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Breast Cancer

, Volume 26, Issue 1, pp 106–112 | Cite as

Effect of denosumab on low bone mineral density in postmenopausal Japanese women receiving adjuvant aromatase inhibitors for non-metastatic breast cancer: 24-month results

  • Katsuhiko Nakatsukasa
  • Hiroshi Koyama
  • Yoshimi Ouchi
  • Hisako Ono
  • Kouichi Sakaguchi
  • Takayuki Matsuda
  • Makoto Kato
  • Takashi Ishikawa
  • Kimito Yamada
  • Mana Yoshimura
  • Kei Koizumi
  • Teruhisa Sakurai
  • Hideo Shigematsu
  • Shunji Takahashi
  • Shinichiro Taira
  • Masato Suzuki
  • Kazutaka Narui
  • Naoki Niikura
  • Yoshie Hasegawa
  • Daishu Miura
  • Eiichi Konishi
  • Tetsuya Taguchi
  • Collaborative Study Group of Scientific Research of the Japanese Breast Cancer Society
Original Article
  • 159 Downloads

Abstract

Background

Aromatase inhibitors (AI) have been established as the gold-standard therapy for postmenopausal patients. Worldwide, adjuvant denosumab at a dose of 60 mg twice per year reduces the risk of clinical fractures in postmenopausal patients with breast cancer who received AI. However, the efficacy of denosumab in the treatment of AI-associated bone loss had not been prospectively evaluated in Japan. Previously, we reported the 12-month effect of denosumab in Japanese patients for the first time; the primary endpoint was the change in the percentage of bone mineral density (BMD) of the lumbar spine from baseline to 12 months.

Methods

This secondary follow-up study prospectively evaluated the change in the percentage of BMD of the lumbar spine from baseline to 24 months. Postmenopausal women with early-stage, histologically confirmed, hormone receptor-positive, invasive breast cancer who were receiving or scheduled to receive AI were included. Denosumab was administered subcutaneously on day 1 of the study and then 6, 12, 18, and 24 months. The lumbar spine and bilateral femoral neck BMD was measured at baseline and 6, 12, 18, and 24 months.

Results

At 18 and 24 months, the lumbar spine BMD increased by 5.9 and 7.0%, respectively. The femoral neck BMD also increased. Grade ≥ 2 hypocalcemia, osteonecrosis of the jaw, and atypical femoral fractures did not occur.

Conclusions

Our prospective study showed that semiannual treatment with denosumab was associated with continuously increased BMD in Japanese women receiving adjuvant AI therapy for up to 24 months, regardless of prior AI treatment.

Keywords

Breast cancer Aromatase inhibitor Denosumab Bone mineral density 

Notes

Acknowledgements

This study was supported in part by Grants-in-Aid for Scientific Research from the Japanese Breast Cancer Society.

Compliance with ethical standards

Conflict of interest

Dr Tetsuya Taguchi received Research grant from Chugai, Taiho and Daiichi Sankyo. Dr Shunji Takahashi received Research grant from Daiichi Sankyo. Other authors declare that they have no conflict of interest.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standard.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© The Japanese Breast Cancer Society 2018

Authors and Affiliations

  • Katsuhiko Nakatsukasa
    • 1
  • Hiroshi Koyama
    • 4
  • Yoshimi Ouchi
    • 1
  • Hisako Ono
    • 1
    • 2
  • Kouichi Sakaguchi
    • 1
  • Takayuki Matsuda
    • 5
  • Makoto Kato
    • 6
  • Takashi Ishikawa
    • 7
  • Kimito Yamada
    • 7
  • Mana Yoshimura
    • 8
  • Kei Koizumi
    • 9
  • Teruhisa Sakurai
    • 10
  • Hideo Shigematsu
    • 11
  • Shunji Takahashi
    • 12
  • Shinichiro Taira
    • 12
  • Masato Suzuki
    • 13
  • Kazutaka Narui
    • 14
  • Naoki Niikura
    • 15
  • Yoshie Hasegawa
    • 16
  • Daishu Miura
    • 17
  • Eiichi Konishi
    • 3
  • Tetsuya Taguchi
    • 1
  • Collaborative Study Group of Scientific Research of the Japanese Breast Cancer Society
  1. 1.Department of Endocrine and Breast SurgeryKyoto Prefectural University of MedicineKyotoJapan
  2. 2.Molecular-Targeting Cancer PreventionKyoto Prefectural University of MedicineKyotoJapan
  3. 3.Surgical PathologyKyoto Prefectural University of MedicineKyotoJapan
  4. 4.Nara City HospitalNaraJapan
  5. 5.Saiseikai Kyoto HospitalKyotoJapan
  6. 6.Kato Breast Surgery ClinicKyotoJapan
  7. 7.Department of BreastTokyo Medical UniversityTokyoJapan
  8. 8.Department of RadiologyTokyo Medical UniversityTokyoJapan
  9. 9.Department of Breast OncologySeirei Hamamatsu General HospitalHamamatsuJapan
  10. 10.Department of SurgeryWakayama Medical University Kihoku HospitalWakayamaJapan
  11. 11.Department of Breast SurgeryNational Hospital Organization Kure Medical Center and Chugoku Cancer CenterKure-CityJapan
  12. 12.Department of Medical OncologyCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
  13. 13.Department of Breast SurgeryNational Hospital Organization Chiba Medical Center, Yokohama City University Medical CenterTokyoJapan
  14. 14.Department of Breast and Thyroid SurgeryYokohama City University Medical CenterYokohamaJapan
  15. 15.Department of Breast and Endocrine SurgeryTokai University School of MedicineTokyoJapan
  16. 16.Department of Breast Surgical OncologyHirosaki Municipal HospitalHirosakiJapan
  17. 17.Akasaka Miura ClinicTokyoJapan

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