多纳非尼辅助治疗肝细胞癌术后高危复发病人安全性和有效性初步研究

Preliminary study on the safety and efficacy of Donafenib as adjuvant therapy of patients with hepatocellular carcinoma at a high risk of recurrence after hepatectomy

目的探讨多纳非尼辅助治疗肝癌术后高危复发病人的安全性和有效性。方法回顾性分析2021年4月至2022年4月中国科学技术大学附属第一医院肝胆外科收治的行根治性肝切除术的27例肝癌病人的临床资料,术后均接受多纳非尼辅助治疗(初始剂量100 mg,每日2次)。通过影像学检查判断病人有无肿瘤复发,参照NCICTCAE 5.0判定不良事件的严重程度。结果中位随访时间为13.6(4.3~21.2)个月,5例病人出现肝内复发,1年无复发生存率为83.3%。治疗期间无病人死亡。中位治疗时间12.0(2.2~17.5)个月,26例(96.3%)病人治疗周期≥6个月。24例(88.9%)病人发生不良事件,主要为Ⅰ~Ⅱ级(22例),未发生致命的不良事件。常见不良事件包括手足综合征、血小板计数降低、牙龈出血、脱发以及腹泻。结论多纳非尼辅助治疗肝癌术后高危复发病人具有潜在的应用价值,表现出良好的安全性和有效性。

Objective To explore the safety and efficacy of donafenib as adjuvant therapy of patients with hepatocellular carcinoma at a high risk of recurrence after hepatectomy.Methods The clinical data of 27 patients with hepatocellular carcinoma who underwent radical hepatectomy admitted to the Department of Hepatobiliary Surgery of the First Affiliated Hospital of University of Science and Technology of China from April 2021 to April 2022 were retrospectively analyzed.All patients received Donafenil adjuvant therapy after surgery(initial dose 100 mg bid).Imaging examination was performed to determine whether the patients had tumor recurrence,and the severity of adverse events were determined according to the NCICTCAE 5.0.Results Up to 2023-02-15,the median follow-up time of the study was 13.6 months(4.3-21.2),and the 1-year RFS was 83.3%.No patient had died during the treatment.The median treatment time of patients was 12.0 months(2.2-17.5),and the treatment period of 26 patients(96.3%)was more than 6 months.In terms of safety,adverse events occurred in 24 patients(88.9%),the severity of which was mainly gradeⅠ-Ⅱ(81.5%),and no fatal adverse events occurred.Common adverse events included hand-foot syndrome,decreased platelet count,bleeding gums,alopecia,and diarrhea.Conclusion Donafenib as adjuvant therapy of patients with hepatocellular carcinoma at high risk of recurrence after hepatectomy has potential application value,and shows good safety and effectiveness.