个人中心| | 帮助
高级检索
当前位置： 首页 > 详情页

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

| 认领 | 导出 | |

文献详情

资源类型：
WOS体系：
Pubmed体系：

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.
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
JCR分区：
出版当年[2023]版：
Q1 ONCOLOGY
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)

相关文献

[1]Cytoreductive surgery for metastatic gastrointestinal stromal tumors followed by sunitinib compared to followed by imatinib-a multi-center cohort study [2]A prospective multicenter phase II study on the efficacy and safety of dasatinib in the treatment of metastatic gastrointestinal stromal tumors failed by imatinib and sunitinib and analysis of NGS in peripheral blood. [3]Second-line treatment options in metastatic castration-resistant prostate cancer after progression on first-line androgen-receptor targeting therapies: A systematic review and Bayesian network analysis [4]食管间质瘤手术方式的选择 [5]Clinicopathologic Characteristics and Prognosis of PDGFRA-Mutant Gastrointestinal Stromal Tumors: A Large-Scale, Multi-Institutional, Observational Study in China [6]Laparoscopic Versus Open Surgery for Rectal Gastrointestinal Stromal Tumor: A Multicenter Propensity Score-Matched Analysis. [7]Laparoscopic Versus Open Surgery for Rectal Gastrointestinal Stromal Tumor: A Multicenter Propensity Score-Matched Analysis. [8]低位直肠胃肠间质瘤手术治疗策略分析 [9]Asian Consensus Guidelines for the Diagnosis and Management of Gastrointestinal Stromal Tumor. [10]Microwave ablation for painful chest wall metastases from gastrointestinal stromal tumor: a case report

资源点击量：43377 今日访问量：0 总访问量：3120 更新日期：2024-09-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 四川省肿瘤医院 技术支持：重庆聚合科技有限公司 地址：成都市人民南路四段55号