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

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