口服结合孕激素/左炔诺孕酮宫内缓释系统治疗早期年轻女性子宫内膜癌的 6 个月应答率：韩国妇科肿瘤学组研究。
Six months response rate of combined oral medroxyprogesterone/levonorgestrel-intrauterine system for early-stage endometrial cancer in young women: a Korean Gynecologic-Oncology Group Study.
机构信息
Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea.
Department of Obstetrics and Gynecology, Konkuk University School of Medicine, Seoul, Korea.
出版信息
J Gynecol Oncol. 2019 Mar;30(2):e47. doi: 10.3802/jgo.2019.30.e47. Epub 2019 Jan 7.
OBJECTIVE
To evaluate the efficacy of combined oral medroxyprogesterone acetate (MPA)/levonorgestrel-intrauterine system (LNG-IUS) treatment and to compare the diagnostic accuracy of endometrial aspiration biopsy with dilatation & curettage (D&C) in young women with early-stage endometrial cancer (EC) who wished to preserve their fertility.
METHODS
A prospective phase II multicenter study was conducted from January 2012 to January 2017. Patients with grade 1 endometrioid adenocarcinoma confined to the endometrium were treated with combined oral MPA (500 mg/day)/LNG-IUS. At 3 and 6 months of treatment, the histologic change of the endometrial tissue was assessed. The regression rate at 6 months treatment and the consistency of the histologic results between the aspiration biopsy and the D&C were evaluated.
RESULTS
Forty-four patients were enrolled. Nine voluntarily withdrew and 35 patients completed the protocol treatment. The complete regression (CR) rate at 6 months was 37.1% (13/35). Partial response was shown in 25.7% of cases (9/35). There were no cases of progressive disease and no treatment-related complications. A comparison of the pathologic results from aspiration biopsy and D&C was carried out for 33 cases. Fifteen cases were diagnosed as "EC" by D&C. Among these, only 8 were diagnosed with EC from aspiration biopsy, yielding a diagnostic concordance of 53.3% (κ=0.55).
CONCLUSION
Combined oral MPA/LNG-IUS treatment for EC showed 37.1% of CR rate at 6 months. Considering the short treatment periods, CR rate may be much higher if the treatment continued to 9 or 12 months. So, this treatment is still a viable treatment option for young women of early-stage EC. Endometrial aspiration biopsy with the LNG-IUS in place is less accurate than D&C for follow-up evaluation of patients undergoing this treatment.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01594879.
目的
评估联合口服甲羟孕酮（MPA）/左炔诺孕酮-宫内节育系统（LNG-IUS）治疗的疗效，并比较子宫内膜抽吸活检与扩张刮宫术（D&C）在希望保留生育能力的早期子宫内膜癌（EC）年轻患者中的诊断准确性。
方法
一项前瞻性 II 期多中心研究于 2012 年 1 月至 2017 年 1 月进行。将局限于子宫内膜的 I 级子宫内膜样腺癌患者采用联合口服 MPA（500mg/天）/LNG-IUS 治疗。在治疗的第 3 和 6 个月，评估子宫内膜组织的组织学变化。评估治疗 6 个月时的缓解率以及抽吸活检与 D&C 之间的组织学结果一致性。
结果
共纳入 44 例患者。9 例患者自愿退出，35 例患者完成了方案治疗。6 个月时完全缓解（CR）率为 37.1%（13/35）。部分缓解率为 25.7%（9/35）。无疾病进展病例，无治疗相关并发症。对 33 例患者的抽吸活检和 D&C 病理结果进行了比较。15 例 D&C 诊断为“EC”。其中，仅 8 例从抽吸活检中诊断为 EC，诊断一致性为 53.3%（κ=0.55）。
结论
EC 患者采用联合口服 MPA/LNG-IUS 治疗 6 个月时的 CR 率为 37.1%。考虑到治疗周期较短，如果将治疗延长至 9 或 12 个月，CR 率可能会更高。因此，对于早期 EC 的年轻女性，这种治疗仍然是一种可行的治疗选择。对于接受这种治疗的患者，放置 LNG-IUS 的子宫内膜抽吸活检不如 D&C 准确。
试验注册
ClinicalTrials.gov 标识符：NCT01594879。
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