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

• Published in: Cancer research and treatment 2015, 47(4), , pp.781-789
• Main Authors: Lee, Choong-kun, Jung, Minkyu, Choi, Hye Jin, Kim, Hye Ryun, Kim, Hyo Song, Roh, Mi Ryung, Ahn, Joong Bae, Chung, Hyun Cheol, Heo, Su Jin, Rha, Sun Young, Shin, Sang Joon
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols; Carboplatin - administration & dosage; Carboplatin - adverse effects; Carboplatin - therapeutic use; Dacarbazine - administration & dosage; Dacarbazine - adverse effects; Dacarbazine - therapeutic use; Female; Humans; Male; Melanoma - drug therapy; Middle Aged; Original; Patient Compliance; Taxoids - administration & dosage; Taxoids - adverse effects; Taxoids - therapeutic use; Young Adult; 의약학
• ISSN: 1598-2998; 2005-9256
• DOI: 10.4143/crt.2014.261

There is no standard second-line regimen for malignant melanoma patients with disease progression after first-line chemotherapy, and platinum-alkylating agents combined with paclitaxel have shown modest efficacy. We conducted a phase II, open-label, single-arm study to test the efficacy of docetaxel combined with carboplatin for malignant melanoma patients who failed previous treatment with dacarbazine. Intravenous docetaxel (35 mg/m(2) on days 1 and 8 of each cycle) and carboplatin (area under the curve 3 on days 1 and 8 of each cycle) was administered every 21 days. Primary end point was objective response rate (ORR). Thirty patients were enrolled in the study, and the median follow-up duration was 19.8 months. Among 25 per-protocol patients, there were three responders (1 with complete response and 2 with partial response) and 17 stable disease patients (ORR, 12.0%). Among the per-protocol population, the median progression-free survival (PFS) was 4.3 months and 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, 9.9 months). The most common grade 3 or 4 adverse event was neutropenia (n=15, 50.0%). Docetaxel combined with carboplatin showed association with an acceptable safety profile and overall efficacy for patients with malignant melanoma who had progressed on chemotherapy containing dacarbazine.