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Journal of Clinical Oncology, Vol 21, Issue 16 (August), 2003: 3127-3132
© 2003 American Society for Clinical Oncology

Randomized Study of High-Dose and Low-Dose Interleukin-2 in Patients With Metastatic Renal Cancer

James C. Yang, Richard M. Sherry, Seth M. Steinberg, Suzanne L. Topalian, Douglas J. Schwartzentruber, Patrick Hwu, Claudia A. Seipp, Linda Rogers-Freezer, Kathleen E. Morton, Donald E. White, David J. Liewehr, Maria J. Merino, Steven A. Rosenberg

From the Surgery Branch, Biostatistics and Data Management Section, Department of Pathology, National Cancer Institute, Bethesda, MD.

Address reprint requests to James C. Yang, MD, Room 2B-37, Building 10, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892; email: james_yang{at}nih.gov.

Purpose: This three-arm randomized study compares response rates and overall survival of patients with metastatic renal cell cancer (RCC) receiving high-dose or one of two low-dose interleukin-2 (IL-2) regimens.

Patients and Methods: Patients with measurable metastatic RCC and a good performance status were randomized to receive either 720,000 U/kg (high-dose [HD]) or 72,000 U/kg (low-dose [LD]), both given by intravenous (IV) bolus every 8 hours. After randomly assigning 117 patients, a third arm of low-dose daily subcutaneous IL-2 was added, and an additional 283 patients were randomly assigned.

Results: A total of 156 patients were randomly assigned to HD IV IL-2, and 150 patients to LD IV IL-2. Toxicities were less frequent with LD IV IL-2 (especially hypotension), but there were no IL-2-related deaths in any arm. There was a higher response proportion with HD IV IL-2 (21%) versus LD IV IL-2 (13%; P = .048) but no overall survival difference. The response rate of subcutaneous IL-2 (10%, partial response and complete response) was similar to that of LD IV IL-2, differing from HD IV (P = .033). Response durability and survival in completely responding patients was superior with HD IV compared with LD IV therapy (P = .04).

Conclusion: Major tumor regressions, as well as complete responses, were seen with all regimens tested. IL-2 was more clinically active at maximal doses, although this did not produce an overall survival benefit. The immunological factors which constrain the curative potential of IL-2 to only a small percentage of patients need to be further elucidated.

Presented at the Society of Biological Therapy Annual Meeting, San Diego, CA, November 8–10, 2002.


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