Chemoimmunotherapy with bleomycin, vincristine, lomustine, dacarbazine (BOLD) plus interferon alpha for metastatic melanoma: a multicentre phase II study

Br J Cancer. 1997;76(2):266-9. doi: 10.1038/bjc.1997.374.

Abstract

High response rates in patients with metastatic melanoma have been achieved with combination chemoimmunotherapy. A response rate of 62% in 45 patients has been reported for treatment with dacarbazine, bleomycin, vincristine, lomustine (BOLD) plus interferon alpha (IFN-alpha). We conducted a multicentre phase II study to confirm these results. Melanoma patients with distant metastases were treated as outpatients with dacarbazine 200 mg m(-2) on days 1-5, vincristine 1 mg m(-2) on days 1 and 4, bleomycin 15 mg on days 2 and 5 i.v. and lomustine 80 mg orally on day 1, repeated every 4 weeks. IFN-alpha-2b was initiated s.c. on day 8 at 3 MU daily for 6 weeks, and 6 MU t.i.w. thereafter. Forty-three patients entered the study. The median number of metastatic sites was three (range 1-5), and 81% of patients had visceral metastases. Nine patients had brain metastases, and seven patients were systemically pretreated. Among the 41 patients that were evaluable for response, the response rate was 27% (95% CI 14-3%), with one complete and ten partial remissions. The response rate in 25 previously untreated patients without brain metastases was 40% (95% CI 21-61%). Median duration of response was 6 (range 2-14+) months; median overall survival was 5 (1-26) months. The main toxicity was malaise/fatigue. We confirm that BOLD plus IFN-alpha has activity in metastatic melanoma. The lower response rate in our study compared with the previous report is probably related to patient selection, as in the previous study 46% of patients had stage III disease, whereas all our patients had stage IV disease, which is associated with a worse prognosis.

Publication types

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

MeSH terms

  • Abdominal Neoplasms / secondary
  • Abdominal Neoplasms / therapy*
  • Adult
  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bleomycin / therapeutic use
  • Brain Neoplasms / secondary
  • Brain Neoplasms / therapy*
  • Dacarbazine / therapeutic use
  • Female
  • Humans
  • Immunotherapy*
  • Interferon-alpha / adverse effects
  • Interferon-alpha / therapeutic use*
  • Lomustine / therapeutic use
  • Male
  • Melanoma / secondary
  • Melanoma / therapy*
  • Middle Aged
  • Neoplasm Staging
  • Skin Neoplasms / pathology
  • Skin Neoplasms / therapy*
  • Treatment Outcome
  • Vincristine / therapeutic use

Substances

  • Antineoplastic Agents
  • Interferon-alpha
  • Bleomycin
  • Vincristine
  • Lomustine
  • Dacarbazine

Supplementary concepts

  • BOLD protocol