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

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Abstract

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.

Original languageEnglish
Pages (from-to)2798-2803
Number of pages6
JournalJournal of Clinical Oncology
Volume25
Issue number19
DOIs
Publication statusPublished - Jul 1 2007

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Medroxyprogesterone Acetate
Endometrial Neoplasms
Hyperplasia
Fertility
Endometrial Hyperplasia
Therapeutics
Recurrence
Progestins
Pregnancy Rate
Aspirin
Multicenter Studies
Weight Gain
Liver Diseases
Japan
Estrogens
Body Weight
Prospective Studies
Pregnancy

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Multicenter phase II study of fertility-sparing treatment with medroxyprogesterone acetate for endometrial carcinoma and atypical hyperplasia in young women. / Ushijima, Kimio; Yahata, Hideaki; Yoshikawa, Hiroyuki; Konishi, Ikuo; Yasugi, Toshiharu; Saito, Toshiaki; Nakanishi, Toru; Sasaki, Hiroshi; Saji, Fumitaka; Iwasaka, Tsuyoshi; Hatae, Masayuki; Kodama, Shoji; Saito, Tsuyoshi; Terakawa, Naoki; Yaegashi, Nobuo; Hiura, Masamichi; Sakamoto, Atsuhiko; Tsuda, Hitoshi; Fukunaga, Masaharu; Kamura, Toshiharu.

In: Journal of Clinical Oncology, Vol. 25, No. 19, 01.07.2007, p. 2798-2803.

Research output: Contribution to journalArticle

Ushijima, K, Yahata, H, Yoshikawa, H, Konishi, I, Yasugi, T, Saito, T, Nakanishi, T, Sasaki, H, Saji, F, Iwasaka, T, Hatae, M, Kodama, S, Saito, T, Terakawa, N, Yaegashi, N, Hiura, M, Sakamoto, A, Tsuda, H, Fukunaga, M & Kamura, T 2007, 'Multicenter phase II study of fertility-sparing treatment with medroxyprogesterone acetate for endometrial carcinoma and atypical hyperplasia in young women', Journal of Clinical Oncology, vol. 25, no. 19, pp. 2798-2803. https://doi.org/10.1200/JCO.2006.08.8344
Ushijima, Kimio ; Yahata, Hideaki ; Yoshikawa, Hiroyuki ; Konishi, Ikuo ; Yasugi, Toshiharu ; Saito, Toshiaki ; Nakanishi, Toru ; Sasaki, Hiroshi ; Saji, Fumitaka ; Iwasaka, Tsuyoshi ; Hatae, Masayuki ; Kodama, Shoji ; Saito, Tsuyoshi ; Terakawa, Naoki ; Yaegashi, Nobuo ; Hiura, Masamichi ; Sakamoto, Atsuhiko ; Tsuda, Hitoshi ; Fukunaga, Masaharu ; Kamura, Toshiharu. / Multicenter phase II study of fertility-sparing treatment with medroxyprogesterone acetate for endometrial carcinoma and atypical hyperplasia in young women. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 19. pp. 2798-2803.
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abstract = "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.",
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T1 - Multicenter phase II study of fertility-sparing treatment with medroxyprogesterone acetate for endometrial carcinoma and atypical hyperplasia in young women

AU - Ushijima, Kimio

AU - Yahata, Hideaki

AU - Yoshikawa, Hiroyuki

AU - Konishi, Ikuo

AU - Yasugi, Toshiharu

AU - Saito, Toshiaki

AU - Nakanishi, Toru

AU - Sasaki, Hiroshi

AU - Saji, Fumitaka

AU - Iwasaka, Tsuyoshi

AU - Hatae, Masayuki

AU - Kodama, Shoji

AU - Saito, Tsuyoshi

AU - Terakawa, Naoki

AU - Yaegashi, Nobuo

AU - Hiura, Masamichi

AU - Sakamoto, Atsuhiko

AU - Tsuda, Hitoshi

AU - Fukunaga, Masaharu

AU - Kamura, Toshiharu

PY - 2007/7/1

Y1 - 2007/7/1

N2 - 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.

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