MUNICH – When it comes to predicting mortality in diabetes patients, the foot may trump the heart.

Over a 5-year period, patients who had the most severe foot pathology were almost four times more likely to die than those who had a constellation of cardiovascular risk factors. The association with foot pathology stayed strong and, in a multivariate analysis, was the only factor that remained significantly associated with death in the cohort, Dragan Tesic, MD, said at the annual meeting of the European Association for the Study of Diabetes.

©donskarpo/thinkstockphotos.com

“On average, our patients with severe foot pathology had a 5-year shortening of their lifespan,” said Dr. Tesic of the University of Novi Sad, Serbia. This finding was even more pronounced in younger patients: Those aged 55 years and younger with severe foot pathology died a median of 14 years earlier than their normal expected lifespan would have ended.

Dr. Tesic and his colleagues conducted a 5-year mortality analysis of 244 patients with diabetes, 12% of whom had type 1 disease. The analysis included cardiovascular risk factors (hypertension, triglycerides, cholesterol levels, fibrinogen, proteinuria, and smoking); diabetes duration; coronary artery and cerebrovascular disease; and peripheral artery disease.

Foot pathology was determined according the recently published clinical guidelines by the International Working Group on the Diabetic Foot (IWGDF) (Diab Met Res Rev. 2016. doi: 10.1002/dmrr.2694).

The document parses the diabetic foot into four severity categories:

• 0: No peripheral neuropathy.

• 1: Peripheral neuropathy.

• 2: Peripheral neuropathy with peripheral artery disease and/or a foot deformity.

• 3: Peripheral neuropathy and a history of a foot ulcer or a lower-extremity amputation.

At baseline, patients were a median of 68 years old, though they ranged in age from 36 to 83 years. The mean duration of diabetes was 17 years, and the mean HbA_1c was 8.9%. About half had retinopathy; no one was on hemodialysis.

By 5 years, 53 patients (22%) had died. Their median age was 70 years – 5 years short of the Serbian national life expectancy. However, deaths were evenly distributed among the age groups, Dr. Tesic said: 30% of deceased patients were aged 40-64, 41% aged 65-74, and 28% aged 74 and older.

The causes of death were sudden cardiac death (38%), acute coronary syndrome (32%), stroke (11%), cancer (13%), and sepsis (6%).

There were no significant between-group differences in the type of diabetes; any lipid parameter; diabetic retinopathy; proteinuria; or cardiovascular or cerebrovascular disease. However, patients who died had significantly more severe foot pathology, with 71% scoring either a 2 or 3 on the IWGDF scale compared with 36% of those who were still alive. This level of foot pathology was seen in every age group of the deceased patients: 75% of those in the youngest, 54% of those in the middle group, and 73% of those in the oldest group.

Those who died had developed their foot lesions earlier (66 years vs. 69 years). They had poorer ankle reflexes, and worse results on the Neuropad, a visual indicator test for human diabetic neuropathy. Those who died were older (70 years vs. 66 years), had a longer diabetes duration (20 years vs. 17 years), and more hypertension (79% vs. 61%).

But in a multivariate analysis, only the IWGDF score remained a significant predictor of mortality (odds ratio, 3.78). All of the cardiovascular risk factors, as well as age, diabetes duration, and glucose measures, had no effect on survivalk in that analysis.

The study underscores the importance of preventing and treating diabetic neuropathy and foot complications, Dr. Tesic stressed.

“I like to say that I see an opportunity in every difficulty. The examination of the diabetic foot may be time-consuming, but without that we are not delivering adequate or appropriate care to our patients.”

He had no financial disclosures.

[email protected]

MUNICH – When it comes to predicting mortality in diabetes patients, the foot may trump the heart.

Over a 5-year period, patients who had the most severe foot pathology were almost four times more likely to die than those who had a constellation of cardiovascular risk factors. The association with foot pathology stayed strong and, in a multivariate analysis, was the only factor that remained significantly associated with death in the cohort, Dragan Tesic, MD, said at the annual meeting of the European Association for the Study of Diabetes.

©donskarpo/thinkstockphotos.com

“On average, our patients with severe foot pathology had a 5-year shortening of their lifespan,” said Dr. Tesic of the University of Novi Sad, Serbia. This finding was even more pronounced in younger patients: Those aged 55 years and younger with severe foot pathology died a median of 14 years earlier than their normal expected lifespan would have ended.

Dr. Tesic and his colleagues conducted a 5-year mortality analysis of 244 patients with diabetes, 12% of whom had type 1 disease. The analysis included cardiovascular risk factors (hypertension, triglycerides, cholesterol levels, fibrinogen, proteinuria, and smoking); diabetes duration; coronary artery and cerebrovascular disease; and peripheral artery disease.

Foot pathology was determined according the recently published clinical guidelines by the International Working Group on the Diabetic Foot (IWGDF) (Diab Met Res Rev. 2016. doi: 10.1002/dmrr.2694).

The document parses the diabetic foot into four severity categories:

• 0: No peripheral neuropathy.

• 1: Peripheral neuropathy.

• 2: Peripheral neuropathy with peripheral artery disease and/or a foot deformity.

• 3: Peripheral neuropathy and a history of a foot ulcer or a lower-extremity amputation.

At baseline, patients were a median of 68 years old, though they ranged in age from 36 to 83 years. The mean duration of diabetes was 17 years, and the mean HbA_1c was 8.9%. About half had retinopathy; no one was on hemodialysis.

By 5 years, 53 patients (22%) had died. Their median age was 70 years – 5 years short of the Serbian national life expectancy. However, deaths were evenly distributed among the age groups, Dr. Tesic said: 30% of deceased patients were aged 40-64, 41% aged 65-74, and 28% aged 74 and older.

The causes of death were sudden cardiac death (38%), acute coronary syndrome (32%), stroke (11%), cancer (13%), and sepsis (6%).

There were no significant between-group differences in the type of diabetes; any lipid parameter; diabetic retinopathy; proteinuria; or cardiovascular or cerebrovascular disease. However, patients who died had significantly more severe foot pathology, with 71% scoring either a 2 or 3 on the IWGDF scale compared with 36% of those who were still alive. This level of foot pathology was seen in every age group of the deceased patients: 75% of those in the youngest, 54% of those in the middle group, and 73% of those in the oldest group.

Those who died had developed their foot lesions earlier (66 years vs. 69 years). They had poorer ankle reflexes, and worse results on the Neuropad, a visual indicator test for human diabetic neuropathy. Those who died were older (70 years vs. 66 years), had a longer diabetes duration (20 years vs. 17 years), and more hypertension (79% vs. 61%).

But in a multivariate analysis, only the IWGDF score remained a significant predictor of mortality (odds ratio, 3.78). All of the cardiovascular risk factors, as well as age, diabetes duration, and glucose measures, had no effect on survivalk in that analysis.

The study underscores the importance of preventing and treating diabetic neuropathy and foot complications, Dr. Tesic stressed.

“I like to say that I see an opportunity in every difficulty. The examination of the diabetic foot may be time-consuming, but without that we are not delivering adequate or appropriate care to our patients.”

He had no financial disclosures.

[email protected]

MUNICH – When it comes to predicting mortality in diabetes patients, the foot may trump the heart.

Over a 5-year period, patients who had the most severe foot pathology were almost four times more likely to die than those who had a constellation of cardiovascular risk factors. The association with foot pathology stayed strong and, in a multivariate analysis, was the only factor that remained significantly associated with death in the cohort, Dragan Tesic, MD, said at the annual meeting of the European Association for the Study of Diabetes.

©donskarpo/thinkstockphotos.com

“On average, our patients with severe foot pathology had a 5-year shortening of their lifespan,” said Dr. Tesic of the University of Novi Sad, Serbia. This finding was even more pronounced in younger patients: Those aged 55 years and younger with severe foot pathology died a median of 14 years earlier than their normal expected lifespan would have ended.

Dr. Tesic and his colleagues conducted a 5-year mortality analysis of 244 patients with diabetes, 12% of whom had type 1 disease. The analysis included cardiovascular risk factors (hypertension, triglycerides, cholesterol levels, fibrinogen, proteinuria, and smoking); diabetes duration; coronary artery and cerebrovascular disease; and peripheral artery disease.

Foot pathology was determined according the recently published clinical guidelines by the International Working Group on the Diabetic Foot (IWGDF) (Diab Met Res Rev. 2016. doi: 10.1002/dmrr.2694).

The document parses the diabetic foot into four severity categories:

• 0: No peripheral neuropathy.

• 1: Peripheral neuropathy.

• 2: Peripheral neuropathy with peripheral artery disease and/or a foot deformity.

• 3: Peripheral neuropathy and a history of a foot ulcer or a lower-extremity amputation.

At baseline, patients were a median of 68 years old, though they ranged in age from 36 to 83 years. The mean duration of diabetes was 17 years, and the mean HbA_1c was 8.9%. About half had retinopathy; no one was on hemodialysis.

By 5 years, 53 patients (22%) had died. Their median age was 70 years – 5 years short of the Serbian national life expectancy. However, deaths were evenly distributed among the age groups, Dr. Tesic said: 30% of deceased patients were aged 40-64, 41% aged 65-74, and 28% aged 74 and older.

The causes of death were sudden cardiac death (38%), acute coronary syndrome (32%), stroke (11%), cancer (13%), and sepsis (6%).

There were no significant between-group differences in the type of diabetes; any lipid parameter; diabetic retinopathy; proteinuria; or cardiovascular or cerebrovascular disease. However, patients who died had significantly more severe foot pathology, with 71% scoring either a 2 or 3 on the IWGDF scale compared with 36% of those who were still alive. This level of foot pathology was seen in every age group of the deceased patients: 75% of those in the youngest, 54% of those in the middle group, and 73% of those in the oldest group.

Those who died had developed their foot lesions earlier (66 years vs. 69 years). They had poorer ankle reflexes, and worse results on the Neuropad, a visual indicator test for human diabetic neuropathy. Those who died were older (70 years vs. 66 years), had a longer diabetes duration (20 years vs. 17 years), and more hypertension (79% vs. 61%).

But in a multivariate analysis, only the IWGDF score remained a significant predictor of mortality (odds ratio, 3.78). All of the cardiovascular risk factors, as well as age, diabetes duration, and glucose measures, had no effect on survivalk in that analysis.

The study underscores the importance of preventing and treating diabetic neuropathy and foot complications, Dr. Tesic stressed.

“I like to say that I see an opportunity in every difficulty. The examination of the diabetic foot may be time-consuming, but without that we are not delivering adequate or appropriate care to our patients.”

He had no financial disclosures.

[email protected]

A pathogen infects some people and not others. Some people spread the infection, others don’t. Is it possible to predict who’s likely to be contagious—and perhaps head off an epidemic or pandemic? The Defense Advanced Research Projects Agency’s new Prometheus program may help.

Related: Legionnaires Disease: An Ever-Growing Risk

Focusing on acute respiratory infections, Prometheus researchers will aim to pin down the biological responses that occur in infection, especially the early molecular signals that are triggered soon after exposure. The goal is to develop a prognostic assay based on information from, for example, the amount of virus detected during viral shedding, the genes inside immune-system cells, messenger RNA, immune-system proteins, and other biomarkers.

Current efforts at outbreak containment rely heavily on reported cases, generated after the fact—someone has already become sick and exposed others to the disease. That doesn’t even include people with mild symptoms who don’t go to the doctor but can still spread the disease. A “minimal set of early host biomarkers” could indicate, less than 24 hours after exposure to a pathogen, who will become contagious, opening a window to allow early treatment or mitigation.

Related: Identification and Management of Middle East Respiratory Syndrome

The announcement by DARPA about Prometheus cites a recent review that shows understanding presymptomatic infection is required to achieve accurate forecasting; using only diagnostics is inadequate. “Our goal with Prometheus is to develop techniques that could alert people that they are likely to become contagious,” said Army Col. Matt Hepburn, Prometheus program manager, “so they can proactively take steps to keep the disease from spreading.”

A pathogen infects some people and not others. Some people spread the infection, others don’t. Is it possible to predict who’s likely to be contagious—and perhaps head off an epidemic or pandemic? The Defense Advanced Research Projects Agency’s new Prometheus program may help.

Related: Legionnaires Disease: An Ever-Growing Risk

Focusing on acute respiratory infections, Prometheus researchers will aim to pin down the biological responses that occur in infection, especially the early molecular signals that are triggered soon after exposure. The goal is to develop a prognostic assay based on information from, for example, the amount of virus detected during viral shedding, the genes inside immune-system cells, messenger RNA, immune-system proteins, and other biomarkers.

Current efforts at outbreak containment rely heavily on reported cases, generated after the fact—someone has already become sick and exposed others to the disease. That doesn’t even include people with mild symptoms who don’t go to the doctor but can still spread the disease. A “minimal set of early host biomarkers” could indicate, less than 24 hours after exposure to a pathogen, who will become contagious, opening a window to allow early treatment or mitigation.

Related: Identification and Management of Middle East Respiratory Syndrome

The announcement by DARPA about Prometheus cites a recent review that shows understanding presymptomatic infection is required to achieve accurate forecasting; using only diagnostics is inadequate. “Our goal with Prometheus is to develop techniques that could alert people that they are likely to become contagious,” said Army Col. Matt Hepburn, Prometheus program manager, “so they can proactively take steps to keep the disease from spreading.”

A pathogen infects some people and not others. Some people spread the infection, others don’t. Is it possible to predict who’s likely to be contagious—and perhaps head off an epidemic or pandemic? The Defense Advanced Research Projects Agency’s new Prometheus program may help.

Related: Legionnaires Disease: An Ever-Growing Risk

Focusing on acute respiratory infections, Prometheus researchers will aim to pin down the biological responses that occur in infection, especially the early molecular signals that are triggered soon after exposure. The goal is to develop a prognostic assay based on information from, for example, the amount of virus detected during viral shedding, the genes inside immune-system cells, messenger RNA, immune-system proteins, and other biomarkers.

Current efforts at outbreak containment rely heavily on reported cases, generated after the fact—someone has already become sick and exposed others to the disease. That doesn’t even include people with mild symptoms who don’t go to the doctor but can still spread the disease. A “minimal set of early host biomarkers” could indicate, less than 24 hours after exposure to a pathogen, who will become contagious, opening a window to allow early treatment or mitigation.

Related: Identification and Management of Middle East Respiratory Syndrome

The announcement by DARPA about Prometheus cites a recent review that shows understanding presymptomatic infection is required to achieve accurate forecasting; using only diagnostics is inadequate. “Our goal with Prometheus is to develop techniques that could alert people that they are likely to become contagious,” said Army Col. Matt Hepburn, Prometheus program manager, “so they can proactively take steps to keep the disease from spreading.”

Prescription medications

Photo courtesy of CDC

Results of a retrospective study suggest statins may decrease the risk of death in patients with multiple myeloma (MM).

Researchers analyzed data from nearly 5000 patients with MM and found that patients who took statins had a significant reduction in all-cause mortality and MM-specific mortality when compared to patients who did not take these drugs.

Kristen Marie Sanfilippo, MD, of Washington University School of Medicine in St Louis, Missouri, and her colleagues reported these findings in the Journal of Clinical Oncology.

The researchers analyzed data from the Veterans Administration Central Cancer Registry and identified 4957 patients who were diagnosed with MM between 1999 and 2013.

Of these patients, 2294 were classified as statin users. The researchers defined statin use as the presence of any prescription for a statin within 3 months before MM diagnosis or any time thereafter.

The data showed that statin users had a longer median survival than non-users—39.5 months and 27 months, respectively.

When the researchers adjusted for potential confounders, they found that statin users had a 21% reduction in the risk of all-cause mortality (adjusted hazard ratio [aHR]=0.79, P<0.001) and a 24% reduction in the risk of MM-specific mortality (aHR=0.76, P<0.001).

In addition, statin users had a 31% reduction in the risk of developing a skeletal-related event (aHR=0.69, P<0.001).

In a 12-month landmark analysis, statin use was associated with a significant reduction in the risk of all-cause mortality (aHR=0.86, P=0.001) and MM-specific mortality (aHR=0.83, P=0.01).

The reduction in all-cause mortality was 12% (P=0.004) for patients taking statins for at least 3 months, 16% (P<0.001) for patients taking statins for at least 6 months, and 18% (P=0.003) for patients taking statins for at least 9 months.

Patients with less than 365 daily defined doses (DDDs) of statins had a 20% reduction in the risk of all-cause mortality (aHR=0.80, P<0.001). And patients with ≥ 365 DDDs had a 22% reduction in the risk of all-cause mortality (aHR=0.78, P<0.001).

The reductions in MM-specific mortality according to DDDs were 22% (aHR=0.78, P=0.001) and 28% (aHR=0.72, P<0.001), respectively.

The researchers further adjusted for baseline differences between statin users and non-users with propensity-score matching. And statin use was still associated with a reduction in all-cause mortality (aHR=0.78, P<0.001) and MM-specific mortality (aHR=0.79, P=0.007).

The researchers said these results suggest a potential role for statin therapy in patients with MM, although the findings should be corroborated in prospective studies.

Prescription medications

Photo courtesy of CDC

Results of a retrospective study suggest statins may decrease the risk of death in patients with multiple myeloma (MM).

Researchers analyzed data from nearly 5000 patients with MM and found that patients who took statins had a significant reduction in all-cause mortality and MM-specific mortality when compared to patients who did not take these drugs.

Kristen Marie Sanfilippo, MD, of Washington University School of Medicine in St Louis, Missouri, and her colleagues reported these findings in the Journal of Clinical Oncology.

The researchers analyzed data from the Veterans Administration Central Cancer Registry and identified 4957 patients who were diagnosed with MM between 1999 and 2013.

Of these patients, 2294 were classified as statin users. The researchers defined statin use as the presence of any prescription for a statin within 3 months before MM diagnosis or any time thereafter.

The data showed that statin users had a longer median survival than non-users—39.5 months and 27 months, respectively.

When the researchers adjusted for potential confounders, they found that statin users had a 21% reduction in the risk of all-cause mortality (adjusted hazard ratio [aHR]=0.79, P<0.001) and a 24% reduction in the risk of MM-specific mortality (aHR=0.76, P<0.001).

In addition, statin users had a 31% reduction in the risk of developing a skeletal-related event (aHR=0.69, P<0.001).

In a 12-month landmark analysis, statin use was associated with a significant reduction in the risk of all-cause mortality (aHR=0.86, P=0.001) and MM-specific mortality (aHR=0.83, P=0.01).

The reduction in all-cause mortality was 12% (P=0.004) for patients taking statins for at least 3 months, 16% (P<0.001) for patients taking statins for at least 6 months, and 18% (P=0.003) for patients taking statins for at least 9 months.

Patients with less than 365 daily defined doses (DDDs) of statins had a 20% reduction in the risk of all-cause mortality (aHR=0.80, P<0.001). And patients with ≥ 365 DDDs had a 22% reduction in the risk of all-cause mortality (aHR=0.78, P<0.001).

The reductions in MM-specific mortality according to DDDs were 22% (aHR=0.78, P=0.001) and 28% (aHR=0.72, P<0.001), respectively.

The researchers further adjusted for baseline differences between statin users and non-users with propensity-score matching. And statin use was still associated with a reduction in all-cause mortality (aHR=0.78, P<0.001) and MM-specific mortality (aHR=0.79, P=0.007).

The researchers said these results suggest a potential role for statin therapy in patients with MM, although the findings should be corroborated in prospective studies.

Prescription medications

Photo courtesy of CDC

Results of a retrospective study suggest statins may decrease the risk of death in patients with multiple myeloma (MM).

Researchers analyzed data from nearly 5000 patients with MM and found that patients who took statins had a significant reduction in all-cause mortality and MM-specific mortality when compared to patients who did not take these drugs.

Kristen Marie Sanfilippo, MD, of Washington University School of Medicine in St Louis, Missouri, and her colleagues reported these findings in the Journal of Clinical Oncology.

The researchers analyzed data from the Veterans Administration Central Cancer Registry and identified 4957 patients who were diagnosed with MM between 1999 and 2013.

Of these patients, 2294 were classified as statin users. The researchers defined statin use as the presence of any prescription for a statin within 3 months before MM diagnosis or any time thereafter.

The data showed that statin users had a longer median survival than non-users—39.5 months and 27 months, respectively.

When the researchers adjusted for potential confounders, they found that statin users had a 21% reduction in the risk of all-cause mortality (adjusted hazard ratio [aHR]=0.79, P<0.001) and a 24% reduction in the risk of MM-specific mortality (aHR=0.76, P<0.001).

In addition, statin users had a 31% reduction in the risk of developing a skeletal-related event (aHR=0.69, P<0.001).

In a 12-month landmark analysis, statin use was associated with a significant reduction in the risk of all-cause mortality (aHR=0.86, P=0.001) and MM-specific mortality (aHR=0.83, P=0.01).

The reduction in all-cause mortality was 12% (P=0.004) for patients taking statins for at least 3 months, 16% (P<0.001) for patients taking statins for at least 6 months, and 18% (P=0.003) for patients taking statins for at least 9 months.

Patients with less than 365 daily defined doses (DDDs) of statins had a 20% reduction in the risk of all-cause mortality (aHR=0.80, P<0.001). And patients with ≥ 365 DDDs had a 22% reduction in the risk of all-cause mortality (aHR=0.78, P<0.001).

The reductions in MM-specific mortality according to DDDs were 22% (aHR=0.78, P=0.001) and 28% (aHR=0.72, P<0.001), respectively.

The researchers further adjusted for baseline differences between statin users and non-users with propensity-score matching. And statin use was still associated with a reduction in all-cause mortality (aHR=0.78, P<0.001) and MM-specific mortality (aHR=0.79, P=0.007).

The researchers said these results suggest a potential role for statin therapy in patients with MM, although the findings should be corroborated in prospective studies.

 

 

Cancer patient receives therapy

Photo by Rhoda Baer

 

A new report highlights recent advances made in the fight against cancer but suggests the burden of cancer in the US is still on the rise.

The AACR Cancer Progress Report 2016 states that the number of cancer survivors in the US rose by 1 million from 2014 to 2016, reaching an estimated 15.5 million.

Meanwhile, the US Food and Drug Administration (FDA) approved new treatments for a range of cancers.

Between August 1, 2015, and July 31, 2016, the FDA approved 13 new anticancer therapies and new uses for 11 previously approved anticancer therapies.

Six of these drugs were approved to treat hematologic malignancies:

• Venetoclax for chronic lymphocytic leukemia
• Daratumumab for multiple myeloma
• Elotuzumab for multiple myeloma
• Ixazomib for multiple myeloma
• Obinutuzumab for follicular lymphoma
• Nivolumab for classical Hodgkin lymphoma.

The report notes that the use of immunotherapy, in particular, is on the rise. For example, on August 1, 2015, checkpoint inhibitors were approved for just 2 cancers—melanoma and lung cancer.

As of September 1, 2016, checkpoint inhibitors have been approved for 6 cancers—Hodgkin lymphoma, bladder cancer, head and neck cancer, kidney cancer, lung cancer, and melanoma.

“The promise of immunotherapy for cancer therapy has never been greater, and the opportunity to make significant progress in this critical area is real,” said Nancy E. Davidson, MD, president of the AACR and director of the University of Pittsburgh Cancer Institute in Pennsylvania.

“However, continued progress is going to require a sustained federal commitment to the research agenda. And in fact, if the necessary funding is provided, we will accelerate the pace of progress and, in turn, markedly reduce morbidity and mortality from cancer.”

Growing burden of cancer

The report emphasizes that although advances are being made against cancers, these diseases continue to exert an immense personal and economic toll, and the burden of cancer is expected to grow in the coming decades.

According to the report:

• More than 595,000 people in the US are projected to die from cancer in 2016
• Cancer is the number one cause of disease-related death among US children
• The number of new cancer cases in the US is predicted to rise from 1.7 million in 2015 to 2.4 million in 2035
• It is estimated that the direct medical costs of cancer care in the US in 2010 were nearly $125 billion, and these costs will rise to $156 billion in 2020.

The report states that the increasing economic and personal burden of cancer underscores the need for more research to develop new approaches to cancer prevention and treatment.

The report also highlights the recommendations of the National Cancer Moonshot Initiative Blue Ribbon Panel for accelerating the pace of progress in cancer research.

“Research has made tremendous advances against cancer,” said Margaret Foti, PhD, MD, chief executive officer of the AACR.

“However, we need to accelerate the pace of progress because it is unacceptable that 1 American will die of cancer every minute of every day this year.”

 

 

Cancer patient receives therapy

Photo by Rhoda Baer

 

A new report highlights recent advances made in the fight against cancer but suggests the burden of cancer in the US is still on the rise.

The AACR Cancer Progress Report 2016 states that the number of cancer survivors in the US rose by 1 million from 2014 to 2016, reaching an estimated 15.5 million.

Meanwhile, the US Food and Drug Administration (FDA) approved new treatments for a range of cancers.

Between August 1, 2015, and July 31, 2016, the FDA approved 13 new anticancer therapies and new uses for 11 previously approved anticancer therapies.

Six of these drugs were approved to treat hematologic malignancies:

• Venetoclax for chronic lymphocytic leukemia
• Daratumumab for multiple myeloma
• Elotuzumab for multiple myeloma
• Ixazomib for multiple myeloma
• Obinutuzumab for follicular lymphoma
• Nivolumab for classical Hodgkin lymphoma.

The report notes that the use of immunotherapy, in particular, is on the rise. For example, on August 1, 2015, checkpoint inhibitors were approved for just 2 cancers—melanoma and lung cancer.

As of September 1, 2016, checkpoint inhibitors have been approved for 6 cancers—Hodgkin lymphoma, bladder cancer, head and neck cancer, kidney cancer, lung cancer, and melanoma.

“The promise of immunotherapy for cancer therapy has never been greater, and the opportunity to make significant progress in this critical area is real,” said Nancy E. Davidson, MD, president of the AACR and director of the University of Pittsburgh Cancer Institute in Pennsylvania.

“However, continued progress is going to require a sustained federal commitment to the research agenda. And in fact, if the necessary funding is provided, we will accelerate the pace of progress and, in turn, markedly reduce morbidity and mortality from cancer.”

Growing burden of cancer

The report emphasizes that although advances are being made against cancers, these diseases continue to exert an immense personal and economic toll, and the burden of cancer is expected to grow in the coming decades.

According to the report:

• More than 595,000 people in the US are projected to die from cancer in 2016
• Cancer is the number one cause of disease-related death among US children
• The number of new cancer cases in the US is predicted to rise from 1.7 million in 2015 to 2.4 million in 2035
• It is estimated that the direct medical costs of cancer care in the US in 2010 were nearly $125 billion, and these costs will rise to $156 billion in 2020.

The report states that the increasing economic and personal burden of cancer underscores the need for more research to develop new approaches to cancer prevention and treatment.

The report also highlights the recommendations of the National Cancer Moonshot Initiative Blue Ribbon Panel for accelerating the pace of progress in cancer research.

“Research has made tremendous advances against cancer,” said Margaret Foti, PhD, MD, chief executive officer of the AACR.

“However, we need to accelerate the pace of progress because it is unacceptable that 1 American will die of cancer every minute of every day this year.”

 

 

Cancer patient receives therapy

Photo by Rhoda Baer

 

A new report highlights recent advances made in the fight against cancer but suggests the burden of cancer in the US is still on the rise.

The AACR Cancer Progress Report 2016 states that the number of cancer survivors in the US rose by 1 million from 2014 to 2016, reaching an estimated 15.5 million.

Meanwhile, the US Food and Drug Administration (FDA) approved new treatments for a range of cancers.

Between August 1, 2015, and July 31, 2016, the FDA approved 13 new anticancer therapies and new uses for 11 previously approved anticancer therapies.

Six of these drugs were approved to treat hematologic malignancies:

• Venetoclax for chronic lymphocytic leukemia
• Daratumumab for multiple myeloma
• Elotuzumab for multiple myeloma
• Ixazomib for multiple myeloma
• Obinutuzumab for follicular lymphoma
• Nivolumab for classical Hodgkin lymphoma.

The report notes that the use of immunotherapy, in particular, is on the rise. For example, on August 1, 2015, checkpoint inhibitors were approved for just 2 cancers—melanoma and lung cancer.

As of September 1, 2016, checkpoint inhibitors have been approved for 6 cancers—Hodgkin lymphoma, bladder cancer, head and neck cancer, kidney cancer, lung cancer, and melanoma.

“The promise of immunotherapy for cancer therapy has never been greater, and the opportunity to make significant progress in this critical area is real,” said Nancy E. Davidson, MD, president of the AACR and director of the University of Pittsburgh Cancer Institute in Pennsylvania.

“However, continued progress is going to require a sustained federal commitment to the research agenda. And in fact, if the necessary funding is provided, we will accelerate the pace of progress and, in turn, markedly reduce morbidity and mortality from cancer.”

Growing burden of cancer

The report emphasizes that although advances are being made against cancers, these diseases continue to exert an immense personal and economic toll, and the burden of cancer is expected to grow in the coming decades.

According to the report:

• More than 595,000 people in the US are projected to die from cancer in 2016
• Cancer is the number one cause of disease-related death among US children
• The number of new cancer cases in the US is predicted to rise from 1.7 million in 2015 to 2.4 million in 2035
• It is estimated that the direct medical costs of cancer care in the US in 2010 were nearly $125 billion, and these costs will rise to $156 billion in 2020.

The report states that the increasing economic and personal burden of cancer underscores the need for more research to develop new approaches to cancer prevention and treatment.

The report also highlights the recommendations of the National Cancer Moonshot Initiative Blue Ribbon Panel for accelerating the pace of progress in cancer research.

“Research has made tremendous advances against cancer,” said Margaret Foti, PhD, MD, chief executive officer of the AACR.

“However, we need to accelerate the pace of progress because it is unacceptable that 1 American will die of cancer every minute of every day this year.”

Doctor and patient in hospital

Photo courtesy of CDC

New research suggests that many patients who die of cancer do not receive strong opioid medications in their last year of life, despite the fact that these drugs are the recommended treatment for cancer-related pain.

Researchers used UK Cancer Registry Data to study more than 6000 cancer patients who died over a 7-year period.

Less than half of these patients received prescriptions for strong opioid medications in their last year of life.

Among those patients who did receive such prescriptions, many received them late.

Lucy Ziegler, PhD, of the University of Leeds in the UK, and her colleagues conducted this study and reported the results in PAIN.

The study included 6080 cancer patients who died between 2005 and 2012.

About 76% (n=4610) of these patients had received one or more prescriptions for analgesics, including 48% (n=2919) who received a strong opioid and 28% (n=1691) who received a non-opioid or weak opioid. The remaining 24% (n=1470) did not receive any prescription analgesic.

The chance of receiving strong opioids was not affected by patients’ age or sex.

However, patients who died in a hospital were 60% less likely to have a prescription for strong opioids during the last year of life, when compared with those who died in hospice.

And patients who received chemotherapy in the last year of life were 30% more likely to receive a strong opioid than patients who did not receive chemotherapy.

Timing of therapy

Among the patients who did receive strong opioids, the median time between receiving the medication and death was 9 weeks. By 6 weeks before death, just 30% of patients had been prescribed a strong opioid.

The researchers noted that these figures don’t match up with previous studies reporting that severe pain can occur “much earlier in the cancer trajectory.”

Older patients were more likely to receive their strong opioid prescription late (defined as later than 9 weeks before death). After other factors were taken into account, patients age 60 or older were about 2 to 4 times more likely to be in the late-prescribing group, compared with those age 50 or younger.

Compared to patients who died in hospice, patients who died in a hospital were 40% more likely to receive a late prescription for a strong opioid. Patients who died in their own home were 2.6 times more likely to receive a late prescription, and patients who died in a care home were 2.8 times more likely to receive a late prescription.

Patients who had surgery were 40% more likely to receive a late prescription than patients who did not undergo surgery.

But patients who received chemotherapy and/or radiotherapy were 30% more likely to have received an early prescription for a strong opioid than patients who did not receive chemo/radiotherapy.

Dr Ziegler and her colleagues noted that this study had its limitations; in particular, the lack of data on pain severity.

Still, the researchers believe their results support the hypothesis of potential under-treatment of cancer pain and suggest that many more patients with advanced cancer and pain may benefit from a strong opioid analgesic.

Doctor and patient in hospital

Photo courtesy of CDC

New research suggests that many patients who die of cancer do not receive strong opioid medications in their last year of life, despite the fact that these drugs are the recommended treatment for cancer-related pain.

Researchers used UK Cancer Registry Data to study more than 6000 cancer patients who died over a 7-year period.

Less than half of these patients received prescriptions for strong opioid medications in their last year of life.

Among those patients who did receive such prescriptions, many received them late.

Lucy Ziegler, PhD, of the University of Leeds in the UK, and her colleagues conducted this study and reported the results in PAIN.

The study included 6080 cancer patients who died between 2005 and 2012.

About 76% (n=4610) of these patients had received one or more prescriptions for analgesics, including 48% (n=2919) who received a strong opioid and 28% (n=1691) who received a non-opioid or weak opioid. The remaining 24% (n=1470) did not receive any prescription analgesic.

The chance of receiving strong opioids was not affected by patients’ age or sex.

However, patients who died in a hospital were 60% less likely to have a prescription for strong opioids during the last year of life, when compared with those who died in hospice.

And patients who received chemotherapy in the last year of life were 30% more likely to receive a strong opioid than patients who did not receive chemotherapy.

Timing of therapy

Among the patients who did receive strong opioids, the median time between receiving the medication and death was 9 weeks. By 6 weeks before death, just 30% of patients had been prescribed a strong opioid.

The researchers noted that these figures don’t match up with previous studies reporting that severe pain can occur “much earlier in the cancer trajectory.”

Older patients were more likely to receive their strong opioid prescription late (defined as later than 9 weeks before death). After other factors were taken into account, patients age 60 or older were about 2 to 4 times more likely to be in the late-prescribing group, compared with those age 50 or younger.

Compared to patients who died in hospice, patients who died in a hospital were 40% more likely to receive a late prescription for a strong opioid. Patients who died in their own home were 2.6 times more likely to receive a late prescription, and patients who died in a care home were 2.8 times more likely to receive a late prescription.

Patients who had surgery were 40% more likely to receive a late prescription than patients who did not undergo surgery.

But patients who received chemotherapy and/or radiotherapy were 30% more likely to have received an early prescription for a strong opioid than patients who did not receive chemo/radiotherapy.

Dr Ziegler and her colleagues noted that this study had its limitations; in particular, the lack of data on pain severity.

Still, the researchers believe their results support the hypothesis of potential under-treatment of cancer pain and suggest that many more patients with advanced cancer and pain may benefit from a strong opioid analgesic.

Doctor and patient in hospital

Photo courtesy of CDC

New research suggests that many patients who die of cancer do not receive strong opioid medications in their last year of life, despite the fact that these drugs are the recommended treatment for cancer-related pain.

Researchers used UK Cancer Registry Data to study more than 6000 cancer patients who died over a 7-year period.

Less than half of these patients received prescriptions for strong opioid medications in their last year of life.

Among those patients who did receive such prescriptions, many received them late.

Lucy Ziegler, PhD, of the University of Leeds in the UK, and her colleagues conducted this study and reported the results in PAIN.

The study included 6080 cancer patients who died between 2005 and 2012.

About 76% (n=4610) of these patients had received one or more prescriptions for analgesics, including 48% (n=2919) who received a strong opioid and 28% (n=1691) who received a non-opioid or weak opioid. The remaining 24% (n=1470) did not receive any prescription analgesic.

The chance of receiving strong opioids was not affected by patients’ age or sex.

However, patients who died in a hospital were 60% less likely to have a prescription for strong opioids during the last year of life, when compared with those who died in hospice.

And patients who received chemotherapy in the last year of life were 30% more likely to receive a strong opioid than patients who did not receive chemotherapy.

Timing of therapy

Among the patients who did receive strong opioids, the median time between receiving the medication and death was 9 weeks. By 6 weeks before death, just 30% of patients had been prescribed a strong opioid.

The researchers noted that these figures don’t match up with previous studies reporting that severe pain can occur “much earlier in the cancer trajectory.”

Older patients were more likely to receive their strong opioid prescription late (defined as later than 9 weeks before death). After other factors were taken into account, patients age 60 or older were about 2 to 4 times more likely to be in the late-prescribing group, compared with those age 50 or younger.

Compared to patients who died in hospice, patients who died in a hospital were 40% more likely to receive a late prescription for a strong opioid. Patients who died in their own home were 2.6 times more likely to receive a late prescription, and patients who died in a care home were 2.8 times more likely to receive a late prescription.

Patients who had surgery were 40% more likely to receive a late prescription than patients who did not undergo surgery.

But patients who received chemotherapy and/or radiotherapy were 30% more likely to have received an early prescription for a strong opioid than patients who did not receive chemo/radiotherapy.

Dr Ziegler and her colleagues noted that this study had its limitations; in particular, the lack of data on pain severity.

Still, the researchers believe their results support the hypothesis of potential under-treatment of cancer pain and suggest that many more patients with advanced cancer and pain may benefit from a strong opioid analgesic.

B-cell precursor ALL

Image by Vashi Donsk

Adding rituximab to a chemotherapy regimen can improve event-free survival (EFS) in adults with newly diagnosed, CD20-positive acute lymphoblastic leukemia (ALL), according to the GRAALL-2005/R study.

The 2-year EFS was significantly higher for patients who received rituximab than for those who received chemotherapy alone.

However, there was no significant difference between the groups in 2-year overall survival.

Sébastien Maury, MD, PhD, of Hȏpital Hénri Mondor in Creteil, France, and his colleagues reported these results in NEJM. Results from this study were previously presented at the 2015 ASH Annual Meeting.

The study included 209 patients with newly diagnosed, Ph-negative, B-cell precursor ALL with 20% or more CD20-positive leukemic blasts.

The patients’ median age was 40.2 (range, 24.5–52.6), 13% had an ECOG performance status greater than 1, 6% had CNS involvement, and 21% had a white blood cell count of 30 x 10⁹/L or higher.

Half of the patients (n=104) were randomized to receive the GRAALL-2005 regimen, and the other half (n=105) were randomized to receive the same regimen plus rituximab. Details on the regimens are available in the supplementary material published with the NEJM paper.

Baseline patient characteristics were well-balanced between the treatment groups.

Results

At a median follow-up of 30 months, 101 patients (48%) had at least 1 event, including 44 (42%) in the rituximab group and 57 (55%) in the control group.

There were 17 induction failures (8 in the rituximab group and 9 in the control group), 57 relapses (22 and 35, respectively), and 27 deaths during remission (14 and 13, respectively). Two patients in the rituximab group were lost to follow-up during the first 12 months.

The 2-year EFS was significantly higher in the rituximab group than the control group—65% and 52%, respectively (hazard ratio [HR]=0.66, P=0.04).

However, the EFS benefit did not translate into a significant improvement in overall survival. The 2-year overall survival was 71% in the rituximab group and 64% in the control group (HR=0.70, P=0.10).

Similarly, the cumulative incidence of death during first remission was not significantly different between the treatment groups—12% for both (HR=0.98, P=0.96).

The researchers said the difference in EFS was mostly due to a lower incidence of relapse in the rituximab group. The 2-year incidence of relapse was 18% in the rituximab group and 32% in the control group (HR=0.52, P=0.02).

In a multivariate analysis, receiving the control treatment, older age, higher white blood cell count at baseline, and CNS involvement were all significantly associated with poor EFS.

There were 245 severe adverse events (AEs) reported in 124 patients—67 patients with 1 event, 26 with 2 events, 13 with 3 events, and 18 with 4 or more events.

The overall incidence of severe AEs did not differ significantly between the treatment groups—96% in the rituximab group and 92% in the control group.

Severe AEs included infection, laboratory abnormalities, allergic reactions, neurologic events, pulmonary events, coagulopathy, cardiac events, gastrointestinal events, and “other” events.

The only severe AE for which there was a significant difference between the treatment groups was allergic reactions. There were 2 severe allergic events in the rituximab group and 14 in the control group (P=0.002). Of these 16 events, all but 1 were due to asparaginase.

The researchers therefore theorized that rituximab might inhibit B-cell protection of antibodies against asparaginase, although they could not confirm this hypothesis.

B-cell precursor ALL

Image by Vashi Donsk

Adding rituximab to a chemotherapy regimen can improve event-free survival (EFS) in adults with newly diagnosed, CD20-positive acute lymphoblastic leukemia (ALL), according to the GRAALL-2005/R study.

The 2-year EFS was significantly higher for patients who received rituximab than for those who received chemotherapy alone.

However, there was no significant difference between the groups in 2-year overall survival.

Sébastien Maury, MD, PhD, of Hȏpital Hénri Mondor in Creteil, France, and his colleagues reported these results in NEJM. Results from this study were previously presented at the 2015 ASH Annual Meeting.

The study included 209 patients with newly diagnosed, Ph-negative, B-cell precursor ALL with 20% or more CD20-positive leukemic blasts.

The patients’ median age was 40.2 (range, 24.5–52.6), 13% had an ECOG performance status greater than 1, 6% had CNS involvement, and 21% had a white blood cell count of 30 x 10⁹/L or higher.

Half of the patients (n=104) were randomized to receive the GRAALL-2005 regimen, and the other half (n=105) were randomized to receive the same regimen plus rituximab. Details on the regimens are available in the supplementary material published with the NEJM paper.

Baseline patient characteristics were well-balanced between the treatment groups.

Results

At a median follow-up of 30 months, 101 patients (48%) had at least 1 event, including 44 (42%) in the rituximab group and 57 (55%) in the control group.

There were 17 induction failures (8 in the rituximab group and 9 in the control group), 57 relapses (22 and 35, respectively), and 27 deaths during remission (14 and 13, respectively). Two patients in the rituximab group were lost to follow-up during the first 12 months.

The 2-year EFS was significantly higher in the rituximab group than the control group—65% and 52%, respectively (hazard ratio [HR]=0.66, P=0.04).

However, the EFS benefit did not translate into a significant improvement in overall survival. The 2-year overall survival was 71% in the rituximab group and 64% in the control group (HR=0.70, P=0.10).

Similarly, the cumulative incidence of death during first remission was not significantly different between the treatment groups—12% for both (HR=0.98, P=0.96).

The researchers said the difference in EFS was mostly due to a lower incidence of relapse in the rituximab group. The 2-year incidence of relapse was 18% in the rituximab group and 32% in the control group (HR=0.52, P=0.02).

In a multivariate analysis, receiving the control treatment, older age, higher white blood cell count at baseline, and CNS involvement were all significantly associated with poor EFS.

There were 245 severe adverse events (AEs) reported in 124 patients—67 patients with 1 event, 26 with 2 events, 13 with 3 events, and 18 with 4 or more events.

The overall incidence of severe AEs did not differ significantly between the treatment groups—96% in the rituximab group and 92% in the control group.

Severe AEs included infection, laboratory abnormalities, allergic reactions, neurologic events, pulmonary events, coagulopathy, cardiac events, gastrointestinal events, and “other” events.

The only severe AE for which there was a significant difference between the treatment groups was allergic reactions. There were 2 severe allergic events in the rituximab group and 14 in the control group (P=0.002). Of these 16 events, all but 1 were due to asparaginase.

The researchers therefore theorized that rituximab might inhibit B-cell protection of antibodies against asparaginase, although they could not confirm this hypothesis.

B-cell precursor ALL

Image by Vashi Donsk

Adding rituximab to a chemotherapy regimen can improve event-free survival (EFS) in adults with newly diagnosed, CD20-positive acute lymphoblastic leukemia (ALL), according to the GRAALL-2005/R study.

The 2-year EFS was significantly higher for patients who received rituximab than for those who received chemotherapy alone.

However, there was no significant difference between the groups in 2-year overall survival.

Sébastien Maury, MD, PhD, of Hȏpital Hénri Mondor in Creteil, France, and his colleagues reported these results in NEJM. Results from this study were previously presented at the 2015 ASH Annual Meeting.

The study included 209 patients with newly diagnosed, Ph-negative, B-cell precursor ALL with 20% or more CD20-positive leukemic blasts.

The patients’ median age was 40.2 (range, 24.5–52.6), 13% had an ECOG performance status greater than 1, 6% had CNS involvement, and 21% had a white blood cell count of 30 x 10⁹/L or higher.

Half of the patients (n=104) were randomized to receive the GRAALL-2005 regimen, and the other half (n=105) were randomized to receive the same regimen plus rituximab. Details on the regimens are available in the supplementary material published with the NEJM paper.

Baseline patient characteristics were well-balanced between the treatment groups.

Results

At a median follow-up of 30 months, 101 patients (48%) had at least 1 event, including 44 (42%) in the rituximab group and 57 (55%) in the control group.

There were 17 induction failures (8 in the rituximab group and 9 in the control group), 57 relapses (22 and 35, respectively), and 27 deaths during remission (14 and 13, respectively). Two patients in the rituximab group were lost to follow-up during the first 12 months.

The 2-year EFS was significantly higher in the rituximab group than the control group—65% and 52%, respectively (hazard ratio [HR]=0.66, P=0.04).

However, the EFS benefit did not translate into a significant improvement in overall survival. The 2-year overall survival was 71% in the rituximab group and 64% in the control group (HR=0.70, P=0.10).

Similarly, the cumulative incidence of death during first remission was not significantly different between the treatment groups—12% for both (HR=0.98, P=0.96).

The researchers said the difference in EFS was mostly due to a lower incidence of relapse in the rituximab group. The 2-year incidence of relapse was 18% in the rituximab group and 32% in the control group (HR=0.52, P=0.02).

In a multivariate analysis, receiving the control treatment, older age, higher white blood cell count at baseline, and CNS involvement were all significantly associated with poor EFS.

There were 245 severe adverse events (AEs) reported in 124 patients—67 patients with 1 event, 26 with 2 events, 13 with 3 events, and 18 with 4 or more events.

The overall incidence of severe AEs did not differ significantly between the treatment groups—96% in the rituximab group and 92% in the control group.

Severe AEs included infection, laboratory abnormalities, allergic reactions, neurologic events, pulmonary events, coagulopathy, cardiac events, gastrointestinal events, and “other” events.

The only severe AE for which there was a significant difference between the treatment groups was allergic reactions. There were 2 severe allergic events in the rituximab group and 14 in the control group (P=0.002). Of these 16 events, all but 1 were due to asparaginase.

The researchers therefore theorized that rituximab might inhibit B-cell protection of antibodies against asparaginase, although they could not confirm this hypothesis.

Team-based care for adolescent depression is cost effective in the long run, and easily meets the most rigid of third-party payer payment thresholds, a study found.

In a randomized, controlled, multisite study, 105 adolescents aged 13-17 years who screened positive for depression in the ROAD (Reaching Out to Adolescents in Distress) trial were given care as usual in a primary care setting or collaborative evidence-based treatment (with antidepressants, psychotherapy or both) plus regular follow-up with a behavioral health specialist. Controls were given their depression screening results and told they could access mental health services from a large health care network at their discretion. Non–English speaking teens, those already in psychiatric care, those with a bipolar or substance misuse diagnosis, and those with a suicide plan or a recent history of attempt were excluded. Ultimately, 101 youths completed the study, with 50 receiving the study intervention, said Davene R.Wright, PhD, of the University of Washington in Seattle, and associates (JAMA Pediatr. 2016. doi: 10.1001/jamapediatrics.2016.1721).

KatarzynaBialasiewicz/Thinkstock

The overall health care plan costs did not differ significantly between the groups, with an average of $5,161 for the study group, compared with $5,752 for controls. The cost of delivering specialty care added an average of $1,475 to cost of care per patient – about 22% of the total collaborative care costs – making $883 the net mean difference in the cost of care between the groups.

The study group had a slightly higher daily utility value at 0.78, compared with 0.73 for controls, based on their Child Depression Rating Scale-Revised scores. This made the difference in the overall effectiveness of the two treatments 0.04 in quality-adjusted life-years (QALY).

When dividing the net cost of the collaborative model by its net effectiveness over time, the cost of treatment was $18,239 per QALY gained. Bootstrap uncertainty analyses used to determine confidence intervals in the study showed that 25.9% of cases would result in the intervention both costing less and increasing QALYs. Third-party payers consider an incremental cost-effectiveness ratio of $50,000 per QALY gained or below the threshold for payment.

The study did not take into account out-of-pocket or time costs incurred by patients’ families, nor did it consider school absenteeism and use of school counseling services, so the total societal costs and economic burden of treating adolescent depression are not accounted for in this study. However, the investigators concluded that collaborative teen depression care saves money and improves outcomes over time, at least from the payer’s perspective.

[email protected]

On Twitter @whitneymcknight

Team-based care for adolescent depression is cost effective in the long run, and easily meets the most rigid of third-party payer payment thresholds, a study found.

In a randomized, controlled, multisite study, 105 adolescents aged 13-17 years who screened positive for depression in the ROAD (Reaching Out to Adolescents in Distress) trial were given care as usual in a primary care setting or collaborative evidence-based treatment (with antidepressants, psychotherapy or both) plus regular follow-up with a behavioral health specialist. Controls were given their depression screening results and told they could access mental health services from a large health care network at their discretion. Non–English speaking teens, those already in psychiatric care, those with a bipolar or substance misuse diagnosis, and those with a suicide plan or a recent history of attempt were excluded. Ultimately, 101 youths completed the study, with 50 receiving the study intervention, said Davene R.Wright, PhD, of the University of Washington in Seattle, and associates (JAMA Pediatr. 2016. doi: 10.1001/jamapediatrics.2016.1721).

KatarzynaBialasiewicz/Thinkstock

The overall health care plan costs did not differ significantly between the groups, with an average of $5,161 for the study group, compared with $5,752 for controls. The cost of delivering specialty care added an average of $1,475 to cost of care per patient – about 22% of the total collaborative care costs – making $883 the net mean difference in the cost of care between the groups.

The study group had a slightly higher daily utility value at 0.78, compared with 0.73 for controls, based on their Child Depression Rating Scale-Revised scores. This made the difference in the overall effectiveness of the two treatments 0.04 in quality-adjusted life-years (QALY).

When dividing the net cost of the collaborative model by its net effectiveness over time, the cost of treatment was $18,239 per QALY gained. Bootstrap uncertainty analyses used to determine confidence intervals in the study showed that 25.9% of cases would result in the intervention both costing less and increasing QALYs. Third-party payers consider an incremental cost-effectiveness ratio of $50,000 per QALY gained or below the threshold for payment.

The study did not take into account out-of-pocket or time costs incurred by patients’ families, nor did it consider school absenteeism and use of school counseling services, so the total societal costs and economic burden of treating adolescent depression are not accounted for in this study. However, the investigators concluded that collaborative teen depression care saves money and improves outcomes over time, at least from the payer’s perspective.

[email protected]

On Twitter @whitneymcknight

Team-based care for adolescent depression is cost effective in the long run, and easily meets the most rigid of third-party payer payment thresholds, a study found.

In a randomized, controlled, multisite study, 105 adolescents aged 13-17 years who screened positive for depression in the ROAD (Reaching Out to Adolescents in Distress) trial were given care as usual in a primary care setting or collaborative evidence-based treatment (with antidepressants, psychotherapy or both) plus regular follow-up with a behavioral health specialist. Controls were given their depression screening results and told they could access mental health services from a large health care network at their discretion. Non–English speaking teens, those already in psychiatric care, those with a bipolar or substance misuse diagnosis, and those with a suicide plan or a recent history of attempt were excluded. Ultimately, 101 youths completed the study, with 50 receiving the study intervention, said Davene R.Wright, PhD, of the University of Washington in Seattle, and associates (JAMA Pediatr. 2016. doi: 10.1001/jamapediatrics.2016.1721).

KatarzynaBialasiewicz/Thinkstock

The overall health care plan costs did not differ significantly between the groups, with an average of $5,161 for the study group, compared with $5,752 for controls. The cost of delivering specialty care added an average of $1,475 to cost of care per patient – about 22% of the total collaborative care costs – making $883 the net mean difference in the cost of care between the groups.

The study group had a slightly higher daily utility value at 0.78, compared with 0.73 for controls, based on their Child Depression Rating Scale-Revised scores. This made the difference in the overall effectiveness of the two treatments 0.04 in quality-adjusted life-years (QALY).

When dividing the net cost of the collaborative model by its net effectiveness over time, the cost of treatment was $18,239 per QALY gained. Bootstrap uncertainty analyses used to determine confidence intervals in the study showed that 25.9% of cases would result in the intervention both costing less and increasing QALYs. Third-party payers consider an incremental cost-effectiveness ratio of $50,000 per QALY gained or below the threshold for payment.

The study did not take into account out-of-pocket or time costs incurred by patients’ families, nor did it consider school absenteeism and use of school counseling services, so the total societal costs and economic burden of treating adolescent depression are not accounted for in this study. However, the investigators concluded that collaborative teen depression care saves money and improves outcomes over time, at least from the payer’s perspective.

[email protected]

On Twitter @whitneymcknight

Vasectomy does not appear to be associated with prostate cancer mortality or prostate cancer incidence, according to findings from a large U.S. prospective cohort of men aged 40 years or older.

Prostate cancer mortality was examined in the overall Cancer Prevention Study II (CPS-II) cohort of 363,726 men, including 7,451 who died as a result of prostate cancer between 1982 and 2012, and no association was found with vasectomy (hazard ratio, 1.01).

©alexdans/Thinkstock

Overall and high-grade prostate cancer incidence rates were examined among 66,542 men from the CPS-II Nutrition cohort subgroup, including 9,133 who were diagnosed with prostate cancer between 1991 and 2011, and again no associations were found with vasectomy (HR, 1.02 and 0.91, respectively), Eric J. Jacobs, PhD, and his colleagues at the American Cancer Society report (J Clin Oncol. 2016 Sep 19. doi: 10.1200/JCO.2015.66.2361).

Results were similar after adjusting for years since vasectomy and in analyses restricted to men aged 50 years and older, the investigators noted.

Findings from prior, smaller studies have been conflicting, but the current study – the largest-known study to date to examine the association between vasectomy and prostate cancer, according to the authors – provides “some reassurance that vasectomy is unlikely to meaningfully increase risk of prostate cancer,” they wrote.

The authors reported having no disclosures.

[email protected]

Vasectomy does not appear to be associated with prostate cancer mortality or prostate cancer incidence, according to findings from a large U.S. prospective cohort of men aged 40 years or older.

Prostate cancer mortality was examined in the overall Cancer Prevention Study II (CPS-II) cohort of 363,726 men, including 7,451 who died as a result of prostate cancer between 1982 and 2012, and no association was found with vasectomy (hazard ratio, 1.01).

©alexdans/Thinkstock

Overall and high-grade prostate cancer incidence rates were examined among 66,542 men from the CPS-II Nutrition cohort subgroup, including 9,133 who were diagnosed with prostate cancer between 1991 and 2011, and again no associations were found with vasectomy (HR, 1.02 and 0.91, respectively), Eric J. Jacobs, PhD, and his colleagues at the American Cancer Society report (J Clin Oncol. 2016 Sep 19. doi: 10.1200/JCO.2015.66.2361).

Results were similar after adjusting for years since vasectomy and in analyses restricted to men aged 50 years and older, the investigators noted.

Findings from prior, smaller studies have been conflicting, but the current study – the largest-known study to date to examine the association between vasectomy and prostate cancer, according to the authors – provides “some reassurance that vasectomy is unlikely to meaningfully increase risk of prostate cancer,” they wrote.

The authors reported having no disclosures.

[email protected]

Vasectomy does not appear to be associated with prostate cancer mortality or prostate cancer incidence, according to findings from a large U.S. prospective cohort of men aged 40 years or older.

Prostate cancer mortality was examined in the overall Cancer Prevention Study II (CPS-II) cohort of 363,726 men, including 7,451 who died as a result of prostate cancer between 1982 and 2012, and no association was found with vasectomy (hazard ratio, 1.01).

©alexdans/Thinkstock

Overall and high-grade prostate cancer incidence rates were examined among 66,542 men from the CPS-II Nutrition cohort subgroup, including 9,133 who were diagnosed with prostate cancer between 1991 and 2011, and again no associations were found with vasectomy (HR, 1.02 and 0.91, respectively), Eric J. Jacobs, PhD, and his colleagues at the American Cancer Society report (J Clin Oncol. 2016 Sep 19. doi: 10.1200/JCO.2015.66.2361).

Results were similar after adjusting for years since vasectomy and in analyses restricted to men aged 50 years and older, the investigators noted.

Findings from prior, smaller studies have been conflicting, but the current study – the largest-known study to date to examine the association between vasectomy and prostate cancer, according to the authors – provides “some reassurance that vasectomy is unlikely to meaningfully increase risk of prostate cancer,” they wrote.

The authors reported having no disclosures.

[email protected]

Primary progressive MS is characterized by steadily increasing, objectively documented neurologic dysfunction or disability without recovery, although patients may have fluctuations and phases of stability.

Primary progressive MS remains a severely disabling condition with high unmet medical need. Investigators believe that B cells contribute to the pathogenesis of MS, including primary progressive MS. Ocrelizumab, a recombinant humanized monoclonal antibody that selectively targets CD20⁺ B cells, showed superior efficacy and favorable safety, compared with placebo, in the phase III ORATORIO study in patients with primary progressive MS.

Xavier Montalban, MD, PhD, Chair of the Department of Neurology-Neuroimmunology and Director of the Multiple Sclerosis Centre of Catalonia at Vall d’Hebron University Hospital in Barcelona, and colleagues sought to assess the effect of ocrelizumab from baseline to Week 120 on the proportion of patients with NEP in the ORATORIO study.

In all, 732 patients were randomized (2:1) to receive 600 mg of ocrelizumab as two 300-mg IV infusions 14 days apart, or placebo every 24 weeks for at least 120 weeks until a prespecified number of 12-week confirmed disability progression events (as measured by Expanded Disability Status Scale score) occurred. Patients with NEP were defined as having no 12-week confirmed disability progression, and no 12-week confirmed progression of 20% or more on the timed 25-foot walk test and on the nine-hole peg test. A total of 230 placebo-treated patients and 461 ocrelizumab-treated patients were evaluable in this exploratory analysis of the ORATORIO trial.

Compared with placebo, ocrelizumab significantly increased the proportion of patients with NEP at Week 120. The relative risk of NEP for ocrelizumab versus placebo was 1.47. The proportions of ocrelizumab- and placebo-treated patients with NEP up to Week 120 were 42.7% and 29.1%, respectively. This result represents a 47% relative increase in the ocrelizumab group. The proportions of ocrelizumab- and placebo-treated patients with NEP for the individual components of NEP up to Week 120 were 68.5% and 63.0%, respectively, for 12-week confirmed disability progression; 51.0% and 38.7%, respectively, for the timed 25-foot walk test; and 82.2% and 71.3%, respectively for the nine-hole peg test.

The study was sponsored by F. Hoffmann-La Roche.

Primary progressive MS is characterized by steadily increasing, objectively documented neurologic dysfunction or disability without recovery, although patients may have fluctuations and phases of stability.

Primary progressive MS remains a severely disabling condition with high unmet medical need. Investigators believe that B cells contribute to the pathogenesis of MS, including primary progressive MS. Ocrelizumab, a recombinant humanized monoclonal antibody that selectively targets CD20⁺ B cells, showed superior efficacy and favorable safety, compared with placebo, in the phase III ORATORIO study in patients with primary progressive MS.

Xavier Montalban, MD, PhD, Chair of the Department of Neurology-Neuroimmunology and Director of the Multiple Sclerosis Centre of Catalonia at Vall d’Hebron University Hospital in Barcelona, and colleagues sought to assess the effect of ocrelizumab from baseline to Week 120 on the proportion of patients with NEP in the ORATORIO study.

In all, 732 patients were randomized (2:1) to receive 600 mg of ocrelizumab as two 300-mg IV infusions 14 days apart, or placebo every 24 weeks for at least 120 weeks until a prespecified number of 12-week confirmed disability progression events (as measured by Expanded Disability Status Scale score) occurred. Patients with NEP were defined as having no 12-week confirmed disability progression, and no 12-week confirmed progression of 20% or more on the timed 25-foot walk test and on the nine-hole peg test. A total of 230 placebo-treated patients and 461 ocrelizumab-treated patients were evaluable in this exploratory analysis of the ORATORIO trial.

Compared with placebo, ocrelizumab significantly increased the proportion of patients with NEP at Week 120. The relative risk of NEP for ocrelizumab versus placebo was 1.47. The proportions of ocrelizumab- and placebo-treated patients with NEP up to Week 120 were 42.7% and 29.1%, respectively. This result represents a 47% relative increase in the ocrelizumab group. The proportions of ocrelizumab- and placebo-treated patients with NEP for the individual components of NEP up to Week 120 were 68.5% and 63.0%, respectively, for 12-week confirmed disability progression; 51.0% and 38.7%, respectively, for the timed 25-foot walk test; and 82.2% and 71.3%, respectively for the nine-hole peg test.

The study was sponsored by F. Hoffmann-La Roche.

Primary progressive MS is characterized by steadily increasing, objectively documented neurologic dysfunction or disability without recovery, although patients may have fluctuations and phases of stability.

Primary progressive MS remains a severely disabling condition with high unmet medical need. Investigators believe that B cells contribute to the pathogenesis of MS, including primary progressive MS. Ocrelizumab, a recombinant humanized monoclonal antibody that selectively targets CD20⁺ B cells, showed superior efficacy and favorable safety, compared with placebo, in the phase III ORATORIO study in patients with primary progressive MS.

Xavier Montalban, MD, PhD, Chair of the Department of Neurology-Neuroimmunology and Director of the Multiple Sclerosis Centre of Catalonia at Vall d’Hebron University Hospital in Barcelona, and colleagues sought to assess the effect of ocrelizumab from baseline to Week 120 on the proportion of patients with NEP in the ORATORIO study.

In all, 732 patients were randomized (2:1) to receive 600 mg of ocrelizumab as two 300-mg IV infusions 14 days apart, or placebo every 24 weeks for at least 120 weeks until a prespecified number of 12-week confirmed disability progression events (as measured by Expanded Disability Status Scale score) occurred. Patients with NEP were defined as having no 12-week confirmed disability progression, and no 12-week confirmed progression of 20% or more on the timed 25-foot walk test and on the nine-hole peg test. A total of 230 placebo-treated patients and 461 ocrelizumab-treated patients were evaluable in this exploratory analysis of the ORATORIO trial.

Compared with placebo, ocrelizumab significantly increased the proportion of patients with NEP at Week 120. The relative risk of NEP for ocrelizumab versus placebo was 1.47. The proportions of ocrelizumab- and placebo-treated patients with NEP up to Week 120 were 42.7% and 29.1%, respectively. This result represents a 47% relative increase in the ocrelizumab group. The proportions of ocrelizumab- and placebo-treated patients with NEP for the individual components of NEP up to Week 120 were 68.5% and 63.0%, respectively, for 12-week confirmed disability progression; 51.0% and 38.7%, respectively, for the timed 25-foot walk test; and 82.2% and 71.3%, respectively for the nine-hole peg test.

The study was sponsored by F. Hoffmann-La Roche.

Spasticity is common in MS and is associated with significant morbidity. The standard treatment is oral administration of baclofen, a γ-aminobutyric acid-b (GABA-b) receptor agonist. Baclofen is a racemic mixture, and its efficacy is thought to result from the R-enantiomer (arbaclofen). Therapeutic doses of baclofen can cause CNS side effects, decreased adherence, and decreased tolerability. Arbaclofen extended-release tablets potentially could reduce dosing frequency and adverse events.

Daniel Kantor, MD, a neurologist from Coconut Creek, Florida, and colleagues conducted a multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of arbaclofen extended-release tablets to those of placebo and baclofen over 12 weeks of treatment in patients with spasticity due to MS. Participants were randomized to receive 20 mg of arbaclofen bid, 20 mg of baclofen tablets qid, or matching placebo. The dose was titrated over four weeks, followed by a 12-week maintenance period. The primary end points were the mean changes in Total Numeric-transformed Modified Ashworth Scale (TNmAS) and Clinician Global Impression of Change (CGIC) at the end of the maintenance period.

Of 354 randomized participants, 59.0% had relapsing-remitting MS and 36.7% had secondary progressive MS. The average baseline TNmAS score was 7.78. Mean changes in TNmAS and CGIC were significantly greater for patients receiving arbaclofen, compared with patients receiving placebo. The researchers observed a greater difference in CGIC between arbaclofen and placebo, compared with that between baclofen and placebo, perhaps because of improved tolerability of arbaclofen, compared with baclofen. Differences between arbaclofen and baclofen were not statistically significant. MS Spasticity Scale (MSSS-88) showed a statistically significant improvement among patients receiving arbaclofen, compared with those receiving placebo. Epworth Sleepiness Scale (ESS) showed a statistically significant increase in sleepiness in the baclofen group, but not in the arbaclofen group, compared with placebo. Drowsiness and dizziness were less frequent in the arbaclofen group, compared with baclofen.

The study was supported by Osmotica Pharmaceutical.

Spasticity is common in MS and is associated with significant morbidity. The standard treatment is oral administration of baclofen, a γ-aminobutyric acid-b (GABA-b) receptor agonist. Baclofen is a racemic mixture, and its efficacy is thought to result from the R-enantiomer (arbaclofen). Therapeutic doses of baclofen can cause CNS side effects, decreased adherence, and decreased tolerability. Arbaclofen extended-release tablets potentially could reduce dosing frequency and adverse events.

Daniel Kantor, MD, a neurologist from Coconut Creek, Florida, and colleagues conducted a multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of arbaclofen extended-release tablets to those of placebo and baclofen over 12 weeks of treatment in patients with spasticity due to MS. Participants were randomized to receive 20 mg of arbaclofen bid, 20 mg of baclofen tablets qid, or matching placebo. The dose was titrated over four weeks, followed by a 12-week maintenance period. The primary end points were the mean changes in Total Numeric-transformed Modified Ashworth Scale (TNmAS) and Clinician Global Impression of Change (CGIC) at the end of the maintenance period.

Of 354 randomized participants, 59.0% had relapsing-remitting MS and 36.7% had secondary progressive MS. The average baseline TNmAS score was 7.78. Mean changes in TNmAS and CGIC were significantly greater for patients receiving arbaclofen, compared with patients receiving placebo. The researchers observed a greater difference in CGIC between arbaclofen and placebo, compared with that between baclofen and placebo, perhaps because of improved tolerability of arbaclofen, compared with baclofen. Differences between arbaclofen and baclofen were not statistically significant. MS Spasticity Scale (MSSS-88) showed a statistically significant improvement among patients receiving arbaclofen, compared with those receiving placebo. Epworth Sleepiness Scale (ESS) showed a statistically significant increase in sleepiness in the baclofen group, but not in the arbaclofen group, compared with placebo. Drowsiness and dizziness were less frequent in the arbaclofen group, compared with baclofen.

The study was supported by Osmotica Pharmaceutical.

Spasticity is common in MS and is associated with significant morbidity. The standard treatment is oral administration of baclofen, a γ-aminobutyric acid-b (GABA-b) receptor agonist. Baclofen is a racemic mixture, and its efficacy is thought to result from the R-enantiomer (arbaclofen). Therapeutic doses of baclofen can cause CNS side effects, decreased adherence, and decreased tolerability. Arbaclofen extended-release tablets potentially could reduce dosing frequency and adverse events.

Daniel Kantor, MD, a neurologist from Coconut Creek, Florida, and colleagues conducted a multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of arbaclofen extended-release tablets to those of placebo and baclofen over 12 weeks of treatment in patients with spasticity due to MS. Participants were randomized to receive 20 mg of arbaclofen bid, 20 mg of baclofen tablets qid, or matching placebo. The dose was titrated over four weeks, followed by a 12-week maintenance period. The primary end points were the mean changes in Total Numeric-transformed Modified Ashworth Scale (TNmAS) and Clinician Global Impression of Change (CGIC) at the end of the maintenance period.

Of 354 randomized participants, 59.0% had relapsing-remitting MS and 36.7% had secondary progressive MS. The average baseline TNmAS score was 7.78. Mean changes in TNmAS and CGIC were significantly greater for patients receiving arbaclofen, compared with patients receiving placebo. The researchers observed a greater difference in CGIC between arbaclofen and placebo, compared with that between baclofen and placebo, perhaps because of improved tolerability of arbaclofen, compared with baclofen. Differences between arbaclofen and baclofen were not statistically significant. MS Spasticity Scale (MSSS-88) showed a statistically significant improvement among patients receiving arbaclofen, compared with those receiving placebo. Epworth Sleepiness Scale (ESS) showed a statistically significant increase in sleepiness in the baclofen group, but not in the arbaclofen group, compared with placebo. Drowsiness and dizziness were less frequent in the arbaclofen group, compared with baclofen.

The study was supported by Osmotica Pharmaceutical.