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Adjuvant Immunotherapy of Resected, Intermediate-Thickness, Node-Negative Melanoma With an Allogeneic Tumor Vaccine: Overall Results of a Randomized Trial of the Southwest Oncology Group

From the University of Michigan Comprehensive Cancer Center, Ann Arbor, and the Karmanos Cancer Institute of the Wayne State University, Detroit, MI; the Statistical Center of the Southwest Oncology Group and the University of Washington, Seattle, WA; the Cleveland Clinic Foundation, Cleveland, OH; the University of Southern California, Los Angeles, and the University of California at Irvine, Orange, CA; Vanderbilt University, Nashville, TN; the University of Texas at San Antonio, San Antonio, TX; and the University of Utah, Salt Lake City, UT.

Address reprint requests to Publications Specialist, Southwest Oncology Group (SWOG-9035), 14980 Omicron Dr, San Antonio, TX 78245-3217.

PURPOSE: Patients with clinically negative nodes constitute over 85% of new melanoma cases. There is no adjuvant therapy for intermediate-thickness, node-negative melanoma patients.

PATIENTS AND METHODS: The Southwest Oncology Group conducted a randomized phase III trial of an allogeneic melanoma vaccine for 2 years versus observation in patients with intermediate-thickness (1.5 to 4.0 mm or Clark’s level IV if thickness unknown), clinically or pathologically node-negative melanoma (T3N0M0).

RESULTS: Six hundred eighty-nine patients were accrued over 4.5 years; 89 patients (13%) were ineligible. Surgical node staging was performed in 24%, the remainder were clinical N0. Thirteen eligible patients refused assigned treatment: seven on the observation arm and six on the vaccine arm. Most vaccine patients experienced mild to moderate local toxicity, but 26 (9%) experienced grade 3 toxicity. After a median follow-up of 5.6 years, there were 107 events (tumor recurrences or deaths) among the 300 eligible patients randomized to vaccine compared with 114 among the 300 eligible patients randomized to observation (hazard ratio, 0.92; Cox-adjusted P₂ = 0.51). There was no difference in vaccine efficacy among patients with tumors 3 mm or > 3 mm.

CONCLUSION: This represents one of the largest randomized, controlled trials of adjuvant vaccine therapy in human cancer reported to date. Compliance with randomization was excellent, with only 2% refusing assigned therapy. There is no evidence of improved disease-free survival among patients randomized to receive vaccine, although the power to detect a small but clinically significant difference was low. Future investigations of adjuvant vaccine approaches for patients with intermediate-thickness melanoma should involve larger numbers of patients and ideally should include sentinel node biopsy staging.

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