Multiple Myeloma

Minimal residual disease negativity following treatment for newly diagnosed multiple myeloma is associated with long-term survival, according to findings from a meta-analysis of relevant data.

The findings suggest that assessment for minimal residual disease (MRD) should be included as an end point in clinical trials of multiple myeloma, Nikhil C. Munshi, MD, of Harvard Medical School, Boston, and his colleagues reported online Sept. 15 in JAMA Oncology.

Dana-Farber Cancer Institute

“This large cohort meta-analysis confirms that MRD status has prognostic value and is a valid surrogate marker for both PFS [progression-free survival] and OS [overall survival] in patients with multiple myeloma, including those who had achieved a CR [complete response],” the researchers wrote, noting that all of the studies confirmed the impact of MRD status on outcome, indicating that the predictive value of MRD status was independent of the type of treatment used.

Of 1,273 patients from 14 studies that looked at the impact of MRD status on PFS, 660 were MRD-negative and 613 were MRD-positive. Of 1,100 patients from 12 studies that looked at the impact of MRD on OS, 599 were MRD-negative, and 501 were MRD-positive. MRD-negative vs. -positive status was associated with better PFS and OS (hazard ratio, 0.41 and 0.57, respectively).

“Median PFS was 54 months for MRD-negative patients and 26 months for MRD-positive patients; median OS was 98 and 82 months, respectively,” the researchers wrote (JAMA Oncol. 2016 Sep 15. doi: 10.1001/jamaoncol.2016.3160).

Further, to evaluate the impact of MRD status on PFS and OS in patients who achieved conventional CR, they analyzed data from five studies looking at PFS in 396 MRD-negative and 178 MRD-positive patients, and 6 studies looking at OS in 430 MRD-negative and 186 MRD-positive patients. In patients achieving CR, the presence of MRD predicted shorter PFS (HR, 0.44) and shorter OS (HR, 0.47), they said.

“Median PFS was 56 months for MRD-negative patients and 34 months for MRD-positive patients, and median OS was 112 and 82 months, respectively. The OS rate was higher for MRD-negative patients, compared with MRD-positive patients at 3 years (94% vs. 80%), 5 years (80% vs. 61%), and 7 years (67% vs. 47%),” they wrote.

Although none of the studies included in the analysis compared the effect of two different treatment approaches on MRD status, five did evaluate MRD status before and after autologous stem cell transplantation, and all indicated that the treatment increased the proportion of MRD-negative patients.

Maintenance therapy also appeared, based on some of the studies, to have a beneficial effect on MRD status. In one study, MRD-negative status was maintained in 96% of patients receiving thalidomide maintenance therapy vs. 69% of MRD-negative patients receiving no maintenance therapy.

Minimal residual disease status is already considered an important prognostic factor in patients with multiple myeloma, and testing could be used to monitor response to therapy and guide subsequent treatment decisions, the investigators wrote, noting that “recent development of multiparameter flow cytometry– and next-generation sequencing–based methods has allowed for MRD assessment in larger studies.”

The findings provide quantitative evidence to support the conceptual basis for integrating MRD assessment after initial treatment in clinical trials as a surrogate end point for PFS and/or OS and in clinical practice to aid in prognostication and to guide treatment. However, “integration of MRD testing into standard practice requires optimization and standardization of MRD assessment and standardization of its timing,” they said.

This study was supported by the National Institutes of Health, the Medical Research Council, and Celgene. Dr. Munshi reported consultancy positions and advisory committee memberships with Celgene, Takeda, Janssen, and Merck.

[email protected]

Minimal residual disease negativity following treatment for newly diagnosed multiple myeloma is associated with long-term survival, according to findings from a meta-analysis of relevant data.

The findings suggest that assessment for minimal residual disease (MRD) should be included as an end point in clinical trials of multiple myeloma, Nikhil C. Munshi, MD, of Harvard Medical School, Boston, and his colleagues reported online Sept. 15 in JAMA Oncology.

Dana-Farber Cancer Institute

“This large cohort meta-analysis confirms that MRD status has prognostic value and is a valid surrogate marker for both PFS [progression-free survival] and OS [overall survival] in patients with multiple myeloma, including those who had achieved a CR [complete response],” the researchers wrote, noting that all of the studies confirmed the impact of MRD status on outcome, indicating that the predictive value of MRD status was independent of the type of treatment used.

Of 1,273 patients from 14 studies that looked at the impact of MRD status on PFS, 660 were MRD-negative and 613 were MRD-positive. Of 1,100 patients from 12 studies that looked at the impact of MRD on OS, 599 were MRD-negative, and 501 were MRD-positive. MRD-negative vs. -positive status was associated with better PFS and OS (hazard ratio, 0.41 and 0.57, respectively).

“Median PFS was 54 months for MRD-negative patients and 26 months for MRD-positive patients; median OS was 98 and 82 months, respectively,” the researchers wrote (JAMA Oncol. 2016 Sep 15. doi: 10.1001/jamaoncol.2016.3160).

Further, to evaluate the impact of MRD status on PFS and OS in patients who achieved conventional CR, they analyzed data from five studies looking at PFS in 396 MRD-negative and 178 MRD-positive patients, and 6 studies looking at OS in 430 MRD-negative and 186 MRD-positive patients. In patients achieving CR, the presence of MRD predicted shorter PFS (HR, 0.44) and shorter OS (HR, 0.47), they said.

“Median PFS was 56 months for MRD-negative patients and 34 months for MRD-positive patients, and median OS was 112 and 82 months, respectively. The OS rate was higher for MRD-negative patients, compared with MRD-positive patients at 3 years (94% vs. 80%), 5 years (80% vs. 61%), and 7 years (67% vs. 47%),” they wrote.

Although none of the studies included in the analysis compared the effect of two different treatment approaches on MRD status, five did evaluate MRD status before and after autologous stem cell transplantation, and all indicated that the treatment increased the proportion of MRD-negative patients.

Maintenance therapy also appeared, based on some of the studies, to have a beneficial effect on MRD status. In one study, MRD-negative status was maintained in 96% of patients receiving thalidomide maintenance therapy vs. 69% of MRD-negative patients receiving no maintenance therapy.

Minimal residual disease status is already considered an important prognostic factor in patients with multiple myeloma, and testing could be used to monitor response to therapy and guide subsequent treatment decisions, the investigators wrote, noting that “recent development of multiparameter flow cytometry– and next-generation sequencing–based methods has allowed for MRD assessment in larger studies.”

The findings provide quantitative evidence to support the conceptual basis for integrating MRD assessment after initial treatment in clinical trials as a surrogate end point for PFS and/or OS and in clinical practice to aid in prognostication and to guide treatment. However, “integration of MRD testing into standard practice requires optimization and standardization of MRD assessment and standardization of its timing,” they said.

This study was supported by the National Institutes of Health, the Medical Research Council, and Celgene. Dr. Munshi reported consultancy positions and advisory committee memberships with Celgene, Takeda, Janssen, and Merck.

[email protected]

Minimal residual disease negativity following treatment for newly diagnosed multiple myeloma is associated with long-term survival, according to findings from a meta-analysis of relevant data.

The findings suggest that assessment for minimal residual disease (MRD) should be included as an end point in clinical trials of multiple myeloma, Nikhil C. Munshi, MD, of Harvard Medical School, Boston, and his colleagues reported online Sept. 15 in JAMA Oncology.

Dana-Farber Cancer Institute

“This large cohort meta-analysis confirms that MRD status has prognostic value and is a valid surrogate marker for both PFS [progression-free survival] and OS [overall survival] in patients with multiple myeloma, including those who had achieved a CR [complete response],” the researchers wrote, noting that all of the studies confirmed the impact of MRD status on outcome, indicating that the predictive value of MRD status was independent of the type of treatment used.

Of 1,273 patients from 14 studies that looked at the impact of MRD status on PFS, 660 were MRD-negative and 613 were MRD-positive. Of 1,100 patients from 12 studies that looked at the impact of MRD on OS, 599 were MRD-negative, and 501 were MRD-positive. MRD-negative vs. -positive status was associated with better PFS and OS (hazard ratio, 0.41 and 0.57, respectively).

“Median PFS was 54 months for MRD-negative patients and 26 months for MRD-positive patients; median OS was 98 and 82 months, respectively,” the researchers wrote (JAMA Oncol. 2016 Sep 15. doi: 10.1001/jamaoncol.2016.3160).

Further, to evaluate the impact of MRD status on PFS and OS in patients who achieved conventional CR, they analyzed data from five studies looking at PFS in 396 MRD-negative and 178 MRD-positive patients, and 6 studies looking at OS in 430 MRD-negative and 186 MRD-positive patients. In patients achieving CR, the presence of MRD predicted shorter PFS (HR, 0.44) and shorter OS (HR, 0.47), they said.

“Median PFS was 56 months for MRD-negative patients and 34 months for MRD-positive patients, and median OS was 112 and 82 months, respectively. The OS rate was higher for MRD-negative patients, compared with MRD-positive patients at 3 years (94% vs. 80%), 5 years (80% vs. 61%), and 7 years (67% vs. 47%),” they wrote.

Although none of the studies included in the analysis compared the effect of two different treatment approaches on MRD status, five did evaluate MRD status before and after autologous stem cell transplantation, and all indicated that the treatment increased the proportion of MRD-negative patients.

Maintenance therapy also appeared, based on some of the studies, to have a beneficial effect on MRD status. In one study, MRD-negative status was maintained in 96% of patients receiving thalidomide maintenance therapy vs. 69% of MRD-negative patients receiving no maintenance therapy.

Minimal residual disease status is already considered an important prognostic factor in patients with multiple myeloma, and testing could be used to monitor response to therapy and guide subsequent treatment decisions, the investigators wrote, noting that “recent development of multiparameter flow cytometry– and next-generation sequencing–based methods has allowed for MRD assessment in larger studies.”

The findings provide quantitative evidence to support the conceptual basis for integrating MRD assessment after initial treatment in clinical trials as a surrogate end point for PFS and/or OS and in clinical practice to aid in prognostication and to guide treatment. However, “integration of MRD testing into standard practice requires optimization and standardization of MRD assessment and standardization of its timing,” they said.

This study was supported by the National Institutes of Health, the Medical Research Council, and Celgene. Dr. Munshi reported consultancy positions and advisory committee memberships with Celgene, Takeda, Janssen, and Merck.

[email protected]

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Family caregivers of patients with high-mortality cancers may often experience high levels of depression and anxiety, results of a survey suggest.

The survey showed that caregivers can spend more than 8 hours a day providing care.

And as caregiving time increases, self-care behaviors such as sleep and exercise decline, which may confer poorer mental health.

These findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 239).

“Caregivers and patients are faced with an enormous physical and emotional toll when dealing with advanced cancer,” said study investigator J. Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham.

“When they put their own health and well-being on the back burner, it can affect their care to the patient.”

Dr Dionne-Odom and his colleagues conducted a cross-sectional survey of 294 family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head and neck, hematologic, or stage IV cancers.

The survey was fielded across 8 cancer centers in Alabama, Florida, and Tennessee. Survey questions explored measures of self-care behaviors and quality of life.

The caregivers had an average age of 66. They were mostly female (72.8%), white (91.2%), retired (54.4%), and the patient’s spouse/partner (60.2%). Nearly half of the caregivers lived in rural areas (46.9%), and more than half had annual incomes less than $50,000 (53.8%).

Most of the caregivers said they provided care 6 to 7 days a week (71%) for more than 1 year (68%).

Twenty-three percent of caregivers reported a high level of depressive symptoms, and 34% reported borderline or high levels of anxiety symptoms, associated with significantly lower scores for self-care.

Lower self-care behavior scores were associated with a longer overall duration of caregiving, more hours in the day spent caregiving, more days of the week spent caregiving, and with fair or poor patient health.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” Dr Dionne-Odom said. “These efforts would help ensure that caregivers are supported and healthy when they take on the important role of caring for an individual with advanced cancer.” 

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Family caregivers of patients with high-mortality cancers may often experience high levels of depression and anxiety, results of a survey suggest.

The survey showed that caregivers can spend more than 8 hours a day providing care.

And as caregiving time increases, self-care behaviors such as sleep and exercise decline, which may confer poorer mental health.

These findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 239).

“Caregivers and patients are faced with an enormous physical and emotional toll when dealing with advanced cancer,” said study investigator J. Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham.

“When they put their own health and well-being on the back burner, it can affect their care to the patient.”

Dr Dionne-Odom and his colleagues conducted a cross-sectional survey of 294 family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head and neck, hematologic, or stage IV cancers.

The survey was fielded across 8 cancer centers in Alabama, Florida, and Tennessee. Survey questions explored measures of self-care behaviors and quality of life.

The caregivers had an average age of 66. They were mostly female (72.8%), white (91.2%), retired (54.4%), and the patient’s spouse/partner (60.2%). Nearly half of the caregivers lived in rural areas (46.9%), and more than half had annual incomes less than $50,000 (53.8%).

Most of the caregivers said they provided care 6 to 7 days a week (71%) for more than 1 year (68%).

Twenty-three percent of caregivers reported a high level of depressive symptoms, and 34% reported borderline or high levels of anxiety symptoms, associated with significantly lower scores for self-care.

Lower self-care behavior scores were associated with a longer overall duration of caregiving, more hours in the day spent caregiving, more days of the week spent caregiving, and with fair or poor patient health.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” Dr Dionne-Odom said. “These efforts would help ensure that caregivers are supported and healthy when they take on the important role of caring for an individual with advanced cancer.” 

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Family caregivers of patients with high-mortality cancers may often experience high levels of depression and anxiety, results of a survey suggest.

The survey showed that caregivers can spend more than 8 hours a day providing care.

And as caregiving time increases, self-care behaviors such as sleep and exercise decline, which may confer poorer mental health.

These findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 239).

“Caregivers and patients are faced with an enormous physical and emotional toll when dealing with advanced cancer,” said study investigator J. Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham.

“When they put their own health and well-being on the back burner, it can affect their care to the patient.”

Dr Dionne-Odom and his colleagues conducted a cross-sectional survey of 294 family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head and neck, hematologic, or stage IV cancers.

The survey was fielded across 8 cancer centers in Alabama, Florida, and Tennessee. Survey questions explored measures of self-care behaviors and quality of life.

The caregivers had an average age of 66. They were mostly female (72.8%), white (91.2%), retired (54.4%), and the patient’s spouse/partner (60.2%). Nearly half of the caregivers lived in rural areas (46.9%), and more than half had annual incomes less than $50,000 (53.8%).

Most of the caregivers said they provided care 6 to 7 days a week (71%) for more than 1 year (68%).

Twenty-three percent of caregivers reported a high level of depressive symptoms, and 34% reported borderline or high levels of anxiety symptoms, associated with significantly lower scores for self-care.

Lower self-care behavior scores were associated with a longer overall duration of caregiving, more hours in the day spent caregiving, more days of the week spent caregiving, and with fair or poor patient health.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” Dr Dionne-Odom said. “These efforts would help ensure that caregivers are supported and healthy when they take on the important role of caring for an individual with advanced cancer.” 

Kathryn Hutchins

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Patients may face challenges when trying to access palliative and supportive care services at cancer centers, a new study suggests.

Researchers took a “mystery shopper” approach and placed calls to cancer centers inquiring about palliative and supportive care services for a family member.

The callers sometimes had difficulty obtaining information about these services, even though all of the centers offer them.

“It’s sobering to hear that such services are not readily accessible at many centers,” said study investigator Kathryn Hutchins, a medical student at Duke University in Durham, North Carolina.

“However, it provides an opportunity for cancer centers to empower their front-line staff, as well as the oncology care team, through education and training so that the entire enterprise has a common understanding of palliative care and how to access it.”

Hutchins and her colleagues presented this research at the 2016 Palliative Care in Oncology Symposium (abstract 122).

The researchers placed 160 calls to 40 major cancer centers. The team chose to focus on National Cancer Institute-designated cancer centers because they all provide palliative care services along with other supportive care services.

The researchers used the same script for every call, asking about services for a 58-year-old female who was recently diagnosed with inoperable liver cancer. The team called each center 4 times on different days.

In 38.2% of the calls, the researchers were not able to receive complete information about supportive care services.

In 9.5% of calls, cancer center staff gave an answer other than “yes” regarding the availability of palliative care services, even though such services were available.

The answers varied and included responses such as:

• Palliative care was for end-of-life patients only (n=2)
• No physicians specialized in symptom management (n=3)
• A medical record review would be needed first (n=2).

In addition, 10 staff members said they were unsure about the availability of palliative care, and 2 were unfamiliar with the term.

Overall, 37.6% of the callers were told that all 7 supportive care services they inquired about were offered.

“As oncologists, we like to believe that, when we refer patients to our institution’s helpline, they will get connected to the services they need, but that doesn’t always happen,” said study investigator Arif Kamal, MD, of Duke Cancer Institute.

“It’s important for oncologists to be aware of these barriers and to work to eliminate them.”

Kathryn Hutchins

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Patients may face challenges when trying to access palliative and supportive care services at cancer centers, a new study suggests.

Researchers took a “mystery shopper” approach and placed calls to cancer centers inquiring about palliative and supportive care services for a family member.

The callers sometimes had difficulty obtaining information about these services, even though all of the centers offer them.

“It’s sobering to hear that such services are not readily accessible at many centers,” said study investigator Kathryn Hutchins, a medical student at Duke University in Durham, North Carolina.

“However, it provides an opportunity for cancer centers to empower their front-line staff, as well as the oncology care team, through education and training so that the entire enterprise has a common understanding of palliative care and how to access it.”

Hutchins and her colleagues presented this research at the 2016 Palliative Care in Oncology Symposium (abstract 122).

The researchers placed 160 calls to 40 major cancer centers. The team chose to focus on National Cancer Institute-designated cancer centers because they all provide palliative care services along with other supportive care services.

The researchers used the same script for every call, asking about services for a 58-year-old female who was recently diagnosed with inoperable liver cancer. The team called each center 4 times on different days.

In 38.2% of the calls, the researchers were not able to receive complete information about supportive care services.

In 9.5% of calls, cancer center staff gave an answer other than “yes” regarding the availability of palliative care services, even though such services were available.

The answers varied and included responses such as:

• Palliative care was for end-of-life patients only (n=2)
• No physicians specialized in symptom management (n=3)
• A medical record review would be needed first (n=2).

In addition, 10 staff members said they were unsure about the availability of palliative care, and 2 were unfamiliar with the term.

Overall, 37.6% of the callers were told that all 7 supportive care services they inquired about were offered.

“As oncologists, we like to believe that, when we refer patients to our institution’s helpline, they will get connected to the services they need, but that doesn’t always happen,” said study investigator Arif Kamal, MD, of Duke Cancer Institute.

“It’s important for oncologists to be aware of these barriers and to work to eliminate them.”

Kathryn Hutchins

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Patients may face challenges when trying to access palliative and supportive care services at cancer centers, a new study suggests.

Researchers took a “mystery shopper” approach and placed calls to cancer centers inquiring about palliative and supportive care services for a family member.

The callers sometimes had difficulty obtaining information about these services, even though all of the centers offer them.

“It’s sobering to hear that such services are not readily accessible at many centers,” said study investigator Kathryn Hutchins, a medical student at Duke University in Durham, North Carolina.

“However, it provides an opportunity for cancer centers to empower their front-line staff, as well as the oncology care team, through education and training so that the entire enterprise has a common understanding of palliative care and how to access it.”

Hutchins and her colleagues presented this research at the 2016 Palliative Care in Oncology Symposium (abstract 122).

The researchers placed 160 calls to 40 major cancer centers. The team chose to focus on National Cancer Institute-designated cancer centers because they all provide palliative care services along with other supportive care services.

The researchers used the same script for every call, asking about services for a 58-year-old female who was recently diagnosed with inoperable liver cancer. The team called each center 4 times on different days.

In 38.2% of the calls, the researchers were not able to receive complete information about supportive care services.

In 9.5% of calls, cancer center staff gave an answer other than “yes” regarding the availability of palliative care services, even though such services were available.

The answers varied and included responses such as:

• Palliative care was for end-of-life patients only (n=2)
• No physicians specialized in symptom management (n=3)
• A medical record review would be needed first (n=2).

In addition, 10 staff members said they were unsure about the availability of palliative care, and 2 were unfamiliar with the term.

Overall, 37.6% of the callers were told that all 7 supportive care services they inquired about were offered.

“As oncologists, we like to believe that, when we refer patients to our institution’s helpline, they will get connected to the services they need, but that doesn’t always happen,” said study investigator Arif Kamal, MD, of Duke Cancer Institute.

“It’s important for oncologists to be aware of these barriers and to work to eliminate them.”

Erin Kent, PhD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—New research suggests caring for a loved one with cancer may be more burdensome than caring for a loved one with a different condition.

Researchers analyzed data from “Caregiving in the U.S. 2015,” an online panel study of unpaid adult caregivers.

The team compared cancer and non-cancer caregivers to determine similarities and differences in characteristics and experiences.

The findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 4).

The study included 1248 caregivers, age 18 and older at the time they were surveyed, who provided care to an adult patient. Seven percent of these caregivers were looking after patients with cancer.

Cancer caregivers reported spending more hours per week providing care than non-cancer caregivers—32.9 and 23.9 hours, respectively.

In addition, cancer caregivers were more likely than other caregivers to communicate with healthcare professionals (82% and 62%, respectively), monitor and adjust patients’ care (76% and 66%, respectively), and advocate on behalf of patients (62% and 49%, respectively).

Despite high levels of engagement with providers, cancer caregivers were nearly twice as likely as non-cancer caregivers to report needing more help and information with making end-of-life decisions—40% and 21%, respectively.

“Our research demonstrates the ripple effect that cancer has on families and patient support systems,” said study investigator Erin Kent, PhD, of the National Cancer Institute in Rockville, Maryland.

“Caregiving can be extremely stressful and demanding—physically, emotionally, and financially. The data show we need to do a better job of supporting these individuals, as their wellbeing is essential to the patient’s quality of life and outcomes.”

Dr Kent emphasized the cyclical nature of cancer care, often requiring short, highly intense periods of time where patients undergo active treatment as a possible reason for the increased intensity in caregiving. She noted that such intensity is also associated with increased caregiver stress and depression.

“Based on our findings, it’s clear we need additional research on caregiving to better understand at what point providers and clinicians should intervene to assess the wellbeing of caregivers,” Dr Kent said.

“Technology, combined with use of a clinical distress rating system, could be promising in the future as a means to ensure caregivers are being supported in a meaningful way.”

Erin Kent, PhD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—New research suggests caring for a loved one with cancer may be more burdensome than caring for a loved one with a different condition.

Researchers analyzed data from “Caregiving in the U.S. 2015,” an online panel study of unpaid adult caregivers.

The team compared cancer and non-cancer caregivers to determine similarities and differences in characteristics and experiences.

The findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 4).

The study included 1248 caregivers, age 18 and older at the time they were surveyed, who provided care to an adult patient. Seven percent of these caregivers were looking after patients with cancer.

Cancer caregivers reported spending more hours per week providing care than non-cancer caregivers—32.9 and 23.9 hours, respectively.

In addition, cancer caregivers were more likely than other caregivers to communicate with healthcare professionals (82% and 62%, respectively), monitor and adjust patients’ care (76% and 66%, respectively), and advocate on behalf of patients (62% and 49%, respectively).

Despite high levels of engagement with providers, cancer caregivers were nearly twice as likely as non-cancer caregivers to report needing more help and information with making end-of-life decisions—40% and 21%, respectively.

“Our research demonstrates the ripple effect that cancer has on families and patient support systems,” said study investigator Erin Kent, PhD, of the National Cancer Institute in Rockville, Maryland.

“Caregiving can be extremely stressful and demanding—physically, emotionally, and financially. The data show we need to do a better job of supporting these individuals, as their wellbeing is essential to the patient’s quality of life and outcomes.”

Dr Kent emphasized the cyclical nature of cancer care, often requiring short, highly intense periods of time where patients undergo active treatment as a possible reason for the increased intensity in caregiving. She noted that such intensity is also associated with increased caregiver stress and depression.

“Based on our findings, it’s clear we need additional research on caregiving to better understand at what point providers and clinicians should intervene to assess the wellbeing of caregivers,” Dr Kent said.

“Technology, combined with use of a clinical distress rating system, could be promising in the future as a means to ensure caregivers are being supported in a meaningful way.”

Erin Kent, PhD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—New research suggests caring for a loved one with cancer may be more burdensome than caring for a loved one with a different condition.

Researchers analyzed data from “Caregiving in the U.S. 2015,” an online panel study of unpaid adult caregivers.

The team compared cancer and non-cancer caregivers to determine similarities and differences in characteristics and experiences.

The findings were presented at the 2016 Palliative Care in Oncology Symposium (abstract 4).

The study included 1248 caregivers, age 18 and older at the time they were surveyed, who provided care to an adult patient. Seven percent of these caregivers were looking after patients with cancer.

Cancer caregivers reported spending more hours per week providing care than non-cancer caregivers—32.9 and 23.9 hours, respectively.

In addition, cancer caregivers were more likely than other caregivers to communicate with healthcare professionals (82% and 62%, respectively), monitor and adjust patients’ care (76% and 66%, respectively), and advocate on behalf of patients (62% and 49%, respectively).

Despite high levels of engagement with providers, cancer caregivers were nearly twice as likely as non-cancer caregivers to report needing more help and information with making end-of-life decisions—40% and 21%, respectively.

“Our research demonstrates the ripple effect that cancer has on families and patient support systems,” said study investigator Erin Kent, PhD, of the National Cancer Institute in Rockville, Maryland.

“Caregiving can be extremely stressful and demanding—physically, emotionally, and financially. The data show we need to do a better job of supporting these individuals, as their wellbeing is essential to the patient’s quality of life and outcomes.”

Dr Kent emphasized the cyclical nature of cancer care, often requiring short, highly intense periods of time where patients undergo active treatment as a possible reason for the increased intensity in caregiving. She noted that such intensity is also associated with increased caregiver stress and depression.

“Based on our findings, it’s clear we need additional research on caregiving to better understand at what point providers and clinicians should intervene to assess the wellbeing of caregivers,” Dr Kent said.

“Technology, combined with use of a clinical distress rating system, could be promising in the future as a means to ensure caregivers are being supported in a meaningful way.”

Ronald M. Epstein, MD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Results of the VOICE study showed that training advanced cancer patients and their oncologists on how to communicate resulted in more clinically meaningful discussions between the parties.

However, these discussions did not significantly improve patients’ understanding of their prognosis, have a significant impact on their quality of life or end-of-life care, or significantly improve the

patient-physician relationship.

Ronald Epstein, MD, of the University of Rochester in New York, and his colleagues reported results from this study in JAMA Oncology and at the 2016 Palliative Care in Oncology Symposium (abstract 2).

The VOICE study included 265 patients with stage 3 or 4 cancer, 130 of whom received communication training. As part of the training, patients received a booklet Dr Epstein’s team wrote called “My Cancer Care: What Now? What Next? What I Prefer.”

The patients and their caregivers also met with social workers or nurses to discuss commonly asked questions and how to express their fears, for example, or how to be assertive and state their preferences.

Of the 38 oncologists studied, 19 received communication training. This included mock office sessions with actors (known as standardized patients), video training, and individualized feedback.

Later, the researchers audio-recorded real sessions between the oncologists and patients, then asked both groups to fill out questionnaires. The team coded the interactions and matched the scores to the goals of the training.

Results

The study’s primary endpoint was a composite of 4 communication measures—engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information.

The researchers found that communication training resulted in a significant improvement in this endpoint (P=0.02).

“We have shown, in the first large study of its kind, that it is possible to change the conversation in advanced cancer,” Dr Epstein said. “This is a huge first step.”

However, when Dr Epstein and his colleagues looked at the individual components of the endpoint, only the engaging measure was significantly different between the intervention and control groups.

Communication training had no significant effect on the patient-physician relationship, patients’ quality of life, or healthcare utilization at the end of life.

Likewise, communication training had no significant effect on patients’ understanding of their prognosis, which was assessed by the discordance in 2-year survival estimates and curability estimates between patients and physicians.

“We need to try harder to communicate well so that it’s harder to miscommunicate,” Dr Epstein said. “Simply having the conversation is not enough. The quality of the conversation will influence a mutual understanding between patients and their oncologists.”

The researchers said a limitation of this study may have been the timing of the training, which was only provided once and not timed to key decision points during patients’ trajectories. The effects of the training may have waned over the months, especially as the cancer progressed.

“We need to embed communication interventions into the fabric of everyday clinical care,” Dr Epstein said. “This does not take a lot of time, but, in our audio-recordings, there was precious little dialogue that reaffirmed the human experience and the needs of patients. The next step is to make good communication the rule, not the exception, so that cancer patients’ voices can be heard.”

Ronald M. Epstein, MD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Results of the VOICE study showed that training advanced cancer patients and their oncologists on how to communicate resulted in more clinically meaningful discussions between the parties.

However, these discussions did not significantly improve patients’ understanding of their prognosis, have a significant impact on their quality of life or end-of-life care, or significantly improve the

patient-physician relationship.

Ronald Epstein, MD, of the University of Rochester in New York, and his colleagues reported results from this study in JAMA Oncology and at the 2016 Palliative Care in Oncology Symposium (abstract 2).

The VOICE study included 265 patients with stage 3 or 4 cancer, 130 of whom received communication training. As part of the training, patients received a booklet Dr Epstein’s team wrote called “My Cancer Care: What Now? What Next? What I Prefer.”

The patients and their caregivers also met with social workers or nurses to discuss commonly asked questions and how to express their fears, for example, or how to be assertive and state their preferences.

Of the 38 oncologists studied, 19 received communication training. This included mock office sessions with actors (known as standardized patients), video training, and individualized feedback.

Later, the researchers audio-recorded real sessions between the oncologists and patients, then asked both groups to fill out questionnaires. The team coded the interactions and matched the scores to the goals of the training.

Results

The study’s primary endpoint was a composite of 4 communication measures—engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information.

The researchers found that communication training resulted in a significant improvement in this endpoint (P=0.02).

“We have shown, in the first large study of its kind, that it is possible to change the conversation in advanced cancer,” Dr Epstein said. “This is a huge first step.”

However, when Dr Epstein and his colleagues looked at the individual components of the endpoint, only the engaging measure was significantly different between the intervention and control groups.

Communication training had no significant effect on the patient-physician relationship, patients’ quality of life, or healthcare utilization at the end of life.

Likewise, communication training had no significant effect on patients’ understanding of their prognosis, which was assessed by the discordance in 2-year survival estimates and curability estimates between patients and physicians.

“We need to try harder to communicate well so that it’s harder to miscommunicate,” Dr Epstein said. “Simply having the conversation is not enough. The quality of the conversation will influence a mutual understanding between patients and their oncologists.”

The researchers said a limitation of this study may have been the timing of the training, which was only provided once and not timed to key decision points during patients’ trajectories. The effects of the training may have waned over the months, especially as the cancer progressed.

“We need to embed communication interventions into the fabric of everyday clinical care,” Dr Epstein said. “This does not take a lot of time, but, in our audio-recordings, there was precious little dialogue that reaffirmed the human experience and the needs of patients. The next step is to make good communication the rule, not the exception, so that cancer patients’ voices can be heard.”

Ronald M. Epstein, MD

©ASCO/Todd Buchanan 2016

SAN FRANCISCO—Results of the VOICE study showed that training advanced cancer patients and their oncologists on how to communicate resulted in more clinically meaningful discussions between the parties.

However, these discussions did not significantly improve patients’ understanding of their prognosis, have a significant impact on their quality of life or end-of-life care, or significantly improve the

patient-physician relationship.

Ronald Epstein, MD, of the University of Rochester in New York, and his colleagues reported results from this study in JAMA Oncology and at the 2016 Palliative Care in Oncology Symposium (abstract 2).

The VOICE study included 265 patients with stage 3 or 4 cancer, 130 of whom received communication training. As part of the training, patients received a booklet Dr Epstein’s team wrote called “My Cancer Care: What Now? What Next? What I Prefer.”

The patients and their caregivers also met with social workers or nurses to discuss commonly asked questions and how to express their fears, for example, or how to be assertive and state their preferences.

Of the 38 oncologists studied, 19 received communication training. This included mock office sessions with actors (known as standardized patients), video training, and individualized feedback.

Later, the researchers audio-recorded real sessions between the oncologists and patients, then asked both groups to fill out questionnaires. The team coded the interactions and matched the scores to the goals of the training.

Results

The study’s primary endpoint was a composite of 4 communication measures—engaging patients in consultations, responding to emotions, informing patients about prognosis and treatment choices, and balanced framing of information.

The researchers found that communication training resulted in a significant improvement in this endpoint (P=0.02).

“We have shown, in the first large study of its kind, that it is possible to change the conversation in advanced cancer,” Dr Epstein said. “This is a huge first step.”

However, when Dr Epstein and his colleagues looked at the individual components of the endpoint, only the engaging measure was significantly different between the intervention and control groups.

Communication training had no significant effect on the patient-physician relationship, patients’ quality of life, or healthcare utilization at the end of life.

Likewise, communication training had no significant effect on patients’ understanding of their prognosis, which was assessed by the discordance in 2-year survival estimates and curability estimates between patients and physicians.

“We need to try harder to communicate well so that it’s harder to miscommunicate,” Dr Epstein said. “Simply having the conversation is not enough. The quality of the conversation will influence a mutual understanding between patients and their oncologists.”

The researchers said a limitation of this study may have been the timing of the training, which was only provided once and not timed to key decision points during patients’ trajectories. The effects of the training may have waned over the months, especially as the cancer progressed.

“We need to embed communication interventions into the fabric of everyday clinical care,” Dr Epstein said. “This does not take a lot of time, but, in our audio-recordings, there was precious little dialogue that reaffirmed the human experience and the needs of patients. The next step is to make good communication the rule, not the exception, so that cancer patients’ voices can be heard.”

HSCT preparation

Photo by Chad McNeeley

New research suggests hematopoietic stem cell transplant (HSCT) may increase the molecular age of peripheral blood T cells.

The study showed an increase in peripheral blood T-cell senescence in patients with hematologic malignancies who were treated with autologous (auto-) or allogeneic (allo-) HSCT.

The patients had elevated levels of p16INK4a, a known marker of cellular senescence.

Auto-HSCT in particular had a strong effect on p16INK4a, increasing the expression of this marker to a degree comparable to 30 years of chronological aging.

Researchers reported these findings in EBioMedicine.

“We know that transplant is life-prolonging, and, in many cases, it’s life-saving for many patients with blood cancers and other disorders,” said study author William Wood, MD, of the University of North Carolina School of Medicine in Chapel Hill.

“At the same time, we’re increasingly recognizing that survivors of transplant are at risk for long-term health problems, and so there is interest in determining what markers may exist to help predict risk for long-term health problems or even in helping choose which patients are best candidates for transplantation.”

With this in mind, Dr Wood and his colleagues looked at levels of p16INK4a in 63 patients who underwent auto- or allo-HSCT to treat myeloma, lymphoma, or leukemia. The researchers assessed p16INK4a expression in T cells before HSCT and 6 months after.

Among auto-HSCT recipients, there were no baseline characteristics associated with pre-transplant p16INK4a expression.

However, allo-HSCT recipients had significantly higher pre-transplant p16INK4a levels the more cycles of chemotherapy they received before transplant (P=0.003), if they had previously undergone auto-HSCT (P=0.01), and if they had been exposed to alkylating agents (P=0.01).

After transplant, allo-HSCT recipients had a 1.93-fold increase in p16INK4a expression (P=0.0004), and auto-HSCT recipients had a 3.05-fold increase (P=0.002).

The researchers said the measured change in p16INK4a from pre- to post-HSCT in allogeneic recipients likely underestimates the age-promoting effects of HSCT, given that the pre-HSCT levels were elevated in the recipients from prior therapeutic exposure.

The researchers also pointed out that this study does not show a clear connection between changes in p16INK4a levels and the actual function of peripheral blood T cells, but they did say that p16INK4a is “arguably one of the best in vivo markers of cellular senescence and is directly associated with age-related deterioration.”

So the results of this research suggest the forced bone marrow repopulation associated with HSCT accelerates the molecular aging of peripheral blood T cells.

“Many oncologists would not be surprised by the finding that stem cell transplant accelerates aspects of aging,” said study author Norman Sharpless, MD, of the University of North Carolina School of Medicine.

“We know that, years after a curative transplant, stem cell transplant survivors are at increased risk for blood problems that can occur with aging, such as reduced immunity, increased risk for bone marrow failure, and increased risk of blood cancers. What is important about this work, however, is that it allows us to quantify the effect of stem cell transplant on molecular age.”

HSCT preparation

Photo by Chad McNeeley

New research suggests hematopoietic stem cell transplant (HSCT) may increase the molecular age of peripheral blood T cells.

The study showed an increase in peripheral blood T-cell senescence in patients with hematologic malignancies who were treated with autologous (auto-) or allogeneic (allo-) HSCT.

The patients had elevated levels of p16INK4a, a known marker of cellular senescence.

Auto-HSCT in particular had a strong effect on p16INK4a, increasing the expression of this marker to a degree comparable to 30 years of chronological aging.

Researchers reported these findings in EBioMedicine.

“We know that transplant is life-prolonging, and, in many cases, it’s life-saving for many patients with blood cancers and other disorders,” said study author William Wood, MD, of the University of North Carolina School of Medicine in Chapel Hill.

“At the same time, we’re increasingly recognizing that survivors of transplant are at risk for long-term health problems, and so there is interest in determining what markers may exist to help predict risk for long-term health problems or even in helping choose which patients are best candidates for transplantation.”

With this in mind, Dr Wood and his colleagues looked at levels of p16INK4a in 63 patients who underwent auto- or allo-HSCT to treat myeloma, lymphoma, or leukemia. The researchers assessed p16INK4a expression in T cells before HSCT and 6 months after.

Among auto-HSCT recipients, there were no baseline characteristics associated with pre-transplant p16INK4a expression.

However, allo-HSCT recipients had significantly higher pre-transplant p16INK4a levels the more cycles of chemotherapy they received before transplant (P=0.003), if they had previously undergone auto-HSCT (P=0.01), and if they had been exposed to alkylating agents (P=0.01).

After transplant, allo-HSCT recipients had a 1.93-fold increase in p16INK4a expression (P=0.0004), and auto-HSCT recipients had a 3.05-fold increase (P=0.002).

The researchers said the measured change in p16INK4a from pre- to post-HSCT in allogeneic recipients likely underestimates the age-promoting effects of HSCT, given that the pre-HSCT levels were elevated in the recipients from prior therapeutic exposure.

The researchers also pointed out that this study does not show a clear connection between changes in p16INK4a levels and the actual function of peripheral blood T cells, but they did say that p16INK4a is “arguably one of the best in vivo markers of cellular senescence and is directly associated with age-related deterioration.”

So the results of this research suggest the forced bone marrow repopulation associated with HSCT accelerates the molecular aging of peripheral blood T cells.

“Many oncologists would not be surprised by the finding that stem cell transplant accelerates aspects of aging,” said study author Norman Sharpless, MD, of the University of North Carolina School of Medicine.

“We know that, years after a curative transplant, stem cell transplant survivors are at increased risk for blood problems that can occur with aging, such as reduced immunity, increased risk for bone marrow failure, and increased risk of blood cancers. What is important about this work, however, is that it allows us to quantify the effect of stem cell transplant on molecular age.”

HSCT preparation

Photo by Chad McNeeley

New research suggests hematopoietic stem cell transplant (HSCT) may increase the molecular age of peripheral blood T cells.

The study showed an increase in peripheral blood T-cell senescence in patients with hematologic malignancies who were treated with autologous (auto-) or allogeneic (allo-) HSCT.

The patients had elevated levels of p16INK4a, a known marker of cellular senescence.

Auto-HSCT in particular had a strong effect on p16INK4a, increasing the expression of this marker to a degree comparable to 30 years of chronological aging.

Researchers reported these findings in EBioMedicine.

“We know that transplant is life-prolonging, and, in many cases, it’s life-saving for many patients with blood cancers and other disorders,” said study author William Wood, MD, of the University of North Carolina School of Medicine in Chapel Hill.

“At the same time, we’re increasingly recognizing that survivors of transplant are at risk for long-term health problems, and so there is interest in determining what markers may exist to help predict risk for long-term health problems or even in helping choose which patients are best candidates for transplantation.”

With this in mind, Dr Wood and his colleagues looked at levels of p16INK4a in 63 patients who underwent auto- or allo-HSCT to treat myeloma, lymphoma, or leukemia. The researchers assessed p16INK4a expression in T cells before HSCT and 6 months after.

Among auto-HSCT recipients, there were no baseline characteristics associated with pre-transplant p16INK4a expression.

However, allo-HSCT recipients had significantly higher pre-transplant p16INK4a levels the more cycles of chemotherapy they received before transplant (P=0.003), if they had previously undergone auto-HSCT (P=0.01), and if they had been exposed to alkylating agents (P=0.01).

After transplant, allo-HSCT recipients had a 1.93-fold increase in p16INK4a expression (P=0.0004), and auto-HSCT recipients had a 3.05-fold increase (P=0.002).

The researchers said the measured change in p16INK4a from pre- to post-HSCT in allogeneic recipients likely underestimates the age-promoting effects of HSCT, given that the pre-HSCT levels were elevated in the recipients from prior therapeutic exposure.

The researchers also pointed out that this study does not show a clear connection between changes in p16INK4a levels and the actual function of peripheral blood T cells, but they did say that p16INK4a is “arguably one of the best in vivo markers of cellular senescence and is directly associated with age-related deterioration.”

So the results of this research suggest the forced bone marrow repopulation associated with HSCT accelerates the molecular aging of peripheral blood T cells.

“Many oncologists would not be surprised by the finding that stem cell transplant accelerates aspects of aging,” said study author Norman Sharpless, MD, of the University of North Carolina School of Medicine.

“We know that, years after a curative transplant, stem cell transplant survivors are at increased risk for blood problems that can occur with aging, such as reduced immunity, increased risk for bone marrow failure, and increased risk of blood cancers. What is important about this work, however, is that it allows us to quantify the effect of stem cell transplant on molecular age.”

Doctor evaluating a patient

Photo courtesy of the CDC

Cancer patients have a heightened risk of injuries 16 weeks before and after their diagnosis, according to a large study.

This includes injuries arising from medical complications and treatments, such as infections or bleeding after invasive treatment, and other types of injuries, such as bruising or fractures from self-harm and accidents.

Fang Fang, MD, PhD, of Karolinska Institutet in Stockholm, Sweden, and her colleagues reported these findings in The BMJ.

The researchers analyzed all injury-related hospital admissions in Swedish patients with cancer between 1990 and 2010. The team compared a diagnostic period—16 weeks before and after diagnosis—with a control period the year before diagnosis.

Among 720,901 patients, there were 7306 injuries from medical complications and drug treatments and 8331 injuries from accidents and self-harm that resulted in hospital admission during the diagnostic period.

Patients with central nervous system cancers had the highest risk of medical-related injuries—a 14.7-fold higher risk during the diagnostic period than the control period.

Patients with lymphatic or hematopoietic cancers had a 4-fold higher risk of such injuries during the diagnostic period than during the control period.

Patients who were younger, were cohabiting, had a higher socioeconomic status or education, and had no pre-existing psychiatric disorder had a higher risk of medical-related injuries during the diagnostic period than other groups of patients.

The risk of other types of injuries from self-harm and accidents was also higher during the diagnostic period. There was a 5.3-fold increased risk during the 2 weeks before diagnosis. The researchers said this suggests that psychological stress is high when patients are expecting a diagnosis.

Patients with lymphatic or hematopoietic cancers and patients with central nervous system cancers had the highest risk of self-harm and accidental injuries—a 2.8-fold increased risk during the diagnostic period compared to the control period (for both groups).

Older patients and those with lower socioeconomic status or education had slightly greater increases in the risk of self-harm and accidental injuries compared to other groups.

The researchers said the estimates of risk in this study are conservative because the team did not account for injuries that failed to result in a hospital admission or for those that were fatal.

Furthermore, this was an observational study, so no firm conclusions about cause and effect can be made.

Still, the researchers said this study sheds light on which patients might be at an increased risk of injuries, providing evidence for clinicians and policy makers to develop targeted prevention strategies.

Doctor evaluating a patient

Photo courtesy of the CDC

Cancer patients have a heightened risk of injuries 16 weeks before and after their diagnosis, according to a large study.

This includes injuries arising from medical complications and treatments, such as infections or bleeding after invasive treatment, and other types of injuries, such as bruising or fractures from self-harm and accidents.

Fang Fang, MD, PhD, of Karolinska Institutet in Stockholm, Sweden, and her colleagues reported these findings in The BMJ.

The researchers analyzed all injury-related hospital admissions in Swedish patients with cancer between 1990 and 2010. The team compared a diagnostic period—16 weeks before and after diagnosis—with a control period the year before diagnosis.

Among 720,901 patients, there were 7306 injuries from medical complications and drug treatments and 8331 injuries from accidents and self-harm that resulted in hospital admission during the diagnostic period.

Patients with central nervous system cancers had the highest risk of medical-related injuries—a 14.7-fold higher risk during the diagnostic period than the control period.

Patients with lymphatic or hematopoietic cancers had a 4-fold higher risk of such injuries during the diagnostic period than during the control period.

Patients who were younger, were cohabiting, had a higher socioeconomic status or education, and had no pre-existing psychiatric disorder had a higher risk of medical-related injuries during the diagnostic period than other groups of patients.

The risk of other types of injuries from self-harm and accidents was also higher during the diagnostic period. There was a 5.3-fold increased risk during the 2 weeks before diagnosis. The researchers said this suggests that psychological stress is high when patients are expecting a diagnosis.

Patients with lymphatic or hematopoietic cancers and patients with central nervous system cancers had the highest risk of self-harm and accidental injuries—a 2.8-fold increased risk during the diagnostic period compared to the control period (for both groups).

Older patients and those with lower socioeconomic status or education had slightly greater increases in the risk of self-harm and accidental injuries compared to other groups.

The researchers said the estimates of risk in this study are conservative because the team did not account for injuries that failed to result in a hospital admission or for those that were fatal.

Furthermore, this was an observational study, so no firm conclusions about cause and effect can be made.

Still, the researchers said this study sheds light on which patients might be at an increased risk of injuries, providing evidence for clinicians and policy makers to develop targeted prevention strategies.

Doctor evaluating a patient

Photo courtesy of the CDC

Cancer patients have a heightened risk of injuries 16 weeks before and after their diagnosis, according to a large study.

This includes injuries arising from medical complications and treatments, such as infections or bleeding after invasive treatment, and other types of injuries, such as bruising or fractures from self-harm and accidents.

Fang Fang, MD, PhD, of Karolinska Institutet in Stockholm, Sweden, and her colleagues reported these findings in The BMJ.

The researchers analyzed all injury-related hospital admissions in Swedish patients with cancer between 1990 and 2010. The team compared a diagnostic period—16 weeks before and after diagnosis—with a control period the year before diagnosis.

Among 720,901 patients, there were 7306 injuries from medical complications and drug treatments and 8331 injuries from accidents and self-harm that resulted in hospital admission during the diagnostic period.

Patients with central nervous system cancers had the highest risk of medical-related injuries—a 14.7-fold higher risk during the diagnostic period than the control period.

Patients with lymphatic or hematopoietic cancers had a 4-fold higher risk of such injuries during the diagnostic period than during the control period.

Patients who were younger, were cohabiting, had a higher socioeconomic status or education, and had no pre-existing psychiatric disorder had a higher risk of medical-related injuries during the diagnostic period than other groups of patients.

The risk of other types of injuries from self-harm and accidents was also higher during the diagnostic period. There was a 5.3-fold increased risk during the 2 weeks before diagnosis. The researchers said this suggests that psychological stress is high when patients are expecting a diagnosis.

Patients with lymphatic or hematopoietic cancers and patients with central nervous system cancers had the highest risk of self-harm and accidental injuries—a 2.8-fold increased risk during the diagnostic period compared to the control period (for both groups).

Older patients and those with lower socioeconomic status or education had slightly greater increases in the risk of self-harm and accidental injuries compared to other groups.

The researchers said the estimates of risk in this study are conservative because the team did not account for injuries that failed to result in a hospital admission or for those that were fatal.

Furthermore, this was an observational study, so no firm conclusions about cause and effect can be made.

Still, the researchers said this study sheds light on which patients might be at an increased risk of injuries, providing evidence for clinicians and policy makers to develop targeted prevention strategies.

Cancer patient receiving

chemotherapy

Photo by Rhoda Baer

The European Society of Cardiology (ESC) has launched a novel position paper, under the auspices of its Committee for Practice Guidelines, on the cardiac toxicity of anticancer therapies.

The paper is a summary and evaluation of relevant scientific evidence that is intended to assist health professionals in selecting the best strategies for preventing and managing cardiac toxicity in patients with cancer, including leukemia, lymphoma, and multiple myeloma.

The paper was published in European Heart Journal and on the ESC website.

The document reviews the potential cardiovascular complications of anticancer therapies.

The complications are divided into 9 categories: myocardial dysfunction and heart failure, coronary artery disease, valvular disease, arrhythmias, arterial hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension, and pericardial complications.

For each type of complication, the authors outline which patients are at risk and how to detect and prevent the possible side effects. Recommendations are given on how to treat and follow patients who develop that type of cardiotoxicity.

Cardiotoxicity is detected using electrocardiogram, cardiac imaging, and biomarkers. Prevention and treatment may involve the use of cardioprotective drugs (such as angiotensin converting enzyme inhibitors or beta-blockers) and adopting a healthy lifestyle (eating a healthy diet, not smoking, exercising regularly, and controlling body weight).

Regarding long-term surveillance for cancer survivors, the paper says patients should be informed of their increased risk of cardiovascular disease at the outset of cancer treatment and supported to make lifestyle changes. They should be told to report early signs and symptoms of cardiovascular disease promptly.

The paper also emphasizes the importance of establishing multidisciplinary teams to provide the best care for cancer patients and survivors. These should include cardiologists, oncologists, nurses, and heart failure and imaging specialists. Ultimately, cardio-oncology centers with a structured service are needed.

The authors note that under- or over-diagnosis of cardiovascular disease sometimes results in failure to prevent adverse events or inappropriate interruption of a potentially life-saving anticancer treatment.

“We need to be clear when it’s a must to stop the treatment, when we should reduce the dose, or when we can continue with the therapy,” said author Jose Luis Zamorano, MD, of University Hospital Ramón in Madrid, Spain. “This position paper provides guidance in this area.”

“We hope the paper will increase awareness about heart disease in cancer patients and survivors and stimulate more research in this area,” added author Patrizio Lancellotti, MD, PhD, of University of Liège Hospital in Liège, Belgium.

“More information is needed on when to screen and monitor patients and on the cardiovascular effects of new anticancer therapies.”

Cancer patient receiving

chemotherapy

Photo by Rhoda Baer

The European Society of Cardiology (ESC) has launched a novel position paper, under the auspices of its Committee for Practice Guidelines, on the cardiac toxicity of anticancer therapies.

The paper is a summary and evaluation of relevant scientific evidence that is intended to assist health professionals in selecting the best strategies for preventing and managing cardiac toxicity in patients with cancer, including leukemia, lymphoma, and multiple myeloma.

The paper was published in European Heart Journal and on the ESC website.

The document reviews the potential cardiovascular complications of anticancer therapies.

The complications are divided into 9 categories: myocardial dysfunction and heart failure, coronary artery disease, valvular disease, arrhythmias, arterial hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension, and pericardial complications.

For each type of complication, the authors outline which patients are at risk and how to detect and prevent the possible side effects. Recommendations are given on how to treat and follow patients who develop that type of cardiotoxicity.

Cardiotoxicity is detected using electrocardiogram, cardiac imaging, and biomarkers. Prevention and treatment may involve the use of cardioprotective drugs (such as angiotensin converting enzyme inhibitors or beta-blockers) and adopting a healthy lifestyle (eating a healthy diet, not smoking, exercising regularly, and controlling body weight).

Regarding long-term surveillance for cancer survivors, the paper says patients should be informed of their increased risk of cardiovascular disease at the outset of cancer treatment and supported to make lifestyle changes. They should be told to report early signs and symptoms of cardiovascular disease promptly.

The paper also emphasizes the importance of establishing multidisciplinary teams to provide the best care for cancer patients and survivors. These should include cardiologists, oncologists, nurses, and heart failure and imaging specialists. Ultimately, cardio-oncology centers with a structured service are needed.

The authors note that under- or over-diagnosis of cardiovascular disease sometimes results in failure to prevent adverse events or inappropriate interruption of a potentially life-saving anticancer treatment.

“We need to be clear when it’s a must to stop the treatment, when we should reduce the dose, or when we can continue with the therapy,” said author Jose Luis Zamorano, MD, of University Hospital Ramón in Madrid, Spain. “This position paper provides guidance in this area.”

“We hope the paper will increase awareness about heart disease in cancer patients and survivors and stimulate more research in this area,” added author Patrizio Lancellotti, MD, PhD, of University of Liège Hospital in Liège, Belgium.

“More information is needed on when to screen and monitor patients and on the cardiovascular effects of new anticancer therapies.”

Cancer patient receiving

chemotherapy

Photo by Rhoda Baer

The European Society of Cardiology (ESC) has launched a novel position paper, under the auspices of its Committee for Practice Guidelines, on the cardiac toxicity of anticancer therapies.

The paper is a summary and evaluation of relevant scientific evidence that is intended to assist health professionals in selecting the best strategies for preventing and managing cardiac toxicity in patients with cancer, including leukemia, lymphoma, and multiple myeloma.

The paper was published in European Heart Journal and on the ESC website.

The document reviews the potential cardiovascular complications of anticancer therapies.

The complications are divided into 9 categories: myocardial dysfunction and heart failure, coronary artery disease, valvular disease, arrhythmias, arterial hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension, and pericardial complications.

For each type of complication, the authors outline which patients are at risk and how to detect and prevent the possible side effects. Recommendations are given on how to treat and follow patients who develop that type of cardiotoxicity.

Cardiotoxicity is detected using electrocardiogram, cardiac imaging, and biomarkers. Prevention and treatment may involve the use of cardioprotective drugs (such as angiotensin converting enzyme inhibitors or beta-blockers) and adopting a healthy lifestyle (eating a healthy diet, not smoking, exercising regularly, and controlling body weight).

Regarding long-term surveillance for cancer survivors, the paper says patients should be informed of their increased risk of cardiovascular disease at the outset of cancer treatment and supported to make lifestyle changes. They should be told to report early signs and symptoms of cardiovascular disease promptly.

The paper also emphasizes the importance of establishing multidisciplinary teams to provide the best care for cancer patients and survivors. These should include cardiologists, oncologists, nurses, and heart failure and imaging specialists. Ultimately, cardio-oncology centers with a structured service are needed.

The authors note that under- or over-diagnosis of cardiovascular disease sometimes results in failure to prevent adverse events or inappropriate interruption of a potentially life-saving anticancer treatment.

“We need to be clear when it’s a must to stop the treatment, when we should reduce the dose, or when we can continue with the therapy,” said author Jose Luis Zamorano, MD, of University Hospital Ramón in Madrid, Spain. “This position paper provides guidance in this area.”

“We hope the paper will increase awareness about heart disease in cancer patients and survivors and stimulate more research in this area,” added author Patrizio Lancellotti, MD, PhD, of University of Liège Hospital in Liège, Belgium.

“More information is needed on when to screen and monitor patients and on the cardiovascular effects of new anticancer therapies.”

Daratumumab (Darzalex)

Photo courtesy of Janssen

Results of the phase 3 CASTOR trial suggest that adding daratumumab to treatment with bortezomib and dexamethasone can improve progression-free survival (PFS) in patients with previously treated multiple myeloma (MM).

Compared to patients who received only bortezomib and dexamethasone, those who received daratumumab as well had a higher response rate and longer PFS, but they also had a higher incidence of grade 3/4 adverse events (AEs).

These results were recently published in NEJM. They were previously presented at the 2016 ASCO Annual Meeting. The CASTOR trial was funded by Janssen Research & Development.

The trial enrolled 498 patients with relapsed or relapsed and refractory MM. Patients were randomized to receive bortezomib (1.3 mg/m²) and dexamethasone (20 mg) alone (control arm) or in combination with daratumumab (16 mg/kg).

Baseline characteristics were well balanced between the treatment arms. Across both groups, the median patient age was 64 (range, 30 to 88), the median time since MM diagnosis was 3.8 years, and the patients had received a median of 2 (range, 1 to 10) previous lines of therapy.

Efficacy

The overall response rate was significantly higher in the daratumumab arm than the control arm—82.9% and 63.2%, respectively (P<0.001). The rate of complete response or better was higher in the daratumumab arm as well—19.2% and 9.0%, respectively (P=0.001).

After a median follow-up of 7.4 months, the median PFS was not reached in the daratumumab arm and was 7.2 months in the control arm (hazard ratio=0.39, P<0.001). The estimated 12-month PFS was 60.7% and 26.9%, respectively.

Overall survival was not reached in either treatment arm.

This trial was unblinded after meeting its primary endpoint of improved PFS in this interim analysis. Based on the recommendation of an independent data monitoring committee, patients in the control arm were offered the option to receive daratumumab following confirmed disease progression.

Safety

AEs occurred in 98.8% of patients in the daratumumab arm and 95.4% of patients in the control arm. Grade 3/4 AEs occurred in 76.1% and 62.4%, respectively.

There was a higher incidence of the following AEs in the daratumumab arm than the control arm—thrombocytopenia (58.8% vs 43.9%), neutropenia (17.7% vs 9.3%), lymphopenia (13.2% vs 3.8%),  peripheral sensory neuropathy (47.3% vs 37.6%), bleeding events (7.0% vs 3.8%), and secondary primary cancers (2.5% vs 0.4%).

Infusion-related reactions associated with daratumumab were reported in 45.3% of patients. These reactions were mostly grade 1 or 2.

The percentage of patients who discontinued treatment because of at least 1 AE was similar between the daratumumab and control arms (7.4% and 9.3%, respectively).

Daratumumab (Darzalex)

Photo courtesy of Janssen

Results of the phase 3 CASTOR trial suggest that adding daratumumab to treatment with bortezomib and dexamethasone can improve progression-free survival (PFS) in patients with previously treated multiple myeloma (MM).

Compared to patients who received only bortezomib and dexamethasone, those who received daratumumab as well had a higher response rate and longer PFS, but they also had a higher incidence of grade 3/4 adverse events (AEs).

These results were recently published in NEJM. They were previously presented at the 2016 ASCO Annual Meeting. The CASTOR trial was funded by Janssen Research & Development.

The trial enrolled 498 patients with relapsed or relapsed and refractory MM. Patients were randomized to receive bortezomib (1.3 mg/m²) and dexamethasone (20 mg) alone (control arm) or in combination with daratumumab (16 mg/kg).

Baseline characteristics were well balanced between the treatment arms. Across both groups, the median patient age was 64 (range, 30 to 88), the median time since MM diagnosis was 3.8 years, and the patients had received a median of 2 (range, 1 to 10) previous lines of therapy.

Efficacy

The overall response rate was significantly higher in the daratumumab arm than the control arm—82.9% and 63.2%, respectively (P<0.001). The rate of complete response or better was higher in the daratumumab arm as well—19.2% and 9.0%, respectively (P=0.001).

After a median follow-up of 7.4 months, the median PFS was not reached in the daratumumab arm and was 7.2 months in the control arm (hazard ratio=0.39, P<0.001). The estimated 12-month PFS was 60.7% and 26.9%, respectively.

Overall survival was not reached in either treatment arm.

This trial was unblinded after meeting its primary endpoint of improved PFS in this interim analysis. Based on the recommendation of an independent data monitoring committee, patients in the control arm were offered the option to receive daratumumab following confirmed disease progression.

Safety

AEs occurred in 98.8% of patients in the daratumumab arm and 95.4% of patients in the control arm. Grade 3/4 AEs occurred in 76.1% and 62.4%, respectively.

There was a higher incidence of the following AEs in the daratumumab arm than the control arm—thrombocytopenia (58.8% vs 43.9%), neutropenia (17.7% vs 9.3%), lymphopenia (13.2% vs 3.8%),  peripheral sensory neuropathy (47.3% vs 37.6%), bleeding events (7.0% vs 3.8%), and secondary primary cancers (2.5% vs 0.4%).

Infusion-related reactions associated with daratumumab were reported in 45.3% of patients. These reactions were mostly grade 1 or 2.

The percentage of patients who discontinued treatment because of at least 1 AE was similar between the daratumumab and control arms (7.4% and 9.3%, respectively).

Daratumumab (Darzalex)

Photo courtesy of Janssen

Results of the phase 3 CASTOR trial suggest that adding daratumumab to treatment with bortezomib and dexamethasone can improve progression-free survival (PFS) in patients with previously treated multiple myeloma (MM).

Compared to patients who received only bortezomib and dexamethasone, those who received daratumumab as well had a higher response rate and longer PFS, but they also had a higher incidence of grade 3/4 adverse events (AEs).

These results were recently published in NEJM. They were previously presented at the 2016 ASCO Annual Meeting. The CASTOR trial was funded by Janssen Research & Development.

The trial enrolled 498 patients with relapsed or relapsed and refractory MM. Patients were randomized to receive bortezomib (1.3 mg/m²) and dexamethasone (20 mg) alone (control arm) or in combination with daratumumab (16 mg/kg).

Baseline characteristics were well balanced between the treatment arms. Across both groups, the median patient age was 64 (range, 30 to 88), the median time since MM diagnosis was 3.8 years, and the patients had received a median of 2 (range, 1 to 10) previous lines of therapy.

Efficacy

The overall response rate was significantly higher in the daratumumab arm than the control arm—82.9% and 63.2%, respectively (P<0.001). The rate of complete response or better was higher in the daratumumab arm as well—19.2% and 9.0%, respectively (P=0.001).

After a median follow-up of 7.4 months, the median PFS was not reached in the daratumumab arm and was 7.2 months in the control arm (hazard ratio=0.39, P<0.001). The estimated 12-month PFS was 60.7% and 26.9%, respectively.

Overall survival was not reached in either treatment arm.

This trial was unblinded after meeting its primary endpoint of improved PFS in this interim analysis. Based on the recommendation of an independent data monitoring committee, patients in the control arm were offered the option to receive daratumumab following confirmed disease progression.

Safety

AEs occurred in 98.8% of patients in the daratumumab arm and 95.4% of patients in the control arm. Grade 3/4 AEs occurred in 76.1% and 62.4%, respectively.

There was a higher incidence of the following AEs in the daratumumab arm than the control arm—thrombocytopenia (58.8% vs 43.9%), neutropenia (17.7% vs 9.3%), lymphopenia (13.2% vs 3.8%),  peripheral sensory neuropathy (47.3% vs 37.6%), bleeding events (7.0% vs 3.8%), and secondary primary cancers (2.5% vs 0.4%).

Infusion-related reactions associated with daratumumab were reported in 45.3% of patients. These reactions were mostly grade 1 or 2.

The percentage of patients who discontinued treatment because of at least 1 AE was similar between the daratumumab and control arms (7.4% and 9.3%, respectively).

Daratumumab significantly improved survival when added to the current two-drug regimen for multiple myeloma, according to published data from a phase III study.

Patients treated with the anti-CD38 antibody in addition to the current standard treatment combination of bortezomib and dexamethasone had a 61% progression-free survival rate compared with a 27% rate seen in controls who received only bortezomib and dexamethasone.

The study results were presented initially at the annual meeting of the American Society of Hematology in 2015.

After an average follow-up of 7 months, 67 disease-progression events or deaths occurred in the daratumumab group, compared with 122 in the control group. Overall treatment response rates also were significantly higher in the daratumumab group compared with controls (83% vs. 63%), reported Antonio Palumbo, MD, of the University of Turin, Italy, and his associates in the CASTOR study.

The multicenter, randomized trial included 251 multiple myeloma patients in the daratumumab group 247 patients in the control group. Demographics were similar between the groups; the median patient age was 64 years.

Although more than 95% of patients in each group reported at least one adverse event, fewer than 10% of patients in each group discontinued treatment as a result. The most common adverse events associated with discontinuation were peripheral sensory neuropathy and pneumonia (N Engl J Med 2016;375:754-66).

The study was funded by Janssen Research and Development.

Daratumumab significantly improved survival when added to the current two-drug regimen for multiple myeloma, according to published data from a phase III study.

Patients treated with the anti-CD38 antibody in addition to the current standard treatment combination of bortezomib and dexamethasone had a 61% progression-free survival rate compared with a 27% rate seen in controls who received only bortezomib and dexamethasone.

The study results were presented initially at the annual meeting of the American Society of Hematology in 2015.

After an average follow-up of 7 months, 67 disease-progression events or deaths occurred in the daratumumab group, compared with 122 in the control group. Overall treatment response rates also were significantly higher in the daratumumab group compared with controls (83% vs. 63%), reported Antonio Palumbo, MD, of the University of Turin, Italy, and his associates in the CASTOR study.

The multicenter, randomized trial included 251 multiple myeloma patients in the daratumumab group 247 patients in the control group. Demographics were similar between the groups; the median patient age was 64 years.

Although more than 95% of patients in each group reported at least one adverse event, fewer than 10% of patients in each group discontinued treatment as a result. The most common adverse events associated with discontinuation were peripheral sensory neuropathy and pneumonia (N Engl J Med 2016;375:754-66).

The study was funded by Janssen Research and Development.

Daratumumab significantly improved survival when added to the current two-drug regimen for multiple myeloma, according to published data from a phase III study.

Patients treated with the anti-CD38 antibody in addition to the current standard treatment combination of bortezomib and dexamethasone had a 61% progression-free survival rate compared with a 27% rate seen in controls who received only bortezomib and dexamethasone.

The study results were presented initially at the annual meeting of the American Society of Hematology in 2015.

After an average follow-up of 7 months, 67 disease-progression events or deaths occurred in the daratumumab group, compared with 122 in the control group. Overall treatment response rates also were significantly higher in the daratumumab group compared with controls (83% vs. 63%), reported Antonio Palumbo, MD, of the University of Turin, Italy, and his associates in the CASTOR study.

The multicenter, randomized trial included 251 multiple myeloma patients in the daratumumab group 247 patients in the control group. Demographics were similar between the groups; the median patient age was 64 years.

Although more than 95% of patients in each group reported at least one adverse event, fewer than 10% of patients in each group discontinued treatment as a result. The most common adverse events associated with discontinuation were peripheral sensory neuropathy and pneumonia (N Engl J Med 2016;375:754-66).

The study was funded by Janssen Research and Development.