Monday, June 25, 2012 (Last Updated: 06/26/2012)MONDAY, June 25 (HealthDay News) -- Patients with BRAF V600E-mutated metastatic melanoma treated with dabrafenib, an inhibitor of mutated BRAF, have significantly improved progression-free survival compared to those treated with dacarbazine, according to a study published online June 25 in The Lancet.
Axel Hauschild, M.D., from the University Hospital in Kiel in Germany, and colleagues investigated the efficacy of dabrafenib in 250 patients with BRAF V600E-mutated metastatic melanoma. Participants, with previously untreated stage IV or unresectable stage III disease, aged 18 years or older, were randomly allocated to receive dabrafenib (187 patients) or dacarbazine (63 patients).
The researchers found the median progression-free survival to be significantly improved with dabrafenib versus dacarbazine (5.1 versus 2.7 months; hazard ratio, 0.30). At data cutoff, 57 and 22 percent of patients, respectively, were still on randomized dabrafenib or dacarbazine. Treatment-related adverse events (grade 2 or higher) were observed in 53 and 44 percent of patients who received dabrafenib and dacarbazine, respectively. In both groups, grade 3 or 4 adverse events were uncommon.
"Despite the encouraging response rate and improvement in progression-free survival, the median progression-free survival was 5.1 months, which shows that melanoma cells become resistant quite quickly," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including GlaxoSmithKline, which funded the study and manufactures dabrafenib.
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