Journal of Clinical Oncology, Vol 21, Issue 7
(April), 2003: 1214-1222
© 2003 American Society for Clinical Oncology
Phase III Study of Interferon Alfa-NL as Adjuvant Treatment for Resectable Renal Cell Carcinoma: An Eastern Cooperative Oncology Group/Intergroup Trial
Edward M. Messing,
Judith Manola,
George Wilding,
Kathleen Propert,
Jonathan Fleischmann,
E. David Crawford,
J. Edson Pontes,
Richard Hahn,
Donald Trump
From the University of Rochester School of Medicine and Dentistry, Rochester, NY; Dana-Farber Cancer Institute, Boston, MA; University of Wisconsin Comprehensive Cancer Center, Madison, WI; University of Pennsylvania School of Medicine, Philadelphia, PA; Einstein and New York Westchester Square, Bronx; Roswell Park Cancer Institute, Buffalo, NY; University of Colorado School of Medicine, Denver, CO; Wayne State University School of Medicine, Detroit, MI; The Mayo Clinic, Rochester, MN.
Address reprint requests to Edward M. Messing, MD, University of Rochester, 601 Elmwood Ave, Box 656, Rochester, NY 14642; email: edward_messing{at}urmc.rochester.edu.
Purpose: To evaluate the role of adjuvant interferon alfa after complete resection of locally extensive renal cell carcinoma.
Patients and Methods: A total of 283 eligible patients with pT3–4a and/or node-positive disease were randomly assigned after radical nephrectomy and lymphadenectomy to observation or to interferon alfa-NL (Wellferon, Burroughs-Wellcome, Research Park, NC) given daily for 5 days every 3 weeks for up to 12 cycles. Patients were stratified on the basis of pathologic stage. Patients remained on treatment until documented recurrence, excessive toxicity, or patient/physician preference deemed removal appropriate.
Results: At median follow-up of 10.4 years, median survival was 7.4 years in the observation arm and 5.1 year in the treatment arm (log-rank P = .09). Median recurrence-free survival was 3.0 years in the observation arm and 2.2 years in the interferon arm (P = .33). Performance status (P = .003), nodal status (N2 v N0, P < .0001), and tumor stage (P = .0002) were significant prognostic factors in multivariate analysis. A proportional hazards model examining the effects of treatment arm and time to recurrence on survival after recurrence among patients who recurred found that random assignment to interferon treatment (P = .009) and shorter time to recurrence (P < .0001) were independent predictors of shorter survival after recurrence. Although no lethal toxicities were observed, severe (grade 4) toxicities including neutropenia, myalgia, fatigue, depression, and other neurologic toxicities occurred in 11.4% of those randomly assigned to interferon treatment.
Conclusion: Adjuvant treatment with interferon did not contribute to survival or relapse-free survival in this group of patients.
Supported by grant no. CA-23318, awarded by the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD.
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