A phase II study of neoadjuvant biochemotherapy for stage III melanoma

Cancer. 2002 Jan 15;94(2):470-6. doi: 10.1002/cncr.10186.

Abstract

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/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 x 10(6) IU/m2/day i.v. over 24 hours, on Days 1-4; and interferon-alpha, 5 x 10(6) 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Dacarbazine / administration & dosage
  • Dacarbazine / adverse effects
  • Disease Progression
  • Female
  • Granulocyte Colony-Stimulating Factor / administration & dosage
  • Granulocyte Colony-Stimulating Factor / adverse effects
  • Humans
  • Interferon-alpha / administration & dosage
  • Interferon-alpha / adverse effects
  • Interleukin-2 / administration & dosage
  • Interleukin-2 / adverse effects
  • Lymphatic Metastasis
  • Male
  • Melanoma / drug therapy*
  • Melanoma / mortality
  • Melanoma / secondary
  • Middle Aged
  • Neoadjuvant Therapy
  • Neoplasm Staging
  • Pilot Projects
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / mortality
  • Skin Neoplasms / secondary
  • Survival Rate
  • Treatment Outcome
  • Vinblastine / administration & dosage
  • Vinblastine / adverse effects

Substances

  • Interferon-alpha
  • Interleukin-2
  • Granulocyte Colony-Stimulating Factor
  • Vinblastine
  • Dacarbazine
  • Cisplatin