Hodgkin Lymphoma

Compared with standard psychosocial care, a one-on-one skills-based intervention improved psychosocial outcomes in adolescents and young adults with cancer, according to results of a pilot randomized study presented at the Palliative and Supportive Care in Oncology Symposium.

The novel intervention was associated with improved patient resilience, cancer-specific quality of life, and hope, plus fewer cases of depression, said lead study author Abby R. Rosenberg, MD, director of palliative care and resilience research at Seattle Children’s Research Institute.

Brief, developmentally-targeted psychosocial interventions are promising for this population of adolescents and young adults with cancer, Dr. Rosenberg said in a press conference at the symposium, which was cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

Adolescents and young adults with cancer tend to have poor psychosocial outcomes, possibly because they have not yet developed skills that would help them manage hardships they encounter as a result of having cancer, according to Dr. Rosenberg.

She and her colleagues previously designed and tested the intervention, called Promoting Resilience in Stress Management (PRISM). The intervention is brief and focuses on helping patients develop skills in stress management, goal setting, positive reframing, and benefit finding.

The clinical evaluation of PRISM presented at the symposium included 100 English-speaking patients aged 12-25 who had new or recently recurrent cancer. They were randomized to the skills-based intervention or standard psychosocial care.

In the PRISM group, the adolescents and young adults participated in four in-person one-on-one training sessions lasting 30-60 minutes, plus a facilitated family meeting. Patients were surveyed at baseline and again at 6 months to measure the impact of the intervention.

A total of 36 patients in the PRISM arm and 38 in the usual-care arm completed the study. Most attrition was due to medical complications or death, the investigators said.

Results showed that, compared with standard psychosocial care, the skills-based intervention was associated with significant improvements in resilience (+2.3; 95% confidence interval, 0.7-4.0), hope (+2.8; 95% CI, 0.5-5.1), quality of life (+6.3; 95% CI, –0.8-13.5), and a trend toward less distress (–1.6; 95% CI –3.3-0.0).

Fewer cases of depression occurred in the PRISM group compared with the standard care group (two versus eight cases), Dr. Rosenberg added.

The psychosocial toll of cancer can be significant, especially in a vulnerable population such as adolescents and young adults, according to Andrew S. Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York. “The intervention by Rosenberg and her coauthors represents an important beacon of hope for improving the cancer experience for this population,” Dr. Epstein said.

Compared with standard psychosocial care, a one-on-one skills-based intervention improved psychosocial outcomes in adolescents and young adults with cancer, according to results of a pilot randomized study presented at the Palliative and Supportive Care in Oncology Symposium.

The novel intervention was associated with improved patient resilience, cancer-specific quality of life, and hope, plus fewer cases of depression, said lead study author Abby R. Rosenberg, MD, director of palliative care and resilience research at Seattle Children’s Research Institute.

Brief, developmentally-targeted psychosocial interventions are promising for this population of adolescents and young adults with cancer, Dr. Rosenberg said in a press conference at the symposium, which was cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

Adolescents and young adults with cancer tend to have poor psychosocial outcomes, possibly because they have not yet developed skills that would help them manage hardships they encounter as a result of having cancer, according to Dr. Rosenberg.

She and her colleagues previously designed and tested the intervention, called Promoting Resilience in Stress Management (PRISM). The intervention is brief and focuses on helping patients develop skills in stress management, goal setting, positive reframing, and benefit finding.

The clinical evaluation of PRISM presented at the symposium included 100 English-speaking patients aged 12-25 who had new or recently recurrent cancer. They were randomized to the skills-based intervention or standard psychosocial care.

In the PRISM group, the adolescents and young adults participated in four in-person one-on-one training sessions lasting 30-60 minutes, plus a facilitated family meeting. Patients were surveyed at baseline and again at 6 months to measure the impact of the intervention.

A total of 36 patients in the PRISM arm and 38 in the usual-care arm completed the study. Most attrition was due to medical complications or death, the investigators said.

Results showed that, compared with standard psychosocial care, the skills-based intervention was associated with significant improvements in resilience (+2.3; 95% confidence interval, 0.7-4.0), hope (+2.8; 95% CI, 0.5-5.1), quality of life (+6.3; 95% CI, –0.8-13.5), and a trend toward less distress (–1.6; 95% CI –3.3-0.0).

Fewer cases of depression occurred in the PRISM group compared with the standard care group (two versus eight cases), Dr. Rosenberg added.

The psychosocial toll of cancer can be significant, especially in a vulnerable population such as adolescents and young adults, according to Andrew S. Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York. “The intervention by Rosenberg and her coauthors represents an important beacon of hope for improving the cancer experience for this population,” Dr. Epstein said.

Compared with standard psychosocial care, a one-on-one skills-based intervention improved psychosocial outcomes in adolescents and young adults with cancer, according to results of a pilot randomized study presented at the Palliative and Supportive Care in Oncology Symposium.

The novel intervention was associated with improved patient resilience, cancer-specific quality of life, and hope, plus fewer cases of depression, said lead study author Abby R. Rosenberg, MD, director of palliative care and resilience research at Seattle Children’s Research Institute.

Brief, developmentally-targeted psychosocial interventions are promising for this population of adolescents and young adults with cancer, Dr. Rosenberg said in a press conference at the symposium, which was cosponsored by AAHPM, ASCO, ASTRO, and MASCC.

Adolescents and young adults with cancer tend to have poor psychosocial outcomes, possibly because they have not yet developed skills that would help them manage hardships they encounter as a result of having cancer, according to Dr. Rosenberg.

She and her colleagues previously designed and tested the intervention, called Promoting Resilience in Stress Management (PRISM). The intervention is brief and focuses on helping patients develop skills in stress management, goal setting, positive reframing, and benefit finding.

The clinical evaluation of PRISM presented at the symposium included 100 English-speaking patients aged 12-25 who had new or recently recurrent cancer. They were randomized to the skills-based intervention or standard psychosocial care.

In the PRISM group, the adolescents and young adults participated in four in-person one-on-one training sessions lasting 30-60 minutes, plus a facilitated family meeting. Patients were surveyed at baseline and again at 6 months to measure the impact of the intervention.

A total of 36 patients in the PRISM arm and 38 in the usual-care arm completed the study. Most attrition was due to medical complications or death, the investigators said.

Results showed that, compared with standard psychosocial care, the skills-based intervention was associated with significant improvements in resilience (+2.3; 95% confidence interval, 0.7-4.0), hope (+2.8; 95% CI, 0.5-5.1), quality of life (+6.3; 95% CI, –0.8-13.5), and a trend toward less distress (–1.6; 95% CI –3.3-0.0).

Fewer cases of depression occurred in the PRISM group compared with the standard care group (two versus eight cases), Dr. Rosenberg added.

The psychosocial toll of cancer can be significant, especially in a vulnerable population such as adolescents and young adults, according to Andrew S. Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York. “The intervention by Rosenberg and her coauthors represents an important beacon of hope for improving the cancer experience for this population,” Dr. Epstein said.

Photo by Bill Branson

Survey results suggest childhood cancer survivors (CCSs) in the US are more likely than individuals without a history of cancer to experience “job lock,” or staying at a job to keep work-related health insurance.

CCSs are also more likely than individuals without a history of cancer to report problems paying medical bills and being denied health insurance.

Anne Kirchhoff, PhD, of Huntsman Cancer Institute at the University of Utah in Salt Lake City, and her colleagues reported these findings in JAMA Oncology.

The researchers analyzed 394 CCSs from pediatric oncology institutions across the US, along with 128 of their siblings who had no history of cancer. All study participants worked 35 hours or more per week.

The most common cancer diagnosis among CCSs was leukemia (35.4%), followed by Hodgkin lymphoma (14.9%). Most patients had undergone chemotherapy (77.2%), radiotherapy (63.9%), and surgery (81.1%).

Overall, sociodemographic and clinical characteristics were similar between CCSs and siblings. However, CCSs were more likely than siblings to have severe, disabling, or life-threatening chronic conditions—33.9% and 17.7%, respectively (P<0.001).

Most CCSs (88.0%) and siblings (88.5%) had employer-sponsored health insurance. Three percent of siblings and 5.3% of CCSs had individual insurance; 1.9% and 2.3%, respectively, had public insurance; and 6.7% and 4.4%, respectively, were uninsured.

Results

CCSs were more likely than siblings to report:

• Job lock—23.2% and 16.9%, respectively (P=0.16)
• Problems paying medical bills—20.1% and 12.9%, respectively (P=0.09)
• Denial of health insurance—13.4% and 1.8%, respectively (P<0.001).

In a multivariable analysis, insurance denial remained significantly more common among CCSs than siblings (relative risk [RR]=7.38).

In another multivariable analysis, 38% of CCSs with a previous insurance denial reported job lock, compared with 20% of those who never experienced insurance denial (RR=1.60). And 44% of CCSs who reported problems paying their medical bills also reported job lock, compared to 16% of those who had no problems paying medical bills (RR=2.43).

The researchers also found that female CCSs (RR=1.70) and CCSs with severe, disabling, or life-threatening chronic conditions (RR=1.72) were more likely to report job lock.

“This information gives us a feel for high-risk groups of survivors who may need more information about insurance,” Dr Kirchhoff said. “Many people experience a gap in education and literacy around insurance, and it’s important for people to understand their options—even those who are employed and consistently had access to insurance through work. We want to know what their concerns are so we can help patients and survivors. Getting healthcare should not be a worry for cancer survivors.”

“Survivors have been through a lot when they were younger and understand the importance of making sure they can get healthcare when they need it. I think a lot of them also saw what their parents and families went through in terms of the financial stress and burden of dealing with a health crisis. So they’re just primed to understand the importance of health insurance.”

Dr Kirchhoff noted that this study was conducted as the Affordable Care Act was rolling out. Therefore, she would like to do a follow-up study to see if the insurance exchanges and Medicaid expansion lessened job-related insurance worries.

Photo by Bill Branson

Survey results suggest childhood cancer survivors (CCSs) in the US are more likely than individuals without a history of cancer to experience “job lock,” or staying at a job to keep work-related health insurance.

CCSs are also more likely than individuals without a history of cancer to report problems paying medical bills and being denied health insurance.

Anne Kirchhoff, PhD, of Huntsman Cancer Institute at the University of Utah in Salt Lake City, and her colleagues reported these findings in JAMA Oncology.

The researchers analyzed 394 CCSs from pediatric oncology institutions across the US, along with 128 of their siblings who had no history of cancer. All study participants worked 35 hours or more per week.

The most common cancer diagnosis among CCSs was leukemia (35.4%), followed by Hodgkin lymphoma (14.9%). Most patients had undergone chemotherapy (77.2%), radiotherapy (63.9%), and surgery (81.1%).

Overall, sociodemographic and clinical characteristics were similar between CCSs and siblings. However, CCSs were more likely than siblings to have severe, disabling, or life-threatening chronic conditions—33.9% and 17.7%, respectively (P<0.001).

Most CCSs (88.0%) and siblings (88.5%) had employer-sponsored health insurance. Three percent of siblings and 5.3% of CCSs had individual insurance; 1.9% and 2.3%, respectively, had public insurance; and 6.7% and 4.4%, respectively, were uninsured.

Results

CCSs were more likely than siblings to report:

• Job lock—23.2% and 16.9%, respectively (P=0.16)
• Problems paying medical bills—20.1% and 12.9%, respectively (P=0.09)
• Denial of health insurance—13.4% and 1.8%, respectively (P<0.001).

In a multivariable analysis, insurance denial remained significantly more common among CCSs than siblings (relative risk [RR]=7.38).

In another multivariable analysis, 38% of CCSs with a previous insurance denial reported job lock, compared with 20% of those who never experienced insurance denial (RR=1.60). And 44% of CCSs who reported problems paying their medical bills also reported job lock, compared to 16% of those who had no problems paying medical bills (RR=2.43).

The researchers also found that female CCSs (RR=1.70) and CCSs with severe, disabling, or life-threatening chronic conditions (RR=1.72) were more likely to report job lock.

“This information gives us a feel for high-risk groups of survivors who may need more information about insurance,” Dr Kirchhoff said. “Many people experience a gap in education and literacy around insurance, and it’s important for people to understand their options—even those who are employed and consistently had access to insurance through work. We want to know what their concerns are so we can help patients and survivors. Getting healthcare should not be a worry for cancer survivors.”

“Survivors have been through a lot when they were younger and understand the importance of making sure they can get healthcare when they need it. I think a lot of them also saw what their parents and families went through in terms of the financial stress and burden of dealing with a health crisis. So they’re just primed to understand the importance of health insurance.”

Dr Kirchhoff noted that this study was conducted as the Affordable Care Act was rolling out. Therefore, she would like to do a follow-up study to see if the insurance exchanges and Medicaid expansion lessened job-related insurance worries.

Photo by Bill Branson

Survey results suggest childhood cancer survivors (CCSs) in the US are more likely than individuals without a history of cancer to experience “job lock,” or staying at a job to keep work-related health insurance.

CCSs are also more likely than individuals without a history of cancer to report problems paying medical bills and being denied health insurance.

Anne Kirchhoff, PhD, of Huntsman Cancer Institute at the University of Utah in Salt Lake City, and her colleagues reported these findings in JAMA Oncology.

The researchers analyzed 394 CCSs from pediatric oncology institutions across the US, along with 128 of their siblings who had no history of cancer. All study participants worked 35 hours or more per week.

The most common cancer diagnosis among CCSs was leukemia (35.4%), followed by Hodgkin lymphoma (14.9%). Most patients had undergone chemotherapy (77.2%), radiotherapy (63.9%), and surgery (81.1%).

Overall, sociodemographic and clinical characteristics were similar between CCSs and siblings. However, CCSs were more likely than siblings to have severe, disabling, or life-threatening chronic conditions—33.9% and 17.7%, respectively (P<0.001).

Most CCSs (88.0%) and siblings (88.5%) had employer-sponsored health insurance. Three percent of siblings and 5.3% of CCSs had individual insurance; 1.9% and 2.3%, respectively, had public insurance; and 6.7% and 4.4%, respectively, were uninsured.

Results

CCSs were more likely than siblings to report:

• Job lock—23.2% and 16.9%, respectively (P=0.16)
• Problems paying medical bills—20.1% and 12.9%, respectively (P=0.09)
• Denial of health insurance—13.4% and 1.8%, respectively (P<0.001).

In a multivariable analysis, insurance denial remained significantly more common among CCSs than siblings (relative risk [RR]=7.38).

In another multivariable analysis, 38% of CCSs with a previous insurance denial reported job lock, compared with 20% of those who never experienced insurance denial (RR=1.60). And 44% of CCSs who reported problems paying their medical bills also reported job lock, compared to 16% of those who had no problems paying medical bills (RR=2.43).

The researchers also found that female CCSs (RR=1.70) and CCSs with severe, disabling, or life-threatening chronic conditions (RR=1.72) were more likely to report job lock.

“This information gives us a feel for high-risk groups of survivors who may need more information about insurance,” Dr Kirchhoff said. “Many people experience a gap in education and literacy around insurance, and it’s important for people to understand their options—even those who are employed and consistently had access to insurance through work. We want to know what their concerns are so we can help patients and survivors. Getting healthcare should not be a worry for cancer survivors.”

“Survivors have been through a lot when they were younger and understand the importance of making sure they can get healthcare when they need it. I think a lot of them also saw what their parents and families went through in terms of the financial stress and burden of dealing with a health crisis. So they’re just primed to understand the importance of health insurance.”

Dr Kirchhoff noted that this study was conducted as the Affordable Care Act was rolling out. Therefore, she would like to do a follow-up study to see if the insurance exchanges and Medicaid expansion lessened job-related insurance worries.

Photo by Rhoda Baer

Countries with the lowest opportunities for natural selection have higher cancer rates than countries with the highest opportunities for natural selection, according to a study published in Evolutionary Applications.

Researchers said this is because modern medicine is enabling people to survive cancers, and their genetic backgrounds are passing from one generation to the next.

The team said the rate of some cancers has doubled and even quadrupled over the past 100 to 150 years, and human evolution has moved away from “survival of the fittest.”

“Modern medicine has enabled the human species to live much longer than would otherwise be expected in the natural world,” said study author Maciej Henneberg, PhD, DSc, of the University of Adelaide in South Australia.

“Besides the obvious benefits that modern medicine gives, it also brings with it an unexpected side-effect—allowing genetic material to be passed from one generation to the next that predisposes people to have poor health, such as type 1 diabetes or cancer.”

“Because of the quality of our healthcare in western society, we have almost removed natural selection as the ‘janitor of the gene pool.’ Unfortunately, the accumulation of genetic mutations over time and across multiple generations is like a delayed death sentence.”

Country comparison

The researchers studied global cancer data from the World Health Organization as well as other health and socioeconomic data from the United Nations and the World Bank of 173 countries. The team compared the top 10 countries with the highest opportunities for natural selection to the 10 countries with the lowest opportunities for natural selection.

“We looked at countries that offered the greatest opportunity to survive cancer compared with those that didn’t,” said study author Wenpeng You, a PhD student at the University of Adelaide. “This does not only take into account factors such as socioeconomic status, urbanization, and quality of medical services but also low mortality and fertility rates, which are the 2 distinguishing features in the ‘better’ world.”

“Countries with low mortality rates may allow more people with cancer genetic background to reproduce and pass cancer genes/mutations to the next generation. Meanwhile, low fertility rates in these countries may not be able to have diverse biological variations to provide the opportunity for selecting a naturally fit population—for example, people without or with less cancer genetic background. Low mortality rate and low fertility rate in the ‘better’ world may have formed a self-reinforcing cycle which has accumulated cancer genetic background at a greater rate than previously thought.”

Based on the researchers’ analysis, the 20 countries are:

Cancer incidence

The researchers found the rates of most cancers were higher in the 10 countries with the lowest opportunities for natural selection. The incidence of all cancers was 2.326 times higher in the low-opportunity countries than the high-opportunity ones.

The increased incidences of hematologic malignancies were as follows:

• Non-Hodgkin lymphoma—2.019 times higher in the low-opportunity countries
• Hodgkin lymphoma—3.314 times higher in the low-opportunity countries
• Leukemia—3.574 times higher in the low-opportunity countries
• Multiple myeloma—4.257 times higher in the low-opportunity countries .

Dr Henneberg said that, having removed natural selection as the “janitor of the gene pool,” our modern society is faced with a controversial issue.

“It may be that the only way humankind can be rid of cancer once and for all is through genetic engineering—to repair our genes and take cancer out of the equation,” he said.

Photo by Rhoda Baer

Countries with the lowest opportunities for natural selection have higher cancer rates than countries with the highest opportunities for natural selection, according to a study published in Evolutionary Applications.

Researchers said this is because modern medicine is enabling people to survive cancers, and their genetic backgrounds are passing from one generation to the next.

The team said the rate of some cancers has doubled and even quadrupled over the past 100 to 150 years, and human evolution has moved away from “survival of the fittest.”

“Modern medicine has enabled the human species to live much longer than would otherwise be expected in the natural world,” said study author Maciej Henneberg, PhD, DSc, of the University of Adelaide in South Australia.

“Besides the obvious benefits that modern medicine gives, it also brings with it an unexpected side-effect—allowing genetic material to be passed from one generation to the next that predisposes people to have poor health, such as type 1 diabetes or cancer.”

“Because of the quality of our healthcare in western society, we have almost removed natural selection as the ‘janitor of the gene pool.’ Unfortunately, the accumulation of genetic mutations over time and across multiple generations is like a delayed death sentence.”

Country comparison

The researchers studied global cancer data from the World Health Organization as well as other health and socioeconomic data from the United Nations and the World Bank of 173 countries. The team compared the top 10 countries with the highest opportunities for natural selection to the 10 countries with the lowest opportunities for natural selection.

“We looked at countries that offered the greatest opportunity to survive cancer compared with those that didn’t,” said study author Wenpeng You, a PhD student at the University of Adelaide. “This does not only take into account factors such as socioeconomic status, urbanization, and quality of medical services but also low mortality and fertility rates, which are the 2 distinguishing features in the ‘better’ world.”

“Countries with low mortality rates may allow more people with cancer genetic background to reproduce and pass cancer genes/mutations to the next generation. Meanwhile, low fertility rates in these countries may not be able to have diverse biological variations to provide the opportunity for selecting a naturally fit population—for example, people without or with less cancer genetic background. Low mortality rate and low fertility rate in the ‘better’ world may have formed a self-reinforcing cycle which has accumulated cancer genetic background at a greater rate than previously thought.”

Based on the researchers’ analysis, the 20 countries are:

Cancer incidence

The researchers found the rates of most cancers were higher in the 10 countries with the lowest opportunities for natural selection. The incidence of all cancers was 2.326 times higher in the low-opportunity countries than the high-opportunity ones.

The increased incidences of hematologic malignancies were as follows:

• Non-Hodgkin lymphoma—2.019 times higher in the low-opportunity countries
• Hodgkin lymphoma—3.314 times higher in the low-opportunity countries
• Leukemia—3.574 times higher in the low-opportunity countries
• Multiple myeloma—4.257 times higher in the low-opportunity countries .

Dr Henneberg said that, having removed natural selection as the “janitor of the gene pool,” our modern society is faced with a controversial issue.

“It may be that the only way humankind can be rid of cancer once and for all is through genetic engineering—to repair our genes and take cancer out of the equation,” he said.

Photo by Rhoda Baer

Countries with the lowest opportunities for natural selection have higher cancer rates than countries with the highest opportunities for natural selection, according to a study published in Evolutionary Applications.

Researchers said this is because modern medicine is enabling people to survive cancers, and their genetic backgrounds are passing from one generation to the next.

The team said the rate of some cancers has doubled and even quadrupled over the past 100 to 150 years, and human evolution has moved away from “survival of the fittest.”

“Modern medicine has enabled the human species to live much longer than would otherwise be expected in the natural world,” said study author Maciej Henneberg, PhD, DSc, of the University of Adelaide in South Australia.

“Besides the obvious benefits that modern medicine gives, it also brings with it an unexpected side-effect—allowing genetic material to be passed from one generation to the next that predisposes people to have poor health, such as type 1 diabetes or cancer.”

“Because of the quality of our healthcare in western society, we have almost removed natural selection as the ‘janitor of the gene pool.’ Unfortunately, the accumulation of genetic mutations over time and across multiple generations is like a delayed death sentence.”

Country comparison

The researchers studied global cancer data from the World Health Organization as well as other health and socioeconomic data from the United Nations and the World Bank of 173 countries. The team compared the top 10 countries with the highest opportunities for natural selection to the 10 countries with the lowest opportunities for natural selection.

“We looked at countries that offered the greatest opportunity to survive cancer compared with those that didn’t,” said study author Wenpeng You, a PhD student at the University of Adelaide. “This does not only take into account factors such as socioeconomic status, urbanization, and quality of medical services but also low mortality and fertility rates, which are the 2 distinguishing features in the ‘better’ world.”

“Countries with low mortality rates may allow more people with cancer genetic background to reproduce and pass cancer genes/mutations to the next generation. Meanwhile, low fertility rates in these countries may not be able to have diverse biological variations to provide the opportunity for selecting a naturally fit population—for example, people without or with less cancer genetic background. Low mortality rate and low fertility rate in the ‘better’ world may have formed a self-reinforcing cycle which has accumulated cancer genetic background at a greater rate than previously thought.”

Based on the researchers’ analysis, the 20 countries are:

Cancer incidence

The researchers found the rates of most cancers were higher in the 10 countries with the lowest opportunities for natural selection. The incidence of all cancers was 2.326 times higher in the low-opportunity countries than the high-opportunity ones.

The increased incidences of hematologic malignancies were as follows:

• Non-Hodgkin lymphoma—2.019 times higher in the low-opportunity countries
• Hodgkin lymphoma—3.314 times higher in the low-opportunity countries
• Leukemia—3.574 times higher in the low-opportunity countries
• Multiple myeloma—4.257 times higher in the low-opportunity countries .

Dr Henneberg said that, having removed natural selection as the “janitor of the gene pool,” our modern society is faced with a controversial issue.

“It may be that the only way humankind can be rid of cancer once and for all is through genetic engineering—to repair our genes and take cancer out of the equation,” he said.

Photo by Rhoda Baer

The National Comprehensive Cancer Network® (NCCN) has announced the release of the newly completed NCCN Radiation Therapy Compendium™.

This resource includes information designed to support clinical decision-making regarding the use of radiation therapy in cancer patients.

The content is based on the NCCN Clinical Practice Guidelines in Oncology and includes information from the 41 guidelines that reference radiation therapy.

“By compiling every recommendation for radiation therapy in one place, we’ve made it significantly easier for specialists . . .  to stay up-to-date on the very latest recommendations, regardless of how many different cancer types they treat,” said Robert W. Carlson, MD, chief executive officer of NCCN.

“This targeted content provides radiation oncologists with the specific, cutting-edge information they need, without forcing them to sift through any extraneous information. It’s part of our ongoing effort to always provide the most pertinent data on emerging treatment practices in the clearest, most efficient way possible.”

The NCCN Radiation Therapy Compendium includes a full complement of radiation therapy recommendations found in the current NCCN guidelines, including specific treatment modalities such as 2D/3D conformal external beam radiation therapy, intensity modulated radiation therapy, intra-operative radiation therapy, stereotactic radiosurgery/stereotactic body radiotherapy/stereotactic ablative body radiotherapy, image-guided radiation therapy, low dose-rate/high dose-rate brachytherapy, radioisotope, and particle therapy.

NCCN first announced the launch of the Radiation Therapy Compendium in March at the NCCN Annual Conference: Improving the Quality, Effectiveness, and Efficiency of Cancer Care.

At the time, the NCCN released a preliminary version of the compendium featuring 24 cancer types. The newly completed version now contains all 41 disease sites that are currently being treated using radiation therapy.

The compendium will be updated on a continual basis in conjunction with the library of clinical guidelines.

For more information and to access the NCCN Radiation Therapy Compendium, visit NCCN.org/RTCompendium. The compendium is available free-of-charge through March 2018.

Photo by Rhoda Baer

The National Comprehensive Cancer Network® (NCCN) has announced the release of the newly completed NCCN Radiation Therapy Compendium™.

This resource includes information designed to support clinical decision-making regarding the use of radiation therapy in cancer patients.

The content is based on the NCCN Clinical Practice Guidelines in Oncology and includes information from the 41 guidelines that reference radiation therapy.

“By compiling every recommendation for radiation therapy in one place, we’ve made it significantly easier for specialists . . .  to stay up-to-date on the very latest recommendations, regardless of how many different cancer types they treat,” said Robert W. Carlson, MD, chief executive officer of NCCN.

“This targeted content provides radiation oncologists with the specific, cutting-edge information they need, without forcing them to sift through any extraneous information. It’s part of our ongoing effort to always provide the most pertinent data on emerging treatment practices in the clearest, most efficient way possible.”

The NCCN Radiation Therapy Compendium includes a full complement of radiation therapy recommendations found in the current NCCN guidelines, including specific treatment modalities such as 2D/3D conformal external beam radiation therapy, intensity modulated radiation therapy, intra-operative radiation therapy, stereotactic radiosurgery/stereotactic body radiotherapy/stereotactic ablative body radiotherapy, image-guided radiation therapy, low dose-rate/high dose-rate brachytherapy, radioisotope, and particle therapy.

NCCN first announced the launch of the Radiation Therapy Compendium in March at the NCCN Annual Conference: Improving the Quality, Effectiveness, and Efficiency of Cancer Care.

At the time, the NCCN released a preliminary version of the compendium featuring 24 cancer types. The newly completed version now contains all 41 disease sites that are currently being treated using radiation therapy.

The compendium will be updated on a continual basis in conjunction with the library of clinical guidelines.

For more information and to access the NCCN Radiation Therapy Compendium, visit NCCN.org/RTCompendium. The compendium is available free-of-charge through March 2018.

Photo by Rhoda Baer

The National Comprehensive Cancer Network® (NCCN) has announced the release of the newly completed NCCN Radiation Therapy Compendium™.

This resource includes information designed to support clinical decision-making regarding the use of radiation therapy in cancer patients.

The content is based on the NCCN Clinical Practice Guidelines in Oncology and includes information from the 41 guidelines that reference radiation therapy.

“By compiling every recommendation for radiation therapy in one place, we’ve made it significantly easier for specialists . . .  to stay up-to-date on the very latest recommendations, regardless of how many different cancer types they treat,” said Robert W. Carlson, MD, chief executive officer of NCCN.

“This targeted content provides radiation oncologists with the specific, cutting-edge information they need, without forcing them to sift through any extraneous information. It’s part of our ongoing effort to always provide the most pertinent data on emerging treatment practices in the clearest, most efficient way possible.”

The NCCN Radiation Therapy Compendium includes a full complement of radiation therapy recommendations found in the current NCCN guidelines, including specific treatment modalities such as 2D/3D conformal external beam radiation therapy, intensity modulated radiation therapy, intra-operative radiation therapy, stereotactic radiosurgery/stereotactic body radiotherapy/stereotactic ablative body radiotherapy, image-guided radiation therapy, low dose-rate/high dose-rate brachytherapy, radioisotope, and particle therapy.

NCCN first announced the launch of the Radiation Therapy Compendium in March at the NCCN Annual Conference: Improving the Quality, Effectiveness, and Efficiency of Cancer Care.

At the time, the NCCN released a preliminary version of the compendium featuring 24 cancer types. The newly completed version now contains all 41 disease sites that are currently being treated using radiation therapy.

The compendium will be updated on a continual basis in conjunction with the library of clinical guidelines.

For more information and to access the NCCN Radiation Therapy Compendium, visit NCCN.org/RTCompendium. The compendium is available free-of-charge through March 2018.

Photo by Bill Branson

A study of cancer drugs approved by the European Commission from 2009 to 2013 showed that few hematology drugs were known to provide a benefit in overall survival (OS) or quality of life (QOL) over existing treatments.

Of 12 drugs approved for 17 hematology indications, 3 drugs had been shown to provide a benefit in OS (for 3 indications) at the time of approval.

None of the other hematology drugs were known to provide an OS benefit even after a median follow-up of 5.4 years.

Two hematology drugs were shown to provide a benefit in QOL (for 2 indications) after approval, but none of the drugs were known to provide a QOL benefit at the time of approval.

These findings were published in The BMJ alongside a related editorial, feature article, and patient commentary.

All cancer drugs

Researchers analyzed reports on all cancer drug approvals by the European Commission from 2009 to 2013.

There were 48 drugs approved for 68 cancer indications during this period. Fifty-one of the indications were for solid tumor malignancies, and 17 were for hematologic malignancies.

For 24 indications (35%), research had demonstrated a significant improvement in OS at the time of the drugs’ approval. For 3 indications, an improvement in OS was demonstrated after approval.

There was a known improvement in QOL for 7 of the indications (10%) at the time of approval and for 5 indications after approval.

The median follow-up was 5.4 years (range, 3.3 years to 8.1 years).

Overall, there was a significant improvement in OS or QOL during the study period for 51% of the indications (35/68). For the other half (49%, n=33), it wasn’t clear if the drugs provide any benefits in OS or QOL.

All cancer trials

The 68 approvals of cancer drugs were supported by 72 clinical trials.

Sixty approvals (88%) were supported by at least 1 randomized, controlled trial. Eight approvals (12%) were based on a single-arm study. This included 6 of 10 conditional marketing authorizations and 2 of 58 regular marketing authorizations.

Eighteen of the approvals (26%) were supported by a pivotal study powered to evaluate OS as the primary endpoint. And 37 of the approvals (54%) had a supporting pivotal trial evaluating QOL, but results were not reported for 2 of these trials.

Hematology trials and drugs

Of the 12 drugs approved for 17 hematology indications, 4 were regular approvals, 5 were conditional approvals, and 8 had orphan drug designation.

The approvals were supported by data from 18 trials—13 randomized and 5 single-arm trials.

The study drug was compared to an active comparator in 9 of the trials. The drug was evaluated as an add-on treatment in 4 trials. And the drug was not compared to anything in 5 trials (the single-arm trials).

OS was the primary endpoint in 1 of the trials, and 17 trials had OS or QOL as a secondary endpoint.

There were 3 drugs that had demonstrated an OS benefit at the time of approval but no QOL benefit at any time:

• Decitabine used for first-line treatment of acute myeloid leukemia in adults 65 and older who are ineligible for chemotherapy
• Pomalidomide in combination with dexamethasone as third-line therapy for relapsed/refractory multiple myeloma (MM)
• Rituximab plus chemotherapy for first-line treatment of chronic lymphocytic leukemia (CLL).

There were 2 drugs that had demonstrated a QOL benefit, only after approval, but they were not known to provide an OS benefit at any time:

• Nilotinib as a treatment for adults with newly diagnosed, chronic phase, Ph+ chronic myeloid leukemia (CML)
• Ofatumumab for CLL that is refractory to fludarabine and alemtuzumab

For the remaining drugs, there was no evidence of an OS or QOL benefit at any time during the period studied. The drugs included:

• Bortezomib given alone or in combination with doxorubicin or dexamethasone as second-line therapy for MM patients ineligible for hematopoietic stem cell transplant (HSCT)
• Bortezomib plus dexamethasone with or without thalidomide as first-line therapy in MM patients eligible for HSCT
• Bosutinib as second- or third-line treatment of Ph+ CML (any phase)
• Brentuximab vedotin for relapsed or refractory systemic anaplastic large-cell lymphoma
• Brentuximab vedotin for relapsed or refractory, CD30+ Hodgkin lymphoma after autologous HSCT or as third-line treatment for patients ineligible for autologous HSCT
• Dasatinib for first-line treatment of chronic phase, Ph+ CML
• Pixantrone for multiply relapsed or refractory B-cell non-Hodgkin lymphoma
• Ponatinib for patients with Ph+ acute lymphoblastic leukemia who are ineligible for imatinib or have disease that is resistant or intolerant to dasatinib or characterized by T315I mutation
• Ponatinib for patients with any phase of CML who are ineligible for imatinib or have disease that is resistant or intolerant to dasatinib/nilotinib or characterized by T315I mutation
• Rituximab as maintenance after induction for patients with follicular lymphoma
• Rituximab plus chemotherapy for relapsed or refractory CLL
• Temsirolimus for relapsed or refractory mantle cell lymphoma.
  

Photo by Bill Branson

A study of cancer drugs approved by the European Commission from 2009 to 2013 showed that few hematology drugs were known to provide a benefit in overall survival (OS) or quality of life (QOL) over existing treatments.

Of 12 drugs approved for 17 hematology indications, 3 drugs had been shown to provide a benefit in OS (for 3 indications) at the time of approval.

None of the other hematology drugs were known to provide an OS benefit even after a median follow-up of 5.4 years.

Two hematology drugs were shown to provide a benefit in QOL (for 2 indications) after approval, but none of the drugs were known to provide a QOL benefit at the time of approval.

These findings were published in The BMJ alongside a related editorial, feature article, and patient commentary.

All cancer drugs

Researchers analyzed reports on all cancer drug approvals by the European Commission from 2009 to 2013.

There were 48 drugs approved for 68 cancer indications during this period. Fifty-one of the indications were for solid tumor malignancies, and 17 were for hematologic malignancies.

For 24 indications (35%), research had demonstrated a significant improvement in OS at the time of the drugs’ approval. For 3 indications, an improvement in OS was demonstrated after approval.

There was a known improvement in QOL for 7 of the indications (10%) at the time of approval and for 5 indications after approval.

The median follow-up was 5.4 years (range, 3.3 years to 8.1 years).

Overall, there was a significant improvement in OS or QOL during the study period for 51% of the indications (35/68). For the other half (49%, n=33), it wasn’t clear if the drugs provide any benefits in OS or QOL.

All cancer trials

The 68 approvals of cancer drugs were supported by 72 clinical trials.

Sixty approvals (88%) were supported by at least 1 randomized, controlled trial. Eight approvals (12%) were based on a single-arm study. This included 6 of 10 conditional marketing authorizations and 2 of 58 regular marketing authorizations.

Eighteen of the approvals (26%) were supported by a pivotal study powered to evaluate OS as the primary endpoint. And 37 of the approvals (54%) had a supporting pivotal trial evaluating QOL, but results were not reported for 2 of these trials.

Hematology trials and drugs

Of the 12 drugs approved for 17 hematology indications, 4 were regular approvals, 5 were conditional approvals, and 8 had orphan drug designation.

The approvals were supported by data from 18 trials—13 randomized and 5 single-arm trials.

The study drug was compared to an active comparator in 9 of the trials. The drug was evaluated as an add-on treatment in 4 trials. And the drug was not compared to anything in 5 trials (the single-arm trials).

OS was the primary endpoint in 1 of the trials, and 17 trials had OS or QOL as a secondary endpoint.

There were 3 drugs that had demonstrated an OS benefit at the time of approval but no QOL benefit at any time:

• Decitabine used for first-line treatment of acute myeloid leukemia in adults 65 and older who are ineligible for chemotherapy
• Pomalidomide in combination with dexamethasone as third-line therapy for relapsed/refractory multiple myeloma (MM)
• Rituximab plus chemotherapy for first-line treatment of chronic lymphocytic leukemia (CLL).

There were 2 drugs that had demonstrated a QOL benefit, only after approval, but they were not known to provide an OS benefit at any time:

• Nilotinib as a treatment for adults with newly diagnosed, chronic phase, Ph+ chronic myeloid leukemia (CML)
• Ofatumumab for CLL that is refractory to fludarabine and alemtuzumab

For the remaining drugs, there was no evidence of an OS or QOL benefit at any time during the period studied. The drugs included:

• Bortezomib given alone or in combination with doxorubicin or dexamethasone as second-line therapy for MM patients ineligible for hematopoietic stem cell transplant (HSCT)
• Bortezomib plus dexamethasone with or without thalidomide as first-line therapy in MM patients eligible for HSCT
• Bosutinib as second- or third-line treatment of Ph+ CML (any phase)
• Brentuximab vedotin for relapsed or refractory systemic anaplastic large-cell lymphoma
• Brentuximab vedotin for relapsed or refractory, CD30+ Hodgkin lymphoma after autologous HSCT or as third-line treatment for patients ineligible for autologous HSCT
• Dasatinib for first-line treatment of chronic phase, Ph+ CML
• Pixantrone for multiply relapsed or refractory B-cell non-Hodgkin lymphoma
• Ponatinib for patients with Ph+ acute lymphoblastic leukemia who are ineligible for imatinib or have disease that is resistant or intolerant to dasatinib or characterized by T315I mutation
• Ponatinib for patients with any phase of CML who are ineligible for imatinib or have disease that is resistant or intolerant to dasatinib/nilotinib or characterized by T315I mutation
• Rituximab as maintenance after induction for patients with follicular lymphoma
• Rituximab plus chemotherapy for relapsed or refractory CLL
• Temsirolimus for relapsed or refractory mantle cell lymphoma.
  

Photo by Bill Branson

A study of cancer drugs approved by the European Commission from 2009 to 2013 showed that few hematology drugs were known to provide a benefit in overall survival (OS) or quality of life (QOL) over existing treatments.

Of 12 drugs approved for 17 hematology indications, 3 drugs had been shown to provide a benefit in OS (for 3 indications) at the time of approval.

None of the other hematology drugs were known to provide an OS benefit even after a median follow-up of 5.4 years.

Two hematology drugs were shown to provide a benefit in QOL (for 2 indications) after approval, but none of the drugs were known to provide a QOL benefit at the time of approval.

These findings were published in The BMJ alongside a related editorial, feature article, and patient commentary.

All cancer drugs

Researchers analyzed reports on all cancer drug approvals by the European Commission from 2009 to 2013.

There were 48 drugs approved for 68 cancer indications during this period. Fifty-one of the indications were for solid tumor malignancies, and 17 were for hematologic malignancies.

For 24 indications (35%), research had demonstrated a significant improvement in OS at the time of the drugs’ approval. For 3 indications, an improvement in OS was demonstrated after approval.

There was a known improvement in QOL for 7 of the indications (10%) at the time of approval and for 5 indications after approval.

The median follow-up was 5.4 years (range, 3.3 years to 8.1 years).

Overall, there was a significant improvement in OS or QOL during the study period for 51% of the indications (35/68). For the other half (49%, n=33), it wasn’t clear if the drugs provide any benefits in OS or QOL.

All cancer trials

The 68 approvals of cancer drugs were supported by 72 clinical trials.

Sixty approvals (88%) were supported by at least 1 randomized, controlled trial. Eight approvals (12%) were based on a single-arm study. This included 6 of 10 conditional marketing authorizations and 2 of 58 regular marketing authorizations.

Eighteen of the approvals (26%) were supported by a pivotal study powered to evaluate OS as the primary endpoint. And 37 of the approvals (54%) had a supporting pivotal trial evaluating QOL, but results were not reported for 2 of these trials.

Hematology trials and drugs

Of the 12 drugs approved for 17 hematology indications, 4 were regular approvals, 5 were conditional approvals, and 8 had orphan drug designation.

The approvals were supported by data from 18 trials—13 randomized and 5 single-arm trials.

The study drug was compared to an active comparator in 9 of the trials. The drug was evaluated as an add-on treatment in 4 trials. And the drug was not compared to anything in 5 trials (the single-arm trials).

OS was the primary endpoint in 1 of the trials, and 17 trials had OS or QOL as a secondary endpoint.

There were 3 drugs that had demonstrated an OS benefit at the time of approval but no QOL benefit at any time:

• Decitabine used for first-line treatment of acute myeloid leukemia in adults 65 and older who are ineligible for chemotherapy
• Pomalidomide in combination with dexamethasone as third-line therapy for relapsed/refractory multiple myeloma (MM)
• Rituximab plus chemotherapy for first-line treatment of chronic lymphocytic leukemia (CLL).

There were 2 drugs that had demonstrated a QOL benefit, only after approval, but they were not known to provide an OS benefit at any time:

• Nilotinib as a treatment for adults with newly diagnosed, chronic phase, Ph+ chronic myeloid leukemia (CML)
• Ofatumumab for CLL that is refractory to fludarabine and alemtuzumab

For the remaining drugs, there was no evidence of an OS or QOL benefit at any time during the period studied. The drugs included:

• Bortezomib given alone or in combination with doxorubicin or dexamethasone as second-line therapy for MM patients ineligible for hematopoietic stem cell transplant (HSCT)
• Bortezomib plus dexamethasone with or without thalidomide as first-line therapy in MM patients eligible for HSCT
• Bosutinib as second- or third-line treatment of Ph+ CML (any phase)
• Brentuximab vedotin for relapsed or refractory systemic anaplastic large-cell lymphoma
• Brentuximab vedotin for relapsed or refractory, CD30+ Hodgkin lymphoma after autologous HSCT or as third-line treatment for patients ineligible for autologous HSCT
• Dasatinib for first-line treatment of chronic phase, Ph+ CML
• Pixantrone for multiply relapsed or refractory B-cell non-Hodgkin lymphoma
• Ponatinib for patients with Ph+ acute lymphoblastic leukemia who are ineligible for imatinib or have disease that is resistant or intolerant to dasatinib or characterized by T315I mutation
• Ponatinib for patients with any phase of CML who are ineligible for imatinib or have disease that is resistant or intolerant to dasatinib/nilotinib or characterized by T315I mutation
• Rituximab as maintenance after induction for patients with follicular lymphoma
• Rituximab plus chemotherapy for relapsed or refractory CLL
• Temsirolimus for relapsed or refractory mantle cell lymphoma.
  

Research Hospital

New research suggests sperm banking may be underutilized by adolescent and young adult males with cancer who are at risk of infertility.

However, the study also showed that patients were more likely to attempt sperm banking if they were physically mature, met with fertility specialists, or their parents recommended sperm banking.

These findings were published in the Journal of Clinical Oncology.

“Research has found that the majority of males who survive childhood cancer desire biological children,” said study author James Klosky, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“Fertility preservation is also associated with a variety of benefits for survivors, including increased optimism about the future. While sperm banking is not for everyone, it is an effective method for preserving male fertility. Yet this study shows that sperm banking remains underutilized by at-risk patients with cancer.”

Dr Klosky and his colleagues surveyed 146 young males with cancer who were at risk of infertility. The researchers also surveyed 144 parents or guardians and 52 oncologists and other healthcare providers.

The patients’ mean age was 16.49 (range, 13.0-21.99). Diagnoses included leukemia and lymphoma (56.2%), solid tumor malignancies (37.7%), and brain tumors (6.2%).

Slightly more than half of the patients (53.4%, n=78) attempted sperm banking prior to starting treatment. Sixty-two, or 82.1%, of those who attempted sperm banking were successful.

In all, 43.8% of the patients successfully banked sperm.

Of the 68 patients who did not attempt sperm banking, 29 reported discussing the option with their families but deciding against it. Twenty-six patients indicated they did not believe sperm banking was necessary, and 9 patients were unsure what it was.

There were several factors that influenced the likelihood of patients making sperm collection attempts as well as successfully banking sperm.

In a multivariable analysis, the following factors were associated with an increased likelihood of attempting to bank sperm:

• Meeting with a fertility specialist (odds ratio[OR]=29.96; 95% CI, 2.48 to 361.41; P=0.007)
• Parent recommending banking (OR=12.30; 95% CI, 2.01 to 75.94; P=0.007)
• Higher Tanner stage (OR=5.42; 95% CI, 1.75 to 16.78; P=0.003).

In another multivariable analysis, successful sperm banking was associated with:

• Patient history of masturbation (OR=5.99; 95% CI, 1.25 to 28.50; P=0.025)
• Higher self-efficacy for banking coordination (OR=1.23; 95% CI, 1.05 to 1.45; P=0.012)
• Medical team member recommending banking (OR=4.26; 95% CI, 1.45 to 12.43; P=0.008)
• Parent recommending banking (OR=4.62; 95% CI, 1.46 to 14.73; P=0.010).

“These results highlight factors that providers can target to empower adolescents to actively participate in their own healthcare,” Dr Klosky said. “These decisions, which are typically made at the time of diagnosis, have high potential to affect their lives as survivors.”

Research Hospital

New research suggests sperm banking may be underutilized by adolescent and young adult males with cancer who are at risk of infertility.

However, the study also showed that patients were more likely to attempt sperm banking if they were physically mature, met with fertility specialists, or their parents recommended sperm banking.

These findings were published in the Journal of Clinical Oncology.

“Research has found that the majority of males who survive childhood cancer desire biological children,” said study author James Klosky, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“Fertility preservation is also associated with a variety of benefits for survivors, including increased optimism about the future. While sperm banking is not for everyone, it is an effective method for preserving male fertility. Yet this study shows that sperm banking remains underutilized by at-risk patients with cancer.”

Dr Klosky and his colleagues surveyed 146 young males with cancer who were at risk of infertility. The researchers also surveyed 144 parents or guardians and 52 oncologists and other healthcare providers.

The patients’ mean age was 16.49 (range, 13.0-21.99). Diagnoses included leukemia and lymphoma (56.2%), solid tumor malignancies (37.7%), and brain tumors (6.2%).

Slightly more than half of the patients (53.4%, n=78) attempted sperm banking prior to starting treatment. Sixty-two, or 82.1%, of those who attempted sperm banking were successful.

In all, 43.8% of the patients successfully banked sperm.

Of the 68 patients who did not attempt sperm banking, 29 reported discussing the option with their families but deciding against it. Twenty-six patients indicated they did not believe sperm banking was necessary, and 9 patients were unsure what it was.

There were several factors that influenced the likelihood of patients making sperm collection attempts as well as successfully banking sperm.

In a multivariable analysis, the following factors were associated with an increased likelihood of attempting to bank sperm:

• Meeting with a fertility specialist (odds ratio[OR]=29.96; 95% CI, 2.48 to 361.41; P=0.007)
• Parent recommending banking (OR=12.30; 95% CI, 2.01 to 75.94; P=0.007)
• Higher Tanner stage (OR=5.42; 95% CI, 1.75 to 16.78; P=0.003).

In another multivariable analysis, successful sperm banking was associated with:

• Patient history of masturbation (OR=5.99; 95% CI, 1.25 to 28.50; P=0.025)
• Higher self-efficacy for banking coordination (OR=1.23; 95% CI, 1.05 to 1.45; P=0.012)
• Medical team member recommending banking (OR=4.26; 95% CI, 1.45 to 12.43; P=0.008)
• Parent recommending banking (OR=4.62; 95% CI, 1.46 to 14.73; P=0.010).

“These results highlight factors that providers can target to empower adolescents to actively participate in their own healthcare,” Dr Klosky said. “These decisions, which are typically made at the time of diagnosis, have high potential to affect their lives as survivors.”

Research Hospital

New research suggests sperm banking may be underutilized by adolescent and young adult males with cancer who are at risk of infertility.

However, the study also showed that patients were more likely to attempt sperm banking if they were physically mature, met with fertility specialists, or their parents recommended sperm banking.

These findings were published in the Journal of Clinical Oncology.

“Research has found that the majority of males who survive childhood cancer desire biological children,” said study author James Klosky, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“Fertility preservation is also associated with a variety of benefits for survivors, including increased optimism about the future. While sperm banking is not for everyone, it is an effective method for preserving male fertility. Yet this study shows that sperm banking remains underutilized by at-risk patients with cancer.”

Dr Klosky and his colleagues surveyed 146 young males with cancer who were at risk of infertility. The researchers also surveyed 144 parents or guardians and 52 oncologists and other healthcare providers.

The patients’ mean age was 16.49 (range, 13.0-21.99). Diagnoses included leukemia and lymphoma (56.2%), solid tumor malignancies (37.7%), and brain tumors (6.2%).

Slightly more than half of the patients (53.4%, n=78) attempted sperm banking prior to starting treatment. Sixty-two, or 82.1%, of those who attempted sperm banking were successful.

In all, 43.8% of the patients successfully banked sperm.

Of the 68 patients who did not attempt sperm banking, 29 reported discussing the option with their families but deciding against it. Twenty-six patients indicated they did not believe sperm banking was necessary, and 9 patients were unsure what it was.

There were several factors that influenced the likelihood of patients making sperm collection attempts as well as successfully banking sperm.

In a multivariable analysis, the following factors were associated with an increased likelihood of attempting to bank sperm:

• Meeting with a fertility specialist (odds ratio[OR]=29.96; 95% CI, 2.48 to 361.41; P=0.007)
• Parent recommending banking (OR=12.30; 95% CI, 2.01 to 75.94; P=0.007)
• Higher Tanner stage (OR=5.42; 95% CI, 1.75 to 16.78; P=0.003).

In another multivariable analysis, successful sperm banking was associated with:

• Patient history of masturbation (OR=5.99; 95% CI, 1.25 to 28.50; P=0.025)
• Higher self-efficacy for banking coordination (OR=1.23; 95% CI, 1.05 to 1.45; P=0.012)
• Medical team member recommending banking (OR=4.26; 95% CI, 1.45 to 12.43; P=0.008)
• Parent recommending banking (OR=4.62; 95% CI, 1.46 to 14.73; P=0.010).

“These results highlight factors that providers can target to empower adolescents to actively participate in their own healthcare,” Dr Klosky said. “These decisions, which are typically made at the time of diagnosis, have high potential to affect their lives as survivors.”

Photo from Business Wire

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to brentuximab vedotin (BV, Adcetris) for use in combination with chemotherapy as frontline treatment of advanced classical Hodgkin lymphoma (HL).

Seattle Genetics and Takeda plan to submit a supplemental biologics license application seeking approval for BV in this indication before the end of this year.

The breakthrough designation is based on positive topline results from the phase 3 ECHELON-1 trial.

Full results from this trial are expected to be presented at the 2017 ASH Annual Meeting in December.

BV is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E.

BV is currently FDA-approved to treat:

• Classical HL after failure of autologous hematopoietic stem cell transplant (auto-HSCT) or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
• Classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation.

BV also has accelerated approval from the FDA for the treatment of systemic anaplastic large-cell lymphoma after failure of at least 1 prior multi-agent chemotherapy regimen. This approval is based on overall response rate. Continued approval of BV for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

ECHELON-1 trial

In this phase 3 trial, researchers compared BV in combination with doxorubicin, vinblastine, and dacarbazine to a recognized standard of care chemotherapy regimen in patients with previously untreated, advanced classical HL.

The study enrolled 1334 patients who had a histologically confirmed diagnosis of stage III or IV classical HL and had not been previously treated with systemic chemotherapy or radiotherapy.

The study’s primary endpoint is modified progression-free survival (PFS) per an independent review facility. Modified PFS is defined as the time to progression, death, or receipt of additional anticancer therapy for patients who are not in complete response after completion of frontline therapy.

There was a significant improvement in modified PFS in the BV arm compared to the control arm (hazard ratio=0.770; P=0.035). The 2-year modified PFS rate was 82.1% in the BV arm and 77.2% in the control arm.

An interim analysis of overall survival revealed a trend in favor of the BV arm.

The safety profile of BV plus chemotherapy was consistent with the profile known for the single-agent components of the regimen.

About breakthrough designation

The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Photo from Business Wire

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to brentuximab vedotin (BV, Adcetris) for use in combination with chemotherapy as frontline treatment of advanced classical Hodgkin lymphoma (HL).

Seattle Genetics and Takeda plan to submit a supplemental biologics license application seeking approval for BV in this indication before the end of this year.

The breakthrough designation is based on positive topline results from the phase 3 ECHELON-1 trial.

Full results from this trial are expected to be presented at the 2017 ASH Annual Meeting in December.

BV is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E.

BV is currently FDA-approved to treat:

• Classical HL after failure of autologous hematopoietic stem cell transplant (auto-HSCT) or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
• Classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation.

BV also has accelerated approval from the FDA for the treatment of systemic anaplastic large-cell lymphoma after failure of at least 1 prior multi-agent chemotherapy regimen. This approval is based on overall response rate. Continued approval of BV for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

ECHELON-1 trial

In this phase 3 trial, researchers compared BV in combination with doxorubicin, vinblastine, and dacarbazine to a recognized standard of care chemotherapy regimen in patients with previously untreated, advanced classical HL.

The study enrolled 1334 patients who had a histologically confirmed diagnosis of stage III or IV classical HL and had not been previously treated with systemic chemotherapy or radiotherapy.

The study’s primary endpoint is modified progression-free survival (PFS) per an independent review facility. Modified PFS is defined as the time to progression, death, or receipt of additional anticancer therapy for patients who are not in complete response after completion of frontline therapy.

There was a significant improvement in modified PFS in the BV arm compared to the control arm (hazard ratio=0.770; P=0.035). The 2-year modified PFS rate was 82.1% in the BV arm and 77.2% in the control arm.

An interim analysis of overall survival revealed a trend in favor of the BV arm.

The safety profile of BV plus chemotherapy was consistent with the profile known for the single-agent components of the regimen.

About breakthrough designation

The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Photo from Business Wire

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to brentuximab vedotin (BV, Adcetris) for use in combination with chemotherapy as frontline treatment of advanced classical Hodgkin lymphoma (HL).

Seattle Genetics and Takeda plan to submit a supplemental biologics license application seeking approval for BV in this indication before the end of this year.

The breakthrough designation is based on positive topline results from the phase 3 ECHELON-1 trial.

Full results from this trial are expected to be presented at the 2017 ASH Annual Meeting in December.

BV is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E.

BV is currently FDA-approved to treat:

• Classical HL after failure of autologous hematopoietic stem cell transplant (auto-HSCT) or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates
• Classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation.

BV also has accelerated approval from the FDA for the treatment of systemic anaplastic large-cell lymphoma after failure of at least 1 prior multi-agent chemotherapy regimen. This approval is based on overall response rate. Continued approval of BV for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

ECHELON-1 trial

In this phase 3 trial, researchers compared BV in combination with doxorubicin, vinblastine, and dacarbazine to a recognized standard of care chemotherapy regimen in patients with previously untreated, advanced classical HL.

The study enrolled 1334 patients who had a histologically confirmed diagnosis of stage III or IV classical HL and had not been previously treated with systemic chemotherapy or radiotherapy.

The study’s primary endpoint is modified progression-free survival (PFS) per an independent review facility. Modified PFS is defined as the time to progression, death, or receipt of additional anticancer therapy for patients who are not in complete response after completion of frontline therapy.

There was a significant improvement in modified PFS in the BV arm compared to the control arm (hazard ratio=0.770; P=0.035). The 2-year modified PFS rate was 82.1% in the BV arm and 77.2% in the control arm.

An interim analysis of overall survival revealed a trend in favor of the BV arm.

The safety profile of BV plus chemotherapy was consistent with the profile known for the single-agent components of the regimen.

About breakthrough designation

The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Photo courtesy of ASTRO

SAN DIEGO—New research suggests a need for mental health screening among cancer patients.

The study revealed a 40% rate of depression among patients treated at an urban cancer center over a 3-year period.

Three-quarters of the depressed patients were previously undiagnosed.

Female patients and those who were unable to work due to disability were more likely to be depressed.

Jason Domogauer, PhD, of Rutgers New Jersey Medical School in Newark, New Jersey, presented these findings at ASTRO’s 59th Annual Meeting.

“Depression is widely recognized as an underdiagnosed disorder, particularly among older adults and cancer patients,” Dr Domogauer said. “Our findings point to a clear need for action, including depression screening during initial and continuing patient visits, initiation of mental health treatments for identified patients, and increased collaboration with mental health providers in cancer treatment centers. These efforts are particularly important for patients in urban centers, those who are female, and those who are unable to work because of their disease.”

Dr Domogauer and his colleagues studied 400 cancer patients who received treatment at Rutgers New Jersey Medical School/University Hospital Cancer Center between 2013 and 2016.

The average patient age was 55 (range, 20-86), and 53% of patients were female. Forty-eight percent of patients were African-American, 29% were non-Hispanic white, and 16% were Hispanic.

Nearly equal numbers of patients reported being able to work (49%) or unable to work due to disability (51%). Most patients (85%) received radiation as part of their cancer treatment.

The researchers assessed depression in the patients using a minimum score of 16 on the Center for Epidemiologic Studies Depression Scale.

In this way, 40% of the patients were diagnosed with depression. In 75% of these patients, depression was previously undiagnosed. This means roughly 30% of the overall patient population suffered from undiagnosed and untreated depression.

Depression was more common among females than males—47% and 32%, respectively (odds ratio [OR]=1.9, P=0.007).

Depression was also more likely among patients who were unable to work due to disability—48%, compared to 33% of those able to work (OR=1.9, P=0.005).

Depression prevalence did not differ significantly among racial/ethnic groups.

When the researchers looked specifically at patients who were previously not diagnosed with depression, the effects of being female or unable to work persisted.

In this subgroup, depression was more common among women than men—43% and 29%, respectively (OR=1.9, P=0.02)—and patients with disability compared to able patients—43% and 31%, respectively (OR=1.7, P=0.03).

Photo courtesy of ASTRO

SAN DIEGO—New research suggests a need for mental health screening among cancer patients.

The study revealed a 40% rate of depression among patients treated at an urban cancer center over a 3-year period.

Three-quarters of the depressed patients were previously undiagnosed.

Female patients and those who were unable to work due to disability were more likely to be depressed.

Jason Domogauer, PhD, of Rutgers New Jersey Medical School in Newark, New Jersey, presented these findings at ASTRO’s 59th Annual Meeting.

“Depression is widely recognized as an underdiagnosed disorder, particularly among older adults and cancer patients,” Dr Domogauer said. “Our findings point to a clear need for action, including depression screening during initial and continuing patient visits, initiation of mental health treatments for identified patients, and increased collaboration with mental health providers in cancer treatment centers. These efforts are particularly important for patients in urban centers, those who are female, and those who are unable to work because of their disease.”

Dr Domogauer and his colleagues studied 400 cancer patients who received treatment at Rutgers New Jersey Medical School/University Hospital Cancer Center between 2013 and 2016.

The average patient age was 55 (range, 20-86), and 53% of patients were female. Forty-eight percent of patients were African-American, 29% were non-Hispanic white, and 16% were Hispanic.

Nearly equal numbers of patients reported being able to work (49%) or unable to work due to disability (51%). Most patients (85%) received radiation as part of their cancer treatment.

The researchers assessed depression in the patients using a minimum score of 16 on the Center for Epidemiologic Studies Depression Scale.

In this way, 40% of the patients were diagnosed with depression. In 75% of these patients, depression was previously undiagnosed. This means roughly 30% of the overall patient population suffered from undiagnosed and untreated depression.

Depression was more common among females than males—47% and 32%, respectively (odds ratio [OR]=1.9, P=0.007).

Depression was also more likely among patients who were unable to work due to disability—48%, compared to 33% of those able to work (OR=1.9, P=0.005).

Depression prevalence did not differ significantly among racial/ethnic groups.

When the researchers looked specifically at patients who were previously not diagnosed with depression, the effects of being female or unable to work persisted.

In this subgroup, depression was more common among women than men—43% and 29%, respectively (OR=1.9, P=0.02)—and patients with disability compared to able patients—43% and 31%, respectively (OR=1.7, P=0.03).

Photo courtesy of ASTRO

SAN DIEGO—New research suggests a need for mental health screening among cancer patients.

The study revealed a 40% rate of depression among patients treated at an urban cancer center over a 3-year period.

Three-quarters of the depressed patients were previously undiagnosed.

Female patients and those who were unable to work due to disability were more likely to be depressed.

Jason Domogauer, PhD, of Rutgers New Jersey Medical School in Newark, New Jersey, presented these findings at ASTRO’s 59th Annual Meeting.

“Depression is widely recognized as an underdiagnosed disorder, particularly among older adults and cancer patients,” Dr Domogauer said. “Our findings point to a clear need for action, including depression screening during initial and continuing patient visits, initiation of mental health treatments for identified patients, and increased collaboration with mental health providers in cancer treatment centers. These efforts are particularly important for patients in urban centers, those who are female, and those who are unable to work because of their disease.”

Dr Domogauer and his colleagues studied 400 cancer patients who received treatment at Rutgers New Jersey Medical School/University Hospital Cancer Center between 2013 and 2016.

The average patient age was 55 (range, 20-86), and 53% of patients were female. Forty-eight percent of patients were African-American, 29% were non-Hispanic white, and 16% were Hispanic.

Nearly equal numbers of patients reported being able to work (49%) or unable to work due to disability (51%). Most patients (85%) received radiation as part of their cancer treatment.

The researchers assessed depression in the patients using a minimum score of 16 on the Center for Epidemiologic Studies Depression Scale.

In this way, 40% of the patients were diagnosed with depression. In 75% of these patients, depression was previously undiagnosed. This means roughly 30% of the overall patient population suffered from undiagnosed and untreated depression.

Depression was more common among females than males—47% and 32%, respectively (odds ratio [OR]=1.9, P=0.007).

Depression was also more likely among patients who were unable to work due to disability—48%, compared to 33% of those able to work (OR=1.9, P=0.005).

Depression prevalence did not differ significantly among racial/ethnic groups.

When the researchers looked specifically at patients who were previously not diagnosed with depression, the effects of being female or unable to work persisted.

In this subgroup, depression was more common among women than men—43% and 29%, respectively (OR=1.9, P=0.02)—and patients with disability compared to able patients—43% and 31%, respectively (OR=1.7, P=0.03).

Children who had developed inflammatory bowel disease had an 18-fold greater risk of gastrointestinal cancers in later life, a new study suggests.

The cohort study found that the risk of all cancers was elevated in individuals with childhood-onset inflammatory bowel disease, but particularly in those with primary sclerosing cholangitis and ulcerative colitis.

Researchers followed 9,405 patients with childhood-onset inflammatory bowel disease to a mean age of 27 years using a Swedish national patient register (BMJ. 2017 Sep 21. doi: 10.1136/bmj.j3951).

Analysis revealed that individuals with childhood-onset inflammatory bowel disease had double the risk of any cancer, compared with the general population (hazard ratio, 2.2; 95% confidence interval, 2.0-2.5), and a 2.7-fold greater risk of developing cancer before the age of 18 years.

copyright varaphoto/Thinkstock

Children who had developed inflammatory bowel disease had an 18-fold greater risk of gastrointestinal cancers in later life, a new study suggests.

The cohort study found that the risk of all cancers was elevated in individuals with childhood-onset inflammatory bowel disease, but particularly in those with primary sclerosing cholangitis and ulcerative colitis.

Researchers followed 9,405 patients with childhood-onset inflammatory bowel disease to a mean age of 27 years using a Swedish national patient register (BMJ. 2017 Sep 21. doi: 10.1136/bmj.j3951).

Analysis revealed that individuals with childhood-onset inflammatory bowel disease had double the risk of any cancer, compared with the general population (hazard ratio, 2.2; 95% confidence interval, 2.0-2.5), and a 2.7-fold greater risk of developing cancer before the age of 18 years.

copyright varaphoto/Thinkstock

Children who had developed inflammatory bowel disease had an 18-fold greater risk of gastrointestinal cancers in later life, a new study suggests.

The cohort study found that the risk of all cancers was elevated in individuals with childhood-onset inflammatory bowel disease, but particularly in those with primary sclerosing cholangitis and ulcerative colitis.

Researchers followed 9,405 patients with childhood-onset inflammatory bowel disease to a mean age of 27 years using a Swedish national patient register (BMJ. 2017 Sep 21. doi: 10.1136/bmj.j3951).

Analysis revealed that individuals with childhood-onset inflammatory bowel disease had double the risk of any cancer, compared with the general population (hazard ratio, 2.2; 95% confidence interval, 2.0-2.5), and a 2.7-fold greater risk of developing cancer before the age of 18 years.

copyright varaphoto/Thinkstock

Photo by Esther Dyson

ATLANTA—New research suggests some racial/ethnic minority groups are underrepresented in clinical trials for cancer patients in the US.

African-American and Hispanic patients were underrepresented in the trials studied, while Asian and non-Hispanic white patients were not.

Patients belonging to other racial/ethnic groups were not studied in detail.

The research also showed that elderly patients were less likely than other age groups to enroll in a cancer trial.

However, the percentage of elderly patients in the trials studied (36%) was more than double the percentage of elderly individuals in the US population (15.2%).

This research was presented at the 10th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved (abstract A26).

“Clinical trials are crucial in studying the effectiveness of new drugs and ultimately bringing them to the market to benefit patients,” said Narjust Duma, MD, of the Mayo Clinic in Rochester, Minnesota.

“However, many clinical trials lack appropriate representation of certain patient populations. As a result, the findings of a clinical trial might not be generalizable to all patients.”

Dr Duma and her colleagues analyzed enrollment data from all cancer therapeutic trials reported as completed on clinicaltrials.gov from 2003 to 2016. These trials included 55,689 subjects, and the racial/ethnic breakdown of the group was as follows:

• Non-Hispanic white—83%
• African-American—6%
• Asian—5.3%
• Hispanic—2.6%
• “Other”—2.4%.

According to the US Census Bureau, as of July 1, 2016, the estimated total US population was 323,127,516. The racial/ethnic breakdown of that population is as follows:

• White alone (excluding Hispanics/Latinos)—61.3%
• Hispanic/Latino*—17.8%
• Black/African-American alone—13.3%
• Asian alone—5.7%
• American Indian/Alaska Native—1.3%
• Native Hawaiian/Other Pacific Islander—0.2%
• Two or more races—2.6%.

Dr Duma and her colleagues said their study suggests African-American and Hispanic representation in cancer trials has declined in recent years, when compared to historical data from 1996 to 2002.

In the 1996-2002 period, African-Americans represented 9.2% of patients in cancer trials (vs 6% in 2003-2016), and Hispanics represented 3.1% (vs 2.6% in 2003-2016).

On the other hand, the recruitment of Asians in cancer trials has more than doubled, from 2% in the historical data to 5.3% in the current data.

The current study also showed that elderly patients (age 65 and older) represented 36% of the subjects enrolled in cancer trials. In comparison, 15.2% of the total US population is 65 or older.

Previous research suggested the elderly are often underrepresented in clinical trials, despite the fact that most cancer cases are diagnosed in individuals age 65 and older, according to the National Cancer Institute’s Surveillance, Epidemiology and End Results database.

Dr Duma said the increasing use of genetic information in clinical trials may be decreasing the numbers of ethnic minorities and elderly patients. In recent years, researchers have sought to study drugs that treat cancers by targeting certain mutations. In order to identify the patients who are most likely to respond to the drugs, many trials now require molecular testing of tumors.

“This is leading to significant advances,” Dr Duma said. “However, it is vastly more expensive to run these trials, often leaving a limited budget to recruit patients or do outreach to the elderly or minorities.”

“Also, this type of testing can only be conducted at the major cancer centers. The mid-sized, regional hospitals are excluded because they don’t have the capacity, and, sadly, this leaves us farther away from these populations.”

Dr Duma added that cultural biases may also make minorities less likely to enroll in clinical trials. Previous research has indicated that members of certain minority groups may be less likely to trust healthcare providers.

Language barriers may also be a factor for minority patients, and the elderly may be dissuaded by difficulty in traveling to and from major cancer centers, Dr Duma noted.

She identified a few potential ways to narrow the gap of participation in clinical trials:

• Increase clinical trial partnerships between major cancer centers and satellite hospitals. Dr Duma suggested that patients could be enrolled at their local hospital and undergo treatment there, while data could be sent to the partnering cancer center.
• Targeted interventions, such as Spanish interpreters, could be used to help enroll minority patients in clinical trials.
• Healthcare providers should be mindful of the need to enroll more patients from underrepresented populations and should be willing to discuss risks and benefits with patients.

Dr Duma said the main limitation of this study is that race and ethnicity are generally self-reported, which could lead to some inconsistencies in data.

*The US Census Bureau notes that Hispanics may be of any race, so they are also included in applicable race categories.

Photo by Esther Dyson

ATLANTA—New research suggests some racial/ethnic minority groups are underrepresented in clinical trials for cancer patients in the US.

African-American and Hispanic patients were underrepresented in the trials studied, while Asian and non-Hispanic white patients were not.

Patients belonging to other racial/ethnic groups were not studied in detail.

The research also showed that elderly patients were less likely than other age groups to enroll in a cancer trial.

However, the percentage of elderly patients in the trials studied (36%) was more than double the percentage of elderly individuals in the US population (15.2%).

This research was presented at the 10th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved (abstract A26).

“Clinical trials are crucial in studying the effectiveness of new drugs and ultimately bringing them to the market to benefit patients,” said Narjust Duma, MD, of the Mayo Clinic in Rochester, Minnesota.

“However, many clinical trials lack appropriate representation of certain patient populations. As a result, the findings of a clinical trial might not be generalizable to all patients.”

Dr Duma and her colleagues analyzed enrollment data from all cancer therapeutic trials reported as completed on clinicaltrials.gov from 2003 to 2016. These trials included 55,689 subjects, and the racial/ethnic breakdown of the group was as follows:

• Non-Hispanic white—83%
• African-American—6%
• Asian—5.3%
• Hispanic—2.6%
• “Other”—2.4%.

According to the US Census Bureau, as of July 1, 2016, the estimated total US population was 323,127,516. The racial/ethnic breakdown of that population is as follows:

• White alone (excluding Hispanics/Latinos)—61.3%
• Hispanic/Latino*—17.8%
• Black/African-American alone—13.3%
• Asian alone—5.7%
• American Indian/Alaska Native—1.3%
• Native Hawaiian/Other Pacific Islander—0.2%
• Two or more races—2.6%.

Dr Duma and her colleagues said their study suggests African-American and Hispanic representation in cancer trials has declined in recent years, when compared to historical data from 1996 to 2002.

In the 1996-2002 period, African-Americans represented 9.2% of patients in cancer trials (vs 6% in 2003-2016), and Hispanics represented 3.1% (vs 2.6% in 2003-2016).

On the other hand, the recruitment of Asians in cancer trials has more than doubled, from 2% in the historical data to 5.3% in the current data.

The current study also showed that elderly patients (age 65 and older) represented 36% of the subjects enrolled in cancer trials. In comparison, 15.2% of the total US population is 65 or older.

Previous research suggested the elderly are often underrepresented in clinical trials, despite the fact that most cancer cases are diagnosed in individuals age 65 and older, according to the National Cancer Institute’s Surveillance, Epidemiology and End Results database.

Dr Duma said the increasing use of genetic information in clinical trials may be decreasing the numbers of ethnic minorities and elderly patients. In recent years, researchers have sought to study drugs that treat cancers by targeting certain mutations. In order to identify the patients who are most likely to respond to the drugs, many trials now require molecular testing of tumors.

“This is leading to significant advances,” Dr Duma said. “However, it is vastly more expensive to run these trials, often leaving a limited budget to recruit patients or do outreach to the elderly or minorities.”

“Also, this type of testing can only be conducted at the major cancer centers. The mid-sized, regional hospitals are excluded because they don’t have the capacity, and, sadly, this leaves us farther away from these populations.”

Dr Duma added that cultural biases may also make minorities less likely to enroll in clinical trials. Previous research has indicated that members of certain minority groups may be less likely to trust healthcare providers.

Language barriers may also be a factor for minority patients, and the elderly may be dissuaded by difficulty in traveling to and from major cancer centers, Dr Duma noted.

She identified a few potential ways to narrow the gap of participation in clinical trials:

• Increase clinical trial partnerships between major cancer centers and satellite hospitals. Dr Duma suggested that patients could be enrolled at their local hospital and undergo treatment there, while data could be sent to the partnering cancer center.
• Targeted interventions, such as Spanish interpreters, could be used to help enroll minority patients in clinical trials.
• Healthcare providers should be mindful of the need to enroll more patients from underrepresented populations and should be willing to discuss risks and benefits with patients.

Dr Duma said the main limitation of this study is that race and ethnicity are generally self-reported, which could lead to some inconsistencies in data.

*The US Census Bureau notes that Hispanics may be of any race, so they are also included in applicable race categories.

Photo by Esther Dyson

ATLANTA—New research suggests some racial/ethnic minority groups are underrepresented in clinical trials for cancer patients in the US.

African-American and Hispanic patients were underrepresented in the trials studied, while Asian and non-Hispanic white patients were not.

Patients belonging to other racial/ethnic groups were not studied in detail.

The research also showed that elderly patients were less likely than other age groups to enroll in a cancer trial.

However, the percentage of elderly patients in the trials studied (36%) was more than double the percentage of elderly individuals in the US population (15.2%).

This research was presented at the 10th AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved (abstract A26).

“Clinical trials are crucial in studying the effectiveness of new drugs and ultimately bringing them to the market to benefit patients,” said Narjust Duma, MD, of the Mayo Clinic in Rochester, Minnesota.

“However, many clinical trials lack appropriate representation of certain patient populations. As a result, the findings of a clinical trial might not be generalizable to all patients.”

Dr Duma and her colleagues analyzed enrollment data from all cancer therapeutic trials reported as completed on clinicaltrials.gov from 2003 to 2016. These trials included 55,689 subjects, and the racial/ethnic breakdown of the group was as follows:

• Non-Hispanic white—83%
• African-American—6%
• Asian—5.3%
• Hispanic—2.6%
• “Other”—2.4%.

According to the US Census Bureau, as of July 1, 2016, the estimated total US population was 323,127,516. The racial/ethnic breakdown of that population is as follows:

• White alone (excluding Hispanics/Latinos)—61.3%
• Hispanic/Latino*—17.8%
• Black/African-American alone—13.3%
• Asian alone—5.7%
• American Indian/Alaska Native—1.3%
• Native Hawaiian/Other Pacific Islander—0.2%
• Two or more races—2.6%.

Dr Duma and her colleagues said their study suggests African-American and Hispanic representation in cancer trials has declined in recent years, when compared to historical data from 1996 to 2002.

In the 1996-2002 period, African-Americans represented 9.2% of patients in cancer trials (vs 6% in 2003-2016), and Hispanics represented 3.1% (vs 2.6% in 2003-2016).

On the other hand, the recruitment of Asians in cancer trials has more than doubled, from 2% in the historical data to 5.3% in the current data.

The current study also showed that elderly patients (age 65 and older) represented 36% of the subjects enrolled in cancer trials. In comparison, 15.2% of the total US population is 65 or older.

Previous research suggested the elderly are often underrepresented in clinical trials, despite the fact that most cancer cases are diagnosed in individuals age 65 and older, according to the National Cancer Institute’s Surveillance, Epidemiology and End Results database.

Dr Duma said the increasing use of genetic information in clinical trials may be decreasing the numbers of ethnic minorities and elderly patients. In recent years, researchers have sought to study drugs that treat cancers by targeting certain mutations. In order to identify the patients who are most likely to respond to the drugs, many trials now require molecular testing of tumors.

“This is leading to significant advances,” Dr Duma said. “However, it is vastly more expensive to run these trials, often leaving a limited budget to recruit patients or do outreach to the elderly or minorities.”

“Also, this type of testing can only be conducted at the major cancer centers. The mid-sized, regional hospitals are excluded because they don’t have the capacity, and, sadly, this leaves us farther away from these populations.”

Dr Duma added that cultural biases may also make minorities less likely to enroll in clinical trials. Previous research has indicated that members of certain minority groups may be less likely to trust healthcare providers.

Language barriers may also be a factor for minority patients, and the elderly may be dissuaded by difficulty in traveling to and from major cancer centers, Dr Duma noted.

She identified a few potential ways to narrow the gap of participation in clinical trials:

• Increase clinical trial partnerships between major cancer centers and satellite hospitals. Dr Duma suggested that patients could be enrolled at their local hospital and undergo treatment there, while data could be sent to the partnering cancer center.
• Targeted interventions, such as Spanish interpreters, could be used to help enroll minority patients in clinical trials.
• Healthcare providers should be mindful of the need to enroll more patients from underrepresented populations and should be willing to discuss risks and benefits with patients.

Dr Duma said the main limitation of this study is that race and ethnicity are generally self-reported, which could lead to some inconsistencies in data.

*The US Census Bureau notes that Hispanics may be of any race, so they are also included in applicable race categories.