Efficacy and safety of anti-PD-1 monoclonal antibody in advanced hepatocellular carcinoma after TACE combined with TKI therapy
10.3760/cma.j.cn112138-20200928-00841
- VernacularTitle:程序性死亡受体-1单抗在肝动脉化疗栓塞联合分子靶向药物治疗后进展期肝细胞癌的疗效分析
- Author:
Zining XU
1
;
Jingjun HUANG
;
Juan ZHOU
;
Wensou HUANG
;
Yongjian GUO
;
Mingyue CAI
;
Jingwen ZHOU
;
Liteng LIN
;
Licong LIANG
;
Kangshun ZHU
Author Information
1. 广州医科大学附属第二医院微创介入科，广州 510260
- Keywords:
Carcinoma, hepatocellular;
Treatment outcome;
Systemic treatment;
PD-1 monoclonal antibody
- From:
Chinese Journal of Internal Medicine
2021;60(7):630-636
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of anti-programmed cell death 1 (PD-1) receptor monoclonal antibody (MoAb) in patients with advanced hepatocellular carcinoma (HCC) after treatment of transcatheter arterial chemoembolization (TACE) combined with tyrosine kinase inhibitor (TKI).Methods:From February 2019 to February 2020, 56 HCC patients who relapsed after TACE-TKI treatment in Department of Interventional Radiology, The Second Affiliated Hospital of Guangzhou Medical University were enrolled. All patients received anti-PD-1 MoAb (sintilimab injection) and followed up every 6 weeks. According to mRECIST, the curative effect was evaluated as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Objective response rate (ORR) and disease control rate (DCR), progression-free survival (PFS) and treatment-related adverse events (TRAEs) were recorded. Univariate analysis by Chi-square test and binary logistic regression model was used to determine the influencing factors of DCR. The Kaplan-Meier method and Cox proportional hazard regression model were used to analyze the survival data.Results:A total of 48 patients were enrolled in this study including 42 males and 6 females, with a median age of 55 years (29-71 years). ECOG scores comprised of 0 in 24 cases, 1-2 in 24 cases. Thirty-six patients were in Child-Pugh grade A of liver function and 12 cases were grade B. The median follow-up time was 4.5 months. There were 2 patients achieved CR, 12 patients with PR and 16 with SD. ORR was 29.2%, DCR was 62.5%. The independent influencing factors of DCR was ECOG score and AFP level ( P=0.031, P=0.012). Median PFS was 4.1 months (95% CI 2.7-5.4 months), and ECOG score was the independent influencing factor of PFS ( P=0.042). Treatment-related adverse events were reported in 70.8% (34/48) patients. Incidence of grade Ⅲ-Ⅳ TRAEs was 22.9% (11/48). Conclusion:In patients with HCC who relapse from TACE and TKI treatment, anti-PD-1 monoclonal antibody is efficacious safe especially in those with ECOG 0 score.
