1. Multicentre, open, noncomparative Phase II trial to evaluate the efficacy and tolerability of fotemustine, cisplatin, alpha-interferon and interleukin-2 in advanced melanoma patients.
- Author
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Ridolfi L, Fiorentini G, Guida M, Michiara M, Freschi A, Aitini E, Ballardini M, Bichisao E, and Ridolfi R
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Brain Neoplasms drug therapy, Brain Neoplasms secondary, Cisplatin administration & dosage, Cisplatin adverse effects, Combined Modality Therapy, Disease Progression, Female, Humans, Immunologic Factors administration & dosage, Immunologic Factors adverse effects, Interferon-alpha administration & dosage, Interferon-alpha adverse effects, Interleukin-2 administration & dosage, Interleukin-2 adverse effects, Male, Melanoma mortality, Melanoma secondary, Middle Aged, Nitrosourea Compounds administration & dosage, Nitrosourea Compounds adverse effects, Organophosphorus Compounds administration & dosage, Organophosphorus Compounds adverse effects, Salvage Therapy, Skin Neoplasms mortality, Survival Analysis, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Immunologic Factors therapeutic use, Immunotherapy adverse effects, Interferon-alpha therapeutic use, Interleukin-2 therapeutic use, Melanoma drug therapy, Skin Neoplasms drug therapy
- Abstract
The efficacy and tolerability of fotemustine, cisplatin, alpha-interferon and interleukin-2 biochemotherapy were evaluated in advanced melanoma patients. The schedule consisted of fotemustine (100 mg/m) and cisplatin (75 mg/m) intravenous on day 1, followed by subcutaneous interleukin-2 at a dose of 4.5 MIU on days 3-5 and 8-12 and alpha-interferon at a dose of 3 MU three times/week, every 3 weeks for six cycles. Sixty patients were evaluated for tumour response, 12 of whom had brain metastases (BM). One patient (1.7%) with BM achieved a complete response and partial responses were observed in 10 patients (16.7%), including one BM patient. Overall response rate was 18.4 and 16.6% in BM patients (median response duration 8.2 months). Disease control, defined as overall response and stable disease, was 58.4% in all patients and 75% in patients with BM. Median time to progression was 3.2 months (4.2 months in BM patients). Median overall survival was 8.9 months (7.6 months in BM patients). Toxic events were mild to moderate. This combination was well tolerated and showed acceptable clinical activity, especially in BM patients.
- Published
- 2009
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