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Randomized Trial of an Allogeneic Melanoma Lysate Vaccine With Low-Dose Interferon Alfa-2b Compared With High-Dose Interferon Alfa-2b for Resected Stage III Cutaneous Melanoma

Malcolm S. Mitchell, Judith Abrams, John A. Thompson, Mohammed Kashani-Sabet, Ronald C. DeConti, Wen-Jen Hwu, Michael B. Atkins, Eric Whitman, Marc S. Ernstoff, Frank G. Haluska, James G. Jakowatz, Tapas K. Das Gupta, Jon M. Richards, Wolfram E. Samlowski, John J. Costanzi, Frederick R. Aronson, Albert B. Deisseroth, Arkadiusz Z. Dudek, Vicky E. Jones

From the University of California, San Diego, School of Medicine and Cancer Center, San Diego; University of California, San Francisco, School of Medicine and Cancer Center, San Francisco; University of California, Irvine Medical School and Cancer Center, Irvine, CA; Karmanos Cancer Institute; Karmanos Cancer Institute, Wayne State University, Detroit; Van Elslander Cancer Center, St John Medical Center, Grosse Pointe Woods, MI; University of Washington School of Medicine, Seattle, WA; Moffitt Cancer Center, University of South Florida, Tampa, FL; Yale Comprehensive Cancer Center, New Haven, CT; Beth Israel Medical Center, Harvard Medical School; Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; The Melanoma Center of St. Louis, St Louis, MO; Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Hanover, NH; University of Illinois at Chicago, Chicago; Oncology Specialists, Park Ridge, IL; Huntsman Cancer Center, University of Utah, Salt Lake City, UT; Lone Star Oncology, Austin, TX; Maine Center for Cancer Medicine, Scarborough, ME; and the University of Minnesota, Minneapolis, MN

Address reprint requests to Malcolm S. Mitchell, MD, University of Texas-El Paso, 500 University Ave, El Paso, TX 79968; e-mail: malcolmsmitchell{at}yahoo.com

Purpose To compare the overall survival (OS) of patients with resected stage III melanoma administered active specific immunotherapy and low-dose interferon alfa-2b (IFN--2b) with the OS achieved using high-dose IFN--2b.

Patients and Methods An Ad Hoc Melanoma Working Group of 25 investigators treated 604 patients from April 1997 to January 2003. Patients were stratified by sex and number of nodes and were randomly assigned to receive either 2 years of treatment with active specific immunotherapy with allogeneic melanoma lysates and low-dose IFN--2b (arm 1) or high-dose IFN--2b alone for 1 year (arm 2). Active specific immunotherapy was injected subcutaneously (SC) weekly for 4 weeks, at week 8, and bimonthly thereafter. IFN--2b SC was begun on week 4 and continued thrice weekly at 5 MU/m² for 2 years. IFN--2b in arm 2 was administered according to the Eastern Cooperative Oncology Group 1684 study regimen.

Results Median follow-up time was 32 months for all patients and 42 months for surviving patients. Median OS time exceeds 84 months in arm 1 and is 83 months in arm 2 (P = .56). Five-year OS rate is 61% in arm 1 and 57% in arm 2. Estimated 5-year relapse-free survival (RFS) rate is 50% in arm 1 and 48% in arm 2, with median RFS times of 58 and 50 months, respectively. The incidence of serious adverse events as a result of treatment was the same in both arms, but more severe neuropsychiatric toxicity was seen in arm 2.

Conclusion OS and RFS achieved by active specific immunotherapy and low-dose IFN--2b were indistinguishable from those achieved by high-dose IFN--2b. Long RFS and OS times were observed in both treatment arms.

Supported by Integrated Therapeutics, Schering-Plough.

An interim analysis was presented at the 36th Annual Meeting of the American Society of Clinical Oncology, May 31-June 3, 2003, Chicago, IL.

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

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