PMID- 37274264 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231102 IS - 2234-943X (Print) IS - 2234-943X (Electronic) IS - 2234-943X (Linking) VI - 13 DP - 2023 TI - Efficacy and safety of ripretinib in Chinese patients with advanced gastrointestinal stromal tumors: a real-world, multicenter, observational study. PG - 1180795 LID - 10.3389/fonc.2023.1180795 [doi] LID - 1180795 AB - INTRODUCTION: Mutations in KIT proto-oncogene, receptor tyrosine kinase (KIT) and platelet-derived growth factor receptor-alpha (PDGFRA) render the available tyrosine kinase inhibitors (TKI) ineffective in treating advanced gastrointestinal stromal tumors (GIST). Ripretinib, a broad-spectrum switch-control kinase inhibitor, has shown increased efficacy and manageable safety, but real-world evidence remains scarce. This study evaluates the efficacy and safety of ripretinib among Chinese patients in a real-world setting. METHODS: Advanced GIST patients (N=23) receiving ripretinib following progression on previous lines of TKI treatment were enrolled to determine the efficacy [progression-free survival (PFS) and overall survival (OS)]. Safety was assessed by the incidence and severity of adverse events (AEs). All statistical analyses were performed using SPSS version 20.0 and a p-value of <0.05 was considered significant. RESULTS: The median PFS (mPFS) of efficacy analysis set (EAS) (N=21) was 7.1 months. mPFS of patients receiving ripretinib following /=3 prior lines of therapy were 7.1 and 9.2 months, respectively. The median OS (mOS) was 12.0 months and shorter interval between the end of the latest TKI and ripretinib therapy was correlated with longer median PFS and OS (p=0.054 and p=0.046), respectively. Alopecia and asthenia were the most common AEs observed. CONCLUSION: Compared to previous lines of TKI in advanced GIST patients, ripretinib showed superior efficacy with clinically manageable AEs. Real-world results are comparable to that of phase III INVICTUS study and its Chinese bridging study. Hence, ripretinib can be used for the clinical management of advanced GIST patients. CI - Copyright (c) 2023 Yang, Qian, Yang, Wang, Qian, Chu, Liu, Sun, Wu, Sun, Zhou, Hu, Chen, Shou, Ruan, Zhang and Yu. FAU - Yang, Weili AU - Yang W AD - Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. FAU - Qian, Haoran AU - Qian H AD - Department of Gastrointestinal Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. FAU - Yang, Litao AU - Yang L AD - Department of Gastric Surgery, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Hangzhou, Zhejiang, China. FAU - Wang, Pengfei AU - Wang P AD - Department of Gastrointestinal Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China. FAU - Qian, Hailong AU - Qian H AD - Department of Gastrointestinal Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo, Zhejiang, China. FAU - Chu, Binbin AU - Chu B AD - Department of Geriatrics, Ningbo Mingzhou Hospital, Ningbo, Zhejiang, China. FAU - Liu, Zhuo AU - Liu Z AD - Department of Colorectal Surgery, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Hangzhou, Zhejiang, China. FAU - Sun, Jingyu AU - Sun J AD - Department of Medical Oncology, Taizhou Municipal Hospital, Taizhou, Zhejiang, China. FAU - Wu, Dan AU - Wu D AD - Department of Gastrointestinal Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. FAU - Sun, Lifeng AU - Sun L AD - Department of Colorectal Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. FAU - Zhou, Wenqiang AU - Zhou W AD - Department of Medical Oncology, Taizhou Cancer Hospital, Taizhou, Zhejiang, China. FAU - Hu, Jingwei AU - Hu J AD - Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, China. FAU - Chen, Xiaolei AU - Chen X AD - Department of Gastrointestinal Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China. FAU - Shou, Chunhui AU - Shou C AD - Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. FAU - Ruan, Lingxiang AU - Ruan L AD - Department of Radiology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. FAU - Zhang, Yunyun AU - Zhang Y AD - Medical Affairs Department, Zai Lab (Shanghai) Co., Ltd, Shanghai, China. FAU - Yu, Jiren AU - Yu J AD - Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. LA - eng PT - Journal Article DEP - 20230518 PL - Switzerland TA - Front Oncol JT - Frontiers in oncology JID - 101568867 PMC - PMC10233743 OTO - NOTNLM OT - Chinese GIST patients OT - gastrointestinal stromal tumors OT - real-world OT - ripretinib OT - tyrosine kinase inhibitors (TKI) COIS- Author YZ was employed by Zai Lab Shanghai Co., Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/06/05 13:04 MHDA- 2023/06/05 13:05 PMCR- 2023/01/01 CRDT- 2023/06/05 12:00 PHST- 2023/03/06 00:00 [received] PHST- 2023/05/04 00:00 [accepted] PHST- 2023/06/05 13:05 [medline] PHST- 2023/06/05 13:04 [pubmed] PHST- 2023/06/05 12:00 [entrez] PHST- 2023/01/01 00:00 [pmc-release] AID - 10.3389/fonc.2023.1180795 [doi] PST - epublish SO - Front Oncol. 2023 May 18;13:1180795. doi: 10.3389/fonc.2023.1180795. eCollection 2023.