作者
Yuankai Shi,Yanzhen Guo,X Y Li,Lin Wu,Zhaohong Chen,Sheng Yang,Minghong Bi,Yanqiu Zhao,Wenxiu Yao,Huiqing Yu,Ke Wang,Wenhua Zhao,Meili Sun,Liangming Zhang,Zhiyong He,Yingcheng Lin,Jianhua Shi,Bo Zhu,Lijun Wang,Yueyin Pan,Huaqiu Shi,Shenghua Sun,Meiling Wen,Rui Zhou,Shuliang Guo,Zhigang Han,Tienan Yi,Hua Zhang,Mingfang Zhao,Zhuang Yu,Diansheng Zhong,Jiuwei Cui,Jian Fang,Jinghua Gao,Manxiang Li,Rui Ma,Mingyan Jiang,Jianwen Qin,Yongqian Shu,Feng Ye,Sheng Hu,Wen Li,Hong Lu,Minglei Yang,Shanyong Yi,Yan Zhang,Yun Fan,Hongbo Ji,Zheng Liu,Haitao Wang,Xiangdong Zhou,Don C. Zhang,Jirong Peng,Haijiao Shen,Feng Gao,Tingting Wang,Anqi Zhou
摘要
Abstract REZOR is a multicenter, double-blinded, randomized phase 3 study aimed to compare the efficacy and safety of rezivertinib (BPI-7711) and gefitinib as first-line therapies in patients with EGFR mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC). The study included eligible patients from 50 hospitals across China. Those who had been histologically or cytologically confirmed NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation by central laboratory were randomly assigned (1:1) to receive once daily either rezivertinib 180 mg or gefitinib 250 mg. The primary endpoint was progression-free survival (PFS) evaluated by blinded independent central review (BICR), which was significantly superior in the rezivertinib group than the gefitinib group (19.3 versus 9.6 months, HR = 0.48, P <��������������������������������������������������������������������������������������������