Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer: Results From a Randomized, Placebo-Controlled, Parallel-Arm, Phase II Trial

Author:

Li Jin1,Qin Shukui1,Xu Jianming1,Guo Weijian1,Xiong Jianping1,Bai Yuxian1,Sun Guoping1,Yang Yan1,Wang Liwei1,Xu Nong1,Cheng Ying1,Wang Zhehai1,Zheng Leizhen1,Tao Min1,Zhu Xiaodong1,Ji Dongmei1,Liu Xin1,Yu Hao1

Affiliation:

1. Jin Li, Weijian Guo, Xiaodong Zhu, Dongmei Ji, and Xin Liu, Shanghai Cancer Center and Shanghai Medical College, Fudan University; Liwei Wang, Shanghai First People's Hospital; Leizhen Zheng, XinHua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai; Shukui Qin, The 81 Hospital of PLA, Nanjing; Hao Yu, School of Public Health, Nanjing Medical University, Nanjing; Jianming Xu, The 307 Hospital of the Academy of Military Medical Sciences, Beijing; Jianping Xiong, The First...

Abstract

Purpose Patients with metastatic gastric cancer (mGC) who do not respond to or who experience progression with second-line chemotherapy have no treatment options that clearly confer a survival benefit. This trial investigated the safety and efficacy of apatinib, an inhibitor of vascular endothelial growth factor receptor, as a treatment option for heavily pretreated patients with mGC. Patients and Methods Patients who experienced treatment failure with at least two chemotherapeutic regimens were randomly assigned to receive placebo (group A), apatinib 850 mg once daily (group B), or apatinib 425 mg twice daily (group C). Results We enrolled 144 patients onto this study. In groups A, B, and C, the median overall survival (OS) times were 2.50 months (95% CI, 1.87 to 3.70 months), 4.83 months (95% CI, 4.03 to 5.97 months), and 4.27 months (95% CI, 3.83 to 4.77 months), respectively, and the median progression-free survival (PFS) times were 1.40 months (95% CI, 1.20 to 1.83 months), 3.67 months (95% CI, 2.17 to 6.80 months), and 3.20 months (95% CI, 2.37 to 4.53 months), respectively. There were statistically significant differences between the apatinib and placebo groups for both PFS (P < .001) and OS (P < .001 and P = .0017). Nine patients had a partial response (three patients in group B and six patients in group C). Toxicities were tolerable or could be clinically managed. The most common grade 3 to 4 adverse events were hand-foot syndrome and hypertension. Hematologic toxicities were moderate, and grade 3 to 4 hematologic toxicities were rare. Conclusion Apatinib showed improved PFS and OS in heavily pretreated patients with mGC who had experienced treatment failure with two or more chemotherapy regimens.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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