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VIDEO: Abiraterone improves survival in high-risk prostate cancer
CHICAGO – Adding abiraterone acetate plus prednisone to androgen deprivation therapy in hormone-naive high-risk prostate cancer patients significantly improves overall survival, according to “practice-changing” results from the phase III LATITUDE trial and the multiarm, multistage STAMPEDE trial.
In the double-blind, randomized, placebo-controlled LATITUDE trial, 597 patients with newly diagnosed high-risk metastatic prostate cancer who received 1,000 mg of abiraterone acetate daily plus 5 mg of prednisone daily in addition to androgen deprivation therapy experienced a 38% reduction in the risk of death and a 53% reduction in the risk of radiographic progression or death at a median follow-up of 30.4 months, compared with 602 such patients who received placebo and androgen deprivation, Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, Villejuif, France, reported at the annual meeting of the American Society of Clinical Oncology.
Significant improvements also were seen in the treatment vs. placebo group for all secondary endpoints, including time to prostate-specific-antigen progression (hazard ratio, 0.30), time to pain progression (HR, 0.70), time to next symptomatic skeletal event (HR, 0.70), time to chemotherapy (HR, 0.44), and time to subsequent prostate cancer therapy (HR, 0.42), Dr. Fizazi said.
He discussed the findings, including side effects, and ongoing and future studies, in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Based on these findings, I believe that using abiraterone up front, together with androgen deprivation therapy, will become the next standard of care for these men,” he said.
Similarly, in the STAMPEDE trial, abiraterone acetate plus prednisone was associated with significantly improved overall survival in 960 high-risk prostate cancer patients starting hormone therapy, compared with 957 such patients receiving placebo and standard-of-care hormone therapy, according to Nicholas D. James, BSc MBBS, PhD, of the Institute of Cancer and Genomic Sciences, University of Birmingham, England.
“Overall, we’ve got about a 30% improvement in survival times for the upfront use of abiraterone. For our metastatic patients, we haven’t reached the median survival yet for the abiraterone patients, but it’s around 3.5 years median survival in the control arm, and we’re projecting that’s going to go up to 6.5 or 7 years in the abiraterone patients,” he said in a video interview, adding that he and his colleagues think this will be one of the biggest survival gains ever reported in adults in such a setting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. James also discussed findings with respect to secondary endpoints, including a 70% improvement in failure-free survival in the treatment vs. placebo group – an improvement that he called an “absolutely spectacularly big gain” – and skeletal-related events, which decreased by 55% in the treatment group.
Both investigators discussed ongoing and recently completed studies that could shed additional light on the use of abiraterone in prostate cancer patients, including plans to look at the effects of giving both abiraterone and docetaxel together.
“My prediction will be that we will be giving both treatments in due course,” Dr. James said, adding, “I think these findings will certainly be practice changing.”
CHICAGO – Adding abiraterone acetate plus prednisone to androgen deprivation therapy in hormone-naive high-risk prostate cancer patients significantly improves overall survival, according to “practice-changing” results from the phase III LATITUDE trial and the multiarm, multistage STAMPEDE trial.
In the double-blind, randomized, placebo-controlled LATITUDE trial, 597 patients with newly diagnosed high-risk metastatic prostate cancer who received 1,000 mg of abiraterone acetate daily plus 5 mg of prednisone daily in addition to androgen deprivation therapy experienced a 38% reduction in the risk of death and a 53% reduction in the risk of radiographic progression or death at a median follow-up of 30.4 months, compared with 602 such patients who received placebo and androgen deprivation, Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, Villejuif, France, reported at the annual meeting of the American Society of Clinical Oncology.
Significant improvements also were seen in the treatment vs. placebo group for all secondary endpoints, including time to prostate-specific-antigen progression (hazard ratio, 0.30), time to pain progression (HR, 0.70), time to next symptomatic skeletal event (HR, 0.70), time to chemotherapy (HR, 0.44), and time to subsequent prostate cancer therapy (HR, 0.42), Dr. Fizazi said.
He discussed the findings, including side effects, and ongoing and future studies, in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Based on these findings, I believe that using abiraterone up front, together with androgen deprivation therapy, will become the next standard of care for these men,” he said.
Similarly, in the STAMPEDE trial, abiraterone acetate plus prednisone was associated with significantly improved overall survival in 960 high-risk prostate cancer patients starting hormone therapy, compared with 957 such patients receiving placebo and standard-of-care hormone therapy, according to Nicholas D. James, BSc MBBS, PhD, of the Institute of Cancer and Genomic Sciences, University of Birmingham, England.
“Overall, we’ve got about a 30% improvement in survival times for the upfront use of abiraterone. For our metastatic patients, we haven’t reached the median survival yet for the abiraterone patients, but it’s around 3.5 years median survival in the control arm, and we’re projecting that’s going to go up to 6.5 or 7 years in the abiraterone patients,” he said in a video interview, adding that he and his colleagues think this will be one of the biggest survival gains ever reported in adults in such a setting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. James also discussed findings with respect to secondary endpoints, including a 70% improvement in failure-free survival in the treatment vs. placebo group – an improvement that he called an “absolutely spectacularly big gain” – and skeletal-related events, which decreased by 55% in the treatment group.
Both investigators discussed ongoing and recently completed studies that could shed additional light on the use of abiraterone in prostate cancer patients, including plans to look at the effects of giving both abiraterone and docetaxel together.
“My prediction will be that we will be giving both treatments in due course,” Dr. James said, adding, “I think these findings will certainly be practice changing.”
CHICAGO – Adding abiraterone acetate plus prednisone to androgen deprivation therapy in hormone-naive high-risk prostate cancer patients significantly improves overall survival, according to “practice-changing” results from the phase III LATITUDE trial and the multiarm, multistage STAMPEDE trial.
In the double-blind, randomized, placebo-controlled LATITUDE trial, 597 patients with newly diagnosed high-risk metastatic prostate cancer who received 1,000 mg of abiraterone acetate daily plus 5 mg of prednisone daily in addition to androgen deprivation therapy experienced a 38% reduction in the risk of death and a 53% reduction in the risk of radiographic progression or death at a median follow-up of 30.4 months, compared with 602 such patients who received placebo and androgen deprivation, Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, Villejuif, France, reported at the annual meeting of the American Society of Clinical Oncology.
Significant improvements also were seen in the treatment vs. placebo group for all secondary endpoints, including time to prostate-specific-antigen progression (hazard ratio, 0.30), time to pain progression (HR, 0.70), time to next symptomatic skeletal event (HR, 0.70), time to chemotherapy (HR, 0.44), and time to subsequent prostate cancer therapy (HR, 0.42), Dr. Fizazi said.
He discussed the findings, including side effects, and ongoing and future studies, in a video interview.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“Based on these findings, I believe that using abiraterone up front, together with androgen deprivation therapy, will become the next standard of care for these men,” he said.
Similarly, in the STAMPEDE trial, abiraterone acetate plus prednisone was associated with significantly improved overall survival in 960 high-risk prostate cancer patients starting hormone therapy, compared with 957 such patients receiving placebo and standard-of-care hormone therapy, according to Nicholas D. James, BSc MBBS, PhD, of the Institute of Cancer and Genomic Sciences, University of Birmingham, England.
“Overall, we’ve got about a 30% improvement in survival times for the upfront use of abiraterone. For our metastatic patients, we haven’t reached the median survival yet for the abiraterone patients, but it’s around 3.5 years median survival in the control arm, and we’re projecting that’s going to go up to 6.5 or 7 years in the abiraterone patients,” he said in a video interview, adding that he and his colleagues think this will be one of the biggest survival gains ever reported in adults in such a setting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. James also discussed findings with respect to secondary endpoints, including a 70% improvement in failure-free survival in the treatment vs. placebo group – an improvement that he called an “absolutely spectacularly big gain” – and skeletal-related events, which decreased by 55% in the treatment group.
Both investigators discussed ongoing and recently completed studies that could shed additional light on the use of abiraterone in prostate cancer patients, including plans to look at the effects of giving both abiraterone and docetaxel together.
“My prediction will be that we will be giving both treatments in due course,” Dr. James said, adding, “I think these findings will certainly be practice changing.”
AT ASCO 2017
Interventions ease cancer-related stress, depression
CHICAGO – Clinicians have gotten much better in recent decades at helping patients cope with physical side effects from cancer care, but mental health interventions aimed at easing stress and fear are often absent or, at best, an afterthought.
As three new studies show, however, early psychological interventions can both improve the quality of life for patients with cancer and enhance clinical outcomes.
For example, an online stress management program dubbed STREAM, developed jointly by oncologists and psychologists, was associated with significantly better quality of life and lower levels of distress for patients 2 months after a new cancer diagnosis, compared with controls who had not yet used it, reported Viviane Hess, MD, a medical oncologist at the University Hospital of Basel (Switzerland).
“From randomized controlled trials, we know that cognitive behavioral therapies are effective in mediating distress. However, the majority of cancer patients lack psychological support, due to both barriers on the patients’ side and lack of resources on the providers’ side,” she said at a briefing at the annual meeting of the American Society of Clinical Oncology.
Other studies presented in the briefing show that psychological interventions can significantly reduce patient anxieties about the possibility of cancer recurrence and help relieve depressive symptoms for at least 6 months among patients with advanced cancers.
STREAM
Dr. Hess and her colleagues conducted a prospective, wait-list controlled trial for patients who had started therapy for a newly diagnosed cancer within the past 12 weeks. The patients were randomized to either immediate use of an online psychological intervention or to a delayed start.
The investigators chose a web-based intervention because a majority of patients with cancer already use the Internet for information, and because Internet interventions can overcome barriers of time and distance, with results comparable to those seen with face-to-face interventions, Dr. Hess said.
The intervention consisted of eight weekly sessions based on approaches used in cognitive behavioral therapy, with focus on bodily reactions to stress, cognitive stress reduction, feelings, and social interactions. Each of the eight sessions focused on a single topic. Patients were given written and audio information about each topic and then were asked to perform exercises and complete questionnaires.
For this “minimal contact” intervention, psychologists based in Basel reviewed each patient’s progress weekly and gave written feedback personalized for that patient via a secure online portal.
In all, 129 patients were randomized (65 to the intervention and 64 controls). The majority were women treated with curative intent for early-stage breast cancer. Patients newly diagnosed with lung, ovarian, and gastrointestinal cancers, as well as melanoma and lymphoma, also were included.
Patients in both the active intervention and control groups were assessed at baseline and at 2 months with three quality-of-life measures: the FACIT-F (Functional Assessment of Chronic Illness Therapy Fatigue subscale), DT (Distress Thermometer), and HADS (Hospital Anxiety and Depression Scale).
At 2 months, the mean FACIT-F score for patients in both the intervention and control groups increased, indicating an improved quality of life, but the change was significantly greater for patients in the intervention group (mean 8.59 points vs. controls; P = .0032). There was also a significant decrease in the DT scale from 6 points at baseline to 4 points at 2 months among patients randomized to the intervention, but no change among controls. There were no significant differences in either anxiety or depression between the groups, however.
“Most oncologists, particularly when we’re meeting patients for the first time and starting on curative intent therapy, it is assumed there is a level of distress … but we assume that that level of distress will fall naturally as we start them on therapy,” commented ASCO expert Don S. Dizon, MD, from the Massachusetts General Hospital Cancer Center in Boston, who was not involved in the study.
“What Dr. Hess is showing is that not only do they have distress, but it’s significant distress,” he said, adding that the study shows that online tools can be effective at providing support, and that the ease of access can help patients who might otherwise never meet with a mental health professional.
Recurrence fears assuaged
In a separate study, investigators from Australia reported results of a randomized phase II trial showing that an intervention called Conquer Fear was effective at lowering fear of recurrence among patients with successfully treated stage I-III breast, colorectal, or melanoma cancers who reported a high level of fear of recurrence.
“Fear of cancer recurrence is associated with poorer quality of life, greater distress, lack of planning for the future, avoidance or excessive use of screening, and greater health care utilization,” said Jane MacNeil Beith, MD, PhD, a medical oncologist at the University of Sydney.
Dr. Beith and her colleagues randomly assigned 222 patients to either the Conquer Fear intervention or relaxation training (control group).
Patients assigned to the control group received five 1-hour individual, face-to-face relaxation sessions over 10 weeks. The sessions included muscle relaxation, meditative relaxation, and visualization and quick relaxation techniques taught by trained study instructors. Patients in each group received instructions for home-based relaxation techniques.
The Conquer Fear intervention is intended to help patients with values clarification, detached mindfulness (focusing on the moment), attention training, meta-cognitive therapy (worry or not worry), and a behavioral contract to ensure appropriate follow-up.
They measured fear of recurrence using the validated 42-item Fear of Cancer Recurrence Inventory (FCRI), which scores fear on a scale of 0-168, with higher scores indicating higher levels of fear, Dr. Beith said.
The mean baseline FCRI scores were 82.7 for patients assigned to the intervention and 85.7 in controls.
Participants in both groups had improvement of all outcomes, but patients in the active intervention group had significantly lower FCRI total scores at the end of the intervention and at 3 and 6 months of follow-up. The severity of fear of recurrence was also lower among patients in the intervention group immediately afterward and at 3 months, but not at 6 months, she reported.
“I applaud Dr. Beith for her trial, particularly because we as oncologists have only about 15 minutes with our patients, and the assessments for our patients, even in follow-up, for the most part concentrate on cancer-related outcomes, because that’s what our patients want to know. They want to know if they’re fine, or they want to know, is their cancer back,” Dr. Dizon commented.
The study demonstrates fear of recurrence is real, but that there are also interventions that can help patients reduce those fears, he said.
CALM
In a third study, Gary Rodin, MD, from the department of supportive care at Princess Margaret Cancer Centre in Toronto, and his colleagues reported that a brief psychological intervention with the acronym CALM (for Managing Cancer and Living Meaningfully) was associated with a “clinically meaningful” reduction in depressive symptoms in patients with advanced cancer.
Patients in CALM receive three to six individual sessions delivered over 3-6 months. The program helps patients cope with symptom management and improve communications with health care providers, understand changes in themselves and their relations with others, find a personal sense of meaning and purpose, and learn to live with thoughts of the future and mortality, Dr. Rodin explained.
In a clinical trial, 52% of the 151 patients randomized to the intervention had clinically important reductions in depressive symptoms at 3 months, compared with 33% of controls assigned to usual care. At 6 months, the respective reductions in depressive symptoms were 64% vs. 35%.
The intervention also was effective at preventing depression among 137 patients without depressive symptoms at baseline. In this group, 13% of patients who received the CALM intervention had depressive symptoms at 3 months, compared with 30% of controls.
In addition, patients who received CALM support at both 3 and 6 months said they were better prepared for the end of life, reported that they had greater opportunity to talk about their concerns for the future, were less frightened, and said they had greater ability to express and manage their feelings. At 6 months these effects were strengthened, and the CALM group also felt more able to understand their cancer experience, deal with changes in relationships as a result of cancer, explore ways of communicating with their health care team and family, and clarify their values and beliefs.
“The intervention addresses both the practical problems that people face, and there are many – How do I manage my pain? My symptoms? – but also the profound problems and issues that people face – What is the meaning of my life? – when having a terminal diagnosis, for instance,” he said.
The investigators are currently establishing a global network to train health professionals in the delivery of CALM, and to evaluate the program’s effectiveness in different clinical settings and cultures, he said.
The STREAM study was institutionally supported. Dr. Hess disclosed travel and accommodations from CSL Behring. The Conquer Fear study was funded by Cancer Australia, beyondBlue, and the Australian National Breast Cancer Foundation. Dr. Beith reported no relevant disclosures. The CALM study was supported by the Canadian Institute of Health Research. Dr. Rodin reported no relevant disclosures.
CHICAGO – Clinicians have gotten much better in recent decades at helping patients cope with physical side effects from cancer care, but mental health interventions aimed at easing stress and fear are often absent or, at best, an afterthought.
As three new studies show, however, early psychological interventions can both improve the quality of life for patients with cancer and enhance clinical outcomes.
For example, an online stress management program dubbed STREAM, developed jointly by oncologists and psychologists, was associated with significantly better quality of life and lower levels of distress for patients 2 months after a new cancer diagnosis, compared with controls who had not yet used it, reported Viviane Hess, MD, a medical oncologist at the University Hospital of Basel (Switzerland).
“From randomized controlled trials, we know that cognitive behavioral therapies are effective in mediating distress. However, the majority of cancer patients lack psychological support, due to both barriers on the patients’ side and lack of resources on the providers’ side,” she said at a briefing at the annual meeting of the American Society of Clinical Oncology.
Other studies presented in the briefing show that psychological interventions can significantly reduce patient anxieties about the possibility of cancer recurrence and help relieve depressive symptoms for at least 6 months among patients with advanced cancers.
STREAM
Dr. Hess and her colleagues conducted a prospective, wait-list controlled trial for patients who had started therapy for a newly diagnosed cancer within the past 12 weeks. The patients were randomized to either immediate use of an online psychological intervention or to a delayed start.
The investigators chose a web-based intervention because a majority of patients with cancer already use the Internet for information, and because Internet interventions can overcome barriers of time and distance, with results comparable to those seen with face-to-face interventions, Dr. Hess said.
The intervention consisted of eight weekly sessions based on approaches used in cognitive behavioral therapy, with focus on bodily reactions to stress, cognitive stress reduction, feelings, and social interactions. Each of the eight sessions focused on a single topic. Patients were given written and audio information about each topic and then were asked to perform exercises and complete questionnaires.
For this “minimal contact” intervention, psychologists based in Basel reviewed each patient’s progress weekly and gave written feedback personalized for that patient via a secure online portal.
In all, 129 patients were randomized (65 to the intervention and 64 controls). The majority were women treated with curative intent for early-stage breast cancer. Patients newly diagnosed with lung, ovarian, and gastrointestinal cancers, as well as melanoma and lymphoma, also were included.
Patients in both the active intervention and control groups were assessed at baseline and at 2 months with three quality-of-life measures: the FACIT-F (Functional Assessment of Chronic Illness Therapy Fatigue subscale), DT (Distress Thermometer), and HADS (Hospital Anxiety and Depression Scale).
At 2 months, the mean FACIT-F score for patients in both the intervention and control groups increased, indicating an improved quality of life, but the change was significantly greater for patients in the intervention group (mean 8.59 points vs. controls; P = .0032). There was also a significant decrease in the DT scale from 6 points at baseline to 4 points at 2 months among patients randomized to the intervention, but no change among controls. There were no significant differences in either anxiety or depression between the groups, however.
“Most oncologists, particularly when we’re meeting patients for the first time and starting on curative intent therapy, it is assumed there is a level of distress … but we assume that that level of distress will fall naturally as we start them on therapy,” commented ASCO expert Don S. Dizon, MD, from the Massachusetts General Hospital Cancer Center in Boston, who was not involved in the study.
“What Dr. Hess is showing is that not only do they have distress, but it’s significant distress,” he said, adding that the study shows that online tools can be effective at providing support, and that the ease of access can help patients who might otherwise never meet with a mental health professional.
Recurrence fears assuaged
In a separate study, investigators from Australia reported results of a randomized phase II trial showing that an intervention called Conquer Fear was effective at lowering fear of recurrence among patients with successfully treated stage I-III breast, colorectal, or melanoma cancers who reported a high level of fear of recurrence.
“Fear of cancer recurrence is associated with poorer quality of life, greater distress, lack of planning for the future, avoidance or excessive use of screening, and greater health care utilization,” said Jane MacNeil Beith, MD, PhD, a medical oncologist at the University of Sydney.
Dr. Beith and her colleagues randomly assigned 222 patients to either the Conquer Fear intervention or relaxation training (control group).
Patients assigned to the control group received five 1-hour individual, face-to-face relaxation sessions over 10 weeks. The sessions included muscle relaxation, meditative relaxation, and visualization and quick relaxation techniques taught by trained study instructors. Patients in each group received instructions for home-based relaxation techniques.
The Conquer Fear intervention is intended to help patients with values clarification, detached mindfulness (focusing on the moment), attention training, meta-cognitive therapy (worry or not worry), and a behavioral contract to ensure appropriate follow-up.
They measured fear of recurrence using the validated 42-item Fear of Cancer Recurrence Inventory (FCRI), which scores fear on a scale of 0-168, with higher scores indicating higher levels of fear, Dr. Beith said.
The mean baseline FCRI scores were 82.7 for patients assigned to the intervention and 85.7 in controls.
Participants in both groups had improvement of all outcomes, but patients in the active intervention group had significantly lower FCRI total scores at the end of the intervention and at 3 and 6 months of follow-up. The severity of fear of recurrence was also lower among patients in the intervention group immediately afterward and at 3 months, but not at 6 months, she reported.
“I applaud Dr. Beith for her trial, particularly because we as oncologists have only about 15 minutes with our patients, and the assessments for our patients, even in follow-up, for the most part concentrate on cancer-related outcomes, because that’s what our patients want to know. They want to know if they’re fine, or they want to know, is their cancer back,” Dr. Dizon commented.
The study demonstrates fear of recurrence is real, but that there are also interventions that can help patients reduce those fears, he said.
CALM
In a third study, Gary Rodin, MD, from the department of supportive care at Princess Margaret Cancer Centre in Toronto, and his colleagues reported that a brief psychological intervention with the acronym CALM (for Managing Cancer and Living Meaningfully) was associated with a “clinically meaningful” reduction in depressive symptoms in patients with advanced cancer.
Patients in CALM receive three to six individual sessions delivered over 3-6 months. The program helps patients cope with symptom management and improve communications with health care providers, understand changes in themselves and their relations with others, find a personal sense of meaning and purpose, and learn to live with thoughts of the future and mortality, Dr. Rodin explained.
In a clinical trial, 52% of the 151 patients randomized to the intervention had clinically important reductions in depressive symptoms at 3 months, compared with 33% of controls assigned to usual care. At 6 months, the respective reductions in depressive symptoms were 64% vs. 35%.
The intervention also was effective at preventing depression among 137 patients without depressive symptoms at baseline. In this group, 13% of patients who received the CALM intervention had depressive symptoms at 3 months, compared with 30% of controls.
In addition, patients who received CALM support at both 3 and 6 months said they were better prepared for the end of life, reported that they had greater opportunity to talk about their concerns for the future, were less frightened, and said they had greater ability to express and manage their feelings. At 6 months these effects were strengthened, and the CALM group also felt more able to understand their cancer experience, deal with changes in relationships as a result of cancer, explore ways of communicating with their health care team and family, and clarify their values and beliefs.
“The intervention addresses both the practical problems that people face, and there are many – How do I manage my pain? My symptoms? – but also the profound problems and issues that people face – What is the meaning of my life? – when having a terminal diagnosis, for instance,” he said.
The investigators are currently establishing a global network to train health professionals in the delivery of CALM, and to evaluate the program’s effectiveness in different clinical settings and cultures, he said.
The STREAM study was institutionally supported. Dr. Hess disclosed travel and accommodations from CSL Behring. The Conquer Fear study was funded by Cancer Australia, beyondBlue, and the Australian National Breast Cancer Foundation. Dr. Beith reported no relevant disclosures. The CALM study was supported by the Canadian Institute of Health Research. Dr. Rodin reported no relevant disclosures.
CHICAGO – Clinicians have gotten much better in recent decades at helping patients cope with physical side effects from cancer care, but mental health interventions aimed at easing stress and fear are often absent or, at best, an afterthought.
As three new studies show, however, early psychological interventions can both improve the quality of life for patients with cancer and enhance clinical outcomes.
For example, an online stress management program dubbed STREAM, developed jointly by oncologists and psychologists, was associated with significantly better quality of life and lower levels of distress for patients 2 months after a new cancer diagnosis, compared with controls who had not yet used it, reported Viviane Hess, MD, a medical oncologist at the University Hospital of Basel (Switzerland).
“From randomized controlled trials, we know that cognitive behavioral therapies are effective in mediating distress. However, the majority of cancer patients lack psychological support, due to both barriers on the patients’ side and lack of resources on the providers’ side,” she said at a briefing at the annual meeting of the American Society of Clinical Oncology.
Other studies presented in the briefing show that psychological interventions can significantly reduce patient anxieties about the possibility of cancer recurrence and help relieve depressive symptoms for at least 6 months among patients with advanced cancers.
STREAM
Dr. Hess and her colleagues conducted a prospective, wait-list controlled trial for patients who had started therapy for a newly diagnosed cancer within the past 12 weeks. The patients were randomized to either immediate use of an online psychological intervention or to a delayed start.
The investigators chose a web-based intervention because a majority of patients with cancer already use the Internet for information, and because Internet interventions can overcome barriers of time and distance, with results comparable to those seen with face-to-face interventions, Dr. Hess said.
The intervention consisted of eight weekly sessions based on approaches used in cognitive behavioral therapy, with focus on bodily reactions to stress, cognitive stress reduction, feelings, and social interactions. Each of the eight sessions focused on a single topic. Patients were given written and audio information about each topic and then were asked to perform exercises and complete questionnaires.
For this “minimal contact” intervention, psychologists based in Basel reviewed each patient’s progress weekly and gave written feedback personalized for that patient via a secure online portal.
In all, 129 patients were randomized (65 to the intervention and 64 controls). The majority were women treated with curative intent for early-stage breast cancer. Patients newly diagnosed with lung, ovarian, and gastrointestinal cancers, as well as melanoma and lymphoma, also were included.
Patients in both the active intervention and control groups were assessed at baseline and at 2 months with three quality-of-life measures: the FACIT-F (Functional Assessment of Chronic Illness Therapy Fatigue subscale), DT (Distress Thermometer), and HADS (Hospital Anxiety and Depression Scale).
At 2 months, the mean FACIT-F score for patients in both the intervention and control groups increased, indicating an improved quality of life, but the change was significantly greater for patients in the intervention group (mean 8.59 points vs. controls; P = .0032). There was also a significant decrease in the DT scale from 6 points at baseline to 4 points at 2 months among patients randomized to the intervention, but no change among controls. There were no significant differences in either anxiety or depression between the groups, however.
“Most oncologists, particularly when we’re meeting patients for the first time and starting on curative intent therapy, it is assumed there is a level of distress … but we assume that that level of distress will fall naturally as we start them on therapy,” commented ASCO expert Don S. Dizon, MD, from the Massachusetts General Hospital Cancer Center in Boston, who was not involved in the study.
“What Dr. Hess is showing is that not only do they have distress, but it’s significant distress,” he said, adding that the study shows that online tools can be effective at providing support, and that the ease of access can help patients who might otherwise never meet with a mental health professional.
Recurrence fears assuaged
In a separate study, investigators from Australia reported results of a randomized phase II trial showing that an intervention called Conquer Fear was effective at lowering fear of recurrence among patients with successfully treated stage I-III breast, colorectal, or melanoma cancers who reported a high level of fear of recurrence.
“Fear of cancer recurrence is associated with poorer quality of life, greater distress, lack of planning for the future, avoidance or excessive use of screening, and greater health care utilization,” said Jane MacNeil Beith, MD, PhD, a medical oncologist at the University of Sydney.
Dr. Beith and her colleagues randomly assigned 222 patients to either the Conquer Fear intervention or relaxation training (control group).
Patients assigned to the control group received five 1-hour individual, face-to-face relaxation sessions over 10 weeks. The sessions included muscle relaxation, meditative relaxation, and visualization and quick relaxation techniques taught by trained study instructors. Patients in each group received instructions for home-based relaxation techniques.
The Conquer Fear intervention is intended to help patients with values clarification, detached mindfulness (focusing on the moment), attention training, meta-cognitive therapy (worry or not worry), and a behavioral contract to ensure appropriate follow-up.
They measured fear of recurrence using the validated 42-item Fear of Cancer Recurrence Inventory (FCRI), which scores fear on a scale of 0-168, with higher scores indicating higher levels of fear, Dr. Beith said.
The mean baseline FCRI scores were 82.7 for patients assigned to the intervention and 85.7 in controls.
Participants in both groups had improvement of all outcomes, but patients in the active intervention group had significantly lower FCRI total scores at the end of the intervention and at 3 and 6 months of follow-up. The severity of fear of recurrence was also lower among patients in the intervention group immediately afterward and at 3 months, but not at 6 months, she reported.
“I applaud Dr. Beith for her trial, particularly because we as oncologists have only about 15 minutes with our patients, and the assessments for our patients, even in follow-up, for the most part concentrate on cancer-related outcomes, because that’s what our patients want to know. They want to know if they’re fine, or they want to know, is their cancer back,” Dr. Dizon commented.
The study demonstrates fear of recurrence is real, but that there are also interventions that can help patients reduce those fears, he said.
CALM
In a third study, Gary Rodin, MD, from the department of supportive care at Princess Margaret Cancer Centre in Toronto, and his colleagues reported that a brief psychological intervention with the acronym CALM (for Managing Cancer and Living Meaningfully) was associated with a “clinically meaningful” reduction in depressive symptoms in patients with advanced cancer.
Patients in CALM receive three to six individual sessions delivered over 3-6 months. The program helps patients cope with symptom management and improve communications with health care providers, understand changes in themselves and their relations with others, find a personal sense of meaning and purpose, and learn to live with thoughts of the future and mortality, Dr. Rodin explained.
In a clinical trial, 52% of the 151 patients randomized to the intervention had clinically important reductions in depressive symptoms at 3 months, compared with 33% of controls assigned to usual care. At 6 months, the respective reductions in depressive symptoms were 64% vs. 35%.
The intervention also was effective at preventing depression among 137 patients without depressive symptoms at baseline. In this group, 13% of patients who received the CALM intervention had depressive symptoms at 3 months, compared with 30% of controls.
In addition, patients who received CALM support at both 3 and 6 months said they were better prepared for the end of life, reported that they had greater opportunity to talk about their concerns for the future, were less frightened, and said they had greater ability to express and manage their feelings. At 6 months these effects were strengthened, and the CALM group also felt more able to understand their cancer experience, deal with changes in relationships as a result of cancer, explore ways of communicating with their health care team and family, and clarify their values and beliefs.
“The intervention addresses both the practical problems that people face, and there are many – How do I manage my pain? My symptoms? – but also the profound problems and issues that people face – What is the meaning of my life? – when having a terminal diagnosis, for instance,” he said.
The investigators are currently establishing a global network to train health professionals in the delivery of CALM, and to evaluate the program’s effectiveness in different clinical settings and cultures, he said.
The STREAM study was institutionally supported. Dr. Hess disclosed travel and accommodations from CSL Behring. The Conquer Fear study was funded by Cancer Australia, beyondBlue, and the Australian National Breast Cancer Foundation. Dr. Beith reported no relevant disclosures. The CALM study was supported by the Canadian Institute of Health Research. Dr. Rodin reported no relevant disclosures.
AT ASCO 2017
Key clinical point: Oncologists and patients may focus on only the clinical aspects of care while overlooking cancer-associated distress, anxiety, or fear.
Major finding: Each of three psychological interventions was effective at reducing mental health symptoms in patients with cancer.
Data source: Randomized trials of interventions aimed at relieving mental health symptoms associated with a new cancer diagnoses, fear of cancer recurrence, and advanced or metastatic disease.
Disclosures: The STREAM study was institutionally supported. Dr. Hess disclosed travel and accommodations from CSL Behring. The Conquer Fear study was funded by Cancer Australia, beyondBlue, and the Australian National Breast Cancer Foundation. Dr. Beith reported no relevant disclosures. The CALM study was supported by the Canadian Institute of Health Research. Dr. Rodin reported no relevant disclosures.
VIDEO: TRK inhibitor shows 76% ORR across diverse cancers harboring TRK fusions
CHICAGO – An integrated analysis of three trials has shown that larotrectinib, an oral selective inhibitor of tropomyosin receptor kinase (TRK), has durable efficacy across diverse adult and pediatric cancers harboring TRK fusions, netting an impressive 76% overall response rate.
Lead study author David Hyman, MD, chief of early drug development at Memorial Sloan Kettering Cancer Center in New York, discussed highlights of the analysis, larotrectinib’s regulatory status, and implications for TRK fusion testing in clinical care at the annual meeting of the American Society of Clinical Oncology.
Dr. Hyman disclosed that he has a consulting or advisory role with Atara Biotherapeutics, Chugai Pharma, and CytomX Therapeutics, and that he receives research funding from AstraZeneca and Puma Biotechnology. The study was funded by Loxo Oncology.
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 – An integrated analysis of three trials has shown that larotrectinib, an oral selective inhibitor of tropomyosin receptor kinase (TRK), has durable efficacy across diverse adult and pediatric cancers harboring TRK fusions, netting an impressive 76% overall response rate.
Lead study author David Hyman, MD, chief of early drug development at Memorial Sloan Kettering Cancer Center in New York, discussed highlights of the analysis, larotrectinib’s regulatory status, and implications for TRK fusion testing in clinical care at the annual meeting of the American Society of Clinical Oncology.
Dr. Hyman disclosed that he has a consulting or advisory role with Atara Biotherapeutics, Chugai Pharma, and CytomX Therapeutics, and that he receives research funding from AstraZeneca and Puma Biotechnology. The study was funded by Loxo Oncology.
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 – An integrated analysis of three trials has shown that larotrectinib, an oral selective inhibitor of tropomyosin receptor kinase (TRK), has durable efficacy across diverse adult and pediatric cancers harboring TRK fusions, netting an impressive 76% overall response rate.
Lead study author David Hyman, MD, chief of early drug development at Memorial Sloan Kettering Cancer Center in New York, discussed highlights of the analysis, larotrectinib’s regulatory status, and implications for TRK fusion testing in clinical care at the annual meeting of the American Society of Clinical Oncology.
Dr. Hyman disclosed that he has a consulting or advisory role with Atara Biotherapeutics, Chugai Pharma, and CytomX Therapeutics, and that he receives research funding from AstraZeneca and Puma Biotechnology. The study was funded by Loxo Oncology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ASCO 2017
Severe health conditions decrease among childhood cancer survivors
CHICAGO—The 15-year cumulative incidence of severe health conditions for survivors of childhood cancer has decreased over the past 30 years, from 12.7% for those diagnosed in the 1970s to 10.1% and 8.9% for those diagnosed in the 1980s and 1990s, respectively. And the decreases were greatest for patients with Wilms’ tumor and Hodgkin lymphoma (HL), followed by patients with astrocytoma, non-Hodgkin lymphoma (NHL), and acute lymphoblastic leukemia (ALL).
Investigators of the Childhood Cancer Survivor Study (CCSS) undertook a retrospective cohort analysis of children aged 0 – 14 years diagnosed with cancer between 1970 and 1999. Their goal was to determine whether cancer therapy modifications have maintained cure rates while decreasing the risk of late effects of therapy.
Todd M. Gibson, PhD, of St Jude Children’s Research Hospital in Memphis, Tennessee, presented the findings at the 2017 annual meeting of the American Society for Clinical Oncology (ASCO) as abstract LBA10500.
Researchers analyzed data from 23,600 childhood cancer survivors in the CCSS who were alive 5 years after diagnosis. The patients had leukemia, lymphoma, CNS malignancies, Wilms tumor, neuroblastoma, or soft-tissue/bone sarcoma.
Dr Gibson noted that while 83% of children with a malignancy achieve a 5-year survival, more than half develop at least one severe, disabling, life-threatening health condition by age 50.
The survivors were a median age at last follow-up of 28 years (range, 5-63) and the median time since diagnosis was 21 years (range, 5-43).
The investigators found significant decreases in severe health conditions in 6 diagnostic groups:
- Wilms tumor, decreased from 13% to 5% (P<0.0001)
- HL, decreased from 18% to 11% (P<0.0001)
- Astrocytoma, decreased from 15% to 9% (P=0.004)
- NHL, decreased from 10% to 6% (P=0.04)
- ALL, decreased from 9% to 7% (P=0.002)
- Ewings sarcoma, decreased from 19% to 10% (P=0.01)
They found no reductions in subsequent severe health conditions among survivors of neuroblastoma, acute myeloid leukemia (AML), soft tissue sarcoma, or osteosarcoma.
The investigators believe the decreases were driven mainly by a reduced incidence of endocrine conditions, subsequent malignant neoplasms, gastrointestinal and neurological conditions, but not cardiac or pulmonary conditions.
They also analyzed the reduction in treatment intensities by decade for different diseases and found they correlated with the reduced incidence of serious chronic health conditions by 15 years after diagnosis.
The National Institutes of Health funded the study.
CHICAGO—The 15-year cumulative incidence of severe health conditions for survivors of childhood cancer has decreased over the past 30 years, from 12.7% for those diagnosed in the 1970s to 10.1% and 8.9% for those diagnosed in the 1980s and 1990s, respectively. And the decreases were greatest for patients with Wilms’ tumor and Hodgkin lymphoma (HL), followed by patients with astrocytoma, non-Hodgkin lymphoma (NHL), and acute lymphoblastic leukemia (ALL).
Investigators of the Childhood Cancer Survivor Study (CCSS) undertook a retrospective cohort analysis of children aged 0 – 14 years diagnosed with cancer between 1970 and 1999. Their goal was to determine whether cancer therapy modifications have maintained cure rates while decreasing the risk of late effects of therapy.
Todd M. Gibson, PhD, of St Jude Children’s Research Hospital in Memphis, Tennessee, presented the findings at the 2017 annual meeting of the American Society for Clinical Oncology (ASCO) as abstract LBA10500.
Researchers analyzed data from 23,600 childhood cancer survivors in the CCSS who were alive 5 years after diagnosis. The patients had leukemia, lymphoma, CNS malignancies, Wilms tumor, neuroblastoma, or soft-tissue/bone sarcoma.
Dr Gibson noted that while 83% of children with a malignancy achieve a 5-year survival, more than half develop at least one severe, disabling, life-threatening health condition by age 50.
The survivors were a median age at last follow-up of 28 years (range, 5-63) and the median time since diagnosis was 21 years (range, 5-43).
The investigators found significant decreases in severe health conditions in 6 diagnostic groups:
- Wilms tumor, decreased from 13% to 5% (P<0.0001)
- HL, decreased from 18% to 11% (P<0.0001)
- Astrocytoma, decreased from 15% to 9% (P=0.004)
- NHL, decreased from 10% to 6% (P=0.04)
- ALL, decreased from 9% to 7% (P=0.002)
- Ewings sarcoma, decreased from 19% to 10% (P=0.01)
They found no reductions in subsequent severe health conditions among survivors of neuroblastoma, acute myeloid leukemia (AML), soft tissue sarcoma, or osteosarcoma.
The investigators believe the decreases were driven mainly by a reduced incidence of endocrine conditions, subsequent malignant neoplasms, gastrointestinal and neurological conditions, but not cardiac or pulmonary conditions.
They also analyzed the reduction in treatment intensities by decade for different diseases and found they correlated with the reduced incidence of serious chronic health conditions by 15 years after diagnosis.
The National Institutes of Health funded the study.
CHICAGO—The 15-year cumulative incidence of severe health conditions for survivors of childhood cancer has decreased over the past 30 years, from 12.7% for those diagnosed in the 1970s to 10.1% and 8.9% for those diagnosed in the 1980s and 1990s, respectively. And the decreases were greatest for patients with Wilms’ tumor and Hodgkin lymphoma (HL), followed by patients with astrocytoma, non-Hodgkin lymphoma (NHL), and acute lymphoblastic leukemia (ALL).
Investigators of the Childhood Cancer Survivor Study (CCSS) undertook a retrospective cohort analysis of children aged 0 – 14 years diagnosed with cancer between 1970 and 1999. Their goal was to determine whether cancer therapy modifications have maintained cure rates while decreasing the risk of late effects of therapy.
Todd M. Gibson, PhD, of St Jude Children’s Research Hospital in Memphis, Tennessee, presented the findings at the 2017 annual meeting of the American Society for Clinical Oncology (ASCO) as abstract LBA10500.
Researchers analyzed data from 23,600 childhood cancer survivors in the CCSS who were alive 5 years after diagnosis. The patients had leukemia, lymphoma, CNS malignancies, Wilms tumor, neuroblastoma, or soft-tissue/bone sarcoma.
Dr Gibson noted that while 83% of children with a malignancy achieve a 5-year survival, more than half develop at least one severe, disabling, life-threatening health condition by age 50.
The survivors were a median age at last follow-up of 28 years (range, 5-63) and the median time since diagnosis was 21 years (range, 5-43).
The investigators found significant decreases in severe health conditions in 6 diagnostic groups:
- Wilms tumor, decreased from 13% to 5% (P<0.0001)
- HL, decreased from 18% to 11% (P<0.0001)
- Astrocytoma, decreased from 15% to 9% (P=0.004)
- NHL, decreased from 10% to 6% (P=0.04)
- ALL, decreased from 9% to 7% (P=0.002)
- Ewings sarcoma, decreased from 19% to 10% (P=0.01)
They found no reductions in subsequent severe health conditions among survivors of neuroblastoma, acute myeloid leukemia (AML), soft tissue sarcoma, or osteosarcoma.
The investigators believe the decreases were driven mainly by a reduced incidence of endocrine conditions, subsequent malignant neoplasms, gastrointestinal and neurological conditions, but not cardiac or pulmonary conditions.
They also analyzed the reduction in treatment intensities by decade for different diseases and found they correlated with the reduced incidence of serious chronic health conditions by 15 years after diagnosis.
The National Institutes of Health funded the study.
Single-dose RT suffices for treatment of spinal cord compression due to mets
CHICAGO – A single dose of radiation therapy appears to work as well as multiple doses given over a week for treating spinal cord compression due to metastatic cancer, according to findings of the SCORAD III trial reported at the annual meeting of the American Society of Clinical Oncology.
“There is no standard radiotherapy schedule,” first author Peter Hoskin, MD, FCRP, FRCR, an oncologist at the Mount Vernon Cancer Centre in Middlesex, England, noted in a press briefing. “A range of radiation doses are used internationally, from single doses of 8 to 10 Gy ranging up to 4 weeks of treatment delivering 40 Gy.”
The noninferiority phase III trial enrolled nearly 700 patients in the United Kingdom and Australia with spinal cord compression due to metastases, the majority of whom were able to walk at baseline. They were randomized evenly to receive either 8 Gy of radiation in a single fraction or 20 Gy split into five fractions given over consecutive days.
Results showed that at 8 weeks, more than two-thirds of patients in each group were able to walk, the trial’s primary endpoint. The lower bound of the confidence interval for the difference between groups fell just outside the trial’s margin for noninferiority.
Additionally, the two groups were statistically indistinguishable with respect to median overall survival, bowel and bladder function, and the rate of grade 3 or 4 toxicity.
“A single dose of 8 Gy is as effective as 20 Gy in five fractions for a range of clinically relevant endpoints, particularly ambulatory status, both at 8 weeks and indeed at all time points between 1 week and 12 weeks,” Dr. Hoskin summarized. The trial also underscores the importance of early diagnosis, as the majority of patients who were ambulatory initially remained so with radiation therapy, regardless of dosing schedule.
“A single dose of radiotherapy in our minds is now recommended in this setting. It has major advantages for these patients,” he maintained. “An important thing to realize is that these patients had a very short survival; median survival in this study was only 13 weeks. A single dose has enormous advantages in those patients with short survival times, and of course, it is increasingly cost effective.”
Findings in context
The trial population was not fully representative of all patients with spinal cord compression due to metastases, with underrepresentation of some cancers, such as breast cancer, and the modest survival, Dr. Hoskin acknowledged.
Some patients on the trial have survived for many months and even years, he noted. “We have looked at patients at longer times, although it was not in the protocol, and there was no obvious difference [in outcomes]. But there is some evidence to suggest that for the longer-surviving patients, a more prolonged fractionation may be appropriate, although clearly that needs to be investigated properly in a formal randomized trial.”
“This is the first study that really shows equal outcomes in terms of meaningful benefits for patients with a single dose of radiotherapy versus a much longer course, allowing patients to spend more time with their families, more time doing the things they want to do,” commented ASCO Expert Joshua A. Jones, MD, MA, of the Hospital of the University of Pennsylvania in Philadelphia.
“We still have work to do to figure out for patients who have longer than this average survival of 3 months what is the most appropriate regimen,” he agreed. “But for many patients, this is going to provide tremendous benefit with the idea that sometimes, less really is more.”
Study details
SCORAD III, which was funded by Cancer Research UK, enrolled 688 patients with metastatic prostate (44%), lung (18%), breast (11%), and gastrointestinal (11%) cancers.
At baseline, 66% were able to walk without or with an aid (ambulatory status 1 or 2), whereas the rest were unable to walk but still had some limb power (ambulatory status 3) or had flaccid paraplegia (ambulatory status 4).
At 8 weeks, the proportion of patients with ambulatory status 1 or 2 was 69.5% in the group who received the 8-Gy single-dose radiation therapy and 73.3% in the group who received the 20-Gy multidose radiation therapy, for a risk difference of –3.78%, reported Dr. Hoskin.
The 90% confidence interval for the difference between groups of –11.85% to 4.28% slightly exceeded the trial’s predefined 11% margin for noninferiority.
Among patients having ambulatory status 1 or 2 at baseline, the proportion maintaining that status at 8 weeks was 62.20% with the single dose and 63.07% with multiple doses. Median overall survival was 12.4 weeks and 13.7 weeks, respectively, a nonsignificant difference.
Patients in the single-dose and multidose groups had similar rates of grade 3 or 4 toxicity (20.6% vs. 20.4%), but the former had a lower rate of grade 1 or 2 toxicity (51.0% vs. 56.9%).
CHICAGO – A single dose of radiation therapy appears to work as well as multiple doses given over a week for treating spinal cord compression due to metastatic cancer, according to findings of the SCORAD III trial reported at the annual meeting of the American Society of Clinical Oncology.
“There is no standard radiotherapy schedule,” first author Peter Hoskin, MD, FCRP, FRCR, an oncologist at the Mount Vernon Cancer Centre in Middlesex, England, noted in a press briefing. “A range of radiation doses are used internationally, from single doses of 8 to 10 Gy ranging up to 4 weeks of treatment delivering 40 Gy.”
The noninferiority phase III trial enrolled nearly 700 patients in the United Kingdom and Australia with spinal cord compression due to metastases, the majority of whom were able to walk at baseline. They were randomized evenly to receive either 8 Gy of radiation in a single fraction or 20 Gy split into five fractions given over consecutive days.
Results showed that at 8 weeks, more than two-thirds of patients in each group were able to walk, the trial’s primary endpoint. The lower bound of the confidence interval for the difference between groups fell just outside the trial’s margin for noninferiority.
Additionally, the two groups were statistically indistinguishable with respect to median overall survival, bowel and bladder function, and the rate of grade 3 or 4 toxicity.
“A single dose of 8 Gy is as effective as 20 Gy in five fractions for a range of clinically relevant endpoints, particularly ambulatory status, both at 8 weeks and indeed at all time points between 1 week and 12 weeks,” Dr. Hoskin summarized. The trial also underscores the importance of early diagnosis, as the majority of patients who were ambulatory initially remained so with radiation therapy, regardless of dosing schedule.
“A single dose of radiotherapy in our minds is now recommended in this setting. It has major advantages for these patients,” he maintained. “An important thing to realize is that these patients had a very short survival; median survival in this study was only 13 weeks. A single dose has enormous advantages in those patients with short survival times, and of course, it is increasingly cost effective.”
Findings in context
The trial population was not fully representative of all patients with spinal cord compression due to metastases, with underrepresentation of some cancers, such as breast cancer, and the modest survival, Dr. Hoskin acknowledged.
Some patients on the trial have survived for many months and even years, he noted. “We have looked at patients at longer times, although it was not in the protocol, and there was no obvious difference [in outcomes]. But there is some evidence to suggest that for the longer-surviving patients, a more prolonged fractionation may be appropriate, although clearly that needs to be investigated properly in a formal randomized trial.”
“This is the first study that really shows equal outcomes in terms of meaningful benefits for patients with a single dose of radiotherapy versus a much longer course, allowing patients to spend more time with their families, more time doing the things they want to do,” commented ASCO Expert Joshua A. Jones, MD, MA, of the Hospital of the University of Pennsylvania in Philadelphia.
“We still have work to do to figure out for patients who have longer than this average survival of 3 months what is the most appropriate regimen,” he agreed. “But for many patients, this is going to provide tremendous benefit with the idea that sometimes, less really is more.”
Study details
SCORAD III, which was funded by Cancer Research UK, enrolled 688 patients with metastatic prostate (44%), lung (18%), breast (11%), and gastrointestinal (11%) cancers.
At baseline, 66% were able to walk without or with an aid (ambulatory status 1 or 2), whereas the rest were unable to walk but still had some limb power (ambulatory status 3) or had flaccid paraplegia (ambulatory status 4).
At 8 weeks, the proportion of patients with ambulatory status 1 or 2 was 69.5% in the group who received the 8-Gy single-dose radiation therapy and 73.3% in the group who received the 20-Gy multidose radiation therapy, for a risk difference of –3.78%, reported Dr. Hoskin.
The 90% confidence interval for the difference between groups of –11.85% to 4.28% slightly exceeded the trial’s predefined 11% margin for noninferiority.
Among patients having ambulatory status 1 or 2 at baseline, the proportion maintaining that status at 8 weeks was 62.20% with the single dose and 63.07% with multiple doses. Median overall survival was 12.4 weeks and 13.7 weeks, respectively, a nonsignificant difference.
Patients in the single-dose and multidose groups had similar rates of grade 3 or 4 toxicity (20.6% vs. 20.4%), but the former had a lower rate of grade 1 or 2 toxicity (51.0% vs. 56.9%).
CHICAGO – A single dose of radiation therapy appears to work as well as multiple doses given over a week for treating spinal cord compression due to metastatic cancer, according to findings of the SCORAD III trial reported at the annual meeting of the American Society of Clinical Oncology.
“There is no standard radiotherapy schedule,” first author Peter Hoskin, MD, FCRP, FRCR, an oncologist at the Mount Vernon Cancer Centre in Middlesex, England, noted in a press briefing. “A range of radiation doses are used internationally, from single doses of 8 to 10 Gy ranging up to 4 weeks of treatment delivering 40 Gy.”
The noninferiority phase III trial enrolled nearly 700 patients in the United Kingdom and Australia with spinal cord compression due to metastases, the majority of whom were able to walk at baseline. They were randomized evenly to receive either 8 Gy of radiation in a single fraction or 20 Gy split into five fractions given over consecutive days.
Results showed that at 8 weeks, more than two-thirds of patients in each group were able to walk, the trial’s primary endpoint. The lower bound of the confidence interval for the difference between groups fell just outside the trial’s margin for noninferiority.
Additionally, the two groups were statistically indistinguishable with respect to median overall survival, bowel and bladder function, and the rate of grade 3 or 4 toxicity.
“A single dose of 8 Gy is as effective as 20 Gy in five fractions for a range of clinically relevant endpoints, particularly ambulatory status, both at 8 weeks and indeed at all time points between 1 week and 12 weeks,” Dr. Hoskin summarized. The trial also underscores the importance of early diagnosis, as the majority of patients who were ambulatory initially remained so with radiation therapy, regardless of dosing schedule.
“A single dose of radiotherapy in our minds is now recommended in this setting. It has major advantages for these patients,” he maintained. “An important thing to realize is that these patients had a very short survival; median survival in this study was only 13 weeks. A single dose has enormous advantages in those patients with short survival times, and of course, it is increasingly cost effective.”
Findings in context
The trial population was not fully representative of all patients with spinal cord compression due to metastases, with underrepresentation of some cancers, such as breast cancer, and the modest survival, Dr. Hoskin acknowledged.
Some patients on the trial have survived for many months and even years, he noted. “We have looked at patients at longer times, although it was not in the protocol, and there was no obvious difference [in outcomes]. But there is some evidence to suggest that for the longer-surviving patients, a more prolonged fractionation may be appropriate, although clearly that needs to be investigated properly in a formal randomized trial.”
“This is the first study that really shows equal outcomes in terms of meaningful benefits for patients with a single dose of radiotherapy versus a much longer course, allowing patients to spend more time with their families, more time doing the things they want to do,” commented ASCO Expert Joshua A. Jones, MD, MA, of the Hospital of the University of Pennsylvania in Philadelphia.
“We still have work to do to figure out for patients who have longer than this average survival of 3 months what is the most appropriate regimen,” he agreed. “But for many patients, this is going to provide tremendous benefit with the idea that sometimes, less really is more.”
Study details
SCORAD III, which was funded by Cancer Research UK, enrolled 688 patients with metastatic prostate (44%), lung (18%), breast (11%), and gastrointestinal (11%) cancers.
At baseline, 66% were able to walk without or with an aid (ambulatory status 1 or 2), whereas the rest were unable to walk but still had some limb power (ambulatory status 3) or had flaccid paraplegia (ambulatory status 4).
At 8 weeks, the proportion of patients with ambulatory status 1 or 2 was 69.5% in the group who received the 8-Gy single-dose radiation therapy and 73.3% in the group who received the 20-Gy multidose radiation therapy, for a risk difference of –3.78%, reported Dr. Hoskin.
The 90% confidence interval for the difference between groups of –11.85% to 4.28% slightly exceeded the trial’s predefined 11% margin for noninferiority.
Among patients having ambulatory status 1 or 2 at baseline, the proportion maintaining that status at 8 weeks was 62.20% with the single dose and 63.07% with multiple doses. Median overall survival was 12.4 weeks and 13.7 weeks, respectively, a nonsignificant difference.
Patients in the single-dose and multidose groups had similar rates of grade 3 or 4 toxicity (20.6% vs. 20.4%), but the former had a lower rate of grade 1 or 2 toxicity (51.0% vs. 56.9%).
At ASCO 2017
Key clinical point:
Major finding: At 8 weeks, the proportion of patients able to walk was 69.5% with 8 Gy given in a single dose and 73.3% with 20 Gy given in five doses.
Data source: A randomized phase III noninferiority trial among 688 patients with spinal cord compression due to metastatic cancer (SCORAD III trial).
Disclosures: Dr. Hoskin disclosed that he receives research funding (institutional) from Varian Medical Systems. The trial was funded by Cancer Research UK.
U.S. malaria cases dipped slightly in 2014
The number of confirmed malaria cases reported in the United States in 2014 is the fourth highest annual total since 1973, according to the Centers for Disease Control and Prevention, but the 2014 number of 1,724 cases is down slightly from 1,741 – the previous year’s number of confirmed cases.
The CDC monitors malaria cases in part to identify any instances of local, rather than imported, transmission. For 2014, no cases of local transmission were reported.
Of the imported transmission cases for which the region of acquisition was known, 1,383 (82.1%) came from Africa and 160 (9.5%) from Asia, making up all but 62 of the imported cases. The four leading countries of origin in Africa were Nigeria, Ghana, Sierra Leone, and Liberia (346, 153, 133, and 125 cases, respectively). Most of the cases from Asia came from India, which accounted for 100 of the 160 cases.
Sierra Leone, Liberia, and Guinea were the countries primarily affected by the Ebola virus disease outbreak in 2014 and into 2015. The study authors, Kimberly E. Mace, PhD, and Paul M. Arguin, MD, noted in the May 26 Morbidity and Mortality Weekly Report that “Ebola negatively impacted the delivery of malaria care and prevention services in the Ebola-affected countries, which could have increased malaria morbidity and mortality” (MMWR Surveill Summ. 2017;66[12]:1-24).
“Despite progress in reducing global prevalence of malaria, the disease remains endemic in many regions and use of appropriate prevention measures by travelers is still inadequate,” they added.
Among all cases, 17% were classified as severe illness, including five deaths (a decrease from 10 deaths in 2013). All five patients who died reported not taking chemoprophylaxis during their travel. More than half (57.5%) of the patients reported that the purpose of their travel was to visit friends and relatives.
“Health care providers should talk to their patients, especially those who would travel to countries where malaria is endemic to visit friends and relatives, about upcoming travel plans and offer education and medicines to prevent malaria,” the authors wrote.
The number of confirmed malaria cases reported in the United States in 2014 is the fourth highest annual total since 1973, according to the Centers for Disease Control and Prevention, but the 2014 number of 1,724 cases is down slightly from 1,741 – the previous year’s number of confirmed cases.
The CDC monitors malaria cases in part to identify any instances of local, rather than imported, transmission. For 2014, no cases of local transmission were reported.
Of the imported transmission cases for which the region of acquisition was known, 1,383 (82.1%) came from Africa and 160 (9.5%) from Asia, making up all but 62 of the imported cases. The four leading countries of origin in Africa were Nigeria, Ghana, Sierra Leone, and Liberia (346, 153, 133, and 125 cases, respectively). Most of the cases from Asia came from India, which accounted for 100 of the 160 cases.
Sierra Leone, Liberia, and Guinea were the countries primarily affected by the Ebola virus disease outbreak in 2014 and into 2015. The study authors, Kimberly E. Mace, PhD, and Paul M. Arguin, MD, noted in the May 26 Morbidity and Mortality Weekly Report that “Ebola negatively impacted the delivery of malaria care and prevention services in the Ebola-affected countries, which could have increased malaria morbidity and mortality” (MMWR Surveill Summ. 2017;66[12]:1-24).
“Despite progress in reducing global prevalence of malaria, the disease remains endemic in many regions and use of appropriate prevention measures by travelers is still inadequate,” they added.
Among all cases, 17% were classified as severe illness, including five deaths (a decrease from 10 deaths in 2013). All five patients who died reported not taking chemoprophylaxis during their travel. More than half (57.5%) of the patients reported that the purpose of their travel was to visit friends and relatives.
“Health care providers should talk to their patients, especially those who would travel to countries where malaria is endemic to visit friends and relatives, about upcoming travel plans and offer education and medicines to prevent malaria,” the authors wrote.
The number of confirmed malaria cases reported in the United States in 2014 is the fourth highest annual total since 1973, according to the Centers for Disease Control and Prevention, but the 2014 number of 1,724 cases is down slightly from 1,741 – the previous year’s number of confirmed cases.
The CDC monitors malaria cases in part to identify any instances of local, rather than imported, transmission. For 2014, no cases of local transmission were reported.
Of the imported transmission cases for which the region of acquisition was known, 1,383 (82.1%) came from Africa and 160 (9.5%) from Asia, making up all but 62 of the imported cases. The four leading countries of origin in Africa were Nigeria, Ghana, Sierra Leone, and Liberia (346, 153, 133, and 125 cases, respectively). Most of the cases from Asia came from India, which accounted for 100 of the 160 cases.
Sierra Leone, Liberia, and Guinea were the countries primarily affected by the Ebola virus disease outbreak in 2014 and into 2015. The study authors, Kimberly E. Mace, PhD, and Paul M. Arguin, MD, noted in the May 26 Morbidity and Mortality Weekly Report that “Ebola negatively impacted the delivery of malaria care and prevention services in the Ebola-affected countries, which could have increased malaria morbidity and mortality” (MMWR Surveill Summ. 2017;66[12]:1-24).
“Despite progress in reducing global prevalence of malaria, the disease remains endemic in many regions and use of appropriate prevention measures by travelers is still inadequate,” they added.
Among all cases, 17% were classified as severe illness, including five deaths (a decrease from 10 deaths in 2013). All five patients who died reported not taking chemoprophylaxis during their travel. More than half (57.5%) of the patients reported that the purpose of their travel was to visit friends and relatives.
“Health care providers should talk to their patients, especially those who would travel to countries where malaria is endemic to visit friends and relatives, about upcoming travel plans and offer education and medicines to prevent malaria,” the authors wrote.
FROM MMWR
Study offers snapshot of common MS comorbidities
NEW ORLEANS – Comorbidities such as hyperlipidemia, hypertension, gastrointestinal disorders, and depression are significantly more common among patients with multiple sclerosis, compared with patients who do not have the condition.
The findings, based on a large analysis of national claims data that was presented at the annual meeting of the Consortium of Multiple Sclerosis Centers, may better inform physicians and patients about potential comorbidities in patients with MS, lead study author Kiren Kresa-Reahl, MD, said in an interview. “The challenge is, what is the underlying problem?” she asked. “Is it the chicken or the egg? It may be that MS lesions on the brain and microvascular disease look similar, so it’s hard to know. There are also conditions that are caused by MS, such as depression. Is it caused by MS the disease or is it a comorbidity with MS? That’s hard to know.”
In an effort to compare the prevalence of comorbidities in patients with and without MS, Dr. Kresa-Reahl and her associates retrospectively evaluated IMS Health Real World Data Adjudicated Claims-U.S. data between Jan. 1, 2011, and Sept. 30, 2015. The database includes about 150 million patients with a medical benefit and a subset of 95 million patients with both medical and pharmacy benefits. MS patients were required to have at least two claims with an ICD-9 diagnosis of MS 30 days apart and to be between the ages of 18 and 65.
The researchers drew from a systematic review of the 10 most common comorbidities in MS (Mult Scler. 2015;21[3]:263-81) and then matched 69,550 MS patients to a pool of 3,129,573 patients without MS by age group, gender, geographic region, and index quarter year. This left 66,616 patients in each cohort. Their mean age was 46 years, 76% were female, and the majority had commercial health insurance (97% of MS patients and 95% of those without the condition).
Of the 10 common comorbidities, eight occurred significantly more frequently among MS patients, compared with those without the condition (P less than .0001 for all). These included hyperlipidemia (27.76% vs. 24.57%, respectively), hypertension (26.91% vs. 23.50%), GI disorders (18.02% vs. 13.84%), depression (16.12% vs. 9.62%), thyroid disease (15.77% vs. 12.05%), anxiety (12.27% vs. 9.32%), and chronic obstructive pulmonary disease (10.39% vs. 9.52%).
Dr. Kresa-Reahl, a neurologist at the Providence Multiple Sclerosis Center in Portland, Ore., and her associates also found that patients with MS had a significantly lower prevalence of alcohol abuse, AIDS, mild liver disease, and moderate liver disease than did patients without MS (P less than .05 for all). There were no differences between groups in the prevalence of diabetes without complications or in metastatic tumor (P greater than .05).
She acknowledged certain limitations of the study, including the potential for missing information and the inability of the researchers to determine which form of MS the patients had. “It might be that if we looked at just Medicare and Medicaid patients, these diagnoses would be a little bit different,” Dr. Kresa-Reahl added. “Maybe they would have more disability or more depression or more limited mobility. It’s hard to know, but this is a snapshot of people who have commercial insurance, so maybe they would be more likely to be employed.”
The study was sponsored by EMD Serono. Dr. Kresa-Reahl disclosed that she has received consulting fees from Biogen and EMD Serono; speakers fees and honoraria from Biogen, EMD Serono, Genzyme, Mallinckrodt, Novartis, and Teva; and grant/research support from Biogen, Genentech, Genzyme, Mallinckrodt, and Novartis.
NEW ORLEANS – Comorbidities such as hyperlipidemia, hypertension, gastrointestinal disorders, and depression are significantly more common among patients with multiple sclerosis, compared with patients who do not have the condition.
The findings, based on a large analysis of national claims data that was presented at the annual meeting of the Consortium of Multiple Sclerosis Centers, may better inform physicians and patients about potential comorbidities in patients with MS, lead study author Kiren Kresa-Reahl, MD, said in an interview. “The challenge is, what is the underlying problem?” she asked. “Is it the chicken or the egg? It may be that MS lesions on the brain and microvascular disease look similar, so it’s hard to know. There are also conditions that are caused by MS, such as depression. Is it caused by MS the disease or is it a comorbidity with MS? That’s hard to know.”
In an effort to compare the prevalence of comorbidities in patients with and without MS, Dr. Kresa-Reahl and her associates retrospectively evaluated IMS Health Real World Data Adjudicated Claims-U.S. data between Jan. 1, 2011, and Sept. 30, 2015. The database includes about 150 million patients with a medical benefit and a subset of 95 million patients with both medical and pharmacy benefits. MS patients were required to have at least two claims with an ICD-9 diagnosis of MS 30 days apart and to be between the ages of 18 and 65.
The researchers drew from a systematic review of the 10 most common comorbidities in MS (Mult Scler. 2015;21[3]:263-81) and then matched 69,550 MS patients to a pool of 3,129,573 patients without MS by age group, gender, geographic region, and index quarter year. This left 66,616 patients in each cohort. Their mean age was 46 years, 76% were female, and the majority had commercial health insurance (97% of MS patients and 95% of those without the condition).
Of the 10 common comorbidities, eight occurred significantly more frequently among MS patients, compared with those without the condition (P less than .0001 for all). These included hyperlipidemia (27.76% vs. 24.57%, respectively), hypertension (26.91% vs. 23.50%), GI disorders (18.02% vs. 13.84%), depression (16.12% vs. 9.62%), thyroid disease (15.77% vs. 12.05%), anxiety (12.27% vs. 9.32%), and chronic obstructive pulmonary disease (10.39% vs. 9.52%).
Dr. Kresa-Reahl, a neurologist at the Providence Multiple Sclerosis Center in Portland, Ore., and her associates also found that patients with MS had a significantly lower prevalence of alcohol abuse, AIDS, mild liver disease, and moderate liver disease than did patients without MS (P less than .05 for all). There were no differences between groups in the prevalence of diabetes without complications or in metastatic tumor (P greater than .05).
She acknowledged certain limitations of the study, including the potential for missing information and the inability of the researchers to determine which form of MS the patients had. “It might be that if we looked at just Medicare and Medicaid patients, these diagnoses would be a little bit different,” Dr. Kresa-Reahl added. “Maybe they would have more disability or more depression or more limited mobility. It’s hard to know, but this is a snapshot of people who have commercial insurance, so maybe they would be more likely to be employed.”
The study was sponsored by EMD Serono. Dr. Kresa-Reahl disclosed that she has received consulting fees from Biogen and EMD Serono; speakers fees and honoraria from Biogen, EMD Serono, Genzyme, Mallinckrodt, Novartis, and Teva; and grant/research support from Biogen, Genentech, Genzyme, Mallinckrodt, and Novartis.
NEW ORLEANS – Comorbidities such as hyperlipidemia, hypertension, gastrointestinal disorders, and depression are significantly more common among patients with multiple sclerosis, compared with patients who do not have the condition.
The findings, based on a large analysis of national claims data that was presented at the annual meeting of the Consortium of Multiple Sclerosis Centers, may better inform physicians and patients about potential comorbidities in patients with MS, lead study author Kiren Kresa-Reahl, MD, said in an interview. “The challenge is, what is the underlying problem?” she asked. “Is it the chicken or the egg? It may be that MS lesions on the brain and microvascular disease look similar, so it’s hard to know. There are also conditions that are caused by MS, such as depression. Is it caused by MS the disease or is it a comorbidity with MS? That’s hard to know.”
In an effort to compare the prevalence of comorbidities in patients with and without MS, Dr. Kresa-Reahl and her associates retrospectively evaluated IMS Health Real World Data Adjudicated Claims-U.S. data between Jan. 1, 2011, and Sept. 30, 2015. The database includes about 150 million patients with a medical benefit and a subset of 95 million patients with both medical and pharmacy benefits. MS patients were required to have at least two claims with an ICD-9 diagnosis of MS 30 days apart and to be between the ages of 18 and 65.
The researchers drew from a systematic review of the 10 most common comorbidities in MS (Mult Scler. 2015;21[3]:263-81) and then matched 69,550 MS patients to a pool of 3,129,573 patients without MS by age group, gender, geographic region, and index quarter year. This left 66,616 patients in each cohort. Their mean age was 46 years, 76% were female, and the majority had commercial health insurance (97% of MS patients and 95% of those without the condition).
Of the 10 common comorbidities, eight occurred significantly more frequently among MS patients, compared with those without the condition (P less than .0001 for all). These included hyperlipidemia (27.76% vs. 24.57%, respectively), hypertension (26.91% vs. 23.50%), GI disorders (18.02% vs. 13.84%), depression (16.12% vs. 9.62%), thyroid disease (15.77% vs. 12.05%), anxiety (12.27% vs. 9.32%), and chronic obstructive pulmonary disease (10.39% vs. 9.52%).
Dr. Kresa-Reahl, a neurologist at the Providence Multiple Sclerosis Center in Portland, Ore., and her associates also found that patients with MS had a significantly lower prevalence of alcohol abuse, AIDS, mild liver disease, and moderate liver disease than did patients without MS (P less than .05 for all). There were no differences between groups in the prevalence of diabetes without complications or in metastatic tumor (P greater than .05).
She acknowledged certain limitations of the study, including the potential for missing information and the inability of the researchers to determine which form of MS the patients had. “It might be that if we looked at just Medicare and Medicaid patients, these diagnoses would be a little bit different,” Dr. Kresa-Reahl added. “Maybe they would have more disability or more depression or more limited mobility. It’s hard to know, but this is a snapshot of people who have commercial insurance, so maybe they would be more likely to be employed.”
The study was sponsored by EMD Serono. Dr. Kresa-Reahl disclosed that she has received consulting fees from Biogen and EMD Serono; speakers fees and honoraria from Biogen, EMD Serono, Genzyme, Mallinckrodt, Novartis, and Teva; and grant/research support from Biogen, Genentech, Genzyme, Mallinckrodt, and Novartis.
AT THE CMSC ANNUAL MEETING
Key clinical point:
Major finding: Of 10 common comorbidities, eight occurred significantly more frequently among MS patients, compared with those without the condition (P less than .0001 for all).
Data source: A retrospective analysis of claims data from 66,616 MS patients and 66,616 patients without the condition.
Disclosures: The study was sponsored by EMD Serono. Dr. Kresa-Reahl disclosed that she has received consulting fees from Biogen and EMD Serono; speakers fees and honoraria from Biogen, EMD Serono, Genzyme, Mallinckrodt, Novartis, and Teva; and grant/research support from Biogen, Genentech, Genzyme, Mallinckrodt, and Novartis.
Severe health conditions decline in childhood cancer survivors
CHICAGO – Severe health problems occurring 5 or more years after diagnosis of a childhood cancer have steadily declined, based on an analysis of 23,600 participants in the Childhood Cancer Survivor Study, funded by the National Institutes of Health.
For all childhood cancer survivors, the 15-year cumulative incidence of severe health conditions decreased from 12.7% in those diagnosed in the 1970s, to 10.1% in the 1980s, and to 8.8% among those diagnosed in the 1990s (per 10 years: hazard ratio, 0.84 [95% confidence interval, 0.80-0.89]), Todd M. Gibson, PhD, of St. Jude Children’s Research Hospital, Memphis, reported at a press conference at the annual meeting of the American Society of Clinical Oncology.
The association with diagnosis decade was attenuated (HR, 0.92 [95% CI, 0.85-1.00]) when detailed treatment data were included in the model, indicating that treatment reductions mediated risk.
Changes in childhood cancer treatment protocols to reduce the intensity of therapy – along with improved screening and early detection – have not only extended lifespan for many survivors, but also have reduced the incidence of serious chronic morbidity, Dr. Gibson said.
As the data address children diagnosed over 15 years ago, it is likely that improvements since then in determining patient risk and targeting therapy might result in further incremental improvements, he said in an interview.
By cancer type, severe health problems by 15 years after diagnosis decreased from 13% to 5% among survivors of Wilms’ tumor, from 18% to 11% among survivors of Hodgkin lymphoma, from 15% to 9% among survivors of astrocytoma, from 10% to 6% among survivors of non-Hodgkin lymphoma, and from 9% to 7% among survivors of acute lymphoblastic leukemia. The conclusions are based on the incidence of severe, disabling/life-threatening, or fatal chronic health conditions (Common Terminology Criteria for Adverse Events, grades 3-5) among 5-year survivors diagnosed prior to age 21 years from 1970 through 1999.
Adjusted for sex and attained age, significant reduction in risk over time was found among survivors of Wilms tumor (HR, 0.57 [95% CI, 0.46-0.70]), Hodgkin lymphoma (HR, 0.75 [95% CI, 0.65-0.85]), astrocytoma (HR, 0.77 [95% CI, 0.64-0.92]), non-Hodgkin lymphoma (HR, 0.79 [95% CI, 0.63-0.99]), and acute lymphoblastic leukemia (HR, 0.86 [95% CI, 0.76-0.98]).
The decreases in serious health conditions were largely driven by a reduced incidence of endocrine conditions (1970s: 4.0% vs. 1990s: 1.6%; HR, 0.66 [95% CI, 0.59-0.73]) and subsequent malignant neoplasms (1970s: 2.4% vs. 1990s: 1.6%; HR, 0.85 [95% CI, 0.76-0.96]).
Gastrointestinal (HR, 0.80 [95% CI, 0.66-0.97]) and neurological conditions (HR, 0.77 [95% CI, 0.65-0.91]) also were reduced, but cardiac and pulmonary conditions were not. Changes in childhood cancer treatment protocols have not only extended lifespan for many survivors, but also have reduced the incidence of serious chronic morbidity in this population, Dr. Gibson concluded.
[email protected]
On Twitter @maryjodales
CHICAGO – Severe health problems occurring 5 or more years after diagnosis of a childhood cancer have steadily declined, based on an analysis of 23,600 participants in the Childhood Cancer Survivor Study, funded by the National Institutes of Health.
For all childhood cancer survivors, the 15-year cumulative incidence of severe health conditions decreased from 12.7% in those diagnosed in the 1970s, to 10.1% in the 1980s, and to 8.8% among those diagnosed in the 1990s (per 10 years: hazard ratio, 0.84 [95% confidence interval, 0.80-0.89]), Todd M. Gibson, PhD, of St. Jude Children’s Research Hospital, Memphis, reported at a press conference at the annual meeting of the American Society of Clinical Oncology.
The association with diagnosis decade was attenuated (HR, 0.92 [95% CI, 0.85-1.00]) when detailed treatment data were included in the model, indicating that treatment reductions mediated risk.
Changes in childhood cancer treatment protocols to reduce the intensity of therapy – along with improved screening and early detection – have not only extended lifespan for many survivors, but also have reduced the incidence of serious chronic morbidity, Dr. Gibson said.
As the data address children diagnosed over 15 years ago, it is likely that improvements since then in determining patient risk and targeting therapy might result in further incremental improvements, he said in an interview.
By cancer type, severe health problems by 15 years after diagnosis decreased from 13% to 5% among survivors of Wilms’ tumor, from 18% to 11% among survivors of Hodgkin lymphoma, from 15% to 9% among survivors of astrocytoma, from 10% to 6% among survivors of non-Hodgkin lymphoma, and from 9% to 7% among survivors of acute lymphoblastic leukemia. The conclusions are based on the incidence of severe, disabling/life-threatening, or fatal chronic health conditions (Common Terminology Criteria for Adverse Events, grades 3-5) among 5-year survivors diagnosed prior to age 21 years from 1970 through 1999.
Adjusted for sex and attained age, significant reduction in risk over time was found among survivors of Wilms tumor (HR, 0.57 [95% CI, 0.46-0.70]), Hodgkin lymphoma (HR, 0.75 [95% CI, 0.65-0.85]), astrocytoma (HR, 0.77 [95% CI, 0.64-0.92]), non-Hodgkin lymphoma (HR, 0.79 [95% CI, 0.63-0.99]), and acute lymphoblastic leukemia (HR, 0.86 [95% CI, 0.76-0.98]).
The decreases in serious health conditions were largely driven by a reduced incidence of endocrine conditions (1970s: 4.0% vs. 1990s: 1.6%; HR, 0.66 [95% CI, 0.59-0.73]) and subsequent malignant neoplasms (1970s: 2.4% vs. 1990s: 1.6%; HR, 0.85 [95% CI, 0.76-0.96]).
Gastrointestinal (HR, 0.80 [95% CI, 0.66-0.97]) and neurological conditions (HR, 0.77 [95% CI, 0.65-0.91]) also were reduced, but cardiac and pulmonary conditions were not. Changes in childhood cancer treatment protocols have not only extended lifespan for many survivors, but also have reduced the incidence of serious chronic morbidity in this population, Dr. Gibson concluded.
[email protected]
On Twitter @maryjodales
CHICAGO – Severe health problems occurring 5 or more years after diagnosis of a childhood cancer have steadily declined, based on an analysis of 23,600 participants in the Childhood Cancer Survivor Study, funded by the National Institutes of Health.
For all childhood cancer survivors, the 15-year cumulative incidence of severe health conditions decreased from 12.7% in those diagnosed in the 1970s, to 10.1% in the 1980s, and to 8.8% among those diagnosed in the 1990s (per 10 years: hazard ratio, 0.84 [95% confidence interval, 0.80-0.89]), Todd M. Gibson, PhD, of St. Jude Children’s Research Hospital, Memphis, reported at a press conference at the annual meeting of the American Society of Clinical Oncology.
The association with diagnosis decade was attenuated (HR, 0.92 [95% CI, 0.85-1.00]) when detailed treatment data were included in the model, indicating that treatment reductions mediated risk.
Changes in childhood cancer treatment protocols to reduce the intensity of therapy – along with improved screening and early detection – have not only extended lifespan for many survivors, but also have reduced the incidence of serious chronic morbidity, Dr. Gibson said.
As the data address children diagnosed over 15 years ago, it is likely that improvements since then in determining patient risk and targeting therapy might result in further incremental improvements, he said in an interview.
By cancer type, severe health problems by 15 years after diagnosis decreased from 13% to 5% among survivors of Wilms’ tumor, from 18% to 11% among survivors of Hodgkin lymphoma, from 15% to 9% among survivors of astrocytoma, from 10% to 6% among survivors of non-Hodgkin lymphoma, and from 9% to 7% among survivors of acute lymphoblastic leukemia. The conclusions are based on the incidence of severe, disabling/life-threatening, or fatal chronic health conditions (Common Terminology Criteria for Adverse Events, grades 3-5) among 5-year survivors diagnosed prior to age 21 years from 1970 through 1999.
Adjusted for sex and attained age, significant reduction in risk over time was found among survivors of Wilms tumor (HR, 0.57 [95% CI, 0.46-0.70]), Hodgkin lymphoma (HR, 0.75 [95% CI, 0.65-0.85]), astrocytoma (HR, 0.77 [95% CI, 0.64-0.92]), non-Hodgkin lymphoma (HR, 0.79 [95% CI, 0.63-0.99]), and acute lymphoblastic leukemia (HR, 0.86 [95% CI, 0.76-0.98]).
The decreases in serious health conditions were largely driven by a reduced incidence of endocrine conditions (1970s: 4.0% vs. 1990s: 1.6%; HR, 0.66 [95% CI, 0.59-0.73]) and subsequent malignant neoplasms (1970s: 2.4% vs. 1990s: 1.6%; HR, 0.85 [95% CI, 0.76-0.96]).
Gastrointestinal (HR, 0.80 [95% CI, 0.66-0.97]) and neurological conditions (HR, 0.77 [95% CI, 0.65-0.91]) also were reduced, but cardiac and pulmonary conditions were not. Changes in childhood cancer treatment protocols have not only extended lifespan for many survivors, but also have reduced the incidence of serious chronic morbidity in this population, Dr. Gibson concluded.
[email protected]
On Twitter @maryjodales
AT ASCO 2017
Key clinical point:
Major finding: For all childhood cancer survivors, the 15-year cumulative incidence of severe health conditions decreased from 12.7% in those diagnosed in the 1970s, to 10.1% in the 1980s, and to 8.8% among those diagnosed in the 1990s (per 10 years: HR, 0.84 [95% CI, 0.80-0.89]).
Data source: An analysis of 23,600 participants in the Childhood Cancer Survivor Study.
Disclosures: The study was funded by the National Institutes of Health.
VIDEO: Low testosterone common after testicular cancer
CHICAGO – More than one-third of testicular cancer survivors have hypogonadism, according to an analysis of nearly 500 male patients conducted by the Platinum Study Group.
Lead author Mohammad Abu Zaid, MBBS, of Indiana University, Indianapolis, discusses the implications for long-term health, screening during follow-up, testing, and testosterone replacement therapy in a video interview at the annual meeting of the American Society of Clinical Oncology.
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 – More than one-third of testicular cancer survivors have hypogonadism, according to an analysis of nearly 500 male patients conducted by the Platinum Study Group.
Lead author Mohammad Abu Zaid, MBBS, of Indiana University, Indianapolis, discusses the implications for long-term health, screening during follow-up, testing, and testosterone replacement therapy in a video interview at the annual meeting of the American Society of Clinical Oncology.
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 – More than one-third of testicular cancer survivors have hypogonadism, according to an analysis of nearly 500 male patients conducted by the Platinum Study Group.
Lead author Mohammad Abu Zaid, MBBS, of Indiana University, Indianapolis, discusses the implications for long-term health, screening during follow-up, testing, and testosterone replacement therapy in a video interview at the annual meeting of the American Society of Clinical Oncology.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ASCO 2017
VIDEO: Single dose of RT suffices, but will radiation oncologists adopt the strategy?
CHICAGO – The randomized SCORAD III trial shows that a single 8-Gy dose of radiation therapy has efficacy similar to that of a 20-Gy dose given over the course of a week for treating metastatic spinal cord compression in patients with modest survival, first author Peter Hoskin, MD, FCRP, FRCR, said in a video interview at the annual meeting of the American Society of Clinical Oncology. But will radiation oncologists adopt this new strategy?
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 – The randomized SCORAD III trial shows that a single 8-Gy dose of radiation therapy has efficacy similar to that of a 20-Gy dose given over the course of a week for treating metastatic spinal cord compression in patients with modest survival, first author Peter Hoskin, MD, FCRP, FRCR, said in a video interview at the annual meeting of the American Society of Clinical Oncology. But will radiation oncologists adopt this new strategy?
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 – The randomized SCORAD III trial shows that a single 8-Gy dose of radiation therapy has efficacy similar to that of a 20-Gy dose given over the course of a week for treating metastatic spinal cord compression in patients with modest survival, first author Peter Hoskin, MD, FCRP, FRCR, said in a video interview at the annual meeting of the American Society of Clinical Oncology. But will radiation oncologists adopt this new strategy?
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ASCO 2017
