2011 ASCO Annual Meeting

CHICAGO –More good news on ipilimumab for metastatic melanoma emerged from the results of a trial reported at the annual meeting of the American Society of Clinical Oncology.

In a double-blind, randomized, phase III study, nearly 21% of 250 metastatic melanoma patients who underwent first-line treatment with ipilimumab (Yervoy, Bristol-Myers Squibb) in combination with dacarbazine were alive after 3 years, compared with 12% of 252 patients given placebo and dacarbazine, Dr. Jedd Wolchok reported during a plenary session at the meeting.

Overall survival was 11.2 months in the ipilimumab plus dacarbazine group and 9.1 months in the placebo plus dacarbazine group. The study was simultaneously published in the New England Journal of Medicine (2011 June 5;doi:10.1056/NEJMoa1104621).

A divergence in the survival curve was evident at 1 year, with 47% survival in the ipilimumab plus dacarbazine group, compared with 36% in the placebo plus dacarbazine group; at 2 years, the survival rates were 28% and 18%, respectively. The hazard ratio was 0.72, or 28% reduction in death.

At last year’s ASCO meeting, ipilimumab monotherapy was shown to prolong survival in previously treated metastatic melanoma patients. The drug was approved earlier this year as a first-line monotherapy treatment at a dosage of 3 mg/kg.

This is the first trial to show efficacy and safety of combining immunotherapy and chemotherapy in metastatic melanoma, said Dr. Wolchok of Memorial Sloan-Kettering Cancer Center, New York. The next step for ipilimumab combination therapy is to look to other combination therapies, such as the investigational agent vemurafenib (PLX4032), as well as other targeted agents and immune-modifying agents.

Dr. Wolchok cautioned that ipilimumab is approved only as a monotherapy and should only be used at the approved dose. Any use in combination therapy should be conducted as part of a clinical trial, several of which are ongoing or about to get underway.

In another plenary presentation at ASCO, Dr. Paul Chapman, also of Memorial Sloan-Kettering, reported a 63% reduction in risk of death with vemurafenib, compared with dacarbazine alone, in metastatic melanoma patients with BRAF mutations. Vemurafenib is an investigational oral drug that inhibits BRAF kinase.

In Dr. Wolchok’s study, progression-free survival was not significantly different between the two treatment groups. Ipilimumab, a monoclonal antibody that blocks CTLA-4 and augments T-cell activation, may improve survival by re-establishing an immuno-equilibrium that allows patients to survive despite the presence of tumors, he said. "The immune system is a ‘living drug,’ able to adapt itself to changes in the tumor ... overall survival is a more accurate way to gauge treatment effectiveness than progression-free survival."

In the trial, patients received either ipilimumab (10 mg/kg, three times per week for 4 weeks) plus dacarbazine (850 mg/m², three times per week for 8 weeks) or placebo plus dacarbazine at the same dose and schedule. More than half of the patients in the study had MC1 disease.

Tumors were assessed at weeks 1, 12, and 24 in the protocol. For the maintenance therapy section of the trial, placebo or ipilimumab at 10 mg/kg once every 12 weeks was given until the disease progressed or patients had toxic effects.

Treatment discontinuations due to disease progression and adverse events were higher in the ipilimumab plus dacarbazine group; 92 patients received all four doses, compared with 165 patients in the placebo plus dacarbazine group.

Most discontinuations were due to disease progression, which occurred in 46% of the ipilimumab plus dacarbazine group and in 77% of the placebo plus dacarbazine group.

Of those who received at least one dose of therapy, 89 of 247 patients in the ipilimumab plus dacarbazine group and 10 of 251 patients given dacarbazine plus placebo discontinued. In the ipilimumab plus dacarbazine group, 85 of 247 discontinued after the induction phase because of a drug-related adverse event as did 10 of 251 in the placebo plus dacarbazine group.

After the maintenance dose, 4 of 43 in the dacarbazine plus ipilimumab group and none of the 53 in the placebo plus dacarbazine group discontinued therapy after receiving the maintenance dose.

The only treatment-related death occurred in the placebo plus dacarbazine group. Immune-related adverse events were seen in 78% of the ipilimumab plus dacarbazine group and in 38% of the placebo plus dacarbazine group. Grade 3 and 4 adverse events occurred in 38% of the ipilimumab plus dacarbazine group and in 4.4% of the placebo plus dacarbazine group. Liver function abnormalities were the most common immune-mediated adverse event. Most of the patients received steroids and their liver function normalized.

The study was funded by Bristol-Myers Squibb, the maker of ipilimumab. Dr. Wolchok is a consultant/advisor to Bristol-Myers Squibb.

CHICAGO –More good news on ipilimumab for metastatic melanoma emerged from the results of a trial reported at the annual meeting of the American Society of Clinical Oncology.

In a double-blind, randomized, phase III study, nearly 21% of 250 metastatic melanoma patients who underwent first-line treatment with ipilimumab (Yervoy, Bristol-Myers Squibb) in combination with dacarbazine were alive after 3 years, compared with 12% of 252 patients given placebo and dacarbazine, Dr. Jedd Wolchok reported during a plenary session at the meeting.

Overall survival was 11.2 months in the ipilimumab plus dacarbazine group and 9.1 months in the placebo plus dacarbazine group. The study was simultaneously published in the New England Journal of Medicine (2011 June 5;doi:10.1056/NEJMoa1104621).

A divergence in the survival curve was evident at 1 year, with 47% survival in the ipilimumab plus dacarbazine group, compared with 36% in the placebo plus dacarbazine group; at 2 years, the survival rates were 28% and 18%, respectively. The hazard ratio was 0.72, or 28% reduction in death.

At last year’s ASCO meeting, ipilimumab monotherapy was shown to prolong survival in previously treated metastatic melanoma patients. The drug was approved earlier this year as a first-line monotherapy treatment at a dosage of 3 mg/kg.

This is the first trial to show efficacy and safety of combining immunotherapy and chemotherapy in metastatic melanoma, said Dr. Wolchok of Memorial Sloan-Kettering Cancer Center, New York. The next step for ipilimumab combination therapy is to look to other combination therapies, such as the investigational agent vemurafenib (PLX4032), as well as other targeted agents and immune-modifying agents.

Dr. Wolchok cautioned that ipilimumab is approved only as a monotherapy and should only be used at the approved dose. Any use in combination therapy should be conducted as part of a clinical trial, several of which are ongoing or about to get underway.

In another plenary presentation at ASCO, Dr. Paul Chapman, also of Memorial Sloan-Kettering, reported a 63% reduction in risk of death with vemurafenib, compared with dacarbazine alone, in metastatic melanoma patients with BRAF mutations. Vemurafenib is an investigational oral drug that inhibits BRAF kinase.

In Dr. Wolchok’s study, progression-free survival was not significantly different between the two treatment groups. Ipilimumab, a monoclonal antibody that blocks CTLA-4 and augments T-cell activation, may improve survival by re-establishing an immuno-equilibrium that allows patients to survive despite the presence of tumors, he said. "The immune system is a ‘living drug,’ able to adapt itself to changes in the tumor ... overall survival is a more accurate way to gauge treatment effectiveness than progression-free survival."

In the trial, patients received either ipilimumab (10 mg/kg, three times per week for 4 weeks) plus dacarbazine (850 mg/m², three times per week for 8 weeks) or placebo plus dacarbazine at the same dose and schedule. More than half of the patients in the study had MC1 disease.

Tumors were assessed at weeks 1, 12, and 24 in the protocol. For the maintenance therapy section of the trial, placebo or ipilimumab at 10 mg/kg once every 12 weeks was given until the disease progressed or patients had toxic effects.

Treatment discontinuations due to disease progression and adverse events were higher in the ipilimumab plus dacarbazine group; 92 patients received all four doses, compared with 165 patients in the placebo plus dacarbazine group.

Most discontinuations were due to disease progression, which occurred in 46% of the ipilimumab plus dacarbazine group and in 77% of the placebo plus dacarbazine group.

Of those who received at least one dose of therapy, 89 of 247 patients in the ipilimumab plus dacarbazine group and 10 of 251 patients given dacarbazine plus placebo discontinued. In the ipilimumab plus dacarbazine group, 85 of 247 discontinued after the induction phase because of a drug-related adverse event as did 10 of 251 in the placebo plus dacarbazine group.

After the maintenance dose, 4 of 43 in the dacarbazine plus ipilimumab group and none of the 53 in the placebo plus dacarbazine group discontinued therapy after receiving the maintenance dose.

The only treatment-related death occurred in the placebo plus dacarbazine group. Immune-related adverse events were seen in 78% of the ipilimumab plus dacarbazine group and in 38% of the placebo plus dacarbazine group. Grade 3 and 4 adverse events occurred in 38% of the ipilimumab plus dacarbazine group and in 4.4% of the placebo plus dacarbazine group. Liver function abnormalities were the most common immune-mediated adverse event. Most of the patients received steroids and their liver function normalized.

The study was funded by Bristol-Myers Squibb, the maker of ipilimumab. Dr. Wolchok is a consultant/advisor to Bristol-Myers Squibb.

CHICAGO –More good news on ipilimumab for metastatic melanoma emerged from the results of a trial reported at the annual meeting of the American Society of Clinical Oncology.

In a double-blind, randomized, phase III study, nearly 21% of 250 metastatic melanoma patients who underwent first-line treatment with ipilimumab (Yervoy, Bristol-Myers Squibb) in combination with dacarbazine were alive after 3 years, compared with 12% of 252 patients given placebo and dacarbazine, Dr. Jedd Wolchok reported during a plenary session at the meeting.

Overall survival was 11.2 months in the ipilimumab plus dacarbazine group and 9.1 months in the placebo plus dacarbazine group. The study was simultaneously published in the New England Journal of Medicine (2011 June 5;doi:10.1056/NEJMoa1104621).

A divergence in the survival curve was evident at 1 year, with 47% survival in the ipilimumab plus dacarbazine group, compared with 36% in the placebo plus dacarbazine group; at 2 years, the survival rates were 28% and 18%, respectively. The hazard ratio was 0.72, or 28% reduction in death.

At last year’s ASCO meeting, ipilimumab monotherapy was shown to prolong survival in previously treated metastatic melanoma patients. The drug was approved earlier this year as a first-line monotherapy treatment at a dosage of 3 mg/kg.

This is the first trial to show efficacy and safety of combining immunotherapy and chemotherapy in metastatic melanoma, said Dr. Wolchok of Memorial Sloan-Kettering Cancer Center, New York. The next step for ipilimumab combination therapy is to look to other combination therapies, such as the investigational agent vemurafenib (PLX4032), as well as other targeted agents and immune-modifying agents.

Dr. Wolchok cautioned that ipilimumab is approved only as a monotherapy and should only be used at the approved dose. Any use in combination therapy should be conducted as part of a clinical trial, several of which are ongoing or about to get underway.

In another plenary presentation at ASCO, Dr. Paul Chapman, also of Memorial Sloan-Kettering, reported a 63% reduction in risk of death with vemurafenib, compared with dacarbazine alone, in metastatic melanoma patients with BRAF mutations. Vemurafenib is an investigational oral drug that inhibits BRAF kinase.

In Dr. Wolchok’s study, progression-free survival was not significantly different between the two treatment groups. Ipilimumab, a monoclonal antibody that blocks CTLA-4 and augments T-cell activation, may improve survival by re-establishing an immuno-equilibrium that allows patients to survive despite the presence of tumors, he said. "The immune system is a ‘living drug,’ able to adapt itself to changes in the tumor ... overall survival is a more accurate way to gauge treatment effectiveness than progression-free survival."

In the trial, patients received either ipilimumab (10 mg/kg, three times per week for 4 weeks) plus dacarbazine (850 mg/m², three times per week for 8 weeks) or placebo plus dacarbazine at the same dose and schedule. More than half of the patients in the study had MC1 disease.

Tumors were assessed at weeks 1, 12, and 24 in the protocol. For the maintenance therapy section of the trial, placebo or ipilimumab at 10 mg/kg once every 12 weeks was given until the disease progressed or patients had toxic effects.

Treatment discontinuations due to disease progression and adverse events were higher in the ipilimumab plus dacarbazine group; 92 patients received all four doses, compared with 165 patients in the placebo plus dacarbazine group.

Most discontinuations were due to disease progression, which occurred in 46% of the ipilimumab plus dacarbazine group and in 77% of the placebo plus dacarbazine group.

Of those who received at least one dose of therapy, 89 of 247 patients in the ipilimumab plus dacarbazine group and 10 of 251 patients given dacarbazine plus placebo discontinued. In the ipilimumab plus dacarbazine group, 85 of 247 discontinued after the induction phase because of a drug-related adverse event as did 10 of 251 in the placebo plus dacarbazine group.

After the maintenance dose, 4 of 43 in the dacarbazine plus ipilimumab group and none of the 53 in the placebo plus dacarbazine group discontinued therapy after receiving the maintenance dose.

The only treatment-related death occurred in the placebo plus dacarbazine group. Immune-related adverse events were seen in 78% of the ipilimumab plus dacarbazine group and in 38% of the placebo plus dacarbazine group. Grade 3 and 4 adverse events occurred in 38% of the ipilimumab plus dacarbazine group and in 4.4% of the placebo plus dacarbazine group. Liver function abnormalities were the most common immune-mediated adverse event. Most of the patients received steroids and their liver function normalized.

The study was funded by Bristol-Myers Squibb, the maker of ipilimumab. Dr. Wolchok is a consultant/advisor to Bristol-Myers Squibb.

CHICAGO – Primary care physicians and oncologists expressed their concerns about continuity and coordination of care for cancer survivors in a survey of more than 2,000 physicians presented at the annual meeting of the American Society of Clinical Oncology.

The degree of concern about different survivor care issues varied by specialty. For example, primary care physicians were more likely than were oncologists to be concerned about malpractice suits and about a lack of adequate training.

The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is the first nationwide study to focus on physician beliefs, knowledge, attitudes and practices regarding breast and colorectal cancer survivorship care.

"Increased coordination of care is needed to ensure continuity of care," said lead author Katherine S. Virgo, Ph.D., director of health services research at the American Cancer Society, which cosponsored the study with the National Cancer Institute. "Yet barriers to achieving care remain in our fragmented health care system."

A total of 1,072 primary care physicians (internists, family physicians, and ob.gyns.) and 1,130 medical oncologists were asked about their perceptions of the barriers to care for survivors of breast and colorectal cancer.

The survey asked about problems encountered when caring for breast or colon cancer survivors who had completed active treatment at least 5 years earlier. Five problem areas were identified in the survey: increased testing as malpractice protection; uncertainty regarding general preventive health care responsibility; duplicated care; missed care; and lack of adequate knowledge or training.

"Bivariate results show that the physicians’ specialty was significantly associated with all five barriers," Dr. Virgo said.

Almost 60% of oncologists said malpractice was never or rarely a barrier, versus almost 50% of primary care physicians. More primary care physicians said fear of malpractice was sometimes (40% versus 31%) or often/always (16% vs. 10%) a barrier, (P less than .001 in all cases).

As for missed care, 43% of primary care physicians said it was never/rarely an issue, versus 40% of oncologists. More oncologists said it was sometimes an issue (48% vs. 42%), but more primary care physicians said it was often or always (15% vs. 12%) an issue, (P less than .0047 in all cases).

"PCPs were also significantly more likely to be concerned about lacking adequate training to manage patient problems," said Dr. Virgo.

Indeed, almost 90% of oncologists said lack of training was never or rarely an issue, versus 54% of primary care physicians (P less than .0001 in all cases).

For primary care physicians and oncologists, duplicated care was never or rarely an issue (52% versus 44%, respectively), sometimes a problem (37% vs. 43%), and often/always a problem (11% vs. 13%), she said. (P = .0035 in all cases).

"Medical oncologists were also significantly more likely to report, often/always and sometimes, concerns about which physician is providing general preventive care services," said Dr. Virgo.

Physicians included in the survey had to practice in a nonfederal setting, be 76 years of age or younger, and dedicate at least 20% of their professional time to patient care. Additional criteria were specific to the specialty: medical oncologists must have cared for breast or colon cancer patients within the past year, and primary care physicians must have had office-based practices.

Dr. Virgo reported no relevant financial conflicts.

CHICAGO – Primary care physicians and oncologists expressed their concerns about continuity and coordination of care for cancer survivors in a survey of more than 2,000 physicians presented at the annual meeting of the American Society of Clinical Oncology.

The degree of concern about different survivor care issues varied by specialty. For example, primary care physicians were more likely than were oncologists to be concerned about malpractice suits and about a lack of adequate training.

The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is the first nationwide study to focus on physician beliefs, knowledge, attitudes and practices regarding breast and colorectal cancer survivorship care.

"Increased coordination of care is needed to ensure continuity of care," said lead author Katherine S. Virgo, Ph.D., director of health services research at the American Cancer Society, which cosponsored the study with the National Cancer Institute. "Yet barriers to achieving care remain in our fragmented health care system."

A total of 1,072 primary care physicians (internists, family physicians, and ob.gyns.) and 1,130 medical oncologists were asked about their perceptions of the barriers to care for survivors of breast and colorectal cancer.

The survey asked about problems encountered when caring for breast or colon cancer survivors who had completed active treatment at least 5 years earlier. Five problem areas were identified in the survey: increased testing as malpractice protection; uncertainty regarding general preventive health care responsibility; duplicated care; missed care; and lack of adequate knowledge or training.

"Bivariate results show that the physicians’ specialty was significantly associated with all five barriers," Dr. Virgo said.

Almost 60% of oncologists said malpractice was never or rarely a barrier, versus almost 50% of primary care physicians. More primary care physicians said fear of malpractice was sometimes (40% versus 31%) or often/always (16% vs. 10%) a barrier, (P less than .001 in all cases).

As for missed care, 43% of primary care physicians said it was never/rarely an issue, versus 40% of oncologists. More oncologists said it was sometimes an issue (48% vs. 42%), but more primary care physicians said it was often or always (15% vs. 12%) an issue, (P less than .0047 in all cases).

"PCPs were also significantly more likely to be concerned about lacking adequate training to manage patient problems," said Dr. Virgo.

Indeed, almost 90% of oncologists said lack of training was never or rarely an issue, versus 54% of primary care physicians (P less than .0001 in all cases).

For primary care physicians and oncologists, duplicated care was never or rarely an issue (52% versus 44%, respectively), sometimes a problem (37% vs. 43%), and often/always a problem (11% vs. 13%), she said. (P = .0035 in all cases).

"Medical oncologists were also significantly more likely to report, often/always and sometimes, concerns about which physician is providing general preventive care services," said Dr. Virgo.

Physicians included in the survey had to practice in a nonfederal setting, be 76 years of age or younger, and dedicate at least 20% of their professional time to patient care. Additional criteria were specific to the specialty: medical oncologists must have cared for breast or colon cancer patients within the past year, and primary care physicians must have had office-based practices.

Dr. Virgo reported no relevant financial conflicts.

CHICAGO – Primary care physicians and oncologists expressed their concerns about continuity and coordination of care for cancer survivors in a survey of more than 2,000 physicians presented at the annual meeting of the American Society of Clinical Oncology.

The degree of concern about different survivor care issues varied by specialty. For example, primary care physicians were more likely than were oncologists to be concerned about malpractice suits and about a lack of adequate training.

The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is the first nationwide study to focus on physician beliefs, knowledge, attitudes and practices regarding breast and colorectal cancer survivorship care.

"Increased coordination of care is needed to ensure continuity of care," said lead author Katherine S. Virgo, Ph.D., director of health services research at the American Cancer Society, which cosponsored the study with the National Cancer Institute. "Yet barriers to achieving care remain in our fragmented health care system."

A total of 1,072 primary care physicians (internists, family physicians, and ob.gyns.) and 1,130 medical oncologists were asked about their perceptions of the barriers to care for survivors of breast and colorectal cancer.

The survey asked about problems encountered when caring for breast or colon cancer survivors who had completed active treatment at least 5 years earlier. Five problem areas were identified in the survey: increased testing as malpractice protection; uncertainty regarding general preventive health care responsibility; duplicated care; missed care; and lack of adequate knowledge or training.

"Bivariate results show that the physicians’ specialty was significantly associated with all five barriers," Dr. Virgo said.

Almost 60% of oncologists said malpractice was never or rarely a barrier, versus almost 50% of primary care physicians. More primary care physicians said fear of malpractice was sometimes (40% versus 31%) or often/always (16% vs. 10%) a barrier, (P less than .001 in all cases).

As for missed care, 43% of primary care physicians said it was never/rarely an issue, versus 40% of oncologists. More oncologists said it was sometimes an issue (48% vs. 42%), but more primary care physicians said it was often or always (15% vs. 12%) an issue, (P less than .0047 in all cases).

"PCPs were also significantly more likely to be concerned about lacking adequate training to manage patient problems," said Dr. Virgo.

Indeed, almost 90% of oncologists said lack of training was never or rarely an issue, versus 54% of primary care physicians (P less than .0001 in all cases).

For primary care physicians and oncologists, duplicated care was never or rarely an issue (52% versus 44%, respectively), sometimes a problem (37% vs. 43%), and often/always a problem (11% vs. 13%), she said. (P = .0035 in all cases).

"Medical oncologists were also significantly more likely to report, often/always and sometimes, concerns about which physician is providing general preventive care services," said Dr. Virgo.

Physicians included in the survey had to practice in a nonfederal setting, be 76 years of age or younger, and dedicate at least 20% of their professional time to patient care. Additional criteria were specific to the specialty: medical oncologists must have cared for breast or colon cancer patients within the past year, and primary care physicians must have had office-based practices.

Dr. Virgo reported no relevant financial conflicts.

CHICAGO – Primary care physicians and oncologists expressed their concerns about continuity and coordination of care for cancer survivors in a survey of more than 2,000 physicians presented at the annual meeting of the American Society of Clinical Oncology.

The degree of concern about different survivor care issues varied by specialty. For example, primary care physicians were more likely than were oncologists to be concerned about malpractice suits and about a lack of adequate training.

The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is the first nationwide study to focus on physician beliefs, knowledge, attitudes and practices regarding breast and colorectal cancer survivorship care.

"Increased coordination of care is needed to ensure continuity of care," said lead author Katherine S. Virgo, Ph.D., director of health services research at the American Cancer Society, which cosponsored the study with the National Cancer Institute. "Yet barriers to achieving care remain in our fragmented health care system."

A total of 1,072 primary care physicians (internists, family physicians, and ob.gyns.) and 1,130 medical oncologists were asked about their perceptions of the barriers to care for survivors of breast and colorectal cancer.

The survey asked about problems encountered when caring for breast or colon cancer survivors who had completed active treatment at least 5 years earlier. Five problem areas were identified in the survey: increased testing as malpractice protection; uncertainty regarding general preventive health care responsibility; duplicated care; missed care; and lack of adequate knowledge or training.

"Bivariate results show that the physicians’ specialty was significantly associated with all five barriers," Dr. Virgo said.

Almost 60% of oncologists said malpractice was never or rarely a barrier, versus almost 50% of primary care physicians. More primary care physicians said fear of malpractice was sometimes (40% versus 31%) or often/always (16% vs. 10%) a barrier, (P less than .001 in all cases).

As for missed care, 43% of primary care physicians said it was never/rarely an issue, versus 40% of oncologists. More oncologists said it was sometimes an issue (48% vs. 42%), but more primary care physicians said it was often or always (15% vs. 12%) an issue, (P less than .0047 in all cases).

"PCPs were also significantly more likely to be concerned about lacking adequate training to manage patient problems," said Dr. Virgo.

Indeed, almost 90% of oncologists said lack of training was never or rarely an issue, versus 54% of primary care physicians (P less than .0001 in all cases).

For primary care physicians and oncologists, duplicated care was never or rarely an issue (52% versus 44%, respectively), sometimes a problem (37% vs. 43%), and often/always a problem (11% vs. 13%), she said. (P = .0035 in all cases).

"Medical oncologists were also significantly more likely to report, often/always and sometimes, concerns about which physician is providing general preventive care services," said Dr. Virgo.

Physicians included in the survey had to practice in a nonfederal setting, be 76 years of age or younger, and dedicate at least 20% of their professional time to patient care. Additional criteria were specific to the specialty: medical oncologists must have cared for breast or colon cancer patients within the past year, and primary care physicians must have had office-based practices.

Dr. Virgo reported no relevant financial conflicts.

CHICAGO – Primary care physicians and oncologists expressed their concerns about continuity and coordination of care for cancer survivors in a survey of more than 2,000 physicians presented at the annual meeting of the American Society of Clinical Oncology.

The degree of concern about different survivor care issues varied by specialty. For example, primary care physicians were more likely than were oncologists to be concerned about malpractice suits and about a lack of adequate training.

The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is the first nationwide study to focus on physician beliefs, knowledge, attitudes and practices regarding breast and colorectal cancer survivorship care.

"Increased coordination of care is needed to ensure continuity of care," said lead author Katherine S. Virgo, Ph.D., director of health services research at the American Cancer Society, which cosponsored the study with the National Cancer Institute. "Yet barriers to achieving care remain in our fragmented health care system."

A total of 1,072 primary care physicians (internists, family physicians, and ob.gyns.) and 1,130 medical oncologists were asked about their perceptions of the barriers to care for survivors of breast and colorectal cancer.

The survey asked about problems encountered when caring for breast or colon cancer survivors who had completed active treatment at least 5 years earlier. Five problem areas were identified in the survey: increased testing as malpractice protection; uncertainty regarding general preventive health care responsibility; duplicated care; missed care; and lack of adequate knowledge or training.

"Bivariate results show that the physicians’ specialty was significantly associated with all five barriers," Dr. Virgo said.

Almost 60% of oncologists said malpractice was never or rarely a barrier, versus almost 50% of primary care physicians. More primary care physicians said fear of malpractice was sometimes (40% versus 31%) or often/always (16% vs. 10%) a barrier, (P less than .001 in all cases).

As for missed care, 43% of primary care physicians said it was never/rarely an issue, versus 40% of oncologists. More oncologists said it was sometimes an issue (48% vs. 42%), but more primary care physicians said it was often or always (15% vs. 12%) an issue, (P less than .0047 in all cases).

"PCPs were also significantly more likely to be concerned about lacking adequate training to manage patient problems," said Dr. Virgo.

Indeed, almost 90% of oncologists said lack of training was never or rarely an issue, versus 54% of primary care physicians (P less than .0001 in all cases).

For primary care physicians and oncologists, duplicated care was never or rarely an issue (52% versus 44%, respectively), sometimes a problem (37% vs. 43%), and often/always a problem (11% vs. 13%), she said. (P = .0035 in all cases).

"Medical oncologists were also significantly more likely to report, often/always and sometimes, concerns about which physician is providing general preventive care services," said Dr. Virgo.

Physicians included in the survey had to practice in a nonfederal setting, be 76 years of age or younger, and dedicate at least 20% of their professional time to patient care. Additional criteria were specific to the specialty: medical oncologists must have cared for breast or colon cancer patients within the past year, and primary care physicians must have had office-based practices.

Dr. Virgo reported no relevant financial conflicts.

CHICAGO – Primary care physicians and oncologists expressed their concerns about continuity and coordination of care for cancer survivors in a survey of more than 2,000 physicians presented at the annual meeting of the American Society of Clinical Oncology.

The degree of concern about different survivor care issues varied by specialty. For example, primary care physicians were more likely than were oncologists to be concerned about malpractice suits and about a lack of adequate training.

The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is the first nationwide study to focus on physician beliefs, knowledge, attitudes and practices regarding breast and colorectal cancer survivorship care.

"Increased coordination of care is needed to ensure continuity of care," said lead author Katherine S. Virgo, Ph.D., director of health services research at the American Cancer Society, which cosponsored the study with the National Cancer Institute. "Yet barriers to achieving care remain in our fragmented health care system."

A total of 1,072 primary care physicians (internists, family physicians, and ob.gyns.) and 1,130 medical oncologists were asked about their perceptions of the barriers to care for survivors of breast and colorectal cancer.

The survey asked about problems encountered when caring for breast or colon cancer survivors who had completed active treatment at least 5 years earlier. Five problem areas were identified in the survey: increased testing as malpractice protection; uncertainty regarding general preventive health care responsibility; duplicated care; missed care; and lack of adequate knowledge or training.

"Bivariate results show that the physicians’ specialty was significantly associated with all five barriers," Dr. Virgo said.

Almost 60% of oncologists said malpractice was never or rarely a barrier, versus almost 50% of primary care physicians. More primary care physicians said fear of malpractice was sometimes (40% versus 31%) or often/always (16% vs. 10%) a barrier, (P less than .001 in all cases).

As for missed care, 43% of primary care physicians said it was never/rarely an issue, versus 40% of oncologists. More oncologists said it was sometimes an issue (48% vs. 42%), but more primary care physicians said it was often or always (15% vs. 12%) an issue, (P less than .0047 in all cases).

"PCPs were also significantly more likely to be concerned about lacking adequate training to manage patient problems," said Dr. Virgo.

Indeed, almost 90% of oncologists said lack of training was never or rarely an issue, versus 54% of primary care physicians (P less than .0001 in all cases).

For primary care physicians and oncologists, duplicated care was never or rarely an issue (52% versus 44%, respectively), sometimes a problem (37% vs. 43%), and often/always a problem (11% vs. 13%), she said. (P = .0035 in all cases).

"Medical oncologists were also significantly more likely to report, often/always and sometimes, concerns about which physician is providing general preventive care services," said Dr. Virgo.

Physicians included in the survey had to practice in a nonfederal setting, be 76 years of age or younger, and dedicate at least 20% of their professional time to patient care. Additional criteria were specific to the specialty: medical oncologists must have cared for breast or colon cancer patients within the past year, and primary care physicians must have had office-based practices.

Dr. Virgo reported no relevant financial conflicts.

CHICAGO – Primary care physicians and oncologists expressed their concerns about continuity and coordination of care for cancer survivors in a survey of more than 2,000 physicians presented at the annual meeting of the American Society of Clinical Oncology.

The degree of concern about different survivor care issues varied by specialty. For example, primary care physicians were more likely than were oncologists to be concerned about malpractice suits and about a lack of adequate training.

The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is the first nationwide study to focus on physician beliefs, knowledge, attitudes and practices regarding breast and colorectal cancer survivorship care.

"Increased coordination of care is needed to ensure continuity of care," said lead author Katherine S. Virgo, Ph.D., director of health services research at the American Cancer Society, which cosponsored the study with the National Cancer Institute. "Yet barriers to achieving care remain in our fragmented health care system."

A total of 1,072 primary care physicians (internists, family physicians, and ob.gyns.) and 1,130 medical oncologists were asked about their perceptions of the barriers to care for survivors of breast and colorectal cancer.

The survey asked about problems encountered when caring for breast or colon cancer survivors who had completed active treatment at least 5 years earlier. Five problem areas were identified in the survey: increased testing as malpractice protection; uncertainty regarding general preventive health care responsibility; duplicated care; missed care; and lack of adequate knowledge or training.

"Bivariate results show that the physicians’ specialty was significantly associated with all five barriers," Dr. Virgo said.

Almost 60% of oncologists said malpractice was never or rarely a barrier, versus almost 50% of primary care physicians. More primary care physicians said fear of malpractice was sometimes (40% versus 31%) or often/always (16% vs. 10%) a barrier, (P less than .001 in all cases).

As for missed care, 43% of primary care physicians said it was never/rarely an issue, versus 40% of oncologists. More oncologists said it was sometimes an issue (48% vs. 42%), but more primary care physicians said it was often or always (15% vs. 12%) an issue, (P less than .0047 in all cases).

"PCPs were also significantly more likely to be concerned about lacking adequate training to manage patient problems," said Dr. Virgo.

Indeed, almost 90% of oncologists said lack of training was never or rarely an issue, versus 54% of primary care physicians (P less than .0001 in all cases).

For primary care physicians and oncologists, duplicated care was never or rarely an issue (52% versus 44%, respectively), sometimes a problem (37% vs. 43%), and often/always a problem (11% vs. 13%), she said. (P = .0035 in all cases).

"Medical oncologists were also significantly more likely to report, often/always and sometimes, concerns about which physician is providing general preventive care services," said Dr. Virgo.

Physicians included in the survey had to practice in a nonfederal setting, be 76 years of age or younger, and dedicate at least 20% of their professional time to patient care. Additional criteria were specific to the specialty: medical oncologists must have cared for breast or colon cancer patients within the past year, and primary care physicians must have had office-based practices.

Dr. Virgo reported no relevant financial conflicts.

CHICAGO – Primary care physicians and oncologists expressed their concerns about continuity and coordination of care for cancer survivors in a survey of more than 2,000 physicians presented at the annual meeting of the American Society of Clinical Oncology.

The degree of concern about different survivor care issues varied by specialty. For example, primary care physicians were more likely than were oncologists to be concerned about malpractice suits and about a lack of adequate training.

The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is the first nationwide study to focus on physician beliefs, knowledge, attitudes and practices regarding breast and colorectal cancer survivorship care.

"Increased coordination of care is needed to ensure continuity of care," said lead author Katherine S. Virgo, Ph.D., director of health services research at the American Cancer Society, which cosponsored the study with the National Cancer Institute. "Yet barriers to achieving care remain in our fragmented health care system."

A total of 1,072 primary care physicians (internists, family physicians, and ob.gyns.) and 1,130 medical oncologists were asked about their perceptions of the barriers to care for survivors of breast and colorectal cancer.

The survey asked about problems encountered when caring for breast or colon cancer survivors who had completed active treatment at least 5 years earlier. Five problem areas were identified in the survey: increased testing as malpractice protection; uncertainty regarding general preventive health care responsibility; duplicated care; missed care; and lack of adequate knowledge or training.

"Bivariate results show that the physicians’ specialty was significantly associated with all five barriers," Dr. Virgo said.

Almost 60% of oncologists said malpractice was never or rarely a barrier, versus almost 50% of primary care physicians. More primary care physicians said fear of malpractice was sometimes (40% versus 31%) or often/always (16% vs. 10%) a barrier, (P less than .001 in all cases).

As for missed care, 43% of primary care physicians said it was never/rarely an issue, versus 40% of oncologists. More oncologists said it was sometimes an issue (48% vs. 42%), but more primary care physicians said it was often or always (15% vs. 12%) an issue, (P less than .0047 in all cases).

"PCPs were also significantly more likely to be concerned about lacking adequate training to manage patient problems," said Dr. Virgo.

Indeed, almost 90% of oncologists said lack of training was never or rarely an issue, versus 54% of primary care physicians (P less than .0001 in all cases).

For primary care physicians and oncologists, duplicated care was never or rarely an issue (52% versus 44%, respectively), sometimes a problem (37% vs. 43%), and often/always a problem (11% vs. 13%), she said. (P = .0035 in all cases).

"Medical oncologists were also significantly more likely to report, often/always and sometimes, concerns about which physician is providing general preventive care services," said Dr. Virgo.

Physicians included in the survey had to practice in a nonfederal setting, be 76 years of age or younger, and dedicate at least 20% of their professional time to patient care. Additional criteria were specific to the specialty: medical oncologists must have cared for breast or colon cancer patients within the past year, and primary care physicians must have had office-based practices.

Dr. Virgo reported no relevant financial conflicts.

CHICAGO – Primary care physicians and oncologists expressed their concerns about continuity and coordination of care for cancer survivors in a survey of more than 2,000 physicians presented at the annual meeting of the American Society of Clinical Oncology.

The degree of concern about different survivor care issues varied by specialty. For example, primary care physicians were more likely than were oncologists to be concerned about malpractice suits and about a lack of adequate training.

The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is the first nationwide study to focus on physician beliefs, knowledge, attitudes and practices regarding breast and colorectal cancer survivorship care.

"Increased coordination of care is needed to ensure continuity of care," said lead author Katherine S. Virgo, Ph.D., director of health services research at the American Cancer Society, which cosponsored the study with the National Cancer Institute. "Yet barriers to achieving care remain in our fragmented health care system."

A total of 1,072 primary care physicians (internists, family physicians, and ob.gyns.) and 1,130 medical oncologists were asked about their perceptions of the barriers to care for survivors of breast and colorectal cancer.

The survey asked about problems encountered when caring for breast or colon cancer survivors who had completed active treatment at least 5 years earlier. Five problem areas were identified in the survey: increased testing as malpractice protection; uncertainty regarding general preventive health care responsibility; duplicated care; missed care; and lack of adequate knowledge or training.

"Bivariate results show that the physicians’ specialty was significantly associated with all five barriers," Dr. Virgo said.

Almost 60% of oncologists said malpractice was never or rarely a barrier, versus almost 50% of primary care physicians. More primary care physicians said fear of malpractice was sometimes (40% versus 31%) or often/always (16% vs. 10%) a barrier, (P less than .001 in all cases).

As for missed care, 43% of primary care physicians said it was never/rarely an issue, versus 40% of oncologists. More oncologists said it was sometimes an issue (48% vs. 42%), but more primary care physicians said it was often or always (15% vs. 12%) an issue, (P less than .0047 in all cases).

"PCPs were also significantly more likely to be concerned about lacking adequate training to manage patient problems," said Dr. Virgo.

Indeed, almost 90% of oncologists said lack of training was never or rarely an issue, versus 54% of primary care physicians (P less than .0001 in all cases).

For primary care physicians and oncologists, duplicated care was never or rarely an issue (52% versus 44%, respectively), sometimes a problem (37% vs. 43%), and often/always a problem (11% vs. 13%), she said. (P = .0035 in all cases).

"Medical oncologists were also significantly more likely to report, often/always and sometimes, concerns about which physician is providing general preventive care services," said Dr. Virgo.

Physicians included in the survey had to practice in a nonfederal setting, be 76 years of age or younger, and dedicate at least 20% of their professional time to patient care. Additional criteria were specific to the specialty: medical oncologists must have cared for breast or colon cancer patients within the past year, and primary care physicians must have had office-based practices.

Dr. Virgo reported no relevant financial conflicts.

CHICAGO – Adding bevacizumab to chemotherapy may prolong survival in women with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer who are at high risk for poor outcomes, suggests an interim analysis from the randomized phase III ICON7 trial.

Trials results, reported at a median follow-up of 28 months, showed that when this antiangiogenic agent was added during and after chemotherapy, the risk of death was reduced by a significant 36% among high-risk patients. There was a nonsignificant 15% risk reduction among the study population as a whole.

"Bevacizumab is the first new active agent for the front-line treatment of ovarian cancer in more than 15 years," lead investigator Dr. Gunnar Kristensen said in a press briefing.

"Based on this interim analysis ... we see there is an overall trend for improvement of overall survival with bevacizumab," he said. "The treatment effect is greater in high-risk patients, which may be of clinical relevance."

Indeed, Dr. Kristensen acknowledged, cost considerations and lack of substantial survival benefit in patients who are not at high risk may ultimately guide use of bevacizumab in this context.

"Here we present our data, and then of course it is up to the doctors how they will use the drug," he said. "Personally, I ... [agree] on restricting it to the high-risk group."

The trial differs from the OCEANS trial, also reported at the meeting, in the dose and duration of bevacizumab used, and the patient population, noted moderator Dr. Andrew Seidman, an attending physician for the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Cornell Medical College, both in New York.

"However, the consistent results of these studies, in addition to a previously reported trial, the GOG-0218 trial, and the already documented efficacy of bevacizumab as a single agent in ovarian cancer, I think do all lend support to a potentially important role for bevacizumab as the first biologic agent to be used in this disease," he said.

The investigators conducted the trial among 1,528 women with newly diagnosed, high-risk early or advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer. All underwent debulking surgery.

The patients were assigned in nearly equal numbers to receive six cycles of standard chemotherapy (carboplatin and paclitaxel) at 3-week intervals alone, or the same chemotherapy given concurrently with bevacizumab (Avastin, 7.5 mg/kg) followed by single-agent bevacizumab every 3 weeks for 12 additional cycles or until progression.

"This treatment was tolerated well, without a substantial increase in side effects," Dr. Kristensen reported. "The side effects were mild and manageable."

The mature progression-free survival results, previously reported at the 2010 European Society for Medical Oncology meeting, showed that the median duration of progression-free survival was 19.0 months with bevacizumab and 17.3 months without it (hazard ratio, 0.81; P = .004).

U.S. and European regulatory authorities requested an interim analysis of overall survival, in support of applications to license the drug for this indication, according to Dr. Kristensen, a senior consultant in the department for gynecologic oncology at Norwegian Radium Hospital in Oslo.

The interim analysis of overall survival, which was based on 53% of the number of events needed for the final analysis, showed that the risk of death in the entire trial population was lower with bevacizumab than without it, but not significantly so (hazard ratio, 0.85; P = .11).

However, in a preplanned subgroup analysis among the 30% of patients falling into a high-risk category – those with stage III disease whose debulking surgery was suboptimal (leaving more than 1 cm of residual tumor) and those with stage IV disease – there was a significant 36% reduction in the risk of death (hazard ratio, 0.64; P = .002). In this subgroup, the median duration of survival was 7.8 months longer with bevacizumab (36.6 vs. 28.8 months).

Final overall survival results are expected in 2013, according to Dr. Kristensen. "We have to remember that the data [are] premature. It’s an interim analysis. There are very few events in this group of patients" not at high risk, he cautioned when presenting the results in a session. "So we have to await the final analysis in 2 years before we can make conclusions about this group."

The reason for the apparent greater benefit in the high-risk group is as yet unclear, he said, while agreeing with an attendee that tumors that are more difficult to optimally debulk may be more aggressive and more susceptible to antiangiogenic therapy.

"We have just used clinical parameters here, whether they were optimally debulked or not, and we see that we have the main effect in the suboptimally debulked population. Then come all the questions about the biology," he commented. "We have an ancillary research program along with the study, but it will, of course, take time."

In the updated analysis of progression-free survival, the median duration of progression-free survival in the entire trial population continued to be better with bevacizumab, at 19.8 months, than without it, at 17.4 months (hazard ratio, 0.87; P = .039).

Dr. Kristensen reported that he is a consultant to Roche. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding bevacizumab to chemotherapy may prolong survival in women with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer who are at high risk for poor outcomes, suggests an interim analysis from the randomized phase III ICON7 trial.

Trials results, reported at a median follow-up of 28 months, showed that when this antiangiogenic agent was added during and after chemotherapy, the risk of death was reduced by a significant 36% among high-risk patients. There was a nonsignificant 15% risk reduction among the study population as a whole.

"Bevacizumab is the first new active agent for the front-line treatment of ovarian cancer in more than 15 years," lead investigator Dr. Gunnar Kristensen said in a press briefing.

"Based on this interim analysis ... we see there is an overall trend for improvement of overall survival with bevacizumab," he said. "The treatment effect is greater in high-risk patients, which may be of clinical relevance."

Indeed, Dr. Kristensen acknowledged, cost considerations and lack of substantial survival benefit in patients who are not at high risk may ultimately guide use of bevacizumab in this context.

"Here we present our data, and then of course it is up to the doctors how they will use the drug," he said. "Personally, I ... [agree] on restricting it to the high-risk group."

The trial differs from the OCEANS trial, also reported at the meeting, in the dose and duration of bevacizumab used, and the patient population, noted moderator Dr. Andrew Seidman, an attending physician for the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Cornell Medical College, both in New York.

"However, the consistent results of these studies, in addition to a previously reported trial, the GOG-0218 trial, and the already documented efficacy of bevacizumab as a single agent in ovarian cancer, I think do all lend support to a potentially important role for bevacizumab as the first biologic agent to be used in this disease," he said.

The investigators conducted the trial among 1,528 women with newly diagnosed, high-risk early or advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer. All underwent debulking surgery.

The patients were assigned in nearly equal numbers to receive six cycles of standard chemotherapy (carboplatin and paclitaxel) at 3-week intervals alone, or the same chemotherapy given concurrently with bevacizumab (Avastin, 7.5 mg/kg) followed by single-agent bevacizumab every 3 weeks for 12 additional cycles or until progression.

"This treatment was tolerated well, without a substantial increase in side effects," Dr. Kristensen reported. "The side effects were mild and manageable."

The mature progression-free survival results, previously reported at the 2010 European Society for Medical Oncology meeting, showed that the median duration of progression-free survival was 19.0 months with bevacizumab and 17.3 months without it (hazard ratio, 0.81; P = .004).

U.S. and European regulatory authorities requested an interim analysis of overall survival, in support of applications to license the drug for this indication, according to Dr. Kristensen, a senior consultant in the department for gynecologic oncology at Norwegian Radium Hospital in Oslo.

The interim analysis of overall survival, which was based on 53% of the number of events needed for the final analysis, showed that the risk of death in the entire trial population was lower with bevacizumab than without it, but not significantly so (hazard ratio, 0.85; P = .11).

However, in a preplanned subgroup analysis among the 30% of patients falling into a high-risk category – those with stage III disease whose debulking surgery was suboptimal (leaving more than 1 cm of residual tumor) and those with stage IV disease – there was a significant 36% reduction in the risk of death (hazard ratio, 0.64; P = .002). In this subgroup, the median duration of survival was 7.8 months longer with bevacizumab (36.6 vs. 28.8 months).

Final overall survival results are expected in 2013, according to Dr. Kristensen. "We have to remember that the data [are] premature. It’s an interim analysis. There are very few events in this group of patients" not at high risk, he cautioned when presenting the results in a session. "So we have to await the final analysis in 2 years before we can make conclusions about this group."

The reason for the apparent greater benefit in the high-risk group is as yet unclear, he said, while agreeing with an attendee that tumors that are more difficult to optimally debulk may be more aggressive and more susceptible to antiangiogenic therapy.

"We have just used clinical parameters here, whether they were optimally debulked or not, and we see that we have the main effect in the suboptimally debulked population. Then come all the questions about the biology," he commented. "We have an ancillary research program along with the study, but it will, of course, take time."

In the updated analysis of progression-free survival, the median duration of progression-free survival in the entire trial population continued to be better with bevacizumab, at 19.8 months, than without it, at 17.4 months (hazard ratio, 0.87; P = .039).

Dr. Kristensen reported that he is a consultant to Roche. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding bevacizumab to chemotherapy may prolong survival in women with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer who are at high risk for poor outcomes, suggests an interim analysis from the randomized phase III ICON7 trial.

Trials results, reported at a median follow-up of 28 months, showed that when this antiangiogenic agent was added during and after chemotherapy, the risk of death was reduced by a significant 36% among high-risk patients. There was a nonsignificant 15% risk reduction among the study population as a whole.

"Bevacizumab is the first new active agent for the front-line treatment of ovarian cancer in more than 15 years," lead investigator Dr. Gunnar Kristensen said in a press briefing.

"Based on this interim analysis ... we see there is an overall trend for improvement of overall survival with bevacizumab," he said. "The treatment effect is greater in high-risk patients, which may be of clinical relevance."

Indeed, Dr. Kristensen acknowledged, cost considerations and lack of substantial survival benefit in patients who are not at high risk may ultimately guide use of bevacizumab in this context.

"Here we present our data, and then of course it is up to the doctors how they will use the drug," he said. "Personally, I ... [agree] on restricting it to the high-risk group."

The trial differs from the OCEANS trial, also reported at the meeting, in the dose and duration of bevacizumab used, and the patient population, noted moderator Dr. Andrew Seidman, an attending physician for the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Cornell Medical College, both in New York.

"However, the consistent results of these studies, in addition to a previously reported trial, the GOG-0218 trial, and the already documented efficacy of bevacizumab as a single agent in ovarian cancer, I think do all lend support to a potentially important role for bevacizumab as the first biologic agent to be used in this disease," he said.

The investigators conducted the trial among 1,528 women with newly diagnosed, high-risk early or advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer. All underwent debulking surgery.

The patients were assigned in nearly equal numbers to receive six cycles of standard chemotherapy (carboplatin and paclitaxel) at 3-week intervals alone, or the same chemotherapy given concurrently with bevacizumab (Avastin, 7.5 mg/kg) followed by single-agent bevacizumab every 3 weeks for 12 additional cycles or until progression.

"This treatment was tolerated well, without a substantial increase in side effects," Dr. Kristensen reported. "The side effects were mild and manageable."

The mature progression-free survival results, previously reported at the 2010 European Society for Medical Oncology meeting, showed that the median duration of progression-free survival was 19.0 months with bevacizumab and 17.3 months without it (hazard ratio, 0.81; P = .004).

U.S. and European regulatory authorities requested an interim analysis of overall survival, in support of applications to license the drug for this indication, according to Dr. Kristensen, a senior consultant in the department for gynecologic oncology at Norwegian Radium Hospital in Oslo.

The interim analysis of overall survival, which was based on 53% of the number of events needed for the final analysis, showed that the risk of death in the entire trial population was lower with bevacizumab than without it, but not significantly so (hazard ratio, 0.85; P = .11).

However, in a preplanned subgroup analysis among the 30% of patients falling into a high-risk category – those with stage III disease whose debulking surgery was suboptimal (leaving more than 1 cm of residual tumor) and those with stage IV disease – there was a significant 36% reduction in the risk of death (hazard ratio, 0.64; P = .002). In this subgroup, the median duration of survival was 7.8 months longer with bevacizumab (36.6 vs. 28.8 months).

Final overall survival results are expected in 2013, according to Dr. Kristensen. "We have to remember that the data [are] premature. It’s an interim analysis. There are very few events in this group of patients" not at high risk, he cautioned when presenting the results in a session. "So we have to await the final analysis in 2 years before we can make conclusions about this group."

The reason for the apparent greater benefit in the high-risk group is as yet unclear, he said, while agreeing with an attendee that tumors that are more difficult to optimally debulk may be more aggressive and more susceptible to antiangiogenic therapy.

"We have just used clinical parameters here, whether they were optimally debulked or not, and we see that we have the main effect in the suboptimally debulked population. Then come all the questions about the biology," he commented. "We have an ancillary research program along with the study, but it will, of course, take time."

In the updated analysis of progression-free survival, the median duration of progression-free survival in the entire trial population continued to be better with bevacizumab, at 19.8 months, than without it, at 17.4 months (hazard ratio, 0.87; P = .039).

Dr. Kristensen reported that he is a consultant to Roche. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding bevacizumab to chemotherapy may prolong survival in women with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer who are at high risk for poor outcomes, suggests an interim analysis from the randomized phase III ICON7 trial.

Trials results, reported at a median follow-up of 28 months, showed that when this antiangiogenic agent was added during and after chemotherapy, the risk of death was reduced by a significant 36% among high-risk patients. There was a nonsignificant 15% risk reduction among the study population as a whole.

"Bevacizumab is the first new active agent for the front-line treatment of ovarian cancer in more than 15 years," lead investigator Dr. Gunnar Kristensen said in a press briefing.

"Based on this interim analysis ... we see there is an overall trend for improvement of overall survival with bevacizumab," he said. "The treatment effect is greater in high-risk patients, which may be of clinical relevance."

Indeed, Dr. Kristensen acknowledged, cost considerations and lack of substantial survival benefit in patients who are not at high risk may ultimately guide use of bevacizumab in this context.

"Here we present our data, and then of course it is up to the doctors how they will use the drug," he said. "Personally, I ... [agree] on restricting it to the high-risk group."

The trial differs from the OCEANS trial, also reported at the meeting, in the dose and duration of bevacizumab used, and the patient population, noted moderator Dr. Andrew Seidman, an attending physician for the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Cornell Medical College, both in New York.

"However, the consistent results of these studies, in addition to a previously reported trial, the GOG-0218 trial, and the already documented efficacy of bevacizumab as a single agent in ovarian cancer, I think do all lend support to a potentially important role for bevacizumab as the first biologic agent to be used in this disease," he said.

The investigators conducted the trial among 1,528 women with newly diagnosed, high-risk early or advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer. All underwent debulking surgery.

The patients were assigned in nearly equal numbers to receive six cycles of standard chemotherapy (carboplatin and paclitaxel) at 3-week intervals alone, or the same chemotherapy given concurrently with bevacizumab (Avastin, 7.5 mg/kg) followed by single-agent bevacizumab every 3 weeks for 12 additional cycles or until progression.

"This treatment was tolerated well, without a substantial increase in side effects," Dr. Kristensen reported. "The side effects were mild and manageable."

The mature progression-free survival results, previously reported at the 2010 European Society for Medical Oncology meeting, showed that the median duration of progression-free survival was 19.0 months with bevacizumab and 17.3 months without it (hazard ratio, 0.81; P = .004).

U.S. and European regulatory authorities requested an interim analysis of overall survival, in support of applications to license the drug for this indication, according to Dr. Kristensen, a senior consultant in the department for gynecologic oncology at Norwegian Radium Hospital in Oslo.

The interim analysis of overall survival, which was based on 53% of the number of events needed for the final analysis, showed that the risk of death in the entire trial population was lower with bevacizumab than without it, but not significantly so (hazard ratio, 0.85; P = .11).

However, in a preplanned subgroup analysis among the 30% of patients falling into a high-risk category – those with stage III disease whose debulking surgery was suboptimal (leaving more than 1 cm of residual tumor) and those with stage IV disease – there was a significant 36% reduction in the risk of death (hazard ratio, 0.64; P = .002). In this subgroup, the median duration of survival was 7.8 months longer with bevacizumab (36.6 vs. 28.8 months).

Final overall survival results are expected in 2013, according to Dr. Kristensen. "We have to remember that the data [are] premature. It’s an interim analysis. There are very few events in this group of patients" not at high risk, he cautioned when presenting the results in a session. "So we have to await the final analysis in 2 years before we can make conclusions about this group."

The reason for the apparent greater benefit in the high-risk group is as yet unclear, he said, while agreeing with an attendee that tumors that are more difficult to optimally debulk may be more aggressive and more susceptible to antiangiogenic therapy.

"We have just used clinical parameters here, whether they were optimally debulked or not, and we see that we have the main effect in the suboptimally debulked population. Then come all the questions about the biology," he commented. "We have an ancillary research program along with the study, but it will, of course, take time."

In the updated analysis of progression-free survival, the median duration of progression-free survival in the entire trial population continued to be better with bevacizumab, at 19.8 months, than without it, at 17.4 months (hazard ratio, 0.87; P = .039).

Dr. Kristensen reported that he is a consultant to Roche. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding bevacizumab to chemotherapy may prolong survival in women with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer who are at high risk for poor outcomes, suggests an interim analysis from the randomized phase III ICON7 trial.

Trials results, reported at a median follow-up of 28 months, showed that when this antiangiogenic agent was added during and after chemotherapy, the risk of death was reduced by a significant 36% among high-risk patients. There was a nonsignificant 15% risk reduction among the study population as a whole.

"Bevacizumab is the first new active agent for the front-line treatment of ovarian cancer in more than 15 years," lead investigator Dr. Gunnar Kristensen said in a press briefing.

"Based on this interim analysis ... we see there is an overall trend for improvement of overall survival with bevacizumab," he said. "The treatment effect is greater in high-risk patients, which may be of clinical relevance."

Indeed, Dr. Kristensen acknowledged, cost considerations and lack of substantial survival benefit in patients who are not at high risk may ultimately guide use of bevacizumab in this context.

"Here we present our data, and then of course it is up to the doctors how they will use the drug," he said. "Personally, I ... [agree] on restricting it to the high-risk group."

The trial differs from the OCEANS trial, also reported at the meeting, in the dose and duration of bevacizumab used, and the patient population, noted moderator Dr. Andrew Seidman, an attending physician for the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Cornell Medical College, both in New York.

"However, the consistent results of these studies, in addition to a previously reported trial, the GOG-0218 trial, and the already documented efficacy of bevacizumab as a single agent in ovarian cancer, I think do all lend support to a potentially important role for bevacizumab as the first biologic agent to be used in this disease," he said.

The investigators conducted the trial among 1,528 women with newly diagnosed, high-risk early or advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer. All underwent debulking surgery.

The patients were assigned in nearly equal numbers to receive six cycles of standard chemotherapy (carboplatin and paclitaxel) at 3-week intervals alone, or the same chemotherapy given concurrently with bevacizumab (Avastin, 7.5 mg/kg) followed by single-agent bevacizumab every 3 weeks for 12 additional cycles or until progression.

"This treatment was tolerated well, without a substantial increase in side effects," Dr. Kristensen reported. "The side effects were mild and manageable."

The mature progression-free survival results, previously reported at the 2010 European Society for Medical Oncology meeting, showed that the median duration of progression-free survival was 19.0 months with bevacizumab and 17.3 months without it (hazard ratio, 0.81; P = .004).

U.S. and European regulatory authorities requested an interim analysis of overall survival, in support of applications to license the drug for this indication, according to Dr. Kristensen, a senior consultant in the department for gynecologic oncology at Norwegian Radium Hospital in Oslo.

The interim analysis of overall survival, which was based on 53% of the number of events needed for the final analysis, showed that the risk of death in the entire trial population was lower with bevacizumab than without it, but not significantly so (hazard ratio, 0.85; P = .11).

However, in a preplanned subgroup analysis among the 30% of patients falling into a high-risk category – those with stage III disease whose debulking surgery was suboptimal (leaving more than 1 cm of residual tumor) and those with stage IV disease – there was a significant 36% reduction in the risk of death (hazard ratio, 0.64; P = .002). In this subgroup, the median duration of survival was 7.8 months longer with bevacizumab (36.6 vs. 28.8 months).

Final overall survival results are expected in 2013, according to Dr. Kristensen. "We have to remember that the data [are] premature. It’s an interim analysis. There are very few events in this group of patients" not at high risk, he cautioned when presenting the results in a session. "So we have to await the final analysis in 2 years before we can make conclusions about this group."

The reason for the apparent greater benefit in the high-risk group is as yet unclear, he said, while agreeing with an attendee that tumors that are more difficult to optimally debulk may be more aggressive and more susceptible to antiangiogenic therapy.

"We have just used clinical parameters here, whether they were optimally debulked or not, and we see that we have the main effect in the suboptimally debulked population. Then come all the questions about the biology," he commented. "We have an ancillary research program along with the study, but it will, of course, take time."

In the updated analysis of progression-free survival, the median duration of progression-free survival in the entire trial population continued to be better with bevacizumab, at 19.8 months, than without it, at 17.4 months (hazard ratio, 0.87; P = .039).

Dr. Kristensen reported that he is a consultant to Roche. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding bevacizumab to chemotherapy may prolong survival in women with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer who are at high risk for poor outcomes, suggests an interim analysis from the randomized phase III ICON7 trial.

Trials results, reported at a median follow-up of 28 months, showed that when this antiangiogenic agent was added during and after chemotherapy, the risk of death was reduced by a significant 36% among high-risk patients. There was a nonsignificant 15% risk reduction among the study population as a whole.

"Bevacizumab is the first new active agent for the front-line treatment of ovarian cancer in more than 15 years," lead investigator Dr. Gunnar Kristensen said in a press briefing.

"Based on this interim analysis ... we see there is an overall trend for improvement of overall survival with bevacizumab," he said. "The treatment effect is greater in high-risk patients, which may be of clinical relevance."

Indeed, Dr. Kristensen acknowledged, cost considerations and lack of substantial survival benefit in patients who are not at high risk may ultimately guide use of bevacizumab in this context.

"Here we present our data, and then of course it is up to the doctors how they will use the drug," he said. "Personally, I ... [agree] on restricting it to the high-risk group."

The trial differs from the OCEANS trial, also reported at the meeting, in the dose and duration of bevacizumab used, and the patient population, noted moderator Dr. Andrew Seidman, an attending physician for the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Cornell Medical College, both in New York.

"However, the consistent results of these studies, in addition to a previously reported trial, the GOG-0218 trial, and the already documented efficacy of bevacizumab as a single agent in ovarian cancer, I think do all lend support to a potentially important role for bevacizumab as the first biologic agent to be used in this disease," he said.

The investigators conducted the trial among 1,528 women with newly diagnosed, high-risk early or advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer. All underwent debulking surgery.

The patients were assigned in nearly equal numbers to receive six cycles of standard chemotherapy (carboplatin and paclitaxel) at 3-week intervals alone, or the same chemotherapy given concurrently with bevacizumab (Avastin, 7.5 mg/kg) followed by single-agent bevacizumab every 3 weeks for 12 additional cycles or until progression.

"This treatment was tolerated well, without a substantial increase in side effects," Dr. Kristensen reported. "The side effects were mild and manageable."

The mature progression-free survival results, previously reported at the 2010 European Society for Medical Oncology meeting, showed that the median duration of progression-free survival was 19.0 months with bevacizumab and 17.3 months without it (hazard ratio, 0.81; P = .004).

U.S. and European regulatory authorities requested an interim analysis of overall survival, in support of applications to license the drug for this indication, according to Dr. Kristensen, a senior consultant in the department for gynecologic oncology at Norwegian Radium Hospital in Oslo.

The interim analysis of overall survival, which was based on 53% of the number of events needed for the final analysis, showed that the risk of death in the entire trial population was lower with bevacizumab than without it, but not significantly so (hazard ratio, 0.85; P = .11).

However, in a preplanned subgroup analysis among the 30% of patients falling into a high-risk category – those with stage III disease whose debulking surgery was suboptimal (leaving more than 1 cm of residual tumor) and those with stage IV disease – there was a significant 36% reduction in the risk of death (hazard ratio, 0.64; P = .002). In this subgroup, the median duration of survival was 7.8 months longer with bevacizumab (36.6 vs. 28.8 months).

Final overall survival results are expected in 2013, according to Dr. Kristensen. "We have to remember that the data [are] premature. It’s an interim analysis. There are very few events in this group of patients" not at high risk, he cautioned when presenting the results in a session. "So we have to await the final analysis in 2 years before we can make conclusions about this group."

The reason for the apparent greater benefit in the high-risk group is as yet unclear, he said, while agreeing with an attendee that tumors that are more difficult to optimally debulk may be more aggressive and more susceptible to antiangiogenic therapy.

"We have just used clinical parameters here, whether they were optimally debulked or not, and we see that we have the main effect in the suboptimally debulked population. Then come all the questions about the biology," he commented. "We have an ancillary research program along with the study, but it will, of course, take time."

In the updated analysis of progression-free survival, the median duration of progression-free survival in the entire trial population continued to be better with bevacizumab, at 19.8 months, than without it, at 17.4 months (hazard ratio, 0.87; P = .039).

Dr. Kristensen reported that he is a consultant to Roche. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding the antiangiogenic agent bevacizumab to platinum-based chemotherapy halves the risk of progression in women with recurrent ovarian, peritoneal, or fallopian tube cancer, new data show.

In OCEANS, a randomized phase III trial, patients given bevacizumab (Avastin) during and after chemotherapy were 52% less likely to have progression of their disease than were patients given placebo.

The absolute difference in median progression-free survival was 4 months, according to results reported at the annual meeting of the American Society of Clinical Oncology. Interim overall survival results also favored the drug.

"The OCEANS study is a positive study," lead investigator Dr. Carol Aghajanian said in a press briefing. The combination therapy "provides a clinically meaningful benefit in recurrent ovarian cancer."

"This regimen should be considered a new option for women with recurrent platinum-sensitive ovarian cancer, recommended Dr. Aghajanian, chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center in New York.

Patients with advanced ovarian cancer often receive multiple lines of chemotherapy, noted Dr. Andrew Seidman, who moderated the press briefing. "There are many chapters in the story, so to speak, and I think the ability to prolong each and every chapter in this disease will, in my estimation, make the story longer – that is, ultimately improve survival. These trial results are certainly an important step in this direction."

Maintenance therapy with a biologic agent also allows patients to avoid the harsh adverse effects of chemotherapy, added Dr. Seidman, an attending physician for breast cancer medicine at Memorial Sloan-Kettering and professor of medicine at Weill Cornell Medical College, New York.

"With the ... prolongation in the time to progression, patients can live with more time to lead full and active lives, in the absence of chemotherapy," he said. "It’s also comforting to see that there were no new safety signals in this trial, and in particular, [no] bowel perforations."

The 484 women enrolled in the trial had platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer; had not received any chemotherapy for their recurrence; and had measurable disease.

They were assigned in equal numbers to receive 6-10 cycles of standard chemotherapy (carboplatin and gemcitabine) plus either bevacizumab, a monoclonal antibody to vascular endothelial growth factor given at a dose of 15 mg/kg every 3 weeks, or a placebo concurrently, followed by single-agent bevacizumab or placebo, respectively.

The bevacizumab dose was based on that showing activity in single-arm phase II trials of the drug leading up to the OCEANS trial, according to Dr. Aghajanian. This dose has not been directly compared with lower doses in ovarian cancer.

Treatment continued until the time of progression, the trial’s primary end point, assessed using RECIST (Response Evaluation Criteria in Solid Tumors).

Trial results showed that the median number of cycles of chemotherapy received was six in each group. The median number of cycles of bevacizumab and placebo was 12 and 10, respectively.

After a median follow-up of 24 months, patients in the bevacizumab group had a slightly more than one-half reduction in the risk of progression relative to their counterparts in the placebo group as assessed by the investigators (hazard ratio, 0.48; P less than .0001).

Median progression-free survival was 12.4 months with bevacizumab, compared with 8.4 months with placebo. "The curves separate at 2 months and remain separated throughout," Dr. Aghajanian noted. The findings were similar when progression was instead ascertained by an independent review committee.

In addition, bevacizumab was associated with better progression-free survival across subgroups of patients stratified by factors such as the platinum-free interval before recurrence, age, and receipt of cytoreductive surgery for recurrence.

Results also showed that patients in the bevacizumab group had a comparatively higher objective response rate (78.5% vs. 57.4%, P less than .0001) and longer duration of response (10.4 vs. 7.4 months, P less than .0001).

Overall survival results are not yet mature, she cautioned. But an interim analysis also showed a trend favoring bevacizumab, with median overall survival of 35.5 months with the drug, compared with 29.9 months with placebo (hazard ratio, 0.75; P = .094).

"The safety data were reassuring and consistent with the known bevacizumab side effect profile," reported Dr. Aghajanian.

Specifically, patients in the bevacizumab group were comparatively more likely to experience grade 3 or higher hypertension (17% vs. less than 1%) and proteinuria (9% vs. 1%). And 1% of patients in that group experienced reversible posterior leukoencephalopathy syndrome, but it resolved in all cases after drug discontinuation.

Of particular note, none of the bevacizumab-treated patients experienced gastrointestinal perforation during treatment, she pointed out. And none experienced previously undescribed adverse effects.

Dr. Aghajanian reported being a consultant to and receiving research funding from Genentech, manufacturer of bevacizumab, and the trial was sponsored by Genentech. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding the antiangiogenic agent bevacizumab to platinum-based chemotherapy halves the risk of progression in women with recurrent ovarian, peritoneal, or fallopian tube cancer, new data show.

In OCEANS, a randomized phase III trial, patients given bevacizumab (Avastin) during and after chemotherapy were 52% less likely to have progression of their disease than were patients given placebo.

The absolute difference in median progression-free survival was 4 months, according to results reported at the annual meeting of the American Society of Clinical Oncology. Interim overall survival results also favored the drug.

"The OCEANS study is a positive study," lead investigator Dr. Carol Aghajanian said in a press briefing. The combination therapy "provides a clinically meaningful benefit in recurrent ovarian cancer."

"This regimen should be considered a new option for women with recurrent platinum-sensitive ovarian cancer, recommended Dr. Aghajanian, chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center in New York.

Patients with advanced ovarian cancer often receive multiple lines of chemotherapy, noted Dr. Andrew Seidman, who moderated the press briefing. "There are many chapters in the story, so to speak, and I think the ability to prolong each and every chapter in this disease will, in my estimation, make the story longer – that is, ultimately improve survival. These trial results are certainly an important step in this direction."

Maintenance therapy with a biologic agent also allows patients to avoid the harsh adverse effects of chemotherapy, added Dr. Seidman, an attending physician for breast cancer medicine at Memorial Sloan-Kettering and professor of medicine at Weill Cornell Medical College, New York.

"With the ... prolongation in the time to progression, patients can live with more time to lead full and active lives, in the absence of chemotherapy," he said. "It’s also comforting to see that there were no new safety signals in this trial, and in particular, [no] bowel perforations."

The 484 women enrolled in the trial had platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer; had not received any chemotherapy for their recurrence; and had measurable disease.

They were assigned in equal numbers to receive 6-10 cycles of standard chemotherapy (carboplatin and gemcitabine) plus either bevacizumab, a monoclonal antibody to vascular endothelial growth factor given at a dose of 15 mg/kg every 3 weeks, or a placebo concurrently, followed by single-agent bevacizumab or placebo, respectively.

The bevacizumab dose was based on that showing activity in single-arm phase II trials of the drug leading up to the OCEANS trial, according to Dr. Aghajanian. This dose has not been directly compared with lower doses in ovarian cancer.

Treatment continued until the time of progression, the trial’s primary end point, assessed using RECIST (Response Evaluation Criteria in Solid Tumors).

Trial results showed that the median number of cycles of chemotherapy received was six in each group. The median number of cycles of bevacizumab and placebo was 12 and 10, respectively.

After a median follow-up of 24 months, patients in the bevacizumab group had a slightly more than one-half reduction in the risk of progression relative to their counterparts in the placebo group as assessed by the investigators (hazard ratio, 0.48; P less than .0001).

Median progression-free survival was 12.4 months with bevacizumab, compared with 8.4 months with placebo. "The curves separate at 2 months and remain separated throughout," Dr. Aghajanian noted. The findings were similar when progression was instead ascertained by an independent review committee.

In addition, bevacizumab was associated with better progression-free survival across subgroups of patients stratified by factors such as the platinum-free interval before recurrence, age, and receipt of cytoreductive surgery for recurrence.

Results also showed that patients in the bevacizumab group had a comparatively higher objective response rate (78.5% vs. 57.4%, P less than .0001) and longer duration of response (10.4 vs. 7.4 months, P less than .0001).

Overall survival results are not yet mature, she cautioned. But an interim analysis also showed a trend favoring bevacizumab, with median overall survival of 35.5 months with the drug, compared with 29.9 months with placebo (hazard ratio, 0.75; P = .094).

"The safety data were reassuring and consistent with the known bevacizumab side effect profile," reported Dr. Aghajanian.

Specifically, patients in the bevacizumab group were comparatively more likely to experience grade 3 or higher hypertension (17% vs. less than 1%) and proteinuria (9% vs. 1%). And 1% of patients in that group experienced reversible posterior leukoencephalopathy syndrome, but it resolved in all cases after drug discontinuation.

Of particular note, none of the bevacizumab-treated patients experienced gastrointestinal perforation during treatment, she pointed out. And none experienced previously undescribed adverse effects.

Dr. Aghajanian reported being a consultant to and receiving research funding from Genentech, manufacturer of bevacizumab, and the trial was sponsored by Genentech. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding the antiangiogenic agent bevacizumab to platinum-based chemotherapy halves the risk of progression in women with recurrent ovarian, peritoneal, or fallopian tube cancer, new data show.

In OCEANS, a randomized phase III trial, patients given bevacizumab (Avastin) during and after chemotherapy were 52% less likely to have progression of their disease than were patients given placebo.

The absolute difference in median progression-free survival was 4 months, according to results reported at the annual meeting of the American Society of Clinical Oncology. Interim overall survival results also favored the drug.

"The OCEANS study is a positive study," lead investigator Dr. Carol Aghajanian said in a press briefing. The combination therapy "provides a clinically meaningful benefit in recurrent ovarian cancer."

"This regimen should be considered a new option for women with recurrent platinum-sensitive ovarian cancer, recommended Dr. Aghajanian, chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center in New York.

Patients with advanced ovarian cancer often receive multiple lines of chemotherapy, noted Dr. Andrew Seidman, who moderated the press briefing. "There are many chapters in the story, so to speak, and I think the ability to prolong each and every chapter in this disease will, in my estimation, make the story longer – that is, ultimately improve survival. These trial results are certainly an important step in this direction."

Maintenance therapy with a biologic agent also allows patients to avoid the harsh adverse effects of chemotherapy, added Dr. Seidman, an attending physician for breast cancer medicine at Memorial Sloan-Kettering and professor of medicine at Weill Cornell Medical College, New York.

"With the ... prolongation in the time to progression, patients can live with more time to lead full and active lives, in the absence of chemotherapy," he said. "It’s also comforting to see that there were no new safety signals in this trial, and in particular, [no] bowel perforations."

The 484 women enrolled in the trial had platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer; had not received any chemotherapy for their recurrence; and had measurable disease.

They were assigned in equal numbers to receive 6-10 cycles of standard chemotherapy (carboplatin and gemcitabine) plus either bevacizumab, a monoclonal antibody to vascular endothelial growth factor given at a dose of 15 mg/kg every 3 weeks, or a placebo concurrently, followed by single-agent bevacizumab or placebo, respectively.

The bevacizumab dose was based on that showing activity in single-arm phase II trials of the drug leading up to the OCEANS trial, according to Dr. Aghajanian. This dose has not been directly compared with lower doses in ovarian cancer.

Treatment continued until the time of progression, the trial’s primary end point, assessed using RECIST (Response Evaluation Criteria in Solid Tumors).

Trial results showed that the median number of cycles of chemotherapy received was six in each group. The median number of cycles of bevacizumab and placebo was 12 and 10, respectively.

After a median follow-up of 24 months, patients in the bevacizumab group had a slightly more than one-half reduction in the risk of progression relative to their counterparts in the placebo group as assessed by the investigators (hazard ratio, 0.48; P less than .0001).

Median progression-free survival was 12.4 months with bevacizumab, compared with 8.4 months with placebo. "The curves separate at 2 months and remain separated throughout," Dr. Aghajanian noted. The findings were similar when progression was instead ascertained by an independent review committee.

In addition, bevacizumab was associated with better progression-free survival across subgroups of patients stratified by factors such as the platinum-free interval before recurrence, age, and receipt of cytoreductive surgery for recurrence.

Results also showed that patients in the bevacizumab group had a comparatively higher objective response rate (78.5% vs. 57.4%, P less than .0001) and longer duration of response (10.4 vs. 7.4 months, P less than .0001).

Overall survival results are not yet mature, she cautioned. But an interim analysis also showed a trend favoring bevacizumab, with median overall survival of 35.5 months with the drug, compared with 29.9 months with placebo (hazard ratio, 0.75; P = .094).

"The safety data were reassuring and consistent with the known bevacizumab side effect profile," reported Dr. Aghajanian.

Specifically, patients in the bevacizumab group were comparatively more likely to experience grade 3 or higher hypertension (17% vs. less than 1%) and proteinuria (9% vs. 1%). And 1% of patients in that group experienced reversible posterior leukoencephalopathy syndrome, but it resolved in all cases after drug discontinuation.

Of particular note, none of the bevacizumab-treated patients experienced gastrointestinal perforation during treatment, she pointed out. And none experienced previously undescribed adverse effects.

Dr. Aghajanian reported being a consultant to and receiving research funding from Genentech, manufacturer of bevacizumab, and the trial was sponsored by Genentech. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding the antiangiogenic agent bevacizumab to platinum-based chemotherapy halves the risk of progression in women with recurrent ovarian, peritoneal, or fallopian tube cancer, new data show.

In OCEANS, a randomized phase III trial, patients given bevacizumab (Avastin) during and after chemotherapy were 52% less likely to have progression of their disease than were patients given placebo.

The absolute difference in median progression-free survival was 4 months, according to results reported at the annual meeting of the American Society of Clinical Oncology. Interim overall survival results also favored the drug.

"The OCEANS study is a positive study," lead investigator Dr. Carol Aghajanian said in a press briefing. The combination therapy "provides a clinically meaningful benefit in recurrent ovarian cancer."

"This regimen should be considered a new option for women with recurrent platinum-sensitive ovarian cancer, recommended Dr. Aghajanian, chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center in New York.

Patients with advanced ovarian cancer often receive multiple lines of chemotherapy, noted Dr. Andrew Seidman, who moderated the press briefing. "There are many chapters in the story, so to speak, and I think the ability to prolong each and every chapter in this disease will, in my estimation, make the story longer – that is, ultimately improve survival. These trial results are certainly an important step in this direction."

Maintenance therapy with a biologic agent also allows patients to avoid the harsh adverse effects of chemotherapy, added Dr. Seidman, an attending physician for breast cancer medicine at Memorial Sloan-Kettering and professor of medicine at Weill Cornell Medical College, New York.

"With the ... prolongation in the time to progression, patients can live with more time to lead full and active lives, in the absence of chemotherapy," he said. "It’s also comforting to see that there were no new safety signals in this trial, and in particular, [no] bowel perforations."

The 484 women enrolled in the trial had platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer; had not received any chemotherapy for their recurrence; and had measurable disease.

They were assigned in equal numbers to receive 6-10 cycles of standard chemotherapy (carboplatin and gemcitabine) plus either bevacizumab, a monoclonal antibody to vascular endothelial growth factor given at a dose of 15 mg/kg every 3 weeks, or a placebo concurrently, followed by single-agent bevacizumab or placebo, respectively.

The bevacizumab dose was based on that showing activity in single-arm phase II trials of the drug leading up to the OCEANS trial, according to Dr. Aghajanian. This dose has not been directly compared with lower doses in ovarian cancer.

Treatment continued until the time of progression, the trial’s primary end point, assessed using RECIST (Response Evaluation Criteria in Solid Tumors).

Trial results showed that the median number of cycles of chemotherapy received was six in each group. The median number of cycles of bevacizumab and placebo was 12 and 10, respectively.

After a median follow-up of 24 months, patients in the bevacizumab group had a slightly more than one-half reduction in the risk of progression relative to their counterparts in the placebo group as assessed by the investigators (hazard ratio, 0.48; P less than .0001).

Median progression-free survival was 12.4 months with bevacizumab, compared with 8.4 months with placebo. "The curves separate at 2 months and remain separated throughout," Dr. Aghajanian noted. The findings were similar when progression was instead ascertained by an independent review committee.

In addition, bevacizumab was associated with better progression-free survival across subgroups of patients stratified by factors such as the platinum-free interval before recurrence, age, and receipt of cytoreductive surgery for recurrence.

Results also showed that patients in the bevacizumab group had a comparatively higher objective response rate (78.5% vs. 57.4%, P less than .0001) and longer duration of response (10.4 vs. 7.4 months, P less than .0001).

Overall survival results are not yet mature, she cautioned. But an interim analysis also showed a trend favoring bevacizumab, with median overall survival of 35.5 months with the drug, compared with 29.9 months with placebo (hazard ratio, 0.75; P = .094).

"The safety data were reassuring and consistent with the known bevacizumab side effect profile," reported Dr. Aghajanian.

Specifically, patients in the bevacizumab group were comparatively more likely to experience grade 3 or higher hypertension (17% vs. less than 1%) and proteinuria (9% vs. 1%). And 1% of patients in that group experienced reversible posterior leukoencephalopathy syndrome, but it resolved in all cases after drug discontinuation.

Of particular note, none of the bevacizumab-treated patients experienced gastrointestinal perforation during treatment, she pointed out. And none experienced previously undescribed adverse effects.

Dr. Aghajanian reported being a consultant to and receiving research funding from Genentech, manufacturer of bevacizumab, and the trial was sponsored by Genentech. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding the antiangiogenic agent bevacizumab to platinum-based chemotherapy halves the risk of progression in women with recurrent ovarian, peritoneal, or fallopian tube cancer, new data show.

In OCEANS, a randomized phase III trial, patients given bevacizumab (Avastin) during and after chemotherapy were 52% less likely to have progression of their disease than were patients given placebo.

The absolute difference in median progression-free survival was 4 months, according to results reported at the annual meeting of the American Society of Clinical Oncology. Interim overall survival results also favored the drug.

"The OCEANS study is a positive study," lead investigator Dr. Carol Aghajanian said in a press briefing. The combination therapy "provides a clinically meaningful benefit in recurrent ovarian cancer."

"This regimen should be considered a new option for women with recurrent platinum-sensitive ovarian cancer, recommended Dr. Aghajanian, chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center in New York.

Patients with advanced ovarian cancer often receive multiple lines of chemotherapy, noted Dr. Andrew Seidman, who moderated the press briefing. "There are many chapters in the story, so to speak, and I think the ability to prolong each and every chapter in this disease will, in my estimation, make the story longer – that is, ultimately improve survival. These trial results are certainly an important step in this direction."

Maintenance therapy with a biologic agent also allows patients to avoid the harsh adverse effects of chemotherapy, added Dr. Seidman, an attending physician for breast cancer medicine at Memorial Sloan-Kettering and professor of medicine at Weill Cornell Medical College, New York.

"With the ... prolongation in the time to progression, patients can live with more time to lead full and active lives, in the absence of chemotherapy," he said. "It’s also comforting to see that there were no new safety signals in this trial, and in particular, [no] bowel perforations."

The 484 women enrolled in the trial had platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer; had not received any chemotherapy for their recurrence; and had measurable disease.

They were assigned in equal numbers to receive 6-10 cycles of standard chemotherapy (carboplatin and gemcitabine) plus either bevacizumab, a monoclonal antibody to vascular endothelial growth factor given at a dose of 15 mg/kg every 3 weeks, or a placebo concurrently, followed by single-agent bevacizumab or placebo, respectively.

The bevacizumab dose was based on that showing activity in single-arm phase II trials of the drug leading up to the OCEANS trial, according to Dr. Aghajanian. This dose has not been directly compared with lower doses in ovarian cancer.

Treatment continued until the time of progression, the trial’s primary end point, assessed using RECIST (Response Evaluation Criteria in Solid Tumors).

Trial results showed that the median number of cycles of chemotherapy received was six in each group. The median number of cycles of bevacizumab and placebo was 12 and 10, respectively.

After a median follow-up of 24 months, patients in the bevacizumab group had a slightly more than one-half reduction in the risk of progression relative to their counterparts in the placebo group as assessed by the investigators (hazard ratio, 0.48; P less than .0001).

Median progression-free survival was 12.4 months with bevacizumab, compared with 8.4 months with placebo. "The curves separate at 2 months and remain separated throughout," Dr. Aghajanian noted. The findings were similar when progression was instead ascertained by an independent review committee.

In addition, bevacizumab was associated with better progression-free survival across subgroups of patients stratified by factors such as the platinum-free interval before recurrence, age, and receipt of cytoreductive surgery for recurrence.

Results also showed that patients in the bevacizumab group had a comparatively higher objective response rate (78.5% vs. 57.4%, P less than .0001) and longer duration of response (10.4 vs. 7.4 months, P less than .0001).

Overall survival results are not yet mature, she cautioned. But an interim analysis also showed a trend favoring bevacizumab, with median overall survival of 35.5 months with the drug, compared with 29.9 months with placebo (hazard ratio, 0.75; P = .094).

"The safety data were reassuring and consistent with the known bevacizumab side effect profile," reported Dr. Aghajanian.

Specifically, patients in the bevacizumab group were comparatively more likely to experience grade 3 or higher hypertension (17% vs. less than 1%) and proteinuria (9% vs. 1%). And 1% of patients in that group experienced reversible posterior leukoencephalopathy syndrome, but it resolved in all cases after drug discontinuation.

Of particular note, none of the bevacizumab-treated patients experienced gastrointestinal perforation during treatment, she pointed out. And none experienced previously undescribed adverse effects.

Dr. Aghajanian reported being a consultant to and receiving research funding from Genentech, manufacturer of bevacizumab, and the trial was sponsored by Genentech. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.

CHICAGO – Adding the antiangiogenic agent bevacizumab to platinum-based chemotherapy halves the risk of progression in women with recurrent ovarian, peritoneal, or fallopian tube cancer, new data show.

In OCEANS, a randomized phase III trial, patients given bevacizumab (Avastin) during and after chemotherapy were 52% less likely to have progression of their disease than were patients given placebo.

The absolute difference in median progression-free survival was 4 months, according to results reported at the annual meeting of the American Society of Clinical Oncology. Interim overall survival results also favored the drug.

"The OCEANS study is a positive study," lead investigator Dr. Carol Aghajanian said in a press briefing. The combination therapy "provides a clinically meaningful benefit in recurrent ovarian cancer."

"This regimen should be considered a new option for women with recurrent platinum-sensitive ovarian cancer, recommended Dr. Aghajanian, chief of the gynecologic medical oncology service at Memorial Sloan-Kettering Cancer Center in New York.

Patients with advanced ovarian cancer often receive multiple lines of chemotherapy, noted Dr. Andrew Seidman, who moderated the press briefing. "There are many chapters in the story, so to speak, and I think the ability to prolong each and every chapter in this disease will, in my estimation, make the story longer – that is, ultimately improve survival. These trial results are certainly an important step in this direction."

Maintenance therapy with a biologic agent also allows patients to avoid the harsh adverse effects of chemotherapy, added Dr. Seidman, an attending physician for breast cancer medicine at Memorial Sloan-Kettering and professor of medicine at Weill Cornell Medical College, New York.

"With the ... prolongation in the time to progression, patients can live with more time to lead full and active lives, in the absence of chemotherapy," he said. "It’s also comforting to see that there were no new safety signals in this trial, and in particular, [no] bowel perforations."

The 484 women enrolled in the trial had platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer; had not received any chemotherapy for their recurrence; and had measurable disease.

They were assigned in equal numbers to receive 6-10 cycles of standard chemotherapy (carboplatin and gemcitabine) plus either bevacizumab, a monoclonal antibody to vascular endothelial growth factor given at a dose of 15 mg/kg every 3 weeks, or a placebo concurrently, followed by single-agent bevacizumab or placebo, respectively.

The bevacizumab dose was based on that showing activity in single-arm phase II trials of the drug leading up to the OCEANS trial, according to Dr. Aghajanian. This dose has not been directly compared with lower doses in ovarian cancer.

Treatment continued until the time of progression, the trial’s primary end point, assessed using RECIST (Response Evaluation Criteria in Solid Tumors).

Trial results showed that the median number of cycles of chemotherapy received was six in each group. The median number of cycles of bevacizumab and placebo was 12 and 10, respectively.

After a median follow-up of 24 months, patients in the bevacizumab group had a slightly more than one-half reduction in the risk of progression relative to their counterparts in the placebo group as assessed by the investigators (hazard ratio, 0.48; P less than .0001).

Median progression-free survival was 12.4 months with bevacizumab, compared with 8.4 months with placebo. "The curves separate at 2 months and remain separated throughout," Dr. Aghajanian noted. The findings were similar when progression was instead ascertained by an independent review committee.

In addition, bevacizumab was associated with better progression-free survival across subgroups of patients stratified by factors such as the platinum-free interval before recurrence, age, and receipt of cytoreductive surgery for recurrence.

Results also showed that patients in the bevacizumab group had a comparatively higher objective response rate (78.5% vs. 57.4%, P less than .0001) and longer duration of response (10.4 vs. 7.4 months, P less than .0001).

Overall survival results are not yet mature, she cautioned. But an interim analysis also showed a trend favoring bevacizumab, with median overall survival of 35.5 months with the drug, compared with 29.9 months with placebo (hazard ratio, 0.75; P = .094).

"The safety data were reassuring and consistent with the known bevacizumab side effect profile," reported Dr. Aghajanian.

Specifically, patients in the bevacizumab group were comparatively more likely to experience grade 3 or higher hypertension (17% vs. less than 1%) and proteinuria (9% vs. 1%). And 1% of patients in that group experienced reversible posterior leukoencephalopathy syndrome, but it resolved in all cases after drug discontinuation.

Of particular note, none of the bevacizumab-treated patients experienced gastrointestinal perforation during treatment, she pointed out. And none experienced previously undescribed adverse effects.

Dr. Aghajanian reported being a consultant to and receiving research funding from Genentech, manufacturer of bevacizumab, and the trial was sponsored by Genentech. Dr. Seidman reported being a consultant to Enzon and Wyeth; receiving honoraria from Abraxis BioScience, Genentech, and Genomic Health; and receiving research funding from Abraxis BioScience.