PD-1和PD-L1抑制剂对食管鳞状细胞癌患者报告结局的影响：临床试验的系统综述

文献信息

中文摘要

目的： 食管鳞状细胞癌（ESCC）预后较差，并伴有吞咽困难等症状，严重损害患者的健康相关生活质量（HRQoL）。化疗联合免疫检查点抑制剂在真实世界实践中广泛使用，并且是不可切除、复发或转移性ESCC的推荐治疗。本系统文献综述评估了在ESCC中评价PD-1/PD-L1抑制剂的临床试验中的患者报告结局（PROs）。
方法： 对PubMed、Embase和Cochrane Library进行了全面检索，并辅以Elicit，以识别报告接受PD-1/PD-L1抑制剂治疗的ESCC患者PROs的临床试验出版物。符合条件的研究发表于2025年7月20日之前，并且符合以下标准：（1）纳入ESCC患者；（2）报告PD-1/PD-L1抑制剂随机临床试验中的PROs，包括HRQoL；（3）以英文发表。
结果： 十三篇临床试验出版物符合纳入标准。研究的药物包括纳武利尤单抗、替雷利珠单抗、卡瑞利珠单抗、信迪利单抗和帕博利珠单抗。PROs使用EORTC QLQ-C30和QLQ-OES18、EQ-5D-5L、EQ-5D-3L和FACT-E问卷进行测量，随访时间为8至60周。EORTC QLQ-C30和QLQ-OES18是最常用的工具。虽然结果因治疗和设置而异，但与化疗相比，基于PD-1/PD-L1抑制剂的方案总体上维持或改善了PROs，包括总体HRQoL和食管癌特异性症状，如疼痛、反流以及进食和吞咽困难。
结论： 在各项试验中，与化疗相比，PD-1/PD-L1抑制剂在ESCC中与PROs的维持或改善相关，尤其是在总体健康状况、功能领域和关键ESCC相关症状方面。

英文摘要

OBJECTIVES: Esophageal squamous cell carcinoma (ESCC) carries a poor prognosis and is associated with symptoms such as dysphagia that substantially impair patients' health-related quality of life (HRQoL). The combination of chemotherapy with an immune checkpoint inhibitor is widely used in real-world practice and is a recommended treatment for unresectable, recurrent, or metastatic ESCC. This systematic literature review assessed patient-reported outcomes (PROs) in clinical trials evaluating PD-1/PD-L1 inhibitors in ESCC.
METHODS: A comprehensive search of PubMed, Embase, and the Cochrane Library, supplemented by Elicit, was conducted to identify clinical trial publications reporting PROs in ESCC patients treated with PD-1/PD-L1 inhibitors. Eligible studies were published through July 20, 2025, and were included if they met the following criteria: (1) enrolled ESCC patients; (2) reported PROs, including HRQoL, in randomized clinical trials of PD-1/PD-L1 inhibitors; and (3) were published in English.
RESULTS: Thirteen clinical trial publications met the inclusion criteria. Investigated agents included nivolumab, tislelizumab, camrelizumab, sintilimab, and pembrolizumab. PROs were measured using the EORTC QLQ-C30 and QLQ-OES18, EQ-5D-5L, EQ-5D-3L, and FACT-E questionnaires, with follow-up ranging from 8 to 60 weeks. The EORTC QLQ-C30 and QLQ-OES18 were the most frequently used instruments. While results varied by treatment and setting, PD-1/PD-L1 inhibitor-based regimens generally maintained or improved PROs compared with chemotherapy, including overall HRQoL and esophageal cancer-specific symptoms such as pain, reflux, and eating and swallowing difficulties.
CONCLUSIONS: Across trials, PD-1/PD-L1 inhibitors were associated with maintenance or improvement in PROs compared with chemotherapy in ESCC, especially in global health status, functional domains, and key ESCC-related symptoms.