PMID- 33209881 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220418 IS - 2305-5839 (Print) IS - 2305-5847 (Electronic) IS - 2305-5839 (Linking) VI - 8 IP - 20 DP - 2020 Oct TI - Adjuvant apatinib treatment after resection of hepatocellular carcinoma with portal vein tumor thrombosis: a phase II trial. PG - 1301 LID - 10.21037/atm-20-6181 [doi] LID - 1301 AB - BACKGROUND: Survival after resection of hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) still remains poor. Apatinib, a vascular endothelial cell growth factor receptor 2 inhibitor, has been shown to be safe and effective in patients with advanced HCC, so in the present study its efficacy and safety in the adjuvant setting was explored. METHODS: In this single-center, open-label phase II trial, the patients received apatinib (500 mg/day) until they experienced disease recurrence or intolerable toxicity. The primary endpoint was recurrence-free survival (RFS); the secondary endpoints included overall survival (OS) and safety. RESULTS: From a total of 49 patients who were screened between August 2017 and December 2018, 30 study participants received apatinib. According to the Liver Cancer Study Group of Japan classification of PVTT, there were 7, 11, and 12 participants with Vp1, Vp2, and Vp3, respectively. The median duration of treatment was 4.8 months [interquartile range (IQR): 2.0-8.8], and the median dose of apatinib was 339.7 mg/day (IQR: 267.7-500 mg/day). The median follow-up was 14.3 months (IQR: 12.3-19.3). The median RFS was 7.6 months [95% confidence interval (CI): 5.7-9.5 months]. The 1-year RFS rate and the 1-year OS rate were 36.1% and 93.3%, respectively. A total of 29 (96.7%) patients experienced adverse events, and 14 (46.7%) had grade 3 or 4 adverse events. No treatment-related deaths occurred. CONCLUSIONS: Apatinib was well tolerated in patients after resection of HCC with PVTT. The median RFS in this group was improved compared with that previously reported. TRIAL REGISTRATION: No.: NCT03261791 (ClinicalTrials.gov). CI - 2020 Annals of Translational Medicine. All rights reserved. FAU - Sun, Hui-Chuan AU - Sun HC AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Zhu, Xiao-Dong AU - Zhu XD AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Zhou, Jian AU - Zhou J AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Gao, Qiang AU - Gao Q AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Shi, Ying-Hong AU - Shi YH AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Ding, Zhen-Bing AU - Ding ZB AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Huang, Cheng AU - Huang C AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Qiu, Shuang-Jian AU - Qiu SJ AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Ren, Ning AU - Ren N AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Shi, Guo-Ming AU - Shi GM AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Sun, Jian AU - Sun J AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Ye, Qing-Hai AU - Ye QH AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Huang, Xiao-Wu AU - Huang XW AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Yang, Xin-Rong AU - Yang XR AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Fan, Jia AU - Fan J AD - Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China. LA - eng SI - ClinicalTrials.gov/NCT03261791 PT - Journal Article PL - China TA - Ann Transl Med JT - Annals of translational medicine JID - 101617978 PMC - PMC7661881 OTO - NOTNLM OT - Apatinib OT - hepatocellular carcinoma (HCC) OT - portal vein COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/atm-20-6181). HCS reports personal fees from Bayer, personal fees from Eisai, personal fees from MSD, personal fees from Hengrui Co., Ltd., personal fees from Innovent Biologics, outside the submitted work; XDZ reports personal fees from Eisai, personal fees from MSD, personal fees from Hengrui Co. Ltd., outside the submitted work. The other authors have no conflicts of interest to declare. EDAT- 2020/11/20 06:00 MHDA- 2020/11/20 06:01 PMCR- 2020/10/01 CRDT- 2020/11/19 05:49 PHST- 2020/11/19 05:49 [entrez] PHST- 2020/11/20 06:00 [pubmed] PHST- 2020/11/20 06:01 [medline] PHST- 2020/10/01 00:00 [pmc-release] AID - atm-08-20-1301 [pii] AID - 10.21037/atm-20-6181 [doi] PST - ppublish SO - Ann Transl Med. 2020 Oct;8(20):1301. doi: 10.21037/atm-20-6181.