Transarterial chemoembolization with PD-(L)1 inhibitors plus molecular targeted therapies for hepatocellular carcinoma (CHANCE001)
Hai‐Dong Zhu, Hai-Liang Li, Mingsheng Huang, Wei-Zhu Yang, Guowen Yin, Bin‐Yan Zhong, Junhui Sun, Zhi‐Cheng Jin, Jian-Jia Chen, Naijian Ge, Wen‐Bin Ding, Wenhui Li, Jinhua Huang, Wei Mu, Shanzhi Gu, Jiaping Li, Hui Zhao, Shu-Wei Wen, Yanming Lei, Yusheng Song, Chunwang Yuan, Weidong Wang, Ming Huang, Wei Zhao, Jianbing Wu, Song Wang, Xu Zhu, Jianjun Han, Weixin Ren, Zaiming Lu, Wenge Xing, Yong Fan, Hailan Lin, Zishu Zhang, Guohui Xu, Wenhao Hu, Qiang Tu, Hongying Su, Chuansheng Zheng, Yong Chen, Xuya Zhao, Zhu-ting Fang, Qi Wang, Qi Wang, Aibing Xu, Jian Xu, Qinghua Wu, Huanzhang Niu, Jian Wang, Feng Dai, Feng Dai, Qingdong Li, Rong-Shu Shi, Jiarui Li, Guang Yang, Hai‐Bin Shi, Jiansong Ji, Yue Liu, Zheng Cai, Po Song Yang, Yang Zhao, Xiaoli Zhu, Ligong Lu, Gao‐Jun Teng, Li-Gong Lu, Gao‐Jun Teng, for the CHANCE001 Investigators
Abstract
There is considerable potential for integrating transarterial chemoembolization (TACE), programmed death-(ligand)1 (PD-[L]1) inhibitors, and molecular targeted treatments (MTT) in hepatocellular carcinoma (HCC). It is necessary to investigate the therapeutic efficacy and safety of TACE combined with PD-(L)1 inhibitors and MTT in real-world situations. In this nationwide, retrospective, cohort study, 826 HCC patients receiving either TACE plus PD-(L)1 blockades and MTT (combination group, n = 376) or TACE monotherapy (monotherapy group, n = 450) were included from January 2018 to May 2021. The primary endpoint was progression-free survival (PFS) according to modified RECIST. The secondary outcomes included overall survival (OS), objective response rate (ORR), and safety. We performed propensity score matching approaches to reduce bias between two groups. After matching, 228 pairs were included with a predominantly advanced disease population. Median PFS in combination group was 9.5 months (95% confidence interval [CI], 8.4-11.0) versus 8.0 months (95% CI, 6.6-9.5) (adjusted hazard ratio [HR], 0.70, P = 0.002). OS and ORR were also significantly higher in combination group (median OS, 19.2 [16.1-27.3] vs. 15.7 months [13.0-20.2]; adjusted HR, 0.63, P = 0.001; ORR, 60.1% vs. 32.0%; P < 0.001). Grade 3/4 adverse events were observed at a rate of 15.8% and 7.5% in combination and monotherapy groups, respectively. Our results suggest that TACE plus PD-(L)1 blockades and MTT could significantly improve PFS, OS, and ORR versus TACE monotherapy for Chinese patients with predominantly advanced HCC in real-world practice, with an acceptable safety profile.