Multiple Myeloma

Photo courtesy of NIH

Primary care may not meet the healthcare needs of cancer survivors in the US, according to research published in JAMA Internal Medicine.

Researchers examined 12 advanced primary care practices selected from a national registry of “workforce innovators” and found that none of these practices had a comprehensive survivorship care program in place.

In addition, there were 3 main barriers to survivorship care—not treating cancer survivors as a distinct population, limitations of electronic health records, and a lack of information and guidance for clinicians.

“This is troubling because these are highly innovative practices that have a national reputation,” said study author Benjamin Crabtree, PhD, of Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey.

Dr Crabtree and his colleagues evaluated survivorship care* at the 12 practices, which were based in Colorado, Illinois, Maine, New York, Pennsylvania, and Washington.

Over nearly 2 years, the team spent 10 to 12 days observing each of the practices and interviewing clinicians and administrators.

In this way, the researchers identified 3 main barriers to integrating survivorship care into primary medicine.

Barrier 1

The first barrier was that clinicians did not treat cancer survivors as a distinct population or clinical category.

“There is no diagnosis code for ‘cancer survivor’ that can be entered into the medical record, which is important if you want physicians to pay attention,” Dr Crabtree said.

Some of the clinicians interviewed said their care was comprehensive enough to address the needs of all patients. Other clinicians did not understand what survivorship care entails.

Barrier 2

The second barrier was that electronic health record systems didn’t support survivorship care.

Clinicians reported an inability to identify patients with a history of cancer. Even if a patient’s cancer history was included in his or her record, it might take searching through multiple screens to find the information.

In addition, medical records were sometimes lost as patients changed clinicians over the years, which left it up to patients to report their cancer histories.

Barrier 3

The third barrier was that clinicians did not receive adequate information or guidance for follow-up care of cancer survivors.

Although some of the practices received cancer-related information about their patients, it was considered “inadequate” or “not actionable.”

Clinicians expressed concerns about their knowledge gaps in cancer care and the need to monitor changing information in oncology.

“There is nothing in the residency curriculum about cancer survivorship,” Dr Crabtree said. “There is also nothing in Continuing Medical Education courses. It’s just not there.”

Dr Crabtree and his colleagues believe these barriers must be addressed so that comprehensive cancer survivorship services can move to the forefront of primary care.

* Survivorship care includes checking for cancer recurrence, monitoring long-term effects of radiation and chemotherapy, and assessing a patient’s psychological well-being.

Photo courtesy of NIH

Primary care may not meet the healthcare needs of cancer survivors in the US, according to research published in JAMA Internal Medicine.

Researchers examined 12 advanced primary care practices selected from a national registry of “workforce innovators” and found that none of these practices had a comprehensive survivorship care program in place.

In addition, there were 3 main barriers to survivorship care—not treating cancer survivors as a distinct population, limitations of electronic health records, and a lack of information and guidance for clinicians.

“This is troubling because these are highly innovative practices that have a national reputation,” said study author Benjamin Crabtree, PhD, of Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey.

Dr Crabtree and his colleagues evaluated survivorship care* at the 12 practices, which were based in Colorado, Illinois, Maine, New York, Pennsylvania, and Washington.

Over nearly 2 years, the team spent 10 to 12 days observing each of the practices and interviewing clinicians and administrators.

In this way, the researchers identified 3 main barriers to integrating survivorship care into primary medicine.

Barrier 1

The first barrier was that clinicians did not treat cancer survivors as a distinct population or clinical category.

“There is no diagnosis code for ‘cancer survivor’ that can be entered into the medical record, which is important if you want physicians to pay attention,” Dr Crabtree said.

Some of the clinicians interviewed said their care was comprehensive enough to address the needs of all patients. Other clinicians did not understand what survivorship care entails.

Barrier 2

The second barrier was that electronic health record systems didn’t support survivorship care.

Clinicians reported an inability to identify patients with a history of cancer. Even if a patient’s cancer history was included in his or her record, it might take searching through multiple screens to find the information.

In addition, medical records were sometimes lost as patients changed clinicians over the years, which left it up to patients to report their cancer histories.

Barrier 3

The third barrier was that clinicians did not receive adequate information or guidance for follow-up care of cancer survivors.

Although some of the practices received cancer-related information about their patients, it was considered “inadequate” or “not actionable.”

Clinicians expressed concerns about their knowledge gaps in cancer care and the need to monitor changing information in oncology.

“There is nothing in the residency curriculum about cancer survivorship,” Dr Crabtree said. “There is also nothing in Continuing Medical Education courses. It’s just not there.”

Dr Crabtree and his colleagues believe these barriers must be addressed so that comprehensive cancer survivorship services can move to the forefront of primary care.

* Survivorship care includes checking for cancer recurrence, monitoring long-term effects of radiation and chemotherapy, and assessing a patient’s psychological well-being.

Photo courtesy of NIH

Primary care may not meet the healthcare needs of cancer survivors in the US, according to research published in JAMA Internal Medicine.

Researchers examined 12 advanced primary care practices selected from a national registry of “workforce innovators” and found that none of these practices had a comprehensive survivorship care program in place.

In addition, there were 3 main barriers to survivorship care—not treating cancer survivors as a distinct population, limitations of electronic health records, and a lack of information and guidance for clinicians.

“This is troubling because these are highly innovative practices that have a national reputation,” said study author Benjamin Crabtree, PhD, of Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey.

Dr Crabtree and his colleagues evaluated survivorship care* at the 12 practices, which were based in Colorado, Illinois, Maine, New York, Pennsylvania, and Washington.

Over nearly 2 years, the team spent 10 to 12 days observing each of the practices and interviewing clinicians and administrators.

In this way, the researchers identified 3 main barriers to integrating survivorship care into primary medicine.

Barrier 1

The first barrier was that clinicians did not treat cancer survivors as a distinct population or clinical category.

“There is no diagnosis code for ‘cancer survivor’ that can be entered into the medical record, which is important if you want physicians to pay attention,” Dr Crabtree said.

Some of the clinicians interviewed said their care was comprehensive enough to address the needs of all patients. Other clinicians did not understand what survivorship care entails.

Barrier 2

The second barrier was that electronic health record systems didn’t support survivorship care.

Clinicians reported an inability to identify patients with a history of cancer. Even if a patient’s cancer history was included in his or her record, it might take searching through multiple screens to find the information.

In addition, medical records were sometimes lost as patients changed clinicians over the years, which left it up to patients to report their cancer histories.

Barrier 3

The third barrier was that clinicians did not receive adequate information or guidance for follow-up care of cancer survivors.

Although some of the practices received cancer-related information about their patients, it was considered “inadequate” or “not actionable.”

Clinicians expressed concerns about their knowledge gaps in cancer care and the need to monitor changing information in oncology.

“There is nothing in the residency curriculum about cancer survivorship,” Dr Crabtree said. “There is also nothing in Continuing Medical Education courses. It’s just not there.”

Dr Crabtree and his colleagues believe these barriers must be addressed so that comprehensive cancer survivorship services can move to the forefront of primary care.

* Survivorship care includes checking for cancer recurrence, monitoring long-term effects of radiation and chemotherapy, and assessing a patient’s psychological well-being.

Woman on a scale

Cancers associated with being overweight or obese accounted for about 40% of all cancers diagnosed in the US in 2014, according to the latest Vital Signs report by the US Centers for Disease Control and Prevention.

The International Agency for Research on Cancer has identified 13 cancers associated with overweight and obesity—multiple myeloma (MM), meningioma, adenocarcinoma of the esophagus, and thyroid, postmenopausal breast, gallbladder, stomach, liver, pancreatic, kidney, ovarian, uterine, and colorectal cancers.

For the Vital Signs report, researchers reviewed US data from 2005 to 2014 to determine trends for cancers associated with being overweight (having a body mass index [BMI] of 25 to 29.9 kg/m²) or obese (having a BMI of 30 kg/m² and higher).

In 2014, roughly 631,000 people were diagnosed with cancers associated with overweight and obesity, which represents 40% of all cancers diagnosed.

Fifty-five percent of all cancers diagnosed in women and 24% of those diagnosed in men were associated with overweight and obesity.

Incidence rates of the 13 cancers combined were highest in non-Hispanic blacks, followed by non-Hispanic whites, American Indians/Alaska Natives, Hispanics, and Asians/Pacific Islanders.

Incidence over time

Overall, the incidence of cancers associated with overweight and obesity decreased 2% from 2005 to 2014.

However, when colorectal cancer was excluded, the incidence of the other 12 cancers combined increased 7% from 2005 to 2014. The incidence of colorectal cancer decreased 23% during that time. Researchers said this was due, in large part, to screening.

The incidence of cancers not associated with overweight and obesity decreased 13% from 2005 to 2014.

The incidence of MM increased over the period studied, but it was not a significant increase. The incidence rate of MM was 5.6 per 100,000 persons (age-adjusted to the 2000 US standard population) in 2005 and 6.0 per 100,000 persons in 2014.

So overall, there was an 8% increase in MM incidence rate from 2005 to 2014, or a 1.1% average annual increase. There was a 2% increase in the risk of MM per 1 kg/m² increase in BMI.

Like MM, 3 other cancers had fairly stable incidence rates over the study period—adenocarcinoma of the esophagus, gallbladder cancer, and postmenopausal breast cancer.

However, incidence rates increased significantly each year for thyroid cancer (4.0% per year), liver cancer (2.9%), gastric cardia cancer (1.2%), endometrial cancer (1.1%), pancreatic cancer (0.8%), and kidney cancer (0.7%).

And incidence rates decreased signifi­cantly each year for meningioma (-3.8%), colorectal cancer (-2.9%), and ovarian cancer (-2.0%).

Woman on a scale

Cancers associated with being overweight or obese accounted for about 40% of all cancers diagnosed in the US in 2014, according to the latest Vital Signs report by the US Centers for Disease Control and Prevention.

The International Agency for Research on Cancer has identified 13 cancers associated with overweight and obesity—multiple myeloma (MM), meningioma, adenocarcinoma of the esophagus, and thyroid, postmenopausal breast, gallbladder, stomach, liver, pancreatic, kidney, ovarian, uterine, and colorectal cancers.

For the Vital Signs report, researchers reviewed US data from 2005 to 2014 to determine trends for cancers associated with being overweight (having a body mass index [BMI] of 25 to 29.9 kg/m²) or obese (having a BMI of 30 kg/m² and higher).

In 2014, roughly 631,000 people were diagnosed with cancers associated with overweight and obesity, which represents 40% of all cancers diagnosed.

Fifty-five percent of all cancers diagnosed in women and 24% of those diagnosed in men were associated with overweight and obesity.

Incidence rates of the 13 cancers combined were highest in non-Hispanic blacks, followed by non-Hispanic whites, American Indians/Alaska Natives, Hispanics, and Asians/Pacific Islanders.

Incidence over time

Overall, the incidence of cancers associated with overweight and obesity decreased 2% from 2005 to 2014.

However, when colorectal cancer was excluded, the incidence of the other 12 cancers combined increased 7% from 2005 to 2014. The incidence of colorectal cancer decreased 23% during that time. Researchers said this was due, in large part, to screening.

The incidence of cancers not associated with overweight and obesity decreased 13% from 2005 to 2014.

The incidence of MM increased over the period studied, but it was not a significant increase. The incidence rate of MM was 5.6 per 100,000 persons (age-adjusted to the 2000 US standard population) in 2005 and 6.0 per 100,000 persons in 2014.

So overall, there was an 8% increase in MM incidence rate from 2005 to 2014, or a 1.1% average annual increase. There was a 2% increase in the risk of MM per 1 kg/m² increase in BMI.

Like MM, 3 other cancers had fairly stable incidence rates over the study period—adenocarcinoma of the esophagus, gallbladder cancer, and postmenopausal breast cancer.

However, incidence rates increased significantly each year for thyroid cancer (4.0% per year), liver cancer (2.9%), gastric cardia cancer (1.2%), endometrial cancer (1.1%), pancreatic cancer (0.8%), and kidney cancer (0.7%).

And incidence rates decreased signifi­cantly each year for meningioma (-3.8%), colorectal cancer (-2.9%), and ovarian cancer (-2.0%).

Woman on a scale

Cancers associated with being overweight or obese accounted for about 40% of all cancers diagnosed in the US in 2014, according to the latest Vital Signs report by the US Centers for Disease Control and Prevention.

The International Agency for Research on Cancer has identified 13 cancers associated with overweight and obesity—multiple myeloma (MM), meningioma, adenocarcinoma of the esophagus, and thyroid, postmenopausal breast, gallbladder, stomach, liver, pancreatic, kidney, ovarian, uterine, and colorectal cancers.

For the Vital Signs report, researchers reviewed US data from 2005 to 2014 to determine trends for cancers associated with being overweight (having a body mass index [BMI] of 25 to 29.9 kg/m²) or obese (having a BMI of 30 kg/m² and higher).

In 2014, roughly 631,000 people were diagnosed with cancers associated with overweight and obesity, which represents 40% of all cancers diagnosed.

Fifty-five percent of all cancers diagnosed in women and 24% of those diagnosed in men were associated with overweight and obesity.

Incidence rates of the 13 cancers combined were highest in non-Hispanic blacks, followed by non-Hispanic whites, American Indians/Alaska Natives, Hispanics, and Asians/Pacific Islanders.

Incidence over time

Overall, the incidence of cancers associated with overweight and obesity decreased 2% from 2005 to 2014.

However, when colorectal cancer was excluded, the incidence of the other 12 cancers combined increased 7% from 2005 to 2014. The incidence of colorectal cancer decreased 23% during that time. Researchers said this was due, in large part, to screening.

The incidence of cancers not associated with overweight and obesity decreased 13% from 2005 to 2014.

The incidence of MM increased over the period studied, but it was not a significant increase. The incidence rate of MM was 5.6 per 100,000 persons (age-adjusted to the 2000 US standard population) in 2005 and 6.0 per 100,000 persons in 2014.

So overall, there was an 8% increase in MM incidence rate from 2005 to 2014, or a 1.1% average annual increase. There was a 2% increase in the risk of MM per 1 kg/m² increase in BMI.

Like MM, 3 other cancers had fairly stable incidence rates over the study period—adenocarcinoma of the esophagus, gallbladder cancer, and postmenopausal breast cancer.

However, incidence rates increased significantly each year for thyroid cancer (4.0% per year), liver cancer (2.9%), gastric cardia cancer (1.2%), endometrial cancer (1.1%), pancreatic cancer (0.8%), and kidney cancer (0.7%).

And incidence rates decreased signifi­cantly each year for meningioma (-3.8%), colorectal cancer (-2.9%), and ovarian cancer (-2.0%).

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).

Photo courtesy of Janssen

The Ministry of Health, Labor and Welfare in Japan has approved the use of daratumumab (DARZALEX®) in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone to treat adults with relapsed or refractory multiple myeloma (MM).

Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, which is highly expressed on the surface of MM cells.

The drug is being developed by Janssen Biotech, Inc. under an exclusive worldwide license from Genmab.

The approval of daratumumab is based on data from the phase 3 POLLUX and CASTOR trials.

In the POLLUX trial, researchers compared treatment with lenalidomide and dexamethasone to treatment with daratumumab, lenalidomide, and dexamethasone in patients with relapsed or refractory MM.

Patients who received daratumumab in combination had a significantly higher response rate and longer progression-free survival than patients who received the 2-drug combination.

However, treatment with daratumumab was associated with infusion-related reactions and a higher incidence of neutropenia.

Results from this trial were published in NEJM in October 2016.

In the CASTOR trial, researchers compared treatment with bortezomib and dexamethasone to treatment with daratumumab, bortezomib, and dexamethasone in patients with previously treated MM.

Patients who received the 3-drug combination had a higher response rate, longer progression-free survival, and a higher incidence of grade 3/4 adverse events than those who received the 2-drug combination.

Results from this trial were published in NEJM in August 2016.

Photo courtesy of Janssen

The Ministry of Health, Labor and Welfare in Japan has approved the use of daratumumab (DARZALEX®) in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone to treat adults with relapsed or refractory multiple myeloma (MM).

Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, which is highly expressed on the surface of MM cells.

The drug is being developed by Janssen Biotech, Inc. under an exclusive worldwide license from Genmab.

The approval of daratumumab is based on data from the phase 3 POLLUX and CASTOR trials.

In the POLLUX trial, researchers compared treatment with lenalidomide and dexamethasone to treatment with daratumumab, lenalidomide, and dexamethasone in patients with relapsed or refractory MM.

Patients who received daratumumab in combination had a significantly higher response rate and longer progression-free survival than patients who received the 2-drug combination.

However, treatment with daratumumab was associated with infusion-related reactions and a higher incidence of neutropenia.

Results from this trial were published in NEJM in October 2016.

In the CASTOR trial, researchers compared treatment with bortezomib and dexamethasone to treatment with daratumumab, bortezomib, and dexamethasone in patients with previously treated MM.

Patients who received the 3-drug combination had a higher response rate, longer progression-free survival, and a higher incidence of grade 3/4 adverse events than those who received the 2-drug combination.

Results from this trial were published in NEJM in August 2016.

Photo courtesy of Janssen

The Ministry of Health, Labor and Welfare in Japan has approved the use of daratumumab (DARZALEX®) in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone to treat adults with relapsed or refractory multiple myeloma (MM).

Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, which is highly expressed on the surface of MM cells.

The drug is being developed by Janssen Biotech, Inc. under an exclusive worldwide license from Genmab.

The approval of daratumumab is based on data from the phase 3 POLLUX and CASTOR trials.

In the POLLUX trial, researchers compared treatment with lenalidomide and dexamethasone to treatment with daratumumab, lenalidomide, and dexamethasone in patients with relapsed or refractory MM.

Patients who received daratumumab in combination had a significantly higher response rate and longer progression-free survival than patients who received the 2-drug combination.

However, treatment with daratumumab was associated with infusion-related reactions and a higher incidence of neutropenia.

Results from this trial were published in NEJM in October 2016.

In the CASTOR trial, researchers compared treatment with bortezomib and dexamethasone to treatment with daratumumab, bortezomib, and dexamethasone in patients with previously treated MM.

Patients who received the 3-drug combination had a higher response rate, longer progression-free survival, and a higher incidence of grade 3/4 adverse events than those who received the 2-drug combination.

Results from this trial were published in NEJM in August 2016.

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.

Photo by Rhoda Baer

A new study suggests cancer patients may be open to using marijuana, but healthcare providers may be falling short in educating patients on marijuana use.

This single-center study included more than 900 cancer patients in a US state with legalized medicinal and recreational marijuana.

More than 90% of the patients surveyed said they were interested in learning more about marijuana use in the context of cancer, and nearly three-quarters of the patients wanted their cancer care providers to supply information on the topic.

However, less than 15% of patients received such information from providers. Instead, patients learned about marijuana use from sources such as the Internet or other patients.

“Cancer patients desire but are not receiving information from their cancer doctors about marijuana use during their treatment, so many of them are seeking information from alternate, non-scientific sources,” said Steven Pergam, MD, of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

Dr Pergam and his colleagues reported this finding in the journal Cancer.

Eight US states and the District of Columbia have legalized recreational marijuana, and more than half of states have passed laws allowing for medical marijuana in some form. Marijuana is purported to alleviate symptoms related to cancer treatment, but patterns of use among cancer patients are not well known.

To investigate, Dr Pergam and his colleagues surveyed 926 patients at the Seattle Cancer Center Alliance. The patients’ median age was 58, 52% were male, and 59% had at least a college degree. Thirty-four percent of patients had hematologic malignancies.

Results

Sixty-six percent of patients said they had used marijuana in the past, 24% used in the last year, and 21% used in the last month.

A random analysis of patient urine samples showed that 14% of patients had evidence of recent marijuana use, similar to the 18% of users who reported at least weekly marijuana use.

When compared to patients who never used marijuana and those who previously used marijuana but quit, patients currently using marijuana said they were more likely to do so because the drug had been legalized. Women were more likely than men to use because of legalization.

Current marijuana users were younger, had less education, and were less likely to have undergone hematopoietic stem cell transplant. There was no difference in marijuana use according to a patient’s cancer type.

Most patients said they used marijuana to relieve physical symptoms (75%) and neuropsychiatric symptoms (63%), though some also used it recreationally (35%).

In addition, 26% of current marijuana users said they believed the drug was helping to treat their cancer. And 5% of these users said this was their only reason for marijuana use.

Most patients (92%) said they wanted to learn more about marijuana and cancer. However, the level of interest varied with age, with younger patients expressing the most interest.

Seventy-four percent of patients said they would prefer to get information on marijuana use from their cancer team, but less than 15% received such information from their cancer physician or nurse.

Patients said they received information on marijuana and cancer from friends and family, newspaper and magazine articles, websites and blogs, or another cancer patient.

More than a third of patients said they had not received any information on marijuana and cancer.

“We hope that this study helps to open up the door for more studies aimed at evaluating the risks and benefits of marijuana in this population,” Dr Pergam said. “This is important because if we do not educate our patients about marijuana, they will continue to get their information elsewhere.”

Photo by Rhoda Baer

A new study suggests cancer patients may be open to using marijuana, but healthcare providers may be falling short in educating patients on marijuana use.

This single-center study included more than 900 cancer patients in a US state with legalized medicinal and recreational marijuana.

More than 90% of the patients surveyed said they were interested in learning more about marijuana use in the context of cancer, and nearly three-quarters of the patients wanted their cancer care providers to supply information on the topic.

However, less than 15% of patients received such information from providers. Instead, patients learned about marijuana use from sources such as the Internet or other patients.

“Cancer patients desire but are not receiving information from their cancer doctors about marijuana use during their treatment, so many of them are seeking information from alternate, non-scientific sources,” said Steven Pergam, MD, of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

Dr Pergam and his colleagues reported this finding in the journal Cancer.

Eight US states and the District of Columbia have legalized recreational marijuana, and more than half of states have passed laws allowing for medical marijuana in some form. Marijuana is purported to alleviate symptoms related to cancer treatment, but patterns of use among cancer patients are not well known.

To investigate, Dr Pergam and his colleagues surveyed 926 patients at the Seattle Cancer Center Alliance. The patients’ median age was 58, 52% were male, and 59% had at least a college degree. Thirty-four percent of patients had hematologic malignancies.

Results

Sixty-six percent of patients said they had used marijuana in the past, 24% used in the last year, and 21% used in the last month.

A random analysis of patient urine samples showed that 14% of patients had evidence of recent marijuana use, similar to the 18% of users who reported at least weekly marijuana use.

When compared to patients who never used marijuana and those who previously used marijuana but quit, patients currently using marijuana said they were more likely to do so because the drug had been legalized. Women were more likely than men to use because of legalization.

Current marijuana users were younger, had less education, and were less likely to have undergone hematopoietic stem cell transplant. There was no difference in marijuana use according to a patient’s cancer type.

Most patients said they used marijuana to relieve physical symptoms (75%) and neuropsychiatric symptoms (63%), though some also used it recreationally (35%).

In addition, 26% of current marijuana users said they believed the drug was helping to treat their cancer. And 5% of these users said this was their only reason for marijuana use.

Most patients (92%) said they wanted to learn more about marijuana and cancer. However, the level of interest varied with age, with younger patients expressing the most interest.

Seventy-four percent of patients said they would prefer to get information on marijuana use from their cancer team, but less than 15% received such information from their cancer physician or nurse.

Patients said they received information on marijuana and cancer from friends and family, newspaper and magazine articles, websites and blogs, or another cancer patient.

More than a third of patients said they had not received any information on marijuana and cancer.

“We hope that this study helps to open up the door for more studies aimed at evaluating the risks and benefits of marijuana in this population,” Dr Pergam said. “This is important because if we do not educate our patients about marijuana, they will continue to get their information elsewhere.”

Photo by Rhoda Baer

A new study suggests cancer patients may be open to using marijuana, but healthcare providers may be falling short in educating patients on marijuana use.

This single-center study included more than 900 cancer patients in a US state with legalized medicinal and recreational marijuana.

More than 90% of the patients surveyed said they were interested in learning more about marijuana use in the context of cancer, and nearly three-quarters of the patients wanted their cancer care providers to supply information on the topic.

However, less than 15% of patients received such information from providers. Instead, patients learned about marijuana use from sources such as the Internet or other patients.

“Cancer patients desire but are not receiving information from their cancer doctors about marijuana use during their treatment, so many of them are seeking information from alternate, non-scientific sources,” said Steven Pergam, MD, of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

Dr Pergam and his colleagues reported this finding in the journal Cancer.

Eight US states and the District of Columbia have legalized recreational marijuana, and more than half of states have passed laws allowing for medical marijuana in some form. Marijuana is purported to alleviate symptoms related to cancer treatment, but patterns of use among cancer patients are not well known.

To investigate, Dr Pergam and his colleagues surveyed 926 patients at the Seattle Cancer Center Alliance. The patients’ median age was 58, 52% were male, and 59% had at least a college degree. Thirty-four percent of patients had hematologic malignancies.

Results

Sixty-six percent of patients said they had used marijuana in the past, 24% used in the last year, and 21% used in the last month.

A random analysis of patient urine samples showed that 14% of patients had evidence of recent marijuana use, similar to the 18% of users who reported at least weekly marijuana use.

When compared to patients who never used marijuana and those who previously used marijuana but quit, patients currently using marijuana said they were more likely to do so because the drug had been legalized. Women were more likely than men to use because of legalization.

Current marijuana users were younger, had less education, and were less likely to have undergone hematopoietic stem cell transplant. There was no difference in marijuana use according to a patient’s cancer type.

Most patients said they used marijuana to relieve physical symptoms (75%) and neuropsychiatric symptoms (63%), though some also used it recreationally (35%).

In addition, 26% of current marijuana users said they believed the drug was helping to treat their cancer. And 5% of these users said this was their only reason for marijuana use.

Most patients (92%) said they wanted to learn more about marijuana and cancer. However, the level of interest varied with age, with younger patients expressing the most interest.

Seventy-four percent of patients said they would prefer to get information on marijuana use from their cancer team, but less than 15% received such information from their cancer physician or nurse.

Patients said they received information on marijuana and cancer from friends and family, newspaper and magazine articles, websites and blogs, or another cancer patient.

More than a third of patients said they had not received any information on marijuana and cancer.

“We hope that this study helps to open up the door for more studies aimed at evaluating the risks and benefits of marijuana in this population,” Dr Pergam said. “This is important because if we do not educate our patients about marijuana, they will continue to get their information elsewhere.”

Photo by Rhoda Baer

A new study suggests cancer patients may be more concerned with the human aspects of care than the technical ones.

Researchers studied complaints made by outpatients (or proxies) to a cancer institute over a 2-year period.

A majority of the complaints were management-related issues (48%), such as finance and billing problems, or relationship-related (41%), such as patient-staff dialogue.

Only 11% of the complaints were related to clinical issues, such as errors in diagnosis. However, these complaints were frequently of higher severity than others.

Jennifer W. Mack, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues reported these findings in The Joint Commission Journal on Quality and Patient Safety.

The researchers looked at complaints made to the Patient/Family Relations Office at the Dana-Farber Cancer Institute from January 2013 through December 2014.

There were 78,668 outpatients treated during this time, and 266 complaints were filed. Most complaints were filed by the patient (73%), 17% by the patient’s spouse/partner, 3% by a parent, 12% by another family member, 0.4% by a friend, 2% by the referring provider, and 1% by a social worker.

The complaints were placed in 3 categories—management, relationship, and clinical issues.

For 48% of the complaints, “management” was the primary category. This encompassed complaints related to:

• Service issues—15%
• Delays—13%
• Finance and billing—10%
• Access and admission—6%
• Bureaucracy—2%
• Environment—2%
• Referrals—0.4%.

For 41% of the complaints, “relationship” was the primary category, which encompassed:

• Communication breakdown—15%
• Respect, dignity, caring—15%
• Patient-staff dialogue—5%
• Staff attitudes—3%
• Confidentiality—2%
• Incorrect information—1%.

For 11% of the complaints, “clinical” was the primary category, which encompassed complaints related to:

• Quality of care—4%
• Skills and conduct—2%
• Patient journey—2%
• Treatment—1%
• Errors in diagnosis—1%
• Safety incidents—1%
• Examinations—0.4%.

Fifty-seven percent of clinical complaints were considered high severity, as were 28% of relationship complaints and 7% of management complaints

Overall, most (64%) complaints were classified as low severity, 16% were moderate, and 20% were high severity.

The following aspects raised the severity level of a complaint:

• Involvement of a prescribing oncologist—27%
• Strong affect of the complainant, including anger—15%
• Allegation of a medical error or suboptimal care—6%
• Request or desire to transfer care to another provider (12%) or institution (5%)
• Mention of malpractice or a desire to pursue legal action—1%.

The researchers said this study provides insight into patient and family values when it comes to cancer care, suggesting they prioritize high-quality relationships and communication. And a systematic review of complaints could reveal areas where care fails to meet patient and family needs.

Photo by Rhoda Baer

A new study suggests cancer patients may be more concerned with the human aspects of care than the technical ones.

Researchers studied complaints made by outpatients (or proxies) to a cancer institute over a 2-year period.

A majority of the complaints were management-related issues (48%), such as finance and billing problems, or relationship-related (41%), such as patient-staff dialogue.

Only 11% of the complaints were related to clinical issues, such as errors in diagnosis. However, these complaints were frequently of higher severity than others.

Jennifer W. Mack, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues reported these findings in The Joint Commission Journal on Quality and Patient Safety.

The researchers looked at complaints made to the Patient/Family Relations Office at the Dana-Farber Cancer Institute from January 2013 through December 2014.

There were 78,668 outpatients treated during this time, and 266 complaints were filed. Most complaints were filed by the patient (73%), 17% by the patient’s spouse/partner, 3% by a parent, 12% by another family member, 0.4% by a friend, 2% by the referring provider, and 1% by a social worker.

The complaints were placed in 3 categories—management, relationship, and clinical issues.

For 48% of the complaints, “management” was the primary category. This encompassed complaints related to:

• Service issues—15%
• Delays—13%
• Finance and billing—10%
• Access and admission—6%
• Bureaucracy—2%
• Environment—2%
• Referrals—0.4%.

For 41% of the complaints, “relationship” was the primary category, which encompassed:

• Communication breakdown—15%
• Respect, dignity, caring—15%
• Patient-staff dialogue—5%
• Staff attitudes—3%
• Confidentiality—2%
• Incorrect information—1%.

For 11% of the complaints, “clinical” was the primary category, which encompassed complaints related to:

• Quality of care—4%
• Skills and conduct—2%
• Patient journey—2%
• Treatment—1%
• Errors in diagnosis—1%
• Safety incidents—1%
• Examinations—0.4%.

Fifty-seven percent of clinical complaints were considered high severity, as were 28% of relationship complaints and 7% of management complaints

Overall, most (64%) complaints were classified as low severity, 16% were moderate, and 20% were high severity.

The following aspects raised the severity level of a complaint:

• Involvement of a prescribing oncologist—27%
• Strong affect of the complainant, including anger—15%
• Allegation of a medical error or suboptimal care—6%
• Request or desire to transfer care to another provider (12%) or institution (5%)
• Mention of malpractice or a desire to pursue legal action—1%.

The researchers said this study provides insight into patient and family values when it comes to cancer care, suggesting they prioritize high-quality relationships and communication. And a systematic review of complaints could reveal areas where care fails to meet patient and family needs.

Photo by Rhoda Baer

A new study suggests cancer patients may be more concerned with the human aspects of care than the technical ones.

Researchers studied complaints made by outpatients (or proxies) to a cancer institute over a 2-year period.

A majority of the complaints were management-related issues (48%), such as finance and billing problems, or relationship-related (41%), such as patient-staff dialogue.

Only 11% of the complaints were related to clinical issues, such as errors in diagnosis. However, these complaints were frequently of higher severity than others.

Jennifer W. Mack, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, and her colleagues reported these findings in The Joint Commission Journal on Quality and Patient Safety.

The researchers looked at complaints made to the Patient/Family Relations Office at the Dana-Farber Cancer Institute from January 2013 through December 2014.

There were 78,668 outpatients treated during this time, and 266 complaints were filed. Most complaints were filed by the patient (73%), 17% by the patient’s spouse/partner, 3% by a parent, 12% by another family member, 0.4% by a friend, 2% by the referring provider, and 1% by a social worker.

The complaints were placed in 3 categories—management, relationship, and clinical issues.

For 48% of the complaints, “management” was the primary category. This encompassed complaints related to:

• Service issues—15%
• Delays—13%
• Finance and billing—10%
• Access and admission—6%
• Bureaucracy—2%
• Environment—2%
• Referrals—0.4%.

For 41% of the complaints, “relationship” was the primary category, which encompassed:

• Communication breakdown—15%
• Respect, dignity, caring—15%
• Patient-staff dialogue—5%
• Staff attitudes—3%
• Confidentiality—2%
• Incorrect information—1%.

For 11% of the complaints, “clinical” was the primary category, which encompassed complaints related to:

• Quality of care—4%
• Skills and conduct—2%
• Patient journey—2%
• Treatment—1%
• Errors in diagnosis—1%
• Safety incidents—1%
• Examinations—0.4%.

Fifty-seven percent of clinical complaints were considered high severity, as were 28% of relationship complaints and 7% of management complaints

Overall, most (64%) complaints were classified as low severity, 16% were moderate, and 20% were high severity.

The following aspects raised the severity level of a complaint:

• Involvement of a prescribing oncologist—27%
• Strong affect of the complainant, including anger—15%
• Allegation of a medical error or suboptimal care—6%
• Request or desire to transfer care to another provider (12%) or institution (5%)
• Mention of malpractice or a desire to pursue legal action—1%.

The researchers said this study provides insight into patient and family values when it comes to cancer care, suggesting they prioritize high-quality relationships and communication. And a systematic review of complaints could reveal areas where care fails to meet patient and family needs.

MADRID – Patients with refractory/relapsed multiple myeloma had similar rates of progression-free survival (PFS) whether they were younger than age 65 or 65 years and older, based on the results of eight recent phase 3 trials in an analysis presented at the European Society for Medical Oncology Congress.

“The PFS benefit was significant in both younger and older patients with relapsed and refractory multiple myeloma with a cut off at 75 years,” reported Thierry Landre, PharmD, of the department of geriatric oncology, University of Paris 13, France. “Age, by itself, should not be a contraindication to the new myeloma drugs.”

In this meta-analysis, 5,421 patients were evaluated from the CASTOR and POLLUX trials, which evaluated daratumumab; the ELOQUENT-2 trial, which evaluated elotuzumab; the ASPIRE and ENDEAVOR trials, which evaluated carfilzomib; the TOURMALINE-MM trial, which evaluated ixazomib; the PANORAMA trial, which evaluated panobinostat; and the VANTAGE trial, which evaluated vorinostat.

For the analysis, patients were stratified by age younger than 65 years and age 65 years and older. Hazard ratios for benefit were calculated for the experimental and comparator arm for these two age groups. Though the number of patients over age 75 was small, hazard ratios were determined on an exploratory basis for that age group.

For the experimental arm relative to the comparator arm, all hazard ratios were statistically significant for patients less than age 65 with the exception of patients receiving elotuzumab in ELOQUENT-2. In that trial, the hazard ratio slightly exceeded the upward bound of the 95% confidence interval (95% CI, 0.55-1.02).

When the data were combined for the eight trials, the hazard ratio for PFS was 0.62 for newer agents relative to the comparator arms.

Similar results were seen for individual trial and aggregated trial data when the same calculations were done in patients aged 65-75. When the data for the eight trials were combined, the hazard ratio for PFS was 0.67 for newer agents relative to comparators.

The calculations for patients over age 75 were more limited because of the small numbers of trial participants in that age group. Of the hazard ratio estimates that were done, however, they were again of the same general magnitude seen in younger patients.

When PFS was broken down by type of therapy, the hazard ratios for patients younger than age 65 and those aged 65-75 were 0.57 and 0.52, respectively, for monoclonal antibodies. For combined data with the histone deacetylase inhibitors panobinostat and vorinostat, the respective hazard ratios were 0.67 and 0.78, respectively. For the second generation proteasome inhibitors carfilzomib and ixazomib, the respective hazard ratios were 0.61 and 0.70.

The ESMO-invited discussant for this presentation, Evangelos Terpos, MD, PhD, of the University of Athens, called the results reassuring. These data support treating relatively fit elderly patients with the newer agents.

“The data with the monoclonal antibodies suggest that these drugs actually provide their best results in elderly patients,” noted Dr. Terpos, pointing to the numerical advantage for the hazard ratio in older versus younger patients. The efficacy of monoclonal antibodies in older patients was further reinforced by the narrow confidence interval (95% CI, 0.42-0.61).

“There are many new drugs in the refractory setting [of multiple myeloma],” Dr. Terpos remarked. “It is helpful to have some data to show that these are also beneficial in the age group where this disease is most common.”

Dr. Landre agreed, noting that the median age at diagnosis of multiple myeloma is 69. This analysis helps to address the gap of “data available for evaluating efficacy in those older than 65 years and older than 75 years of age.”

MADRID – Patients with refractory/relapsed multiple myeloma had similar rates of progression-free survival (PFS) whether they were younger than age 65 or 65 years and older, based on the results of eight recent phase 3 trials in an analysis presented at the European Society for Medical Oncology Congress.

“The PFS benefit was significant in both younger and older patients with relapsed and refractory multiple myeloma with a cut off at 75 years,” reported Thierry Landre, PharmD, of the department of geriatric oncology, University of Paris 13, France. “Age, by itself, should not be a contraindication to the new myeloma drugs.”

In this meta-analysis, 5,421 patients were evaluated from the CASTOR and POLLUX trials, which evaluated daratumumab; the ELOQUENT-2 trial, which evaluated elotuzumab; the ASPIRE and ENDEAVOR trials, which evaluated carfilzomib; the TOURMALINE-MM trial, which evaluated ixazomib; the PANORAMA trial, which evaluated panobinostat; and the VANTAGE trial, which evaluated vorinostat.

For the analysis, patients were stratified by age younger than 65 years and age 65 years and older. Hazard ratios for benefit were calculated for the experimental and comparator arm for these two age groups. Though the number of patients over age 75 was small, hazard ratios were determined on an exploratory basis for that age group.

For the experimental arm relative to the comparator arm, all hazard ratios were statistically significant for patients less than age 65 with the exception of patients receiving elotuzumab in ELOQUENT-2. In that trial, the hazard ratio slightly exceeded the upward bound of the 95% confidence interval (95% CI, 0.55-1.02).

When the data were combined for the eight trials, the hazard ratio for PFS was 0.62 for newer agents relative to the comparator arms.

Similar results were seen for individual trial and aggregated trial data when the same calculations were done in patients aged 65-75. When the data for the eight trials were combined, the hazard ratio for PFS was 0.67 for newer agents relative to comparators.

The calculations for patients over age 75 were more limited because of the small numbers of trial participants in that age group. Of the hazard ratio estimates that were done, however, they were again of the same general magnitude seen in younger patients.

When PFS was broken down by type of therapy, the hazard ratios for patients younger than age 65 and those aged 65-75 were 0.57 and 0.52, respectively, for monoclonal antibodies. For combined data with the histone deacetylase inhibitors panobinostat and vorinostat, the respective hazard ratios were 0.67 and 0.78, respectively. For the second generation proteasome inhibitors carfilzomib and ixazomib, the respective hazard ratios were 0.61 and 0.70.

The ESMO-invited discussant for this presentation, Evangelos Terpos, MD, PhD, of the University of Athens, called the results reassuring. These data support treating relatively fit elderly patients with the newer agents.

“The data with the monoclonal antibodies suggest that these drugs actually provide their best results in elderly patients,” noted Dr. Terpos, pointing to the numerical advantage for the hazard ratio in older versus younger patients. The efficacy of monoclonal antibodies in older patients was further reinforced by the narrow confidence interval (95% CI, 0.42-0.61).

“There are many new drugs in the refractory setting [of multiple myeloma],” Dr. Terpos remarked. “It is helpful to have some data to show that these are also beneficial in the age group where this disease is most common.”

Dr. Landre agreed, noting that the median age at diagnosis of multiple myeloma is 69. This analysis helps to address the gap of “data available for evaluating efficacy in those older than 65 years and older than 75 years of age.”

MADRID – Patients with refractory/relapsed multiple myeloma had similar rates of progression-free survival (PFS) whether they were younger than age 65 or 65 years and older, based on the results of eight recent phase 3 trials in an analysis presented at the European Society for Medical Oncology Congress.

“The PFS benefit was significant in both younger and older patients with relapsed and refractory multiple myeloma with a cut off at 75 years,” reported Thierry Landre, PharmD, of the department of geriatric oncology, University of Paris 13, France. “Age, by itself, should not be a contraindication to the new myeloma drugs.”

In this meta-analysis, 5,421 patients were evaluated from the CASTOR and POLLUX trials, which evaluated daratumumab; the ELOQUENT-2 trial, which evaluated elotuzumab; the ASPIRE and ENDEAVOR trials, which evaluated carfilzomib; the TOURMALINE-MM trial, which evaluated ixazomib; the PANORAMA trial, which evaluated panobinostat; and the VANTAGE trial, which evaluated vorinostat.

For the analysis, patients were stratified by age younger than 65 years and age 65 years and older. Hazard ratios for benefit were calculated for the experimental and comparator arm for these two age groups. Though the number of patients over age 75 was small, hazard ratios were determined on an exploratory basis for that age group.

For the experimental arm relative to the comparator arm, all hazard ratios were statistically significant for patients less than age 65 with the exception of patients receiving elotuzumab in ELOQUENT-2. In that trial, the hazard ratio slightly exceeded the upward bound of the 95% confidence interval (95% CI, 0.55-1.02).

When the data were combined for the eight trials, the hazard ratio for PFS was 0.62 for newer agents relative to the comparator arms.

Similar results were seen for individual trial and aggregated trial data when the same calculations were done in patients aged 65-75. When the data for the eight trials were combined, the hazard ratio for PFS was 0.67 for newer agents relative to comparators.

The calculations for patients over age 75 were more limited because of the small numbers of trial participants in that age group. Of the hazard ratio estimates that were done, however, they were again of the same general magnitude seen in younger patients.

When PFS was broken down by type of therapy, the hazard ratios for patients younger than age 65 and those aged 65-75 were 0.57 and 0.52, respectively, for monoclonal antibodies. For combined data with the histone deacetylase inhibitors panobinostat and vorinostat, the respective hazard ratios were 0.67 and 0.78, respectively. For the second generation proteasome inhibitors carfilzomib and ixazomib, the respective hazard ratios were 0.61 and 0.70.

The ESMO-invited discussant for this presentation, Evangelos Terpos, MD, PhD, of the University of Athens, called the results reassuring. These data support treating relatively fit elderly patients with the newer agents.

“The data with the monoclonal antibodies suggest that these drugs actually provide their best results in elderly patients,” noted Dr. Terpos, pointing to the numerical advantage for the hazard ratio in older versus younger patients. The efficacy of monoclonal antibodies in older patients was further reinforced by the narrow confidence interval (95% CI, 0.42-0.61).

“There are many new drugs in the refractory setting [of multiple myeloma],” Dr. Terpos remarked. “It is helpful to have some data to show that these are also beneficial in the age group where this disease is most common.”

Dr. Landre agreed, noting that the median age at diagnosis of multiple myeloma is 69. This analysis helps to address the gap of “data available for evaluating efficacy in those older than 65 years and older than 75 years of age.”

Anderson Cancer Center

Researchers say they have created guidelines for managing the unique toxicities associated with chimeric antigen receptor (CAR) T-cell therapy.

The guidelines focus on cytokine release syndrome (CRS); neurological toxicity, which the researchers have dubbed “CAR-T-cell-related encephalopathy syndrome (CRES);” and adverse effects related to these syndromes.

“The toxicities are unique, and every member of the care team needs to be trained to recognize them and act accordingly,” said Sattva Neelapu, MD, of University of Texas MD Anderson Cancer Center in Houston.

Dr Neelapu and his colleagues described the toxicities and related recommendations in Nature Reviews Clinical Oncology.

The team’s guidelines include supportive-care considerations for patients receiving CAR T‑cell therapy. For example, they recommend:

• Baseline brain MRI to rule out central nervous system disease
• Cardiac monitoring starting on the day of CAR T‑cell infusion
• Assessing a patient’s vital signs every 4 hours after CAR T-cell infusion
• Assessing and grading CRS at least twice daily and whenever the patient’s status changes
• Assessing and grading CRES at least every 8 hours.

CRS

One section of the guidelines is dedicated to CRS, with subsections on pathophysiology, precautions and supportive care, the use of corticosteroids and IL‑6/IL‑6R antagonists, and grading CRS.

The researchers noted that CRS typically manifests with constitutional symptoms, such as fever, malaise, anorexia, and myalgias. However, CRS can affect any organ system in the body.

The team recommends managing CRS according to grade. For example, patients with grade 1 CRS should typically receive supportive care. However, physicians should consider giving tocilizumab or siltuximab to grade 1 patients who have a refractory fever lasting more than 3 days.

The researchers also noted that CRS can evolve into fulminant hemophagocytic lymphohistiocytosis (HLH), also known as macrophage-activation syndrome (MAS).

The team said HLH/MAS encompasses a group of severe immunological disorders characterized by hyperactivation of macrophages and lymphocytes, proinflammatory cytokine production, lymphohistiocytic tissue infiltration, and immune-mediated multi-organ failure.

The guidelines include diagnostic criteria for CAR T‑cell-related HLH/MAS and recommendations for managing the condition.

CRES

One section of the guidelines is dedicated to the grading and treatment of CRES, which typically mani­fests as a toxic encephalopathy.

The researchers said the earliest signs of CRES are diminished attention, language disturbance, and impaired handwriting. Other symptoms include confusion, disorientation, agitation, apha­sia, somnolence, and tremors.

Patients with severe CRES (grade >2) may experience seizures, motor weakness, incontinence, mental obtundation, increased intracra­nial pressure, papilledema, and cerebral edema.

Therefore, the guidelines include recommendations for the management of status epilepticus and raised intracranial pressure after CAR T‑cell therapy.

The researchers also devised an algorithm, known as CARTOX-10, for identifying neurotoxicity. (An existing general method didn’t effectively quantify the neurological effects caused by CAR T-cell therapies.)

CARTOX-10 is a 10-point test in which patients are asked to do the following:

• Name the current month (1 point) and year (1 point)
• Name the city (1 point) and hospital they are in (1 point)
• Name the president/prime minister of their home country (1 point)
• Name 3 nearby objects (3 points)
• Write a standard sentence (1 point)
• Count backward from 100 by tens (1 point).

A perfect score indicates normal cognitive function. A patient has mild to severe impairment depending on the number of questions or activities missed.

Dr Neelapu and his colleagues believe their recommendations will be applicable to other types of cell-based immunotherapy as well, including CAR natural killer cells, T-cell receptor engineered T cells, and combination drugs that use an antibody to connect T cells to targets on cancer cells.

Researchers involved in this work have received funding from companies developing/marketing CAR T-cell therapies.

Anderson Cancer Center

Researchers say they have created guidelines for managing the unique toxicities associated with chimeric antigen receptor (CAR) T-cell therapy.

The guidelines focus on cytokine release syndrome (CRS); neurological toxicity, which the researchers have dubbed “CAR-T-cell-related encephalopathy syndrome (CRES);” and adverse effects related to these syndromes.

“The toxicities are unique, and every member of the care team needs to be trained to recognize them and act accordingly,” said Sattva Neelapu, MD, of University of Texas MD Anderson Cancer Center in Houston.

Dr Neelapu and his colleagues described the toxicities and related recommendations in Nature Reviews Clinical Oncology.

The team’s guidelines include supportive-care considerations for patients receiving CAR T‑cell therapy. For example, they recommend:

• Baseline brain MRI to rule out central nervous system disease
• Cardiac monitoring starting on the day of CAR T‑cell infusion
• Assessing a patient’s vital signs every 4 hours after CAR T-cell infusion
• Assessing and grading CRS at least twice daily and whenever the patient’s status changes
• Assessing and grading CRES at least every 8 hours.

CRS

One section of the guidelines is dedicated to CRS, with subsections on pathophysiology, precautions and supportive care, the use of corticosteroids and IL‑6/IL‑6R antagonists, and grading CRS.

The researchers noted that CRS typically manifests with constitutional symptoms, such as fever, malaise, anorexia, and myalgias. However, CRS can affect any organ system in the body.

The team recommends managing CRS according to grade. For example, patients with grade 1 CRS should typically receive supportive care. However, physicians should consider giving tocilizumab or siltuximab to grade 1 patients who have a refractory fever lasting more than 3 days.

The researchers also noted that CRS can evolve into fulminant hemophagocytic lymphohistiocytosis (HLH), also known as macrophage-activation syndrome (MAS).

The team said HLH/MAS encompasses a group of severe immunological disorders characterized by hyperactivation of macrophages and lymphocytes, proinflammatory cytokine production, lymphohistiocytic tissue infiltration, and immune-mediated multi-organ failure.

The guidelines include diagnostic criteria for CAR T‑cell-related HLH/MAS and recommendations for managing the condition.

CRES

One section of the guidelines is dedicated to the grading and treatment of CRES, which typically mani­fests as a toxic encephalopathy.

The researchers said the earliest signs of CRES are diminished attention, language disturbance, and impaired handwriting. Other symptoms include confusion, disorientation, agitation, apha­sia, somnolence, and tremors.

Patients with severe CRES (grade >2) may experience seizures, motor weakness, incontinence, mental obtundation, increased intracra­nial pressure, papilledema, and cerebral edema.

Therefore, the guidelines include recommendations for the management of status epilepticus and raised intracranial pressure after CAR T‑cell therapy.

The researchers also devised an algorithm, known as CARTOX-10, for identifying neurotoxicity. (An existing general method didn’t effectively quantify the neurological effects caused by CAR T-cell therapies.)

CARTOX-10 is a 10-point test in which patients are asked to do the following:

• Name the current month (1 point) and year (1 point)
• Name the city (1 point) and hospital they are in (1 point)
• Name the president/prime minister of their home country (1 point)
• Name 3 nearby objects (3 points)
• Write a standard sentence (1 point)
• Count backward from 100 by tens (1 point).

A perfect score indicates normal cognitive function. A patient has mild to severe impairment depending on the number of questions or activities missed.

Dr Neelapu and his colleagues believe their recommendations will be applicable to other types of cell-based immunotherapy as well, including CAR natural killer cells, T-cell receptor engineered T cells, and combination drugs that use an antibody to connect T cells to targets on cancer cells.

Researchers involved in this work have received funding from companies developing/marketing CAR T-cell therapies.

Anderson Cancer Center

Researchers say they have created guidelines for managing the unique toxicities associated with chimeric antigen receptor (CAR) T-cell therapy.

The guidelines focus on cytokine release syndrome (CRS); neurological toxicity, which the researchers have dubbed “CAR-T-cell-related encephalopathy syndrome (CRES);” and adverse effects related to these syndromes.

“The toxicities are unique, and every member of the care team needs to be trained to recognize them and act accordingly,” said Sattva Neelapu, MD, of University of Texas MD Anderson Cancer Center in Houston.

Dr Neelapu and his colleagues described the toxicities and related recommendations in Nature Reviews Clinical Oncology.

The team’s guidelines include supportive-care considerations for patients receiving CAR T‑cell therapy. For example, they recommend:

• Baseline brain MRI to rule out central nervous system disease
• Cardiac monitoring starting on the day of CAR T‑cell infusion
• Assessing a patient’s vital signs every 4 hours after CAR T-cell infusion
• Assessing and grading CRS at least twice daily and whenever the patient’s status changes
• Assessing and grading CRES at least every 8 hours.

CRS

One section of the guidelines is dedicated to CRS, with subsections on pathophysiology, precautions and supportive care, the use of corticosteroids and IL‑6/IL‑6R antagonists, and grading CRS.

The researchers noted that CRS typically manifests with constitutional symptoms, such as fever, malaise, anorexia, and myalgias. However, CRS can affect any organ system in the body.

The team recommends managing CRS according to grade. For example, patients with grade 1 CRS should typically receive supportive care. However, physicians should consider giving tocilizumab or siltuximab to grade 1 patients who have a refractory fever lasting more than 3 days.

The researchers also noted that CRS can evolve into fulminant hemophagocytic lymphohistiocytosis (HLH), also known as macrophage-activation syndrome (MAS).

The team said HLH/MAS encompasses a group of severe immunological disorders characterized by hyperactivation of macrophages and lymphocytes, proinflammatory cytokine production, lymphohistiocytic tissue infiltration, and immune-mediated multi-organ failure.

The guidelines include diagnostic criteria for CAR T‑cell-related HLH/MAS and recommendations for managing the condition.

CRES

One section of the guidelines is dedicated to the grading and treatment of CRES, which typically mani­fests as a toxic encephalopathy.

The researchers said the earliest signs of CRES are diminished attention, language disturbance, and impaired handwriting. Other symptoms include confusion, disorientation, agitation, apha­sia, somnolence, and tremors.

Patients with severe CRES (grade >2) may experience seizures, motor weakness, incontinence, mental obtundation, increased intracra­nial pressure, papilledema, and cerebral edema.

Therefore, the guidelines include recommendations for the management of status epilepticus and raised intracranial pressure after CAR T‑cell therapy.

The researchers also devised an algorithm, known as CARTOX-10, for identifying neurotoxicity. (An existing general method didn’t effectively quantify the neurological effects caused by CAR T-cell therapies.)

CARTOX-10 is a 10-point test in which patients are asked to do the following:

• Name the current month (1 point) and year (1 point)
• Name the city (1 point) and hospital they are in (1 point)
• Name the president/prime minister of their home country (1 point)
• Name 3 nearby objects (3 points)
• Write a standard sentence (1 point)
• Count backward from 100 by tens (1 point).

A perfect score indicates normal cognitive function. A patient has mild to severe impairment depending on the number of questions or activities missed.

Dr Neelapu and his colleagues believe their recommendations will be applicable to other types of cell-based immunotherapy as well, including CAR natural killer cells, T-cell receptor engineered T cells, and combination drugs that use an antibody to connect T cells to targets on cancer cells.

Researchers involved in this work have received funding from companies developing/marketing CAR T-cell therapies.

Photo from Genentech

Roche has announced a partial clinical hold on 2 trials of the anti-PD-L1 antibody atezolizumab (Tecentriq).

One is a phase 1b/2 study (NCT02631577) in which researchers are evaluating atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma.

The other is a phase 1b study (NCT02431208) of atezolizumab alone or in combination with an immunomodulatory drug and/or daratumumab in patients with multiple myeloma (MM).

The partial clinical hold on these trials means patients who are currently enrolled and are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled.

The decision to place these trials on hold is related to risks identified in 2 trials of the anti-PD-1 agent pembrolizumab. Results from these trials showed that combining pembrolizumab with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) increases the risk of death in patients with MM.

The results led to clinical holds on these trials (and a third trial of pembrolizumab) as well as an investigation by the US Food and Drug Administration (FDA).

The FDA has stressed its belief that the benefits of taking pembrolizumab and other PD-1/PD-L1 inhibitors for their approved uses continue to outweigh the risks.

However, the agency also thinks there may be an unfavorable risk-benefit ratio for patients receiving PD-1/PD-L1 treatment alone or in other combinations in unapproved indications.

Therefore, the FDA is investigating trials of PD-1/PD-L1 inhibitors being studied in combination with immunomodulatory agents or other classes of drugs in patients with hematologic malignancies.

In the course of this investigation, the FDA has placed holds on trials of nivolumab and durvalumab as well as atezolizumab.

According to Roche, there is no evidence of an increased risk of death or serious events with the use of atezolizumab in combination with immunomodulatory agents.

Photo from Genentech

Roche has announced a partial clinical hold on 2 trials of the anti-PD-L1 antibody atezolizumab (Tecentriq).

One is a phase 1b/2 study (NCT02631577) in which researchers are evaluating atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma.

The other is a phase 1b study (NCT02431208) of atezolizumab alone or in combination with an immunomodulatory drug and/or daratumumab in patients with multiple myeloma (MM).

The partial clinical hold on these trials means patients who are currently enrolled and are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled.

The decision to place these trials on hold is related to risks identified in 2 trials of the anti-PD-1 agent pembrolizumab. Results from these trials showed that combining pembrolizumab with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) increases the risk of death in patients with MM.

The results led to clinical holds on these trials (and a third trial of pembrolizumab) as well as an investigation by the US Food and Drug Administration (FDA).

The FDA has stressed its belief that the benefits of taking pembrolizumab and other PD-1/PD-L1 inhibitors for their approved uses continue to outweigh the risks.

However, the agency also thinks there may be an unfavorable risk-benefit ratio for patients receiving PD-1/PD-L1 treatment alone or in other combinations in unapproved indications.

Therefore, the FDA is investigating trials of PD-1/PD-L1 inhibitors being studied in combination with immunomodulatory agents or other classes of drugs in patients with hematologic malignancies.

In the course of this investigation, the FDA has placed holds on trials of nivolumab and durvalumab as well as atezolizumab.

According to Roche, there is no evidence of an increased risk of death or serious events with the use of atezolizumab in combination with immunomodulatory agents.

Photo from Genentech

Roche has announced a partial clinical hold on 2 trials of the anti-PD-L1 antibody atezolizumab (Tecentriq).

One is a phase 1b/2 study (NCT02631577) in which researchers are evaluating atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma.

The other is a phase 1b study (NCT02431208) of atezolizumab alone or in combination with an immunomodulatory drug and/or daratumumab in patients with multiple myeloma (MM).

The partial clinical hold on these trials means patients who are currently enrolled and are deriving clinical benefit may continue to receive treatment, but no additional patients will be enrolled.

The decision to place these trials on hold is related to risks identified in 2 trials of the anti-PD-1 agent pembrolizumab. Results from these trials showed that combining pembrolizumab with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) increases the risk of death in patients with MM.

The results led to clinical holds on these trials (and a third trial of pembrolizumab) as well as an investigation by the US Food and Drug Administration (FDA).

The FDA has stressed its belief that the benefits of taking pembrolizumab and other PD-1/PD-L1 inhibitors for their approved uses continue to outweigh the risks.

However, the agency also thinks there may be an unfavorable risk-benefit ratio for patients receiving PD-1/PD-L1 treatment alone or in other combinations in unapproved indications.

Therefore, the FDA is investigating trials of PD-1/PD-L1 inhibitors being studied in combination with immunomodulatory agents or other classes of drugs in patients with hematologic malignancies.

In the course of this investigation, the FDA has placed holds on trials of nivolumab and durvalumab as well as atezolizumab.

According to Roche, there is no evidence of an increased risk of death or serious events with the use of atezolizumab in combination with immunomodulatory agents.