针对曾接受过治疗的亚洲肝细胞癌患者的 Pembrolizumab 与安慰剂的 3 期研究:来自 KEYNOTE-394 的健康相关生活质量分析

IF 11.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Liver Cancer Pub Date : 2024-01-10 DOI:10.1159/000535338
Shukui Qin, Weijia Fang, Zhenggang Ren, Shuangyan Ou, Ho Yeong Lim, Feng Zhang, Kin Chung Lee, Hye Jin Choi, Jiandong Tong, Min Tao, A. Xu, Ashley Cheng, Chang-Hsien Lu, Chang-Fang Chiu, Mohamed Ibrahim Abdul Wahid, Shital Kamble, Josephine M. Norquist, Wenyan Zhong, Chen Li, Zhendong Chen
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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.\n\nResults\nThe 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 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).\n\nConclusion\nPatients receiving placebo showed greater decline in HRQoL than those receiving pembrolizumab. 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引用次数: 0

摘要

导言KEYNOTE-394显示,与安慰剂相比,pembrolizumab能显著改善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反应率,且安全性可控。我们将介绍健康相关生活质量(HRQoL)的结果。方法HRQoL采用EORTC生活质量问卷-核心30(EORTC QLQ-C30)和EuroQol-5D-3L(EQ-5D-3L)问卷进行评估。关键的HRQoL终点为从基线到第12周的最小二乘法平均值(LSM)得分变化和EORTC QLQ-C30总体健康状况(GHS)/QoL的恶化时间(TTD)。结果HRQoL人群包括随机分配到pembrolizumab(n = 298)和安慰剂(n = 152)的患者。从基线到第12周,观察到安慰剂(LSM,-8.4;95% CI:-11.7至-5.1)与pembrolizumab(-4.0;95% CI:-6.4至-1.6;与安慰剂的差异:4.4;95% CI:0.5至8.4;名义p = 0.0142)相比,EORTC QLQ-C30 GHS/QoL评分下降幅度更大。同样,安慰剂(-6.9;95% CI:-9.4 至-4.5)与 pembrolizumab(-2.7;95% CI:-4.5 至-1.0;与安慰剂的差异:4.2;95% CI:1.2 至 7.2;标称 p = 0.0030)相比,观察到 EQ-5D-3L 视觉模拟量表评分下降幅度更大。两组患者在 EORTC QLQ-C30 GHS/QoL 评分方面的 TTD 相似(危险比为 0.85;95% CI:0.58-1.25;标称 p = 0.1993)。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pembrolizumab作为晚期肝细胞癌患者二线治疗的临床意义和可控耐受性。
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A Phase 3 Study of Pembrolizumab Versus Placebo for Previously Treated Patients From Asia With Hepatocellular Carcinoma: Health-Related Quality of Life Analysis From KEYNOTE-394
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 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 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.
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来源期刊
Liver Cancer
Liver Cancer Medicine-Oncology
CiteScore
20.80
自引率
7.20%
发文量
53
审稿时长
16 weeks
期刊介绍: Liver Cancer is a journal that serves the international community of researchers and clinicians by providing a platform for research results related to the causes, mechanisms, and therapy of liver cancer. It focuses on molecular carcinogenesis, prevention, surveillance, diagnosis, and treatment, including molecular targeted therapy. The journal publishes clinical and translational research in the field of liver cancer in both humans and experimental models. It publishes original and review articles and has an Impact Factor of 13.8. The journal is indexed and abstracted in various platforms including PubMed, PubMed Central, Web of Science, Science Citation Index, Science Citation Index Expanded, Google Scholar, DOAJ, Chemical Abstracts Service, Scopus, Embase, Pathway Studio, and WorldCat.
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