KEYNOTE-564研究中的患者报告结果：辅助治疗的Pembrolizumab与安慰剂对肾细胞癌的比较。
Patient-Reported Outcomes in KEYNOTE-564: Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma.
发表日期：2023 Aug 17
作者：
Toni K Choueiri, Piotr Tomczak, Se Hoon Park, Balaji Venugopal, Stefan Symeonides, Jaroslav Hajek, Thomas Ferguson, Yen-Hwa Chang, Jae Lyun Lee, Naomi Haas, Piotr Sawrycki, Naveed Sarwar, Marine Gross-Goupil, Antoine Thiery-Vuillemin, Mauricio Mahave, Go Kimura, Rodolfo F Perini, Todd L Saretsky, Rituparna Bhattacharya, Lei Xu, Thomas Powles
来源：
PHYSICAL THERAPY & REHABILITATION JOURNAL
摘要：
在参加III期KEYNOTE-564试验（NCT03142334）的肾细胞癌（RCC）患者中，辅助性使用排列唑单抗治疗相较于安慰剂能延长肾切除术后的无疾病生存期（DFS）。患者报告的结果（PROs）对于健康相关生命质量（HRQoL）的测量具有重要意义，能够补充疗效和安全性结果。在KEYNOTE-564试验中，将994名患者随机分配到静脉注射排列唑单抗200 mg组（n = 496）或安慰剂组（n = 498），每3周给予治疗不超过17个周期。本分析纳入那些接受过≥1剂治疗并完成过≥1次HRQoL评估的患者。采用EORTC QLQ-C30，FKSI-DRS和EQ VAS评估HRQoL终点。预先指定和探索性PRO终点为EORTC QLQ-C30 GHS/QoL评分基线变化均值、EORTC QLQ-C30体能亚量表评分和FKSI-DRS评分。在52周时，EORTC QLQ-C30 GHS/QoL评分（-2.5；95% CI -5.2至0.1）、EORTC QLQ-C30体能亚量表评分（-0.87；95% CI -2.7至1.0）和FKSI-DRS评分（-0.7；95% CI -1.2至-0.1）的最小二乘均值分数中，排列唑单抗与安慰剂之间没有临床意义上的差异。大多数PRO评分对于EORTC QLQ-C30 GHS/QoL（排列唑单抗，54.3%；安慰剂，67.5%）、EORTC QLQ-C30体能亚量表（排列唑单抗，64.7%；安慰剂，68.8%）和FKSI-DRS（排列唑单抗，58.2%；安慰剂，66.3%）保持稳定或改善。辅助性使用排列唑单抗治疗没有导致HRQoL的恶化。这些结果与安全性和疗效结果一起支持术后辅助性使用排列唑单抗治疗。Clinicaltrials.gov识别号：NCT03142334。© The Author(s) 2023. Published by Oxford University Press.
In patients with renal cell carcinoma (RCC) enrolled in the phase III KEYNOTE-564 trial (NCT03142334), disease-free survival (DFS) following nephrectomy was prolonged with use of adjuvant pembrolizumab therapy versus placebo. Patient-reported outcomes (PROs) provide an important measure of health-related quality of life (HRQoL) and can complement efficacy and safety results.In KEYNOTE-564, 994 patients were randomly assigned to receive pembrolizumab 200 mg (n = 496) or placebo (n = 498) intravenously every 3 weeks for ≤17 cycles. Patients who received ≥1 dose of treatment and completed ≥1 HRQoL assessment were included in this analysis. HRQoL end points were assessed using the EORTC QLQ-C30, FKSI-DRS, and EQ VAS. Prespecified and exploratory PRO end points were mean change from baseline in EORTC QLQ-C30 GHS/QoL score, EORTC QLQ-C30 physical function subscale score, and FKSI-DRS score.No clinically meaningful difference in least squares mean scores for pembrolizumab versus placebo were observed at week 52 for EORTC QLQ-C30 GHS/QoL (-2.5; 95% CI -5.2 to 0.1), EORTC QLQ-C30 physical functioning (-0.87; 95% CI -2.7 to 1.0), and FKSI-DRS (-0.7; 95% CI -1.2 to -0.1). Most PRO scores remained stable or improved for the EORTC QLQ-C30 GHS/QoL (pembrolizumab, 54.3%; placebo, 67.5%), EORTC QLQ-C30 physical functioning (pembrolizumab, 64.7%; placebo, 68.8%), and FKSI-DRS (pembrolizumab, 58.2%; placebo, 66.3%).Adjuvant treatment with pembrolizumab did not result in deterioration of HRQoL. These findings together with the safety and efficacy findings support adjuvant pembrolizumab treatment following nephrectomy.Clinicaltrials.gov Identifier: NCT03142334.© The Author(s) 2023. Published by Oxford University Press.