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 (<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.

中文翻译：

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接受韦罗非尼辅助治疗的完全切除BRAFV600突变阳性黑色素瘤患者的健康相关生活质量。

研究的目的该研究的目的是评估辅助性维罗非尼单药治疗对IIC-IIIC期黑色素瘤切除患者的健康相关生活质量（HRQOL）的影响。方法3期BRIM8研究（NCT01667419）将BRAFV600突变阳性，切除的IIC-IIIC黑色素瘤患者随机分为960 mg vemurafenib每天两次或匹配安慰剂52周（13×28天周期）。患者在基线，第1周期（第1、15和22天），第2周期（第1和15天），基线完成了欧洲癌症研究和治疗组织的生活质量问卷核心30（EORTC QLQ-C30）第3版。随后的每4周周期，治疗结束访视和随访期间的每次访视。结果EORTC QLQ-C30问卷的完成率很高（> 80％）。在接受vemurafenib治疗的患者中，在第1周期的第15天和第22天，总体健康状况（GHS）/生活质量（QOL）得分分别平均下降了17.4（±22.9）和17.3（±24.1）点在剩余的治疗期间内，患者恢复至基线以下约10点的水平。在所有功能量表中，除了认知功能（在所有就诊时均自基线变化<10点变化）以及食欲不振，疲劳和疼痛的症状评分中均观察到了类似的趋势。正如对GHS / QOL评分所观察到的，在完成计划的vemurafenib治疗或终止治疗后，所有评分均迅速恢复至基线。结论HRQOL评估时间表可对急性治疗相关症状的影响进行准确而完整的评估。