title: Phase II study of interferon alpha-2a and dacarbazine in advanced melanoma.
abstract: Based on the report of some activity of combination therapy with dacarbazine (DTIC) and interferon alpha-2a (rIFN alpha-2a) in disseminated melanoma, we conducted a phase II study to determine the feasibility and efficacy in a large series of patients. DTIC was administered in 79 patients at the dose of 800 mg/m2 every 3 weeks and rIFN alpha-2a was given daily at the dose of 9 X 10(6) IU for the first 10 weeks and three times a week thereafter. Among the 75 evaluable patients, 25% achieved an objective response, with 8% complete and 17% partial remissions. The regression occurred within a mean time of 1.9 +/- 1.03 months from starting therapy and the mean duration of response was 8.2 +/- 4.2 months. The major side effects were vomiting, anorexia, fever, fatigue, and myalgia. There was one death related to sepsis after myelosuppression. In the other patients bone marrow and liver toxicities were not remarkable. Our data reveal that a combination regimen of rIFN alpha-2a with a cytotoxic agent has some therapeutic activity in the management of advanced malignant melanoma.
authors.affiliation: Italian Cooperative Group, Istituto Nazionale Tumori, Milan.
authors.forename: E
authors.initials: E
authors.lastname: Bajetta
authors.forename: E
authors.initials: E
authors.lastname: Negretti
authors.forename: B
authors.initials: B
authors.lastname: Giannotti
authors.forename: L
authors.initials: L
authors.lastname: Brogelli
authors.forename: I
authors.initials: I
authors.lastname: Brunetti
authors.forename: M R
authors.initials: MR
authors.lastname: Sertoli
authors.forename: M G
authors.initials: MG
authors.lastname: Bernengo
authors.forename: M C
authors.initials: MC
authors.lastname: Sofra
authors.forename: G
authors.initials: G
authors.lastname: Maifredi
authors.forename: G
authors.initials: G
authors.lastname: Zumiani
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D008875:Middle Aged; D011994:Recombinant Proteins; D012074:Remission Induction; D012878:Skin Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D003606:Dacarbazine