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Phase II Multicenter Study of Neoadjuvant Biochemotherapy for Patients With Stage III Malignant Melanoma

Karl D. Lewis, William A. Robinson, Martin McCarter, Nathan Pearlman, Steven J. O'Day, Clay Anderson, Thomas T. Amatruda, Anna Baron, Chan Zeng, Maude Becker, Susan Dollarhide, Karen Matijevich, Rene Gonzalez

From the University of Colorado Health Sciences Center, Aurora, CO; The Angeles Clinic and Research Institute, Santa Monica, CA; Ellis Fischel Cancer Center, University of Missouri, Columbia, MO; North Memorial Health Care, Hubert H. Humphrey Cancer Center, Robbinsdale, MN

Address reprint requests to Rene Gonzalez, MD, Anschutz Cancer Pavilion, Mail Stop F703, 1635 N Ursula St, PO Box 6510, Aurora, CO 80045; e-mail: rene.gonzalez{at}uchsc.edu

PURPOSE: To determine the relapse-free survival, overall survival, and response rate of patients with stage III melanoma treated with neoadjuvant biochemotherapy in a multicenter setting.

PATIENTS AND METHODS: Patients with pathologically proven stage III melanoma, either via clinical detection or sentinel lymph node positivity, were eligible for enrollment. Patients received two cycles of preoperative biochemotherapy followed by complete regional lymphadenectomy and two postoperative courses of biochemotherapy. The biochemotherapy regimen consisted of the following: cisplatin 20 mg/m² on days 1 to 4, dacarbazine 800 mg/m² on day 1 only, vinblastine 1.6 mg/m² on days 1 to 4, interleukin-2 total dose of 36 MU/m² during 4 days, and interferon alfa 5 MU/m² on days 1 to 5. Growth factor support was administered with each cycle.

RESULTS: Ninety-two patients were eligible for the study. At a median follow-up of 40.4 months, relapse-free survival and overall survival are 64% and 78%, respectively. There was a lower relapse rate and improved survival for patients with a positive sentinel lymph node compared with patients with clinically detected lymph nodes, although this difference did not reach statistical significance. Of the 50 patients with measurable disease, the overall response rate was 26%. Toxicity of the biochemotherapy was high but generally manageable.

CONCLUSION: The current study has expanded the preliminary evidence on neoadjuvant biochemotherapy for stage III melanoma.

Supported by Grants from Chiron, Amgen, and Schering-Plough, and by University of Colorado Cancer Center core Grant P30 CA046934.

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