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: |
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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 |
Externí odkaz: |
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