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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

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收录情况： ◇ SCIE

作者：
Li Jian[1] * ; Zhang Jun[2] * ; Zhang Yanqiao[3] * ; Qiu Haibo[4] * ; Zhou Yanbing[5] * ; Zhou Yongjian[6] ; Zhang Xinhua[7] ; Zhou Ye[8] ; Zhu Yuping[9] ; Li Yong[10] ; Wang Ming[11] ; Shen Kuntang[12] ; Tao Kaixiong[13] ; Wu Xin[14] ; Wang Haijiang[15] ; Zhang Bo[16] ; Ling Jiayu[17] ; Ye Yingjiang[18] ; Wu Xingye[2] ; Qu Hongyan[3] ; Ma Yue[3] ; Jiao Xuelong[5] ; Zheng Hualong[6] ; Jin Jiejie[8] ; Liu Zhuo[9] ; Tan Ming[10] ; Fang Yong[12] ; Zhang Peng[13] ; Zhang Nan[14] ; Lei Cheng[15] ; Cai Zhaolun[16] ; Liang Bin[18] ; Peng Zhangyan[19] ; Huang Zhao[19] ; Dong Juan[19] ; Shen Lin[1,*1] ;
机构： [1]Peking University Cancer Hospital & Institute, Beijing, China [2]The First Affiliated Hospital of Chongqing Medical University, Chongqing, China [3]Harbin Medical University Cancer Hospital, Harbin, China [4]Sun Yat-sen University Cancer Center, Guangzhou, China [5]The Affiliated Hospital of Qingdao University, Qingdao, China [6]Fujian Medical University Union Hospital, Fuzhou, China [7]The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China [8]Fudan University Shanghai Cancer Center, Shanghai, China [9]Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China [10]The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital), Shijiazhuang, China [11]Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China [12]Fudan University Zhongshan Hospital, Shanghai, China [13]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [14]Chinese PLA General Hospital, Beijing, China [15]Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China [16]West China hospital, Sichuan University, Chengdu, China [17]The Sixth Affiliated hospital, Sun Yat-sen University, Guangzhou, China [18]Peking University People’s Hospital, Beijing, China [19]Zai Lab (Shanghai) Co., Ltd, Shanghai, China
出处：
DOI： 10.1016/j.ejca.2023.113439
ISSN：

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

摘要：
A bridging study of INTRIGUE study to assess the efficacy and safety of ripretinib versus sunitinib as second-line treatment in Chinese GIST patients.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).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 primary 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 4·9 months in sunitinib arm). Fewer patients experienced grade 3/4 treatment-related treatment-emergent adverse events with ripretinib (17%) versus sunitinib (56%).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.Copyright © 2023. Published by Elsevier Ltd.

基金：
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 sponsored by the funder.
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出版当年[2024]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
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出版当年[2024]版：
无
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [1]Peking University Cancer Hospital & Institute, Beijing, China
共同第一作者：
通讯作者：
通讯机构： [1]Peking University Cancer Hospital & Institute, Beijing, China [*1]Peking University Cancer Hospital & Institute, 52 Fucheng Rd, Beijing, China.
推荐引用方式(GB/T 7714)：
Li Jian,Zhang Jun,Zhang Yanqiao,et al.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[J].EUROPEAN JOURNAL OF CANCER.2024,196:doi:10.1016/j.ejca.2023.113439.
APA：
Li Jian,Zhang Jun,Zhang Yanqiao,Qiu Haibo,Zhou Yanbing...&Shen Lin.(2024).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.EUROPEAN JOURNAL OF CANCER,196,
MLA：
Li Jian,et al."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".EUROPEAN JOURNAL OF CANCER 196.(2024)

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