目的:在生育年龄的早期子宫内膜癌患者中越来越多地使用保留生育力的治疗方法,需要强有力的证据证明口服孕激素和左炔诺孕酮宫内节育器(LNG-IUD)的有效性。我们进行了系统评价和荟萃分析,以检查这两种基于孕激素的主要治疗方法在生育年龄早期子宫内膜癌患者中的结局。
方法:我们在Cochrane手册指导下对观察性研究和随机对照试验进行了系统评价。从研究开始到2024年4月16日,我们对五个数据库和一个试验注册进行了文献检索。
方法:研究报告了在临床分期IA子宫内膜样癌接受孕激素治疗的育龄期患者一年内完全缓解。我们使用了来自观察性和随机对照研究的数据。
方法:评估的主要暴露是孕激素治疗的类型(口服孕激素或LNG-IUD)。主要结果是主要孕前治疗一年内最佳完全缓解(CR)的合并比例。我们进行了比例荟萃分析以估计治疗反应。通过移除具有极端效应大小的研究或移除2级肿瘤来进行敏感性分析。在每个研究中使用JoannaBriggs研究所关键评估清单评估偏倚的风险结果:我们的分析涉及754名被诊断患有子宫内膜癌的育龄期患者,490人接受口服孕激素和264人接受LNG-宫内节育器作为主要的孕前治疗。口服孕激素和LNG-IUD治疗12个月内最佳CR的合并比例为66%(95%CI,55-76)和86%(95%CI,69-95),分别。删除异常研究后,口服孕激素组的合并比例为66%(95%CI,57-73),LNG-宫内节育器组的89%(95%CI,75-96),表现出降低的异质性。具体来说,在包括1级肿瘤在内的研究中,口服孕激素组的合并比例为66%(95%CI,54~77),LNG-IUD组的合并比例为83%(95%CI,50~96).口服孕激素治疗后的合并妊娠率为58%(95%CI,37-76),LNG-IUD治疗后的合并妊娠率为44%(95%CI,6-90)。
结论:这项荟萃分析为希望保留生育能力的早期子宫内膜癌患者在12个月时间内口服孕激素和LNG-IUD治疗的有效性提供了有价值的见解。这些发现有可能帮助患者做出个性化的治疗决策。
OBJECTIVE: The increasing use of fertility-preserving treatments in reproductive-aged patients with early-stage endometrial cancer necessitates robust evidence on the effectiveness of oral progestins and levonorgestrel-releasing intrauterine device. We conducted a systematic review and meta-analysis to examine the outcomes following these 2 primary progestin-based therapies in reproductive-aged patients with early-stage endometrial cancer.
METHODS: We conducted a systematic review of observational studies and randomized controlled trials following the Cochrane Handbook guidance. We conducted a literature search of 5 databases and 1 trial registry from inception of the study to April 16, 2024.
METHODS: Studies reporting complete response within 1 year in reproductive-aged patients with clinical stage IA endometrioid cancer undergoing progestin therapy treatment were included. We used data from both observational and randomized controlled studies.
METHODS: The primary exposure assessed was the type of progestational treatment (oral progestins or LNG-IUD). The primary outcome was the pooled proportion of the best complete response (CR) within 1 year of primary progestational treatment. We performed a proportional meta-analysis to estimate the treatment response. Sensitivity analyses were performed by removing studies with extreme effect sizes or removing grade 2 tumors. The risk of bias was assessed in each study using the Joanna Briggs Institute critical appraisal checklist.
RESULTS: Our analysis involved 754 reproductive-aged patients diagnosed with endometrial cancer, with 490 receiving oral progestin and 264 receiving levonorgestrel-releasing intrauterine device as their primary progestational treatment. The pooled proportion of the best complete response within 12 months of oral progestin and levonorgestrel-releasing intrauterine device treatment were 66% (95% CI, 55-76) and 86% (95% CI, 69-95), respectively. After removing outlier studies, the pooled proportion was 66% (95% CI, 57-73) for the oral progestin group and 89% (95% CI, 75-96) for the levonorgestrel-releasing intrauterine device group, showing reduced heterogeneity. Specifically, among studies including grade 1 tumors, the pooled proportions were 66% (95% CI, 54-77) for the oral progestin group and 83% (95% CI, 50-96) for the levonorgestrel-releasing intrauterine device group. The pooled pregnancy rate was 58% (95% CI, 37-76) after oral progestin treatment and 44% (95% CI, 6-90) after levonorgestrel-releasing intrauterine device treatment.
CONCLUSIONS: This meta-analysis provides valuable insights into the effectiveness of oral progestins and levonorgestrel-releasing intrauterine device treatment within a 12-month timeframe for patients with early-stage endometrial cancer who desire to preserve fertility. These findings have the potential to assist in personalized treatment decision-making for patients.