title: Fotemustine and dacarbazine plus recombinant interferon alpha 2a in thetreatment of advanced melanoma.
abstract: Forty-three consecutive patients with advanced melanoma not previously treated with cytotoxic drugs (22 of them had already received adjuvant recombinant interferon alpha 2a (rIFN alpha 2a)) were given a combination of intravenous (i.v.) fotemustine (FM), 100 mg/m2 on day 1, and dacarbazine (DTIC), 250 mg/m2 i.v. on days 2-5, every 3 weeks. rIFN alpha 2a was administered at the dosage of 3 MIU subcutaneously 3 times a week until progression. Four complete and 13 partial responses were registered, for an overall response rate of 40% (95% CI, 25-56%). Activity of this regimen was similar in patients with mainly visceral (10/22, 45%) or soft tissue (6/13, 46%) involvement. The median duration of responses was 24 weeks. Median survival time was 40 weeks, with a 13% 2 year survival rate. Neutropenia and thrombocytopenia affected 67% and 51% of patients, but were of WHO grade 4 in only 2% and 5% of them, respectively. Side-effects attributable to rIFN alpha 2a were mild and manageable. In conclusion, the combination of FM + DTIC and rIFN alpha 2a seemed well tolerated and relatively active in patients with advanced melanoma. However, the role of rIFN alpha 2a in affecting the long-term outcome of patients is still questionable.
authors.affiliation: Division of Medical Oncology A, National Tumor Institute, Naples, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Comella
authors.forename: A
authors.initials: A
authors.lastname: Daponte
authors.forename: R
authors.initials: R
authors.lastname: Casaretti
authors.forename: F
authors.initials: F
authors.lastname: Ionna
authors.forename: F
authors.initials: F
authors.lastname: Fiore
authors.forename: F
authors.initials: F
authors.lastname: Presutti
authors.forename: G
authors.initials: G
authors.lastname: Frasci
authors.forename: F
authors.initials: F
authors.lastname: Caponigro
authors.forename: A
authors.initials: A
authors.lastname: Gravina
authors.forename: A P
authors.initials: AP
authors.lastname: Parziale
authors.forename: N
authors.initials: N
authors.lastname: Mozzillo
authors.forename: G
authors.initials: G
authors.lastname: Comella
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000556:secondary* / Q000628:therapy*; D008875:Middle Aged; D009607:Nitrosourea Compounds / Q000008:administration & dosage / Q000009:adverse effects; D009943:Organophosphorus Compounds / Q000008:administration & dosage / Q000009:adverse effects; D011994:Recombinant Proteins; D015996:Survival Rate
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009607:Nitrosourea Compounds; D009943:Organophosphorus Compounds; D011994:Recombinant Proteins; D003606:Dacarbazine; C054368:fotemustine