Abstract
9590Background: Adjuvant tx of resected stage III BRAF-mutant melanoma with D + T significantly reduced risk of recurrence vs placebo (pbo). In the COMBI-AD study, 1-y tx with D + T resulted in improvements in relapse-free survival, distant metastasis–free survival, freedom from relapse, and overall survival. The effect of D + T on HRQOL in the adjuvant setting is reported here. Methods: COMBI-AD (NCT01682083) was a randomized, double-blind, phase 3 study evaluating pts with resected stage III BRAF V600E/K–mutant melanoma. Pts were randomized 1:1 to receive D 150 mg twice daily plus T 2 mg once daily or matching pbo for 12 mo. HRQOL assessment using the EuroQol-5D (EQ-5D-3L) questionnaire and visual analogue scale (VAS) was an exploratory endpoint. A mixed-model, repeated-measures analysis was used to assess differences in mean scores. Results: A total of 870 pts were randomized (D + T, n = 438; pbo, n = 432). Although pts available for assessment declined during study primarily due to consent withdrawal,...
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