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
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.
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