Cancer Res Treat.  2015 Oct;47(4):781-789. 10.4143/crt.2014.261.

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

• Lee CK
• Jung M
• Choi HJ
• Kim HR
• Kim HS
• Roh MR
• Ahn JB
• Chung HC
• Heo SJ
• Rha SY
• Shin SJ

• KMID: 2403397
• DOI: http://doi.org/10.4143/crt.2014.261

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.

Keyword

Melanoma; Docetaxel; Carboplatin; Second-line chemotherapy

MeSH Terms

Carboplatin*
Dacarbazine*
Disease Progression
Disease-Free Survival
Drug Therapy
Follow-Up Studies
Humans
Melanoma*
Neutropenia
Paclitaxel
Prognosis
Carboplatin
Dacarbazine
Paclitaxel

Figure

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  Fig. 1. Study flow diagram.

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  Fig. 2. Survival analysis. Kaplan-Meier curves for progression-free survival (PFS) and overall survival (OS) of per-protocol patients (n=25).

Reference

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