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Study pinpoints skin cancer risk factors after hematopoietic cell transplant
CHICAGO – The 10-year incidence rates for both squamous cell carcinoma and basal cell carcinoma arising after hematopoietic cell transplantation are impressively high at 17%-plus for each, but the malignancies occur on two very different timelines, according to Jeffrey F. Scott, MD, a fellow in micrographic surgery and dermatologic oncology at Case Western Reserve University in Cleveland.
Most of the squamous cell carcinomas (SCCs) in a large multicenter retrospective study developed within the first 5 years following hematopoietic cell transplantation (HCT), while the majority of the basal cell carcinomas (BCCs) occurred after that point, Dr. Scott reported at the annual meeting of the American College of Mohs Surgery.
He presented the results of the study, which included 876 HCT recipients followed for a mean of 6.1 years. The study objective was to pin down the risk factors for skin cancer after HCT, especially the patient-specific ones. This has become a pressing issue because the use of HCT is steadily growing, and the 5-year survival rate now exceeds 50%.
The transplant-specific risk factors have previously been fairly well described by others. They include the donor source, type of disease, the conditioning regimen, whether whole body irradiation was used, immunosuppression, graft versus host disease (GVHD), and others.
The patient-centric risk factors, in contrast, have not been well characterized. And it’s critical to thoroughly understand these risk factors in order to develop targeted prevention and surveillance strategies, Dr. Scott said.
“There remains a significant knowledge gap within our field. I would venture that the majority of this audience has treated a patient with skin cancer who has had a transplant,” he said. “Yet when a patient asks us, ‘Doc, what is my risk for skin cancer after my HCT?’ we’re really unable to give them an accurate and complete assessment of that risk. That’s because we’re missing the second major category of risk factors: the patient-specific risk factors.”
The reason for that, he added, is that the major population-based studies and national HCT registries are run by hematologists and oncologists, and they haven’t adequately captured the patient-specific skin cancer risk factors. But these are variables very familiar to dermatologists. They include skin phenotype, history of UV radiation exposure, and history of pre-HCT skin cancer.
Dr. Scott said the multicenter study he presented has two major advantages over prior studies: its large size and thorough followup. Nearly all 876 patients were followed by both an oncologist and a dermatologist at the same institution.
During followup, the HCT recipients collectively developed 63 SCCs, 55 BCCs, and 16 malignant melanomas. The 5- and 10-year incidence rates for SCC were 10.6% and 17.2%. For BCC, the 5- and 10-year rates were 5.7% and 17.6%. All 16 cases of melanoma occurred within 5 years after HCT.
In multivariate Cox proportional hazard analyses, photodamage documented on examination was independently associated with a 3.2-fold increased risk of post-HCT SCC and a 3.5-fold increased risk of BCC.
A pre-transplant history of BCC was associated with a 3.9-fold increased likelihood of developing a BCC afterwards. Similarly, a pre-HCT history of SCC conferred a 4.2-fold increased risk of post-transplant SCC and was also independently associated with a 6.6-fold increased risk of developing melanoma post-HCT.
Fitzpatrick skin types I and II were respectively associated with 9.3- and 7.2-fold increased risks of post-HCT nonmelanoma skin cancer, compared with skin types III-VI.
Acute GVHD wasn’t associated with an increased risk of nonmelanoma skin cancer after HCT. However, in an observation that hasn’t previously been reported by others, chronic GVHD with skin involvement was associated with a 2.7-fold increased likelihood of SCC post-HCT, Dr. Scott noted.
What’s next for Dr. Scott and his coinvestigators? “Our ultimate goal with this project is to develop an interactive risk assessment tool like the National Cancer Institute’s Breast Cancer Risk Assessment Tool that can be online and used by patients and providers to estimate their individualized risk of basal cell carcinoma, squamous cell carcinoma, and melanoma after HCT,” he said.
Dr. Scott reported having no financial conflicts related to the study.
CHICAGO – The 10-year incidence rates for both squamous cell carcinoma and basal cell carcinoma arising after hematopoietic cell transplantation are impressively high at 17%-plus for each, but the malignancies occur on two very different timelines, according to Jeffrey F. Scott, MD, a fellow in micrographic surgery and dermatologic oncology at Case Western Reserve University in Cleveland.
Most of the squamous cell carcinomas (SCCs) in a large multicenter retrospective study developed within the first 5 years following hematopoietic cell transplantation (HCT), while the majority of the basal cell carcinomas (BCCs) occurred after that point, Dr. Scott reported at the annual meeting of the American College of Mohs Surgery.
He presented the results of the study, which included 876 HCT recipients followed for a mean of 6.1 years. The study objective was to pin down the risk factors for skin cancer after HCT, especially the patient-specific ones. This has become a pressing issue because the use of HCT is steadily growing, and the 5-year survival rate now exceeds 50%.
The transplant-specific risk factors have previously been fairly well described by others. They include the donor source, type of disease, the conditioning regimen, whether whole body irradiation was used, immunosuppression, graft versus host disease (GVHD), and others.
The patient-centric risk factors, in contrast, have not been well characterized. And it’s critical to thoroughly understand these risk factors in order to develop targeted prevention and surveillance strategies, Dr. Scott said.
“There remains a significant knowledge gap within our field. I would venture that the majority of this audience has treated a patient with skin cancer who has had a transplant,” he said. “Yet when a patient asks us, ‘Doc, what is my risk for skin cancer after my HCT?’ we’re really unable to give them an accurate and complete assessment of that risk. That’s because we’re missing the second major category of risk factors: the patient-specific risk factors.”
The reason for that, he added, is that the major population-based studies and national HCT registries are run by hematologists and oncologists, and they haven’t adequately captured the patient-specific skin cancer risk factors. But these are variables very familiar to dermatologists. They include skin phenotype, history of UV radiation exposure, and history of pre-HCT skin cancer.
Dr. Scott said the multicenter study he presented has two major advantages over prior studies: its large size and thorough followup. Nearly all 876 patients were followed by both an oncologist and a dermatologist at the same institution.
During followup, the HCT recipients collectively developed 63 SCCs, 55 BCCs, and 16 malignant melanomas. The 5- and 10-year incidence rates for SCC were 10.6% and 17.2%. For BCC, the 5- and 10-year rates were 5.7% and 17.6%. All 16 cases of melanoma occurred within 5 years after HCT.
In multivariate Cox proportional hazard analyses, photodamage documented on examination was independently associated with a 3.2-fold increased risk of post-HCT SCC and a 3.5-fold increased risk of BCC.
A pre-transplant history of BCC was associated with a 3.9-fold increased likelihood of developing a BCC afterwards. Similarly, a pre-HCT history of SCC conferred a 4.2-fold increased risk of post-transplant SCC and was also independently associated with a 6.6-fold increased risk of developing melanoma post-HCT.
Fitzpatrick skin types I and II were respectively associated with 9.3- and 7.2-fold increased risks of post-HCT nonmelanoma skin cancer, compared with skin types III-VI.
Acute GVHD wasn’t associated with an increased risk of nonmelanoma skin cancer after HCT. However, in an observation that hasn’t previously been reported by others, chronic GVHD with skin involvement was associated with a 2.7-fold increased likelihood of SCC post-HCT, Dr. Scott noted.
What’s next for Dr. Scott and his coinvestigators? “Our ultimate goal with this project is to develop an interactive risk assessment tool like the National Cancer Institute’s Breast Cancer Risk Assessment Tool that can be online and used by patients and providers to estimate their individualized risk of basal cell carcinoma, squamous cell carcinoma, and melanoma after HCT,” he said.
Dr. Scott reported having no financial conflicts related to the study.
CHICAGO – The 10-year incidence rates for both squamous cell carcinoma and basal cell carcinoma arising after hematopoietic cell transplantation are impressively high at 17%-plus for each, but the malignancies occur on two very different timelines, according to Jeffrey F. Scott, MD, a fellow in micrographic surgery and dermatologic oncology at Case Western Reserve University in Cleveland.
Most of the squamous cell carcinomas (SCCs) in a large multicenter retrospective study developed within the first 5 years following hematopoietic cell transplantation (HCT), while the majority of the basal cell carcinomas (BCCs) occurred after that point, Dr. Scott reported at the annual meeting of the American College of Mohs Surgery.
He presented the results of the study, which included 876 HCT recipients followed for a mean of 6.1 years. The study objective was to pin down the risk factors for skin cancer after HCT, especially the patient-specific ones. This has become a pressing issue because the use of HCT is steadily growing, and the 5-year survival rate now exceeds 50%.
The transplant-specific risk factors have previously been fairly well described by others. They include the donor source, type of disease, the conditioning regimen, whether whole body irradiation was used, immunosuppression, graft versus host disease (GVHD), and others.
The patient-centric risk factors, in contrast, have not been well characterized. And it’s critical to thoroughly understand these risk factors in order to develop targeted prevention and surveillance strategies, Dr. Scott said.
“There remains a significant knowledge gap within our field. I would venture that the majority of this audience has treated a patient with skin cancer who has had a transplant,” he said. “Yet when a patient asks us, ‘Doc, what is my risk for skin cancer after my HCT?’ we’re really unable to give them an accurate and complete assessment of that risk. That’s because we’re missing the second major category of risk factors: the patient-specific risk factors.”
The reason for that, he added, is that the major population-based studies and national HCT registries are run by hematologists and oncologists, and they haven’t adequately captured the patient-specific skin cancer risk factors. But these are variables very familiar to dermatologists. They include skin phenotype, history of UV radiation exposure, and history of pre-HCT skin cancer.
Dr. Scott said the multicenter study he presented has two major advantages over prior studies: its large size and thorough followup. Nearly all 876 patients were followed by both an oncologist and a dermatologist at the same institution.
During followup, the HCT recipients collectively developed 63 SCCs, 55 BCCs, and 16 malignant melanomas. The 5- and 10-year incidence rates for SCC were 10.6% and 17.2%. For BCC, the 5- and 10-year rates were 5.7% and 17.6%. All 16 cases of melanoma occurred within 5 years after HCT.
In multivariate Cox proportional hazard analyses, photodamage documented on examination was independently associated with a 3.2-fold increased risk of post-HCT SCC and a 3.5-fold increased risk of BCC.
A pre-transplant history of BCC was associated with a 3.9-fold increased likelihood of developing a BCC afterwards. Similarly, a pre-HCT history of SCC conferred a 4.2-fold increased risk of post-transplant SCC and was also independently associated with a 6.6-fold increased risk of developing melanoma post-HCT.
Fitzpatrick skin types I and II were respectively associated with 9.3- and 7.2-fold increased risks of post-HCT nonmelanoma skin cancer, compared with skin types III-VI.
Acute GVHD wasn’t associated with an increased risk of nonmelanoma skin cancer after HCT. However, in an observation that hasn’t previously been reported by others, chronic GVHD with skin involvement was associated with a 2.7-fold increased likelihood of SCC post-HCT, Dr. Scott noted.
What’s next for Dr. Scott and his coinvestigators? “Our ultimate goal with this project is to develop an interactive risk assessment tool like the National Cancer Institute’s Breast Cancer Risk Assessment Tool that can be online and used by patients and providers to estimate their individualized risk of basal cell carcinoma, squamous cell carcinoma, and melanoma after HCT,” he said.
Dr. Scott reported having no financial conflicts related to the study.
REPORTING FROM THE ACMS ANNUAL MEETING
Key clinical point:
Major finding: Photodamage documented on examination more than triples the risk of developing nonmelanoma skin cancer after hematopoietic cell transplantation.
Study details: A multicenter retrospective study of 876 hematopoietic cell recipients followed for a mean of 6.1 years.
Disclosures: The presenter reported having no financial conflicts related to the study, which was conducted without commercial support.
FDA database reveals many rheumatic and musculoskeletal adverse events on immunotherapies
AMSTERDAM – Mining of the Food and Drug Administration adverse events database revealed a more substantial risk of rheumatic and musculoskeletal events on checkpoint inhibitor therapy than has been previously reported, according to Xerxes N. Pundole, PhD, an instructor in the research faculty at the University of Texas MD Anderson Cancer Center, Houston.
In a video interview, Dr. Pundole summarized data he presented at the European Congress of Rheumatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
So far, according to Dr. Pundole, there have been a relatively limited number of reports in the medical literature of inflammatory rheumatic or musculoskeletal events from checkpoint inhibitors. However, other inflammatory conditions, such as colitis and pneumonitis, are known to occur commonly with these agents. The FDA adverse event database provided an opportunity to evaluate how often rheumatic and musculoskeletal events are reported in the real world.
In this interview, Dr. Pundole explained that rheumatic and musculoskeletal events do occur at higher rates than would be expected in patients not treated with a checkpoint inhibitor. With data from more than 30,000 unique patients, the relative risks of some of these adverse events, such as polymyositis, were more than doubled, although the event rates were not evenly distributed.
Specifically, rheumatic and musculoskeletal adverse events were far less common with the cytotoxic T-lymphocyte antigen 4 checkpoint inhibitor ipilimumab (Yervoy) relative to programmed cell death protein 1 inhibitors, particularly nivolumab (Opdivo).
In another notable finding, a demographic stratification of the FDA database found elderly men to be overrepresented among patients developing adverse events related to musculoskeletal inflammation.
Overall, his data do support a relationship between checkpoint inhibitors and a greater risk of rheumatic and musculoskeletal adverse events than has been previously reported, but he noted that these data provide no specific guidance for those who already have RA or another inflammatory condition.
“Can you identify these adverse events early on to keep the patients on immune checkpoint inhibitor therapy and not have to stop their cancer treatment? That’s a question,” Dr. Pundole said. However, he suggested that the FDA data support clinician awareness of the problem and the studies that will establish strategies for preserving the benefit-to-risk ratio of checkpoint inhibitors in patients who are at greater risk of adverse events relative to immune function because of a preexisting inflammatory condition.
SOURCE: Pundole XN et al. Ann Rheum Dis. 2018;77(Suppl 2):147-148. Abstract OP0197.
AMSTERDAM – Mining of the Food and Drug Administration adverse events database revealed a more substantial risk of rheumatic and musculoskeletal events on checkpoint inhibitor therapy than has been previously reported, according to Xerxes N. Pundole, PhD, an instructor in the research faculty at the University of Texas MD Anderson Cancer Center, Houston.
In a video interview, Dr. Pundole summarized data he presented at the European Congress of Rheumatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
So far, according to Dr. Pundole, there have been a relatively limited number of reports in the medical literature of inflammatory rheumatic or musculoskeletal events from checkpoint inhibitors. However, other inflammatory conditions, such as colitis and pneumonitis, are known to occur commonly with these agents. The FDA adverse event database provided an opportunity to evaluate how often rheumatic and musculoskeletal events are reported in the real world.
In this interview, Dr. Pundole explained that rheumatic and musculoskeletal events do occur at higher rates than would be expected in patients not treated with a checkpoint inhibitor. With data from more than 30,000 unique patients, the relative risks of some of these adverse events, such as polymyositis, were more than doubled, although the event rates were not evenly distributed.
Specifically, rheumatic and musculoskeletal adverse events were far less common with the cytotoxic T-lymphocyte antigen 4 checkpoint inhibitor ipilimumab (Yervoy) relative to programmed cell death protein 1 inhibitors, particularly nivolumab (Opdivo).
In another notable finding, a demographic stratification of the FDA database found elderly men to be overrepresented among patients developing adverse events related to musculoskeletal inflammation.
Overall, his data do support a relationship between checkpoint inhibitors and a greater risk of rheumatic and musculoskeletal adverse events than has been previously reported, but he noted that these data provide no specific guidance for those who already have RA or another inflammatory condition.
“Can you identify these adverse events early on to keep the patients on immune checkpoint inhibitor therapy and not have to stop their cancer treatment? That’s a question,” Dr. Pundole said. However, he suggested that the FDA data support clinician awareness of the problem and the studies that will establish strategies for preserving the benefit-to-risk ratio of checkpoint inhibitors in patients who are at greater risk of adverse events relative to immune function because of a preexisting inflammatory condition.
SOURCE: Pundole XN et al. Ann Rheum Dis. 2018;77(Suppl 2):147-148. Abstract OP0197.
AMSTERDAM – Mining of the Food and Drug Administration adverse events database revealed a more substantial risk of rheumatic and musculoskeletal events on checkpoint inhibitor therapy than has been previously reported, according to Xerxes N. Pundole, PhD, an instructor in the research faculty at the University of Texas MD Anderson Cancer Center, Houston.
In a video interview, Dr. Pundole summarized data he presented at the European Congress of Rheumatology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
So far, according to Dr. Pundole, there have been a relatively limited number of reports in the medical literature of inflammatory rheumatic or musculoskeletal events from checkpoint inhibitors. However, other inflammatory conditions, such as colitis and pneumonitis, are known to occur commonly with these agents. The FDA adverse event database provided an opportunity to evaluate how often rheumatic and musculoskeletal events are reported in the real world.
In this interview, Dr. Pundole explained that rheumatic and musculoskeletal events do occur at higher rates than would be expected in patients not treated with a checkpoint inhibitor. With data from more than 30,000 unique patients, the relative risks of some of these adverse events, such as polymyositis, were more than doubled, although the event rates were not evenly distributed.
Specifically, rheumatic and musculoskeletal adverse events were far less common with the cytotoxic T-lymphocyte antigen 4 checkpoint inhibitor ipilimumab (Yervoy) relative to programmed cell death protein 1 inhibitors, particularly nivolumab (Opdivo).
In another notable finding, a demographic stratification of the FDA database found elderly men to be overrepresented among patients developing adverse events related to musculoskeletal inflammation.
Overall, his data do support a relationship between checkpoint inhibitors and a greater risk of rheumatic and musculoskeletal adverse events than has been previously reported, but he noted that these data provide no specific guidance for those who already have RA or another inflammatory condition.
“Can you identify these adverse events early on to keep the patients on immune checkpoint inhibitor therapy and not have to stop their cancer treatment? That’s a question,” Dr. Pundole said. However, he suggested that the FDA data support clinician awareness of the problem and the studies that will establish strategies for preserving the benefit-to-risk ratio of checkpoint inhibitors in patients who are at greater risk of adverse events relative to immune function because of a preexisting inflammatory condition.
SOURCE: Pundole XN et al. Ann Rheum Dis. 2018;77(Suppl 2):147-148. Abstract OP0197.
REPORTING FROM THE EULAR 2018 CONGRESS
NIH launches HEAL Initiative to combat opioid crisis
The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.
“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.
HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.
“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”
The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.
For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”
Better overdose antidotes are needed as well, he said, particularly for fentanyl overdose. “Narcan may not be strong enough for those long-lasting and very potent opioids like fentanyl,” he said.
HEAL also will seek a better understanding of neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome, which has become alarmingly common as more women of childbearing potential struggle with opioid addiction.
“Innovative methods to identify and treat newborns exposed to opioids, often along with other drugs, have the potential to improve both short- and long-term developmental outcomes in such children,” Dr. Collins and colleagues noted. “To determine better approaches, HEAL will expand Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). This pilot study is designed to assess the prevalence of NOWS, understand current approaches to managing NOWS , and develop common approaches for larger-scale studies that will determine best practices for clinical care of infants with NOWS throughout the country.”
HEAL efforts also seek to find integrated approaches to OUD treatment.
“One particularly bold element is to put together a number of pilot projects that enable bringing together all of the ways in which we are trying to turn this epidemic around by making it possible to assess whether individuals who are addicted can be successfully treated and maintained in abstinence for long periods of time,” Dr. Collins said. “Right now, the success is not so great.
“Suppose we brought together all of the treatment programs – the primary care facilities, the emergency rooms, the fire departments, the social work experts, the health departments in the states, the local communities, the criminal justice system. We brought together all of those players in a research design where we can really see what was working. Could we do a lot more to turn this around than basically doing one of those at a time? There is this multisite idea of a national research effort, still somewhat in development, but to do integration of all of these efforts. I am pretty excited about that one.”
In looking for better ways to treat pain safely and effectively, “we need to understand how it is that people transition from acute pain to chronic pain … and what can we do increase the likelihood of recovery from acute pain without making that transition,” Dr. Collins said. “Then we need to identify additional novel targets for developing pain therapies, both devices and pharmaceuticals. We need better means of testing those ideas.”
In addition to gaining a better understanding of chronic pain, HEAL aims to investigate new nonaddictive pain treatments and find ways to expedite those treatments through the clinical pipeline, according to Dr. Collins and colleagues.
HEAL “lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership. In collaboration with biopharmaceutical groups, the Food and Drug Administration, and the Foundation for the NIH, the NIH will collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction,” they wrote.
SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.
The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.
“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.
HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.
“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”
The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.
For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”
Better overdose antidotes are needed as well, he said, particularly for fentanyl overdose. “Narcan may not be strong enough for those long-lasting and very potent opioids like fentanyl,” he said.
HEAL also will seek a better understanding of neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome, which has become alarmingly common as more women of childbearing potential struggle with opioid addiction.
“Innovative methods to identify and treat newborns exposed to opioids, often along with other drugs, have the potential to improve both short- and long-term developmental outcomes in such children,” Dr. Collins and colleagues noted. “To determine better approaches, HEAL will expand Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). This pilot study is designed to assess the prevalence of NOWS, understand current approaches to managing NOWS , and develop common approaches for larger-scale studies that will determine best practices for clinical care of infants with NOWS throughout the country.”
HEAL efforts also seek to find integrated approaches to OUD treatment.
“One particularly bold element is to put together a number of pilot projects that enable bringing together all of the ways in which we are trying to turn this epidemic around by making it possible to assess whether individuals who are addicted can be successfully treated and maintained in abstinence for long periods of time,” Dr. Collins said. “Right now, the success is not so great.
“Suppose we brought together all of the treatment programs – the primary care facilities, the emergency rooms, the fire departments, the social work experts, the health departments in the states, the local communities, the criminal justice system. We brought together all of those players in a research design where we can really see what was working. Could we do a lot more to turn this around than basically doing one of those at a time? There is this multisite idea of a national research effort, still somewhat in development, but to do integration of all of these efforts. I am pretty excited about that one.”
In looking for better ways to treat pain safely and effectively, “we need to understand how it is that people transition from acute pain to chronic pain … and what can we do increase the likelihood of recovery from acute pain without making that transition,” Dr. Collins said. “Then we need to identify additional novel targets for developing pain therapies, both devices and pharmaceuticals. We need better means of testing those ideas.”
In addition to gaining a better understanding of chronic pain, HEAL aims to investigate new nonaddictive pain treatments and find ways to expedite those treatments through the clinical pipeline, according to Dr. Collins and colleagues.
HEAL “lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership. In collaboration with biopharmaceutical groups, the Food and Drug Administration, and the Foundation for the NIH, the NIH will collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction,” they wrote.
SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.
The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.
“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.
HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.
“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”
The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.
For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”
Better overdose antidotes are needed as well, he said, particularly for fentanyl overdose. “Narcan may not be strong enough for those long-lasting and very potent opioids like fentanyl,” he said.
HEAL also will seek a better understanding of neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome, which has become alarmingly common as more women of childbearing potential struggle with opioid addiction.
“Innovative methods to identify and treat newborns exposed to opioids, often along with other drugs, have the potential to improve both short- and long-term developmental outcomes in such children,” Dr. Collins and colleagues noted. “To determine better approaches, HEAL will expand Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). This pilot study is designed to assess the prevalence of NOWS, understand current approaches to managing NOWS , and develop common approaches for larger-scale studies that will determine best practices for clinical care of infants with NOWS throughout the country.”
HEAL efforts also seek to find integrated approaches to OUD treatment.
“One particularly bold element is to put together a number of pilot projects that enable bringing together all of the ways in which we are trying to turn this epidemic around by making it possible to assess whether individuals who are addicted can be successfully treated and maintained in abstinence for long periods of time,” Dr. Collins said. “Right now, the success is not so great.
“Suppose we brought together all of the treatment programs – the primary care facilities, the emergency rooms, the fire departments, the social work experts, the health departments in the states, the local communities, the criminal justice system. We brought together all of those players in a research design where we can really see what was working. Could we do a lot more to turn this around than basically doing one of those at a time? There is this multisite idea of a national research effort, still somewhat in development, but to do integration of all of these efforts. I am pretty excited about that one.”
In looking for better ways to treat pain safely and effectively, “we need to understand how it is that people transition from acute pain to chronic pain … and what can we do increase the likelihood of recovery from acute pain without making that transition,” Dr. Collins said. “Then we need to identify additional novel targets for developing pain therapies, both devices and pharmaceuticals. We need better means of testing those ideas.”
In addition to gaining a better understanding of chronic pain, HEAL aims to investigate new nonaddictive pain treatments and find ways to expedite those treatments through the clinical pipeline, according to Dr. Collins and colleagues.
HEAL “lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership. In collaboration with biopharmaceutical groups, the Food and Drug Administration, and the Foundation for the NIH, the NIH will collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction,” they wrote.
SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.
FROM JAMA
FDA approves first biosimilar to pegfilgrastim
to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.
The approval is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates pegfilgrastim-jmdb is biosimilar to pegfilgrastim, the FDA said in a statement.
The FDA warns that “patients with a history of serious allergic reactions to human granulocyte colony–stimulating factors such as pegfilgrastim or filgrastim products should not take pegfilgrastim-jmdb.”
This approval is part of the FDA’s efforts to “help promote competition that can reduce drug costs and promote access,” FDA commissioner Scott Gottlieb, MD, said in the statement. “This summer, we’ll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development. Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”
Pegfilgrastim-jmdb will be marketed as Fulphila by Mylan GmbH.
to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.
The approval is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates pegfilgrastim-jmdb is biosimilar to pegfilgrastim, the FDA said in a statement.
The FDA warns that “patients with a history of serious allergic reactions to human granulocyte colony–stimulating factors such as pegfilgrastim or filgrastim products should not take pegfilgrastim-jmdb.”
This approval is part of the FDA’s efforts to “help promote competition that can reduce drug costs and promote access,” FDA commissioner Scott Gottlieb, MD, said in the statement. “This summer, we’ll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development. Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”
Pegfilgrastim-jmdb will be marketed as Fulphila by Mylan GmbH.
to decrease the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy and are at risk of febrile neutropenia.
The approval is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates pegfilgrastim-jmdb is biosimilar to pegfilgrastim, the FDA said in a statement.
The FDA warns that “patients with a history of serious allergic reactions to human granulocyte colony–stimulating factors such as pegfilgrastim or filgrastim products should not take pegfilgrastim-jmdb.”
This approval is part of the FDA’s efforts to “help promote competition that can reduce drug costs and promote access,” FDA commissioner Scott Gottlieb, MD, said in the statement. “This summer, we’ll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development. Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”
Pegfilgrastim-jmdb will be marketed as Fulphila by Mylan GmbH.
Geriatric assessments improve oncologist-patient communications
CHICAGO – Elderly cancer patients have better communication with their oncologists and report greater satisfaction with their care when the oncologists are provided with geriatric assessment summaries prior to the patient visit.
Although “satisfaction” can be subjective, the conclusion about the benefit of previsit geriatric assessments is objective, reported Supriya Gupta Mohile, MD, of the University of Rochester, New York.
“Physicians often don’t know patients’ and caregivers’ age-related concerns, such as concerns about memory or concerns about falling. Many patients and caregivers do not ask about age-related concerns, because of their unclear understanding of the relevance of those issues to an oncology clinical encounter,” she added.
The aim of the researchers was to see whether communication between physicians and their elderly patients could be improved, and patient support needs addressed, with the aid of the Geriatric Assessment (GA), a multidisciplinary diagnostic and treatment instrument.
The GA evaluates patients in the domains of functional status, objective physical performance, comorbidities, cognition, nutritional status, psychological status, and social support, and identifies vulnerabilities that could be addressed by specific interventions.
For example, patients with suboptimal physical performance may trigger recommendations for fall prevention and a review of medications that could increase fall risk. For patients with decrements in functional status, recommendations may include physical therapy, safety evaluation, and/or vision assessment.
Each domain independently predicts morbidity and/or mortality in older patients.
The investigators enrolled 31 oncology practices in the National Cancer Institute’s Community Oncology Research Program that were treating patients aged 70 or older with advanced solid tumors or lymphoma. Patients who were enrolled had at least one impaired GA domain. In all, 542 patients across the sites were enrolled.
All patients in each arm completed the GA.
Randomization was by practice, with practices in arm 1 randomized to receive GA intervention results. Oncologists in this trial arm were provided with a GA summary and list of recommended GA-guided interventions.
Practices in arm 2 (controls) did not receive summaries or lists of recommendations, but oncologists were notified if patients had clinically significant depression or cognitive impairment.
In the intervention group, patients completed all assessments within 30 minutes, and less than 10 minutes of practice staff time was required for administration of objective tests.
The investigators made audio recordings and transcripts of clinic visits after GA in both arms, with two blinded coders evaluating quality of communication and plans for follow-up interventions. Patients were surveyed by telephone about their satisfaction, via the Health Care Climate Questionnaire (HCCQ) and the same instrument modified for age-related concerns (HCCQ-age).
“We found that patients enrolled in the study had a high prevalence of impairments of Geriatric Assessment domains, ranging from over 90% for physical performance, to 25% for psychological status, mainly depression. Of note, more than 30% of patients ... screened positive for cognitive impairment.” Dr. Mohile said.
For the coprimary endpoint of communication about age-related concerns, the mean number of discussions was 7.74 in the GA arm, compared with 4.24 in the control arm, a difference of 3.5 (P less than .0001).
Arm 1 was rated as having more discussions with higher-quality communications (mean 4.42 vs. 2.47, P less than .0001), and had more discussions leading to an intervention (3.08 vs. 1.15, P less than .0001).
Patients in arm 1 consistently rated their satisfaction with communication (the other coprimary endpoint) higher than did patients in arm 2, at both baseline, 4-6 weeks after the visit, and 3 months after the visit.
“This is a very important study that I think is likely to have a direct impact on the care of older patients with cancer,” ASCO expert Joshua A. Jones, MD, of the University of Pennsylvania, Philadelphia, said at the meeting.
“This study shows in a randomized fashion that we can, with a simple intervention, improve communication about what’s really important to older patients with cancer,” he said. “We have interventions, things like physical therapy, things like counseling, supports that can be provided to patients and families as they are thinking through treatment decisions, helping us to provide the most appropriate care for these individuals.”
SOURCE: Mohile SG et al. ASCO 2018, abstract LBA10003.
CHICAGO – Elderly cancer patients have better communication with their oncologists and report greater satisfaction with their care when the oncologists are provided with geriatric assessment summaries prior to the patient visit.
Although “satisfaction” can be subjective, the conclusion about the benefit of previsit geriatric assessments is objective, reported Supriya Gupta Mohile, MD, of the University of Rochester, New York.
“Physicians often don’t know patients’ and caregivers’ age-related concerns, such as concerns about memory or concerns about falling. Many patients and caregivers do not ask about age-related concerns, because of their unclear understanding of the relevance of those issues to an oncology clinical encounter,” she added.
The aim of the researchers was to see whether communication between physicians and their elderly patients could be improved, and patient support needs addressed, with the aid of the Geriatric Assessment (GA), a multidisciplinary diagnostic and treatment instrument.
The GA evaluates patients in the domains of functional status, objective physical performance, comorbidities, cognition, nutritional status, psychological status, and social support, and identifies vulnerabilities that could be addressed by specific interventions.
For example, patients with suboptimal physical performance may trigger recommendations for fall prevention and a review of medications that could increase fall risk. For patients with decrements in functional status, recommendations may include physical therapy, safety evaluation, and/or vision assessment.
Each domain independently predicts morbidity and/or mortality in older patients.
The investigators enrolled 31 oncology practices in the National Cancer Institute’s Community Oncology Research Program that were treating patients aged 70 or older with advanced solid tumors or lymphoma. Patients who were enrolled had at least one impaired GA domain. In all, 542 patients across the sites were enrolled.
All patients in each arm completed the GA.
Randomization was by practice, with practices in arm 1 randomized to receive GA intervention results. Oncologists in this trial arm were provided with a GA summary and list of recommended GA-guided interventions.
Practices in arm 2 (controls) did not receive summaries or lists of recommendations, but oncologists were notified if patients had clinically significant depression or cognitive impairment.
In the intervention group, patients completed all assessments within 30 minutes, and less than 10 minutes of practice staff time was required for administration of objective tests.
The investigators made audio recordings and transcripts of clinic visits after GA in both arms, with two blinded coders evaluating quality of communication and plans for follow-up interventions. Patients were surveyed by telephone about their satisfaction, via the Health Care Climate Questionnaire (HCCQ) and the same instrument modified for age-related concerns (HCCQ-age).
“We found that patients enrolled in the study had a high prevalence of impairments of Geriatric Assessment domains, ranging from over 90% for physical performance, to 25% for psychological status, mainly depression. Of note, more than 30% of patients ... screened positive for cognitive impairment.” Dr. Mohile said.
For the coprimary endpoint of communication about age-related concerns, the mean number of discussions was 7.74 in the GA arm, compared with 4.24 in the control arm, a difference of 3.5 (P less than .0001).
Arm 1 was rated as having more discussions with higher-quality communications (mean 4.42 vs. 2.47, P less than .0001), and had more discussions leading to an intervention (3.08 vs. 1.15, P less than .0001).
Patients in arm 1 consistently rated their satisfaction with communication (the other coprimary endpoint) higher than did patients in arm 2, at both baseline, 4-6 weeks after the visit, and 3 months after the visit.
“This is a very important study that I think is likely to have a direct impact on the care of older patients with cancer,” ASCO expert Joshua A. Jones, MD, of the University of Pennsylvania, Philadelphia, said at the meeting.
“This study shows in a randomized fashion that we can, with a simple intervention, improve communication about what’s really important to older patients with cancer,” he said. “We have interventions, things like physical therapy, things like counseling, supports that can be provided to patients and families as they are thinking through treatment decisions, helping us to provide the most appropriate care for these individuals.”
SOURCE: Mohile SG et al. ASCO 2018, abstract LBA10003.
CHICAGO – Elderly cancer patients have better communication with their oncologists and report greater satisfaction with their care when the oncologists are provided with geriatric assessment summaries prior to the patient visit.
Although “satisfaction” can be subjective, the conclusion about the benefit of previsit geriatric assessments is objective, reported Supriya Gupta Mohile, MD, of the University of Rochester, New York.
“Physicians often don’t know patients’ and caregivers’ age-related concerns, such as concerns about memory or concerns about falling. Many patients and caregivers do not ask about age-related concerns, because of their unclear understanding of the relevance of those issues to an oncology clinical encounter,” she added.
The aim of the researchers was to see whether communication between physicians and their elderly patients could be improved, and patient support needs addressed, with the aid of the Geriatric Assessment (GA), a multidisciplinary diagnostic and treatment instrument.
The GA evaluates patients in the domains of functional status, objective physical performance, comorbidities, cognition, nutritional status, psychological status, and social support, and identifies vulnerabilities that could be addressed by specific interventions.
For example, patients with suboptimal physical performance may trigger recommendations for fall prevention and a review of medications that could increase fall risk. For patients with decrements in functional status, recommendations may include physical therapy, safety evaluation, and/or vision assessment.
Each domain independently predicts morbidity and/or mortality in older patients.
The investigators enrolled 31 oncology practices in the National Cancer Institute’s Community Oncology Research Program that were treating patients aged 70 or older with advanced solid tumors or lymphoma. Patients who were enrolled had at least one impaired GA domain. In all, 542 patients across the sites were enrolled.
All patients in each arm completed the GA.
Randomization was by practice, with practices in arm 1 randomized to receive GA intervention results. Oncologists in this trial arm were provided with a GA summary and list of recommended GA-guided interventions.
Practices in arm 2 (controls) did not receive summaries or lists of recommendations, but oncologists were notified if patients had clinically significant depression or cognitive impairment.
In the intervention group, patients completed all assessments within 30 minutes, and less than 10 minutes of practice staff time was required for administration of objective tests.
The investigators made audio recordings and transcripts of clinic visits after GA in both arms, with two blinded coders evaluating quality of communication and plans for follow-up interventions. Patients were surveyed by telephone about their satisfaction, via the Health Care Climate Questionnaire (HCCQ) and the same instrument modified for age-related concerns (HCCQ-age).
“We found that patients enrolled in the study had a high prevalence of impairments of Geriatric Assessment domains, ranging from over 90% for physical performance, to 25% for psychological status, mainly depression. Of note, more than 30% of patients ... screened positive for cognitive impairment.” Dr. Mohile said.
For the coprimary endpoint of communication about age-related concerns, the mean number of discussions was 7.74 in the GA arm, compared with 4.24 in the control arm, a difference of 3.5 (P less than .0001).
Arm 1 was rated as having more discussions with higher-quality communications (mean 4.42 vs. 2.47, P less than .0001), and had more discussions leading to an intervention (3.08 vs. 1.15, P less than .0001).
Patients in arm 1 consistently rated their satisfaction with communication (the other coprimary endpoint) higher than did patients in arm 2, at both baseline, 4-6 weeks after the visit, and 3 months after the visit.
“This is a very important study that I think is likely to have a direct impact on the care of older patients with cancer,” ASCO expert Joshua A. Jones, MD, of the University of Pennsylvania, Philadelphia, said at the meeting.
“This study shows in a randomized fashion that we can, with a simple intervention, improve communication about what’s really important to older patients with cancer,” he said. “We have interventions, things like physical therapy, things like counseling, supports that can be provided to patients and families as they are thinking through treatment decisions, helping us to provide the most appropriate care for these individuals.”
SOURCE: Mohile SG et al. ASCO 2018, abstract LBA10003.
REPORTING FROM ASCO 2018
Key clinical point: Geriatric cancer patients may have age-related concerns that they don’t bring up during an oncology visit, but that could affect their care.
Major finding: Patients whose oncologists received geriatric assessment results had significantly more and higher quality discussions of age-related concerns, and were significantly more satisfied with their communications at follow-up.
Study details: Cluster randomized controlled trial comprising 542 patients aged 70 and older from 31 community oncology sites.
Disclosures: The National Cancer Institute funded the study. Dr. Mohile disclosed a consulting/advisory role with Seattle Genetics. Dr. Jones reported no conflicts of interest relevant to the study.
Source: Mohile SG et al. ASCO 2018, abstract LBA10003.
Tumor analysis: Test all MSI-high patients for Lynch Syndrome
CHICAGO – , according to “absolutely practice changing” findings from a prospective analysis of more than 15,000 tumor samples.
“The impact of these findings cannot be understated,” ASCO expert Shannon N. Westin, MD, said during a discussion of the findings presented by Zsofia K. Stadler, MD, at a press briefing at the annual meeting of the American Society of Clinical Oncology.
Lynch Syndrome (LS), an autosomal dominant inherited cancer predisposition syndrome caused by germline mutation in the DNA mismatch repair genes, is responsible for about 3% of colorectal and endometrial cancers; universal testing for tumor markers of LS is recommended in all patients with these types of cancers, said Dr. Stadler, director of the Clinical Genetics Service at Memorial Sloan Kettering Cancer Center, New York.
“This is usually done either via MSI analysis or immunohistochemical staining for the DNA mismatch repair proteins,” she said, noting that genetic testing and counseling is recommended in patients with tumors suggestive of LS, and increased surveillance and/or risk-reducing surgery is recommended in those recognized as having LS.
MSI-high is a hallmark of LS-associated cancers and has recently been implicated as a marker for response to immunotherapy. This has led to increased MSI testing in metastatic cancer regardless of cancer type.
However, the prevalence of germline mutations in the DNA mismatch repair genes diagnostic of LS across all MSI-high tumors is unknown, she said.
In 15,045 tumor samples across more than 50 cancer types, germline mutations were analyzed across tumor types and according to MSI status.
As expected, the highest level of MSI-high was seen in small bowel cancer (25%), followed by endometrial, colorectal, and gastric cancer (16%, 14%, and 6%, respectively), Dr. Stadler said.
“High frequency MSI was also seen in a number of other tumors as suggested by other papers previously,” she noted.
LS was present in 16.3% of MSI-high tumors vs. 1.9% of MSI-indeterminate (moderate MSI level) tumors, and 0.3% of microsatellite stable (MSS) tumors, she added.
Additional tumor evaluations, including immunohistochemical staining for the mismatch repair genes, were also performed.
“Our analysis corroborated the finding that in these Lynch patients, the MSI-high and MSI-indeterminate tumors were caused by Lynch Syndrome. This is in contrast to our Lynch Syndrome patients with microsatellite stable tumors; their tumor signature suggested that the Lynch Syndrome did not cause these cancers,” she said. “In fact, the prevalence of Lynch Syndrome in the MSS cohort of 0.3% is equivalent to the presence of Lynch Syndrome in the general at-large population.”
Of note, 50% of LS patients with MSI-high and indeterminate tumors had cancers other than colorectal or endometrial cancer, including prostate, sarcoma, mesothelioma, adrenocortical carcinoma, and ovarian germ cell carcinoma, which have been rarely or not previously associated with LS, and 45% of those patients did not meet clinical testing criteria for LS and would not have undergone LS testing.
This finding underscores the previously unknown heterogeneity of the phenotype.
“Our study supports that MSI-high is predictive of LS across tumor types...and also supports that the spectrum of cancers associated with Lynch Syndrome seems to be much broader that previously thought, she said, concluding that “MSI-high tumor signature, regardless of cancer subtype and irrespective of the family cancer history, should prompt germline genetic assessment for the evaluation of Lynch [Syndrome].
“This will result in an increased ability to recognize Lynch Syndrome not only in cancer patients, but also in at-risk family members who will benefit from genetic testing for Lynch [Syndrome] and subsequent enhanced cancer surveillance and risk reduction measures.”
In emphasizing the practice-changing nature of these findings, Dr. Westin, a gynecologic oncologist at MD Anderson Cancer Center, Houston, said that with the rise of precision medicine, increasing numbers of patients are undergoing testing for microsatellite instability, mainly to determine if their tumor can be affected by an-approved therapy.
“What we’ve learned is that MSI not only has therapeutic implications, it also has cancer prevention implications,” she said. “We’ve only been testing the tip of the iceberg of patients who are affected by Lynch Syndrome, and what we now know is that under the surface there is a larger number of patients with specific cancer types that should be tested for Lynch Syndrome.”
She added that this is “a straightforward testing strategy which can be immediately implemented to impact not only the patients themselves and their risk of cancer, but also their family members and their risk of cancer.”
This study was funded by Romeo Milio Lynch Syndrome Foundation, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, the Robert and Kate Niehaus Center for Inherited Cancer Genomics, the Fieldstone Family Fund, Stand Up to Cancer Colorectal Cancer Dream Team Translational Research Grant and the NIH/NCI Cancer Center Support Grant. Dr. Stadler reported consulting or advisory roles on the part of an immediate family member for Allergan, Genentech/Roche, Regeneron, Optos, and Adverum.
SOURCE: Schwark A et al., ASCO 2018 LBA1509.
CHICAGO – , according to “absolutely practice changing” findings from a prospective analysis of more than 15,000 tumor samples.
“The impact of these findings cannot be understated,” ASCO expert Shannon N. Westin, MD, said during a discussion of the findings presented by Zsofia K. Stadler, MD, at a press briefing at the annual meeting of the American Society of Clinical Oncology.
Lynch Syndrome (LS), an autosomal dominant inherited cancer predisposition syndrome caused by germline mutation in the DNA mismatch repair genes, is responsible for about 3% of colorectal and endometrial cancers; universal testing for tumor markers of LS is recommended in all patients with these types of cancers, said Dr. Stadler, director of the Clinical Genetics Service at Memorial Sloan Kettering Cancer Center, New York.
“This is usually done either via MSI analysis or immunohistochemical staining for the DNA mismatch repair proteins,” she said, noting that genetic testing and counseling is recommended in patients with tumors suggestive of LS, and increased surveillance and/or risk-reducing surgery is recommended in those recognized as having LS.
MSI-high is a hallmark of LS-associated cancers and has recently been implicated as a marker for response to immunotherapy. This has led to increased MSI testing in metastatic cancer regardless of cancer type.
However, the prevalence of germline mutations in the DNA mismatch repair genes diagnostic of LS across all MSI-high tumors is unknown, she said.
In 15,045 tumor samples across more than 50 cancer types, germline mutations were analyzed across tumor types and according to MSI status.
As expected, the highest level of MSI-high was seen in small bowel cancer (25%), followed by endometrial, colorectal, and gastric cancer (16%, 14%, and 6%, respectively), Dr. Stadler said.
“High frequency MSI was also seen in a number of other tumors as suggested by other papers previously,” she noted.
LS was present in 16.3% of MSI-high tumors vs. 1.9% of MSI-indeterminate (moderate MSI level) tumors, and 0.3% of microsatellite stable (MSS) tumors, she added.
Additional tumor evaluations, including immunohistochemical staining for the mismatch repair genes, were also performed.
“Our analysis corroborated the finding that in these Lynch patients, the MSI-high and MSI-indeterminate tumors were caused by Lynch Syndrome. This is in contrast to our Lynch Syndrome patients with microsatellite stable tumors; their tumor signature suggested that the Lynch Syndrome did not cause these cancers,” she said. “In fact, the prevalence of Lynch Syndrome in the MSS cohort of 0.3% is equivalent to the presence of Lynch Syndrome in the general at-large population.”
Of note, 50% of LS patients with MSI-high and indeterminate tumors had cancers other than colorectal or endometrial cancer, including prostate, sarcoma, mesothelioma, adrenocortical carcinoma, and ovarian germ cell carcinoma, which have been rarely or not previously associated with LS, and 45% of those patients did not meet clinical testing criteria for LS and would not have undergone LS testing.
This finding underscores the previously unknown heterogeneity of the phenotype.
“Our study supports that MSI-high is predictive of LS across tumor types...and also supports that the spectrum of cancers associated with Lynch Syndrome seems to be much broader that previously thought, she said, concluding that “MSI-high tumor signature, regardless of cancer subtype and irrespective of the family cancer history, should prompt germline genetic assessment for the evaluation of Lynch [Syndrome].
“This will result in an increased ability to recognize Lynch Syndrome not only in cancer patients, but also in at-risk family members who will benefit from genetic testing for Lynch [Syndrome] and subsequent enhanced cancer surveillance and risk reduction measures.”
In emphasizing the practice-changing nature of these findings, Dr. Westin, a gynecologic oncologist at MD Anderson Cancer Center, Houston, said that with the rise of precision medicine, increasing numbers of patients are undergoing testing for microsatellite instability, mainly to determine if their tumor can be affected by an-approved therapy.
“What we’ve learned is that MSI not only has therapeutic implications, it also has cancer prevention implications,” she said. “We’ve only been testing the tip of the iceberg of patients who are affected by Lynch Syndrome, and what we now know is that under the surface there is a larger number of patients with specific cancer types that should be tested for Lynch Syndrome.”
She added that this is “a straightforward testing strategy which can be immediately implemented to impact not only the patients themselves and their risk of cancer, but also their family members and their risk of cancer.”
This study was funded by Romeo Milio Lynch Syndrome Foundation, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, the Robert and Kate Niehaus Center for Inherited Cancer Genomics, the Fieldstone Family Fund, Stand Up to Cancer Colorectal Cancer Dream Team Translational Research Grant and the NIH/NCI Cancer Center Support Grant. Dr. Stadler reported consulting or advisory roles on the part of an immediate family member for Allergan, Genentech/Roche, Regeneron, Optos, and Adverum.
SOURCE: Schwark A et al., ASCO 2018 LBA1509.
CHICAGO – , according to “absolutely practice changing” findings from a prospective analysis of more than 15,000 tumor samples.
“The impact of these findings cannot be understated,” ASCO expert Shannon N. Westin, MD, said during a discussion of the findings presented by Zsofia K. Stadler, MD, at a press briefing at the annual meeting of the American Society of Clinical Oncology.
Lynch Syndrome (LS), an autosomal dominant inherited cancer predisposition syndrome caused by germline mutation in the DNA mismatch repair genes, is responsible for about 3% of colorectal and endometrial cancers; universal testing for tumor markers of LS is recommended in all patients with these types of cancers, said Dr. Stadler, director of the Clinical Genetics Service at Memorial Sloan Kettering Cancer Center, New York.
“This is usually done either via MSI analysis or immunohistochemical staining for the DNA mismatch repair proteins,” she said, noting that genetic testing and counseling is recommended in patients with tumors suggestive of LS, and increased surveillance and/or risk-reducing surgery is recommended in those recognized as having LS.
MSI-high is a hallmark of LS-associated cancers and has recently been implicated as a marker for response to immunotherapy. This has led to increased MSI testing in metastatic cancer regardless of cancer type.
However, the prevalence of germline mutations in the DNA mismatch repair genes diagnostic of LS across all MSI-high tumors is unknown, she said.
In 15,045 tumor samples across more than 50 cancer types, germline mutations were analyzed across tumor types and according to MSI status.
As expected, the highest level of MSI-high was seen in small bowel cancer (25%), followed by endometrial, colorectal, and gastric cancer (16%, 14%, and 6%, respectively), Dr. Stadler said.
“High frequency MSI was also seen in a number of other tumors as suggested by other papers previously,” she noted.
LS was present in 16.3% of MSI-high tumors vs. 1.9% of MSI-indeterminate (moderate MSI level) tumors, and 0.3% of microsatellite stable (MSS) tumors, she added.
Additional tumor evaluations, including immunohistochemical staining for the mismatch repair genes, were also performed.
“Our analysis corroborated the finding that in these Lynch patients, the MSI-high and MSI-indeterminate tumors were caused by Lynch Syndrome. This is in contrast to our Lynch Syndrome patients with microsatellite stable tumors; their tumor signature suggested that the Lynch Syndrome did not cause these cancers,” she said. “In fact, the prevalence of Lynch Syndrome in the MSS cohort of 0.3% is equivalent to the presence of Lynch Syndrome in the general at-large population.”
Of note, 50% of LS patients with MSI-high and indeterminate tumors had cancers other than colorectal or endometrial cancer, including prostate, sarcoma, mesothelioma, adrenocortical carcinoma, and ovarian germ cell carcinoma, which have been rarely or not previously associated with LS, and 45% of those patients did not meet clinical testing criteria for LS and would not have undergone LS testing.
This finding underscores the previously unknown heterogeneity of the phenotype.
“Our study supports that MSI-high is predictive of LS across tumor types...and also supports that the spectrum of cancers associated with Lynch Syndrome seems to be much broader that previously thought, she said, concluding that “MSI-high tumor signature, regardless of cancer subtype and irrespective of the family cancer history, should prompt germline genetic assessment for the evaluation of Lynch [Syndrome].
“This will result in an increased ability to recognize Lynch Syndrome not only in cancer patients, but also in at-risk family members who will benefit from genetic testing for Lynch [Syndrome] and subsequent enhanced cancer surveillance and risk reduction measures.”
In emphasizing the practice-changing nature of these findings, Dr. Westin, a gynecologic oncologist at MD Anderson Cancer Center, Houston, said that with the rise of precision medicine, increasing numbers of patients are undergoing testing for microsatellite instability, mainly to determine if their tumor can be affected by an-approved therapy.
“What we’ve learned is that MSI not only has therapeutic implications, it also has cancer prevention implications,” she said. “We’ve only been testing the tip of the iceberg of patients who are affected by Lynch Syndrome, and what we now know is that under the surface there is a larger number of patients with specific cancer types that should be tested for Lynch Syndrome.”
She added that this is “a straightforward testing strategy which can be immediately implemented to impact not only the patients themselves and their risk of cancer, but also their family members and their risk of cancer.”
This study was funded by Romeo Milio Lynch Syndrome Foundation, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, the Robert and Kate Niehaus Center for Inherited Cancer Genomics, the Fieldstone Family Fund, Stand Up to Cancer Colorectal Cancer Dream Team Translational Research Grant and the NIH/NCI Cancer Center Support Grant. Dr. Stadler reported consulting or advisory roles on the part of an immediate family member for Allergan, Genentech/Roche, Regeneron, Optos, and Adverum.
SOURCE: Schwark A et al., ASCO 2018 LBA1509.
REPORTING FROM ASCO 2018
Key clinical point: All MSI-high patients should be tested for LS regardless of cancer type or family history.
Major finding: LS was present in 16.3% of MSI-high tumors vs. 1.9% and 0.3% of MSI-indeterminate and stable tumors, respectively.
Study details: An analysis of 15,045 tumor samples.
Disclosures: This study was funded by Romeo Milio Lynch Syndrome Foundation, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, the Robert and Kate Niehaus Center for Inherited Cancer Genomics, the Fieldstone Family Fund, Stand Up to Cancer Colorectal Cancer Dream Team Translational Research Grant, and the NIH/NCI Cancer Center Support Grant. Dr. Stadler reported consulting or advisory roles on the part of an immediate family member for Allergan, Genentech/Roche, Regeneron, Optos, and Adverum.
Source: Schwark A et al. ASCO 2018 LBA 1509.
Geriatric assessments enhance patient care in advanced cancer
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO –
and boosted patient satisfaction, results of a randomized trial show.In this video interview from the annual meeting of the American Society of Clinical Oncology, Supriya Gupta Mohile, MD, MS, from the University of Rochester, New York, discusses how a standardized written questionnaire and objective tests for physical performance and cognition can enhance the doctor-patient relationship and lead to specific recommendations for interventions, compared with usual care.
Dr. Mohile had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO –
and boosted patient satisfaction, results of a randomized trial show.In this video interview from the annual meeting of the American Society of Clinical Oncology, Supriya Gupta Mohile, MD, MS, from the University of Rochester, New York, discusses how a standardized written questionnaire and objective tests for physical performance and cognition can enhance the doctor-patient relationship and lead to specific recommendations for interventions, compared with usual care.
Dr. Mohile had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO –
and boosted patient satisfaction, results of a randomized trial show.In this video interview from the annual meeting of the American Society of Clinical Oncology, Supriya Gupta Mohile, MD, MS, from the University of Rochester, New York, discusses how a standardized written questionnaire and objective tests for physical performance and cognition can enhance the doctor-patient relationship and lead to specific recommendations for interventions, compared with usual care.
Dr. Mohile had no relevant financial disclosures.
REPORTING FROM ASCO 2018
David Henry’s JCSO podcast, May-June 2018
In his bimonthly podcast, Dr Henry, the JCSO Editor-in-Chief, discusses a round-up by JCSO Editor Dr Howard Burris of the top takeaways from this year’s annual ASCO meeting, as well as a series of articles focusing on CAR T-cell therapies. He also looks at reports on psychosocial factors and treatment satisfaction after radical prostatectomy; the impact of inpatient rehabilitation on outcomes for patients with cancer; and the long-term effects of posttreatment exercise on pain in young women with breast cancer. Patient-specific cases of carcinoma of the colon in a child, managing severe radiation dermatitis after head and neck radiotherapy, striking rash in a patient on a checkpoint inhibitor, and a small gastric GIST with high mitotic index are also included. Dr Henry rounds off his comments with an examination of the challenges presented by tumor heterogeneity in the war on cancer.
Listen to the podcast below
In his bimonthly podcast, Dr Henry, the JCSO Editor-in-Chief, discusses a round-up by JCSO Editor Dr Howard Burris of the top takeaways from this year’s annual ASCO meeting, as well as a series of articles focusing on CAR T-cell therapies. He also looks at reports on psychosocial factors and treatment satisfaction after radical prostatectomy; the impact of inpatient rehabilitation on outcomes for patients with cancer; and the long-term effects of posttreatment exercise on pain in young women with breast cancer. Patient-specific cases of carcinoma of the colon in a child, managing severe radiation dermatitis after head and neck radiotherapy, striking rash in a patient on a checkpoint inhibitor, and a small gastric GIST with high mitotic index are also included. Dr Henry rounds off his comments with an examination of the challenges presented by tumor heterogeneity in the war on cancer.
Listen to the podcast below
In his bimonthly podcast, Dr Henry, the JCSO Editor-in-Chief, discusses a round-up by JCSO Editor Dr Howard Burris of the top takeaways from this year’s annual ASCO meeting, as well as a series of articles focusing on CAR T-cell therapies. He also looks at reports on psychosocial factors and treatment satisfaction after radical prostatectomy; the impact of inpatient rehabilitation on outcomes for patients with cancer; and the long-term effects of posttreatment exercise on pain in young women with breast cancer. Patient-specific cases of carcinoma of the colon in a child, managing severe radiation dermatitis after head and neck radiotherapy, striking rash in a patient on a checkpoint inhibitor, and a small gastric GIST with high mitotic index are also included. Dr Henry rounds off his comments with an examination of the challenges presented by tumor heterogeneity in the war on cancer.
Listen to the podcast below
In CRC patients, chemo yields more toxicities in women than in men
Compared with men, women receiving fluorouracil-based chemotherapy for colorectal cancer had higher rates of treatment-emergent adverse events, a retrospective analysis shows.
Women had statistically significant and clinically relevant increased risks of multiple hematologic and nonhematologic toxicities in the analysis, which was based on data from the PETACC-3 trial conducted by the EORTC Gastrointestinal Group.
The findings suggest that drug targets may be different between women and men, as may be the optimal doses needed to hit those targets with acceptable levels of adverse events, said Valerie Cristina, MD, of Lausanne (Switzerland) University Hospital, and her coinvestigators.
“In an age of personalized medicine, and also considering growing knowledge about sex-related differences in molecular profiles and disease biology, the potential effect of sex on efficacy and toxic effects of systemic treatments in oncology deserves more awareness and further investigation,” the researchers wrote. The report was published in JAMA Oncology.
Patients in this retrospective study had stage II-III colorectal cancer and had received treatment with either adjuvant fluorouracil/leucovorin or leucovorin, fluorouracil, and irinotecan (FOLFIRI). Of 2,974 patients, 1,656 (55.7%) were men and 1,318 (44.3%) were women.
The primary analysis in the study was a comparison by sex of treatment-emergent adverse events of any grade. The investigators found women had significantly higher rates of all-grade alopecia, anemia, cholinergic syndrome, constipation, cramping, lethargy, leukopenia, nausea, neutropenia, stomatitis, and vomiting.
Significant differences were reported for hematologic adverse events such as leukopenia of any grade, which was seen in 49.6% of women and 38.9% of men (P less than .001), and nonhematologic adverse events, such as nausea of any grade, seen in 61.8% of women and 53.7% of men (P less than .001).
More serious toxicities (grade 3 or 4) occurring significantly more often in women were alopecia, anemia, diarrhea, leukopenia, nausea, neutropenia, and stomatitis, according to the report.
Treatment with FOLFIRI was associated with higher rates of toxicity overall, and numerically increased differences in incidence between women and men, the investigators said. They noted that incidence of grade 3 or 4 alopecia, diarrhea, lethargy, and stomatitis were all significantly higher among FOLFIRI-treated women.
This was the largest systematic analysis of sex-related differences in adverse effects related to standard fluorouracil with or without irinotecan, according to the researchers, who noted that a previous study had identified female sex as a risk factor for irinotecan-induced neutropenia.
Dr. Cristina had no conflicts of interest to disclose. Coauthors reported disclosures related to Amgen, Bayer, Boehringer, Bristol-Myers Squibb, Celgene, Ipsen, Lilly, Merck, Merck KgA, Novartis, Pfizer, Roche, Sanofi, Servier, and Shire.
SOURCE: Cristina V et al. JAMA Oncol. 2018 May 24. doi: 10.1001/jamaoncol.2018.1080.
Compared with men, women receiving fluorouracil-based chemotherapy for colorectal cancer had higher rates of treatment-emergent adverse events, a retrospective analysis shows.
Women had statistically significant and clinically relevant increased risks of multiple hematologic and nonhematologic toxicities in the analysis, which was based on data from the PETACC-3 trial conducted by the EORTC Gastrointestinal Group.
The findings suggest that drug targets may be different between women and men, as may be the optimal doses needed to hit those targets with acceptable levels of adverse events, said Valerie Cristina, MD, of Lausanne (Switzerland) University Hospital, and her coinvestigators.
“In an age of personalized medicine, and also considering growing knowledge about sex-related differences in molecular profiles and disease biology, the potential effect of sex on efficacy and toxic effects of systemic treatments in oncology deserves more awareness and further investigation,” the researchers wrote. The report was published in JAMA Oncology.
Patients in this retrospective study had stage II-III colorectal cancer and had received treatment with either adjuvant fluorouracil/leucovorin or leucovorin, fluorouracil, and irinotecan (FOLFIRI). Of 2,974 patients, 1,656 (55.7%) were men and 1,318 (44.3%) were women.
The primary analysis in the study was a comparison by sex of treatment-emergent adverse events of any grade. The investigators found women had significantly higher rates of all-grade alopecia, anemia, cholinergic syndrome, constipation, cramping, lethargy, leukopenia, nausea, neutropenia, stomatitis, and vomiting.
Significant differences were reported for hematologic adverse events such as leukopenia of any grade, which was seen in 49.6% of women and 38.9% of men (P less than .001), and nonhematologic adverse events, such as nausea of any grade, seen in 61.8% of women and 53.7% of men (P less than .001).
More serious toxicities (grade 3 or 4) occurring significantly more often in women were alopecia, anemia, diarrhea, leukopenia, nausea, neutropenia, and stomatitis, according to the report.
Treatment with FOLFIRI was associated with higher rates of toxicity overall, and numerically increased differences in incidence between women and men, the investigators said. They noted that incidence of grade 3 or 4 alopecia, diarrhea, lethargy, and stomatitis were all significantly higher among FOLFIRI-treated women.
This was the largest systematic analysis of sex-related differences in adverse effects related to standard fluorouracil with or without irinotecan, according to the researchers, who noted that a previous study had identified female sex as a risk factor for irinotecan-induced neutropenia.
Dr. Cristina had no conflicts of interest to disclose. Coauthors reported disclosures related to Amgen, Bayer, Boehringer, Bristol-Myers Squibb, Celgene, Ipsen, Lilly, Merck, Merck KgA, Novartis, Pfizer, Roche, Sanofi, Servier, and Shire.
SOURCE: Cristina V et al. JAMA Oncol. 2018 May 24. doi: 10.1001/jamaoncol.2018.1080.
Compared with men, women receiving fluorouracil-based chemotherapy for colorectal cancer had higher rates of treatment-emergent adverse events, a retrospective analysis shows.
Women had statistically significant and clinically relevant increased risks of multiple hematologic and nonhematologic toxicities in the analysis, which was based on data from the PETACC-3 trial conducted by the EORTC Gastrointestinal Group.
The findings suggest that drug targets may be different between women and men, as may be the optimal doses needed to hit those targets with acceptable levels of adverse events, said Valerie Cristina, MD, of Lausanne (Switzerland) University Hospital, and her coinvestigators.
“In an age of personalized medicine, and also considering growing knowledge about sex-related differences in molecular profiles and disease biology, the potential effect of sex on efficacy and toxic effects of systemic treatments in oncology deserves more awareness and further investigation,” the researchers wrote. The report was published in JAMA Oncology.
Patients in this retrospective study had stage II-III colorectal cancer and had received treatment with either adjuvant fluorouracil/leucovorin or leucovorin, fluorouracil, and irinotecan (FOLFIRI). Of 2,974 patients, 1,656 (55.7%) were men and 1,318 (44.3%) were women.
The primary analysis in the study was a comparison by sex of treatment-emergent adverse events of any grade. The investigators found women had significantly higher rates of all-grade alopecia, anemia, cholinergic syndrome, constipation, cramping, lethargy, leukopenia, nausea, neutropenia, stomatitis, and vomiting.
Significant differences were reported for hematologic adverse events such as leukopenia of any grade, which was seen in 49.6% of women and 38.9% of men (P less than .001), and nonhematologic adverse events, such as nausea of any grade, seen in 61.8% of women and 53.7% of men (P less than .001).
More serious toxicities (grade 3 or 4) occurring significantly more often in women were alopecia, anemia, diarrhea, leukopenia, nausea, neutropenia, and stomatitis, according to the report.
Treatment with FOLFIRI was associated with higher rates of toxicity overall, and numerically increased differences in incidence between women and men, the investigators said. They noted that incidence of grade 3 or 4 alopecia, diarrhea, lethargy, and stomatitis were all significantly higher among FOLFIRI-treated women.
This was the largest systematic analysis of sex-related differences in adverse effects related to standard fluorouracil with or without irinotecan, according to the researchers, who noted that a previous study had identified female sex as a risk factor for irinotecan-induced neutropenia.
Dr. Cristina had no conflicts of interest to disclose. Coauthors reported disclosures related to Amgen, Bayer, Boehringer, Bristol-Myers Squibb, Celgene, Ipsen, Lilly, Merck, Merck KgA, Novartis, Pfizer, Roche, Sanofi, Servier, and Shire.
SOURCE: Cristina V et al. JAMA Oncol. 2018 May 24. doi: 10.1001/jamaoncol.2018.1080.
FROM JAMA ONCOLOGY
Key clinical point: Risks of adverse events were significantly higher in women treated with fluorouracil with or without irinotecan.
Major finding: Compared with men, women had significantly higher rates of all-grade alopecia, anemia, cholinergic syndrome, constipation, cramping, lethargy, leukopenia, nausea, neutropenia, stomatitis, and vomiting.
Study details: A retrospective analysis of treatment-emergent adverse events for 2,974 participants in the PETACC-3 trial conducted by the EORTC Gastrointestinal Group.
Disclosures: The authors reported disclosures related to Amgen, Bayer, Boehringer, Bristol-Myers Squibb, Celgene, Ipsen, Lilly, Merck, Merck KgA, Novartis, Pfizer, Roche, Sanofi, Servier, and Shire.
Source: Cristina V et al. JAMA Oncol. 2018 May 24. doi: 10.1001/jamaoncol.2018.1080.
Dermatologic complaints prolong hospital stay for hematologic cancer
and are associated with an increased mean length of hospital stay, according to a large retrospective chart review from a major cancer center.
The substantial burden imposed by dermatologic complications in patients with cancer, particularly a hematologic malignancy, highlights the importance of greater collaboration between oncology and dermatology services to mitigate the impact of these events on both quality of life and outcome, wrote Gregory S. Phillips of Memorial Sloan Kettering Cancer Center, New York, and his associates. The study was published in the Journal of the American Academy of Dermatology.
The data that produced these conclusions were drawn from a retrospective chart review of 11,533 cancer patients treated at the center during 2015. Of these, 412 (3.6%) were referred for a dermatology consultation.
Those who received a dermatology consultation were comparable for median age (60 years) and gender (roughly 50:50 male:female), compared with those who did not. However, the odds ratio (OR) for a dermatology consultation was 6.56 among those with a hematologic malignancy compared with those who had a solid tumor. In those with leukemia, the proportion receiving a dermatologic consult was nearly ninefold greater.
Whether or not undertaken in a patient with a hematologic malignancy, dermatologic consults correlated with significantly greater morbidity, as well as mortality. This included a longer median length of stay (11 vs. 5 days; P less than .0001) and a higher in-hospital rate of death (9% vs. 2%; P less than .0001), compared with patients not needing a dermatology consultation.
Of dermatologic consultations in the total study population, the most common were for inflammatory conditions (27%), infections (24%), and drug reactions (17%). Neoplasm was the dermatologic diagnosis in 10% of the total population, but in 13% of those with hematologic malignancies.
Inpatient dermatology consultations were most frequently ordered by the hematology-oncology service, accounting for 44% of the total, followed by the solid tumor oncology service (27%) and the surgery service (15%). Multiple consultations were more likely in patients with leukemia or lymphoma than other forms of cancer.
In the dermatology consult, biopsy was employed for diagnosis in only 18%. As for treatment, 42% received topical therapy alone, and 38% received a systemic therapy. Dermatologic consultations that subsequently involved consultation with another service such as allergy and immunology, were rare, occurring in only 4% of cases.
Furthermore, they suggested that the data support increased attention to dermatologic complications in cancer. Although the impact of consultations on outcome was not evaluated in this study, the authors cited another recent study in which there was a more than 2-day reduction in hospital stay when a dermatology consultation was employed in noncancer patients with an inflammatory skin disease (JAMA Dermatol. 2017 Jun 1;153[6]:523-8). Moreover, they speculated that a prompt resolution of dermatologic complaints in cancer patients has implications for better outcomes if they result in fewer delays in anti-cancer therapy.
The study was partly funded by the a grant from the National Cancer Institute’s Cancer Centers Program. Dr. Lacouture reported financial relationships with AstraZeneca, Adgero Biopharmaceuticals, Berg, Bristol-Myers Squibb, Foamix, Janssen, Legacy Healthcare, NovoCure, and Quintiles. Another author reported ties with Amgen, Roche, Eaisi, and P Value Communications.
SOURCE: Phillips GS et al. J Am Acad Dermatol. 2018 Jun;78(6):1102-9.
and are associated with an increased mean length of hospital stay, according to a large retrospective chart review from a major cancer center.
The substantial burden imposed by dermatologic complications in patients with cancer, particularly a hematologic malignancy, highlights the importance of greater collaboration between oncology and dermatology services to mitigate the impact of these events on both quality of life and outcome, wrote Gregory S. Phillips of Memorial Sloan Kettering Cancer Center, New York, and his associates. The study was published in the Journal of the American Academy of Dermatology.
The data that produced these conclusions were drawn from a retrospective chart review of 11,533 cancer patients treated at the center during 2015. Of these, 412 (3.6%) were referred for a dermatology consultation.
Those who received a dermatology consultation were comparable for median age (60 years) and gender (roughly 50:50 male:female), compared with those who did not. However, the odds ratio (OR) for a dermatology consultation was 6.56 among those with a hematologic malignancy compared with those who had a solid tumor. In those with leukemia, the proportion receiving a dermatologic consult was nearly ninefold greater.
Whether or not undertaken in a patient with a hematologic malignancy, dermatologic consults correlated with significantly greater morbidity, as well as mortality. This included a longer median length of stay (11 vs. 5 days; P less than .0001) and a higher in-hospital rate of death (9% vs. 2%; P less than .0001), compared with patients not needing a dermatology consultation.
Of dermatologic consultations in the total study population, the most common were for inflammatory conditions (27%), infections (24%), and drug reactions (17%). Neoplasm was the dermatologic diagnosis in 10% of the total population, but in 13% of those with hematologic malignancies.
Inpatient dermatology consultations were most frequently ordered by the hematology-oncology service, accounting for 44% of the total, followed by the solid tumor oncology service (27%) and the surgery service (15%). Multiple consultations were more likely in patients with leukemia or lymphoma than other forms of cancer.
In the dermatology consult, biopsy was employed for diagnosis in only 18%. As for treatment, 42% received topical therapy alone, and 38% received a systemic therapy. Dermatologic consultations that subsequently involved consultation with another service such as allergy and immunology, were rare, occurring in only 4% of cases.
Furthermore, they suggested that the data support increased attention to dermatologic complications in cancer. Although the impact of consultations on outcome was not evaluated in this study, the authors cited another recent study in which there was a more than 2-day reduction in hospital stay when a dermatology consultation was employed in noncancer patients with an inflammatory skin disease (JAMA Dermatol. 2017 Jun 1;153[6]:523-8). Moreover, they speculated that a prompt resolution of dermatologic complaints in cancer patients has implications for better outcomes if they result in fewer delays in anti-cancer therapy.
The study was partly funded by the a grant from the National Cancer Institute’s Cancer Centers Program. Dr. Lacouture reported financial relationships with AstraZeneca, Adgero Biopharmaceuticals, Berg, Bristol-Myers Squibb, Foamix, Janssen, Legacy Healthcare, NovoCure, and Quintiles. Another author reported ties with Amgen, Roche, Eaisi, and P Value Communications.
SOURCE: Phillips GS et al. J Am Acad Dermatol. 2018 Jun;78(6):1102-9.
and are associated with an increased mean length of hospital stay, according to a large retrospective chart review from a major cancer center.
The substantial burden imposed by dermatologic complications in patients with cancer, particularly a hematologic malignancy, highlights the importance of greater collaboration between oncology and dermatology services to mitigate the impact of these events on both quality of life and outcome, wrote Gregory S. Phillips of Memorial Sloan Kettering Cancer Center, New York, and his associates. The study was published in the Journal of the American Academy of Dermatology.
The data that produced these conclusions were drawn from a retrospective chart review of 11,533 cancer patients treated at the center during 2015. Of these, 412 (3.6%) were referred for a dermatology consultation.
Those who received a dermatology consultation were comparable for median age (60 years) and gender (roughly 50:50 male:female), compared with those who did not. However, the odds ratio (OR) for a dermatology consultation was 6.56 among those with a hematologic malignancy compared with those who had a solid tumor. In those with leukemia, the proportion receiving a dermatologic consult was nearly ninefold greater.
Whether or not undertaken in a patient with a hematologic malignancy, dermatologic consults correlated with significantly greater morbidity, as well as mortality. This included a longer median length of stay (11 vs. 5 days; P less than .0001) and a higher in-hospital rate of death (9% vs. 2%; P less than .0001), compared with patients not needing a dermatology consultation.
Of dermatologic consultations in the total study population, the most common were for inflammatory conditions (27%), infections (24%), and drug reactions (17%). Neoplasm was the dermatologic diagnosis in 10% of the total population, but in 13% of those with hematologic malignancies.
Inpatient dermatology consultations were most frequently ordered by the hematology-oncology service, accounting for 44% of the total, followed by the solid tumor oncology service (27%) and the surgery service (15%). Multiple consultations were more likely in patients with leukemia or lymphoma than other forms of cancer.
In the dermatology consult, biopsy was employed for diagnosis in only 18%. As for treatment, 42% received topical therapy alone, and 38% received a systemic therapy. Dermatologic consultations that subsequently involved consultation with another service such as allergy and immunology, were rare, occurring in only 4% of cases.
Furthermore, they suggested that the data support increased attention to dermatologic complications in cancer. Although the impact of consultations on outcome was not evaluated in this study, the authors cited another recent study in which there was a more than 2-day reduction in hospital stay when a dermatology consultation was employed in noncancer patients with an inflammatory skin disease (JAMA Dermatol. 2017 Jun 1;153[6]:523-8). Moreover, they speculated that a prompt resolution of dermatologic complaints in cancer patients has implications for better outcomes if they result in fewer delays in anti-cancer therapy.
The study was partly funded by the a grant from the National Cancer Institute’s Cancer Centers Program. Dr. Lacouture reported financial relationships with AstraZeneca, Adgero Biopharmaceuticals, Berg, Bristol-Myers Squibb, Foamix, Janssen, Legacy Healthcare, NovoCure, and Quintiles. Another author reported ties with Amgen, Roche, Eaisi, and P Value Communications.
SOURCE: Phillips GS et al. J Am Acad Dermatol. 2018 Jun;78(6):1102-9.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Key clinical point: Dermatologic complications are more common in hematologic than solid tumor cancers and correlate with adverse outcomes.
Major finding: In cancer patients, dermatologic consults are associated with longer hospital stay (11 vs. 5 days) and death (9% vs. 2%).
Study details: Retrospective chart review of inpatient dermatology consultations during 2015.
Disclosures: The study was partly funded by the a grant from the National Cancer Institute’s Cancer Centers Program. Dr. Lacouture reported financial relationships with AstraZeneca, Adgero Biopharmaceuticals, Berg, Bristol-Myers Squibb, Foamix, Janssen, Legacy Healthcare, NovoCure, and Quintiles. Another author reported ties with Amgen, Roche, Eaisi, and P Value Communications.
Source: Phillips et al. J Am Acad Dermatol. 2018;78:1102-9.