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Article Open Access

Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial

  • Authors:
    • Reiki Nishimura
    • Keisei Anan
    • Yutaka Yamamoto
    • Kenji Higaki
    • Maki  Tanaka
    • Kenji Shibuta
    • Yasuaki Sagara
    • Shinji Ohno
    • Shigeru  Tsuyuki
    • Takahiro Mase
    • Satoshi Teramukai
  • View Affiliations / Copyright

    Affiliations: Department of Breast and Endocrine Surgery, Kumamoto City Hospital, Kumamoto 862-8505, Japan, Department of Surgery, Kitakyushu Municipal Medical Center, Kitakyushu 802-0077, Japan, Department of Breast and Endocrine Surgery, Kumamoto University Hospital, Kumamoto 860-8556, Japan, Department of Breast Surgery, Hiroshima City Hospital, Hiroshima 730-8518, Japan, Department of Surgery, Social Insurance Kurume Daiichi Hospital, Kurume 830‑0013, Japan, Department of Breast Surgery, Ueo Breast Surgical Hospital, Oita 870-0854, Japan, Department of Breast/Thyroid Gland, Hakuaikai Medical Corporation, Sagara Hospital, Kagoshima 892-0833, Japan, Division of Breast Oncology, National Kyushu Cancer Center, Fukuoka 811-1395, Japan, Department of Breast and General Surgery, Osaka Red-Cross Hospital, Osaka 543-8555, Japan, Department of Breast and Endocrine surgery, Ichinomiya Municipal Hospital, Ichinomiya 491-8558, Japan, Department of Clinical Trial Design and Management Translational Research Center, Kyoto University Hospital, Kyoto 606-8507, Japan
    Copyright: © Nishimura et al. This is an open access article distributed under the terms of Creative Commons Attribution License [CC BY_NC 3.0].
  • Pages: 1707-1713
    |
    Published online on: February 27, 2013
       https://doi.org/10.3892/or.2013.2312
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Abstract

The aim of the present study was to assess the efficacy and tolerability of a luteinizing hormone-releasing hormone (LH-RH) analogue plus an aromatase inhibitor following failure to respond to standard LH-RH analogue plus tamoxifen (TAM) in premenopausal patients. Premenopausal women with estrogen receptor (ER)-positive and/or progesterone-receptor positive, advanced or recurrent breast cancer refractory to an LH-RH analogue plus TAM received goserelin (GOS) in conjunction with anastrozole (ANA). The primary endpoint was the objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR) and safety. Between September 2008 and November 2010, 37 patients were enrolled. Thirty-five patients (94.6%) had ER-positive tumors, and 36 (97.3%) had human epidermal growth factor receptor (HER) 2-negative tumors. Thirty-six (97.3%) had measurable lesions and 1 (2.7%) had only bone metastasis. The ORR was 18.9% [95% confidence interval (CI), 8.0-35.2%], the CBR was 62.2% (95% CI, 44.8-77.5%) and the median PFS was 7.3 months. Eight patients had adverse drug reactions but none resulted in discontinuation of treatment. GOS plus ANA is a safe effective treatment for premenopausal women with hormone receptor-positive, recurrent or advanced breast cancer. The treatment may become viable treatment in the future, particularly when TAM is ineffective or contraindicated. Further studies and discussion are warranted.
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Copy and paste a formatted citation
Spandidos Publications style
Nishimura R, Anan K, Yamamoto Y, Higaki K, Tanaka M, Shibuta K, Sagara Y, Ohno S, Tsuyuki S, Mase T, Mase T, et al: Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial. Oncol Rep 29: 1707-1713, 2013.
APA
Nishimura, R., Anan, K., Yamamoto, Y., Higaki, K., Tanaka, M., Shibuta, K. ... Teramukai, S. (2013). Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial. Oncology Reports, 29, 1707-1713. https://doi.org/10.3892/or.2013.2312
MLA
Nishimura, R., Anan, K., Yamamoto, Y., Higaki, K., Tanaka, M., Shibuta, K., Sagara, Y., Ohno, S., Tsuyuki, S., Mase, T., Teramukai, S."Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial". Oncology Reports 29.5 (2013): 1707-1713.
Chicago
Nishimura, R., Anan, K., Yamamoto, Y., Higaki, K., Tanaka, M., Shibuta, K., Sagara, Y., Ohno, S., Tsuyuki, S., Mase, T., Teramukai, S."Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial". Oncology Reports 29, no. 5 (2013): 1707-1713. https://doi.org/10.3892/or.2013.2312
Copy and paste a formatted citation
x
Spandidos Publications style
Nishimura R, Anan K, Yamamoto Y, Higaki K, Tanaka M, Shibuta K, Sagara Y, Ohno S, Tsuyuki S, Mase T, Mase T, et al: Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial. Oncol Rep 29: 1707-1713, 2013.
APA
Nishimura, R., Anan, K., Yamamoto, Y., Higaki, K., Tanaka, M., Shibuta, K. ... Teramukai, S. (2013). Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial. Oncology Reports, 29, 1707-1713. https://doi.org/10.3892/or.2013.2312
MLA
Nishimura, R., Anan, K., Yamamoto, Y., Higaki, K., Tanaka, M., Shibuta, K., Sagara, Y., Ohno, S., Tsuyuki, S., Mase, T., Teramukai, S."Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial". Oncology Reports 29.5 (2013): 1707-1713.
Chicago
Nishimura, R., Anan, K., Yamamoto, Y., Higaki, K., Tanaka, M., Shibuta, K., Sagara, Y., Ohno, S., Tsuyuki, S., Mase, T., Teramukai, S."Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial". Oncology Reports 29, no. 5 (2013): 1707-1713. https://doi.org/10.3892/or.2013.2312
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