研究动态
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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切除肝细胞癌: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.

发表日期:2024 Aug 01
作者: Jingzhong Ouyang, Yi Yang, Yanzhao Zhou, Xu Chang, Zhengzheng Wang, Qingjun Li, Yu Tang, Jianqiang Cai, Jinxue Zhou, Zhen Huang, Hong Zhao
来源: Hepatobiliary Surgery and Nutrition

摘要:

肝细胞癌(HCC)治疗目前缺乏具有高水平支持证据的辅助治疗来减少肝切除术后的复发。本研究旨在评估卡瑞利珠单抗联合阿帕替尼辅助治疗伴有微血管侵犯(MVI)的 HCC 患者的安全性和有效性。回顾性收集连续接受根治性切除并诊断为 MVI 阳性肿瘤的 HCC 患者的数据。 2019 年 10 月和 2022 年 6 月在四个中心举行。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,报告了辅助治疗的3级或4级治疗相关不良事件(TRAE)。入组时辅助治疗组111例患者和观察组276例患者中,辅助治疗组和观察组分别有99例和172例。分别为 PSM 后的组。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 则不然(HR 0.62;95% CI:0.39 至 0.99;P=0.079)。这些结果在 PSM 后得到了证实。亚组分析总体上一致支持辅助卡瑞利珠单抗加阿帕替尼具有更好的 RFS。辅助治疗期间3级或4级TRAE占20.7%;最常见的 TRAE 包括高血压和蛋白尿。术后辅助卡瑞利珠单抗联合阿帕替尼显着改善了患有 MVI 的 HCC 患者的 RFS 益处,且毒性可接受。2024 肝胆外科和营养。版权所有。
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).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.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.Postoperative adjuvant camrelizumab plus apatinib significantly improved the RFS benefits with acceptable toxicities in patients with HCC with MVI.2024 Hepatobiliary Surgery and Nutrition. All rights reserved.