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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2023
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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). |
format | Online Article Text |
id | pubmed-10213795 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
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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