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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

647 Scopus citations

Abstract

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 14 and 7 months (P = .14), 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.

Original languageEnglish (US)
Pages (from-to)133-141
Number of pages9
JournalJournal of Clinical Oncology
Volume23
Issue number1
DOIs
StatePublished - Jan 1 2005

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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