Results of a phase II trial with cystemustine at 90 mg/m(2) as a first- or second-line treatment in advanced malignant melanoma: a trial of the EORTC Clinical Studies Group.
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| Abstract |
From May 1991 to January 1996, 54 patients with advanced malignant melanoma were enrolled into a phase II trial testing the new nitrosourea cystemustine, administrated intravenously as a 15 min infusion every 2 weeks at 90 mg/m2 for three cycles followed by 60 mg/m2. Out of the 54 enrolled patients, 10 were Ineligible, leaving 44 fully evaluable patients (World Health Organization criteria). Twenty one patients had already received first-line palliative chemotherapy and/or immunotherapy. The median age was 62 years (range 30-74 years) and the median performance status was 0 (grade 0, 19 patients; grade 1, 21 patients; grade 2, 4 patients). Five patients with partial responses (lasting 16-29 weeks, mean duration 24 weeks), nine with stable disease and 28 showing progression were observed, giving an overall response rate of 11% (confidence interval 3.8-24.6%). Toxicity was mild and consisted mainly of neutropenia (39% grade III-IV), thrombocytopenia (42% grade III-IV); febrile aplasia was rare. Cystemustine administered to this schedule appears to have limited clinical activity and acceptable toxicity in untreated or second-line advanced malignant melanoma.
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| Authors | H Cure, P Souteyrand, R Ouabdesselam, H Roche, A Ravaud, M D'incan, P Viens, P Fargeot, M A Lentz, P Fumoleau, A Hanauske, P Chollet |
| Journal | Melanoma research (Melanoma Res) Vol. 9 Issue 6 Pg. 607-10 (Dec 1999) ISSN: 0960-8931 [Print] England |
| PMID | 10661773 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article) |
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