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.
- Author:
Choong Kun LEE
1
;
Minkyu JUNG
;
Hye Jin CHOI
;
Hye Ryun KIM
;
Hyo Song KIM
;
Mi Ryung ROH
;
Joong Bae AHN
;
Hyun Cheol CHUNG
;
Su Jin HEO
;
Sun Young RHA
;
Sang Joon SHIN
Author Information
- Publication Type:Original Article
- Keywords: Melanoma; Docetaxel; Carboplatin; Second-line chemotherapy
- MeSH: Carboplatin*; Dacarbazine*; Disease Progression; Disease-Free Survival; Drug Therapy; Follow-Up Studies; Humans; Melanoma*; Neutropenia; Paclitaxel; Prognosis
- From:Cancer Research and Treatment 2015;47(4):781-789
- CountryRepublic of Korea
- Language:English
- Abstract: PURPOSE: 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. MATERIALS AND METHODS: 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/m2 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). RESULTS: 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%). CONCLUSION: 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.
