Fu Yun, Zhuang Zhigang
Department of Breast Surgery, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine Shanghai, China.
Int J Clin Exp Pathol. 2014 Sep 15;7(10):6419-29. eCollection 2014.
The aim of the study is to assess the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) on the tamoxifen-induced endometrial lesions in breast cancer patients.
PubMed and EMBASE databases were searched for eligible studies. Odds ratios were obtained to estimate the association between the LNG-IUS and tamoxifen-induced endometrial lesions. The fixed effects or random-effects model was used to combine data depending on heterogeneity.
With three eligible randomized clinical trials involving 359 patients, this analysis demonstrated tamoxifen-treated breast cancer patients using the LNG-IUS derived benefit from de novo polyps prevention (P < 0.0001, OR 0.18, 95% CI: 0.08-0.42). However, the LNG-IUS only showed a trend of maintaining endometrial proliferation or secretory status (P = 0.05, OR 0.36, 95% CI 0.13-1.02) and no statistical difference in atrophic or inactive changes (P = 0.13, OR 0.24, 95% CI 0.04-1.53) or endometrial hyperplasia without atypia (P = 0.08, OR 0.20, 95% CI 0.04-1.18). The LNG-IUS didn't have an increased incidence in breast cancer recurrence (P = 0.28, OR 1.75, 95% CI: 0.64-4.80) and cancer-induced death (P = 0.71, OR 1.22, 95% CI: 0.42-3.52). Bleeding in the treatment group was statistically more frequent than that in the control group (OR 6.20, 95% CI: 2.99-12.85, P < 0.00001).
This analysis verifies the efficacy of the LNG-IUS in preventing tamoxifen-induced polyps. The LNG-IUS didn't have an increased incidence in breast cancer recurrence and cancer-induced death. Long-term, large randomized studies of the LNG-IUS will be necessary to determine the benefit and risk in tamoxifen-treated breast cancer patients.
本研究旨在评估左炔诺孕酮宫内节育系统(LNG-IUS)对乳腺癌患者中他莫昔芬诱导的子宫内膜病变的疗效。
检索PubMed和EMBASE数据库以获取符合条件的研究。获得比值比以估计LNG-IUS与他莫昔芬诱导的子宫内膜病变之间的关联。根据异质性使用固定效应或随机效应模型合并数据。
三项符合条件的随机临床试验纳入了359例患者,该分析表明使用LNG-IUS的他莫昔芬治疗的乳腺癌患者在预防新发息肉方面获益(P<0.0001,比值比0.18,95%置信区间:0.08 - 0.42)。然而,LNG-IUS仅显示出维持子宫内膜增殖或分泌状态的趋势(P = 0.05,比值比0.36,95%置信区间0.13 - 1.02),在萎缩或静止性改变方面无统计学差异(P = 0.13,比值比0.24,95%置信区间0.04 - 1.53),在无不典型增生的子宫内膜增生方面也无统计学差异(P = 0.08,比值比0.20,95%置信区间0.04 - 1.18)。LNG-IUS在乳腺癌复发(P = 0.28,比值比1.75,95%置信区间:0.64 - 4.80)和癌症导致的死亡(P = 0.71,比值比1.22,95%置信区间:0.42 - 3.52)方面发病率未增加。治疗组的出血在统计学上比对照组更频繁(比值比6.20,95%置信区间:2.99 - 12.85,P<0.00001)。
该分析验证了LNG-IUS在预防他莫昔芬诱导的息肉方面的疗效。LNG-IUS在乳腺癌复发和癌症导致的死亡方面发病率未增加。有必要对LNG-IUS进行长期、大型随机研究以确定其在他莫昔芬治疗的乳腺癌患者中的获益和风险。