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Pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer and brain metastases (PERMEATE trial): overall survival results from a multicenter, single-arm, two-cohort, phase 2 trial

文献类型：期刊论文

作者Yan, Min2,3; Ouyang, Quchang4; Sun, Tao5; Niu, Limin2,3; Yang, Jin6; Li, Li7; Song, Yuhua1; Hao, Chunfang8; Chen, Zhanhong9; Liu, Zhenzhen2,3
刊名ECLINICALMEDICINE
出版日期2024-10-01
卷号76
关键词Pyrotinib Human epidermal growth factor receptor 2 Breast cancer Brain metastases Overall survival
DOI10.1016/j.eclinm.2024.102837
通讯作者Yan, Min(ym200678@126.com)
英文摘要Background The phase 2 PERMEATE study has shown the antitumor activity and safety of pyrotinib plus capecitabine in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer and brain metastases. In this report, survival results were updated with extended follow-up. Methods Between January 29, 2019 and July 10, 2020, adult patients with HER2-positive metastatic breast cancer who had radiotherapy-na & iuml;ve brain metastases (cohort A, n = 59) or progressive disease after radiotherapy (cohort B, n =19) were enrolled and received pyrotinib (400 mg once daily) and capecitabine (1000 mg/m(2) twice daily on days 1-14 - 14 of each 21-day cycle) until disease progression or unacceptable toxicity. Secondary endpoints progression-free survival (PFS) and overall survival (OS) were updated, and post-hoc central nervous system (CNS)-PFS was analyzed. This study is registered with ClinicalTrials.gov (NCT03691051). Findings As of February 2, 2023, the median follow-up duration was 30.9 months (interquartile range, 16.1-39.8). - 39.8). Median PFS was 10.9 months (95% confidence fi dence interval [CI], 7.6-14.6) - 14.6) in cohort A and 5.7 months (95% CI, 3.4-11.5) - 11.5) in cohort B. Median OS was 35.9 months (95% CI, 24.4-not reached) in cohort A and 30.6 months (95% CI, 12.6-33.3) - 33.3) in cohort B. Median CNS-PFS was 13.6 months (95% CI, 9.0-15.8) - 15.8) in cohort A and 5.7 months (95% CI, 3.4-11.5) - 11.5) in cohort B. Median OS was 34.1 months (95% CI, 21.7-not reached) for 14 patients with intracranial progression only in cohort A who restarted pyrotinib plus capecitabine after local radiotherapy. Interpretation These data support further validation in a randomized controlled trial for the assessment of pyrotinib in combination with capecitabine as systemic therapy for patients with HER2-positive breast cancer and brain metastases. Copyright (c) 2024 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-NDlicense (http://creativecommons.org/licenses/by-nc-nd/4.0/).
WOS关键词OPEN-LABEL ; TRASTUZUMAB EMTANSINE ; LAPATINIB ; RADIOTHERAPY ; OUTCOMES ; PLACEBO ; PHOEBE
资助项目National Cancer Center Climbing Foundation Key Project of China ; Jiangsu Hengrui Pharmaceuticals
WOS研究方向General & Internal Medicine
语种英语
WOS记录号WOS:001321341000001
出版者ELSEVIER
资助机构National Cancer Center Climbing Foundation Key Project of China ; Jiangsu Hengrui Pharmaceuticals
源URL[http://ir.hfcas.ac.cn:8080/handle/334002/135755]  
专题中国科学院合肥物质科学研究院
通讯作者Yan, Min
作者单位1.Qingdao Univ, Breast Canc Ctr, Affiliated Hosp, Qingdao, Peoples R China
2.Zhengzhou Univ, Affiliated Canc Hosp, Henan Breast Canc Ctr, 127 Dongming Rd, Zhengzhou 450003, Peoples R China
3.Henan Canc Hosp, 127 Dongming Rd, Zhengzhou 450003, Peoples R China
4.Cent South Univ, Hunan Canc Hosp, Affiliated Canc Hosp, Xiangya Sch Med,Dept Breast Med, Changsha, Peoples R China
5.China Med Univ, Canc Hosp, Liaoning Canc Hosp, Breast Med, Shenyang, Peoples R China
6.Xi An Jiao Tong Univ, Affiliated Hosp 1, Canc Ctr, Xian, Peoples R China
7.Shandong Univ, Qilu Hosp, Dept Oncol, Jinan, Peoples R China
8.Tianjin Med Univ Canc Inst & Hosp, Dept Breast Oncol, Tianjin, Peoples R China
9.Univ Chinese Acad Sci, Canc Hosp, Dept Breast Canc Internal Med, Hangzhou, Peoples R China
10.Xinxiang Cent Hosp, Dept Med Oncol, Xinxiang, Peoples R China
推荐引用方式
GB/T 7714		 Yan, Min,Ouyang, Quchang,Sun, Tao,et al. Pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer and brain metastases (PERMEATE trial): overall survival results from a multicenter, single-arm, two-cohort, phase 2 trial[J]. ECLINICALMEDICINE,2024,76.
APA Yan, Min.,Ouyang, Quchang.,Sun, Tao.,Niu, Limin.,Yang, Jin.,...&Xia, Fangzhou.(2024).Pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer and brain metastases (PERMEATE trial): overall survival results from a multicenter, single-arm, two-cohort, phase 2 trial.ECLINICALMEDICINE,76.
MLA Yan, Min,et al."Pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer and brain metastases (PERMEATE trial): overall survival results from a multicenter, single-arm, two-cohort, phase 2 trial".ECLINICALMEDICINE 76(2024).

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来源：合肥物质科学研究院

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