IMMUNOCHEMOTHERAPY WITH RECOMBINANT INTERFERON-ALPHA-2B PLUS DACARBAZINE IN THE TREATMENT OF ADVANCED MALIGNANT-MELANOMA

In order to estimate the therapeutic activity and tolerability of immu nochemotherapy with recombinant interferon-alpha 2b (rIFN-alpha 2b) pl us dacarbazine (DTIC), a study was carried out in 61 patients with cyt ologically and/or histologically confirmed metastatic malignant melano ma. The treatment regimen was as follows: rIFN-alpha 2b 2 x 10(6) IU i ntramuscularly on days 1 to 4, and DTIC 800 mg/m(2) intravenously on d ay 5, repeated at 3-week intervals until the progression of the diseas e or, in the case of a complete response, for up to 6 months, The over all response rate was 28%-12% complete response (CR) and 16% partial r esponse (PR). The median response duration was 10.9 months (CR 11.5 mo nths, PR 9.3 months; P > 0.05). Responses occurred in soft tissue and lung metastases only. The median times to treatment failure for respon ding and non-responding patients were 10.9 and 3 months, respectively (P < 0.0001), and the median survival durations were 16.5 and 5.8 mont hs, respectively (P < 0.0001). The stratification of the patients into a low-risk group (World Health Organization performance status [WHO P S] less than or equal to 1 and soft tissue or lung metastases) and a h igh-risk group (WHO PS = 2 or disease localization other than skin, ly mph nodes or lung) showed a significant advantage for the first group with respect to the response rate, median time to treatment failure an d survival duration. A flu-like syndrome was recorded in 72% of patien ts, nausea and vomiting in 34%, haematological toxicity in 26%, hepati c toxicity in 5%, and neurotoxicity in 5%. In view of the results obta ined in our study and those reported in the literature, IFN plus DTIC immunochemotherapy represents a reasonable treatment option, particula rly for patients with soft tissue and lung metastases.