Phase II Study of Interferon Gamma in Malignant Carcinoid Tumors (E9292): A Trial of the Eastern Cooperative Oncology Group

Abstract
Purpose: To determine the safety and efficacy of treatment with gamma interferon (IFNγ) in patients with metastatic carcinoid tumor. Patients and methods: 51 patients were enrolled on this Phase II Eastern Cooperative Oncology Group (ECOG) study. Seventy five percent of them had hormonally active tumors. Treatment consisted of IFNγ subcutaneously at a daily dose of 0.1 mg/m2. Patents were evaluated for toxicity weekly for the first month and monthly thereafter; response was determined radiologically every 8 weeks. Results: Patients received treatment with IFNγ for a median of 17.9 weeks (range 2–175). Toxicity was generally mild and expected: 61% experienced noninfected fever and 21% developed granulocytopenia. Three patients (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 IFNγ in patients with metastatic carcinoid tumor 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.