Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, NY; Department of Gynecology, Kanagawa Cancer Center, Yokohama, Kanagawa, Japan.
Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, NY; Joseph L. Mailman School of Public Health, Columbia University, New York, NY.
Am J Obstet Gynecol. 2024 Dec;231(6):599-610.e17. doi: 10.1016/j.ajog.2024.07.018. Epub 2024 Jul 19.
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.
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.
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.
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.
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.
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.
在患有早期子宫内膜癌的育龄患者中越来越多地使用生育保护治疗，这就需要有关于口服孕激素和左炔诺孕酮宫内节育器有效性的强有力证据。我们进行了一项系统评价和荟萃分析，以检查这两种主要孕激素治疗在患有早期子宫内膜癌的育龄患者中的治疗结果。
我们按照 Cochrane 手册的指导进行了观察性研究和随机对照试验的系统评价。我们对 5 个数据库和 1 个试验注册处进行了文献检索，检索时间从研究开始到 2024 年 4 月 16 日。
报道了在接受孕激素治疗的临床 IA 型子宫内膜样癌的育龄患者中，1 年内完全缓解的完整反应的研究。我们使用了来自观察性研究和随机对照研究的数据。
主要暴露因素评估为孕激素治疗的类型（口服孕激素或 LNG-IUD）。主要结局是主要孕激素治疗后 1 年内最佳完全缓解的汇总比例。我们采用比例荟萃分析来估计治疗反应。通过去除具有极端效应大小的研究或去除 2 级肿瘤来进行敏感性分析。使用 Joanna Briggs 研究所的批判性评价检查表评估每个研究的偏倚风险。
我们的分析涉及 754 名诊断为子宫内膜癌的育龄患者，其中 490 名接受口服孕激素治疗，264 名接受左炔诺孕酮宫内节育器作为主要孕激素治疗。口服孕激素和左炔诺孕酮宫内节育器治疗 12 个月内最佳完全缓解的汇总比例分别为 66%（95%CI，55-76）和 86%（95%CI，69-95）。去除离群值研究后，口服孕激素组的汇总比例为 66%（95%CI，57-73），左炔诺孕酮宫内节育器组为 89%（95%CI，75-96），异质性降低。具体来说，在包括 1 级肿瘤的研究中，口服孕激素组的汇总比例为 66%（95%CI，54-77），左炔诺孕酮宫内节育器组为 83%（95%CI，50-96）。口服孕激素治疗后的妊娠率为 58%（95%CI，37-76），左炔诺孕酮宫内节育器治疗后的妊娠率为 44%（95%CI，6-90）。
这项荟萃分析提供了有关口服孕激素和左炔诺孕酮宫内节育器治疗在 12 个月内对希望保留生育能力的早期子宫内膜癌患者有效性的有价值的见解。这些发现有可能帮助患者做出个性化的治疗决策。
