Journal of Clinical Oncology, Vol 18, Issue 10
(May), 2000: 2010-2016
© 2000 American Society for Clinical Oncology
Interferon Alfa Consolidation After Intensive Chemotherapy Does Not Prolong the Progression-Free Survival of Patients With Low-Grade Non-Hodgkin’s Lymphoma: Results of the Southwest Oncology Group Randomized Phase III Study 8809
By Richard I. Fisher,
Bruce W. Dana,
Michael LeBlanc,
Carl Kjeldsberg,
Jeffrey D. Forman,
Joseph M. Unger,
Stanley P. Balcerzak,
Ellen R. Gaynor,
Vivek Roy,
Thomas Miller
From the Loyola University Stritch School of Medicine, Maywood, IL; Columbia River CCOP, Portland, OR; Southwest Oncology Group Statistical Center, Seattle, WA; University of Utah Medical Center, Salt lake City, UT; Wayne State University, Karmanos Cancer Center, Detroit, MI; Ohio State University Health Center, Columbus, OH; University of Oklahoma Health Science Center, Oklahoma City, OK; and University of Arizona Cancer Center, Tucson, AZ.
Address reprint requests to Southwest Oncology Group (SWOG-8809), Operations Office, 14980 Omicron Dr, San Antonio, TX 78245-3217.
PURPOSE: S8809 is a randomized phase III trial determining whether intensive cytoreductive treatment, followed by interferon consolidation at the time of minimal residual disease, prolongs the progression-free survival (PFS) or overall survival (OS) of indolent lymphoma patients.
PATIENTS AND METHODS: Five hundred seventy-one patients with previously untreated stage III or IV low-grade non-Hodgkin’s lymphoma were registered. Patients received six to eight cycles of prednisone, methotrexate, doxorubicin, cyclophosphamide, and etoposide/mechlorethamine, vincristine, procarbazine, and prednisone (ProMACE[day 1]-MOPP[day 8]) chemotherapy or chemotherapy plus radiotherapy. Responding patients were randomized to observation alone or to interferon consolidation. Interferon alfa-2b 2 mU/m2 was given subcutaneously three times weekly for 2 years.
RESULTS: Two hundred sixty-eight eligible patients were randomized to interferon alfa consolidation (n = 144) or observation alone (n = 124). With a median follow-up time from randomization among patients still alive of 6.2 years, the median PFS time was 4.1 years for patients who received interferon consolidation therapy and 3.2 years for patients who were observed after ProMACE-MOPP induction (P = .25). The adjusted hazard ratio for relapse for observation to interferon was 0.83 (95% confidence interval [CI], 0.61 to 1.13). The median OS has not been reached in either group. At 5 years, OS is 78% for the interferon group and 77% for the observation group (P = .65). The adjusted hazard ratio for survival for observation to interferon is 1.11 (95% CI, 0.69 to 1.79).
CONCLUSION: Interferon alfa consolidation therapy after intensive treatment with anthracycline-containing combination chemotherapy and involved-field radiation therapy does not prolong the PFS or OS of patients with low-grade non-Hodgkin’s lymphoma.
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