辅助性乐伐替尼联合PD-1抗体治疗肝切除术后高复发风险肝细胞癌：一项回顾性标志性分析
Adjuvant Lenvatinib Plus PD-1 Antibody for Hepatocellular Carcinoma with High Recurrence Risks After Hepatectomy: A Retrospective Landmark Analysis.
作者信息
Ouyang Jingzhong, Wang Zhengzheng, Yuan Kun, Yang Yi, Zhou Yanzhao, Li Qingjun, Yang Nanmu, Zhao Haitao, Zhao Hong, Zhou Jinxue
机构信息
Department of Hepatobiliary and Pancreatic Surgery, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, Henan, People's Republic of China.
School of Public Health, Capital Medical University, Beijing, People's Republic of China.
出版信息
J Hepatocell Carcinoma. 2023 Sep 6;10:1465-1477. doi: 10.2147/JHC.S424616. eCollection 2023.
PURPOSE
To evaluate the efficacy and safety of lenvatinib plus programmed death-1 (PD-1) antibody as postoperative adjuvant therapy in patients with hepatocellular carcinoma (HCC) at high risks of recurrence.
PATIENTS AND METHODS
A series of 137 patients with HCC at high risks of recurrence who underwent hepatectomy at our hospital between October 2019 and January 2022 were retrospectively analyzed. Recurrence-free survival (RFS), overall survival (OS), and treatment-related adverse events (TRAEs) were assessed. Landmark analysis was used to compare short- and long-term RFS. Univariable and multivariable analyses were used to identify prognostic factors, and subgroup analyses were performed according to high risks of recurrence.
RESULTS
A total of 85 patients underwent hepatectomy alone and 52 patients received postoperative adjuvant therapy. Compared with the hepatectomy group (HG), RFS was significantly improved in the adjuvant therapy group (ATG) ( < 0.001), but OS was not ( = 0.098). Landmark analysis revealed that RFS within 6 months of the HG was significantly different from that of the ATG ( < 0.001) but not after 6 months ( = 0.486). Multivariable analysis showed that without adjuvant therapy, high Child-Pugh classification, high alpha-fetoprotein levels, microvascular invasion, and satellite lesions were independent risk factors for recurrence within 6 months after hepatectomy. Subgroup analysis revealed that patients with MVI significantly benefited from adjuvant therapy in RFS. But for OS, adjuvant therapy was only significantly effective in patients with single tumor. The most common treatment-related adverse events during adjuvant therapy were hypertension (36.5%), rash or itching (28.8%), diarrhea (23.1%), and fatigue (21.2%).
CONCLUSION
Postoperative adjuvant lenvatinib plus PD-1 antibody significantly improved RFS in patients with HCC at high risks of recurrence with acceptable safeties.
目的
评估乐伐替尼联合程序性死亡受体-1（PD-1）抗体作为术后辅助治疗对高复发风险肝细胞癌（HCC）患者的疗效和安全性。
患者与方法
回顾性分析2019年10月至2022年1月在我院接受肝切除术的137例高复发风险HCC患者。评估无复发生存期（RFS）、总生存期（OS）和治疗相关不良事件（TRAEs）。采用标志性分析比较短期和长期RFS。单因素和多因素分析用于确定预后因素，并根据复发高风险进行亚组分析。
结果
共85例患者单纯接受肝切除术，52例患者接受术后辅助治疗。与肝切除组（HG）相比，辅助治疗组（ATG）的RFS显著改善（<0.001），但OS无显著改善（=0.098）。标志性分析显示，HG组6个月内的RFS与ATG组有显著差异（<0.001），但6个月后无显著差异（=0.486）。多因素分析显示，在未接受辅助治疗的情况下，Child-Pugh分级高、甲胎蛋白水平高、微血管侵犯和卫星灶是肝切除术后6个月内复发的独立危险因素。亚组分析显示，微血管侵犯患者在RFS方面从辅助治疗中显著获益。但对于OS，辅助治疗仅对单发肿瘤患者显著有效。辅助治疗期间最常见的治疗相关不良事件为高血压（36.5%）、皮疹或瘙痒（28.8%）、腹泻（23.1%）和疲劳（21.2%）。
结论
术后辅助使用乐伐替尼联合PD-1抗体可显著改善高复发风险HCC患者的RFS，且安全性可接受。
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