Introduction KEYNOTE-394 showed pembrolizumab significantly improved overall survival, progression-free survival, and objective response rate with manageable safety versus placebo for patients from Asia with previously treated advanced hepatocellular carcinoma. We present results on health-related quality of life (HRQoL). Methods HRQoL was evaluated using the EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and EuroQol-5D-3L (EQ-5D-3L) questionnaires. Key HRQoL endpoints were least squares mean (LSM) score changes from baseline to week 12 and time to deterioration (TTD) for EORTC QLQ-C30 global health status (GHS)/QoL. p values were one-sided and nominal without adjustment for multiplicity. Results The HRQoL population included patients randomly assigned to pembrolizumab (n = 298) and placebo (n = 152). From baseline to week 12, a greater decline in EORTC QLQ-C30 GHS/QoL score was observed with placebo (LSM, -8.4; 95% CI: -11.7 to -5.1) versus pembrolizumab (-4.0; 95% CI: -6.4 to -1.6; difference vs. placebo: 4.4; 95% CI: 0.5-8.4; nominal p = 0.0142). Similarly, a greater decline in the EQ-5D-3L visual analog scale score was observed with placebo (-6.9; 95% CI: -9.4 to -4.5) versus pembrolizumab (-2.7; 95% CI: -4.5 to -1.0; difference vs. placebo: 4.2; 95% CI: 1.2-7.2; nominal p = 0.0030). TTD in EORTC QLQ-C30 GHS/QoL score was similar between arms (hazard ratio, 0.85; 95% CI: 0.58-1.25; nominal p = 0.1993). Conclusion Patients receiving placebo showed a greater decline in HRQoL than those receiving pembrolizumab. Combined with efficacy and safety data from KEYNOTE-394 and the global KEYNOTE-240 and KEYNOTE-224 trials, our data support the clinically meaningful benefit and manageable tolerability of pembrolizumab as second-line therapy for patients with advanced hepatocellular carcinoma.

中文翻译：

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针对先前接受过治疗的亚洲肝细胞癌患者的 Pembrolizumab 与安慰剂对比的 3 期研究：来自 KEYNOTE-394 的健康相关生活质量分析。


简介 KEYNOTE-394 显示，与安慰剂相比，pembrolizumab 显着改善了亚洲既往接受过治疗的晚期肝细胞癌患者的总生存期、无进展生存期和客观缓解率，且安全性可控。我们展示与健康相关的生活质量 (HRQoL) 的结果。方法 使用 EORTC 生活质量问卷-核心 30 (EORTC QLQ-C30) 和 EuroQol-5D-3L (EQ-5D-3L) 问卷评估 HRQoL。关键 HRQoL 终点是 EORTC QLQ-C30 全球健康状况 (GHS)/QoL 从基线到第 12 周的最小二乘均值 (LSM) 评分变化以及恶化时间 (TTD)。 p 值是单方面的且名义上的，未对多重性进行调整。结果 HRQoL 人群包括随机分配至派姆单抗组 (n = 298) 和安慰剂组 (n = 152) 的患者。从基线到第 12 周，与派姆单抗 (-4.0；95% CI：-6.4) 相比，安慰剂组 (LSM，-8.4；95% CI：-11.7 至 -5.1) 的 EORTC QLQ-C30 GHS/QoL 评分下降幅度更大至 -1.6；与安慰剂的差异：4.4；95% CI：0.5-8.4；名义 p = 0.0142）。同样，安慰剂组（-6.9；95% CI：-9.4 至 -4.5）与帕博利珠单抗组（-2.7；95% CI：-4.5 至 -1.0；-2.7；95% CI：-4.5 至 -1.0；与安慰剂的差异：4.2；95% CI：1.2-7.2；名义 p = 0.0030）。 EORTC QLQ-C30 GHS/QoL 评分中的 TTD 组间相似（风险比，0.85；95% CI：0.58-1.25；名义 p = 0.1993）。结论 接受安慰剂的患者比接受派姆单抗的患者 HRQoL 下降幅度更大。 结合 KEYNOTE-394 以及全球 KEYNOTE-240 和 KEYNOTE-224 试验的疗效和安全性数据，我们的数据支持派姆单抗作为晚期肝细胞癌患者二线治疗具有临床意义的益处和可控的耐受性。