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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

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 endocr...

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Autores principales: Xu, Binghe, Zhang, Qingyuan, Hu, Xichun, Li, Qing, Sun, Tao, Li, Wei, Ouyang, Quchang, Wang, Jingfen, Tong, Zhongsheng, Yan, Min, Li, Huiping, Zeng, Xiaohua, Shan, Changping, Wang, Xian, Yan, Xi, Zhang, Jian, Zhang, Yue, Wang, Jiani, Zhang, Liang, Lin, Ying, Feng, Jifeng, Chen, Qianjun, Huang, Jian, Zhang, Lu, Yang, Lisong, Tian, Ying, Shang, Hongyan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10213795/
https://www.ncbi.nlm.nih.gov/pubmed/37250148
http://dx.doi.org/10.1016/j.apsb.2023.02.001
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author Xu, Binghe
Zhang, Qingyuan
Hu, Xichun
Li, Qing
Sun, Tao
Li, Wei
Ouyang, Quchang
Wang, Jingfen
Tong, Zhongsheng
Yan, Min
Li, Huiping
Zeng, Xiaohua
Shan, Changping
Wang, Xian
Yan, Xi
Zhang, Jian
Zhang, Yue
Wang, Jiani
Zhang, Liang
Lin, Ying
Feng, Jifeng
Chen, Qianjun
Huang, Jian
Zhang, Lu
Yang, Lisong
Tian, Ying
Shang, Hongyan
author_facet Xu, Binghe
Zhang, Qingyuan
Hu, Xichun
Li, Qing
Sun, Tao
Li, Wei
Ouyang, Quchang
Wang, Jingfen
Tong, Zhongsheng
Yan, Min
Li, Huiping
Zeng, Xiaohua
Shan, Changping
Wang, Xian
Yan, Xi
Zhang, Jian
Zhang, Yue
Wang, Jiani
Zhang, Liang
Lin, Ying
Feng, Jifeng
Chen, Qianjun
Huang, Jian
Zhang, Lu
Yang, Lisong
Tian, Ying
Shang, Hongyan
author_sort Xu, Binghe
collection PubMed
description 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).
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spelling pubmed-102137952023-05-27 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 Xu, Binghe Zhang, Qingyuan Hu, Xichun Li, Qing Sun, Tao Li, Wei Ouyang, Quchang Wang, Jingfen Tong, Zhongsheng Yan, Min Li, Huiping Zeng, Xiaohua Shan, Changping Wang, Xian Yan, Xi Zhang, Jian Zhang, Yue Wang, Jiani Zhang, Liang Lin, Ying Feng, Jifeng Chen, Qianjun Huang, Jian Zhang, Lu Yang, Lisong Tian, Ying Shang, Hongyan Acta Pharm Sin B Clinical Trials 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). Elsevier 2023-05 2023-02-09 /pmc/articles/PMC10213795/ /pubmed/37250148 http://dx.doi.org/10.1016/j.apsb.2023.02.001 Text en © 2023 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier B.V. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Clinical Trials
Xu, Binghe
Zhang, Qingyuan
Hu, Xichun
Li, Qing
Sun, Tao
Li, Wei
Ouyang, Quchang
Wang, Jingfen
Tong, Zhongsheng
Yan, Min
Li, Huiping
Zeng, Xiaohua
Shan, Changping
Wang, Xian
Yan, Xi
Zhang, Jian
Zhang, Yue
Wang, Jiani
Zhang, Liang
Lin, Ying
Feng, Jifeng
Chen, Qianjun
Huang, Jian
Zhang, Lu
Yang, Lisong
Tian, Ying
Shang, Hongyan
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Clinical Trials
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10213795/
https://www.ncbi.nlm.nih.gov/pubmed/37250148
http://dx.doi.org/10.1016/j.apsb.2023.02.001
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