Oncology Medical News about unresectable stage lll or stage IV melanoma;Sorafenib in combination with Carboplatin and Paclitaxel

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Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma
Journal of Clinical Oncology, 06/10/09

Hauschild A et al. - In a trial to evaluate the efficacy and safety of sorafenib with carboplatin and paclitaxel (CP) in pts with advanced melanoma who had progressed on a dacarbazine- or temozolomide-containing regimen, the addition of sorafenib to CP did not improve any of the endpoints over placebo plus CP and cannot be recommended in second-line setting for pts with advanced melanoma. Both regimens had clinically acceptable toxicity profiles with no unexpected adverse events.

Methods

270 pts were randomly assigned to receive intravenous paclitaxel 225 mg/m2 plus intravenous carboplatin at area under curve 6 (AUC 6) on day 1 of a 21-day cycle followed by either placebo (n=135) or oral sorafenib 400 mg (n=135) twice daily on days 2 to 19.
Primary efficacy endpoint was progression-free survival (PFS); secondary and tertiary endpoints included overall survival and incidence of best response, respectively.

Results

Median PFS was 17.9 wks for the placebo plus CP arm and 17.4 wks for the sorafenib plus CP arm.
Response rate was 11% with placebo vs 12% with sorafenib.
Dermatologic events, grade 3 thrombocytopenia, diarrhea, and fatigue were more common in pts treated with sorafenib plus CP vs placebo plus CP.

Exclusive Author Commentary
Sanjiv S. Agarwala, MD, 06/10/09

This trial was the first randomized study of sorafenib in combination with paclitaxel and carboplatin tested in patients with metastatic melanoma. It showed that sorafenib did not improve the efficacy of the chemotherapy alone in terms of it's primary end point, progression free survival, in patients who have been previously treated with dacarbazine or temozolomide based therapy. A recently reported trial conducted by the Eastern Cooperative Oncology Group of the same design but in first-line therapy showed similar results. Sorafenib is therefore not effective in combinaton with this chemotherapy regimen in patients with metastatic melanoma.

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