Health-related quality of life in patients with fully resected BRAFV⁶⁰⁰ mutation–positive melanoma receiving adjuvant vemurafenib

Autor: Schadendorf, Dirk, Di Giacomo, Anna Maria, Demidov, Lev, Merelli, Barbara, Bondarenko, Igor, Ascierto, Paolo A., Herbert, Christopher, Mackiewicz, Andrzej, Rutkowski, Piotr, Guminski, Alexander, Goodman, Grant R., Simmons, Brian, Ye, Chenglin, Hong, Agnes, Lewis, Karl
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Popis: Aim of study: The aim of the study was to assess the impact of treatment with adjuvant vemurafenib monotherapy on health-related quality of life (HRQOL) in patients with resected stage IIC–IIIC melanoma. Methods: The phase 3 BRIM8 study (NCT01667419) randomised patients with BRAFV⁶⁰⁰ mutation–positive resected stage IIC–IIIC melanoma to 960 mg of vemurafenib twice daily or matching placebo for 52 weeks (13 × 28-day cycles). Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3 at baseline, cycle 1 (days 1, 15 and 22), cycle 2 (days 1 and 15), day 1 of every subsequent 4-week cycle, the end-of-treatment visit and each visit during the follow-up period. Results: Completion rates for the EORTC QLQ-C30 questionnaire were high (>80%). There was a mean decline in the global health status (GHS)/quality of life (QOL) score of 17.4 (±22.9) and 17.3 (±24.1) points at days 15 and 22 of cycle 1, respectively, among vemurafenib-treated patients who recovered to approximately 10 points below baseline for the remainder of the treatment period. A similar trend was observed in all functional scales except for cognitive function (
Databáze: OpenAIRE