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 and purpose: Endometria! cancer in young and especially null gravid women is a challenging problem with increasing frequency for women delaying their plans for pregnancy. The study aimed to assess the efficacy of fertility-sparing treatment using rnegestiol acetate for well-differentiated endometrioid carcinoma (EC) and atypical endometrial hyperplasia (AH) in young women. Methods; This prospective study was carried out in Fudan University Shanghai Cancer Center since 2006. Patients with well-differentiated EC, positive progesterone receptor, no myometrial invasion, no cervical involvement, no node metastasis and no ovarian mass or AH younger than 40 years of age were enrolled. All patients were given a daily oral dose of 160 mg of megestrol acetate. I iistologic change of endometrial tissue was assessed every 12 weeks, another 12 weeks of megestrol acetate was recommended for patients with complete response. Definitive surgery was provided for patients with, persistent disease, recurrent disease or progressive disease. The primary end point was no pathologic complete response rate. Toxicity and pregnancy rate were secondary end points. Results: Twenty patients, including 14 EC and 6 AH, were enrolled, and complete response was found in 17 patients (85.0%) 24 weeks later. No irreversible severe toxiciiies were observed. With a median follow-up of 26 months (range 9-60 months), 4 patients recurred between 9 to 24 months, and 3 patients underwent definitive surgery. Six patients attempted to conceive and two of them conceived spontaneously and delivered a healthy baby. Conclusion: The feasibility, efficacy and safety of fertility-sparing treatment with megestrol acetate for EC and AH were proven by this single institution prospective trial. Even in responders, however, close follow-up is required because of the substantial high rate of recurrence.
展开▼
