Mary Jo M. Dales

CHICAGO – In Medicare patients with poor prognosis cancers, aggressive treatments were more likely to be pursued in the patients with the highest socioeconomic status, but the treatments did not result in better 2-year survival rates.

Among Medicare patients with lung, esophageal, and pancreatic cancers, Dr. Sandra L. Wong of the University of Michigan, Ann Arbor, found that patients who ranked in the highest of five socioeconomic categories were more likely to receive aggressive treatments across all three cancer groups. Yet, after researchers adjusted for risk factors, there was no difference in the 2-year survival rates for patients at the lowest and highest socioeconomic levels.

Primary cancers of the lung, esophagus, and pancreas account for more than 35% of all cancer deaths in the United States and a sizable share of cancer-related costs, Dr. Wong observed. Survival rates have not improved much for patients with these poor prognosis cancers, yet aggressive treatment has increased in this patient group.

Dr. Wong and her colleagues examined 1992-2005 data from the Surveillance Epidemiology and End Results (SEER) registry, which is linked to Medicare claims data, for fee-for-service patients over age 65 years. There were 68,167 patients with lung cancer, 4,350 with esophageal cancer, and 12,779 with pancreatic cancer. Cancer stage at diagnosis was similar for those in the highest and lowest socioeconomic groups. Patients were placed in one of five groups based on measures derived on the basis of wealth and income, education, employment, and zip code.

Patients in the lowest socioeconomic group were more likely to be black, to need urgent admission, and to be treated at nonteaching hospitals with low patient volumes. About 35% of patients in the lowest socioeconomic status had advanced disease at diagnosis, and they were more likely to receive no cancer-directed treatments, according to the results of the study.

For all three cancer types, patients in the highest socioeconomic group were more likely to receive radiation, surgery, and chemotherapy. For the lowest socioeconomic group of patients with lung cancer, radiation therapy was given to 44%, surgery to 13%, and chemotherapy to more than 35%. For the highest socioeconomic group, the respective rates were 50%, 19%, and 39%. No cancer-directed therapy was given to 44% of patients in the lowest socioeconomic group versus 37% of the highest socioeconomic group.

Where care was delivered mattered to lung cancer outcomes, she said. When hospitals were located in high socioeconomic areas, there was a modest difference in adjusted 2-year survival for lung cancer patients based on patient socioeconomic status, at 12% for lowest and 14% for highest. But when hospitals were located in low socioeconomic areas, adjusted 2-year survival was 8% for those in the lowest socioeconomic group and 3% for those in the highest socioeconomic group.

Dr. Wong reported having no relevant financial disclosures.

CHICAGO – In Medicare patients with poor prognosis cancers, aggressive treatments were more likely to be pursued in the patients with the highest socioeconomic status, but the treatments did not result in better 2-year survival rates.

Among Medicare patients with lung, esophageal, and pancreatic cancers, Dr. Sandra L. Wong of the University of Michigan, Ann Arbor, found that patients who ranked in the highest of five socioeconomic categories were more likely to receive aggressive treatments across all three cancer groups. Yet, after researchers adjusted for risk factors, there was no difference in the 2-year survival rates for patients at the lowest and highest socioeconomic levels.

Primary cancers of the lung, esophagus, and pancreas account for more than 35% of all cancer deaths in the United States and a sizable share of cancer-related costs, Dr. Wong observed. Survival rates have not improved much for patients with these poor prognosis cancers, yet aggressive treatment has increased in this patient group.

Dr. Wong and her colleagues examined 1992-2005 data from the Surveillance Epidemiology and End Results (SEER) registry, which is linked to Medicare claims data, for fee-for-service patients over age 65 years. There were 68,167 patients with lung cancer, 4,350 with esophageal cancer, and 12,779 with pancreatic cancer. Cancer stage at diagnosis was similar for those in the highest and lowest socioeconomic groups. Patients were placed in one of five groups based on measures derived on the basis of wealth and income, education, employment, and zip code.

Patients in the lowest socioeconomic group were more likely to be black, to need urgent admission, and to be treated at nonteaching hospitals with low patient volumes. About 35% of patients in the lowest socioeconomic status had advanced disease at diagnosis, and they were more likely to receive no cancer-directed treatments, according to the results of the study.

For all three cancer types, patients in the highest socioeconomic group were more likely to receive radiation, surgery, and chemotherapy. For the lowest socioeconomic group of patients with lung cancer, radiation therapy was given to 44%, surgery to 13%, and chemotherapy to more than 35%. For the highest socioeconomic group, the respective rates were 50%, 19%, and 39%. No cancer-directed therapy was given to 44% of patients in the lowest socioeconomic group versus 37% of the highest socioeconomic group.

Where care was delivered mattered to lung cancer outcomes, she said. When hospitals were located in high socioeconomic areas, there was a modest difference in adjusted 2-year survival for lung cancer patients based on patient socioeconomic status, at 12% for lowest and 14% for highest. But when hospitals were located in low socioeconomic areas, adjusted 2-year survival was 8% for those in the lowest socioeconomic group and 3% for those in the highest socioeconomic group.

Dr. Wong reported having no relevant financial disclosures.

CHICAGO – In Medicare patients with poor prognosis cancers, aggressive treatments were more likely to be pursued in the patients with the highest socioeconomic status, but the treatments did not result in better 2-year survival rates.

Among Medicare patients with lung, esophageal, and pancreatic cancers, Dr. Sandra L. Wong of the University of Michigan, Ann Arbor, found that patients who ranked in the highest of five socioeconomic categories were more likely to receive aggressive treatments across all three cancer groups. Yet, after researchers adjusted for risk factors, there was no difference in the 2-year survival rates for patients at the lowest and highest socioeconomic levels.

Primary cancers of the lung, esophagus, and pancreas account for more than 35% of all cancer deaths in the United States and a sizable share of cancer-related costs, Dr. Wong observed. Survival rates have not improved much for patients with these poor prognosis cancers, yet aggressive treatment has increased in this patient group.

Dr. Wong and her colleagues examined 1992-2005 data from the Surveillance Epidemiology and End Results (SEER) registry, which is linked to Medicare claims data, for fee-for-service patients over age 65 years. There were 68,167 patients with lung cancer, 4,350 with esophageal cancer, and 12,779 with pancreatic cancer. Cancer stage at diagnosis was similar for those in the highest and lowest socioeconomic groups. Patients were placed in one of five groups based on measures derived on the basis of wealth and income, education, employment, and zip code.

Patients in the lowest socioeconomic group were more likely to be black, to need urgent admission, and to be treated at nonteaching hospitals with low patient volumes. About 35% of patients in the lowest socioeconomic status had advanced disease at diagnosis, and they were more likely to receive no cancer-directed treatments, according to the results of the study.

For all three cancer types, patients in the highest socioeconomic group were more likely to receive radiation, surgery, and chemotherapy. For the lowest socioeconomic group of patients with lung cancer, radiation therapy was given to 44%, surgery to 13%, and chemotherapy to more than 35%. For the highest socioeconomic group, the respective rates were 50%, 19%, and 39%. No cancer-directed therapy was given to 44% of patients in the lowest socioeconomic group versus 37% of the highest socioeconomic group.

Where care was delivered mattered to lung cancer outcomes, she said. When hospitals were located in high socioeconomic areas, there was a modest difference in adjusted 2-year survival for lung cancer patients based on patient socioeconomic status, at 12% for lowest and 14% for highest. But when hospitals were located in low socioeconomic areas, adjusted 2-year survival was 8% for those in the lowest socioeconomic group and 3% for those in the highest socioeconomic group.

Dr. Wong reported having no relevant financial disclosures.

CHICAGO – In Medicare patients with poor prognosis cancers, aggressive treatments were more likely to be pursued in the patients with the highest socioeconomic status, but the treatments did not result in better 2-year survival rates.

Among Medicare patients with lung, esophageal, and pancreatic cancers, Dr. Sandra L. Wong of the University of Michigan, Ann Arbor, found that patients who ranked in the highest of five socioeconomic categories were more likely to receive aggressive treatments across all three cancer groups. Yet, after researchers adjusted for risk factors, there was no difference in the 2-year survival rates for patients at the lowest and highest socioeconomic levels.

Primary cancers of the lung, esophagus, and pancreas account for more than 35% of all cancer deaths in the United States and a sizable share of cancer-related costs, Dr. Wong observed. Survival rates have not improved much for patients with these poor prognosis cancers, yet aggressive treatment has increased in this patient group.

Dr. Wong and her colleagues examined 1992-2005 data from the Surveillance Epidemiology and End Results (SEER) registry, which is linked to Medicare claims data, for fee-for-service patients over age 65 years. There were 68,167 patients with lung cancer, 4,350 with esophageal cancer, and 12,779 with pancreatic cancer. Cancer stage at diagnosis was similar for those in the highest and lowest socioeconomic groups. Patients were placed in one of five groups based on measures derived on the basis of wealth and income, education, employment, and zip code.

Patients in the lowest socioeconomic group were more likely to be black, to need urgent admission, and to be treated at nonteaching hospitals with low patient volumes. About 35% of patients in the lowest socioeconomic status had advanced disease at diagnosis, and they were more likely to receive no cancer-directed treatments, according to the results of the study.

For all three cancer types, patients in the highest socioeconomic group were more likely to receive radiation, surgery, and chemotherapy. For the lowest socioeconomic group of patients with lung cancer, radiation therapy was given to 44%, surgery to 13%, and chemotherapy to more than 35%. For the highest socioeconomic group, the respective rates were 50%, 19%, and 39%. No cancer-directed therapy was given to 44% of patients in the lowest socioeconomic group versus 37% of the highest socioeconomic group.

Where care was delivered mattered to lung cancer outcomes, she said. When hospitals were located in high socioeconomic areas, there was a modest difference in adjusted 2-year survival for lung cancer patients based on patient socioeconomic status, at 12% for lowest and 14% for highest. But when hospitals were located in low socioeconomic areas, adjusted 2-year survival was 8% for those in the lowest socioeconomic group and 3% for those in the highest socioeconomic group.

Dr. Wong reported having no relevant financial disclosures.

CHICAGO – In Medicare patients with poor prognosis cancers, aggressive treatments were more likely to be pursued in the patients with the highest socioeconomic status, but the treatments did not result in better 2-year survival rates.

Among Medicare patients with lung, esophageal, and pancreatic cancers, Dr. Sandra L. Wong of the University of Michigan, Ann Arbor, found that patients who ranked in the highest of five socioeconomic categories were more likely to receive aggressive treatments across all three cancer groups. Yet, after researchers adjusted for risk factors, there was no difference in the 2-year survival rates for patients at the lowest and highest socioeconomic levels.

Primary cancers of the lung, esophagus, and pancreas account for more than 35% of all cancer deaths in the United States and a sizable share of cancer-related costs, Dr. Wong observed. Survival rates have not improved much for patients with these poor prognosis cancers, yet aggressive treatment has increased in this patient group.

Dr. Wong and her colleagues examined 1992-2005 data from the Surveillance Epidemiology and End Results (SEER) registry, which is linked to Medicare claims data, for fee-for-service patients over age 65 years. There were 68,167 patients with lung cancer, 4,350 with esophageal cancer, and 12,779 with pancreatic cancer. Cancer stage at diagnosis was similar for those in the highest and lowest socioeconomic groups. Patients were placed in one of five groups based on measures derived on the basis of wealth and income, education, employment, and zip code.

Patients in the lowest socioeconomic group were more likely to be black, to need urgent admission, and to be treated at nonteaching hospitals with low patient volumes. About 35% of patients in the lowest socioeconomic status had advanced disease at diagnosis, and they were more likely to receive no cancer-directed treatments, according to the results of the study.

For all three cancer types, patients in the highest socioeconomic group were more likely to receive radiation, surgery, and chemotherapy. For the lowest socioeconomic group of patients with lung cancer, radiation therapy was given to 44%, surgery to 13%, and chemotherapy to more than 35%. For the highest socioeconomic group, the respective rates were 50%, 19%, and 39%. No cancer-directed therapy was given to 44% of patients in the lowest socioeconomic group versus 37% of the highest socioeconomic group.

Where care was delivered mattered to lung cancer outcomes, she said. When hospitals were located in high socioeconomic areas, there was a modest difference in adjusted 2-year survival for lung cancer patients based on patient socioeconomic status, at 12% for lowest and 14% for highest. But when hospitals were located in low socioeconomic areas, adjusted 2-year survival was 8% for those in the lowest socioeconomic group and 3% for those in the highest socioeconomic group.

Dr. Wong reported having no relevant financial disclosures.

CHICAGO – In Medicare patients with poor prognosis cancers, aggressive treatments were more likely to be pursued in the patients with the highest socioeconomic status, but the treatments did not result in better 2-year survival rates.

Among Medicare patients with lung, esophageal, and pancreatic cancers, Dr. Sandra L. Wong of the University of Michigan, Ann Arbor, found that patients who ranked in the highest of five socioeconomic categories were more likely to receive aggressive treatments across all three cancer groups. Yet, after researchers adjusted for risk factors, there was no difference in the 2-year survival rates for patients at the lowest and highest socioeconomic levels.

Primary cancers of the lung, esophagus, and pancreas account for more than 35% of all cancer deaths in the United States and a sizable share of cancer-related costs, Dr. Wong observed. Survival rates have not improved much for patients with these poor prognosis cancers, yet aggressive treatment has increased in this patient group.

Dr. Wong and her colleagues examined 1992-2005 data from the Surveillance Epidemiology and End Results (SEER) registry, which is linked to Medicare claims data, for fee-for-service patients over age 65 years. There were 68,167 patients with lung cancer, 4,350 with esophageal cancer, and 12,779 with pancreatic cancer. Cancer stage at diagnosis was similar for those in the highest and lowest socioeconomic groups. Patients were placed in one of five groups based on measures derived on the basis of wealth and income, education, employment, and zip code.

Patients in the lowest socioeconomic group were more likely to be black, to need urgent admission, and to be treated at nonteaching hospitals with low patient volumes. About 35% of patients in the lowest socioeconomic status had advanced disease at diagnosis, and they were more likely to receive no cancer-directed treatments, according to the results of the study.

For all three cancer types, patients in the highest socioeconomic group were more likely to receive radiation, surgery, and chemotherapy. For the lowest socioeconomic group of patients with lung cancer, radiation therapy was given to 44%, surgery to 13%, and chemotherapy to more than 35%. For the highest socioeconomic group, the respective rates were 50%, 19%, and 39%. No cancer-directed therapy was given to 44% of patients in the lowest socioeconomic group versus 37% of the highest socioeconomic group.

Where care was delivered mattered to lung cancer outcomes, she said. When hospitals were located in high socioeconomic areas, there was a modest difference in adjusted 2-year survival for lung cancer patients based on patient socioeconomic status, at 12% for lowest and 14% for highest. But when hospitals were located in low socioeconomic areas, adjusted 2-year survival was 8% for those in the lowest socioeconomic group and 3% for those in the highest socioeconomic group.

Dr. Wong reported having no relevant financial disclosures.

CHICAGO – In Medicare patients with poor prognosis cancers, aggressive treatments were more likely to be pursued in the patients with the highest socioeconomic status, but the treatments did not result in better 2-year survival rates.

Among Medicare patients with lung, esophageal, and pancreatic cancers, Dr. Sandra L. Wong of the University of Michigan, Ann Arbor, found that patients who ranked in the highest of five socioeconomic categories were more likely to receive aggressive treatments across all three cancer groups. Yet, after researchers adjusted for risk factors, there was no difference in the 2-year survival rates for patients at the lowest and highest socioeconomic levels.

Primary cancers of the lung, esophagus, and pancreas account for more than 35% of all cancer deaths in the United States and a sizable share of cancer-related costs, Dr. Wong observed. Survival rates have not improved much for patients with these poor prognosis cancers, yet aggressive treatment has increased in this patient group.

Dr. Wong and her colleagues examined 1992-2005 data from the Surveillance Epidemiology and End Results (SEER) registry, which is linked to Medicare claims data, for fee-for-service patients over age 65 years. There were 68,167 patients with lung cancer, 4,350 with esophageal cancer, and 12,779 with pancreatic cancer. Cancer stage at diagnosis was similar for those in the highest and lowest socioeconomic groups. Patients were placed in one of five groups based on measures derived on the basis of wealth and income, education, employment, and zip code.

Patients in the lowest socioeconomic group were more likely to be black, to need urgent admission, and to be treated at nonteaching hospitals with low patient volumes. About 35% of patients in the lowest socioeconomic status had advanced disease at diagnosis, and they were more likely to receive no cancer-directed treatments, according to the results of the study.

For all three cancer types, patients in the highest socioeconomic group were more likely to receive radiation, surgery, and chemotherapy. For the lowest socioeconomic group of patients with lung cancer, radiation therapy was given to 44%, surgery to 13%, and chemotherapy to more than 35%. For the highest socioeconomic group, the respective rates were 50%, 19%, and 39%. No cancer-directed therapy was given to 44% of patients in the lowest socioeconomic group versus 37% of the highest socioeconomic group.

Where care was delivered mattered to lung cancer outcomes, she said. When hospitals were located in high socioeconomic areas, there was a modest difference in adjusted 2-year survival for lung cancer patients based on patient socioeconomic status, at 12% for lowest and 14% for highest. But when hospitals were located in low socioeconomic areas, adjusted 2-year survival was 8% for those in the lowest socioeconomic group and 3% for those in the highest socioeconomic group.

Dr. Wong reported having no relevant financial disclosures.

CHICAGO – In Medicare patients with poor prognosis cancers, aggressive treatments were more likely to be pursued in the patients with the highest socioeconomic status, but the treatments did not result in better 2-year survival rates.

Among Medicare patients with lung, esophageal, and pancreatic cancers, Dr. Sandra L. Wong of the University of Michigan, Ann Arbor, found that patients who ranked in the highest of five socioeconomic categories were more likely to receive aggressive treatments across all three cancer groups. Yet, after researchers adjusted for risk factors, there was no difference in the 2-year survival rates for patients at the lowest and highest socioeconomic levels.

Primary cancers of the lung, esophagus, and pancreas account for more than 35% of all cancer deaths in the United States and a sizable share of cancer-related costs, Dr. Wong observed. Survival rates have not improved much for patients with these poor prognosis cancers, yet aggressive treatment has increased in this patient group.

Dr. Wong and her colleagues examined 1992-2005 data from the Surveillance Epidemiology and End Results (SEER) registry, which is linked to Medicare claims data, for fee-for-service patients over age 65 years. There were 68,167 patients with lung cancer, 4,350 with esophageal cancer, and 12,779 with pancreatic cancer. Cancer stage at diagnosis was similar for those in the highest and lowest socioeconomic groups. Patients were placed in one of five groups based on measures derived on the basis of wealth and income, education, employment, and zip code.

Patients in the lowest socioeconomic group were more likely to be black, to need urgent admission, and to be treated at nonteaching hospitals with low patient volumes. About 35% of patients in the lowest socioeconomic status had advanced disease at diagnosis, and they were more likely to receive no cancer-directed treatments, according to the results of the study.

For all three cancer types, patients in the highest socioeconomic group were more likely to receive radiation, surgery, and chemotherapy. For the lowest socioeconomic group of patients with lung cancer, radiation therapy was given to 44%, surgery to 13%, and chemotherapy to more than 35%. For the highest socioeconomic group, the respective rates were 50%, 19%, and 39%. No cancer-directed therapy was given to 44% of patients in the lowest socioeconomic group versus 37% of the highest socioeconomic group.

Where care was delivered mattered to lung cancer outcomes, she said. When hospitals were located in high socioeconomic areas, there was a modest difference in adjusted 2-year survival for lung cancer patients based on patient socioeconomic status, at 12% for lowest and 14% for highest. But when hospitals were located in low socioeconomic areas, adjusted 2-year survival was 8% for those in the lowest socioeconomic group and 3% for those in the highest socioeconomic group.

Dr. Wong reported having no relevant financial disclosures.

CHICAGO – In Medicare patients with poor prognosis cancers, aggressive treatments were more likely to be pursued in the patients with the highest socioeconomic status, but the treatments did not result in better 2-year survival rates.

Among Medicare patients with lung, esophageal, and pancreatic cancers, Dr. Sandra L. Wong of the University of Michigan, Ann Arbor, found that patients who ranked in the highest of five socioeconomic categories were more likely to receive aggressive treatments across all three cancer groups. Yet, after researchers adjusted for risk factors, there was no difference in the 2-year survival rates for patients at the lowest and highest socioeconomic levels.

Primary cancers of the lung, esophagus, and pancreas account for more than 35% of all cancer deaths in the United States and a sizable share of cancer-related costs, Dr. Wong observed. Survival rates have not improved much for patients with these poor prognosis cancers, yet aggressive treatment has increased in this patient group.

Dr. Wong and her colleagues examined 1992-2005 data from the Surveillance Epidemiology and End Results (SEER) registry, which is linked to Medicare claims data, for fee-for-service patients over age 65 years. There were 68,167 patients with lung cancer, 4,350 with esophageal cancer, and 12,779 with pancreatic cancer. Cancer stage at diagnosis was similar for those in the highest and lowest socioeconomic groups. Patients were placed in one of five groups based on measures derived on the basis of wealth and income, education, employment, and zip code.

Patients in the lowest socioeconomic group were more likely to be black, to need urgent admission, and to be treated at nonteaching hospitals with low patient volumes. About 35% of patients in the lowest socioeconomic status had advanced disease at diagnosis, and they were more likely to receive no cancer-directed treatments, according to the results of the study.

For all three cancer types, patients in the highest socioeconomic group were more likely to receive radiation, surgery, and chemotherapy. For the lowest socioeconomic group of patients with lung cancer, radiation therapy was given to 44%, surgery to 13%, and chemotherapy to more than 35%. For the highest socioeconomic group, the respective rates were 50%, 19%, and 39%. No cancer-directed therapy was given to 44% of patients in the lowest socioeconomic group versus 37% of the highest socioeconomic group.

Where care was delivered mattered to lung cancer outcomes, she said. When hospitals were located in high socioeconomic areas, there was a modest difference in adjusted 2-year survival for lung cancer patients based on patient socioeconomic status, at 12% for lowest and 14% for highest. But when hospitals were located in low socioeconomic areas, adjusted 2-year survival was 8% for those in the lowest socioeconomic group and 3% for those in the highest socioeconomic group.

Dr. Wong reported having no relevant financial disclosures.

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 –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 –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 - Screening for ovarian cancer did not reduce the risk of dying from the disease for women with average risk, according to results of a multicenter screening study of nearly 80,000 women.

Screening nearly 40,000 post-menopausal women with transvaginal ultrasound for 4 years and CA-124 for 6 years did not decrease ovarian cancer mortality compared to nearly 40,000 control women. Further, there was evidence of harm in the 3,285 women with false positive results; 1080 women had surgery and 163 of them had 222 major complications, according to Dr. Saundra Buys, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, whose presentation of the data was given on June 4 at the annual meeting of the American Society of Clinical Oncology. The study appears in the June 8 issue of JAMA (2011;305:2295-303). 

Among women who underwent screening, 118 died of ovarian cancer, whereas 100 women who received usual care died as a result of the disease. The difference was not significant.

"It is possible that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening," Dr. Buys said.

More ovarian cancers were diagnosed in the screened women (212 vs. 176), although this difference was not significant. This suggests "that some of the additional cancers detected by screening were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their lifetimes," for example, with overdiagnosis, the researchers observed. Stage III and IV cancers were the most common in each group (77% of the screening group and 78% of the usual care group).

The women in this study were part of the PLCO (Prostate, Lung, Colorectal and Ovarian) cancer screening trial. In all, 68,557 women aged 55-74 years were assigned to either annual screening (34,253 women) or usual care (34,304 women) in 1993-2001 and remained in the analysis. Women in the screening arm were offered annual CA 125 testing for 6 years and transvaginal ultrasound for 4 years. Those in the usual care arm were not offered the screening tests. The median follow-up was 12.4 years.

Women with a CA 125 level of 35 U/mL or greater were classified as abnormal. Transvaginal ultrasound was conducted using a 5-7.5 MHz transvaginal probe. Results were considered abnormal if the ovarian volume was greater than 10 cm³, if the cyst volume was greater than 10 cm³, if any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size was present, or if any mixed (solid and cystic) component within a cystic ovarian tumor was present.

Both the women and their physicians were notified in writing about suspicious abnormalities found through screening. The women’s primary care physicians were responsible for managing the diagnostic process to assess abnormalities.

Among women in the screening arm, there were a greater number of false positives (3,285 false positives vs. 212 true positives). Of women who had a false positive test, one-third (1,080 women) underwent surgery for biopsy to evaluate positive test results. Of these, 163 (15%) women had 222 distinct major complications.

One of the authors, Jonathan D. Clapp, reported having a financial interest in Human Genome Sciences Inc. The other authors reported that they had no relevant financial relationships. The National Cancer Institute funded the PLCO cancer screening trial.

Kerri Wachter contributed to this article.

CHICAGO - Screening for ovarian cancer did not reduce the risk of dying from the disease for women with average risk, according to results of a multicenter screening study of nearly 80,000 women.

Screening nearly 40,000 post-menopausal women with transvaginal ultrasound for 4 years and CA-124 for 6 years did not decrease ovarian cancer mortality compared to nearly 40,000 control women. Further, there was evidence of harm in the 3,285 women with false positive results; 1080 women had surgery and 163 of them had 222 major complications, according to Dr. Saundra Buys, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, whose presentation of the data was given on June 4 at the annual meeting of the American Society of Clinical Oncology. The study appears in the June 8 issue of JAMA (2011;305:2295-303). 

Among women who underwent screening, 118 died of ovarian cancer, whereas 100 women who received usual care died as a result of the disease. The difference was not significant.

"It is possible that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening," Dr. Buys said.

More ovarian cancers were diagnosed in the screened women (212 vs. 176), although this difference was not significant. This suggests "that some of the additional cancers detected by screening were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their lifetimes," for example, with overdiagnosis, the researchers observed. Stage III and IV cancers were the most common in each group (77% of the screening group and 78% of the usual care group).

The women in this study were part of the PLCO (Prostate, Lung, Colorectal and Ovarian) cancer screening trial. In all, 68,557 women aged 55-74 years were assigned to either annual screening (34,253 women) or usual care (34,304 women) in 1993-2001 and remained in the analysis. Women in the screening arm were offered annual CA 125 testing for 6 years and transvaginal ultrasound for 4 years. Those in the usual care arm were not offered the screening tests. The median follow-up was 12.4 years.

Women with a CA 125 level of 35 U/mL or greater were classified as abnormal. Transvaginal ultrasound was conducted using a 5-7.5 MHz transvaginal probe. Results were considered abnormal if the ovarian volume was greater than 10 cm³, if the cyst volume was greater than 10 cm³, if any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size was present, or if any mixed (solid and cystic) component within a cystic ovarian tumor was present.

Both the women and their physicians were notified in writing about suspicious abnormalities found through screening. The women’s primary care physicians were responsible for managing the diagnostic process to assess abnormalities.

Among women in the screening arm, there were a greater number of false positives (3,285 false positives vs. 212 true positives). Of women who had a false positive test, one-third (1,080 women) underwent surgery for biopsy to evaluate positive test results. Of these, 163 (15%) women had 222 distinct major complications.

One of the authors, Jonathan D. Clapp, reported having a financial interest in Human Genome Sciences Inc. The other authors reported that they had no relevant financial relationships. The National Cancer Institute funded the PLCO cancer screening trial.

Kerri Wachter contributed to this article.

CHICAGO - Screening for ovarian cancer did not reduce the risk of dying from the disease for women with average risk, according to results of a multicenter screening study of nearly 80,000 women.

Screening nearly 40,000 post-menopausal women with transvaginal ultrasound for 4 years and CA-124 for 6 years did not decrease ovarian cancer mortality compared to nearly 40,000 control women. Further, there was evidence of harm in the 3,285 women with false positive results; 1080 women had surgery and 163 of them had 222 major complications, according to Dr. Saundra Buys, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, whose presentation of the data was given on June 4 at the annual meeting of the American Society of Clinical Oncology. The study appears in the June 8 issue of JAMA (2011;305:2295-303). 

Among women who underwent screening, 118 died of ovarian cancer, whereas 100 women who received usual care died as a result of the disease. The difference was not significant.

"It is possible that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening," Dr. Buys said.

More ovarian cancers were diagnosed in the screened women (212 vs. 176), although this difference was not significant. This suggests "that some of the additional cancers detected by screening were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their lifetimes," for example, with overdiagnosis, the researchers observed. Stage III and IV cancers were the most common in each group (77% of the screening group and 78% of the usual care group).

The women in this study were part of the PLCO (Prostate, Lung, Colorectal and Ovarian) cancer screening trial. In all, 68,557 women aged 55-74 years were assigned to either annual screening (34,253 women) or usual care (34,304 women) in 1993-2001 and remained in the analysis. Women in the screening arm were offered annual CA 125 testing for 6 years and transvaginal ultrasound for 4 years. Those in the usual care arm were not offered the screening tests. The median follow-up was 12.4 years.

Women with a CA 125 level of 35 U/mL or greater were classified as abnormal. Transvaginal ultrasound was conducted using a 5-7.5 MHz transvaginal probe. Results were considered abnormal if the ovarian volume was greater than 10 cm³, if the cyst volume was greater than 10 cm³, if any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size was present, or if any mixed (solid and cystic) component within a cystic ovarian tumor was present.

Both the women and their physicians were notified in writing about suspicious abnormalities found through screening. The women’s primary care physicians were responsible for managing the diagnostic process to assess abnormalities.

Among women in the screening arm, there were a greater number of false positives (3,285 false positives vs. 212 true positives). Of women who had a false positive test, one-third (1,080 women) underwent surgery for biopsy to evaluate positive test results. Of these, 163 (15%) women had 222 distinct major complications.

One of the authors, Jonathan D. Clapp, reported having a financial interest in Human Genome Sciences Inc. The other authors reported that they had no relevant financial relationships. The National Cancer Institute funded the PLCO cancer screening trial.

Kerri Wachter contributed to this article.

CHICAGO - Screening for ovarian cancer did not reduce the risk of dying from the disease for women with average risk, according to results of a multicenter screening study of nearly 80,000 women.

Screening nearly 40,000 post-menopausal women with transvaginal ultrasound for 4 years and CA-124 for 6 years did not decrease ovarian cancer mortality compared to nearly 40,000 control women. Further, there was evidence of harm in the 3,285 women with false positive results; 1080 women had surgery and 163 of them had 222 major complications, according to Dr. Saundra Buys, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, whose presentation of the data was given on June 4 at the annual meeting of the American Society of Clinical Oncology. The study appears in the June 8 issue of JAMA (2011;305:2295-303). 

Among women who underwent screening, 118 died of ovarian cancer, whereas 100 women who received usual care died as a result of the disease. The difference was not significant.

"It is possible that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening," Dr. Buys said.

More ovarian cancers were diagnosed in the screened women (212 vs. 176), although this difference was not significant. This suggests "that some of the additional cancers detected by screening were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their lifetimes," for example, with overdiagnosis, the researchers observed. Stage III and IV cancers were the most common in each group (77% of the screening group and 78% of the usual care group).

The women in this study were part of the PLCO (Prostate, Lung, Colorectal and Ovarian) cancer screening trial. In all, 68,557 women aged 55-74 years were assigned to either annual screening (34,253 women) or usual care (34,304 women) in 1993-2001 and remained in the analysis. Women in the screening arm were offered annual CA 125 testing for 6 years and transvaginal ultrasound for 4 years. Those in the usual care arm were not offered the screening tests. The median follow-up was 12.4 years.

Women with a CA 125 level of 35 U/mL or greater were classified as abnormal. Transvaginal ultrasound was conducted using a 5-7.5 MHz transvaginal probe. Results were considered abnormal if the ovarian volume was greater than 10 cm³, if the cyst volume was greater than 10 cm³, if any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size was present, or if any mixed (solid and cystic) component within a cystic ovarian tumor was present.

Both the women and their physicians were notified in writing about suspicious abnormalities found through screening. The women’s primary care physicians were responsible for managing the diagnostic process to assess abnormalities.

Among women in the screening arm, there were a greater number of false positives (3,285 false positives vs. 212 true positives). Of women who had a false positive test, one-third (1,080 women) underwent surgery for biopsy to evaluate positive test results. Of these, 163 (15%) women had 222 distinct major complications.

One of the authors, Jonathan D. Clapp, reported having a financial interest in Human Genome Sciences Inc. The other authors reported that they had no relevant financial relationships. The National Cancer Institute funded the PLCO cancer screening trial.

Kerri Wachter contributed to this article.

CHICAGO - Screening for ovarian cancer did not reduce the risk of dying from the disease for women with average risk, according to results of a multicenter screening study of nearly 80,000 women.

Screening nearly 40,000 post-menopausal women with transvaginal ultrasound for 4 years and CA-124 for 6 years did not decrease ovarian cancer mortality compared to nearly 40,000 control women. Further, there was evidence of harm in the 3,285 women with false positive results; 1080 women had surgery and 163 of them had 222 major complications, according to Dr. Saundra Buys, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, whose presentation of the data was given on June 4 at the annual meeting of the American Society of Clinical Oncology. The study appears in the June 8 issue of JAMA (2011;305:2295-303). 

Among women who underwent screening, 118 died of ovarian cancer, whereas 100 women who received usual care died as a result of the disease. The difference was not significant.

"It is possible that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening," Dr. Buys said.

More ovarian cancers were diagnosed in the screened women (212 vs. 176), although this difference was not significant. This suggests "that some of the additional cancers detected by screening were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their lifetimes," for example, with overdiagnosis, the researchers observed. Stage III and IV cancers were the most common in each group (77% of the screening group and 78% of the usual care group).

The women in this study were part of the PLCO (Prostate, Lung, Colorectal and Ovarian) cancer screening trial. In all, 68,557 women aged 55-74 years were assigned to either annual screening (34,253 women) or usual care (34,304 women) in 1993-2001 and remained in the analysis. Women in the screening arm were offered annual CA 125 testing for 6 years and transvaginal ultrasound for 4 years. Those in the usual care arm were not offered the screening tests. The median follow-up was 12.4 years.

Women with a CA 125 level of 35 U/mL or greater were classified as abnormal. Transvaginal ultrasound was conducted using a 5-7.5 MHz transvaginal probe. Results were considered abnormal if the ovarian volume was greater than 10 cm³, if the cyst volume was greater than 10 cm³, if any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size was present, or if any mixed (solid and cystic) component within a cystic ovarian tumor was present.

Both the women and their physicians were notified in writing about suspicious abnormalities found through screening. The women’s primary care physicians were responsible for managing the diagnostic process to assess abnormalities.

Among women in the screening arm, there were a greater number of false positives (3,285 false positives vs. 212 true positives). Of women who had a false positive test, one-third (1,080 women) underwent surgery for biopsy to evaluate positive test results. Of these, 163 (15%) women had 222 distinct major complications.

One of the authors, Jonathan D. Clapp, reported having a financial interest in Human Genome Sciences Inc. The other authors reported that they had no relevant financial relationships. The National Cancer Institute funded the PLCO cancer screening trial.

Kerri Wachter contributed to this article.

CHICAGO - Screening for ovarian cancer did not reduce the risk of dying from the disease for women with average risk, according to results of a multicenter screening study of nearly 80,000 women.

Screening nearly 40,000 post-menopausal women with transvaginal ultrasound for 4 years and CA-124 for 6 years did not decrease ovarian cancer mortality compared to nearly 40,000 control women. Further, there was evidence of harm in the 3,285 women with false positive results; 1080 women had surgery and 163 of them had 222 major complications, according to Dr. Saundra Buys, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, whose presentation of the data was given on June 4 at the annual meeting of the American Society of Clinical Oncology. The study appears in the June 8 issue of JAMA (2011;305:2295-303). 

Among women who underwent screening, 118 died of ovarian cancer, whereas 100 women who received usual care died as a result of the disease. The difference was not significant.

"It is possible that even an optimized program of annual screening may be insufficient to detect cancers early enough to reduce mortality. Evidence from modeling suggests that aggressive cancers progress rapidly through the early stages, limiting the ability to detect these cancers with yearly screening," Dr. Buys said.

More ovarian cancers were diagnosed in the screened women (212 vs. 176), although this difference was not significant. This suggests "that some of the additional cancers detected by screening were not clinically important and, if left undetected, may never have caused any symptoms or affected the women during their lifetimes," for example, with overdiagnosis, the researchers observed. Stage III and IV cancers were the most common in each group (77% of the screening group and 78% of the usual care group).

The women in this study were part of the PLCO (Prostate, Lung, Colorectal and Ovarian) cancer screening trial. In all, 68,557 women aged 55-74 years were assigned to either annual screening (34,253 women) or usual care (34,304 women) in 1993-2001 and remained in the analysis. Women in the screening arm were offered annual CA 125 testing for 6 years and transvaginal ultrasound for 4 years. Those in the usual care arm were not offered the screening tests. The median follow-up was 12.4 years.

Women with a CA 125 level of 35 U/mL or greater were classified as abnormal. Transvaginal ultrasound was conducted using a 5-7.5 MHz transvaginal probe. Results were considered abnormal if the ovarian volume was greater than 10 cm³, if the cyst volume was greater than 10 cm³, if any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size was present, or if any mixed (solid and cystic) component within a cystic ovarian tumor was present.

Both the women and their physicians were notified in writing about suspicious abnormalities found through screening. The women’s primary care physicians were responsible for managing the diagnostic process to assess abnormalities.

Among women in the screening arm, there were a greater number of false positives (3,285 false positives vs. 212 true positives). Of women who had a false positive test, one-third (1,080 women) underwent surgery for biopsy to evaluate positive test results. Of these, 163 (15%) women had 222 distinct major complications.

One of the authors, Jonathan D. Clapp, reported having a financial interest in Human Genome Sciences Inc. The other authors reported that they had no relevant financial relationships. The National Cancer Institute funded the PLCO cancer screening trial.

Kerri Wachter contributed to this article.

The meningococcal disease vaccine Menactra is approved for use in children as young as 9 months old, the Food and Drug Administration announced April 22.

Previously, the vaccine was approved for use in people ages 2 through 55 years.

Menactra (Sanofi Pasteur Inc.) is approved for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Neisseria meningitidis is a leading cause of meningitis in young children. About 15% of people who develop meningococcal disease die from the infection; another 10%-20% experience complications, according to the agency.

"The highest rate of meningococcal disease occurs in children under 1 year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement issued by the agency.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which more than 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability.

Menactra is given as a two-dose series beginning at 9 months, 3 months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

The meningococcal disease vaccine Menactra is approved for use in children as young as 9 months old, the Food and Drug Administration announced April 22.

Previously, the vaccine was approved for use in people ages 2 through 55 years.

Menactra (Sanofi Pasteur Inc.) is approved for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Neisseria meningitidis is a leading cause of meningitis in young children. About 15% of people who develop meningococcal disease die from the infection; another 10%-20% experience complications, according to the agency.

"The highest rate of meningococcal disease occurs in children under 1 year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement issued by the agency.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which more than 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability.

Menactra is given as a two-dose series beginning at 9 months, 3 months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

The meningococcal disease vaccine Menactra is approved for use in children as young as 9 months old, the Food and Drug Administration announced April 22.

Previously, the vaccine was approved for use in people ages 2 through 55 years.

Menactra (Sanofi Pasteur Inc.) is approved for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Neisseria meningitidis is a leading cause of meningitis in young children. About 15% of people who develop meningococcal disease die from the infection; another 10%-20% experience complications, according to the agency.

"The highest rate of meningococcal disease occurs in children under 1 year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement issued by the agency.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which more than 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability.

Menactra is given as a two-dose series beginning at 9 months, 3 months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

INTERNAL MEDICINE NEWS is changing its look and content to meet your information needs.

Over the last year, we listened as our readers and editorial advisers described how they want to read the news.

You told us that you want a front page that offers information about what's inside each issue.

You want news reports that allow you to see at a glance the article's most salient point as well as the source and strength of the data.

You want transparency regarding conflicts of interest.

You value more perspectives on the news from both peers and experts as well as insights on how new findings might affect your practice.

We heard you.

The front page now features “What's New,” offering brief article summaries that will help you navigate the publication.

Inside, you'll find “Vitals.” These handy boxes give a quick overview of an article's major finding, data source, and disclosures. You'll see a few “Vitals” boxes in this issue and more in the months to come.

“My Take” boxes will accompany selected articles; they will underline take-home messages and provide contrasting viewpoints on the news. [email protected]

INTERNAL MEDICINE NEWS is changing its look and content to meet your information needs.

Over the last year, we listened as our readers and editorial advisers described how they want to read the news.

You told us that you want a front page that offers information about what's inside each issue.

You want news reports that allow you to see at a glance the article's most salient point as well as the source and strength of the data.

You want transparency regarding conflicts of interest.

You value more perspectives on the news from both peers and experts as well as insights on how new findings might affect your practice.

We heard you.

The front page now features “What's New,” offering brief article summaries that will help you navigate the publication.

Inside, you'll find “Vitals.” These handy boxes give a quick overview of an article's major finding, data source, and disclosures. You'll see a few “Vitals” boxes in this issue and more in the months to come.

“My Take” boxes will accompany selected articles; they will underline take-home messages and provide contrasting viewpoints on the news. [email protected]

INTERNAL MEDICINE NEWS is changing its look and content to meet your information needs.

Over the last year, we listened as our readers and editorial advisers described how they want to read the news.

You told us that you want a front page that offers information about what's inside each issue.

You want news reports that allow you to see at a glance the article's most salient point as well as the source and strength of the data.

You want transparency regarding conflicts of interest.

You value more perspectives on the news from both peers and experts as well as insights on how new findings might affect your practice.

We heard you.

The front page now features “What's New,” offering brief article summaries that will help you navigate the publication.

Inside, you'll find “Vitals.” These handy boxes give a quick overview of an article's major finding, data source, and disclosures. You'll see a few “Vitals” boxes in this issue and more in the months to come.

“My Take” boxes will accompany selected articles; they will underline take-home messages and provide contrasting viewpoints on the news. [email protected]