Safety and effectiveness of apatinib in patients with previously treated metastatic gastric cancer: a sub-analysis from the real-world study of apatinib for gastric cancer treatment (AHEAD-G202).

Abstract

Apatinib, a VEGFR2 receptor tyrosine kinase inhibitor, showed survival benefits in Asian patients with heavily pretreated advanced gastric cancer. However, the adverse event (AEs) profile of apatinib has limited its use. Dosing schedules are used to alleviate toxicities despite no supportive evidence. This study aimed to analyze the toxicity and effectiveness of apatinib alone, especially with different dosing strategies in advanced gastric cancer patients under a real-world setting. Data from the subpopulation of patients who failed ≥2 chemotherapy regimens enrolled in the AHEAD-G202 trial were analyzed. The primary endpoint was safety. The secondary endpoints were overall survival (OS) and progression-free survival (PFS). Totally 120 patients were included into three groups by the initial daily doses: 43 (35.8%) patients in the low-dose (250 mg) group, 67 (55.8%) patients in the mid-dose (425 mg to 500 mg) group, and 10 (8.3%) patients in the high-dose (675 to 850 mg) group. Grade 3/4 treatment-emergent AEs were infrequent (<5%), with the most commonly reported grade 3/4 AEs being hand-foot syndrome (4.2%), hypertension (4.2%,), fatigue (4.2%), and difficulty in swallowing (4.2%) which gradually decreased among the high-, mid-, and low-dose groups. The median OS and PFS were 6.33 months (95% CI, 4.57-7.73) and 3.83 months (95% CI: 1.40-4.20), respectively and were comparable among the three doses groups. We found heavily pretreated advanced gastric cancer patients can tolerate and benefit from lower-doses of apatinib therapy. The lower initial daily dosing strategy represents an alternative approach for optimizing apatinib dosing in clinical practice.

• Authors: Xiang Wang, Junyan Yu, Mudan Yang, Likun Liu, Jinghua Gao, Yuchuan Ren, Ruixing Zhang, Diansheng Zhong, Nan Du, Zhanzhao Fu, Junmei Jia, Qingshan Li, Jianfeng Diao, Junping Zhang, Jun Guo, Xiaomei Li, Xiang Song, Yan Zhang, Zhonghe Yu, Liwen Ma, Zaiwen Fan, Zheng Liu, Guozhong Li, Feng Liang, Huaqing Wang, Yunge Gao, Ping Yang, Chunmei Bai, Aimin Zang, Xiubao Ren
• Journal: American journal of cancer research (Am J Cancer Res) Vol. 10 Issue 3 Pg. 987-996 ( 2020) ISSN: 2156-6976 [Print] United States
• PMID: 32266105 (Publication Type: Journal Article)
• Copyright: AJCR Copyright © 2020.