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Nab-paclitaxel significantly extended PFS in metastatic melanoma

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Chemotherapy-naive patients with metastatic melanoma treated with nanoparticle albumin-bound paclitaxel demonstrated significantly longer PFS than those treated with dacarbazine, according to a sub-analysis of phase 3 study results presented at the Society for Melanoma Research 2013 Congress.

Researchers also observed a trend toward longer OS with nab-paclitaxel (Abraxane, Celgene) in that patient population, according to an interim analysis.

The study included 529 patients with chemotherapy-naive, stage IV melanoma (M1c, 65%; elevated lactate dehydrogenase, 28%) with an ECOG performance status of 0 or 1. The median age of patients was 63 years, and 66% were men.

 

Evan M. Hersh

The sub-analysis accounted for sex, metastatic stage, baseline lactate dehydrogenase levels and BRAF mutation status.

Evan M. Hersh, MD, of the Arizona Cancer Center at the University of Arizona, and colleagues determined BRAF status in 67% of the intention-to-treat population. Of this group, 37% had BRAF-mutant disease and 63% had BRAF wild-type disease.

Researchers randomly assigned 264 patients to 150 mg/m² nab-paclitaxel on days 1, 8 and 15 of a 28-day cycle. The other 265 patients received 1,000 mg/m² dacarbazine (DTIC) on the first day of 21-day cycles.

Data from an interim analysis of the entire cohort indicated nab-paclitaxel significantly improved PFS (4.8 vs. 2.5 months; HR=0.792; P=.044). Researchers also observed a trend toward improved OS (HR=0.831; P=.094).

Results of the stratified analysis demonstrated consistent benefit with nab-paclitaxel across a majority of patient subgroups. Researchers observed significant improvements in PFS among patients with M1c disease (HR=0.734; P=.028) and among men (HR=0.659; P=.004).

Researchers did not observe the PFS benefit among women (HR=1.004; P=.984) or among those with M1b disease (HR=1.027; P=.901).

In the interim OS analysis, researchers reported a significant treatment benefit with nab-paclitaxel among patients with lactate dehydrogenase levels of 0.8 to ˂1.1 times the upper limit of normal (HR=0.659; P=.043).

The benefits associated with nab-paclitaxel were consistent regardless of BRAF mutation status.

“Nab-paclitaxel demonstrated consistent improvement in PFS and a trend towards improved OS compared with dacarbazine across most patient subgroups, particularly patients with M1c disease who have the poorest prognosis,” Hersh and colleagues wrote. “Based on these results, nab-paclitaxel may be considered as a treatment option in chemotherapy-naive patients with metastatic melanoma.”

For more information:

Hersh EM. Nab-paclitaxel versus dacarbazine in chemotherapy-naive patients with metastatic melanoma: Subgroup analysis of a phase 3 trial. Presented at: Society for Melanoma Research 2013 Congress; Nov. 17-20, 2013; Philadelphia.