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CHICAGO – Adding docetaxel chemotherapy to standard management improved survival in men with high-risk, localized, hormone-sensitive prostate cancer, results from the phase III RTOG 0521 study show.

At 4 years, overall survival was 89% without docetaxel and 93% with the addition of docetaxel (Toxotere) and prednisone after completing radiotherapy and long-term hormonal suppression (Hazard ratio, 0.70; P = .04).

“For the first time, improvement in overall survival was observed with adjuvant chemotherapy for localized, high-risk, hormone-sensitive prostate cancer,” Dr. Howard Sandler said in a press conference in advance of the formal presentation of the late-breaking study at the annual meeting of the American Society of Clinical Oncology.

The implications of the study are clinically relevant and wide-ranging, particularly in patients with high-risk disease, press briefing moderator Dr. Don Dizon, commented.

Dr. Sandler, chair of radiation oncology at Cedars-Sinai Medical Center, Los Angeles, gives details of this practice-changing study in a video interview.

The study was funded by the National Institutes of Health. Dr. Sandler reported financial relationships with several firms including Sanofi Aventis, maker of docetaxel.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Adding docetaxel chemotherapy to standard management improved survival in men with high-risk, localized, hormone-sensitive prostate cancer, results from the phase III RTOG 0521 study show.

At 4 years, overall survival was 89% without docetaxel and 93% with the addition of docetaxel (Toxotere) and prednisone after completing radiotherapy and long-term hormonal suppression (Hazard ratio, 0.70; P = .04).

“For the first time, improvement in overall survival was observed with adjuvant chemotherapy for localized, high-risk, hormone-sensitive prostate cancer,” Dr. Howard Sandler said in a press conference in advance of the formal presentation of the late-breaking study at the annual meeting of the American Society of Clinical Oncology.

The implications of the study are clinically relevant and wide-ranging, particularly in patients with high-risk disease, press briefing moderator Dr. Don Dizon, commented.

Dr. Sandler, chair of radiation oncology at Cedars-Sinai Medical Center, Los Angeles, gives details of this practice-changing study in a video interview.

The study was funded by the National Institutes of Health. Dr. Sandler reported financial relationships with several firms including Sanofi Aventis, maker of docetaxel.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Adding docetaxel chemotherapy to standard management improved survival in men with high-risk, localized, hormone-sensitive prostate cancer, results from the phase III RTOG 0521 study show.

At 4 years, overall survival was 89% without docetaxel and 93% with the addition of docetaxel (Toxotere) and prednisone after completing radiotherapy and long-term hormonal suppression (Hazard ratio, 0.70; P = .04).

“For the first time, improvement in overall survival was observed with adjuvant chemotherapy for localized, high-risk, hormone-sensitive prostate cancer,” Dr. Howard Sandler said in a press conference in advance of the formal presentation of the late-breaking study at the annual meeting of the American Society of Clinical Oncology.

The implications of the study are clinically relevant and wide-ranging, particularly in patients with high-risk disease, press briefing moderator Dr. Don Dizon, commented.

Dr. Sandler, chair of radiation oncology at Cedars-Sinai Medical Center, Los Angeles, gives details of this practice-changing study in a video interview.

The study was funded by the National Institutes of Health. Dr. Sandler reported financial relationships with several firms including Sanofi Aventis, maker of docetaxel.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Immune checkpoint inhibition with nivolumab every 2 weeks provides a better response than does standard treatment for advanced liver cancer, phase I/II results suggest.

The overall response rate was 19%, with 8 of the 42 evaluable patients experiencing at least 30% tumor shrinkage.

Moreover, responses to nivolumab (Opdivo) have been durable, with 62% of patients still alive at 12 months, Dr. Anthony El-Khoueiry reported in a press briefing in advance of the formal presentation of the study at the annual meeting of the American Society of Clinical Oncology.

In contrast, just 2% of patients have at least 30% tumor shrinkage with sorafenib (Nexavar) and the average overall survival is about 10-11 months. Sorafenib, a multitargeted tyrosine kinase inhibitor, is currently the only Food and Drug Administration–approved systemic treatment for advanced liver disease, he noted.

Nivolumab, a programmed death-1 (PD-1) inhibitor, is approved for previously treated melanoma and gained a second indication in March for use in previously treated squamous non–small cell lung cancer.

“This is the first study to show antitumor activity of a PD-1 immune checkpoint inhibitor in patients with liver cancer,” said Dr. El-Khoueiry of the University of Southern California Norris Comprehensive Cancer Center, Los Angeles.The durability of those responses was particularly impressive, Dr. Peter Paul Yu, ASCO president, said in an interview.

“This is a small study, but the signal is unusually robust in comparison to what the standard of care would be, which is why this is so promising,” he added.

Press briefing moderator Dr. Lynn Schuchter, chief of hematology-oncology at University of Pennsylvania in Philadelphia, said in a statement, “The fact that this drug might stop advanced liver cancer in its tracks for months, even a year, is great news for patients. To understand the full impact of this approach, however, larger trials are needed.”

Hear more about the promising results from the late-breaking abstract in our interview with Dr. El-Khoueiry.

The study was funded by Bristol-Myers Squibb. Dr. El-Khoueiry reported financial relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech/Roche, Amgen, Exelixis, AstraZeneca, and Astex Pharmaceuticals. Several coauthors also had ties to BMS including employment and/or stock ownership. Dr. Schuchter reported institutional research funding from BMS, Genentech, GSK, Merck, and Roche.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Immune checkpoint inhibition with nivolumab every 2 weeks provides a better response than does standard treatment for advanced liver cancer, phase I/II results suggest.

The overall response rate was 19%, with 8 of the 42 evaluable patients experiencing at least 30% tumor shrinkage.

Moreover, responses to nivolumab (Opdivo) have been durable, with 62% of patients still alive at 12 months, Dr. Anthony El-Khoueiry reported in a press briefing in advance of the formal presentation of the study at the annual meeting of the American Society of Clinical Oncology.

In contrast, just 2% of patients have at least 30% tumor shrinkage with sorafenib (Nexavar) and the average overall survival is about 10-11 months. Sorafenib, a multitargeted tyrosine kinase inhibitor, is currently the only Food and Drug Administration–approved systemic treatment for advanced liver disease, he noted.

Nivolumab, a programmed death-1 (PD-1) inhibitor, is approved for previously treated melanoma and gained a second indication in March for use in previously treated squamous non–small cell lung cancer.

“This is the first study to show antitumor activity of a PD-1 immune checkpoint inhibitor in patients with liver cancer,” said Dr. El-Khoueiry of the University of Southern California Norris Comprehensive Cancer Center, Los Angeles.The durability of those responses was particularly impressive, Dr. Peter Paul Yu, ASCO president, said in an interview.

“This is a small study, but the signal is unusually robust in comparison to what the standard of care would be, which is why this is so promising,” he added.

Press briefing moderator Dr. Lynn Schuchter, chief of hematology-oncology at University of Pennsylvania in Philadelphia, said in a statement, “The fact that this drug might stop advanced liver cancer in its tracks for months, even a year, is great news for patients. To understand the full impact of this approach, however, larger trials are needed.”

Hear more about the promising results from the late-breaking abstract in our interview with Dr. El-Khoueiry.

The study was funded by Bristol-Myers Squibb. Dr. El-Khoueiry reported financial relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech/Roche, Amgen, Exelixis, AstraZeneca, and Astex Pharmaceuticals. Several coauthors also had ties to BMS including employment and/or stock ownership. Dr. Schuchter reported institutional research funding from BMS, Genentech, GSK, Merck, and Roche.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Immune checkpoint inhibition with nivolumab every 2 weeks provides a better response than does standard treatment for advanced liver cancer, phase I/II results suggest.

The overall response rate was 19%, with 8 of the 42 evaluable patients experiencing at least 30% tumor shrinkage.

Moreover, responses to nivolumab (Opdivo) have been durable, with 62% of patients still alive at 12 months, Dr. Anthony El-Khoueiry reported in a press briefing in advance of the formal presentation of the study at the annual meeting of the American Society of Clinical Oncology.

In contrast, just 2% of patients have at least 30% tumor shrinkage with sorafenib (Nexavar) and the average overall survival is about 10-11 months. Sorafenib, a multitargeted tyrosine kinase inhibitor, is currently the only Food and Drug Administration–approved systemic treatment for advanced liver disease, he noted.

Nivolumab, a programmed death-1 (PD-1) inhibitor, is approved for previously treated melanoma and gained a second indication in March for use in previously treated squamous non–small cell lung cancer.

“This is the first study to show antitumor activity of a PD-1 immune checkpoint inhibitor in patients with liver cancer,” said Dr. El-Khoueiry of the University of Southern California Norris Comprehensive Cancer Center, Los Angeles.The durability of those responses was particularly impressive, Dr. Peter Paul Yu, ASCO president, said in an interview.

“This is a small study, but the signal is unusually robust in comparison to what the standard of care would be, which is why this is so promising,” he added.

Press briefing moderator Dr. Lynn Schuchter, chief of hematology-oncology at University of Pennsylvania in Philadelphia, said in a statement, “The fact that this drug might stop advanced liver cancer in its tracks for months, even a year, is great news for patients. To understand the full impact of this approach, however, larger trials are needed.”

Hear more about the promising results from the late-breaking abstract in our interview with Dr. El-Khoueiry.

The study was funded by Bristol-Myers Squibb. Dr. El-Khoueiry reported financial relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech/Roche, Amgen, Exelixis, AstraZeneca, and Astex Pharmaceuticals. Several coauthors also had ties to BMS including employment and/or stock ownership. Dr. Schuchter reported institutional research funding from BMS, Genentech, GSK, Merck, and Roche.

pwendling@frontlinemedcom.com

On Twitter @pwendl

CHICAGO – Tumors that carry a genetic signature known as mismatch repair deficiency are highly responsive to immune checkpoint blockade with pembrolizumab, according to results from a small proof-of-concept study.

“This is the first study to use genetics in a prospective manner to guide immunotherapy,” study author Dr. Dung T. Le said in a press conference at the annual meeting of the American Society of Clinical Oncology.

The phase II study, also published online May 30 in the New England Journal of Medicine, enrolled three cohorts, all of which had previously treated metastatic cancer. Pembrolizumab (Keytruda) 10 mg/kg was given intravenously every two weeks.

An objective response was observed in 62% of 25 patients with mismatch repair-deficient colorectal cancer versus none of the 25 patients with mismatch repair-proficient colorectal cancer, she said.

Disease control rates, which also included stable disease for at least 12 weeks, were 92% vs. 16%, respectively.

In a third cohort of 21 patients with a variety of mismatch repair-deficient cancers including pancreatic/bile duct, uterine, small bowel, stomach, and prostate, the response rate was 60% and disease control rate 70%.

Median overall survival has not been reached in the mismatch repair-deficient cohorts, with some patients continuing to respond to the immunotherapy drug for more than a year Dr. Le, with the Johns Hopkins Kimmel Cancer Center in Baltimore, said. Median overall survival was about 7.6 months in the mismatch repair-proficient colorectal cohort.

“These data suggest that genomics is more influential than histology for mismatch repair-deficient tumors when treated with anti-PD-1,” she said.

Defects in mismatch repair genes disable cells’ ability to repair errors in the DNA replication process. As a result, tumors deficient in mismatch repair proteins produce hundreds to thousands of mutations. Immunotherapy may work best in patients with more mutations in their tumors because multiple mutations trigger production of more abnormal proteins in cancer cells, and in turn prompt the immune system to mount a bigger response.

Indeed, higher somatic mutation loads were associated with better response and prolonged progression free-survival. On average, mismatch repair-deficient tumors had about 1,700 mutations vs. about 70 mutations in mismatch repair-proficient tumors (P = .007), Dr. Le said.

“Seventeen-hundred mutations: that’s like you put a red flag on the cancer cell and say to the immune system, ‘Here I am,’ ” press conference moderator Dr. Lynn Schuchter, chief of hematology-oncology at University of Pennsylvania in Philadelphia, remarked to reporters.

The study was funded by Swim Across America, The Commonwealth Fund, The Ludwig Center at Johns Hopkins, and the National Institutes of Health. Merck provided the study drug. Personal Genome Diagnostics performed the sequencing analysis. Dr. Le reported having no financial disclosures. Dr. Schuchter reported institutional research funding from Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Merck, and Roche.

pwendling@frontlinemedcom.com

CHICAGO – Tumors that carry a genetic signature known as mismatch repair deficiency are highly responsive to immune checkpoint blockade with pembrolizumab, according to results from a small proof-of-concept study.

“This is the first study to use genetics in a prospective manner to guide immunotherapy,” study author Dr. Dung T. Le said in a press conference at the annual meeting of the American Society of Clinical Oncology.

The phase II study, also published online May 30 in the New England Journal of Medicine, enrolled three cohorts, all of which had previously treated metastatic cancer. Pembrolizumab (Keytruda) 10 mg/kg was given intravenously every two weeks.

An objective response was observed in 62% of 25 patients with mismatch repair-deficient colorectal cancer versus none of the 25 patients with mismatch repair-proficient colorectal cancer, she said.

Disease control rates, which also included stable disease for at least 12 weeks, were 92% vs. 16%, respectively.

In a third cohort of 21 patients with a variety of mismatch repair-deficient cancers including pancreatic/bile duct, uterine, small bowel, stomach, and prostate, the response rate was 60% and disease control rate 70%.

Median overall survival has not been reached in the mismatch repair-deficient cohorts, with some patients continuing to respond to the immunotherapy drug for more than a year Dr. Le, with the Johns Hopkins Kimmel Cancer Center in Baltimore, said. Median overall survival was about 7.6 months in the mismatch repair-proficient colorectal cohort.

“These data suggest that genomics is more influential than histology for mismatch repair-deficient tumors when treated with anti-PD-1,” she said.

Defects in mismatch repair genes disable cells’ ability to repair errors in the DNA replication process. As a result, tumors deficient in mismatch repair proteins produce hundreds to thousands of mutations. Immunotherapy may work best in patients with more mutations in their tumors because multiple mutations trigger production of more abnormal proteins in cancer cells, and in turn prompt the immune system to mount a bigger response.

Indeed, higher somatic mutation loads were associated with better response and prolonged progression free-survival. On average, mismatch repair-deficient tumors had about 1,700 mutations vs. about 70 mutations in mismatch repair-proficient tumors (P = .007), Dr. Le said.

“Seventeen-hundred mutations: that’s like you put a red flag on the cancer cell and say to the immune system, ‘Here I am,’ ” press conference moderator Dr. Lynn Schuchter, chief of hematology-oncology at University of Pennsylvania in Philadelphia, remarked to reporters.

The study was funded by Swim Across America, The Commonwealth Fund, The Ludwig Center at Johns Hopkins, and the National Institutes of Health. Merck provided the study drug. Personal Genome Diagnostics performed the sequencing analysis. Dr. Le reported having no financial disclosures. Dr. Schuchter reported institutional research funding from Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Merck, and Roche.

pwendling@frontlinemedcom.com

CHICAGO – Tumors that carry a genetic signature known as mismatch repair deficiency are highly responsive to immune checkpoint blockade with pembrolizumab, according to results from a small proof-of-concept study.

“This is the first study to use genetics in a prospective manner to guide immunotherapy,” study author Dr. Dung T. Le said in a press conference at the annual meeting of the American Society of Clinical Oncology.

The phase II study, also published online May 30 in the New England Journal of Medicine, enrolled three cohorts, all of which had previously treated metastatic cancer. Pembrolizumab (Keytruda) 10 mg/kg was given intravenously every two weeks.

An objective response was observed in 62% of 25 patients with mismatch repair-deficient colorectal cancer versus none of the 25 patients with mismatch repair-proficient colorectal cancer, she said.

Disease control rates, which also included stable disease for at least 12 weeks, were 92% vs. 16%, respectively.

In a third cohort of 21 patients with a variety of mismatch repair-deficient cancers including pancreatic/bile duct, uterine, small bowel, stomach, and prostate, the response rate was 60% and disease control rate 70%.

Median overall survival has not been reached in the mismatch repair-deficient cohorts, with some patients continuing to respond to the immunotherapy drug for more than a year Dr. Le, with the Johns Hopkins Kimmel Cancer Center in Baltimore, said. Median overall survival was about 7.6 months in the mismatch repair-proficient colorectal cohort.

“These data suggest that genomics is more influential than histology for mismatch repair-deficient tumors when treated with anti-PD-1,” she said.

Defects in mismatch repair genes disable cells’ ability to repair errors in the DNA replication process. As a result, tumors deficient in mismatch repair proteins produce hundreds to thousands of mutations. Immunotherapy may work best in patients with more mutations in their tumors because multiple mutations trigger production of more abnormal proteins in cancer cells, and in turn prompt the immune system to mount a bigger response.

Indeed, higher somatic mutation loads were associated with better response and prolonged progression free-survival. On average, mismatch repair-deficient tumors had about 1,700 mutations vs. about 70 mutations in mismatch repair-proficient tumors (P = .007), Dr. Le said.

“Seventeen-hundred mutations: that’s like you put a red flag on the cancer cell and say to the immune system, ‘Here I am,’ ” press conference moderator Dr. Lynn Schuchter, chief of hematology-oncology at University of Pennsylvania in Philadelphia, remarked to reporters.

The study was funded by Swim Across America, The Commonwealth Fund, The Ludwig Center at Johns Hopkins, and the National Institutes of Health. Merck provided the study drug. Personal Genome Diagnostics performed the sequencing analysis. Dr. Le reported having no financial disclosures. Dr. Schuchter reported institutional research funding from Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Merck, and Roche.

pwendling@frontlinemedcom.com

INDIANAPOLIS – Although an estimated 10%-20% of multiple sclerosis patients currently smoke cannabis for pain control or to alleviate symptoms, new research from Canada suggests that smoking the drug can worsen cognitive function in some patients with the disease.

“We already know that 40%-70% of people with MS already have cognitive problems,” Dr. Anthony Feinstein, professor of psychiatrist at the University of Toronto, said in a video interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. “Some of the research that I’ve done shows that, in the presence of cannabis, these rates go up.”

Even so, he emphasized that patients should weigh such side effects against the benefits of use.

“I think it’s going to be an individual decision,” he said. “If it’s helping with pain, that’s good. Our data needs to be replicated by other groups.”

Dr. Feinstein disclosed that his work on MS and cannabis is funded by the Multiple Sclerosis Society of Canada.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

INDIANAPOLIS – Although an estimated 10%-20% of multiple sclerosis patients currently smoke cannabis for pain control or to alleviate symptoms, new research from Canada suggests that smoking the drug can worsen cognitive function in some patients with the disease.

“We already know that 40%-70% of people with MS already have cognitive problems,” Dr. Anthony Feinstein, professor of psychiatrist at the University of Toronto, said in a video interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. “Some of the research that I’ve done shows that, in the presence of cannabis, these rates go up.”

Even so, he emphasized that patients should weigh such side effects against the benefits of use.

“I think it’s going to be an individual decision,” he said. “If it’s helping with pain, that’s good. Our data needs to be replicated by other groups.”

Dr. Feinstein disclosed that his work on MS and cannabis is funded by the Multiple Sclerosis Society of Canada.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

INDIANAPOLIS – Although an estimated 10%-20% of multiple sclerosis patients currently smoke cannabis for pain control or to alleviate symptoms, new research from Canada suggests that smoking the drug can worsen cognitive function in some patients with the disease.

“We already know that 40%-70% of people with MS already have cognitive problems,” Dr. Anthony Feinstein, professor of psychiatrist at the University of Toronto, said in a video interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. “Some of the research that I’ve done shows that, in the presence of cannabis, these rates go up.”

Even so, he emphasized that patients should weigh such side effects against the benefits of use.

“I think it’s going to be an individual decision,” he said. “If it’s helping with pain, that’s good. Our data needs to be replicated by other groups.”

Dr. Feinstein disclosed that his work on MS and cannabis is funded by the Multiple Sclerosis Society of Canada.

dbrunk@frontlinemedcom.com

On Twitter @dougbrunk

TORONTO – The federal mental health parity law, combined with the new focus on value-based payment, will accelerate the revolution in mental health assessment and treatment in the United States and will reduce the financial risk physicians will be exposed to in their practices.

In this interview at the annual meeting of the American Psychiatric Association, former U.S. Rep. Patrick J. Kennedy (D-R.I.) – who, while in Congress, sponsored* the Mental Health Parity and Addiction Equity Act of 2008 – shared his thoughts on how mental health care is about to change.

*Correction, 5/19/2015: An earlier version of this story misstated former Rep. Kennedy's connection to the parity legislation.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

TORONTO – The federal mental health parity law, combined with the new focus on value-based payment, will accelerate the revolution in mental health assessment and treatment in the United States and will reduce the financial risk physicians will be exposed to in their practices.

In this interview at the annual meeting of the American Psychiatric Association, former U.S. Rep. Patrick J. Kennedy (D-R.I.) – who, while in Congress, sponsored* the Mental Health Parity and Addiction Equity Act of 2008 – shared his thoughts on how mental health care is about to change.

*Correction, 5/19/2015: An earlier version of this story misstated former Rep. Kennedy's connection to the parity legislation.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

TORONTO – The federal mental health parity law, combined with the new focus on value-based payment, will accelerate the revolution in mental health assessment and treatment in the United States and will reduce the financial risk physicians will be exposed to in their practices.

In this interview at the annual meeting of the American Psychiatric Association, former U.S. Rep. Patrick J. Kennedy (D-R.I.) – who, while in Congress, sponsored* the Mental Health Parity and Addiction Equity Act of 2008 – shared his thoughts on how mental health care is about to change.

*Correction, 5/19/2015: An earlier version of this story misstated former Rep. Kennedy's connection to the parity legislation.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight