(ChemotherapyAdvisor) – Nab-paclitaxel significantly improved progression-free survival (PFS), the primary end point, when compared with dacarbazine in treatment-naïve patients with metastatic malignant melanoma, investigators reported during the Society for Melanoma Research 2012 Congress, held in Hollywood, CA.
A trend was also observed with nab-paclitaxel vs dacarbazine toward improved overall survival (OS), Evan M. Hersh, MD, of the Arizona Cancer Center, Tucson, AZ, USA, and colleagues noted.
The global phase 3 open-label trial enrolled 529 patients with stage IV metastatic malignant melanoma with no brain metastasis, who were randomly assigned to receive nab-paclitaxel 150 mg/m2 on days 1, 8, and 15 every 4 weeks (n=264) or dacarbazine 1000 mg/m2 every 3 weeks (n=265) between April 2009 and June 2011.
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Baseline patient characteristics were well balanced; the majority were male (66%), had an ECOG status of 0 (71%), and had M1c stage disease (65%).
In the intent-to-treat population, median PFS, based on blinded assessment of CT scans obtained every 8 weeks and evaluated per RECIST, was 4.8 months in the nab-paclitaxel arm and 2.5 months in the dacarbazine arm (HR 0.792; 95.1% CI 0.631–0.992; P=0.044).
Interim OS, conducted at the time of primary PFS analysis, was 12.8 months in the nab-paclitaxel arm and 10.7 months in the dacarbazine arm (HR 0.831; 99.9% CI 0.578–1.196; P=0.094).
“Seventy-three percent patients received subsequent therapies, which were well balanced between the two arms,” Dr. Hersh noted. Objective response rate, independently assessed, was 15% in the nab-paclitaxel arm vs 11% in the dacarbazine arm (P=0.239) and disease-control rate was 39% vs 27% (P=0.004), respectively.
The most common grade 3 or 4 treatment-related adverse events reported in >10% of patients were neuropathy, 25% in the nab-paclitaxel arm vs 0% in the dacarbazine arm (P<0.001), and neutropenia, 20% vs 10%, respectively (P=0.004). Median time to neuropathy improvement was 28 days.
The study was sponsored by Celgene Corp., the manufacturer of nab-paclitaxel (Abraxane).
Abstract (search for Hersh)
