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

Schadendorf, Dirk and Di Giacomo, Anna Maria and Demidov, Lev and Merelli, Barbara and Bondarenko, Igor and Ascierto, Paolo A. and Herbert, Christopher and Mackiewicz, Andrzej and Rutkowski, Piotr and Guminski, Alexander and Goodman, Grant R. and Simmons, Brian and Ye, Chenglin and Hong, Agnes and Lewis, Karl and the BRIM8 Investigators (2019) Health-related quality of life in patients with fully resected BRAFV600 mutation–positive melanoma receiving adjuvant vemurafenib. European Journal of Cancer, V.123. pp. 155-161. ISSN 0959-8049

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Abstract

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) randomized 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 Organization 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 (<10-point change from baseline at all visits) and in the symptom scores for appetite loss, fatigue and pain. As observed for the GHS/QOL score, all scores rapidly returned to baseline after completion of planned vemurafenib treatment or treatment discontinuation. Conclusions: The schedule of HRQOL assessments allowed for an accurate and complete evaluation of the impact of acute treatment-related symptoms. Vemurafenib-treated patients experience clinically meaningful moderate worsening in some treatment- or disease-related symptoms and GHS/QOL that resolve over time.

Item Type:	Article
Additional Information:	http://www.ejcancer.com/ https://doi.org/10.1016/j.ejca.2019.09.019
Uncontrolled Keywords:	Resected melanoma; Health-related quality of life; Adjuvant treatment; Vemurafenib; BRAF
Subjects:	Oncology
Divisions:	Departments > Department of Oncology and Medical Radiology
Depositing User:	Елена Шрамко
Date Deposited:	31 Mar 2021 13:59
Last Modified:	31 Mar 2021 13:59
URI:	http://repo.dma.dp.ua/id/eprint/6391

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