A phase II study of neoadjuvant biochemotherapy for stage III melanoma

BACKGROUND. Phase II studies of biochemotherapy (combining interleukin-2, interferon-alpha, and multiagent chemotherapy) have reported high response rates and a significant number of durable complete responses in patients with metastatic melanoma. METHODS. A pilot Phase II study was performed to explore the safety and activity of neoadjuvant biochemotherapy in patients with Stage III melanoma. Forty-eight patients were enrolled between April 1996 and May 1999. The median age of the patients was 46 years (range, 19-70 years). Two cycles of biochemotherapy were administered prior to and after complete lymph node dissection, Each cycle was comprised of Cisplatin, 20 mg/m(2) intravenously (i.v.). on Days 1-4: vinblastine, 1.6 mg/m(2) i.v., on Days 1-4; dacarbazine, 800 mg/m(2) i.v,, on Day 1: interleukin-2, 9 X 10(6) IU/m(2)/day i.v. over 24 hours, on Days 1-4; and interferon-alpha, 5 x 10(6) IU/m(2)/day subcutaneously, on Days 1-5, every 3 weeks. Twelve patients did not have measurable disease. All patients were evaluable for toxicity and survival. RESULTS. Clinical responses were observed in 14 of 36 patients (38.9%) with measurable disease, including 13 partial responses (36.1%) and 1 complete response (2.8%). Complete pathologic responses were noted in 4 patients (11.1%). Toxicity, although severe, was manageable and typically short-lived. There were no Denver, Colorado, treatment-related deaths reported. At a median follow-up of 31 months, 38 Of the 48 patients (79.2%) were alive and 31 patients (64.6%) remained free of disease progression. CONCLUSIONS, Neoadjuvant biochemotherapy appear to have promising activity in patients with Stage III melanoma. A larger multicenter study currently is underway to explore this approach further. (C) 2002 American Cancer Society.