Jin Li1, Shukui Qin, Jianming Xu, Weijian Guo, Jianping Xiong, Yuxian Bai, Guoping Sun, Yan Yang, Liwei Wang, Nong Xu, Ying Cheng, Zhehai Wang, Leizhen Zheng, Min Tao, Xiaodong Zhu, Dongmei Ji, Xin Liu, Hao Yu. 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 Affiliated Hospital of Nanchang University, Nanchang; Yuxian Bai, The Third Affiliated Hospital of Harbin Medical University, Harbin; Guoping Sun, The First Affiliated Hospital of Anhui Medical University, Hefei; Yan Yang, Gansu Cancer Hospital, Lanzhou; Nong Xu, The First Affiliated Hospital of Zhejiang University, Hangzhou; Ying Cheng, Jilin Cancer Hospital, Changchun; Zhehai Wang, Shandong Cancer Hospital, Jinan; and Min Tao, The First Affiliated Hospital of Soochow University, Suzhou, China.
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.
RCT Entities:
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.
Authors: Y Shimodaira; E Elimova; R Wadhwa; H Shiozaki; N Charalampakis; V Planjery; J E Rogers; S Song; J A Ajani Journal: Expert Opin Orphan Drugs Date: 2015-05-25 Impact factor: 0.694