title: Immunochemotherapy with recombinant interferon-alpha 2b plus dacarbazine in the treatment of advanced malignant melanoma.
abstract: In order to estimate the therapeutic activity and tolerability of immunochemotherapy with recombinant interferon-alpha 2b (rIFN-alpha 2b) plus dacarbazine (DTIC), a study was carried out in 61 patients with cytologically and/or histologically confirmed metastatic malignant melanoma. The treatment regimen was as follows: rIFN-alpha 2b 2 x 10(6) IU intramuscularly on days 1 to 4, and DTIC 800 mg/m2 intravenously on day 5, repeated at 3-week intervals until the progression of the disease or, in the case of a complete response, for up to 6 months. The overall response rate was 28%-12% complete response (CR) and 16% partial response (PR). The median response duration was 10.9 months (CR 11.5 months, PR 9.3 months; P > 0.05). Responses occurred in soft tissue and lung metastases only. The median times to treatment failure for responding 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 months, respectively (P < 0.0001). The stratification of the patients into a low-risk group (World Health Organization performance status [WHO PS] < or = 1 and soft tissue or lung metastases) and a high-risk group (WHO PS = 2 or disease localization other than skin, lymph nodes or lung) showed a significant advantage for the first group with respect to the response rate, median time to treatment failure and survival duration. A flu-like syndrome was recorded in 72% of patients, nausea and vomiting in 34%, haematological toxicity in 26%, hepatic toxicity in 5%, and neurotoxicity in 5%. In view of the results obtained in our study and those reported in the literature, IFN plus DTIC immunochemotherapy represents a reasonable treatment option, particularly for patients with soft tissue and lung metastases.
authors.affiliation: Institute of Oncology, Ljubljana, Slovenia.
authors.forename: P
authors.initials: P
authors.lastname: Strojan
authors.forename: Z
authors.initials: Z
authors.lastname: Rudolf
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000556:secondary / Q000628:therapy; D008207:Lymphatic Metastasis; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000473:pathology / Q000556:secondary / Q000628:therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011994:Recombinant Proteins; D012878:Skin Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D012983:Soft Tissue Neoplasms / Q000556:secondary / Q000628:therapy; D015996:Survival Rate; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D003606:Dacarbazine