"Efficacy and safety of ripretinib vs. sunitinib in patients with advanced gastrointestinal stromal tumor previously treated with imatinib: A phase 2, multicenter, randomized, open-label study in China"

作者全名："Li, Jian; Zhang, Jun; Zhang, Yanqiao; Qiu, Haibo; Zhou, Yanbing; Zhou, Yongjian; Zhang, Xinhua; Zhou, Ye; Zhu, Yuping; Li, Yong; Wang, Ming; Shen, Kuntang; Tao, Kaixiong; Wu, Xin; Wang, Haijiang; Zhang, Bo; Ling, Jiayu; Ye, Yingjiang; Wu, Xingye; Qu, Hongyan; Ma, Yue; Jiao, Xuelong; Zheng, Hualong; Jin, Jiejie; Liu, Zhuo; Tan, Ming; Fang, Yong; Zhang, Peng; Zhang, Nan; Lei, Cheng; Cai, Zhaolun; Liang, Bin; Peng, Zhangyan; Huang, Zhao; Dong, Juan; Shen, Lin"

作者地址："[Li, Jian; Shen, Lin] Peking Univ Canc Hosp & Inst, Beijing, Peoples R China; [Zhang, Jun; Wu, Xingye] Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China; [Zhang, Yanqiao; Qu, Hongyan; Ma, Yue] Harbin Med Univ, Canc Hosp, Harbin, Peoples R China; [Qiu, Haibo] Sun Yat Sen Univ, Canc Ctr, Guangzhou, Peoples R China; [Zhou, Yanbing; Jiao, Xuelong] Qingdao Univ, Affiliated Hosp, Qingdao, Peoples R China; [Zhou, Yongjian; Zheng, Hualong] Fujian Med Univ, Union Hosp, Fuzhou, Peoples R China; [Zhang, Xinhua] Sun Yat Sen Univ, Affiliated Hosp 1, Guangzhou, Peoples R China; [Zhou, Ye; Jin, Jiejie] Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China; [Zhu, Yuping; Liu, Zhuo; Fang, Yong] Univ Chinese Acad Sci, Zhejiang Canc Hosp, Canc Hosp, Hangzhou, Peoples R China; [Li, Yong; Tan, Ming] Hebei Med Univ, Hebei Tumor Hosp, Hosp 4, Shijiazhuang, Peoples R China; [Wang, Ming] Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Shanghai, Peoples R China; [Shen, Kuntang] Fudan Univ, Zhongshan Hosp, Shanghai, Peoples R China; [Tao, Kaixiong; Zhang, Peng] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Wuhan, Peoples R China; [Wu, Xin; Zhang, Nan] Chinese Peoples Liberat Army Gen Hosp, Beijing, Peoples R China; [Wang, Haijiang] Xinjiang Med Univ, Affiliated Tumor Hosp, Urumqi, Peoples R China; [Zhang, Bo; Lei, Cheng; Cai, Zhaolun] Sichuan Univ, West China Hosp, Chengdu, Peoples R China; [Ling, Jiayu] Sun Yat Sen Univ, Affiliated Hosp 6, Guangzhou, Peoples R China; [Ye, Yingjiang; Liang, Bin] Peking Univ, Peoples Hosp, Beijing, Peoples R China; [Peng, Zhangyan; Huang, Zhao; Dong, Juan] Zai Lab Shanghai Co Ltd, Shanghai, Peoples R China; [Shen, Lin] Peking Univ Canc Hosp & Inst, 52 Fucheng Rd, Beijing 100142, Peoples R China"

通信作者："Shen, L (通讯作者)，Peking Univ Canc Hosp & Inst, 52 Fucheng Rd, Beijing 100142, Peoples R China."

来源：EUROPEAN JOURNAL OF CANCER

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001120157800001

JCR分区：Q1

影响因子：8.4

年份：2024

卷号：196

期号：　

开始页：　

结束页：　

文献类型：Article

关键词：Ripretinib; Sunitinib; Second -line treatment; Gastrointestinal stromal tumor

摘要："Aim: A bridging study of INTRIGUE study to assess the efficacy and safety of ripretinib versus sunitinib as second -line treatment in Chinese GIST patients. Methods: This was a phase 2, multicenter, randomized, open-label study in China. GIST patients previously treated with imatinib were randomized (1:1) to receive ripretinib 150 mg once daily (QD) by continuous dosing in 42-day cycles or sunitinib 50 mg QD in 42-day cycles (four weeks on/two weeks off). Primary endpoint was progression-free survival (PFS) by independent radiological review (IRR). Results: Between 6 December 2020 and 15 September 2021, 108 patients were randomized to receive ripretinib (n = 54) or sunitinib (n = 54) (all-patient [AP] intention-to-treat [ITT] population). Seventy patients had pri-mary KIT exon 11 mutations (ripretinib, n = 35; sunitinib, n = 35; Ex11 ITT population). By data cut-off (20 July 2022), in AP ITT population, PFS by IRR was comparable between ripretinib and sunitinib arms (HR 0.99, 95 % CI 0.57, 1.69; nominal p = 0.92; median PFS [mPFS] 10.3 vs 8.3 months). In Ex11 ITT population, PFS by IRR was longer for ripretinib than sunitinib (HR 0.46, 95 % CI 0.23, 0.92; nominal p = 0.03; mPFS not reached in ripretinib arm and 4 & sdot;9 months in sunitinib arm). Fewer patients experienced grade 3/4 treatment-related treatment-emergent adverse events with ripretinib (17%) versus sunitinib (56%). Conclusions: Ripretinib demonstrated similar efficacy and a favorable safety profile versus sunitinib as second -line treatment in Chinese GIST patients. Furthermore, ripretinib provided greater clinically meaningful benefit versus sunitinib in patients with KIT exon 11 mutation."

基金机构："Zai Lab (Shanghai) Co., Ltd."

基金资助正文："Funding This work was supported by Zai Lab (Shanghai) Co., Ltd. The trial design, data collection, analysis, and interpretation were performed by the funder, in collaboration with the investigators. The manuscript was written by the authors with medical writing support, which was spon-sored by the funder."