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Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer

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Abstract

This study compared the efficacy and safety of a 3-monthly 10.8-mg depot goserelin (ZoladexTM) injection with the current 3.6 mg monthly dose in pre-menopausal Japanese women with estrogen receptor-positive (ER+) early breast cancer. This was a multicenter, open-label, randomized study. Primary endpoint was a non-inferiority analysis (10.8/3.6 mg) of the area under the concentration–time curve (AUC) of estradiol (E2) over the first 24 weeks. Secondary endpoints included E2 and follicle-stimulating hormone (FSH) concentrations, menstruation, and safety and tolerability. In total, 170 patients were randomized to receive goserelin 10.8 mg every 3 months (n = 86) or 3.6 mg every month (n = 84). Mean AUCs for E2 were similar between treatment groups (18.32 and 18.95 pg/ml·week for goserelin 10.8 and 3.6 mg, respectively). AUC ratio was 0.974 (95% confidence interval, 0.80, 1.19), indicating non-inferiority for goserelin 10.8 mg. Serum E2 and FSH remained suppressed throughout the study and no patient experienced menses after week 16. No clinically important differences in safety and tolerability were observed between the two groups. In terms of E2 suppression, 3-monthly goserelin 10.8 mg was non-inferior to monthly goserelin 3.6 mg in pre-menopausal women with ER+ breast cancer.

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Acknowledgments

This work was sponsored by AstraZeneca, who provided support for the conduct of the study, data collection and project management. We thank all the patients and investigators who participated in the study. We also thank Simon Vass, PhD, from Complete Medical Communications who provided medical writing support funded by AstraZeneca. The following investigators (institutions) participated in the study: Seiichi Takenoshita, Tohru Ohtake (Fukushima Medical University Hospital); Yasuo Hozumi (Jichi Medical University Hospital); Jiro Ando (Tochigi Cancer Center); Hidetaka Mochizuki, Kazuhiko Fukatsu (National Defence Medical College Hospital); Kimito Suemasu (Saitama Cancer Center); Takayuki Kinoshita (National Cancer Center Hospital); Seigo Nakamura (St. Luke’s International Hospital); Tsunehiro Nishi (Mitsui Memorial Hospital); Takuji Iwase (The Cancer Institute Hospital of Japanese Foundation for Cancer Research); Shigeru Imoto, Noriaki Wada (National Cancer Center Hospital East); Naohito Yamamoto (Chiba Cancer Center); Yutaka Tokuda (Hospital of the Tokai University School of Medicine); Mamoru Fukuda (St. Marianna University School of Medicine Hospital); Muneaki Sano, Nobuaki Sato (Niigata Cancer Center Hospital); Tetsuya Taguchi (Osaka University Graduate School of Medicine); Hideo Inaji (Osaka Medical Center for Cancer and Cardiovascular Disease); Masahira Watatani (Hospital of Kinki University School of Medicine); Shozo Ohsumi (National Hospital Organization Shikoku Cancer Center); Shinji Ohno (National Hospital Organization Kyusyu Cancer Center); Reiki Nishimura (Kumamoto City Hospital); Hirotaka Iwase (Kumamoto University Hospital); Hidemi Furusawa (Breastopia NAMBA Hospital).

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Authors and Affiliations

  1. National Hospital Organization Osaka National Hospital, Osaka, Japan

    Norikazu Masuda

  2. Aichi Cancer Center Hospital, Nagoya, Aichi, Japan

    Hiraji Iwata

  3. Sagara Hospital, Kagoshima, Japan

    Yoshiaki Rai

  4. Kitakyushu Municipal Medical Center, Fukuoka, Japan

    Keisei Anan

  5. Marumo Hospital, Nagoya, Aichi, Japan

    Toru Takeuchi

  6. Tokyo Medical University Hospital, Tokyo, Japan

    Norio Kohno

  7. Saitama Cancer Center, Saitama, Japan

    Hiroyuki Takei

  8. Gunma Cancer Center, Ota, Gunma, Japan

    Yasuhiro Yanagita

  9. Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan

    Shinzaburo Noguchi

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  1. Norikazu Masuda
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  2. Hiraji Iwata
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  3. Yoshiaki Rai
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  4. Keisei Anan
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  5. Toru Takeuchi
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  7. Hiroyuki Takei
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  8. Yasuhiro Yanagita
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  9. Shinzaburo Noguchi
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Correspondence to Shinzaburo Noguchi.

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Masuda, N., Iwata, H., Rai, Y. et al. Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer. Breast Cancer Res Treat 126, 443–451 (2011). https://doi.org/10.1007/s10549-010-1332-y

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  • DOI: https://doi.org/10.1007/s10549-010-1332-y

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