帕博利珠单抗对比化疗对转移性三阴性乳腺癌患者健康相关生活质量的影响：来自 III 期随机 KEYNOTE-119 研究的结果。
Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study.
机构信息
Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University London, London, UK.
Medical Oncology, Republican Clinical Oncology Dispensary, Ufa, Republic of Bashkortostan, Russia.
出版信息
Eur J Cancer. 2023 Dec;195:113393. doi: 10.1016/j.ejca.2023.113393. Epub 2023 Oct 21.
BACKGROUND
In KEYNOTE-119 (ClinicalTrials.gov, NCT02555657), overall survival (primary end-point) was similar between pembrolizumab and chemotherapy in patients with previously treated metastatic triple-negative breast cancer (TNBC), although the pembrolizumab treatment effect increased with tumour PD-L1 expression. We report results of prespecified health-related quality of life (HRQoL) analyses from KEYNOTE-119.
METHODS
Eligible patients were randomised 1:1 to pembrolizumab 200 mg Q3W intravenously for up to 35 cycles or treatment of physician's choice per local/country guidelines. Prespecified exploratory end-points were the change from baseline in HRQoL (EORTC QLQ-C30, QLQ-BR23) and to characterise utilities (EQ-5D-3L). Time to deterioration (TTD) was the time from start of treatment to first onset of a ≥10-point worsening from baseline.
RESULTS
HRQoL analyses included 187 patients with tumour PD-L1 combined positive score (CPS) ≥10. Changes from baseline at 6 weeks (primary analysis time point) were directionally better with pembrolizumab versus chemotherapy for QLQ-C30 GHS/QoL (between-group difference in least-squares mean scores of 4.21 [95% CI, -1.38 to 9.80]), QLQ-C30 functional scales (physical, role, cognitive, social), QLQ-C30 symptom scales/items (fatigue, nausea/vomiting, dyspnoea, appetite loss), and QLQ-BR23 symptom scales/items (systemic therapy side-effects, upset by hair loss). Median TTD was directionally longer for pembrolizumab versus chemotherapy for QLQ-C30 QHS/QoL (4.3 versus 1.7 months), QLQ-C30 nausea/vomiting (7.7 versus 4.8 months), and QLQ-BR23 systemic therapy side-effects (6.1 versus 3.4 months). Minimal treatment differences were observed for other HRQoL end-points.
CONCLUSIONS
HRQoL results were consistent with clinical outcomes and appeared to be driven by results for patients with tumour PD-L1 CPS ≥10.
背景
在 KEYNOTE-119 试验（ClinicalTrials.gov，NCT02555657）中，先前接受过治疗的转移性三阴性乳腺癌（TNBC）患者中，与化疗相比，帕博利珠单抗的总生存期（主要终点）相似，尽管帕博利珠单抗的治疗效果随着肿瘤 PD-L1 表达的增加而提高。我们报告了 KEYNOTE-119 中预先指定的健康相关生活质量（HRQoL）分析结果。
方法
符合条件的患者按 1:1 随机分配接受帕博利珠单抗 200mg，每 3 周静脉注射 1 次，最多 35 个周期，或根据当地/国家指南接受医生选择的治疗。预先指定的探索性终点是 HRQoL（EORTC QLQ-C30、QLQ-BR23）从基线的变化和特征效用（EQ-5D-3L）。从治疗开始到首次出现基线恶化≥10 分的时间为恶化时间（TTD）。
结果
HRQoL 分析包括 187 例肿瘤 PD-L1 联合阳性评分（CPS）≥10 的患者。与化疗相比，6 周时（主要分析时间点），帕博利珠单抗治疗方向上使 QLQ-C30 GHS/QoL（组间最小二乘均值差为 4.21[95%CI，-1.38 至 9.80]）、QLQ-C30 功能量表（身体、角色、认知、社会）、QLQ-C30 症状量表/项目（疲劳、恶心/呕吐、呼吸困难、食欲下降）和 QLQ-BR23 症状量表/项目（全身治疗副作用、脱发烦恼）得到改善。与化疗相比，帕博利珠单抗治疗方向上使 QLQ-C30 QHS/QoL（4.3 个月对 1.7 个月）、QLQ-C30 恶心/呕吐（7.7 个月对 4.8 个月）和 QLQ-BR23 全身治疗副作用（6.1 个月对 3.4 个月）的 TTD 中位数延长。其他 HRQoL 终点观察到最小的治疗差异。
结论
HRQoL 结果与临床结果一致，似乎是由肿瘤 PD-L1 CPS≥10 的患者的结果驱动的。
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