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

Author:

Sondak Vernon K.1,Liu P.-Y.1,Tuthill Ralph J.1,Kempf Raymond A.1,Unger Joseph M.1,Sosman Jeffrey A.1,Thompson John A.1,Weiss Geoffrey R.1,Redman Bruce G.1,Jakowatz James G.1,Noyes R. Dirk1,Flaherty Lawrence E.1

Affiliation:

1. 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...

Abstract

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Reference20 articles.

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