A phase II study of neoadjuvant biochemotherapy for stage III melanoma

Abstract

BACKGROUND Phase II studies of biochemotherapy (combining interleukin‐2, interferon‐α, 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/m² intravenously (i.v.), on Days 1–4; vinblastine, 1.6 mg/m² i.v., on Days 1–4; dacarbazine, 800 mg/m² i.v., on Day 1; interleukin‐2, 9 × 10⁶ IU/m²/day i.v. over 24 hours, on Days 1–4; and interferon‐α, 5 × 10⁶ IU/m²/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 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 appears to have promising activity in patients with Stage III melanoma. A larger multicenter study currently is underway to explore this approach further. Cancer 2002;94:470–6. © 2002 American Cancer Society.