Doxorubicin-containing regimen with or without interferon alfa-2b for advanced follicular lymphomas:: Final analysis of survival and toxicity in the Groupe d'Etude des Lymphomes Folliculaires 86 trial

Purpose: To compare progression-free survival (PFS), overall survival (OS), and toxicity of a doxorubicin-containing regimen administered alone or in combination with interferon alfa-2b (IFN alpha) in patients with low-grade follicular lymphoma (FL) and poor prognostic factors. Patients and Methods: Two hundred sixty-eight patients with advanced-stage FL received cyclophosphamide, doxorubicin, teniposide, and prednisone (CHVP) monthly for 6 months, then every 2 months for 12 months. After randomization, 242 patients were evaluated for efficacy: 119 received CHVP alone, and 123 also received IFN alpha at a dose of 5 million units three times weekly for 18 months. Results: After a 6-year median follow-vp, the patients treated with CHVP + IFN alpha showed significantly longer median PFS than those who received CHVP alone (2.9 years v 1.5 years, respectively; P = .0002) and significantly longer median OS (not reached v 5.6 years, respectively; P = .008). Although some side effects, which included neutropenia, asthenia, fever, elevated serum transaminase levels, flu-like symptoms, and thrombocytopenia, were more frequently observed in patients who received the combination regimen, these reactions were moderate. IFN alpha was withdrawn because of toxicity in 10% of the patients, and a dosage reduction or temporary suspension was required in 28%. Conclusion: With long-term follow-vp of 6 years, these results confirm that the addition of IFN alpha to a doxorubicin-containing regimen for patients with advanced-stage and clinically aggressive FL not only increased PFS, as in most other similar trials, but also prolonged OS. Toxicity was moderate. The beneficial effects of this combined chemotherapy and IFN alpha regimen on OS probably reflect the selection of FL patients with poor prognostic factors. (C) 1998 by American Society of Clinical Oncology.