803P Patient-reported outcomes in patients with resected, stage III BRAF V600+ melanoma treated with adjuvant dabrafenib + trametinib: COMBI-APlus study

Abstract

COMBI-APlus, an open-label, phase 3b study, met its primary endpoint of significant reduction in composite pyrexia events compared with a historical control from COMBI-AD. Here, we report the patient-reported outcomes (PROs) during the 12-month adjuvant dabrafenib plus trametinib (D + T) treatment in patients (pts) with stage III BRAF V600+ melanoma after complete resection. Eligible pts aged ≥18 years with resected stage III BRAF V600E/K–mutant melanoma received oral adjuvant D (150 mg twice daily) + T (2 mg once daily) for up to 12 months (mo). A 16-item melanoma subscale of the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) tool was used to assess the quality of life (QOL). Respondents were asked to score the statements related to their QoL with melanoma, based on a four-point response scale, with 4 being the best response. The FACT-M scores were assessed at baseline and at every month up to month 12. Time to first deterioration, which was defined as the time from inclusion in the study to the first decrease in QoL scores according to baseline score, and effect of age, stage, baseline score, visit, and status visit on PRO using a mixed-effect model were also evaluated. A total of 552 pts were enrolled and included in this analysis. The mean (SD) FACT-M score at baseline for all pts was 57.44 (5.203), which changed to 55.31 (7.392) at 6 months, and 56.02 (7.324) at 12 months. Overall, data of individual questions showed that pts were at their best state at most of the visits, with non-relapsed pts showing better change in scores than relapsed pts. The minimal point of worsening was observed at point 5, and the median time for minimal worsening of melanoma-related symptoms was 5.55 mo. The mixed-effect model showed that the disease stage at baseline had a significant effect on the change in PRO score. PRO data from COMBI-APlus study showed no clear worsening of QOL during the treatment unless there was a relapse. This implies that disease evolution but not treatment affects the QOL, supporting use of D + T as adjuvant treatment in pts with stage III BRAF V600+ melanoma after complete resection.