Results of a Phase II Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Patients Who Failed First-Line Therapy Containing Dacarbazine
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Purpose There is no standard second-line regimen for malignant melanoma patients with diseaseprogression after first-line chemotherapy, and platinum-alkylating agents combined withpaclitaxel have shown modest efficacy. Materials and MethodsWe conducted a phase II, open-label, single-arm study to test the efficacy of docetaxelcombined with carboplatin for malignant melanoma patients who failed previous treatmentwith dacarbazine. Intravenous docetaxel (35 mg/m2 on days 1 and 8 of each cycle) andcarboplatin (area under the curve 3 on days 1 and 8 of each cycle) was administered every21 days. Primary end point was objective response rate (ORR). ResultsThirty patients were enrolled in the study, and the median follow-up duration was 19.8months. Among 25 per-protocol patients, there were three responders (1 with completeresponse and 2 with partial response) and 17 stable disease patients (ORR, 12.0%). Amongthe per-protocol population, the median progression-free survival (PFS) was 4.3 monthsand the median overall survival (OS) was 9.6 months. Uveal melanoma patients (n=9)showed the best prognosis compared to other subtypes (median PFS, 7.6 months; OS, 9.9months). The most common grade 3 or 4 adverse event was neutropenia (n=15, 50.0%). ConclusionDocetaxel combined with carboplatin showed association with an acceptable safety profileand overall efficacy for patients with malignant melanoma who had progressed onchemotherapy containing dacarbazine.
Abstract
Purpose There is no standard second-line regimen for malignant melanoma patients with diseaseprogression after first-line chemotherapy, and platinum-alkylating agents combined withpaclitaxel have shown modest efficacy. Materials and MethodsWe conducted a phase II, open-label, single-arm study to test the efficacy of docetaxelcombined with carboplatin for malignant melanoma patients who failed previous treatmentwith dacarbazine. Intravenous docetaxel (35 mg/m2 on days 1 and 8 of each cycle) andcarboplatin (area under the curve 3 on days 1 and 8 of each cycle) was administered every21 days. Primary end point was objective response rate (ORR). ResultsThirty patients were enrolled in the study, and the median follow-up duration was 19.8months. Among 25 per-protocol patients, there were three responders (1 with completeresponse and 2 with partial response) and 17 stable disease patients (ORR, 12.0%). Amongthe per-protocol population, the median progression-free survival (PFS) was 4.3 monthsand the median overall survival (OS) was 9.6 months. Uveal melanoma patients (n=9)showed the best prognosis compared to other subtypes (median PFS, 7.6 months; OS, 9.9months). The most common grade 3 or 4 adverse event was neutropenia (n=15, 50.0%). ConclusionDocetaxel combined with carboplatin showed association with an acceptable safety profileand overall efficacy for patients with malignant melanoma who had progressed onchemotherapy containing dacarbazine.
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