Multicenter phase II study of fertility-sparing treatment with medroxyprogesterone acetate for endometrial carcinoma and atypical hyperplasia in young women
Multicenter phase II study of fertility-sparing treatment with medroxyprogesterone acetate for endometrial carcinoma and atypical hyperplasia in young women
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DOI：
10.1200/jco.2006.08.8344
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发表时间：
2007-07-01
影响因子：
45.3
通讯作者：
Kamura, Toshiharu
中科院分区：
文献类型：
--
作者：
Ushijima, Kimio;Yahata, Hideaki;Kamura, Toshiharu
目的评价醋酸甲羟孕酮（MPA）保生育治疗年轻女性子宫内膜癌（EC）和不典型子宫内膜增生（AH）的疗效。患者和方法本多中心前瞻性研究在日本16家机构进行。28例假定为IA期的EC患者和17例年龄小于40岁的AH患者被纳入研究。所有患者均给予每日口服剂量600mg MPA和低剂量阿司匹林。这种治疗持续了26周，只要患者有反应。在治疗8周和16周时评估子宫内膜组织的组织学变化。对MPA治疗后的应答者进行雌激素-黄体酮治疗或生育治疗。主要终点是病理完全缓解（CR）率。毒性、妊娠率和无进展间期是次要终点。结果55%的EC病例和82%的AH病例存在scr。总CR率为67%。未观察到治疗性死亡或不可逆毒性；然而，两名患者有3级体重增加，一名患者有3级肝功能障碍。在3年的随访期间，经MPA治疗后12例妊娠，7例正常分娩。在7 - 36个月期间，30例患者中有14例（47%）复发。结论本前瞻性试验证实了大剂量MPA对EC和AH的保生育治疗效果。然而，即使在应答者中，由于复发率很高，也需要密切随访。
PurposeTo assess the efficacy of fertility-sparing treatment using medroxyprogesterone acetate (MPA) for endometrial carcinoma (EC) and atypical endometrial hyperplasia (AH) in young women.Patients and MethodsThis multicenter prospective study was carried out at 16 institutions in Japan. Twenty-eight patients having EC at presumed stage IA and 17 patients with AH at younger than 40 years of age were enrolled. All patients were given a daily oral dose of 600 mg of MPA with low-dose aspirin. This treatment continued for 26 weeks, as long as the patients responded. Histologic change of endometrial tissue was assessed at 8 and 16 weeks of treatment. Either estrogen-progestin therapy or fertility treatment was provided for the responders after MPA therapy. The primary end point was a pathologic complete response (CR) rate. Toxicity, pregnancy rate, and progression-free interval were secondary end points.ResultsCR was found in 55% of EC cases and 82% of AH cases. The overall CR rate was 67%. Neither therapeutic death nor irreversible toxicities were observed; however, two patients had grade 3 body weight gain, and one patient had grade 3 liver dysfunction. During the 3-year follow-up period, 12 pregnancies and seven normal deliveries were achieved after MPA therapy. Fourteen recurrences were found in 30 patients (47%) between 7 and 36 months.ConclusionThe efficacy of fertility-sparing treatment with a high-dose of MPA for EC and AH was proven by this prospective trial. Even in responders, however, close follow-up is required because of the substantial rate of recurrence.