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Efficacy and clinical outcome of chemotherapy and endocrine therapy as first-line treatment in patients with hormone receptor-positive HER2-negative metastatic breast cancer

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Chinese Medical Journal 2023年第12期136卷 1459-1467页

作者： Yang Yuan Shaohua Zhang Tao Wang Li Bian Min Yan Yongmei Yin Yuhua Song Yi Wen Jianbin Li Zefei Jiang Department of Oncology No.4 Ward The Fifth Medical Center of Chinese People’s Liberation Army(PLA)General HospitalBeijing 100071China Department of Oncology No.3 Ward The Fifth Medical Center of Chinese People’s Liberation Army(PLA)General HospitalBeijing 100071China Department of Breast Disease Henan Breast Cancer CenterThe Affiliated Cancer Hospital of Zhengzhou University&Henan Cancer HospitalZhengzhouHenan 450008 China Department of Breast Cancer Jiangsu Province Hospital&The First Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsu 210029 China Department of Breast Cancer Center The Affiliated Hospital of Qingdao UniversityQingdaoShandong 260000 China Medical Department Medpion(Beijing)Medical Technology Co.LtdBeijing 100062 China

Background:Endocrine therapy(ET)and ET-based regimens are the preferred first-line treatment options for hormone receptor(HR)-positive and human epidermal growth factor receptor 2(HER2)-negative metastatic breast cancer(HR+/HER2-MBC),while chemotherapy(CT)is commonly used in clinical practice.The aim of this study was to investigate the efficacy and clinical outcome of ET and CT as first-line treatment in Chinese patients with HR+/HER2-MBC.Methods:Patients diagnosed with HR+/HER2-MBC between January 1st,1996 and September 30th,2018 were screened from the Chinese Society of Clinical Oncology Breast Cancer database.The initial and maintenance first-line treatment,progression-free survival(PFS),and overall survival(OS)were analyzed.Results:Among the 1877 included patients,1215(64.7%)received CT and 662(35.3%)received ET as initial first-line treatment.There were no statistically significant differences in PFS and OS between patients receiving ET and CT as initial first-line treatment in the total population(PFS:12.0 vs.11.0 months,P=0.22;OS:54.0 vs.49.0 months,P=0.09)and propensity score matched population.For patients without disease progression after at least 3 months of initial therapy,maintenance ET following initial CT(CT-ET cohort,n=449)and continuous schedule of ET(ET cohort,n=527)had longer PFS than continuous schedule of CT(CT cohort,n=406)in the total population(CT-ET cohort vs.CT cohort:17.0 vs.8.5 months;P<0.01;ET cohort vs.CT cohort:14.0 vs.8.5 months;P<0.01)and propensity score matched population.OS in the three cohorts yielded the same results as PFS.Conclusions:ET was associated with similar clinical outcome to CT as initial first-line treatment.For patients without disease progression after initial CT,switching to maintenance ET showed superiority in clinical outcome over continuous schedule of CT.

关键词： Breast neoplasms Metastatic breast cancer hormone receptor-positive HER2-negative Chemotherapy Endocrine therapy First-line treatment Maintenance therapy

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Entinostat,a classⅠselective 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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Acta Pharmaceutica Sinica B 2023年第5期13卷 2250-2258页

作者： Binghe Xu Qingyuan Zhang Xichun Hu Qing Li Tao Sun Wei Li Quchang Ouyang Jingfen Wang Zhongsheng Tong Min Yan Huiping Li Xiaohua Zeng Changping Shan Xian Wang Xi Yan Jian Zhang Yue Zhang Jiani Wang Liang Zhang Ying Lin Jifeng Feng Qianjun Chen Jian Huang Lu Zhang Lisong Yang Ying Tian Hongyan Shang Department of Medical Oncology and State Key Laboratory of Molecular Oncology National Cancer Cener/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin 150000China Department of Medical Oncology Fudan University Shanghai Cancer CenterShanghai 200000China Department of Galactophore Liaoning Cancer Hospital&InstituteShenyang 110801China Department of Oncology the First Hospital of Jilin UniversityChangchun 130061China Department of Galactophore Hunan Cancer HospitalChangsha 410000China Department of Galactophore Linyi Cancer HospitalLinyi 276000China Department of Breast Medical Oncology Tianjin Medical University Cancer Institute&HospitalTianjin 300000China Department of Breast Disease Henan Breast Cancer Centerthe Affiliated Cancer Hospital of Zhengzhou University&Henan Cancer HospitalZhengzhou 450008China Department of Breast Oncology Beijing Cancer HospitalBeijing 100000China Breast Cancer Center Chongqing University Cancer HospitalChongqing 400000China Department of Breast and Thyroid Oncology Affiliated Hospital of Jining Medical UniversityChangchun 130021China Department of Medical Oncology Run Run Shaw HospitalAffiliated Hospital of Zhejiang UniversityHangzhou 310003China Department of Head and Heck Oncology West China HospitalSichuan UniversityChengdu 610000China Department of Thyroid&Breast Surgery the First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou 510000China Department of Medical Oncology Jiangsu Cancer HospitalNanjing 210000China Department of Galactophore Guangdong Hospital of Traditional Chinese MedicineGuangzhou 510000China Department of Oncological Surgery the Second Affiliated HospitalZhejiang University School of MedicineHangzhou 310000China Taizhou EOC Pharma Co. Ltd.Taizhou 318000China

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).

关键词： Advanced breast cancer hormone receptor-positive Histone deacetylase inhibitors Phase 3 clinical trial

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Exploratory clinical study of chidamide,an oral subtype-selective histone deacetylase inhibitor,in combination with exemestane in hormone receptor-positive advanced breast cancer

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Chinese Journal of Cancer Research 2018年第6期30卷 605-612页

作者： Qingyuan Zhang Tao Wang Cuizhi Geng Yue Zhang Jinwen Zhang Zhiqiang Ning Zefei Jiang Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin 150081China Department of Breast Cancer the 307th hospital of Chinese People's Liberation ArmyBeijing 100071China The Fourth Hospital of Hebei Medical University Shijiazhuang 050011China Shenzhen Chipscreen Biosciences Shenzhen 518057China

Objective: The recurrence or progression under endocrine therapy in hormone receptor-positive(HR+)advanced breast cancer(ABC) remained a critical clinical challenge.Chidamide is an oral subtype-selective histone deacetylase(HDAC) inhibitor with multiple functions in tumor growth inhibition and microenvironment modulation via epigenetic reprogramming.The purpose of this study was to evaluate the safety,pharmacokinetics(PK),and preliminary efficacy of chidamide in combination with exemestane in HR+ ABC patients.Methods: Eligible patients were postmenopausal women with HR+ ABC recurrent or progressed to at least one endocrine therapy.Blood samples were obtained in the run-in period and the first day of combination treatment for PK analysis.In combination treatment,patients were given exemestane 25mg daily and chidamide 30mg twice a week(BIW) until progression of disease or intolerable toxicities.A treatment cycle was defined as 4 weeks.Safety,PK parameters,and preliminary efficacy were evaluated.Results: A total of 20 patients were enrolled between July and December,2015.The median number of treatments cycle was 5.2(20.8 weeks) with 2 patients still on treatment at the data cut-off date of October,2017.The treatment-related adverse events(AE) ≥ grade 3 in more than 2 patients were neutropenia(35%),thrombocytopenia(30%),and leucopenia(20%).The plasma exposure of exemestane was consistent in the presence or absence of chidamide.A slight increase in chidamide exposure was noted in the presence of exemestane,probably due to the inter-and intra-patient variations.The best response in 16 evaluable patients was assessed by Response Evaluation Criteria in Solid Tumors(RECIST),including 4 patients with partial response,10 patients with stable disease.The median progression-free survival(PFS) was 7.6 months.Conclusions: The combination of chidamide with exemestane was generally well tolerated with promising preliminary efficacy in HR+ ABC patients.The overall results from this study encourage further pivotal trial in this pat

关键词： Advanced breast cancer hormone receptor-positive chidamide exemestane

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