Xu Binghe, Li Huiping, Jiang Zefei, Gu Lin, Tang Jinhai, Xie Hui, Pan Yueyin, Liu Yunjiang, Cui Shude, Wang Xiaojia, Cai Li, Zhang Yiqiong, Zhao Huadong, Shao Zhimin
Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
Chin J Cancer Res. 2022 Dec 30;34(6):592-600. doi: 10.21147/j.issn.1000-9604.2022.06.07.
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.
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.
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.
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.
本批准后安全性研究评估了在中国接受他莫昔芬治疗2 - 3年的雌激素受体阳性（ER +）早期乳腺癌绝经后妇女中，依西美坦的疗效和安全性。
入组患者接受了2 - 3年的他莫昔芬治疗，然后改用依西美坦完成连续5年的辅助内分泌治疗。主要终点是从入组到原发性乳腺癌首次出现局部/远处复发、出现第二原发性或对侧乳腺癌或因任何原因死亡的时间。其他终点包括经历各事件的患者比例、每年的发病率、人表皮生长因子受体2状态与事件发生时间的关系以及疾病史变量与事件发生时间的关系。
总体而言，558例患者纳入全分析集：397例（71.1%）完成研究，20例发生事件，141例停药[47例因不良事件（AE）；37例不再愿意参与]。中位治疗持续时间为29.5（范围0.1 - 57.7）个月。未达到事件发生的中位时间。36个月时无事件生存概率为91.4%（95%CI，87.7% - 95.1%）。依西美坦治疗总暴露时间内的事件发生率为3.5事件/100人年（20/565）。多因素分析显示初始诊断时肿瘤、淋巴结和转移分期与事件发生时间之间存在关联[风险比：1.532（95%CI，1.129 - 2.080）；P = 0.006]。大多数AE严重程度为1级或2级，关节痛（7.7%）是最常见的治疗相关AE。
本研究支持依西美坦在先前接受2 - 3年辅助他莫昔芬治疗的中国绝经后ER +乳腺癌妇女中的疗效和安全性。在中国人群中未发现新的安全信号。
