ORIGINAL ARTICLES: Clinical researchMulticentre, open, noncomparative Phase II trial to evaluate the efficacy and tolerability of fotemustine, cisplatin, alpha-interferon and interleukin-2 in advanced melanoma patientsRidolfi, Lauraa; Fiorentini, Giammariab; Guida, Michelec; Michiara, Mariad; Freschi, Andreae; Aitini, Enricof; Ballardini, Michelaa; Bichisao, Ettoreg; Ridolfi, Ruggeroa on behalf of the Italian Melanoma IntergroupAuthor Information aIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Forlì bDepartment of Medical Oncology, S. Giuseppe Hospital, Empoli cBari Cancer Institute, Bari dDepartment of Medical Oncology, General Hospital, Parma eAviano Cancer Institute, Aviano fDepartment of Medical Oncology, C. Poma Hospital, Mantua gItalfarmaco Medical Department, Milan, Italy Correspondence to Dr Ruggero Ridolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via P. Maroncelli 40, Meldola (FC) 47014, Italy Tel: +39 543 739252; fax: +39 543 739249; e-mail: [email protected] Received 18 December 2007 Accepted 4 January 2009 Melanoma Research: April 2009 - Volume 19 - Issue 2 - p 100-105 doi: 10.1097/CMR.0b013e328328f7ec Buy Metrics Abstract The efficacy and tolerability of fotemustine, cisplatin, α-interferon and interleukin-2 biochemotherapy were evaluated in advanced melanoma patients. The schedule consisted of fotemustine (100 mg/m2) and cisplatin (75 mg/m2) intravenous on day 1, followed by subcutaneous interleukin-2 at a dose of 4.5 MIU on days 3–5 and 8–12 and α-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. © 2009 Lippincott Williams & Wilkins, Inc.