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卡瑞利珠单抗联合阿帕替尼辅助治疗伴有微血管侵犯的肝细胞癌切除术后患者:一项多中心真实世界研究

Adjuvant camrelizumab plus apatinib in resected hepatocellular carcinoma with microvascular invasion: a multi-center real world study.

作者信息

Ouyang Jingzhong, Yang Yi, Zhou Yanzhao, Chang Xu, Wang Zhengzheng, Li Qingjun, Tang Yu, Cai Jianqiang, Zhou Jinxue, Huang Zhen, Zhao Hong

机构信息

Department of Hepatobiliary and Pancreatic Surgery, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.

Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

出版信息

Hepatobiliary Surg Nutr. 2024 Aug 1;13(4):616-631. doi: 10.21037/hbsn-23-363. Epub 2024 Feb 23.

Abstract

BACKGROUND

Hepatocellular carcinoma (HCC) treatment currently lacks adjuvant therapy with a high level of supporting evidence to reduce recurrence after hepatectomy. This study aimed to assess the safety and efficacy of camrelizumab plus apatinib in the adjuvant therapy of patients with HCC with microvascular invasion (MVI).

METHODS

Data were retrospectively collected on consecutive patients with HCC who underwent radical resection and were diagnosed with MVI-positive tumors between October 2019 and June 2022 at four centers. The association between adjuvant therapy and prognosis [recurrence-free survival (RFS), overall survival (OS)] was evaluated by propensity score matching (PSM), the log-rank test, Cox regression analysis, and subgroup analysis. Furthermore, grade 3 or 4 treatment-related adverse events (TRAEs) of adjuvant therapy were reported.

RESULTS

Among the 111 patients in the adjuvant therapy group and 276 patients in the observation group at enrolment, there were 99 and 172 in the adjuvant therapy and observation groups after PSM, respectively. RFS was better in the adjuvant therapy group [hazard ratio (HR) 0.52; 95% confidence interval (CI): 0.39 to 0.69; P<0.001], whereas OS was not (HR 0.62; 95% CI: 0.39 to 0.99; P=0.079). These results were confirmed after PSM. Subgroup analyses were generally consistent in favour of adjuvant camrelizumab plus apatinib with better RFS. Grade 3 or 4 TRAEs accounted for 20.7% during adjuvant therapy; the most common TRAEs included hypertension and proteinuria.

CONCLUSIONS

Postoperative adjuvant camrelizumab plus apatinib significantly improved the RFS benefits with acceptable toxicities in patients with HCC with MVI.

摘要

背景

肝细胞癌(HCC)治疗目前缺乏能有力支持减少肝切除术后复发的辅助治疗方法。本研究旨在评估卡瑞利珠单抗联合阿帕替尼在伴有微血管侵犯(MVI)的HCC患者辅助治疗中的安全性和疗效。

方法

回顾性收集2019年10月至2022年6月期间在四个中心接受根治性切除且被诊断为MVI阳性肿瘤的连续HCC患者的数据。通过倾向评分匹配(PSM)、对数秩检验、Cox回归分析和亚组分析评估辅助治疗与预后[无复发生存期(RFS)、总生存期(OS)]之间的关联。此外,报告辅助治疗的3级或4级治疗相关不良事件(TRAEs)。

结果

入组时,辅助治疗组有111例患者,观察组有276例患者,PSM后辅助治疗组和观察组分别有99例和172例。辅助治疗组的RFS更好[风险比(HR)0.52;95%置信区间(CI):0.39至0.69;P<0.001],而OS并非如此(HR 0.62;95%CI:0.39至0.99;P=0.079)。PSM后这些结果得到证实。亚组分析总体上一致支持辅助使用卡瑞利珠单抗联合阿帕替尼可获得更好的RFS。辅助治疗期间3级或4级TRAEs占20.7%;最常见的TRAEs包括高血压和蛋白尿。

结论

术后辅助使用卡瑞利珠单抗联合阿帕替尼可显著改善伴有MVI的HCC患者的RFS,且毒性可接受。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/00b1/11336524/3089225adf2c/hbsn-13-04-616-f1.jpg

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