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
机构:[1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Dept Med Oncol, Beijing 100021, Peoples R China[2]Peking Univ Canc Hosp & Inst, Dept Breast Oncol, Minist Educ, Key Lab Carcinogenesis & Translat Res, Beijing 100142, Peoples R China[3]Fifth Med Ctr Chinese PLA Gen Hosp, Dept Breast Canc, Beijing 100071, Peoples R China[4]Tianjin Canc Inst & Hosp, Dept Breast Canc, Tianjin 300060, Peoples R China[5]Jiangsu Prov Hosp, Dept Breast Canc, Nanjing 210029, Peoples R China江苏省人民医院[6]Chinese Univ Sci & Technol, Affiliated Hosp 1, Dept Breast Canc, Hefei 230001, Peoples R China[7]Hebei Med Univ, Hosp 4, Dept Breast Canc, Shijiazhuang 050011, Peoples R China河北医科大学第四医院外一科临床科室[8]Henan Canc Hosp, Dept Breast Canc, Zhengzhou 450008, Peoples R China河南省肿瘤医院[9]Zhejiang Canc Hosp, Dept Breast Canc, Hangzhou 310012, Peoples R China浙江省肿瘤医院[10]Harbin Med Univ, Dept Breast Canc, Canc Hosp, Harbin 150081, Peoples R China[11]Pfizer China R&D Co Ltd, Dept Clin Dev, Shanghai 201203, Peoples R China[12]Pfizer China R&D Co Ltd, Dept Stat, Shanghai 201203, Peoples R China[13]Fudan Univ, Canc Inst, Shanghai Med Coll, Shanghai Canc Ctr,Dept Breast Surg, Shanghai 200032, Peoples R China
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 China. Methods: Enrolled patients had received 2-3 years of tamoxifen and were then switched to exemestane for completion of 5 consecutive years of adjuvant endocrine therapy. The 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 cause. Other 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 event. Results: Overall, 558 patients were included in the full analysis set: 397 (71.1%) completed the study, 20 experienced 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) months. Median time to event was not reached. Event -free 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 AE. Conclusions: 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 years. No new safety signals were identified in the Chinese population.
第一作者机构:[1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Dept Med Oncol, Beijing 100021, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[13]Fudan Univ, Canc Inst, Shanghai Med Coll, Shanghai Canc Ctr,Dept Breast Surg, Shanghai 200032, Peoples R China[*1]Department of Breast Surgery, Shanghai Cancer Center/Cancer Institute, Shanghai Medical College, Fudan University, Shanghai 200032, China.
推荐引用方式(GB/T 7714):
Xu Binghe,Li Huiping,Jiang Zefei,et al.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[J].CHINESE JOURNAL OF CANCER RESEARCH.2022,34(6):592-+.doi:10.21147/j.issn.1000-9604.2022.06.07.
APA:
Xu, Binghe,Li, Huiping,Jiang, Zefei,Gu, Lin,Tang, Jinhai...&Shao, Zhimin.(2022).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.CHINESE JOURNAL OF CANCER RESEARCH,34,(6)
MLA:
Xu, Binghe,et al."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".CHINESE JOURNAL OF CANCER RESEARCH 34..6(2022):592-+