Interleukin-2-based biochemotherapy for patients with stage IV melanoma: long-term survivors outside a clinical trial...

The role of Interleukin-2 (IL-2)-based biochemotherapy (BCT) for patients with metastatic melanoma remains controversial and few data of patients treated outside a specialized trial setting are available.

Sixty-six consecutive patients treated with BCT for stage IV melanoma were analyzed retrospectively. All patients received BCT consisting of dacarbazine, cisplatin and vinblastine (CVD), interferon alfa-2a (IFN), and IL-2. IL-2 was administered at two different dose levels: 3 x 10(6) U/m(2)/day (BCT-3) and 9 x 10(6) U/m(2)/day (BCT-9), each intravenously on 4 consecutive days (days 5-8, 17-20, 26-29).

Nine of 66 patients achieved a complete (CR) and 11 patients a partial response (PR), resulting in an overall response rate of 30%. Five responses (2 CR and 3 PR) were observed in the 29 patients treated according to the BCT-3 protocol, 15 responses (7 CR and 8 PR) in the 37 patients treated according to the more IL-2 dose-intense BCT-9 protocol (17 vs. 41%; p = 0.033). Median overall survival (OS) for all 66 patients was 10 (range 3-119+) months. Responders had a superior OS than nonresponders (14 vs. 7 months, p < 0.001). After a median follow-up of 70 months, 5 patients are alive. Among them, 4 are in stable CR at 30+, 48+, 79+ and 119+ months, respectively, amounting to a disease-free survival rate of 6% (4/66).

Long-term disease-free survival for patients with stage IV melanoma can be achieved with BCT outside a highly specialized clinical trial setting. Better selection criteria are needed in order to avoid the unnecessary toxic treatment of the majority of patients.