Background: The benefit of adding ovarian function suppression (OFS) to tamoxifen in the adjuvant treatment of premenopausal women with breast cancer is uncertain. We conducted a meta-analysis of randomized controlled trials that addressed this question. Methods: Systematic search of PubMed, the web of science, and the meeting library of ASCO, ESMO, and SABCS was conducted using the following keywords: tamoxifen, ovarian suppression, and breast cancer. Eligible studies were those recruiting patients with breast cancer randomized to receive adjuvant tamoxifen and OFS versus tamoxifen alone. Pooled hazard ratio [HR]) for disease-free (DFS) and overall survival (OS) with 95% confidence interval (CI) were calculated using the fixed effect model. Results: We searched a total of 845 records, of which 5 clinical trials, including 7557 patients, were eligible for our analysis. Adding OFS to tamoxifen improved DFS with pooled HR: 0.88 (95% CI: 0.80-0.96, P= 0.004) and OS (pooled HR: 0.87 {95% CI: 0.77-0.98, P= 0.02}) compared to tamoxifen alone. The benefit of the addition of OFS to tamoxifen was mostly observed in patients younger than 40 years where the pooled HRs of DFS was 0.76 (95% CI: 0.63-0.91; P= 0.004), and in those who received adjuvant chemotherapy with pooled HRs of DFS 0.80 (95% CI: 0.65-0.99, P= 0.042). There was an increase in the incidence of all grade musculoskeletal symptoms and high-grade hot flushes with the addition of OFS with risk ratios of 1.12 (95% CI: 1.07-1.17, P< 0.001) and 2.14 (95% CI: 1.01-4.51, P= 0.047) respectively. Conclusion: Our analysis indicates that the addition of OFS to tamoxifen improves DFS and OS. This strategy could be considered in patients in which tamoxifen alone is not deemed sufficient or in case of poor tolerance to OFS with aromatase inhibitors.

背景：在他莫昔芬的基础上加入卵巢功能抑制 (OFS) 辅助治疗绝经前乳腺癌患者的益处尚不确定。我们对解决这个问题的随机对照试验进行了荟萃分析。方法：使用以下关键词对 PubMed、科学网络以及 ASCO、ESMO 和 SABCS 的会议图书馆进行系统搜索：他莫昔芬、卵巢抑制和乳腺癌。符合条件的研究是招募乳腺癌患者随机接受他莫昔芬和 OFS 辅助治疗与单独接受他莫昔芬治疗的研究。使用固定效应模型计算具有 95% 置信区间 (CI) 的无病生存 (DFS) 和总生存 (OS) 的合并风险比 [HR])。结果：我们总共检索了 845 条记录，其中 5 项临床试验（包括 7557 名患者）符合我们的分析条件。与单独使用他莫昔芬相比，将 OFS 添加到他莫昔芬可改善 DFS，合并 HR：0.88（95% CI：0.80-0.96，P = 0.004）和 OS（合并 HR：0.87 {95% CI：0.77-0.98，P = 0.02}）。在 40 岁以下的患者中观察到在他莫昔芬中添加 OFS 的益处，其中 DFS 的汇总 HR 为 0.76（95% CI：0.63-0.91；P = 0.004），以及在那些接受辅助化疗并汇总 HR 的患者中观察到DFS 0.80 (95% CI: 0.65-0.99, P= 0.042）。添加 OFS 后所有级别的肌肉骨骼症状和高度潮热的发生率均增加，风险比为 1.12（95% CI：1.07-1.17，P < 0.001）和 2.14（95% CI：1.01-） 4.51，P = 0.047)。结论：我们的分析表明，在他莫昔芬中添加 OFS 可改善 DFS 和 OS。在认为单独使用他莫昔芬不足的患者或对使用芳香酶抑制剂的 OFS 耐受性差的患者中，可以考虑这种策略。