Abstract | BACKGROUND: 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).
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Authors | Hui-Chuan Sun, Xiao-Dong Zhu, Jian Zhou, Qiang Gao, Ying-Hong Shi, Zhen-Bing Ding, Cheng Huang, Shuang-Jian Qiu, Ning Ren, Guo-Ming Shi, Jian Sun, Qing-Hai Ye, Xiao-Wu Huang, Xin-Rong Yang, Jia Fan |
Journal | Annals of translational medicine
(Ann Transl Med)
Vol. 8
Issue 20
Pg. 1301
(Oct 2020)
ISSN: 2305-5839 [Print] China |
PMID | 33209881
(Publication Type: Journal Article)
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Copyright | 2020 Annals of Translational Medicine. All rights reserved. |