Neil Osterweil

CHICAGO – The combination of two immune checkpoint inhibitors, nivolumab and ipilimumab, has resulted in "unprecedented" 2-year overall survival rates for patients with metastatic melanoma, early study results show.

In an expanded phase I trial evaluating dosing, safety and efficacy of nivolumab and ipilimumab (Yervoy) either concurrently or in sequence, the 2-year overall survival for 53 patients in three concurrent dosing cohorts was 79%, reported Dr. Mario Sznol, a professor of medical oncology at Yale University, New Haven, Conn.

"We saw significant activity in patients with BRAF mutations, which means this is a very good option in addition to targeted therapy for patients who have BRAF mutations," Dr. Sznol said during a media briefing at the annual meeting of the American Society of Clinical Oncology.

"I almost feel like I’m looking at childhood leukemia survival curves, when we’re starting to approach an 80% plateau," commented Dr. Steven O’Day from the Beverly Hills (Calif.) Cancer Center, who moderated the briefing but was not involved in the study.

He cautioned that the study was small and that randomized, controlled phase III trials will be required before the full benefits of the combined therapies are evident.

Two checkpoints

Both agents are monoclonal antibodies directed against receptors in immune system checkpoints. Ipilimumab is a cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitor that acts at an early "brake" point in the immune response; nivolumab is a programmed cell death-1 (PD-1) inhibitor that serves as a late brake. By releasing the brakes, the drugs allow the immune system to operate full throttle against melanoma.

Ipilimumab is approved by the Food and Drug Administration for the treatment of metastatic melanoma. Nivolumab is an investigational agent that has been shown to have good antitumor activity in monotherapy.

"PD-1 and CTLA-4 both, as you\'ve heard before, are nonredundant checkpoints in T-cell differentiation and function, and there are several animal models that show synergy by combining these two agents," Dr. Sznol said in an oral abstract session.

As single agents, ipilimumab is associated with a 2-year overall survival rate of 24%, and nivolumab with a 2-year OS of 43%.

The investigators reported at ASCO 2013 and in the New England Journal of Medicine that the combined agents were associated with a 1-year OS of 82%.

Complex protocol

In the head-spinningly complex phase I dose-escalation study, patients with unresectable stage III or IV malignant melanoma were assigned to one of eight different dosing cohorts, looking at doses of nivolumab ranging from 0.3 to 10 mg/kg delivered in a 60 or 90 minute infusion every 2 or 3 weeks for up to 21 weeks, and to ipilimumab at doses ranging from 3 to 10 mg/kg delivered in 60- to 90-minute infusions every 3 weeks for 9 to 21 weeks of induction, followed by 84 to 96 weeks of maintenance therapy.

For the current report, Dr. Sznol and his colleagues looked at follow-up of 53 patients in dosing cohorts 1-3, all of whom received the drugs concurrently every 3 weeks for four doses, followed by nivolumab every 3 weeks for four doses, and then the combined agents every 12 weeks for eight doses. They also reported on a new, eighth cohort of 41 patients who received both drugs on the same induction schedule, followed by maintenance with nivolumab 3 mg/kg alone every 2 weeks until disease progression. This dosing schedule is being evaluated in phase II/III trials.

The overall response rate (ORR) for cohorts 1-3 was 42%, with 17% of patients having a complete response according to RECIST (Response Evaluation Criteria in Solid Tumors). In cohort 8, 40 of the 41 patients enrolled were evaluable for response, with an ORR of 43, and a 10% complete response rate (CRRs), although two of the CRRs were unconfirmed.

80% tumor shrinkage

In cohorts 1-3, 42% of patients had a reduction in tumor size of more than 80%, and many of these patients had complete or near-complete responses, Dr. Sznol said. Tumor shrinkage appeared similar in cohort 8, as shown on a waterfall plot, but Dr. Sznol did not report specifics about tumor dimensions in this group.

The median duration of responses in all four cohorts discussed has not been reached.

Grade 3 or 4 toxicities occurred in 62% of patients, with gastrointestinal side effects and elevated liver function tests occurring in 14% each, and increases in serum lipase in 15% and amylase in 6%. No new safety signals have emerged over 22 months of follow-up of patients in the initial cohorts, Dr. Sznol noted.

Dr. Jeffrey Weber of the Moffit Cancer Center in Tampa, Fla., the invited discussant, who has treated patients using the drugs in combination, commented that "Yes, you do see a large rate of patients with asymptomatic liver-function abnormalities that get better, and then you can retreat them."

Grade 3 elevated lipase or amylase may not require treatment, and grade 4 events may resolve with treatment interruption. Much of the toxicity occurs early with the concurrent regimen, and lessens during maintenance with nivolumab alone, he added.

Of the 94 patients in cohorts 1-3 and 8, 22 (23%) discontinued therapy due to treatment-related adverse events. One patient died from multiorgan failure associated with treatment-induced colitis; this patient was in cohort 8.

The study is supported by Bristol-Myers Squibb, Medarex, and Ono Pharma USA. Dr. Sznol disclosed consultant/advisory relationships with Bristol-Myers Squibb and several other companies. Dr. Weber disclosed consulting/advising, and received honoraria and research funding from Bristol-Myers Squibb and other companies. Dr. O’Day has received grants for research support from Bristol-Myers Squibb and Medarex, and he has served on the speakers bureau for Bristol-Myers Squibb.

CHICAGO – The combination of two immune checkpoint inhibitors, nivolumab and ipilimumab, has resulted in "unprecedented" 2-year overall survival rates for patients with metastatic melanoma, early study results show.

In an expanded phase I trial evaluating dosing, safety and efficacy of nivolumab and ipilimumab (Yervoy) either concurrently or in sequence, the 2-year overall survival for 53 patients in three concurrent dosing cohorts was 79%, reported Dr. Mario Sznol, a professor of medical oncology at Yale University, New Haven, Conn.

"We saw significant activity in patients with BRAF mutations, which means this is a very good option in addition to targeted therapy for patients who have BRAF mutations," Dr. Sznol said during a media briefing at the annual meeting of the American Society of Clinical Oncology.

"I almost feel like I’m looking at childhood leukemia survival curves, when we’re starting to approach an 80% plateau," commented Dr. Steven O’Day from the Beverly Hills (Calif.) Cancer Center, who moderated the briefing but was not involved in the study.

He cautioned that the study was small and that randomized, controlled phase III trials will be required before the full benefits of the combined therapies are evident.

Two checkpoints

Both agents are monoclonal antibodies directed against receptors in immune system checkpoints. Ipilimumab is a cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitor that acts at an early "brake" point in the immune response; nivolumab is a programmed cell death-1 (PD-1) inhibitor that serves as a late brake. By releasing the brakes, the drugs allow the immune system to operate full throttle against melanoma.

Ipilimumab is approved by the Food and Drug Administration for the treatment of metastatic melanoma. Nivolumab is an investigational agent that has been shown to have good antitumor activity in monotherapy.

"PD-1 and CTLA-4 both, as you\'ve heard before, are nonredundant checkpoints in T-cell differentiation and function, and there are several animal models that show synergy by combining these two agents," Dr. Sznol said in an oral abstract session.

As single agents, ipilimumab is associated with a 2-year overall survival rate of 24%, and nivolumab with a 2-year OS of 43%.

The investigators reported at ASCO 2013 and in the New England Journal of Medicine that the combined agents were associated with a 1-year OS of 82%.

Complex protocol

In the head-spinningly complex phase I dose-escalation study, patients with unresectable stage III or IV malignant melanoma were assigned to one of eight different dosing cohorts, looking at doses of nivolumab ranging from 0.3 to 10 mg/kg delivered in a 60 or 90 minute infusion every 2 or 3 weeks for up to 21 weeks, and to ipilimumab at doses ranging from 3 to 10 mg/kg delivered in 60- to 90-minute infusions every 3 weeks for 9 to 21 weeks of induction, followed by 84 to 96 weeks of maintenance therapy.

For the current report, Dr. Sznol and his colleagues looked at follow-up of 53 patients in dosing cohorts 1-3, all of whom received the drugs concurrently every 3 weeks for four doses, followed by nivolumab every 3 weeks for four doses, and then the combined agents every 12 weeks for eight doses. They also reported on a new, eighth cohort of 41 patients who received both drugs on the same induction schedule, followed by maintenance with nivolumab 3 mg/kg alone every 2 weeks until disease progression. This dosing schedule is being evaluated in phase II/III trials.

The overall response rate (ORR) for cohorts 1-3 was 42%, with 17% of patients having a complete response according to RECIST (Response Evaluation Criteria in Solid Tumors). In cohort 8, 40 of the 41 patients enrolled were evaluable for response, with an ORR of 43, and a 10% complete response rate (CRRs), although two of the CRRs were unconfirmed.

80% tumor shrinkage

In cohorts 1-3, 42% of patients had a reduction in tumor size of more than 80%, and many of these patients had complete or near-complete responses, Dr. Sznol said. Tumor shrinkage appeared similar in cohort 8, as shown on a waterfall plot, but Dr. Sznol did not report specifics about tumor dimensions in this group.

The median duration of responses in all four cohorts discussed has not been reached.

Grade 3 or 4 toxicities occurred in 62% of patients, with gastrointestinal side effects and elevated liver function tests occurring in 14% each, and increases in serum lipase in 15% and amylase in 6%. No new safety signals have emerged over 22 months of follow-up of patients in the initial cohorts, Dr. Sznol noted.

Dr. Jeffrey Weber of the Moffit Cancer Center in Tampa, Fla., the invited discussant, who has treated patients using the drugs in combination, commented that "Yes, you do see a large rate of patients with asymptomatic liver-function abnormalities that get better, and then you can retreat them."

Grade 3 elevated lipase or amylase may not require treatment, and grade 4 events may resolve with treatment interruption. Much of the toxicity occurs early with the concurrent regimen, and lessens during maintenance with nivolumab alone, he added.

Of the 94 patients in cohorts 1-3 and 8, 22 (23%) discontinued therapy due to treatment-related adverse events. One patient died from multiorgan failure associated with treatment-induced colitis; this patient was in cohort 8.

The study is supported by Bristol-Myers Squibb, Medarex, and Ono Pharma USA. Dr. Sznol disclosed consultant/advisory relationships with Bristol-Myers Squibb and several other companies. Dr. Weber disclosed consulting/advising, and received honoraria and research funding from Bristol-Myers Squibb and other companies. Dr. O’Day has received grants for research support from Bristol-Myers Squibb and Medarex, and he has served on the speakers bureau for Bristol-Myers Squibb.

CHICAGO – The combination of two immune checkpoint inhibitors, nivolumab and ipilimumab, has resulted in "unprecedented" 2-year overall survival rates for patients with metastatic melanoma, early study results show.

In an expanded phase I trial evaluating dosing, safety and efficacy of nivolumab and ipilimumab (Yervoy) either concurrently or in sequence, the 2-year overall survival for 53 patients in three concurrent dosing cohorts was 79%, reported Dr. Mario Sznol, a professor of medical oncology at Yale University, New Haven, Conn.

"We saw significant activity in patients with BRAF mutations, which means this is a very good option in addition to targeted therapy for patients who have BRAF mutations," Dr. Sznol said during a media briefing at the annual meeting of the American Society of Clinical Oncology.

"I almost feel like I’m looking at childhood leukemia survival curves, when we’re starting to approach an 80% plateau," commented Dr. Steven O’Day from the Beverly Hills (Calif.) Cancer Center, who moderated the briefing but was not involved in the study.

He cautioned that the study was small and that randomized, controlled phase III trials will be required before the full benefits of the combined therapies are evident.

Two checkpoints

Both agents are monoclonal antibodies directed against receptors in immune system checkpoints. Ipilimumab is a cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitor that acts at an early "brake" point in the immune response; nivolumab is a programmed cell death-1 (PD-1) inhibitor that serves as a late brake. By releasing the brakes, the drugs allow the immune system to operate full throttle against melanoma.

Ipilimumab is approved by the Food and Drug Administration for the treatment of metastatic melanoma. Nivolumab is an investigational agent that has been shown to have good antitumor activity in monotherapy.

"PD-1 and CTLA-4 both, as you\'ve heard before, are nonredundant checkpoints in T-cell differentiation and function, and there are several animal models that show synergy by combining these two agents," Dr. Sznol said in an oral abstract session.

As single agents, ipilimumab is associated with a 2-year overall survival rate of 24%, and nivolumab with a 2-year OS of 43%.

The investigators reported at ASCO 2013 and in the New England Journal of Medicine that the combined agents were associated with a 1-year OS of 82%.

Complex protocol

In the head-spinningly complex phase I dose-escalation study, patients with unresectable stage III or IV malignant melanoma were assigned to one of eight different dosing cohorts, looking at doses of nivolumab ranging from 0.3 to 10 mg/kg delivered in a 60 or 90 minute infusion every 2 or 3 weeks for up to 21 weeks, and to ipilimumab at doses ranging from 3 to 10 mg/kg delivered in 60- to 90-minute infusions every 3 weeks for 9 to 21 weeks of induction, followed by 84 to 96 weeks of maintenance therapy.

For the current report, Dr. Sznol and his colleagues looked at follow-up of 53 patients in dosing cohorts 1-3, all of whom received the drugs concurrently every 3 weeks for four doses, followed by nivolumab every 3 weeks for four doses, and then the combined agents every 12 weeks for eight doses. They also reported on a new, eighth cohort of 41 patients who received both drugs on the same induction schedule, followed by maintenance with nivolumab 3 mg/kg alone every 2 weeks until disease progression. This dosing schedule is being evaluated in phase II/III trials.

The overall response rate (ORR) for cohorts 1-3 was 42%, with 17% of patients having a complete response according to RECIST (Response Evaluation Criteria in Solid Tumors). In cohort 8, 40 of the 41 patients enrolled were evaluable for response, with an ORR of 43, and a 10% complete response rate (CRRs), although two of the CRRs were unconfirmed.

80% tumor shrinkage

In cohorts 1-3, 42% of patients had a reduction in tumor size of more than 80%, and many of these patients had complete or near-complete responses, Dr. Sznol said. Tumor shrinkage appeared similar in cohort 8, as shown on a waterfall plot, but Dr. Sznol did not report specifics about tumor dimensions in this group.

The median duration of responses in all four cohorts discussed has not been reached.

Grade 3 or 4 toxicities occurred in 62% of patients, with gastrointestinal side effects and elevated liver function tests occurring in 14% each, and increases in serum lipase in 15% and amylase in 6%. No new safety signals have emerged over 22 months of follow-up of patients in the initial cohorts, Dr. Sznol noted.

Dr. Jeffrey Weber of the Moffit Cancer Center in Tampa, Fla., the invited discussant, who has treated patients using the drugs in combination, commented that "Yes, you do see a large rate of patients with asymptomatic liver-function abnormalities that get better, and then you can retreat them."

Grade 3 elevated lipase or amylase may not require treatment, and grade 4 events may resolve with treatment interruption. Much of the toxicity occurs early with the concurrent regimen, and lessens during maintenance with nivolumab alone, he added.

Of the 94 patients in cohorts 1-3 and 8, 22 (23%) discontinued therapy due to treatment-related adverse events. One patient died from multiorgan failure associated with treatment-induced colitis; this patient was in cohort 8.

The study is supported by Bristol-Myers Squibb, Medarex, and Ono Pharma USA. Dr. Sznol disclosed consultant/advisory relationships with Bristol-Myers Squibb and several other companies. Dr. Weber disclosed consulting/advising, and received honoraria and research funding from Bristol-Myers Squibb and other companies. Dr. O’Day has received grants for research support from Bristol-Myers Squibb and Medarex, and he has served on the speakers bureau for Bristol-Myers Squibb.

CHICAGO – The investigational targeted agent pembrolizumab induced durable treatment responses in a high percentage of patients with advanced metastatic melanoma, in a phase I study.

Of 411 patients, 1-year overall survival was 69%, and 88% of patients who had a treatment response continued to have a response at 1 year, reported Dr. Antoni Ribas, professor of medicine at the University of California, Los Angeles, at a media briefing and in an oral abstract session at the annual meeting of the American Society for Clinical Oncology.

Neil Osterweil/ Frontline Medical News

"We used to say that melanoma had a median survival of 6-9 months – that wasn’t that long ago. Then we said well, maybe it’s getting closer to 12 months. Here, we have not reached the median overall survival," Dr. Ribas said.

At 18 months of follow-up, overall survival is 62%, and seems to be plateauing, but longer follow-up will be required to see how long the survival benefit can be maintained, he said.

"The remarkable thing is that almost 90% of these patients are having durable responses with a toxicity profile that is almost unheard of in metastatic cancer," commented Dr. Steven O’Day of the Beverly Hills (Calif.) Cancer Center, who moderated the briefing but was not involved in the study.

Grade 3 or 4 toxicities occurred in 12% of patients, making pembrolizumab "one of the most benign therapies that I have ever used in my clinic," he said.

New name, same PD-1 antibody

Pembrolizumab, formerly known as lambrolizumab or MK-3475, is a humanized monoclonal antibody targeted against the PD-1 immune system checkpoint. By binding to and inhibiting what Dr. Ribas called the "do not kill me" signal, the antibody allows the immune system to recognize and mount a more potent T-cell–mediated defense against melanoma.

The Food and Drug Administration previously granted permbrolizumab a breakthrough therapy designation, and in May 2014 gave it a priority review designation under the agency’s accelerated approval program.

At the 2013 ASCO annual meeting, Dr. Ribas and colleagues reported a 41% overall response rate (ORR) in the first 135 patients with metastatic melanoma treated with the antibody in the phase I study KEYNOTE 001.

The data he presented at this year’s ASCO meeting on the melanoma expansion cohort from that trial support the earlier findings from the study, showing an overall ORR of 34%, with responses seen in 44% of treatment-naive patients, 28% of those who had previously been treated with a different checkpoint inhibitor, ipilimumab (Yervoy), and 40% in patients who had received prior therapies other than ipilimumab.

The current study is an analysis of pooled data on 411 patients, 221 of whom had disease progression on ipilimumab and 190 of whom had never received ipilimumab. All patients had melanoma metastatic to the lungs or other organs.

Neil Osterweil/ Frontline Medical News

The patients received pembrolizumab in one of three dosing schedules: 10 mg/kg every 2 weeks (57 patients) or every 3 weeks (192), or 2 mg/kg every 3 weeks (162).

As noted, the overall survival rate at 1 year was 69% (74% for ipilimumab-naive patients and 65% for ipilimumab-treated patients), with the median overall survival not yet reached.

Dr. O’Day said it was encouraging that prior exposure to ipilimumab did not appear to dramatically decrease the benefit from pembrolizumab.

"This is critical to us understanding whether to combine or sequence these drugs, because there does not seem to be a lot of cross-resistance between ipilimumab and PD-1 [inhibition]," he said.

The most common adverse event of any grade was fatigue, occurring in 36% of patients, but only 2% of patients had grade 3 or 4 fatigue. Other common events were pruritus (24%), rash (20%), diarrhea (16%), arthralgia (16%), nausea (12%), and vitiligo (11%). The overall rate of any adverse events was 83%, but as noted before, only 12% of patients had a grade 3 or 4 adverse event. These events were manageable across all doses and in both ipilmumab-naive and experienced patients.

Pembrolizumab is currently being investigated in international, randomized controlled clinical trials, Dr. Ribas noted.

The study was supported by Merck. Dr. Ribas disclosed serving as a consultant/adviser to the company. Dr. O’Day reported having no relevant disclosures.

CHICAGO – The investigational targeted agent pembrolizumab induced durable treatment responses in a high percentage of patients with advanced metastatic melanoma, in a phase I study.

Of 411 patients, 1-year overall survival was 69%, and 88% of patients who had a treatment response continued to have a response at 1 year, reported Dr. Antoni Ribas, professor of medicine at the University of California, Los Angeles, at a media briefing and in an oral abstract session at the annual meeting of the American Society for Clinical Oncology.

Neil Osterweil/ Frontline Medical News

"We used to say that melanoma had a median survival of 6-9 months – that wasn’t that long ago. Then we said well, maybe it’s getting closer to 12 months. Here, we have not reached the median overall survival," Dr. Ribas said.

At 18 months of follow-up, overall survival is 62%, and seems to be plateauing, but longer follow-up will be required to see how long the survival benefit can be maintained, he said.

"The remarkable thing is that almost 90% of these patients are having durable responses with a toxicity profile that is almost unheard of in metastatic cancer," commented Dr. Steven O’Day of the Beverly Hills (Calif.) Cancer Center, who moderated the briefing but was not involved in the study.

Grade 3 or 4 toxicities occurred in 12% of patients, making pembrolizumab "one of the most benign therapies that I have ever used in my clinic," he said.

New name, same PD-1 antibody

Pembrolizumab, formerly known as lambrolizumab or MK-3475, is a humanized monoclonal antibody targeted against the PD-1 immune system checkpoint. By binding to and inhibiting what Dr. Ribas called the "do not kill me" signal, the antibody allows the immune system to recognize and mount a more potent T-cell–mediated defense against melanoma.

The Food and Drug Administration previously granted permbrolizumab a breakthrough therapy designation, and in May 2014 gave it a priority review designation under the agency’s accelerated approval program.

At the 2013 ASCO annual meeting, Dr. Ribas and colleagues reported a 41% overall response rate (ORR) in the first 135 patients with metastatic melanoma treated with the antibody in the phase I study KEYNOTE 001.

The data he presented at this year’s ASCO meeting on the melanoma expansion cohort from that trial support the earlier findings from the study, showing an overall ORR of 34%, with responses seen in 44% of treatment-naive patients, 28% of those who had previously been treated with a different checkpoint inhibitor, ipilimumab (Yervoy), and 40% in patients who had received prior therapies other than ipilimumab.

The current study is an analysis of pooled data on 411 patients, 221 of whom had disease progression on ipilimumab and 190 of whom had never received ipilimumab. All patients had melanoma metastatic to the lungs or other organs.

Neil Osterweil/ Frontline Medical News

The patients received pembrolizumab in one of three dosing schedules: 10 mg/kg every 2 weeks (57 patients) or every 3 weeks (192), or 2 mg/kg every 3 weeks (162).

As noted, the overall survival rate at 1 year was 69% (74% for ipilimumab-naive patients and 65% for ipilimumab-treated patients), with the median overall survival not yet reached.

Dr. O’Day said it was encouraging that prior exposure to ipilimumab did not appear to dramatically decrease the benefit from pembrolizumab.

"This is critical to us understanding whether to combine or sequence these drugs, because there does not seem to be a lot of cross-resistance between ipilimumab and PD-1 [inhibition]," he said.

The most common adverse event of any grade was fatigue, occurring in 36% of patients, but only 2% of patients had grade 3 or 4 fatigue. Other common events were pruritus (24%), rash (20%), diarrhea (16%), arthralgia (16%), nausea (12%), and vitiligo (11%). The overall rate of any adverse events was 83%, but as noted before, only 12% of patients had a grade 3 or 4 adverse event. These events were manageable across all doses and in both ipilmumab-naive and experienced patients.

Pembrolizumab is currently being investigated in international, randomized controlled clinical trials, Dr. Ribas noted.

The study was supported by Merck. Dr. Ribas disclosed serving as a consultant/adviser to the company. Dr. O’Day reported having no relevant disclosures.

CHICAGO – The investigational targeted agent pembrolizumab induced durable treatment responses in a high percentage of patients with advanced metastatic melanoma, in a phase I study.

Of 411 patients, 1-year overall survival was 69%, and 88% of patients who had a treatment response continued to have a response at 1 year, reported Dr. Antoni Ribas, professor of medicine at the University of California, Los Angeles, at a media briefing and in an oral abstract session at the annual meeting of the American Society for Clinical Oncology.

Neil Osterweil/ Frontline Medical News

"We used to say that melanoma had a median survival of 6-9 months – that wasn’t that long ago. Then we said well, maybe it’s getting closer to 12 months. Here, we have not reached the median overall survival," Dr. Ribas said.

At 18 months of follow-up, overall survival is 62%, and seems to be plateauing, but longer follow-up will be required to see how long the survival benefit can be maintained, he said.

"The remarkable thing is that almost 90% of these patients are having durable responses with a toxicity profile that is almost unheard of in metastatic cancer," commented Dr. Steven O’Day of the Beverly Hills (Calif.) Cancer Center, who moderated the briefing but was not involved in the study.

Grade 3 or 4 toxicities occurred in 12% of patients, making pembrolizumab "one of the most benign therapies that I have ever used in my clinic," he said.

New name, same PD-1 antibody

Pembrolizumab, formerly known as lambrolizumab or MK-3475, is a humanized monoclonal antibody targeted against the PD-1 immune system checkpoint. By binding to and inhibiting what Dr. Ribas called the "do not kill me" signal, the antibody allows the immune system to recognize and mount a more potent T-cell–mediated defense against melanoma.

The Food and Drug Administration previously granted permbrolizumab a breakthrough therapy designation, and in May 2014 gave it a priority review designation under the agency’s accelerated approval program.

At the 2013 ASCO annual meeting, Dr. Ribas and colleagues reported a 41% overall response rate (ORR) in the first 135 patients with metastatic melanoma treated with the antibody in the phase I study KEYNOTE 001.

The data he presented at this year’s ASCO meeting on the melanoma expansion cohort from that trial support the earlier findings from the study, showing an overall ORR of 34%, with responses seen in 44% of treatment-naive patients, 28% of those who had previously been treated with a different checkpoint inhibitor, ipilimumab (Yervoy), and 40% in patients who had received prior therapies other than ipilimumab.

The current study is an analysis of pooled data on 411 patients, 221 of whom had disease progression on ipilimumab and 190 of whom had never received ipilimumab. All patients had melanoma metastatic to the lungs or other organs.

Neil Osterweil/ Frontline Medical News

The patients received pembrolizumab in one of three dosing schedules: 10 mg/kg every 2 weeks (57 patients) or every 3 weeks (192), or 2 mg/kg every 3 weeks (162).

As noted, the overall survival rate at 1 year was 69% (74% for ipilimumab-naive patients and 65% for ipilimumab-treated patients), with the median overall survival not yet reached.

Dr. O’Day said it was encouraging that prior exposure to ipilimumab did not appear to dramatically decrease the benefit from pembrolizumab.

"This is critical to us understanding whether to combine or sequence these drugs, because there does not seem to be a lot of cross-resistance between ipilimumab and PD-1 [inhibition]," he said.

The most common adverse event of any grade was fatigue, occurring in 36% of patients, but only 2% of patients had grade 3 or 4 fatigue. Other common events were pruritus (24%), rash (20%), diarrhea (16%), arthralgia (16%), nausea (12%), and vitiligo (11%). The overall rate of any adverse events was 83%, but as noted before, only 12% of patients had a grade 3 or 4 adverse event. These events were manageable across all doses and in both ipilmumab-naive and experienced patients.

Pembrolizumab is currently being investigated in international, randomized controlled clinical trials, Dr. Ribas noted.

The study was supported by Merck. Dr. Ribas disclosed serving as a consultant/adviser to the company. Dr. O’Day reported having no relevant disclosures.

CHICAGO –The answer was nearly a decade in coming, but worth the wait: Adding docetaxel to initial hormonal therapy in men with metastatic, hormone-sensitive prostate cancer can extend overall survival by more than a year.

Dr. Christopher Sweeney of the Lank Center of Genitourinary Oncology at the Dana-Farber Cancer Institute, Boston, discusses the implications of the results before presenting the phase III study at the annual meeting of the American Society of Clinical Oncology.

The study was funded by the National Cancer Institute. Dr. Sweeney disclosed serving in consulting or advisory roles to Astellas Pharma, BIND Biosciences, and other companies. One of his coauthors disclosed consulting/advising or receiving research funding from Astellas, Bayer, and other companies, and another coauthor served as a Data and Safety Monitoring Board chair for Genentech and received research grants from Onyx Pharmaceuticals and Merck.

CHICAGO –The answer was nearly a decade in coming, but worth the wait: Adding docetaxel to initial hormonal therapy in men with metastatic, hormone-sensitive prostate cancer can extend overall survival by more than a year.

Dr. Christopher Sweeney of the Lank Center of Genitourinary Oncology at the Dana-Farber Cancer Institute, Boston, discusses the implications of the results before presenting the phase III study at the annual meeting of the American Society of Clinical Oncology.

The study was funded by the National Cancer Institute. Dr. Sweeney disclosed serving in consulting or advisory roles to Astellas Pharma, BIND Biosciences, and other companies. One of his coauthors disclosed consulting/advising or receiving research funding from Astellas, Bayer, and other companies, and another coauthor served as a Data and Safety Monitoring Board chair for Genentech and received research grants from Onyx Pharmaceuticals and Merck.

CHICAGO –The answer was nearly a decade in coming, but worth the wait: Adding docetaxel to initial hormonal therapy in men with metastatic, hormone-sensitive prostate cancer can extend overall survival by more than a year.

Dr. Christopher Sweeney of the Lank Center of Genitourinary Oncology at the Dana-Farber Cancer Institute, Boston, discusses the implications of the results before presenting the phase III study at the annual meeting of the American Society of Clinical Oncology.

The study was funded by the National Cancer Institute. Dr. Sweeney disclosed serving in consulting or advisory roles to Astellas Pharma, BIND Biosciences, and other companies. One of his coauthors disclosed consulting/advising or receiving research funding from Astellas, Bayer, and other companies, and another coauthor served as a Data and Safety Monitoring Board chair for Genentech and received research grants from Onyx Pharmaceuticals and Merck.

CHICAGO – The answer was nearly a decade in coming, but worth the wait: Adding docetaxel to initial hormonal therapy in men with metastatic, hormone-sensitive prostate cancer can extend overall survival by more than a year.

In a randomized phase III trial, median overall survival for men who received upfront androgen deprivation therapy (ADT) alone for 18 weeks was 44 months, compared with 57.6 months for men who received ADT plus docetaxel (Taxotere), reported Dr. Christopher Sweeney of the Lank Center of Genitourinary Oncology at the Dana-Farber Cancer Institute, Boston.

Neil Osterweil/Frontline Medical News

"The certainty of the data is strong for patients with a high volume of metastatic disease and clearly justifies the treatment burden. This is one of the biggest improvements in survival we have seen involving patients with an adult, node-metastatic solid tumor," said Dr. Sweeney, who presented the data at a media briefing and in a plenary session at the annual meeting of the American Society of Clinical Oncology.

"In prostate cancer, I’m not aware of an historical study that ever offered up quite this magnitude of improvement in survival," commented Dr. Clifford Hudis, who moderated the briefing and the plenary session.

Dr. Hudis, president of ASCO and chief of the breast cancer service at Memorial Sloan–Kettering Cancer Center in New York, was not involved in the study.

In this study of 790 men with newly diagnosed metastatic prostate cancer, those with more extensive disease at study entry (520 patients) experienced the greatest benefit from the docetaxel-ADT combination, with a median overall survival of 49.2 months, compared with 32.2 months for men with extensive disease who received ADT alone.

Median overall survival for men with less invasive disease, has not yet been reached, Dr. Sweeney noted.

Start docetaxel earlier?

The CHAARTED (Chemo Hormonal Therapy vs. Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer) study began enrolling patients in 2006. Because there was evidence to show that docetaxel improves overall survival of men with metastatic prostate cancer who had disease progression while on ADT, the investigators wanted to see whether starting docetaxel earlier might provide additional benefit.

They randomly assigned men on a 1:1 basis to receive either ADT alone, or ADT plus docetaxel 75 mg/m² every 3 weeks for six cycles within 4 months of starting ADT. Patients were stratified by low- vs. high volume disease, with high-volume defined as visceral metastases and/or four or more metastatic bone lesions; antiandrogen therapy use beyond 30 days, age, ECOG (Eastern Cooperative Oncology Group) performance status, prior adjuvant ADT for less than or more than 1 year, and whether they had used a Food and Drug Administration–approved drug for preventing skeletal events, such as a bisphosphonate.

Of the patients assigned to ADT only, 124 received docetaxel at the time of disease progression. Of those in the combination group, 45 who had disease progression received additional docetaxel.

Data released early

Neil Osterweil/Frontline Medical News

At the fourth planned interim analysis in September 2013, when 53% of planned information had been accrued, the data-monitoring committee determined that the ADT-docetaxel combination had crossed the O’Brien-Fleming upper boundary, signaling statistically significant efficacy, and decided to release all available data.

As of Jan. 16, 2014, with a median follow-up of 29 months, there had been 137 deaths among patients treated with ADT alone, compared with 104 treated with ADT-docetaxel.

As noted before, median overall survival was 44 months for those on ADT alone, compared with 57.6 months for those on the combination (P = .0006). This translated into a hazard ratio for death of 0.61 (P = .0003).

The hazard ratio was similar for the subset of men with high-volume disease, at 0.60 (P = .0006), who received both ADT and docetaxel. The hazard ratio for men with low-volume disease was not significant, but as noted before, median overall survival in this group has not yet been reached, likely because men with low-volume disease tend to derive greater benefit from ADT, suggesting that it may take longer follow-up for an added effect of docetaxel to be seen.

In addition to the survival advantage, the combination was better than ADT alone at driving down prostate-specific antigen (PSA) levels, with 27.5% of patients on the ADT-docetaxel arm having a PSA below 0.2 ng/mL at 6 months, compared with 14% of patients treated with ADT alone (P less than .0001). At 12 months, the respective percentages were 22.7% and 11.7% (P less than .0001)

The combination was also better at delaying the median time to development of castration-resistant prostate cancer (20.7 vs. 14.7 months; P less than .0001), and the median time to clinical progression (32.7 vs. 19.8 months).

The most serious adverse events were febrile neutropenia and neuropathy. Of the 101 patients in the combination group who died, 84 of the deaths (83.2%) were from prostate cancer, 8 were from unknown causes, and 1 was attributed to the study protocol. Of the 136 in the ADT-alone arm who died, 112 deaths (83.6%) were from prostate cancers, and 22 were from other or unknown causes; data on the causes of death in 2 patients were missing.

"The clinical interpretation of the data is that six cycles of docetaxel in addition to ADT represents an appropriate option for men with metastatic prostate cancer commencing ADT who are suitable for docetaxel therapy," Dr. Sweeney said in the plenary session.

Dr. Michael J, Morris, the invited discussant, pointed out that the superior overall survival seen with the combination in this study far outstrips that of other drugs tried in this population, with median overall survival benefits ranging from 2.2 to 5.2 months.

"The investigators have adequately shown that high-volume patients with castration-sensitive metastatic disease can benefit from upfront docetaxel," he said. "But there is insufficient data at this after 29 months of median follow-up to recommend that low-volume patients with castration-sensitive disease undergo chemotherapy. We need to optimize the distinction between those who benefit from chemotherapy and those who don’t."

Dr. Morris of Memorial Sloan–Kettering Cancer Center and of Weill Cornell Medical College in New York was not involved in the study.

The study was funded by the National Cancer Institute. Dr. Sweeney disclosed serving in a consulting or advisory role to Astellas Pharma, BIND Biosciences; Bionomics, Exelixis, Genentech, Janssen Pharmaceuticals, Roche and Sanofi. Dr. Morris disclosed consulting/advising Astellas, Bayer, Janssen, Millennium, and Progenics, stock ownership in Biogen Idec, Procter & Gamble, and Teva, and research funding from Agensys, Algeta, Bayer, Medivation, and Sanofi. Dr. Hudis served as a DSMB Chair for Genentech and received research grants from Onyx Pharmaceuticals and Merck & Co.

CHICAGO – The answer was nearly a decade in coming, but worth the wait: Adding docetaxel to initial hormonal therapy in men with metastatic, hormone-sensitive prostate cancer can extend overall survival by more than a year.

In a randomized phase III trial, median overall survival for men who received upfront androgen deprivation therapy (ADT) alone for 18 weeks was 44 months, compared with 57.6 months for men who received ADT plus docetaxel (Taxotere), reported Dr. Christopher Sweeney of the Lank Center of Genitourinary Oncology at the Dana-Farber Cancer Institute, Boston.

Neil Osterweil/Frontline Medical News

"The certainty of the data is strong for patients with a high volume of metastatic disease and clearly justifies the treatment burden. This is one of the biggest improvements in survival we have seen involving patients with an adult, node-metastatic solid tumor," said Dr. Sweeney, who presented the data at a media briefing and in a plenary session at the annual meeting of the American Society of Clinical Oncology.

"In prostate cancer, I’m not aware of an historical study that ever offered up quite this magnitude of improvement in survival," commented Dr. Clifford Hudis, who moderated the briefing and the plenary session.

Dr. Hudis, president of ASCO and chief of the breast cancer service at Memorial Sloan–Kettering Cancer Center in New York, was not involved in the study.

In this study of 790 men with newly diagnosed metastatic prostate cancer, those with more extensive disease at study entry (520 patients) experienced the greatest benefit from the docetaxel-ADT combination, with a median overall survival of 49.2 months, compared with 32.2 months for men with extensive disease who received ADT alone.

Median overall survival for men with less invasive disease, has not yet been reached, Dr. Sweeney noted.

Start docetaxel earlier?

The CHAARTED (Chemo Hormonal Therapy vs. Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer) study began enrolling patients in 2006. Because there was evidence to show that docetaxel improves overall survival of men with metastatic prostate cancer who had disease progression while on ADT, the investigators wanted to see whether starting docetaxel earlier might provide additional benefit.

They randomly assigned men on a 1:1 basis to receive either ADT alone, or ADT plus docetaxel 75 mg/m² every 3 weeks for six cycles within 4 months of starting ADT. Patients were stratified by low- vs. high volume disease, with high-volume defined as visceral metastases and/or four or more metastatic bone lesions; antiandrogen therapy use beyond 30 days, age, ECOG (Eastern Cooperative Oncology Group) performance status, prior adjuvant ADT for less than or more than 1 year, and whether they had used a Food and Drug Administration–approved drug for preventing skeletal events, such as a bisphosphonate.

Of the patients assigned to ADT only, 124 received docetaxel at the time of disease progression. Of those in the combination group, 45 who had disease progression received additional docetaxel.

Data released early

Neil Osterweil/Frontline Medical News

At the fourth planned interim analysis in September 2013, when 53% of planned information had been accrued, the data-monitoring committee determined that the ADT-docetaxel combination had crossed the O’Brien-Fleming upper boundary, signaling statistically significant efficacy, and decided to release all available data.

As of Jan. 16, 2014, with a median follow-up of 29 months, there had been 137 deaths among patients treated with ADT alone, compared with 104 treated with ADT-docetaxel.

As noted before, median overall survival was 44 months for those on ADT alone, compared with 57.6 months for those on the combination (P = .0006). This translated into a hazard ratio for death of 0.61 (P = .0003).

The hazard ratio was similar for the subset of men with high-volume disease, at 0.60 (P = .0006), who received both ADT and docetaxel. The hazard ratio for men with low-volume disease was not significant, but as noted before, median overall survival in this group has not yet been reached, likely because men with low-volume disease tend to derive greater benefit from ADT, suggesting that it may take longer follow-up for an added effect of docetaxel to be seen.

In addition to the survival advantage, the combination was better than ADT alone at driving down prostate-specific antigen (PSA) levels, with 27.5% of patients on the ADT-docetaxel arm having a PSA below 0.2 ng/mL at 6 months, compared with 14% of patients treated with ADT alone (P less than .0001). At 12 months, the respective percentages were 22.7% and 11.7% (P less than .0001)

The combination was also better at delaying the median time to development of castration-resistant prostate cancer (20.7 vs. 14.7 months; P less than .0001), and the median time to clinical progression (32.7 vs. 19.8 months).

The most serious adverse events were febrile neutropenia and neuropathy. Of the 101 patients in the combination group who died, 84 of the deaths (83.2%) were from prostate cancer, 8 were from unknown causes, and 1 was attributed to the study protocol. Of the 136 in the ADT-alone arm who died, 112 deaths (83.6%) were from prostate cancers, and 22 were from other or unknown causes; data on the causes of death in 2 patients were missing.

"The clinical interpretation of the data is that six cycles of docetaxel in addition to ADT represents an appropriate option for men with metastatic prostate cancer commencing ADT who are suitable for docetaxel therapy," Dr. Sweeney said in the plenary session.

Dr. Michael J, Morris, the invited discussant, pointed out that the superior overall survival seen with the combination in this study far outstrips that of other drugs tried in this population, with median overall survival benefits ranging from 2.2 to 5.2 months.

"The investigators have adequately shown that high-volume patients with castration-sensitive metastatic disease can benefit from upfront docetaxel," he said. "But there is insufficient data at this after 29 months of median follow-up to recommend that low-volume patients with castration-sensitive disease undergo chemotherapy. We need to optimize the distinction between those who benefit from chemotherapy and those who don’t."

Dr. Morris of Memorial Sloan–Kettering Cancer Center and of Weill Cornell Medical College in New York was not involved in the study.

The study was funded by the National Cancer Institute. Dr. Sweeney disclosed serving in a consulting or advisory role to Astellas Pharma, BIND Biosciences; Bionomics, Exelixis, Genentech, Janssen Pharmaceuticals, Roche and Sanofi. Dr. Morris disclosed consulting/advising Astellas, Bayer, Janssen, Millennium, and Progenics, stock ownership in Biogen Idec, Procter & Gamble, and Teva, and research funding from Agensys, Algeta, Bayer, Medivation, and Sanofi. Dr. Hudis served as a DSMB Chair for Genentech and received research grants from Onyx Pharmaceuticals and Merck & Co.

CHICAGO – The answer was nearly a decade in coming, but worth the wait: Adding docetaxel to initial hormonal therapy in men with metastatic, hormone-sensitive prostate cancer can extend overall survival by more than a year.

In a randomized phase III trial, median overall survival for men who received upfront androgen deprivation therapy (ADT) alone for 18 weeks was 44 months, compared with 57.6 months for men who received ADT plus docetaxel (Taxotere), reported Dr. Christopher Sweeney of the Lank Center of Genitourinary Oncology at the Dana-Farber Cancer Institute, Boston.

Neil Osterweil/Frontline Medical News

"The certainty of the data is strong for patients with a high volume of metastatic disease and clearly justifies the treatment burden. This is one of the biggest improvements in survival we have seen involving patients with an adult, node-metastatic solid tumor," said Dr. Sweeney, who presented the data at a media briefing and in a plenary session at the annual meeting of the American Society of Clinical Oncology.

"In prostate cancer, I’m not aware of an historical study that ever offered up quite this magnitude of improvement in survival," commented Dr. Clifford Hudis, who moderated the briefing and the plenary session.

Dr. Hudis, president of ASCO and chief of the breast cancer service at Memorial Sloan–Kettering Cancer Center in New York, was not involved in the study.

In this study of 790 men with newly diagnosed metastatic prostate cancer, those with more extensive disease at study entry (520 patients) experienced the greatest benefit from the docetaxel-ADT combination, with a median overall survival of 49.2 months, compared with 32.2 months for men with extensive disease who received ADT alone.

Median overall survival for men with less invasive disease, has not yet been reached, Dr. Sweeney noted.

Start docetaxel earlier?

The CHAARTED (Chemo Hormonal Therapy vs. Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer) study began enrolling patients in 2006. Because there was evidence to show that docetaxel improves overall survival of men with metastatic prostate cancer who had disease progression while on ADT, the investigators wanted to see whether starting docetaxel earlier might provide additional benefit.

They randomly assigned men on a 1:1 basis to receive either ADT alone, or ADT plus docetaxel 75 mg/m² every 3 weeks for six cycles within 4 months of starting ADT. Patients were stratified by low- vs. high volume disease, with high-volume defined as visceral metastases and/or four or more metastatic bone lesions; antiandrogen therapy use beyond 30 days, age, ECOG (Eastern Cooperative Oncology Group) performance status, prior adjuvant ADT for less than or more than 1 year, and whether they had used a Food and Drug Administration–approved drug for preventing skeletal events, such as a bisphosphonate.

Of the patients assigned to ADT only, 124 received docetaxel at the time of disease progression. Of those in the combination group, 45 who had disease progression received additional docetaxel.

Data released early

Neil Osterweil/Frontline Medical News

At the fourth planned interim analysis in September 2013, when 53% of planned information had been accrued, the data-monitoring committee determined that the ADT-docetaxel combination had crossed the O’Brien-Fleming upper boundary, signaling statistically significant efficacy, and decided to release all available data.

As of Jan. 16, 2014, with a median follow-up of 29 months, there had been 137 deaths among patients treated with ADT alone, compared with 104 treated with ADT-docetaxel.

As noted before, median overall survival was 44 months for those on ADT alone, compared with 57.6 months for those on the combination (P = .0006). This translated into a hazard ratio for death of 0.61 (P = .0003).

The hazard ratio was similar for the subset of men with high-volume disease, at 0.60 (P = .0006), who received both ADT and docetaxel. The hazard ratio for men with low-volume disease was not significant, but as noted before, median overall survival in this group has not yet been reached, likely because men with low-volume disease tend to derive greater benefit from ADT, suggesting that it may take longer follow-up for an added effect of docetaxel to be seen.

In addition to the survival advantage, the combination was better than ADT alone at driving down prostate-specific antigen (PSA) levels, with 27.5% of patients on the ADT-docetaxel arm having a PSA below 0.2 ng/mL at 6 months, compared with 14% of patients treated with ADT alone (P less than .0001). At 12 months, the respective percentages were 22.7% and 11.7% (P less than .0001)

The combination was also better at delaying the median time to development of castration-resistant prostate cancer (20.7 vs. 14.7 months; P less than .0001), and the median time to clinical progression (32.7 vs. 19.8 months).

The most serious adverse events were febrile neutropenia and neuropathy. Of the 101 patients in the combination group who died, 84 of the deaths (83.2%) were from prostate cancer, 8 were from unknown causes, and 1 was attributed to the study protocol. Of the 136 in the ADT-alone arm who died, 112 deaths (83.6%) were from prostate cancers, and 22 were from other or unknown causes; data on the causes of death in 2 patients were missing.

"The clinical interpretation of the data is that six cycles of docetaxel in addition to ADT represents an appropriate option for men with metastatic prostate cancer commencing ADT who are suitable for docetaxel therapy," Dr. Sweeney said in the plenary session.

Dr. Michael J, Morris, the invited discussant, pointed out that the superior overall survival seen with the combination in this study far outstrips that of other drugs tried in this population, with median overall survival benefits ranging from 2.2 to 5.2 months.

"The investigators have adequately shown that high-volume patients with castration-sensitive metastatic disease can benefit from upfront docetaxel," he said. "But there is insufficient data at this after 29 months of median follow-up to recommend that low-volume patients with castration-sensitive disease undergo chemotherapy. We need to optimize the distinction between those who benefit from chemotherapy and those who don’t."

Dr. Morris of Memorial Sloan–Kettering Cancer Center and of Weill Cornell Medical College in New York was not involved in the study.

The study was funded by the National Cancer Institute. Dr. Sweeney disclosed serving in a consulting or advisory role to Astellas Pharma, BIND Biosciences; Bionomics, Exelixis, Genentech, Janssen Pharmaceuticals, Roche and Sanofi. Dr. Morris disclosed consulting/advising Astellas, Bayer, Janssen, Millennium, and Progenics, stock ownership in Biogen Idec, Procter & Gamble, and Teva, and research funding from Agensys, Algeta, Bayer, Medivation, and Sanofi. Dr. Hudis served as a DSMB Chair for Genentech and received research grants from Onyx Pharmaceuticals and Merck & Co.

CHICAGO – Lenvatinib significantly prolonged progression-free survival and produced high response rates compared with placebo in patients with relapsed iodine-refractory differentiated thyroid cancer. We catch up with study coauthor Dr. Lori C. Wirth, medical director of the Center for Head and Neck Cancers at Massachusetts General Hospital, Boston, to discuss the promising results at the annual meeting of the American Society of Clinical Oncology.

The study was funded by Eisai. Dr. Wirth reported no financial disclosures.

CHICAGO – Lenvatinib significantly prolonged progression-free survival and produced high response rates compared with placebo in patients with relapsed iodine-refractory differentiated thyroid cancer. We catch up with study coauthor Dr. Lori C. Wirth, medical director of the Center for Head and Neck Cancers at Massachusetts General Hospital, Boston, to discuss the promising results at the annual meeting of the American Society of Clinical Oncology.

The study was funded by Eisai. Dr. Wirth reported no financial disclosures.

CHICAGO – Lenvatinib significantly prolonged progression-free survival and produced high response rates compared with placebo in patients with relapsed iodine-refractory differentiated thyroid cancer. We catch up with study coauthor Dr. Lori C. Wirth, medical director of the Center for Head and Neck Cancers at Massachusetts General Hospital, Boston, to discuss the promising results at the annual meeting of the American Society of Clinical Oncology.

The study was funded by Eisai. Dr. Wirth reported no financial disclosures.

CHICAGO – For the first time an oral drug, ibrutinib, has been shown to significantly improve both progression-free and overall survival of patients with relapsed or refractory chronic lymphocytic leukemia, compared with a systemic agent.

We interviewed lead author Dr. John Byrd about the first interim analysis from RESONATE, a phase III randomized trial, comparing ibrutinib with ofatumumab for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma at the annual meeting of the American Society of Clinical Oncology. The analysis showed that 1-year overall survival for patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma assigned to receive ibrutinib (Imbruvica) was 90%, compared with 81% for patients assigned to ofatumumab (Arzerra).

Dr. Byrd is professor of medicine at the Ohio State University Comprehensive Cancer Center, Columbus. The study was supported by Pharmacyclics. Dr. Byrd disclosed receiving research funding and serving as an unpaid advisor to the company.

CHICAGO – For the first time an oral drug, ibrutinib, has been shown to significantly improve both progression-free and overall survival of patients with relapsed or refractory chronic lymphocytic leukemia, compared with a systemic agent.

We interviewed lead author Dr. John Byrd about the first interim analysis from RESONATE, a phase III randomized trial, comparing ibrutinib with ofatumumab for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma at the annual meeting of the American Society of Clinical Oncology. The analysis showed that 1-year overall survival for patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma assigned to receive ibrutinib (Imbruvica) was 90%, compared with 81% for patients assigned to ofatumumab (Arzerra).

Dr. Byrd is professor of medicine at the Ohio State University Comprehensive Cancer Center, Columbus. The study was supported by Pharmacyclics. Dr. Byrd disclosed receiving research funding and serving as an unpaid advisor to the company.

CHICAGO – For the first time an oral drug, ibrutinib, has been shown to significantly improve both progression-free and overall survival of patients with relapsed or refractory chronic lymphocytic leukemia, compared with a systemic agent.

We interviewed lead author Dr. John Byrd about the first interim analysis from RESONATE, a phase III randomized trial, comparing ibrutinib with ofatumumab for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma at the annual meeting of the American Society of Clinical Oncology. The analysis showed that 1-year overall survival for patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma assigned to receive ibrutinib (Imbruvica) was 90%, compared with 81% for patients assigned to ofatumumab (Arzerra).

Dr. Byrd is professor of medicine at the Ohio State University Comprehensive Cancer Center, Columbus. The study was supported by Pharmacyclics. Dr. Byrd disclosed receiving research funding and serving as an unpaid advisor to the company.

CHICAGO – For the first time an oral drug, ibrutinib, has been shown to significantly improve both progression-free and overall survival of patients with relapsed or refractory chronic lymphocytic leukemia, compared with a systemic agent.

The first interim analysis of a phase III randomized trial showed that 1-year overall survival for patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) assigned to receive ibrutinib (Imbruvica) was 90%, compared with 81% for patients assigned to ofatumumab (Arzerra).

The hazard ratio (HR) for death for patients assigned to ibrutinib was 0.43 (P = .005), reported lead author Dr. John Byrd, professor of medicine at the Ohio State University Comprehensive Cancer Center, Columbus, at a media briefing at the annual meeting of the American Society of Clinical Oncology.

The median time to progression for patients on ibrutinib had not been reached, compared with 8.08 months for those on ofatumumab. At 15 months follow-up, the median progression-free survival (PFS) was 8.4 months in the ofatumumab group vs. not reached for patients on ibrutinib.

Ibrutinib reduced by 78% the risk of disease progression or death, compared with ofatumumab, Dr. Byrd noted.

The overall survival advantage shown with ibrutinib persisted even after 57 patients who had disease progression while on ofatumumab were crossed over to ibrutinib, Dr. Byrd said.

"These patients who have a short response to first-line therapy, or who are elderly, have very few treatment options that induce durable remissions. Identifying new therapies in this patient population, particularly those that extend survival, is very important," he said.

"The issue now is how to best use the drug and how to most effectively move this into the front-line setting. This is a transformative drug," commented Dr. Olatoyosi Odenike, a leukemia specialist from the University of Chicago, who was not involved in the study.

Dr. Gregory A. Masters of Jefferson Medical College, Philadelphia, and the Helen F. Graham Cancer Center in Newark, Del., who moderated the briefing, but was not involved in the study, echoed those sentiments.

"I think this drug’s efficacy may in fact transform the treatment of CLL, potentially replacing more toxic chemotherapy," he said.

B-cell signaling inhibitor

Ibrutinib is an oral inhibitor of Bruton’s tyrosine kinase, an enzyme essential for B-cell receptor signaling and adhesion that is present in many types of B-cell malignancies. Based on the results of phase II studies, ibrutinib received Food and Drug Administration approval for relapsed mantle cell lymphoma in November 2013 and for CLL in February 2014.

Ofatumumab, a CD20 inhibitor, was approved for the treatment of CLL based on a single group study in which patients whose disease was resistant to fludarabine and alemtuzumab had an overall response rate of 58%.

In the RESONATE trial, Dr. Byrd and his colleagues enrolled 391 patients with relapsed or refractory CLL or SLL and randomly assigned them to receive either oral ibrutinib 420 mg once daily until disease progression or unacceptable toxicity (195 patients) or to IV ofatumumab at an initial dose of 300 mg followed by 11 doses at 2,000 mg (196 patients).

At a median follow-up of 9.4 months, the median duration of PFS, the primary endpoint, had not been reached in ibrutinib-treated patients (88% of whom had PFS at 6 months), compared with 8.1 months for patients treated with ofatumumab.

In all, 42.6% of patients on ibrutinib had a partial response rate, compared with 4.1% of those on ofatumumab. In addition, 20% of patients on ibrutinib had a partial response with lymphocytosis. Lymphocytosis occurred in 69% of all patients treated with ibrutinib. The investigators did not consider lymphocytosis to be disease progression, and the condition resolved in 77% of these patients during follow-up.

Nonhematologic adverse events occurring in at least 20% of patients included diarrhea, fatigue, pyrexia, and nausea in patients on ibrutinib, and fatigue, infusion-related reactions, and cough in those on ofatumumab.

In all, 4% of patients on ibrutinib and 5% on ofatumumab discontinued the assigned drug because of adverse events.

Richter’s transformation – CLL evolving into an aggressive, rapidly growing large-cell lymphoma – occurred in two patients in each treatment arm. One patient on ibrutinib developed prolymphocytic leukemia.

Dr. Byrd noted that the improved PFS, overall survival, and response rates with ibrutinib were seem across all patient subgroups, including patients who were resistant to chemoimmunotherapy and those with the notorious chromosome 17p13.1 deletion.

Ibrutinib is currently being explored in patients with previously untreated CLL or SLL. The study was supported by Pharmacyclics. Dr. Byrd disclosed receiving research funding and serving as an unpaid advisor to the company. Dr. Odenike and Dr. Masters reported having no relevant disclosures.

CHICAGO – For the first time an oral drug, ibrutinib, has been shown to significantly improve both progression-free and overall survival of patients with relapsed or refractory chronic lymphocytic leukemia, compared with a systemic agent.

The first interim analysis of a phase III randomized trial showed that 1-year overall survival for patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) assigned to receive ibrutinib (Imbruvica) was 90%, compared with 81% for patients assigned to ofatumumab (Arzerra).

The hazard ratio (HR) for death for patients assigned to ibrutinib was 0.43 (P = .005), reported lead author Dr. John Byrd, professor of medicine at the Ohio State University Comprehensive Cancer Center, Columbus, at a media briefing at the annual meeting of the American Society of Clinical Oncology.

The median time to progression for patients on ibrutinib had not been reached, compared with 8.08 months for those on ofatumumab. At 15 months follow-up, the median progression-free survival (PFS) was 8.4 months in the ofatumumab group vs. not reached for patients on ibrutinib.

Ibrutinib reduced by 78% the risk of disease progression or death, compared with ofatumumab, Dr. Byrd noted.

The overall survival advantage shown with ibrutinib persisted even after 57 patients who had disease progression while on ofatumumab were crossed over to ibrutinib, Dr. Byrd said.

"These patients who have a short response to first-line therapy, or who are elderly, have very few treatment options that induce durable remissions. Identifying new therapies in this patient population, particularly those that extend survival, is very important," he said.

"The issue now is how to best use the drug and how to most effectively move this into the front-line setting. This is a transformative drug," commented Dr. Olatoyosi Odenike, a leukemia specialist from the University of Chicago, who was not involved in the study.

Dr. Gregory A. Masters of Jefferson Medical College, Philadelphia, and the Helen F. Graham Cancer Center in Newark, Del., who moderated the briefing, but was not involved in the study, echoed those sentiments.

"I think this drug’s efficacy may in fact transform the treatment of CLL, potentially replacing more toxic chemotherapy," he said.

B-cell signaling inhibitor

Ibrutinib is an oral inhibitor of Bruton’s tyrosine kinase, an enzyme essential for B-cell receptor signaling and adhesion that is present in many types of B-cell malignancies. Based on the results of phase II studies, ibrutinib received Food and Drug Administration approval for relapsed mantle cell lymphoma in November 2013 and for CLL in February 2014.

Ofatumumab, a CD20 inhibitor, was approved for the treatment of CLL based on a single group study in which patients whose disease was resistant to fludarabine and alemtuzumab had an overall response rate of 58%.

In the RESONATE trial, Dr. Byrd and his colleagues enrolled 391 patients with relapsed or refractory CLL or SLL and randomly assigned them to receive either oral ibrutinib 420 mg once daily until disease progression or unacceptable toxicity (195 patients) or to IV ofatumumab at an initial dose of 300 mg followed by 11 doses at 2,000 mg (196 patients).

At a median follow-up of 9.4 months, the median duration of PFS, the primary endpoint, had not been reached in ibrutinib-treated patients (88% of whom had PFS at 6 months), compared with 8.1 months for patients treated with ofatumumab.

In all, 42.6% of patients on ibrutinib had a partial response rate, compared with 4.1% of those on ofatumumab. In addition, 20% of patients on ibrutinib had a partial response with lymphocytosis. Lymphocytosis occurred in 69% of all patients treated with ibrutinib. The investigators did not consider lymphocytosis to be disease progression, and the condition resolved in 77% of these patients during follow-up.

Nonhematologic adverse events occurring in at least 20% of patients included diarrhea, fatigue, pyrexia, and nausea in patients on ibrutinib, and fatigue, infusion-related reactions, and cough in those on ofatumumab.

In all, 4% of patients on ibrutinib and 5% on ofatumumab discontinued the assigned drug because of adverse events.

Richter’s transformation – CLL evolving into an aggressive, rapidly growing large-cell lymphoma – occurred in two patients in each treatment arm. One patient on ibrutinib developed prolymphocytic leukemia.

Dr. Byrd noted that the improved PFS, overall survival, and response rates with ibrutinib were seem across all patient subgroups, including patients who were resistant to chemoimmunotherapy and those with the notorious chromosome 17p13.1 deletion.

Ibrutinib is currently being explored in patients with previously untreated CLL or SLL. The study was supported by Pharmacyclics. Dr. Byrd disclosed receiving research funding and serving as an unpaid advisor to the company. Dr. Odenike and Dr. Masters reported having no relevant disclosures.

CHICAGO – For the first time an oral drug, ibrutinib, has been shown to significantly improve both progression-free and overall survival of patients with relapsed or refractory chronic lymphocytic leukemia, compared with a systemic agent.

The first interim analysis of a phase III randomized trial showed that 1-year overall survival for patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) assigned to receive ibrutinib (Imbruvica) was 90%, compared with 81% for patients assigned to ofatumumab (Arzerra).

The hazard ratio (HR) for death for patients assigned to ibrutinib was 0.43 (P = .005), reported lead author Dr. John Byrd, professor of medicine at the Ohio State University Comprehensive Cancer Center, Columbus, at a media briefing at the annual meeting of the American Society of Clinical Oncology.

The median time to progression for patients on ibrutinib had not been reached, compared with 8.08 months for those on ofatumumab. At 15 months follow-up, the median progression-free survival (PFS) was 8.4 months in the ofatumumab group vs. not reached for patients on ibrutinib.

Ibrutinib reduced by 78% the risk of disease progression or death, compared with ofatumumab, Dr. Byrd noted.

The overall survival advantage shown with ibrutinib persisted even after 57 patients who had disease progression while on ofatumumab were crossed over to ibrutinib, Dr. Byrd said.

"These patients who have a short response to first-line therapy, or who are elderly, have very few treatment options that induce durable remissions. Identifying new therapies in this patient population, particularly those that extend survival, is very important," he said.

"The issue now is how to best use the drug and how to most effectively move this into the front-line setting. This is a transformative drug," commented Dr. Olatoyosi Odenike, a leukemia specialist from the University of Chicago, who was not involved in the study.

Dr. Gregory A. Masters of Jefferson Medical College, Philadelphia, and the Helen F. Graham Cancer Center in Newark, Del., who moderated the briefing, but was not involved in the study, echoed those sentiments.

"I think this drug’s efficacy may in fact transform the treatment of CLL, potentially replacing more toxic chemotherapy," he said.

B-cell signaling inhibitor

Ibrutinib is an oral inhibitor of Bruton’s tyrosine kinase, an enzyme essential for B-cell receptor signaling and adhesion that is present in many types of B-cell malignancies. Based on the results of phase II studies, ibrutinib received Food and Drug Administration approval for relapsed mantle cell lymphoma in November 2013 and for CLL in February 2014.

Ofatumumab, a CD20 inhibitor, was approved for the treatment of CLL based on a single group study in which patients whose disease was resistant to fludarabine and alemtuzumab had an overall response rate of 58%.

In the RESONATE trial, Dr. Byrd and his colleagues enrolled 391 patients with relapsed or refractory CLL or SLL and randomly assigned them to receive either oral ibrutinib 420 mg once daily until disease progression or unacceptable toxicity (195 patients) or to IV ofatumumab at an initial dose of 300 mg followed by 11 doses at 2,000 mg (196 patients).

At a median follow-up of 9.4 months, the median duration of PFS, the primary endpoint, had not been reached in ibrutinib-treated patients (88% of whom had PFS at 6 months), compared with 8.1 months for patients treated with ofatumumab.

In all, 42.6% of patients on ibrutinib had a partial response rate, compared with 4.1% of those on ofatumumab. In addition, 20% of patients on ibrutinib had a partial response with lymphocytosis. Lymphocytosis occurred in 69% of all patients treated with ibrutinib. The investigators did not consider lymphocytosis to be disease progression, and the condition resolved in 77% of these patients during follow-up.

Nonhematologic adverse events occurring in at least 20% of patients included diarrhea, fatigue, pyrexia, and nausea in patients on ibrutinib, and fatigue, infusion-related reactions, and cough in those on ofatumumab.

In all, 4% of patients on ibrutinib and 5% on ofatumumab discontinued the assigned drug because of adverse events.

Richter’s transformation – CLL evolving into an aggressive, rapidly growing large-cell lymphoma – occurred in two patients in each treatment arm. One patient on ibrutinib developed prolymphocytic leukemia.

Dr. Byrd noted that the improved PFS, overall survival, and response rates with ibrutinib were seem across all patient subgroups, including patients who were resistant to chemoimmunotherapy and those with the notorious chromosome 17p13.1 deletion.

Ibrutinib is currently being explored in patients with previously untreated CLL or SLL. The study was supported by Pharmacyclics. Dr. Byrd disclosed receiving research funding and serving as an unpaid advisor to the company. Dr. Odenike and Dr. Masters reported having no relevant disclosures.

NEW YORK – Remote psychiatric evaluations and consultations appear to be a good call for patients in rural or underserved areas, a telepsychiatrist says.

In a 32-month study, no significant differences were found in the number of adult and child/adolescent evaluations and follow-ups between face-to-face and telepsychiatric services, and both patients and psychiatrists appeared to be happy with the remote interviews, said Dr. Yilmaz Yildirim of the department of psychiatric medicine at East Carolina University in Greenville, N. C.

"The young population loved it," he said in a face-to-face interview.

Elderly patients, particularly women, were hesitant at first, but became "very comfortable" with telepsychiatry over time, he said at the annual meeting of the American Psychiatric Association.

Dr. Yildirim said he was so happy with the results himself that he closed his face-to-face clinic and now conducts all new evaluations and follow-up visits via remote telecommunications.

From August 2010 through March 2013, he provided mental health services in a community health clinic in New Bern, N.C., or via telepsychiatry services to rural counties in eastern North Carolina. The psychiatrist alternated face-to-face and telepsychiatry days.

Over the study period, there were 107 face-to-face clinic days with a total of 1,077 patients and 93 telepsychiatry clinic days seeing 890 patients.

Dr. Yildirim found that the mean number of patients seen per day was 9.79 for the remote visits, compared with 10.40 for face-to-face encounters, a difference that was not significant.

The mean number of new evaluations of adult patients per day was 1.06 for remote visits vs. 0.97 for face-to-face visits (no significant difference), and the mean number of daily adult follow-up visits also was similar at 3.52 and 3.64.

New evaluations of children per day averaged 0.78 for telepsychiatry and 0.93 for the face-to-face clinic, and the mean number of children seen for follow-up daily was identical to that of adult follow-up visits at 3.52 and 3.64, respectively.

The findings show that telepsychiatry is feasible as a means of providing mental health services to adults, children, and adolescents in areas where psychiatrists are few and far between. Telepsychiatry also could be used to provide some forms of therapy, Dr. Yildirim said.

"More telepsychiatry programs should be funded to provide mental health services in rural areas where access to mental health services is difficult," he wrote in a poster presentation.

"I think this would be very good for my country, Brazil, which has a shortage of psychiatrists all over. I think it’s an excellent solution" said Dr. Carlos Horta, a psychiatrist who practices in São Paulo, Brazil.

Dr. Horta was not involved in the study.

The research was supported by East Carolina University. Dr. Yildirim and Dr. Horta reported having no conflicts of interest.

NEW YORK – Remote psychiatric evaluations and consultations appear to be a good call for patients in rural or underserved areas, a telepsychiatrist says.

In a 32-month study, no significant differences were found in the number of adult and child/adolescent evaluations and follow-ups between face-to-face and telepsychiatric services, and both patients and psychiatrists appeared to be happy with the remote interviews, said Dr. Yilmaz Yildirim of the department of psychiatric medicine at East Carolina University in Greenville, N. C.

"The young population loved it," he said in a face-to-face interview.

Elderly patients, particularly women, were hesitant at first, but became "very comfortable" with telepsychiatry over time, he said at the annual meeting of the American Psychiatric Association.

Dr. Yildirim said he was so happy with the results himself that he closed his face-to-face clinic and now conducts all new evaluations and follow-up visits via remote telecommunications.

From August 2010 through March 2013, he provided mental health services in a community health clinic in New Bern, N.C., or via telepsychiatry services to rural counties in eastern North Carolina. The psychiatrist alternated face-to-face and telepsychiatry days.

Over the study period, there were 107 face-to-face clinic days with a total of 1,077 patients and 93 telepsychiatry clinic days seeing 890 patients.

Dr. Yildirim found that the mean number of patients seen per day was 9.79 for the remote visits, compared with 10.40 for face-to-face encounters, a difference that was not significant.

The mean number of new evaluations of adult patients per day was 1.06 for remote visits vs. 0.97 for face-to-face visits (no significant difference), and the mean number of daily adult follow-up visits also was similar at 3.52 and 3.64.

New evaluations of children per day averaged 0.78 for telepsychiatry and 0.93 for the face-to-face clinic, and the mean number of children seen for follow-up daily was identical to that of adult follow-up visits at 3.52 and 3.64, respectively.

The findings show that telepsychiatry is feasible as a means of providing mental health services to adults, children, and adolescents in areas where psychiatrists are few and far between. Telepsychiatry also could be used to provide some forms of therapy, Dr. Yildirim said.

"More telepsychiatry programs should be funded to provide mental health services in rural areas where access to mental health services is difficult," he wrote in a poster presentation.

"I think this would be very good for my country, Brazil, which has a shortage of psychiatrists all over. I think it’s an excellent solution" said Dr. Carlos Horta, a psychiatrist who practices in São Paulo, Brazil.

Dr. Horta was not involved in the study.

The research was supported by East Carolina University. Dr. Yildirim and Dr. Horta reported having no conflicts of interest.

NEW YORK – Remote psychiatric evaluations and consultations appear to be a good call for patients in rural or underserved areas, a telepsychiatrist says.

In a 32-month study, no significant differences were found in the number of adult and child/adolescent evaluations and follow-ups between face-to-face and telepsychiatric services, and both patients and psychiatrists appeared to be happy with the remote interviews, said Dr. Yilmaz Yildirim of the department of psychiatric medicine at East Carolina University in Greenville, N. C.

"The young population loved it," he said in a face-to-face interview.

Elderly patients, particularly women, were hesitant at first, but became "very comfortable" with telepsychiatry over time, he said at the annual meeting of the American Psychiatric Association.

Dr. Yildirim said he was so happy with the results himself that he closed his face-to-face clinic and now conducts all new evaluations and follow-up visits via remote telecommunications.

From August 2010 through March 2013, he provided mental health services in a community health clinic in New Bern, N.C., or via telepsychiatry services to rural counties in eastern North Carolina. The psychiatrist alternated face-to-face and telepsychiatry days.

Over the study period, there were 107 face-to-face clinic days with a total of 1,077 patients and 93 telepsychiatry clinic days seeing 890 patients.

Dr. Yildirim found that the mean number of patients seen per day was 9.79 for the remote visits, compared with 10.40 for face-to-face encounters, a difference that was not significant.

The mean number of new evaluations of adult patients per day was 1.06 for remote visits vs. 0.97 for face-to-face visits (no significant difference), and the mean number of daily adult follow-up visits also was similar at 3.52 and 3.64.

New evaluations of children per day averaged 0.78 for telepsychiatry and 0.93 for the face-to-face clinic, and the mean number of children seen for follow-up daily was identical to that of adult follow-up visits at 3.52 and 3.64, respectively.

The findings show that telepsychiatry is feasible as a means of providing mental health services to adults, children, and adolescents in areas where psychiatrists are few and far between. Telepsychiatry also could be used to provide some forms of therapy, Dr. Yildirim said.

"More telepsychiatry programs should be funded to provide mental health services in rural areas where access to mental health services is difficult," he wrote in a poster presentation.

"I think this would be very good for my country, Brazil, which has a shortage of psychiatrists all over. I think it’s an excellent solution" said Dr. Carlos Horta, a psychiatrist who practices in São Paulo, Brazil.

Dr. Horta was not involved in the study.

The research was supported by East Carolina University. Dr. Yildirim and Dr. Horta reported having no conflicts of interest.

NEW YORK – Remote psychiatric evaluations and consultations appear to be a good call for patients in rural or underserved areas, a telepsychiatrist says.

In a 32-month study, no significant differences were found in the number of adult and child/adolescent evaluations and follow-ups between face-to-face and telepsychiatric services, and both patients and psychiatrists appeared to be happy with the remote interviews, said Dr. Yilmaz Yildirim of the department of psychiatric medicine at East Carolina University in Greenville, N. C.

"The young population loved it," he said in a face-to-face interview.

Elderly patients, particularly women, were hesitant at first, but became "very comfortable" with telepsychiatry over time, he said at the annual meeting of the American Psychiatric Association.

Dr. Yildirim said he was so happy with the results himself that he closed his face-to-face clinic and now conducts all new evaluations and follow-up visits via remote telecommunications.

From August 2010 through March 2013, he provided mental health services in a community health clinic in New Bern, N.C., or via telepsychiatry services to rural counties in eastern North Carolina. The psychiatrist alternated face-to-face and telepsychiatry days.

Over the study period, there were 107 face-to-face clinic days with a total of 1,077 patients and 93 telepsychiatry clinic days seeing 890 patients.

Dr. Yildirim found that the mean number of patients seen per day was 9.79 for the remote visits, compared with 10.40 for face-to-face encounters, a difference that was not significant.

The mean number of new evaluations of adult patients per day was 1.06 for remote visits vs. 0.97 for face-to-face visits (no significant difference), and the mean number of daily adult follow-up visits also was similar at 3.52 and 3.64.

New evaluations of children per day averaged 0.78 for telepsychiatry and 0.93 for the face-to-face clinic, and the mean number of children seen for follow-up daily was identical to that of adult follow-up visits at 3.52 and 3.64, respectively.

The findings show that telepsychiatry is feasible as a means of providing mental health services to adults, children, and adolescents in areas where psychiatrists are few and far between. Telepsychiatry also could be used to provide some forms of therapy, Dr. Yildirim said.

"More telepsychiatry programs should be funded to provide mental health services in rural areas where access to mental health services is difficult," he wrote in a poster presentation.

"I think this would be very good for my country, Brazil, which has a shortage of psychiatrists all over. I think it’s an excellent solution" said Dr. Carlos Horta, a psychiatrist who practices in São Paulo, Brazil.

Dr. Horta was not involved in the study.

The research was supported by East Carolina University. Dr. Yildirim and Dr. Horta reported having no conflicts of interest.

NEW YORK – Remote psychiatric evaluations and consultations appear to be a good call for patients in rural or underserved areas, a telepsychiatrist says.

In a 32-month study, no significant differences were found in the number of adult and child/adolescent evaluations and follow-ups between face-to-face and telepsychiatric services, and both patients and psychiatrists appeared to be happy with the remote interviews, said Dr. Yilmaz Yildirim of the department of psychiatric medicine at East Carolina University in Greenville, N. C.

"The young population loved it," he said in a face-to-face interview.

Elderly patients, particularly women, were hesitant at first, but became "very comfortable" with telepsychiatry over time, he said at the annual meeting of the American Psychiatric Association.

Dr. Yildirim said he was so happy with the results himself that he closed his face-to-face clinic and now conducts all new evaluations and follow-up visits via remote telecommunications.

From August 2010 through March 2013, he provided mental health services in a community health clinic in New Bern, N.C., or via telepsychiatry services to rural counties in eastern North Carolina. The psychiatrist alternated face-to-face and telepsychiatry days.

Over the study period, there were 107 face-to-face clinic days with a total of 1,077 patients and 93 telepsychiatry clinic days seeing 890 patients.

Dr. Yildirim found that the mean number of patients seen per day was 9.79 for the remote visits, compared with 10.40 for face-to-face encounters, a difference that was not significant.

The mean number of new evaluations of adult patients per day was 1.06 for remote visits vs. 0.97 for face-to-face visits (no significant difference), and the mean number of daily adult follow-up visits also was similar at 3.52 and 3.64.

New evaluations of children per day averaged 0.78 for telepsychiatry and 0.93 for the face-to-face clinic, and the mean number of children seen for follow-up daily was identical to that of adult follow-up visits at 3.52 and 3.64, respectively.

The findings show that telepsychiatry is feasible as a means of providing mental health services to adults, children, and adolescents in areas where psychiatrists are few and far between. Telepsychiatry also could be used to provide some forms of therapy, Dr. Yildirim said.

"More telepsychiatry programs should be funded to provide mental health services in rural areas where access to mental health services is difficult," he wrote in a poster presentation.

"I think this would be very good for my country, Brazil, which has a shortage of psychiatrists all over. I think it’s an excellent solution" said Dr. Carlos Horta, a psychiatrist who practices in São Paulo, Brazil.

Dr. Horta was not involved in the study.

The research was supported by East Carolina University. Dr. Yildirim and Dr. Horta reported having no conflicts of interest.

NEW YORK – Remote psychiatric evaluations and consultations appear to be a good call for patients in rural or underserved areas, a telepsychiatrist says.

In a 32-month study, no significant differences were found in the number of adult and child/adolescent evaluations and follow-ups between face-to-face and telepsychiatric services, and both patients and psychiatrists appeared to be happy with the remote interviews, said Dr. Yilmaz Yildirim of the department of psychiatric medicine at East Carolina University in Greenville, N. C.

"The young population loved it," he said in a face-to-face interview.

Elderly patients, particularly women, were hesitant at first, but became "very comfortable" with telepsychiatry over time, he said at the annual meeting of the American Psychiatric Association.

Dr. Yildirim said he was so happy with the results himself that he closed his face-to-face clinic and now conducts all new evaluations and follow-up visits via remote telecommunications.

From August 2010 through March 2013, he provided mental health services in a community health clinic in New Bern, N.C., or via telepsychiatry services to rural counties in eastern North Carolina. The psychiatrist alternated face-to-face and telepsychiatry days.

Over the study period, there were 107 face-to-face clinic days with a total of 1,077 patients and 93 telepsychiatry clinic days seeing 890 patients.

Dr. Yildirim found that the mean number of patients seen per day was 9.79 for the remote visits, compared with 10.40 for face-to-face encounters, a difference that was not significant.

The mean number of new evaluations of adult patients per day was 1.06 for remote visits vs. 0.97 for face-to-face visits (no significant difference), and the mean number of daily adult follow-up visits also was similar at 3.52 and 3.64.

New evaluations of children per day averaged 0.78 for telepsychiatry and 0.93 for the face-to-face clinic, and the mean number of children seen for follow-up daily was identical to that of adult follow-up visits at 3.52 and 3.64, respectively.

The findings show that telepsychiatry is feasible as a means of providing mental health services to adults, children, and adolescents in areas where psychiatrists are few and far between. Telepsychiatry also could be used to provide some forms of therapy, Dr. Yildirim said.

"More telepsychiatry programs should be funded to provide mental health services in rural areas where access to mental health services is difficult," he wrote in a poster presentation.

"I think this would be very good for my country, Brazil, which has a shortage of psychiatrists all over. I think it’s an excellent solution" said Dr. Carlos Horta, a psychiatrist who practices in São Paulo, Brazil.

Dr. Horta was not involved in the study.

The research was supported by East Carolina University. Dr. Yildirim and Dr. Horta reported having no conflicts of interest.