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Adjuvant tamoxifen switched to exemestane treatment in postmenopausal women with estrogen receptor-positive early breast cancer:A pragmatic,multicenter,and prospective clinical trial in China

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Chinese Journal of Cancer Research 2022年第6期34卷 592-600页

作者： Binghe Xu Huiping Li Zefei Jiang Lin Gu Jinhai Tang Hui Xie Yueyin Pan Yunjiang Liu Shude Cui Xiaojia Wang Li Cai Yiqiong Zhang Huadong Zhao Zhimin Shao Department of Medical Oncology National Cancer Center/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of Breast OncologyPeking University Cancer Hospital&InstituteBeijing 100142China Department of Breast Cancer the Fifth Medical Center of Chinese PLA General HospitalBeijing 100071China Department of Breast Cancer Tianjin Cancer Institute and HospitalTianjin 300060China Department of Breast Cancer Jiangsu Provincial HospitalNanjing 210029China Department of Breast Cancer the First Affliated Hospital of China University of Science and TechnologyHefei 230001China Department of Breast Cancer the Fourth Hospital of Hebei Medical UniversityShijiazhuang 050011China Department of Breast Cancer Henan Cancer HospitalZhengzhou 450008China Department of Breast Cancer Zhejiang Cancer HospitalHangzhou 310012China Department of Breast Cancer Harbin Medical University Cancer HospitalHarbin 150081China Department of Clinical Development Pfizer(China)R&D Co.LtdShanghai 201203China Department of Statistics Pfizer(China)R&D Co.LtdShanghai 201203China Department of Breast Surgery Shanghai Cancer Center/Cancer InstituteShanghai Medical CollegeFudan UniversityShanghai 200032China

Objective:This post-approval safety study assessed the efficacy and safety of exemestane after 2-3 years of tamoxifen treatment among postmenopausal women with estrogen receptor-positive(ER+)early breast cancer in ***:Enrolled patients had received 2-3 years of tamoxifen and were then switched to exemestane for completion of 5 consecutive years of adjuvant endocrine *** primary endpoint was the time from enrollment to the first occurrence of locoregional/distant recurrence of the primary breast cancer,appearance of a second primary or contralateral breast cancer,or death due to any *** endpoints included the proportion of patients experiencing each event,incidence rate per annum,relationships between human epidermal growth factor receptor 2 status and time to event,and relationship between disease history variables and time to ***:Overall,558 patients were included in the full analysis set:397(71.1%)completed the study,20experienced an event,and 141 discontinued[47 owing to an adverse event(AE);37 no longer willing to participate].Median duration of treatment was 29.5(range,0.1-57.7)*** time to event was not *** survival probability at 36 months was 91.4%(95%CI,87.7%-95.1%).The event incidence over the total exposure time of exemestane therapy was 3.5 events/100 person-years(20/565).Multivariate analysis showed an association between tumor,lymph node,and metastasis stage at initial diagnosis and time to event[hazard ratio:1.532(95%CI,1.129-2.080);P=0.006].Most AEs were grade 1 or 2 in severity,with arthralgia(7.7%)being the most common treatment-related ***:This study supports the efficacy and safety of exemestane in postmenopausal Chinese women with ER+breast cancer previously treated with adjuvant tamoxifen for 2-3 *** new safety signals were identified in the Chinese population.

关键词： Chinese early breast cancer exemestane tamoxifen postmenopausal women estrogen receptor-positive

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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 *** is an oral subtype-selective histone deacetylase(HDAC) inhibitor with multiple functions in tumor growth inhibition and microenvironment modulation via epigenetic *** purpose of this study was to evaluate the safety,pharmacokinetics(PK),and preliminary efficacy of chidamide in combination with exemestane in HR+ ABC ***: Eligible patients were postmenopausal women with HR+ ABC recurrent or progressed to at least one endocrine *** samples were obtained in the run-in period and the first day of combination treatment for PK *** 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 ***,PK parameters,and preliminary efficacy were ***: A total of 20 patients were enrolled between July and December,*** 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,*** 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 *** 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 *** median progression-free survival(PFS) was 7.6 ***: The combination of chidamide with exemestane was generally well tolerated with promising preliminary efficacy in HR+ ABC *** overall results from this s

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

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Bilateral oophorectomy combined with exemestane treating advanced refractory breast cancer

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The Chinese-German Journal of Clinical Oncology 2011年第1期10卷 43-46页

作者： Xinhong Wu Yaojun Feng Juan Xu Yiping Gong Biao Ma Department of Breast Cancer Hubei Cancer Hospital Wuhan 430079 China

Objective： Taking tamoxifen orally is the main endocrine therapy of the premenopausal breast cancer with positive hormone receptor, but numerous patients developed to be advanced refractory breast cancer because of drug resistance. Our study investigated a role of the combination of bilateral oophorectomy and exemestane in the management of advanced refractory breast cancer. Methods： The bilateral oophorectomy was carried out in 17 patients. One week after the operation, exemestane was taken orally （25 mg/d）. The median time to progression （TTP）, the median survival time and the survival rate were calculated using Kaplan-Meier methods. Results： Seventeen patients age ranged from 26 to 44 years （median, 36 years） were treated with an overall response rate of 64.70%, TTP was 8 months and the median survival time was 31 months. The survival rate of 1-year, 3 years and 5 years was 88.24%, 64.71%, 29.41%, respectively. There have no grade Ⅲ/Ⅳ side effects appeared. Conclusion： Bilateral oophorectomy combined with exemestane is safe and effective for advanced refractory premenopausal breast cancer with positive hormone receptor and it is well-torerated.

关键词： advanced breast cancer exemestane oophorectomy

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芳香酶抑制剂依西美坦(exemestane)的合成

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中国现代应用药学 2002年第1期19卷 44-46页

作者：徐军柴雨柱严相平叶惠敏王浦海冷宗康江苏省药物研究所南京210009

目的 :合成依西美坦并改进合成工艺。方法 :以雄甾烯二酮为原料 ,经 Mannich反应、溴化、脱溴等数步反应制得依西美坦。结果 :所得产物经元素分析、紫外光谱、红外光谱、核磁共振谱及质谱等确证了结构。结论

关键词：抗癌药低西美坦合成芳香酶抑制剂 exemestane

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甾体芳构化酶抑制剂exemestane

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药学进展 2000年第2期24卷 118-120页

作者：霍彬

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晚期乳腺癌治疗药—exemestane

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国外新药介绍 2001年第3期 3-5页

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抗肿瘤药依西美坦(exemestane)

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世界临床药物 2000年第5期 300-300页

作者：杨曼瑾郭传勇钟敏章

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世界药物新闻(七十八)

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天津药学 2005年第6期17卷 69-70页

作者：张骏

1美国扩大Aromasin在乳腺癌治疗中的应用美国FDA已经批准将辉瑞制药公司的芳香酶抑制剂Aromasin(通用名:依西美坦片,exemestane tablet)用于连续5年接受激素辅助治疗的、患早期乳腺癌的绝经后妇女.这些妇女应是先接受2～3年他莫昔芬的治... 详细信息

1美国扩大Aromasin在乳腺癌治疗中的应用美国FDA已经批准将辉瑞制药公司的芳香酶抑制剂Aromasin(通用名:依西美坦片,exemestane tablet)用于连续5年接受激素辅助治疗的、患早期乳腺癌的绝经后妇女.这些妇女应是先接受2～3年他莫昔芬的治疗,并且雌激素受体呈阳性.

关键词：世界药物新闻 exemestane 绝经后妇女雌激素受体十八芳香酶抑制剂辅助治疗依西美坦片美国FDA 早期乳腺癌

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依西美坦与阿那曲唑用于绝经后激素受体阳性乳腺癌患者辅助治疗的对比研究

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中华乳腺病杂志（电子版） 2013年第2期7卷 10-10页

作者：徐琰(摘译) 姜军(审校) 第三军医大学西南医院乳腺外科重庆400038

Paul ***等在2013年31卷11期（Journal of Clinical Oncology））发表题为《exemestane versus anastrozole in postmenopausal women with eady breast cancer：NCICCTGMA．27-a randomized controlled phase Ⅲ trial》的论著，

关键词：乳腺癌患者辅助治疗激素受体阿那曲唑依西美坦 anastrozole exemestane 绝经后

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