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Journal of Clinical Oncology, Vol 23, No 1 (January 1), 2005: pp. 133-141
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.03.206
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Randomized Phase III Trial of High-Dose Interleukin-2 Versus Subcutaneous Interleukin-2 and Interferon in Patients With Metastatic Renal Cell Carcinoma

David F. McDermott, Meredith M. Regan, Joseph I. Clark, Lawrence E. Flaherty, Geoffery R. Weiss, Theodore F. Logan, John M. Kirkwood, Michael S. Gordon, Jeffrey A. Sosman, Marc S. Ernstoff, Christopher P.G. Tretter, Walter J. Urba, John W. Smith, Kim A. Margolin, James W. Mier, Jared A. Gollob, Janice P. Dutcher, Michael B. Atkins

From the Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute, Boston, MA; Loyola University Chicago, Maywood; University of Illinois at Chicago, Chicago, IL; Wayne State University, Detroit, MI; University of Texas, San Antonio, TX; Pittsburgh Cancer Institute, Pittsburgh, PA; Indiana University, Indianapolis, IN; Dartmouth Hitchcock Medical Center, Hanover, NH; Earle Chiles Cancer Center, Portland, OR; City of Hope Comprehensive Cancer Center, Duarte, CA; and Our Lady of Mercy, Bronx, NY

Address reprint requests to David F. McDermott, MD, Department of Medicine, Division of Hematology/Oncology, Beth Israel Deaconess Medical Center, 330 Brookline Ave, E/KS-153, Boston, MA 02215; e-mail: dmcdermo{at}bidmc.harvard.edu

PURPOSE: The Cytokine Working Group conducted a randomized phase III trial to determine the value of outpatient interleukin-2 (IL-2) and interferon alfa-2b (IFN) relative to high-dose (HD) IL-2 in patients with metastatic renal cell carcinoma.

PATIENTS AND METHODS: Patients were stratified for bone and liver metastases, primary tumor in place, and Eastern Cooperative Oncology Group performance status 0 or 1 and then randomly assigned to receive either IL-2 (5 MIU/m2 subcutaneously every 8 hours for three doses on day 1, then daily 5 days/wk for 4 weeks) and IFN (5 MIU/m2 subcutaneously three times per week for 4 weeks) every 6 weeks or HD IL-2 (600,000 U/kg/dose intravenously every 8 hours on days 1 through 5 and 15 to 19 [maximum 28 doses]) every 12 weeks.

RESULTS: One hundred ninety-two patients were enrolled between April 1997 and July 2000. Toxicities were as anticipated for these regimens. The response rate was 23.2% (22 of 95 patients) for HD IL-2 versus 9.9% (nine of 91 patients) for IL-2/IFN (P = .018). Ten patients receiving HD IL-2 were progression-free at 3 years versus three patients receiving IL-2 and IFN (P = .082). The median response durations were 24 and 15 months (P = .18), and median survivals were 17.5 and 13 months (P = .24). For patients with bone or liver metastases (P = .001) or a primary tumor in place (P = .040), survival was superior with HD IL-2.

CONCLUSION: This randomized phase III trial provides additional evidence that HD IL-2 should remain the preferred therapy for selected patients with metastatic renal cell carcinoma.

Supported in part by grants to each institution from Chiron Therapeutics, Division of Chiron Corporation, Emeryville, CA; and Schering Plough Corporation, Kenilworth, NJ.

Presented at the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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