Institute of Medical Information/Medical Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Breast Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Breast Cancer. 2021 May;28(3):630-643. doi: 10.1007/s12282-020-01196-8. Epub 2021 Jan 2.
The optimal duration of endocrine therapy for patients with hormone receptor-positive (HR-positive) breast cancer is still unclear. This meta-analysis aims to determine the optimal duration of endocrine therapy with extended aromatase inhibitors (AI) for postmenopausal patients with HR-positive early breast cancer who have finished 5 years of endocrine therapy.
Eligible randomized controlled trials were classified into three categories according to the whole duration of endocrine therapy (10 years versus 5 years, 7-8 years versus 5 years, and 10 years versus 7-8 years). For each category, hazard ratio (HR) for disease-free survival (DFS) and overall survival (OS), and risk ratio (RR) for the incidence of adverse events were pooled.
Altogether 9 RCTs enrolling a total of 22,313 postmenopausal women with HR-positive breast cancer were included. Pooled data showed an improvement in DFS when extending endocrine therapy from 5 to 7-8 years (HR = 0.79 [0.69, 0.91]), specifically among those who had been treated with only tamoxifen (HR = 0.40 [0.22, 0.73]) or sequential tamoxifen followed by AI (HR = 0.82 [0.71, 0.95]), with tumors that were node-positive (HR = 0.72 [0.56, 0.93]), estrogen receptor (ER) and progesterone receptor (PR) positive (HR = 0.61 [0.47, 0.78]), or ≥ 2 cm in size (HR = 0.72 [0.51, 0.98]). However, no improvement in DFS was obtained when extending from 7-8 to 10 years (HR = 0.98 [0.87, 1.11]). In addition, the extension of endocrine therapy was not associated with an improvement in OS, but was associated with an increased risk of bone fracture and osteopenia/osteoporosis.
Patients who have been treated with AI for 5 years, with tumors that are node-negative, ER+/PR- or ER-/PR+, and < 2 cm in size do not need to receive extended AI therapy. For those who have been treated with only tamoxifen or sequential tamoxifen followed by an AI for a total of 5 years, with tumors that are node-positive, ER+/PR+ or ≥ 2 cm in size, 2-3 years of extended AI is necessary and maybe enough.
激素受体阳性（HR 阳性）乳腺癌患者内分泌治疗的最佳持续时间仍不清楚。本荟萃分析旨在确定延长芳香化酶抑制剂（AI）治疗结束后 5 年的 HR 阳性早期乳腺癌绝经后患者的内分泌治疗最佳持续时间。
根据内分泌治疗的总持续时间（10 年与 5 年、7-8 年与 5 年、10 年与 7-8 年），将符合条件的随机对照试验分为三类。对于每一类，无病生存（DFS）和总生存（OS）的风险比（HR）和不良事件发生率的风险比（RR）均进行了汇总。
共纳入 9 项 RCT，共纳入 22313 例 HR 阳性乳腺癌绝经后女性。汇总数据显示，从 5 年延长至 7-8 年的内分泌治疗可改善 DFS（HR=0.79 [0.69, 0.91]），尤其是仅接受他莫昔芬治疗的患者（HR=0.40 [0.22, 0.73]）或序贯他莫昔芬后接受 AI 治疗的患者（HR=0.82 [0.71, 0.95]），肿瘤有淋巴结转移（HR=0.72 [0.56, 0.93]）、雌激素受体（ER）和孕激素受体（PR）阳性（HR=0.61 [0.47, 0.78]）或肿瘤大小≥2cm（HR=0.72 [0.51, 0.98]）。然而，从 7-8 年延长至 10 年并没有改善 DFS（HR=0.98 [0.87, 1.11]）。此外，延长内分泌治疗与 OS 改善无关，但与骨折和骨量减少/骨质疏松症风险增加有关。
对于接受 5 年 AI 治疗、肿瘤无淋巴结转移、ER+/PR-或 ER-/PR+且肿瘤大小<2cm 的患者，不需要接受延长的 AI 治疗。对于接受他莫昔芬或序贯他莫昔芬加 AI 治疗 5 年的患者，对于肿瘤有淋巴结转移、ER+/PR+或肿瘤大小≥2cm 的患者，需要进行 2-3 年的延长 AI 治疗，也许就足够了。
