Article
作者: Bai, Yuxian ; Zhou, Fuxiang ; Deng, Yanhong ; Ma, Dong ; Zhang, Tao ; Xu, Rui-Hua ; Yin, Xianli ; Pan, Yueyin ; Li, Qiu ; Wang, Shubin ; Gu, Kangsheng ; Shi, Michael ; Qin, Yanru ; Zhong, Haijun ; Li, Guoxin ; Yang, Lei ; Zhao, Fuyou ; Tang, Yong ; Li, Wei ; Ye, Feng ; Liu, Qiqi ; Cheng, Ying ; Wang, Feng ; Chen, Zhendong ; Mao, Weidong ; Hu, Wenwei ; Guo, Weijian ; Dai, Wenxiang ; Li, Man ; Chen, Donghui ; Shen, Lin ; Su, Weiguo ; Wang, Jufeng ; Liu, Tianshu ; Fan, Songhua ; Tan, Panfeng ; Li, Jin ; Pan, Hongming ; Shu, Yongqian ; Qin, Shukui ; Yuan, Ying
The vascular endothelial growth factor pathway plays a key role in the pathogenesis of gastric cancer. In the multicenter, double-blind phase 3 FRUTIGA trial, 703 patients with advanced gastric or gastroesophageal junction adenocarcinoma who progressed on fluorouracil- and platinum-containing chemotherapy were randomized (1:1) to receive fruquintinib (an inhibitor of vascular endothelial growth factor receptor-1/2/3; 4 mg orally, once daily) or placebo for 3 weeks, followed by 1 week off, plus paclitaxel (80 mg/m2 intravenously on days 1/8/15 per cycle). The study results were positive as one of the dual primary endpoints, progression-free survival (PFS), was met (median PFS, 5.6 months in the fruquintinib arm versus 2.7 months in the placebo arm; hazard ratio 0.57; 95% confidence interval 0.48-0.68; P < 0.0001). The other dual primary endpoint, overall survival (OS), was not met (median OS, 9.6 months versus 8.4 months; hazard ratio 0.96, 95% confidence interval 0.81-1.13; P = 0.6064). The most common grade ≥3 adverse events were neutropenia, leukopenia and anemia. Fruquintinib plus paclitaxel as a second-line treatment significantly improved PFS, but not OS, in Chinese patients with advanced gastric or gastroesophageal junction adenocarcinoma and could potentially be another treatment option for these patients. ClinicalTrials.gov registration: NCT03223376 .