Nab-paclitaxel significantly improved progression-free survival and disease control rate compared with dacarbazine, with a manageable safety profile, in patients with metastatic melanoma, a new study published online ahead of print in the journal Annals of Oncology has shown.1
For the study, researchers sought to evaluate the efficacy and safety of nab-paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma.
Researchers enrolled 529 chemotherapy-naïve patients with stage 4 melanoma and randomly assigned them to receive nab-paclitaxel 150 mg/m2 intravenously on days 1, 8, and 15, every 28 days or dacarbazine 1,000 mg/m2 intravenously every 21 days.
Most of patients enrolled were male, had an ECOG performance status of 0, and had M1c stage disease.
Results showed that median progression-free survival was 4.8 months with nab-paclitaxel compared with 2.5 months with dacarbazine (HR = 0.792; 95.1% CI: 0.631-0.992; P=0.044). Disease control rate was 39% and 27%, respectively (P=0.004).
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However, researchers observed no statistically significant difference in median overall survival (12.6 months vs 10.5 months; HR=0.897; 95.1% CI: 0.738-1.089; P=0.271) or overall response rate (15% vs 11%; P=0.239).
In regard to safety, the most frequent grade 3 or higher nab-paclitaxel-related adverse events were neuropathy and neutropenia.
- Hersh EM, Del Vecchio M, Brown MP, et al. A randomized, controlled phase III trial of nab-paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma [published online ahead of print September 26, 2015]. Ann Oncol. doi: 10.1093/annonc/mdv324.