicine. The Society of Hospital Medicine (SHM) is proud that HM17 brings together a broad range of stakeholders in hospital medicine, including physicians of many specialties, acute-care providers, administrators, pharmacists, C-suite executives, recruiters, and educators. Your decision to join your colleagues at HM17 demonstrates your commitment to not only the specialty of hospital medicine but also to the patients you serve.
This year’s renowned speakers will present important sessions addressing the rapidly evolving healthcare landscape. To open the main meeting on Tuesday, Karen DeSalvo, MD, MPH, MSc, former acting assistant secretary for health for the U.S. Department of Health & Human Services, will present her featured address, “Rethinking Health: The Vital Role of Hospitals and the Hospitalist.” On Wednesday, Patrick Conway, MD, MSc, MHM, an SHM member, the Centers for Medicare & Medicaid Services deputy administrator for innovation and quality, and director of the Center for Medicare and Medicaid Innovation, will speak about “Health Care System Transformation.”
Please make sure to download the HM17 at Hand meeting app, a wonderful resource for every HM17 attendee that puts the meeting at your fingertips. Create an individualized conference experience from your smartphone, tablet, or laptop.
Don’t miss the opportunity to meet one on one with members of SHM’s Board of Directors, who will be available in the exhibit hall in the SHM booth during scheduled visit times. Please consult the Meet the Board schedule in the HM17 at Hand app for further information.
On behalf of the SHM Board of Directors and staff, welcome to HM17 and to Las Vegas. Through this meeting’s rich selection of educational opportunities, research offerings, and networking events, SHM continues its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, continuing to transform medical care and revolutionize patient care.
Dr. Wellikson is CEO of SHM.
Welcome to Hospital Medicine 2017 (HM17), the largest meeting ever held specifically for hospital medicine. The Society of Hospital Medicine (SHM) is proud that HM17 brings together a broad range of stakeholders in hospital medicine, including physicians of many specialties, acute-care providers, administrators, pharmacists, C-suite executives, recruiters, and educators. Your decision to join your colleagues at HM17 demonstrates your commitment to not only the specialty of hospital medicine but also to the patients you serve.
This year’s renowned speakers will present important sessions addressing the rapidly evolving healthcare landscape. To open the main meeting on Tuesday, Karen DeSalvo, MD, MPH, MSc, former acting assistant secretary for health for the U.S. Department of Health & Human Services, will present her featured address, “Rethinking Health: The Vital Role of Hospitals and the Hospitalist.” On Wednesday, Patrick Conway, MD, MSc, MHM, an SHM member, the Centers for Medicare & Medicaid Services deputy administrator for innovation and quality, and director of the Center for Medicare and Medicaid Innovation, will speak about “Health Care System Transformation.”
Please make sure to download the HM17 at Hand meeting app, a wonderful resource for every HM17 attendee that puts the meeting at your fingertips. Create an individualized conference experience from your smartphone, tablet, or laptop.
Don’t miss the opportunity to meet one on one with members of SHM’s Board of Directors, who will be available in the exhibit hall in the SHM booth during scheduled visit times. Please consult the Meet the Board schedule in the HM17 at Hand app for further information.
On behalf of the SHM Board of Directors and staff, welcome to HM17 and to Las Vegas. Through this meeting’s rich selection of educational opportunities, research offerings, and networking events, SHM continues its mission to promote excellence in the practice of hospital medicine. SHM remains at the forefront of health care today, continuing to transform medical care and revolutionize patient care.
Dr. Wellikson is CEO of SHM.
VIDEO: How to pick surgical margins with mixed breast lesions
LAS VEGAS – According to recent guidelines, no ink on tumor is the right surgical margin for early stage invasive breast cancer and 2 mm is the right lumpectomy margin for ductal carcinoma in situ (DCIS) treated with whole breast radiation. But, what do you do when invasive carcinoma is associated with DCIS?
It’s a common question for breast surgeons. Monica Morrow, MD, chief of breast surgery at Memorial Sloan-Kettering Cancer Center in New York City, explained how to handle the situation in a video interview at the annual meeting of the American Society of Breast Surgeons.
She was the senior author on the 2014 invasive breast cancer guidelines and the lead author on the 2016 DCIS guidelines, both of which were consensus statements on surgical margins from the Society of Surgical Oncology and other groups (Ann Surg Oncol. 2014 Mar;21[3]:704-16; Ann Surg Oncol. 2016 Nov;23[12]:3801-10).
Dr. Morrow explained the thinking behind the guidelines and how to apply them to mixed lesions and other clinical scenarios, as well as their limitations and what remains to be determined. A key point is that a margin less than 2 mm is not by itself an indication for mastectomy in DCIS.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – According to recent guidelines, no ink on tumor is the right surgical margin for early stage invasive breast cancer and 2 mm is the right lumpectomy margin for ductal carcinoma in situ (DCIS) treated with whole breast radiation. But, what do you do when invasive carcinoma is associated with DCIS?
It’s a common question for breast surgeons. Monica Morrow, MD, chief of breast surgery at Memorial Sloan-Kettering Cancer Center in New York City, explained how to handle the situation in a video interview at the annual meeting of the American Society of Breast Surgeons.
She was the senior author on the 2014 invasive breast cancer guidelines and the lead author on the 2016 DCIS guidelines, both of which were consensus statements on surgical margins from the Society of Surgical Oncology and other groups (Ann Surg Oncol. 2014 Mar;21[3]:704-16; Ann Surg Oncol. 2016 Nov;23[12]:3801-10).
Dr. Morrow explained the thinking behind the guidelines and how to apply them to mixed lesions and other clinical scenarios, as well as their limitations and what remains to be determined. A key point is that a margin less than 2 mm is not by itself an indication for mastectomy in DCIS.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – According to recent guidelines, no ink on tumor is the right surgical margin for early stage invasive breast cancer and 2 mm is the right lumpectomy margin for ductal carcinoma in situ (DCIS) treated with whole breast radiation. But, what do you do when invasive carcinoma is associated with DCIS?
It’s a common question for breast surgeons. Monica Morrow, MD, chief of breast surgery at Memorial Sloan-Kettering Cancer Center in New York City, explained how to handle the situation in a video interview at the annual meeting of the American Society of Breast Surgeons.
She was the senior author on the 2014 invasive breast cancer guidelines and the lead author on the 2016 DCIS guidelines, both of which were consensus statements on surgical margins from the Society of Surgical Oncology and other groups (Ann Surg Oncol. 2014 Mar;21[3]:704-16; Ann Surg Oncol. 2016 Nov;23[12]:3801-10).
Dr. Morrow explained the thinking behind the guidelines and how to apply them to mixed lesions and other clinical scenarios, as well as their limitations and what remains to be determined. A key point is that a margin less than 2 mm is not by itself an indication for mastectomy in DCIS.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
From ASBS 2017
Resection reduces inflammatory breast cancer lesion recurrence
LAS VEGAS – In patients with nonmetastatic inflammatory breast cancer (IBC), aggressive surgical resection can reduce local/regional recurrence rates to levels comparable to those seen in patients with noninflammatory breast cancer.
The key to the improved outcome is the presence of a plastic surgeon who can help close a tricky incision. “We have a multidisciplinary team that allows us to call upon the plastic surgeons if we can’t control the incision, and they help us with a flap closure,” said Kelly Rosso, MD, a breast surgical oncology fellow at the MD Anderson Cancer Center, Houston, who presented the study results at the annual meeting of the American Society of Breast Surgeons.
To see if their surgical interventions were producing better outcomes, the team analyzed data from 114 patients with nonmetastatic inflammatory breast cancer who had received trimodality therapy (neoadjuvant chemotherapy, surgery, and radiation therapy) from 2007 to 2015.
The median patient age was 52 years, and the median follow-up period was 3.6 years. In total, 55% of patients had N2 IBC, and 45% had N3 disease.
Nearly all (113 of 114) patients had negative surgical margins. A total of 29 patients died during the follow-up period, and the 5-year survival rate was 69%. The odds of a local/regional recurrence over 2 years was 3% (95% confidence interval, 1%-10%). The 2-year odds of recurrence or distant metastasis was 23% (95% CI, 16%-32%).
Dr. Lucci said that he suspects that many surgeons avoid resection of inflammatory breast cancer lesions under the assumption that the disease is metastatic in nature and fear that an attempt at local control would put the patient through unnecessary surgery with little benefit.
The new study challenges that belief. “I think this is a changing paradigm. We have to consider that those patients need to be thought of as still resectable and think about getting rid of that local disease, at the very least to improve their quality of life and hopefully to improve their overall outcome,” Dr. Lucci said.
The results should be readily achievable in other centers, he added. “If they have a plastic surgeon who’s willing to help them, they can resect to negative margins just as well [as in noninflammatory patients]. And, if they have a radiation therapist who’s dedicated to doing a more aggressive course, they can achieve the same results.”
Dr. Rosso and Dr. Lucci reported having no financial disclosures.
LAS VEGAS – In patients with nonmetastatic inflammatory breast cancer (IBC), aggressive surgical resection can reduce local/regional recurrence rates to levels comparable to those seen in patients with noninflammatory breast cancer.
The key to the improved outcome is the presence of a plastic surgeon who can help close a tricky incision. “We have a multidisciplinary team that allows us to call upon the plastic surgeons if we can’t control the incision, and they help us with a flap closure,” said Kelly Rosso, MD, a breast surgical oncology fellow at the MD Anderson Cancer Center, Houston, who presented the study results at the annual meeting of the American Society of Breast Surgeons.
To see if their surgical interventions were producing better outcomes, the team analyzed data from 114 patients with nonmetastatic inflammatory breast cancer who had received trimodality therapy (neoadjuvant chemotherapy, surgery, and radiation therapy) from 2007 to 2015.
The median patient age was 52 years, and the median follow-up period was 3.6 years. In total, 55% of patients had N2 IBC, and 45% had N3 disease.
Nearly all (113 of 114) patients had negative surgical margins. A total of 29 patients died during the follow-up period, and the 5-year survival rate was 69%. The odds of a local/regional recurrence over 2 years was 3% (95% confidence interval, 1%-10%). The 2-year odds of recurrence or distant metastasis was 23% (95% CI, 16%-32%).
Dr. Lucci said that he suspects that many surgeons avoid resection of inflammatory breast cancer lesions under the assumption that the disease is metastatic in nature and fear that an attempt at local control would put the patient through unnecessary surgery with little benefit.
The new study challenges that belief. “I think this is a changing paradigm. We have to consider that those patients need to be thought of as still resectable and think about getting rid of that local disease, at the very least to improve their quality of life and hopefully to improve their overall outcome,” Dr. Lucci said.
The results should be readily achievable in other centers, he added. “If they have a plastic surgeon who’s willing to help them, they can resect to negative margins just as well [as in noninflammatory patients]. And, if they have a radiation therapist who’s dedicated to doing a more aggressive course, they can achieve the same results.”
Dr. Rosso and Dr. Lucci reported having no financial disclosures.
LAS VEGAS – In patients with nonmetastatic inflammatory breast cancer (IBC), aggressive surgical resection can reduce local/regional recurrence rates to levels comparable to those seen in patients with noninflammatory breast cancer.
The key to the improved outcome is the presence of a plastic surgeon who can help close a tricky incision. “We have a multidisciplinary team that allows us to call upon the plastic surgeons if we can’t control the incision, and they help us with a flap closure,” said Kelly Rosso, MD, a breast surgical oncology fellow at the MD Anderson Cancer Center, Houston, who presented the study results at the annual meeting of the American Society of Breast Surgeons.
To see if their surgical interventions were producing better outcomes, the team analyzed data from 114 patients with nonmetastatic inflammatory breast cancer who had received trimodality therapy (neoadjuvant chemotherapy, surgery, and radiation therapy) from 2007 to 2015.
The median patient age was 52 years, and the median follow-up period was 3.6 years. In total, 55% of patients had N2 IBC, and 45% had N3 disease.
Nearly all (113 of 114) patients had negative surgical margins. A total of 29 patients died during the follow-up period, and the 5-year survival rate was 69%. The odds of a local/regional recurrence over 2 years was 3% (95% confidence interval, 1%-10%). The 2-year odds of recurrence or distant metastasis was 23% (95% CI, 16%-32%).
Dr. Lucci said that he suspects that many surgeons avoid resection of inflammatory breast cancer lesions under the assumption that the disease is metastatic in nature and fear that an attempt at local control would put the patient through unnecessary surgery with little benefit.
The new study challenges that belief. “I think this is a changing paradigm. We have to consider that those patients need to be thought of as still resectable and think about getting rid of that local disease, at the very least to improve their quality of life and hopefully to improve their overall outcome,” Dr. Lucci said.
The results should be readily achievable in other centers, he added. “If they have a plastic surgeon who’s willing to help them, they can resect to negative margins just as well [as in noninflammatory patients]. And, if they have a radiation therapist who’s dedicated to doing a more aggressive course, they can achieve the same results.”
Dr. Rosso and Dr. Lucci reported having no financial disclosures.
At ASBS 2017
Key clinical point:
Major finding: The odds of a local/regional recurrence over 2 years were 3%.
Data source: A retrospective analysis of 114 patients.
Disclosures: Dr. Rosso and Dr. Lucci reported having no financial disclosures.
VIDEO: About 1 in 20 ALS patients in Washington state chose assisted suicide
BOSTON – A new study estimates that 3.4%-6.7% of amyotrophic lateral sclerosis (ALS) patients in Washington state sought to commit physician-assisted suicide over a 5-year period.
The rate is many times higher than that among cancer patients in the state, researchers found. They also discovered that ALS patients were significantly more likely than were other terminally ill people to use the deadly medication after getting prescriptions for it.
The findings appear to reflect the unique hopelessness facing ALS patients. “They’re not afforded as much denial of decline and death as are patients with other terminal illnesses,” said Linda Ganzini, MD, MPH, a professor of psychiatry and medicine at Oregon Health & Science University, Portland, who has studied end of life in ALS patients.
“Many cancer patients, even in the final days of life, receive treatments that they hope will extend their lives,” she said in an interview after reviewing the study findings. “In contrast, treatments for ALS are minimally effective.”
Physician-assisted suicide is legal in California, Colorado, the District of Columbia, Montana, Oregon, Vermont, and Washington.
A team led by Leo H. Wang, MD, PhD, of the University of Washington, Seattle, examined the medical records of 39 ALS patients who sought medication to end their lives at three hospitals in Seattle from March 2009 to Dec. 31, 2014.
Washington’s Death with Dignity (DWD) law, which went into effect in 2009, allows physicians to prescribe lethal medication if the patient has a terminal illness and a prognosis of less than 6 months to live as judged by two physicians.
The researchers reported their findings, a follow-up to a previous study (Neurology. 2016 Nov 15;87[20]:2117-22), at the annual meeting of the American Academy of Neurology.
The median age of the ALS patients at symptom onset was 64 (range, 42-83), and a median of 712 days passed (range, 207-2,407) from the date of diagnosis to date of prescription for lethal medication.
The median time from prescription to death was 22 days, with at least one patient dying immediately (range, 0-386 days). All 39 patients had limb involvement, and 82%-92% had bulbar involvement, dysarthria, dysphagia, and/or dyspnea.
The researchers estimate that 3.4%-6.7% of 1,146 ALS patients in Washington who died over the time period of the study sought a physician-assisted death. The 3.4% figure assumes that the 39 patients at the three hospitals make up all the ALS patients who received medication prescriptions. The 6.7% figure assumes that all patients with neurodegenerative disease who sought DWD in the state over that period had ALS.
“Similarly, 5% (92 of 1,795) of Oregon ALS patient who died sought medication under DWD between 1998 and 2014,” Dr. Wang said. “This is slightly increased compared to the percentage during the first decade, following enactment of the Oregon law (1998-2007), when 2.7% (26 of 962) of ALS patients died using DWD medication.”
Using Washington state data, researchers also estimated that 0.6% of 73,319 cancer patients and 0.2% of 298,178 people in the state who died of all causes sought DWD over the study period.
A total of 30 (77%) ALS patients who received the deadly prescriptions chose to take them, compared with 67% of all-cause patients who took advantage of the DWD law and 60% of cancer patients.
All 30 patients died. The nine who chose to not take the prescribed medication died after a median of 76 days. The patients who did not take the medication were more likely to be married (88% vs. 69%), to be college educated (100% vs. 74%), and to use a motorized wheelchair (78% vs. 31%).
Those who chose to not take the prescribed medication were also less motivated by loss of dignity (63% vs. 93% among those who took the medication) and by being a burden on others (25% vs. 66%). They were more likely to identify themselves as religious (80% vs. 35%).
Multiple factors may explain why ALS patients made different choices regarding the deadly drugs, lead study author Dr. Wang said in an interview. “We thought that the loss of communication may have played a role based on our finding, as most patients who followed through had more substantial trouble speaking,” he said. “For the patients who ultimately did not choose to take the medication, we found more of them had stronger religious beliefs than those who did not.”
As for pain, he reported that it was not a major issue. “Only about 10% of ALS patients were worried about pain, as opposed to 30% of the general Death with Dignity patients,” he said.
Dr. Ganzini noted that some patients who seek the prescribed drugs “want reassurance that, if their quality of life becomes unbearable, they have the option of physician-assisted death. But, they continue to cope and find reasons to live. As such, they ultimately die of their disease without taking the medications. Others lose the ability to ingest the medications, often because of sudden worsening of their disease.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
No specific funding was reported. Dr. Ganzini and Dr. Wang had no disclosures.
BOSTON – A new study estimates that 3.4%-6.7% of amyotrophic lateral sclerosis (ALS) patients in Washington state sought to commit physician-assisted suicide over a 5-year period.
The rate is many times higher than that among cancer patients in the state, researchers found. They also discovered that ALS patients were significantly more likely than were other terminally ill people to use the deadly medication after getting prescriptions for it.
The findings appear to reflect the unique hopelessness facing ALS patients. “They’re not afforded as much denial of decline and death as are patients with other terminal illnesses,” said Linda Ganzini, MD, MPH, a professor of psychiatry and medicine at Oregon Health & Science University, Portland, who has studied end of life in ALS patients.
“Many cancer patients, even in the final days of life, receive treatments that they hope will extend their lives,” she said in an interview after reviewing the study findings. “In contrast, treatments for ALS are minimally effective.”
Physician-assisted suicide is legal in California, Colorado, the District of Columbia, Montana, Oregon, Vermont, and Washington.
A team led by Leo H. Wang, MD, PhD, of the University of Washington, Seattle, examined the medical records of 39 ALS patients who sought medication to end their lives at three hospitals in Seattle from March 2009 to Dec. 31, 2014.
Washington’s Death with Dignity (DWD) law, which went into effect in 2009, allows physicians to prescribe lethal medication if the patient has a terminal illness and a prognosis of less than 6 months to live as judged by two physicians.
The researchers reported their findings, a follow-up to a previous study (Neurology. 2016 Nov 15;87[20]:2117-22), at the annual meeting of the American Academy of Neurology.
The median age of the ALS patients at symptom onset was 64 (range, 42-83), and a median of 712 days passed (range, 207-2,407) from the date of diagnosis to date of prescription for lethal medication.
The median time from prescription to death was 22 days, with at least one patient dying immediately (range, 0-386 days). All 39 patients had limb involvement, and 82%-92% had bulbar involvement, dysarthria, dysphagia, and/or dyspnea.
The researchers estimate that 3.4%-6.7% of 1,146 ALS patients in Washington who died over the time period of the study sought a physician-assisted death. The 3.4% figure assumes that the 39 patients at the three hospitals make up all the ALS patients who received medication prescriptions. The 6.7% figure assumes that all patients with neurodegenerative disease who sought DWD in the state over that period had ALS.
“Similarly, 5% (92 of 1,795) of Oregon ALS patient who died sought medication under DWD between 1998 and 2014,” Dr. Wang said. “This is slightly increased compared to the percentage during the first decade, following enactment of the Oregon law (1998-2007), when 2.7% (26 of 962) of ALS patients died using DWD medication.”
Using Washington state data, researchers also estimated that 0.6% of 73,319 cancer patients and 0.2% of 298,178 people in the state who died of all causes sought DWD over the study period.
A total of 30 (77%) ALS patients who received the deadly prescriptions chose to take them, compared with 67% of all-cause patients who took advantage of the DWD law and 60% of cancer patients.
All 30 patients died. The nine who chose to not take the prescribed medication died after a median of 76 days. The patients who did not take the medication were more likely to be married (88% vs. 69%), to be college educated (100% vs. 74%), and to use a motorized wheelchair (78% vs. 31%).
Those who chose to not take the prescribed medication were also less motivated by loss of dignity (63% vs. 93% among those who took the medication) and by being a burden on others (25% vs. 66%). They were more likely to identify themselves as religious (80% vs. 35%).
Multiple factors may explain why ALS patients made different choices regarding the deadly drugs, lead study author Dr. Wang said in an interview. “We thought that the loss of communication may have played a role based on our finding, as most patients who followed through had more substantial trouble speaking,” he said. “For the patients who ultimately did not choose to take the medication, we found more of them had stronger religious beliefs than those who did not.”
As for pain, he reported that it was not a major issue. “Only about 10% of ALS patients were worried about pain, as opposed to 30% of the general Death with Dignity patients,” he said.
Dr. Ganzini noted that some patients who seek the prescribed drugs “want reassurance that, if their quality of life becomes unbearable, they have the option of physician-assisted death. But, they continue to cope and find reasons to live. As such, they ultimately die of their disease without taking the medications. Others lose the ability to ingest the medications, often because of sudden worsening of their disease.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
No specific funding was reported. Dr. Ganzini and Dr. Wang had no disclosures.
BOSTON – A new study estimates that 3.4%-6.7% of amyotrophic lateral sclerosis (ALS) patients in Washington state sought to commit physician-assisted suicide over a 5-year period.
The rate is many times higher than that among cancer patients in the state, researchers found. They also discovered that ALS patients were significantly more likely than were other terminally ill people to use the deadly medication after getting prescriptions for it.
The findings appear to reflect the unique hopelessness facing ALS patients. “They’re not afforded as much denial of decline and death as are patients with other terminal illnesses,” said Linda Ganzini, MD, MPH, a professor of psychiatry and medicine at Oregon Health & Science University, Portland, who has studied end of life in ALS patients.
“Many cancer patients, even in the final days of life, receive treatments that they hope will extend their lives,” she said in an interview after reviewing the study findings. “In contrast, treatments for ALS are minimally effective.”
Physician-assisted suicide is legal in California, Colorado, the District of Columbia, Montana, Oregon, Vermont, and Washington.
A team led by Leo H. Wang, MD, PhD, of the University of Washington, Seattle, examined the medical records of 39 ALS patients who sought medication to end their lives at three hospitals in Seattle from March 2009 to Dec. 31, 2014.
Washington’s Death with Dignity (DWD) law, which went into effect in 2009, allows physicians to prescribe lethal medication if the patient has a terminal illness and a prognosis of less than 6 months to live as judged by two physicians.
The researchers reported their findings, a follow-up to a previous study (Neurology. 2016 Nov 15;87[20]:2117-22), at the annual meeting of the American Academy of Neurology.
The median age of the ALS patients at symptom onset was 64 (range, 42-83), and a median of 712 days passed (range, 207-2,407) from the date of diagnosis to date of prescription for lethal medication.
The median time from prescription to death was 22 days, with at least one patient dying immediately (range, 0-386 days). All 39 patients had limb involvement, and 82%-92% had bulbar involvement, dysarthria, dysphagia, and/or dyspnea.
The researchers estimate that 3.4%-6.7% of 1,146 ALS patients in Washington who died over the time period of the study sought a physician-assisted death. The 3.4% figure assumes that the 39 patients at the three hospitals make up all the ALS patients who received medication prescriptions. The 6.7% figure assumes that all patients with neurodegenerative disease who sought DWD in the state over that period had ALS.
“Similarly, 5% (92 of 1,795) of Oregon ALS patient who died sought medication under DWD between 1998 and 2014,” Dr. Wang said. “This is slightly increased compared to the percentage during the first decade, following enactment of the Oregon law (1998-2007), when 2.7% (26 of 962) of ALS patients died using DWD medication.”
Using Washington state data, researchers also estimated that 0.6% of 73,319 cancer patients and 0.2% of 298,178 people in the state who died of all causes sought DWD over the study period.
A total of 30 (77%) ALS patients who received the deadly prescriptions chose to take them, compared with 67% of all-cause patients who took advantage of the DWD law and 60% of cancer patients.
All 30 patients died. The nine who chose to not take the prescribed medication died after a median of 76 days. The patients who did not take the medication were more likely to be married (88% vs. 69%), to be college educated (100% vs. 74%), and to use a motorized wheelchair (78% vs. 31%).
Those who chose to not take the prescribed medication were also less motivated by loss of dignity (63% vs. 93% among those who took the medication) and by being a burden on others (25% vs. 66%). They were more likely to identify themselves as religious (80% vs. 35%).
Multiple factors may explain why ALS patients made different choices regarding the deadly drugs, lead study author Dr. Wang said in an interview. “We thought that the loss of communication may have played a role based on our finding, as most patients who followed through had more substantial trouble speaking,” he said. “For the patients who ultimately did not choose to take the medication, we found more of them had stronger religious beliefs than those who did not.”
As for pain, he reported that it was not a major issue. “Only about 10% of ALS patients were worried about pain, as opposed to 30% of the general Death with Dignity patients,” he said.
Dr. Ganzini noted that some patients who seek the prescribed drugs “want reassurance that, if their quality of life becomes unbearable, they have the option of physician-assisted death. But, they continue to cope and find reasons to live. As such, they ultimately die of their disease without taking the medications. Others lose the ability to ingest the medications, often because of sudden worsening of their disease.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
No specific funding was reported. Dr. Ganzini and Dr. Wang had no disclosures.
At AAN 2017
Key clinical point:
Major finding: An estimated 3.4%-6.7% of ALS patients in Washington state sought physician-assisted death, and 77% took the prescribed deadly medication, a higher rate than all-cause (67%) and cancer patients (60%).
Data source: Analysis of 39 ALS patients who sought deadly medication from three Seattle hospitals from March 2009 to Dec. 31, 2014.
Disclosures: No specific funding was reported, and Dr. Wang had no disclosures.
Start your day with meditation
Take a breather from conferencing and join your colleagues for a meditation session on Tuesday, May 2, 7–8 a.m., and Thursday, May 4, 7–7:40 a.m.
Physician facilitators with training in mindfulness practices will lead you in exercises that will attune you with the five senses, the language of your mind and body, and the healing power of your breath.
The session will sustain you throughout the day.
Tuesday, May 2 7–8 a.m.
Mandalay Bay K
Facilitators:
Elizabeth Harry, MD, instructor of medicine, Harvard Medical School, Brigham and Women’s Hospital, and Christie Masters, MD, assistant clinical professor, UCLA Hospitalist Service
Thursday, May 4 7–7:40 a.m.
Mandalay Bay K
Facilitator:
Aditi Dave, MD, Carolina East Medical Center, Wake Forest University
Take a breather from conferencing and join your colleagues for a meditation session on Tuesday, May 2, 7–8 a.m., and Thursday, May 4, 7–7:40 a.m.
Physician facilitators with training in mindfulness practices will lead you in exercises that will attune you with the five senses, the language of your mind and body, and the healing power of your breath.
The session will sustain you throughout the day.
Tuesday, May 2 7–8 a.m.
Mandalay Bay K
Facilitators:
Elizabeth Harry, MD, instructor of medicine, Harvard Medical School, Brigham and Women’s Hospital, and Christie Masters, MD, assistant clinical professor, UCLA Hospitalist Service
Thursday, May 4 7–7:40 a.m.
Mandalay Bay K
Facilitator:
Aditi Dave, MD, Carolina East Medical Center, Wake Forest University
Take a breather from conferencing and join your colleagues for a meditation session on Tuesday, May 2, 7–8 a.m., and Thursday, May 4, 7–7:40 a.m.
Physician facilitators with training in mindfulness practices will lead you in exercises that will attune you with the five senses, the language of your mind and body, and the healing power of your breath.
The session will sustain you throughout the day.
Tuesday, May 2 7–8 a.m.
Mandalay Bay K
Facilitators:
Elizabeth Harry, MD, instructor of medicine, Harvard Medical School, Brigham and Women’s Hospital, and Christie Masters, MD, assistant clinical professor, UCLA Hospitalist Service
Thursday, May 4 7–7:40 a.m.
Mandalay Bay K
Facilitator:
Aditi Dave, MD, Carolina East Medical Center, Wake Forest University
Enjoy Las Vegas and HM17
Welcome to HM17 and Las Vegas! We invite you to network and get to know more than 4,000 of your closest colleagues over the next 3 days. Please have fun taking advantage of the many unique learning opportunities we have developed for this year’s meeting. We hope you will be pleased with the offerings that our Annual Meeting Committee has produced on your behalf. You will see committee members wearing buttons that identify them as members of the Annual Meeting Committee. Please take the time to give them your feedback about the meeting and, if you feel so inclined, thank them for the time and energy they committed to create this year’s meeting.
We think you will find this meeting and the precourses have something (many things!) for everyone. Whether you are a community or an academic hospitalist, a newly minted hospitalist or a seasoned veteran, a clinician who takes care of the young or the old (and everyone in between), an advanced practice clinician or hospital medicine administrator, a researcher or educator or clinician (or any combination of the three), we had you in mind as we developed the content for HM17.
We have added medical education and health policy tracks and are bringing back favorites like the young-hospitalist, academic, pediatric, practice management, and quality tracks. Don’t forget to attend our interactive workshops. More than 150 workshop ideas were submitted, and we are proud to feature 18 of the best.
Finally, your HM17 experience will not be complete until you attend the much-anticipated Updates in Hospital Medicine talks and plenary sessions; network with your colleagues at the Research, Innovations, and Clinical Vignettes (RIV) Poster Competition; roam the Exhibit Hall; and join in a Special Interest Forum.
This meeting would not be possible without the tireless effort of the SHM staff and leadership, conference faculty, and committee members. Most importantly, we sincerely thank all of you for attending HM17. We have created this meeting for you, and we hope it is your most valuable educational and networking opportunity of 2017.
Enjoy Las Vegas and HM17, and we will see you in 2018 in Orlando!
Dr. Feldman is a hospitalist at Johns Hopkins in Baltimore and course director for HM17.
Welcome to HM17 and Las Vegas! We invite you to network and get to know more than 4,000 of your closest colleagues over the next 3 days. Please have fun taking advantage of the many unique learning opportunities we have developed for this year’s meeting. We hope you will be pleased with the offerings that our Annual Meeting Committee has produced on your behalf. You will see committee members wearing buttons that identify them as members of the Annual Meeting Committee. Please take the time to give them your feedback about the meeting and, if you feel so inclined, thank them for the time and energy they committed to create this year’s meeting.
We think you will find this meeting and the precourses have something (many things!) for everyone. Whether you are a community or an academic hospitalist, a newly minted hospitalist or a seasoned veteran, a clinician who takes care of the young or the old (and everyone in between), an advanced practice clinician or hospital medicine administrator, a researcher or educator or clinician (or any combination of the three), we had you in mind as we developed the content for HM17.
We have added medical education and health policy tracks and are bringing back favorites like the young-hospitalist, academic, pediatric, practice management, and quality tracks. Don’t forget to attend our interactive workshops. More than 150 workshop ideas were submitted, and we are proud to feature 18 of the best.
Finally, your HM17 experience will not be complete until you attend the much-anticipated Updates in Hospital Medicine talks and plenary sessions; network with your colleagues at the Research, Innovations, and Clinical Vignettes (RIV) Poster Competition; roam the Exhibit Hall; and join in a Special Interest Forum.
This meeting would not be possible without the tireless effort of the SHM staff and leadership, conference faculty, and committee members. Most importantly, we sincerely thank all of you for attending HM17. We have created this meeting for you, and we hope it is your most valuable educational and networking opportunity of 2017.
Enjoy Las Vegas and HM17, and we will see you in 2018 in Orlando!
Dr. Feldman is a hospitalist at Johns Hopkins in Baltimore and course director for HM17.
Welcome to HM17 and Las Vegas! We invite you to network and get to know more than 4,000 of your closest colleagues over the next 3 days. Please have fun taking advantage of the many unique learning opportunities we have developed for this year’s meeting. We hope you will be pleased with the offerings that our Annual Meeting Committee has produced on your behalf. You will see committee members wearing buttons that identify them as members of the Annual Meeting Committee. Please take the time to give them your feedback about the meeting and, if you feel so inclined, thank them for the time and energy they committed to create this year’s meeting.
We think you will find this meeting and the precourses have something (many things!) for everyone. Whether you are a community or an academic hospitalist, a newly minted hospitalist or a seasoned veteran, a clinician who takes care of the young or the old (and everyone in between), an advanced practice clinician or hospital medicine administrator, a researcher or educator or clinician (or any combination of the three), we had you in mind as we developed the content for HM17.
We have added medical education and health policy tracks and are bringing back favorites like the young-hospitalist, academic, pediatric, practice management, and quality tracks. Don’t forget to attend our interactive workshops. More than 150 workshop ideas were submitted, and we are proud to feature 18 of the best.
Finally, your HM17 experience will not be complete until you attend the much-anticipated Updates in Hospital Medicine talks and plenary sessions; network with your colleagues at the Research, Innovations, and Clinical Vignettes (RIV) Poster Competition; roam the Exhibit Hall; and join in a Special Interest Forum.
This meeting would not be possible without the tireless effort of the SHM staff and leadership, conference faculty, and committee members. Most importantly, we sincerely thank all of you for attending HM17. We have created this meeting for you, and we hope it is your most valuable educational and networking opportunity of 2017.
Enjoy Las Vegas and HM17, and we will see you in 2018 in Orlando!
Dr. Feldman is a hospitalist at Johns Hopkins in Baltimore and course director for HM17.
Pembrolizumab could change treatment paradigm, team says
The anti-PD-1 therapy pembrolizumab could change the treatment paradigm of relapsed or refractory classic Hodgkin lymphoma (cHL), according to researchers.
In a phase 2 trial, pembrolizumab produced an overall response rate (ORR) of 69% and a complete response (CR) rate of 22% in adults with cHL who had failed treatment with brentuximab vedotin (BV), autologous hematopoietic stem cell transplant (auto-HSCT), or both.
The researchers said the safety profile of pembrolizumab was “acceptable” and largely consistent with safety in previous studies of the drug.
Twelve percent of patients temporarily stopped taking pembrolizumab due to treatment-related adverse events (AEs), and 4% stopped taking the drug entirely as a result of AEs.
Craig H. Moskowitz, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, and his colleagues reported these results, from the KEYNOTE-087 trial, in the Journal of Clinical Oncology.
The trial was sponsored by Merck, the company that markets pembrolizumab as Keytruda.
In KEYNOTE-087, the researchers evaluated pembrolizumab (a 200 mg fixed dose every 3 weeks) in patients with relapsed or refractory cHL across 3 cohorts:
Cohort 1: Patients who progressed after auto-HSCT and subsequent treatment with BV
Cohort 2: Patients who failed salvage chemotherapy, were ineligible for a transplant, and progressed after BV
Cohort 3: Patients who progressed after auto-HSCT and did not receive BV after transplant.
Efficacy
Across all 210 enrolled patients, the ORR was 69.0%, and the CR rate was 22.4%.
In Cohort 1 (n=69), the ORR was 73.9%. The CR rate was 21.7%, the partial response (PR) rate was 52.2%, 15.9% of patients had stable disease (SD), and 7.2% progressed. In 82.2% of responders, the response lasted 6 months or more.
In Cohort 2 (n=81), the ORR was 64.2%. The CR rate was 24.7%, the PR rate was 39.5%, 12.3% of patients had SD, and 21.0% progressed. In 70.0% of responders, the response lasted 6 months or more.
In Cohort 3 (n=60), the ORR was 70.0%. Twenty percent of patients had a CR, 50.0% had a PR, 16.7% had SD, and 13.3% progressed. In 75.6% of responders, the response lasted 6 months or more.
Results also included an analysis of patients with primary refractory disease (n=73), which was defined as failure to achieve CR or PR with first-line treatment. In this patient population, the ORR was 79.5%.
An ORR of 67.8% was reported in patients who relapsed after 3 or more lines of prior therapy (99/146).
For the entire study cohort, the median duration of response was not reached, and the median overall survival was not reached. At 9 months, the overall survival rate was 97.5%, and the progression-free survival rate was 63.4%.
Safety
The most common AEs related to pembrolizumab were hypothyroidism (12.4%), pyrexia (10.5%), fatigue (9.0%), rash (7.6%), diarrhea (7.1%), headache (6.2%), nausea (5.7%), cough (5.7%), and neutropenia (5.2%).
The most common grade 3/4 treatment-related AEs were neutropenia (2.4%), diarrhea (1.0%), and dyspnea (1.0%). Immune-mediated AEs included pneumonitis (2.9%), hyperthyroidism (2.9%), colitis (1.0%), and myositis (1.0%).
Nine patients (4.3%) stopped taking pembrolizumab due to treatment-related AEs, including myocarditis, myelitis, myositis, pneumonitis, infusion-related reactions, and cytokine release syndrome.
Twenty-six patients (12.4%) had treatment interruptions due to pembrolizumab-related AEs.
Two patients died during follow-up, but neither death was considered related to pembrolizumab. One patient died of septic shock and the other of acute graft-versus-host disease.
The anti-PD-1 therapy pembrolizumab could change the treatment paradigm of relapsed or refractory classic Hodgkin lymphoma (cHL), according to researchers.
In a phase 2 trial, pembrolizumab produced an overall response rate (ORR) of 69% and a complete response (CR) rate of 22% in adults with cHL who had failed treatment with brentuximab vedotin (BV), autologous hematopoietic stem cell transplant (auto-HSCT), or both.
The researchers said the safety profile of pembrolizumab was “acceptable” and largely consistent with safety in previous studies of the drug.
Twelve percent of patients temporarily stopped taking pembrolizumab due to treatment-related adverse events (AEs), and 4% stopped taking the drug entirely as a result of AEs.
Craig H. Moskowitz, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, and his colleagues reported these results, from the KEYNOTE-087 trial, in the Journal of Clinical Oncology.
The trial was sponsored by Merck, the company that markets pembrolizumab as Keytruda.
In KEYNOTE-087, the researchers evaluated pembrolizumab (a 200 mg fixed dose every 3 weeks) in patients with relapsed or refractory cHL across 3 cohorts:
Cohort 1: Patients who progressed after auto-HSCT and subsequent treatment with BV
Cohort 2: Patients who failed salvage chemotherapy, were ineligible for a transplant, and progressed after BV
Cohort 3: Patients who progressed after auto-HSCT and did not receive BV after transplant.
Efficacy
Across all 210 enrolled patients, the ORR was 69.0%, and the CR rate was 22.4%.
In Cohort 1 (n=69), the ORR was 73.9%. The CR rate was 21.7%, the partial response (PR) rate was 52.2%, 15.9% of patients had stable disease (SD), and 7.2% progressed. In 82.2% of responders, the response lasted 6 months or more.
In Cohort 2 (n=81), the ORR was 64.2%. The CR rate was 24.7%, the PR rate was 39.5%, 12.3% of patients had SD, and 21.0% progressed. In 70.0% of responders, the response lasted 6 months or more.
In Cohort 3 (n=60), the ORR was 70.0%. Twenty percent of patients had a CR, 50.0% had a PR, 16.7% had SD, and 13.3% progressed. In 75.6% of responders, the response lasted 6 months or more.
Results also included an analysis of patients with primary refractory disease (n=73), which was defined as failure to achieve CR or PR with first-line treatment. In this patient population, the ORR was 79.5%.
An ORR of 67.8% was reported in patients who relapsed after 3 or more lines of prior therapy (99/146).
For the entire study cohort, the median duration of response was not reached, and the median overall survival was not reached. At 9 months, the overall survival rate was 97.5%, and the progression-free survival rate was 63.4%.
Safety
The most common AEs related to pembrolizumab were hypothyroidism (12.4%), pyrexia (10.5%), fatigue (9.0%), rash (7.6%), diarrhea (7.1%), headache (6.2%), nausea (5.7%), cough (5.7%), and neutropenia (5.2%).
The most common grade 3/4 treatment-related AEs were neutropenia (2.4%), diarrhea (1.0%), and dyspnea (1.0%). Immune-mediated AEs included pneumonitis (2.9%), hyperthyroidism (2.9%), colitis (1.0%), and myositis (1.0%).
Nine patients (4.3%) stopped taking pembrolizumab due to treatment-related AEs, including myocarditis, myelitis, myositis, pneumonitis, infusion-related reactions, and cytokine release syndrome.
Twenty-six patients (12.4%) had treatment interruptions due to pembrolizumab-related AEs.
Two patients died during follow-up, but neither death was considered related to pembrolizumab. One patient died of septic shock and the other of acute graft-versus-host disease.
The anti-PD-1 therapy pembrolizumab could change the treatment paradigm of relapsed or refractory classic Hodgkin lymphoma (cHL), according to researchers.
In a phase 2 trial, pembrolizumab produced an overall response rate (ORR) of 69% and a complete response (CR) rate of 22% in adults with cHL who had failed treatment with brentuximab vedotin (BV), autologous hematopoietic stem cell transplant (auto-HSCT), or both.
The researchers said the safety profile of pembrolizumab was “acceptable” and largely consistent with safety in previous studies of the drug.
Twelve percent of patients temporarily stopped taking pembrolizumab due to treatment-related adverse events (AEs), and 4% stopped taking the drug entirely as a result of AEs.
Craig H. Moskowitz, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, and his colleagues reported these results, from the KEYNOTE-087 trial, in the Journal of Clinical Oncology.
The trial was sponsored by Merck, the company that markets pembrolizumab as Keytruda.
In KEYNOTE-087, the researchers evaluated pembrolizumab (a 200 mg fixed dose every 3 weeks) in patients with relapsed or refractory cHL across 3 cohorts:
Cohort 1: Patients who progressed after auto-HSCT and subsequent treatment with BV
Cohort 2: Patients who failed salvage chemotherapy, were ineligible for a transplant, and progressed after BV
Cohort 3: Patients who progressed after auto-HSCT and did not receive BV after transplant.
Efficacy
Across all 210 enrolled patients, the ORR was 69.0%, and the CR rate was 22.4%.
In Cohort 1 (n=69), the ORR was 73.9%. The CR rate was 21.7%, the partial response (PR) rate was 52.2%, 15.9% of patients had stable disease (SD), and 7.2% progressed. In 82.2% of responders, the response lasted 6 months or more.
In Cohort 2 (n=81), the ORR was 64.2%. The CR rate was 24.7%, the PR rate was 39.5%, 12.3% of patients had SD, and 21.0% progressed. In 70.0% of responders, the response lasted 6 months or more.
In Cohort 3 (n=60), the ORR was 70.0%. Twenty percent of patients had a CR, 50.0% had a PR, 16.7% had SD, and 13.3% progressed. In 75.6% of responders, the response lasted 6 months or more.
Results also included an analysis of patients with primary refractory disease (n=73), which was defined as failure to achieve CR or PR with first-line treatment. In this patient population, the ORR was 79.5%.
An ORR of 67.8% was reported in patients who relapsed after 3 or more lines of prior therapy (99/146).
For the entire study cohort, the median duration of response was not reached, and the median overall survival was not reached. At 9 months, the overall survival rate was 97.5%, and the progression-free survival rate was 63.4%.
Safety
The most common AEs related to pembrolizumab were hypothyroidism (12.4%), pyrexia (10.5%), fatigue (9.0%), rash (7.6%), diarrhea (7.1%), headache (6.2%), nausea (5.7%), cough (5.7%), and neutropenia (5.2%).
The most common grade 3/4 treatment-related AEs were neutropenia (2.4%), diarrhea (1.0%), and dyspnea (1.0%). Immune-mediated AEs included pneumonitis (2.9%), hyperthyroidism (2.9%), colitis (1.0%), and myositis (1.0%).
Nine patients (4.3%) stopped taking pembrolizumab due to treatment-related AEs, including myocarditis, myelitis, myositis, pneumonitis, infusion-related reactions, and cytokine release syndrome.
Twenty-six patients (12.4%) had treatment interruptions due to pembrolizumab-related AEs.
Two patients died during follow-up, but neither death was considered related to pembrolizumab. One patient died of septic shock and the other of acute graft-versus-host disease.
Medicaid acceptance up among cardiologists
Medicaid acceptance was 77% among cardiologists in the 2017 edition of an ongoing survey conducted in 15 large cities by physician recruitment firm Merritt Hawkins.
That was up from 61% in the previous survey, conducted in 2014, and higher than the average of 72% for cardiologists in 15 midsized cities that were included for the first time in 2017, the company reported.
There were four large cities with Medicaid acceptance rates of 100% – Boston, Detroit, Minneapolis (up from just 7% in 2014), and Portland, Ore. – along with four midsized cities – Cedar Rapids, Iowa; Evansville, Ind.; Fargo, N.D.; and Yakima, Wash. The lowest rate among the large cities was in Dallas (15%), with the midsized basement occupied by Lafayette, La., at 13%, Merritt Hawkins said.
Investigators called 259 randomly selected cardiologists in the large cities and 87 cardiologists in the midsized cities in January and February. It was the fourth such survey the company has conducted since 2004.
The survey also included four other specialties – dermatology, family medicine, ob.gyn., and orthopedic surgery. The Medicaid acceptance rate for all 1,414 physicians in all five specialties in the 15 large cities was 53%, and the average rate for all specialties in the midsized cities was 60% for the 494 offices surveyed, the company said. Cardiology had the highest rates by specialty and dermatology the lowest in both the large and midsized cities.
Medicaid acceptance was 77% among cardiologists in the 2017 edition of an ongoing survey conducted in 15 large cities by physician recruitment firm Merritt Hawkins.
That was up from 61% in the previous survey, conducted in 2014, and higher than the average of 72% for cardiologists in 15 midsized cities that were included for the first time in 2017, the company reported.
There were four large cities with Medicaid acceptance rates of 100% – Boston, Detroit, Minneapolis (up from just 7% in 2014), and Portland, Ore. – along with four midsized cities – Cedar Rapids, Iowa; Evansville, Ind.; Fargo, N.D.; and Yakima, Wash. The lowest rate among the large cities was in Dallas (15%), with the midsized basement occupied by Lafayette, La., at 13%, Merritt Hawkins said.
Investigators called 259 randomly selected cardiologists in the large cities and 87 cardiologists in the midsized cities in January and February. It was the fourth such survey the company has conducted since 2004.
The survey also included four other specialties – dermatology, family medicine, ob.gyn., and orthopedic surgery. The Medicaid acceptance rate for all 1,414 physicians in all five specialties in the 15 large cities was 53%, and the average rate for all specialties in the midsized cities was 60% for the 494 offices surveyed, the company said. Cardiology had the highest rates by specialty and dermatology the lowest in both the large and midsized cities.
Medicaid acceptance was 77% among cardiologists in the 2017 edition of an ongoing survey conducted in 15 large cities by physician recruitment firm Merritt Hawkins.
That was up from 61% in the previous survey, conducted in 2014, and higher than the average of 72% for cardiologists in 15 midsized cities that were included for the first time in 2017, the company reported.
There were four large cities with Medicaid acceptance rates of 100% – Boston, Detroit, Minneapolis (up from just 7% in 2014), and Portland, Ore. – along with four midsized cities – Cedar Rapids, Iowa; Evansville, Ind.; Fargo, N.D.; and Yakima, Wash. The lowest rate among the large cities was in Dallas (15%), with the midsized basement occupied by Lafayette, La., at 13%, Merritt Hawkins said.
Investigators called 259 randomly selected cardiologists in the large cities and 87 cardiologists in the midsized cities in January and February. It was the fourth such survey the company has conducted since 2004.
The survey also included four other specialties – dermatology, family medicine, ob.gyn., and orthopedic surgery. The Medicaid acceptance rate for all 1,414 physicians in all five specialties in the 15 large cities was 53%, and the average rate for all specialties in the midsized cities was 60% for the 494 offices surveyed, the company said. Cardiology had the highest rates by specialty and dermatology the lowest in both the large and midsized cities.
VIDEO: Surgery use declines for non–small cell lung cancer
BOSTON – The use of surgical therapy for early stage lung cancer in the United States has declined as other nonsurgical treatment options have become available, according to a study reported at the annual meeting of the American Association for Thoracic Surgery.
Most notably, the study finds that surgery for early stage non–small cell lung cancer decreased by 12% from 2004 to 2013.
In a video interview, Keith Naunheim, MD, a professor of surgery at Saint Louis University, discusses the study findings and the potential reasons behind declining surgery use for lung cancer. Dr. Naunheim also addresses why physicians should keep an open mind about alternative therapy options for lung cancer, while ensuring that the treatments are safe and effective for patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – The use of surgical therapy for early stage lung cancer in the United States has declined as other nonsurgical treatment options have become available, according to a study reported at the annual meeting of the American Association for Thoracic Surgery.
Most notably, the study finds that surgery for early stage non–small cell lung cancer decreased by 12% from 2004 to 2013.
In a video interview, Keith Naunheim, MD, a professor of surgery at Saint Louis University, discusses the study findings and the potential reasons behind declining surgery use for lung cancer. Dr. Naunheim also addresses why physicians should keep an open mind about alternative therapy options for lung cancer, while ensuring that the treatments are safe and effective for patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
BOSTON – The use of surgical therapy for early stage lung cancer in the United States has declined as other nonsurgical treatment options have become available, according to a study reported at the annual meeting of the American Association for Thoracic Surgery.
Most notably, the study finds that surgery for early stage non–small cell lung cancer decreased by 12% from 2004 to 2013.
In a video interview, Keith Naunheim, MD, a professor of surgery at Saint Louis University, discusses the study findings and the potential reasons behind declining surgery use for lung cancer. Dr. Naunheim also addresses why physicians should keep an open mind about alternative therapy options for lung cancer, while ensuring that the treatments are safe and effective for patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @legal_med
AT THE AATS ANNUAL MEETING