Consistent survival benefit seen across several prespecified subgroups, including those with a BRAF V600E mutation<\/p>\n<\/h3>\n
By Elana Gotkine HealthDay Reporter<\/b><\/p>\n
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MONDAY, June 24, 2024 (HealthDay News) — For patients with resected stage III melanoma, adjuvant therapy with dabrafenib plus trametinib is associated with a nonsignificant benefit in terms of overall survival, according to a study published online June 19 in the New England Journal of Medicine<\/em>.<\/p>\n Georgina V. Long, M.D., Ph.D., from the University of Sydney, and colleagues randomly assigned 870 patients with resected stage III melanoma with BRAF<\/em> V600 mutations to receive 12 months of dabrafenib plus trametinib or two matched placebos. The median duration of follow-up was 8.33 and 6.87 years for dabrafenib plus trametinib and placebo, respectively.<\/p>\n The researchers found that for overall survival, the Kaplan-Meier estimates favored dabrafenib plus trametinib over placebo, but the benefit was not significant (hazard ratio, 0.80; 95 percent confidence interval, 0.62 to 1.01; P = 0.06). Across several prespecified subgroups, a consistent survival benefit was seen, including among 792 patients with melanoma with a BRAF<\/em> V600E mutation (hazard ratio for death, 0.75; 95 percent confidence interval, 0.58 to 0.96). Significant benefits were also seen for dabrafenib plus trametinib versus placebo for relapse-free survival (hazard ratio for relapse or death, 0.52; 95 percent confidence interval, 0.43 to 0.63) and for distant metastasis-free survival (hazard ratio for distant metastasis or death, 0.56; 95 percent confidence interval, 0.44 to 0.71). There were no new reports of safety signals.<\/p>\n “Whether or how therapies administered after relapse may have reduced the effect of adjuvant therapy on overall survival is unclear,” the authors write.<\/p>\n GlaxoSmithKline and Novartis funded the study; Novartis is the manufacturer of dabrafenib and trametinib.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n