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背景与目的:早期子宫内膜癌保留生育功能的治疗是妇瘤科医生面临的一个挑战。本研究旨在评估醋酸甲地孕酮治疗早期高分化子宫内膜样腺癌和(或)子宫内膜复杂性不典型增生过长的可行性、安全性。方法:本研究为一项单臂、开放性、前瞻性研究。研究对象为40岁以下高分化子宫内膜样腺癌和(或)子宫内膜不典型增生过长且有强烈保留生育功能愿望的初治患者。治疗前清除子宫内膜全部病灶并排除子宫外转移;所有患者激素受体阳性表达。口服醋酸甲地孕酮160 mg/d,每12周进行1次疗效评估;无效者改行手术治疗,完全缓解者巩固1个疗程后进入随访阶段。结果:2006年至今共20例患者纳入本研究,其中14例为子宫内膜癌,6例为子宫内膜不典型增生;治疗24周(2个疗程)后共计17例(85.0%)患者完全缓解,无严重不良事件发生。初次治疗结束后中位随访26个月(9～60个月),所有患者均存活。4例患者在治疗结束后10～24个月复发,1例患者再次行孕激素治疗后缓解,另外3例患者接受手术治疗。6例计划妊娠的患者中2例自然受孕,其中1例患者已经顺产一健康女婴。结论:醋酸甲地孕酮治疗早期高分化子宫内膜样腺癌和(或)子宫内膜不典型增生安全、可行、有效;但是治疗后复发率较高,所有保守治疗者需要密切随访。
BACKGROUND & OBJECTIVE: The treatment of early stage endometrial cancer that preserves fertility is a challenge for oncologists. This study was designed to evaluate the feasibility and safety of megestrol acetate in the treatment of advanced well-differentiated endometrial adenocarcinoma and / or endometrial atypia hyperplasia. Methods: This study is a one-arm, open-label, prospective study. Subjects underwent 40-year-old well-differentiated endometrioid adenocarcinoma and (or) endometrial atypical hyperplasia and had a strong desire to retain the function of fertility-naive patients. All lesions of the endometrium were removed before treatment and the extrauterine metastasis was excluded. All patients had hormone receptor positive expression. Oral administration of megestrol acetate 160 mg / d, once every 12 weeks to evaluate the efficacy; ineffective switch to surgical treatment, complete remission to consolidate a course of treatment to enter the follow-up stage. Results: A total of 20 patients were enrolled in this study from 2006 to now, of which 14 were endometrial carcinomas and 6 were endometrial atypical hyperplasia. A total of 17 patients (85.0%) were completely treated after 24 weeks (2 cycles) Relieved, no serious adverse events occurred. The median follow-up after the initial treatment was 26 months (range, 9 to 60 months), and all patients survived. Four patients relapsed 10 to 24 months after the end of treatment, one patient underwent progestogen therapy again and the other three patients underwent surgery. Two of six women who planned pregnancy naturally became pregnant and one of them had had a healthy baby girl. CONCLUSION: Megestrol acetate is safe and effective in the treatment of advanced well-differentiated endometrial adenocarcinoma and / or endometrial dysplasia. However, the relapse rate after treatment is high, and all conservatives need close follow-up.