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卡瑞利珠单抗治疗晚期食管癌的有效性、安全性及使用模式:一项对来自三项前瞻性队列研究的987例患者的个体患者数据汇总分析

Effectiveness, safety, and patterns of use of camrelizumab in advanced esophageal cancer: an individual patient data pooled analysis of 987 patients from three prospective cohort studies.

作者信息

Lu Zhihao, Sun Guoping, Li Jiancheng, Zhao Jun, Wang Zishu, Qian Dong, Yang Zhe, Li Na, Wang Junsheng, Yuan Shuanghu, Wang Yusheng, Li Suyi, Yang Zhen, Ran Fengming, Ji Yinghua, Zhu Shaojin, Zhang Yanqiao, Wang Chen, Wan Lixin, Zheng Rongrong, Deng Wenjie, Cheng Fengzhuo, Shen Lin

机构信息

Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, 52 Fucheng Road, Beijing, China.

Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.

出版信息

Cancer Immunol Immunother. 2025 Mar 8;74(4):138. doi: 10.1007/s00262-025-03970-z.

Abstract

BACKGROUND AND AIMS

This individual patient data pooled analysis aimed to evaluate the effectiveness, safety, and patterns of use of camrelizumab in a large cohort of advanced esophageal cancer (AEC) patients.

APPROACH AND RESULTS

Adult patients (≥ 18 years) who had received camrelizumab as part of AEC treatment were pooled from three independent, prospective observational cohort studies (NCT04616040, ChiCTR1900027275, and ChiCTR2000039499). The main outcomes were patterns of camrelizumab use, progression-free survival (PFS), overall survival (OS), and safety in the overall population and specific subgroups of underrepresented patients. Among 987 patients, 450 (45.6%) received camrelizumab in the first line, 398 (40.3%) in the second line, and 139 (14.1%) in the third line or later. Most (69.7%) patients received camrelizumab plus chemotherapy regardless of treatment lines. The median PFS was 9.9 (95% CI 7.4, 14.4), 6.6 (95% CI 5.1, 8.8), and 5.7 (95% CI 3.1, 9.6) months in the first line, second line, and third line or later, respectively. The corresponding median OS was 15.5 (95% CI 12.6, 18.4), 12.1 (95% CI 10.0, 14.7), and 10.9 (95% CI 8.1, 14.5) months. Patients with poor performance status (ECOG PS ≥ 2) and with camrelizumab in the second line or later, but not patients with older age (≥ 75 years), were associated with poor survival. Adverse events occurred in 721 (73.0%) patients, with no new safety signals.

CONCLUSIONS

This study provides an overview of camrelizumab use in unselected AEC patients. The real-world effectiveness and safety of camrelizumab are generally consistent with those observed in pivotal trials.

摘要

背景与目的

这项个体患者数据汇总分析旨在评估卡瑞利珠单抗在一大群晚期食管癌(AEC)患者中的有效性、安全性及使用模式。

方法与结果

从三项独立的前瞻性观察队列研究(NCT04616040、ChiCTR1900027275和ChiCTR2000039499)中汇总接受卡瑞利珠单抗作为AEC治疗一部分的成年患者(≥18岁)。主要结局是卡瑞利珠单抗的使用模式、无进展生存期(PFS)、总生存期(OS)以及总体人群和代表性不足患者特定亚组的安全性。在987例患者中,450例(45.6%)一线接受卡瑞利珠单抗治疗,398例(40.3%)二线接受治疗,139例(14.1%)三线及更后线接受治疗。大多数(69.7%)患者无论治疗线数均接受卡瑞利珠单抗联合化疗。一线、二线、三线及更后线的中位PFS分别为9.9个月(95%CI 7.4,14.4)、6.6个月(95%CI 5.1,8.8)和5.7个月(95%CI 3.1,9.6)。相应的中位OS分别为15.5个月(95%CI 12.6,18.4)、12.1个月(95%CI 10.0,14.7)和10.9个月(95%CI 8.1,14.5)。体能状态较差(ECOG PS≥2)且二线及更后线接受卡瑞利珠单抗治疗的患者,但≥75岁的患者除外,生存期较差。721例(73.0%)患者发生不良事件,未发现新的安全信号。

结论

本研究概述了卡瑞利珠单抗在未经选择的AEC患者中的使用情况。卡瑞利珠单抗的真实世界有效性和安全性与关键试验中观察到的情况总体一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d3fc/11890476/098770815132/262_2025_3970_Fig1_HTML.jpg

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