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Multicenter Phase II Study of Fertility-Sparing Treatment With Medroxyprogesterone Acetate for Endometrial Carcinoma and Atypical Hyperplasia in Young Women

Kimio Ushijima, Hideaki Yahata, Hiroyuki Yoshikawa, Ikuo Konishi, Toshiharu Yasugi, Toshiaki Saito, Toru Nakanishi, Hiroshi Sasaki, Fumitaka Saji, Tsuyoshi Iwasaka, Masayuki Hatae, Shoji Kodama, Tsuyoshi Saito, Naoki Terakawa, Nobuo Yaegashi, Masamichi Hiura, Atsuhiko Sakamoto, Hitoshi Tsuda, Masaharu Fukunaga, Toshiharu Kamura

From the Japan Gynecologic Cancer Study Group, Tokyo; Department of Obstetrics and Gynecology, Kurume University, Kurume; Department of Obstetrics and Gynecology, Kyushu University; Department of Gynecology, National Kyushu Cancer Center, Fukuoka; Department of Obstetrics and Gynecology, University of Tsukuba, Tsukuba; Department of Obstetrics and Gynecology, Shinshu University, Matsumoto; Department of Obstetrics and Gynecology, University of Tokyo, Tokyo; Department of Gynecology, Aichi Cancer Center Hospital, Nagoya; Department of Obstetrics and Gynecology, Kashiwa Hospital, Jikei University, Kashiwa; Department of Obstetrics and Gynecology, National Kure Medical Center, Kure; Department of Obstetrics and Gynecology, Saga University, Saga; Department of Obstetrics and Gynecology Kagoshima City Hospital, Kagoshima; Department of Gynecology, Niigata Cancer Center, Niigata; Department of Obstetrics and Gynecology, Sapporo Medical University, Sapporo; Department of Obstetrics and Gynecology, Tottori University, Yonago; Department of Obstetrics and Gynecology, Tohoku University, Sendai; Department of Gynecology, National Shikoku Cancer Center, Matsuyama; Department of Pathology, Kyorin University, Mitaka; Department of Pathology, National Defense Medical College, Tokorozawa; and the Department of Pathology, Third Hospital, Jikei Medical University, Komae, Japan

Address reprint requests to Kimio Ushijima, MD, PhD, Department of Obstetrics and Gynecology, Kurume University School of Medicine, 67 Asahi-Machi, Kurume 830-0011, Japan; e-mail: kimi{at}med.kurume-u.ac.jp

Purpose To 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 Methods This 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.

Results CR 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.

Conclusion The 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.

Supported by a Grant-in-Aid for research of cancer treatment from the Ministry of Health, Labor, and Welfare of Japan (No.14-10).

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL.

Author's disclosures of potential conflicts of interests are found at the end of this article.

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