Phase II study of interferon gamma in malignant XXXX (E9292): a trial of the Eastern Cooperative Oncology Group.

@entity1 @entity137 @entity5 @entity379 @entity3028
PURPOSE: To determine the safety and efficacy of treatment with gamma interferon ( @entity379 ) in @entity1 with metastatic @entity5 . @entity1 AND METHODS: 51 @entity1 were enrolled on this Phase II Eastern Cooperative Oncology Group (ECOG) study. Seventy five percent of them had hormonally active @entity5 . Treatment consisted of @entity379 subcutaneously at a daily dose of 0.1 mg/m(2). Patents were evaluated for @entity137 weekly for the first month and monthly thereafter; response was determined radiologically every 8 weeks. RESULTS: @entity1 received treatment with @entity379 for a median of 17.9 weeks (range 2-175). @entity137 was generally mild and expected: 61% experienced noninfected fever and 21% developed @entity3028 . Three @entity1 (6%) had a partial response; there were no complete responses. Median time to progression was 5.5 months (95% confidence interval 3.9-11.1). The 1-year progression free rate was 28% (13.4-43.4%). Median survival was 42 months, with a 1-year survival rate of 67% (53.3-80%). DISCUSSION: This Phase II study demonstrated that therapy with @entity379 in @entity1 with metastatic @entity5 was well-tolerated, but did not produce significant antitumor effects. The overall results were somewhat comparable to those previously seen with alpha interferons as well as cytotoxic drugs.
