Tislelizumab versus chemotherapy as second-line treatment of advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life.
Tislelizumab versus chemotherapy as second-line treatment of advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life.
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DOI：
10.1016/j.esmoop.2022.100517
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发表时间：
2022-08
期刊：
影响因子：
7.3
通讯作者：
Kim, S-B
中科院分区：
文献类型：
--
作者：
Van Cutsem, E.;Kato, K.;Ajani, J.;Shen, L.;Xia, T.;Ding, N.;Zhan, L.;Barnes, G.;Kim, S-B
理由302 （NCT03430843）是一项开放标签的III期研究，研究了晚期/转移性食管鳞状细胞癌（ESCC）的二线治疗，该研究报告称，相对于研究者选择的化疗（ICC）， tislelizumab与总生存期的改善和良好的安全性相关。本研究在理论基础302中评估了患者的健康相关生活质量（HRQoL）和escc相关症状。在既往全身治疗后病情进展的晚期/转移性ESCC成人患者随机接受1∶1的替利单抗或ICC（紫杉醇、多西他赛或伊立替康）治疗。HRQoL采用欧洲癌症研究与治疗组织生活质量问卷核心30项（EORTC QLQ-C30）、EORTC食管癌生活质量问卷模块18项（QLQ-OES18）和EuroQoL五维五级（EQ-5D-5L）视觉模拟量表进行测量。重复测量的混合效应模型检查了从基线到第12周和第18周的变化。Kaplan-Meier法用于检验退化时间。总的来说，512名患者被随机分配到tislelizumab （n = 256）或ICC （n = 256）。tislelizumab组维持QLQ-C30整体健康状态/质量，而ICC组在第12周恶化{最小二乘（LS）平均变化差值：5.8[95%置信区间（CI）： 2.0-9.5], P = 0.0028}和第18周[LS平均变化差值：8.1 (95% CI: 3.4-12.8), P = 0.0008]。与ICC组相比，tislelizumab组的身体功能（第18周）和疲劳（第12周和第18周）恶化较少。tislelizumab组的反流症状得到改善，而ICC在第12周恶化[LS平均变化差异：- 4.1 (95% CI: - 7.6至- 0.6),P = 0.0229]。在tislelizumab组中，视觉模拟量表保持一致，而在ICC组中则恶化。与ICC患者相比，tislelizumab患者在身体功能和反流方面恶化的时间风险较低。与接受icc治疗的患者相比，接受tislelizumab治疗的晚期或转移性ESCC患者的HRQoL（包括疲劳症状和身体功能）得以维持。这些结果为tislelizumab在该患者群体中的益处提供了额外的支持。tislelizumab组的整体健康状况和HRQoL保持一致，而ICC组出现恶化。双臂疲劳和身体机能恶化；然而，国际商会部门的恶化程度更大。tislelizumab组达到身体功能恶化和反流阈值的风险较低。
RATIONALE 302 (NCT03430843) an open-label, phase III study of second-line treatment of advanced/metastatic esophageal squamous cell carcinoma (ESCC), reported that tislelizumab, relative to investigator-chosen chemotherapy (ICC), was associated with improvements in overall survival and a favorable safety profile. This study assessed the health-related quality of life (HRQoL) and ESCC-related symptoms of patients in RATIONALE 302. Adults with advanced/metastatic ESCC whose disease progressed following prior systemic therapy were randomized 1 : 1 to receive either tislelizumab or ICC (paclitaxel, docetaxel, or irinotecan). HRQoL was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30), the EORTC Quality of Life Questionnaire Oesophageal Cancer Module 18 items (QLQ-OES18), and the EuroQoL Five-Dimensions Five-Levels (EQ-5D-5L) visual analogue scale. Mixed effect modeling for repeated measurements examined changes from baseline to weeks 12 and 18. The Kaplan–Meier method was used to examine time to deterioration. Overall, 512 patients were randomized to tislelizumab (n = 256) or ICC (n = 256). The tislelizumab arm maintained QLQ-C30 global health status/quality whereas the ICC arm worsened at week 12 {difference in least square (LS) mean change: 5.8 [95% confidence interval (CI): 2.0-9.5], P = 0.0028} and week 18 [difference in LS mean change: 8.1 (95% CI: 3.4-12.8), P = 0.0008]. Physical functioning (week 18) and fatigue (weeks 12 and 18) worsened less in the tislelizumab compared with the ICC arm. The tislelizumab arm improved in reflux symptoms, whereas the ICC worsened at week 12 [difference in LS mean change: −4.1 (95% CI: −7.6 to −0.6), P = 0.0229]. The visual analogue scale remained consistent in the tislelizumab arm whereas it worsened in the ICC arm. The hazard of time to deterioration was lower in tislelizumab patients compared with ICC for physical functioning and reflux. HRQoL, including fatigue symptoms and physical functioning, was maintained in patients with advanced or metastatic ESCC receiving tislelizumab compared with ICC-treated patients. These results provide additional support for the benefits of tislelizumab in this patient population. Global health status and HRQoL remained consistent in the tislelizumab arm whereas the ICC arm experienced worsening. Fatigue and physical functioning worsened in both arms; however, the worsening was greater in the ICC arm. The tislelizumab arm was at lower risk of reaching the threshold for worsening in physical functioning and reflux.
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