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基于卡瑞利珠单抗的疗法治疗晚期肺癌:一项前瞻性、开放标签、多中心、观察性的真实世界研究。

Camrelizumab-based therapies for the treatment of advanced lung cancer: a prospective, open-label, multicenter, observational, real-world study.

作者信息

Zhao Dong, Bi Minghong, Cheng Xiaofei, Wang Shuhong, Cheng Huaidong, Xia Xiaoyang, Chen Huan, Zhang Yanbei, Hu Zhiqiang, Cao Qisheng, Liang Hui, Wang Fan, Min Xuhong, Xu Ling, Feng Kehai, Zhou Jinhua, Li Xinzhong, Wang Rui, Xie Hua, Chen Xiaosi, Gu Kangsheng

机构信息

Department of Oncology, Lixin County People's Hospital, Bozhou, China.

Department of Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.

出版信息

Front Immunol. 2025 Mar 7;16:1494708. doi: 10.3389/fimmu.2025.1494708. eCollection 2025.

Abstract

OBJECTIVE

Camrelizumab, a programmed death-1 inhibitor, is effective and safe for treating patients with advanced lung cancer according to previous phase 3 trials. However, relevant real-world clinical evidence is required. This study intended to explore the efficacy and safety of camrelizumab-based therapies in patients with advanced lung cancer.

METHODS

Patients with advanced lung cancer who received camrelizumab-based therapies as first-line or above treatment were consecutively enrolled in this study. The median follow-up duration was 5 months.

RESULTS

A total of 298 subjects were enrolled. Objective response rate (ORR) and disease control rate (DCR) were 27.2% and 82.2%. Multivariable logistic regression analysis showed that previous pulmonary surgery [odds ratio (OR)=0.440, =0.024], previous radiotherapy (OR=0.410, =0.010), and Eastern Cooperative Oncology Group Performance Status (ECOG PS) score (>1 vs. 0~1) (OR=0.414, =0.046) were independently and negatively associated with ORR. The median progression-free survival (PFS) [95% confidence interval] was 10.0 (7.8-12.2) months. Median overall survival (OS) was not reached. Multivariable Cox regression analysis suggested that brain metastasis [hazard ratio (HR)=1.548, =0.036] and liver metastasis (HR=1.733, =0.035) were independently associated with shorter PFS. Previous chemotherapy (HR=2.376, =0.022), brain metastasis (HR=2.688, =0.006), and liver metastasis (HR=2.583, =0.039) were independently associated with shorter OS. Most adverse events were grade I or II. Grade III and IV adverse events rarely occurred. The occurrence of adverse events was associated with a higher DCR (=0.003).

CONCLUSIONS

Camrelizumab-based therapies may serve as potential treatments for patients with advanced lung cancer. However, further studies with an extended follow-up duration are warranted.

摘要

目的

根据先前的3期试验,程序性死亡-1抑制剂卡瑞利珠单抗治疗晚期肺癌患者有效且安全。然而,需要相关的真实世界临床证据。本研究旨在探讨基于卡瑞利珠单抗的治疗方案在晚期肺癌患者中的疗效和安全性。

方法

将接受基于卡瑞利珠单抗的治疗方案作为一线或以上治疗的晚期肺癌患者连续纳入本研究。中位随访时间为5个月。

结果

共纳入298例受试者。客观缓解率(ORR)和疾病控制率(DCR)分别为27.2%和82.2%。多变量逻辑回归分析显示,既往肺部手术[比值比(OR)=0.440,P=0.024]、既往放疗(OR=0.410,P=0.010)以及东部肿瘤协作组体能状态(ECOG PS)评分(>1 vs. 0~1)(OR=0.414,P=0.046)与ORR独立负相关。中位无进展生存期(PFS)[95%置信区间]为10.0(7.8-12.2)个月。中位总生存期(OS)未达到。多变量Cox回归分析表明,脑转移[风险比(HR)=1.548,P=0.036]和肝转移(HR=1.733,P=0.035)与较短的PFS独立相关。既往化疗(HR=2.376,P=0.022)、脑转移(HR=2.688,P=0.006)和肝转移(HR=2.583,P=0.039)与较短的OS独立相关。大多数不良事件为I级或II级。III级和IV级不良事件很少发生。不良事件的发生与较高的DCR相关(P=0.003)。

结论

基于卡瑞利珠单抗的治疗方案可能是晚期肺癌患者的潜在治疗方法。然而,有必要进行随访时间更长的进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4b0/11925761/7bb844e2b237/fimmu-16-1494708-g001.jpg

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