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Entinostat, a class I selective histone deacetylase inhibitor, plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial

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收录情况： ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ 卓越：领军期刊

作者：
Xu Binghe[1] * ; Zhang Qingyuan[2] * ; Hu Xichun[3] * ; Li Qing[1] * ; Sun Tao[4] ; Li Wei[5] ; Ouyang Quchang[6] ; Wang Jingfen[7] ; Tong Zhongsheng[8] ; Yan Min[9] ; Li Huiping[10] ; Zeng Xiaohua[11] ; Shan Changping[12] ; Wang Xian[13] ; Yan Xi[14] ; Zhang Jian[3] ; Zhang Yue[2] ; Wang Jiani[1] ; Zhang Liang[4] ; Lin Ying[15] ; Feng Jifeng[16] ; Chen Qianjun[17] ; Huang Jian[18] ; Zhang Lu[19] ; Yang Lisong[19] ; Tian Ying[19] ; Shang Hongyan[19] ;
机构： [1]Department of Medical Oncology and State Key Laboratory of Molecular Oncology, National Cancer Cener/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China [2]Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin 150000, China [3]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200000, China [4]Department of Galactophore, Liaoning Cancer Hospital & Institute, Shenyang 110801, China [5]Department of Oncology, the First Hospital of Jilin University, Changchun 130061, China [6]Department of Galactophore, Hunan Cancer Hospital, Changsha 410000, China [7]Department of Galactophore, Linyi Cancer Hospital, Linyi 276000, China [8]Department of Breast Medical Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin 300000, China [9]Department of Breast Disease, Henan Breast Cancer Center, the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou 450008, China [10]Department of Breast Oncology, Beijing Cancer Hospital, Beijing 100000, China [11]Breast Cancer Center, Chongqing University Cancer Hospital, Chongqing 400000, China [12]Department of Breast and Thyroid Oncology, Affiliated Hospital of Jining Medical University, Changchun 130021, China [13]Department of Medical Oncology, Run Run Shaw Hospital, Affiliated Hospital of Zhejiang University, Hangzhou 310003, China [14]Department of Head and Heck Oncology, West China Hospital, Sichuan University, Chengdu 610000, China [15]Department of Thyroid & Breast Surgery, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510000, China [16]Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing 210000, China [17]Department of Galactophore, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou 510000, China [18]Department of Oncological Surgery, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310000, China [19]Taizhou EOC Pharma Co., Ltd., Taizhou 318000, China
出处：
DOI： 10.1016/j.apsb.2023.02.001
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关键词： Advanced breast cancer Hormone receptorpositive Histone deacetylase inhibitors Phase 3 clinical trial

摘要：
Entinostat plus exemestane in hormone receptor-positive (HR+) advanced breast cancer (ABC) previously showed encouraging outcomes. This multicenter phase 3 trial evaluated the efficacy and safety of entinostat plus exemestane in Chinese patients with HR + ABC that relapsed/progressed after ≥1 endocrine therapy. Patients were randomized (2:1) to oral exemestane 25 mg/day plus entinostat (n = 235) or placebo (n = 119) 5 mg/week in 28-day cycles. The primary endpoint was the independent radiographic committee (IRC)-assessed progression-free survival (PFS). The median age was 52 (range, 28-75) years and 222 (62.7%) patients were postmenopausal. CDK4/6 inhibitors and fulvestrant were previously used in 23 (6.5%) and 92 (26.0%) patients, respectively. The baseline characteristics were comparable between the entinostat and placebo groups. The median PFS was 6.32 (95% CI, 5.30-9.11) and 3.72 (95% CI, 1.91-5.49) months in the entinostat and placebo groups (HR, 0.76; 95% CI, 0.58-0.98; P = 0.046), respectively. Grade ≥3 adverse events (AEs) occurred in 154 (65.5%) patients in the entinostat group versus 23 (19.3%) in the placebo group, and the most common grade ≥3 treatment-related AEs were neutropenia [103 (43.8%)], thrombocytopenia [20 (8.5%)], and leucopenia [15 (6.4%)]. Entinostat plus exemestane significantly improved PFS compared with exemestane, with generally manageable toxicities in HR + ABC (ClinicalTrials.gov #NCT03538171).© 2023 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier B.V.

基金编号： 2021-I2M-1-014

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出版当年[2023]版：
大类 | 1 区 医学
小类 | 1 区 药学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 药学
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出版当年[2023]版：
Q1 PHARMACOLOGY & PHARMACY
最新[2023]版：
Q1 PHARMACOLOGY & PHARMACY

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[2022版]

第一作者：
第一作者机构： [1]Department of Medical Oncology and State Key Laboratory of Molecular Oncology, National Cancer Cener/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Xu Binghe,Zhang Qingyuan,Hu Xichun,et al.Entinostat, a class I selective histone deacetylase inhibitor, plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial[J].ACTA PHARMACEUTICA SINICA B.2023,13(5):2250-2258.doi:10.1016/j.apsb.2023.02.001.
APA：
Xu Binghe,Zhang Qingyuan,Hu Xichun,Li Qing,Sun Tao...&Shang Hongyan.(2023).Entinostat, a class I selective histone deacetylase inhibitor, plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial.ACTA PHARMACEUTICA SINICA B,13,(5)
MLA：
Xu Binghe,et al."Entinostat, a class I selective histone deacetylase inhibitor, plus exemestane for Chinese patients with hormone receptor-positive advanced breast cancer: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial".ACTA PHARMACEUTICA SINICA B 13..5(2023):2250-2258

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