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

Autor: Nakatsukasa K; Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan., Koyama H; Nara City Hospital, Nara, Japan., Ouchi Y; Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan., Ono H; Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.; Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan., Sakaguchi K; Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan., Matsuda T; Saiseikai Kyoto Hospital, Kyoto, Japan., Kato M; Kato Breast Surgery Clinic, Kyoto, Japan., Ishikawa T; Department of Breast, Tokyo Medical University, Tokyo, Japan., Yamada K; Department of Breast, Tokyo Medical University, Tokyo, Japan., Yoshimura M; Department of Radiology, Tokyo Medical University, Tokyo, Japan., Koizumi K; Department of Breast Oncology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan., Sakurai T; Department of Surgery, Wakayama Medical University Kihoku Hospital, Wakayama, Japan., Shigematsu H; Department of Breast Surgery, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure-City, Hiroshima, Japan., Takahashi S; Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan., Taira S; Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan., Suzuki M; Department of Breast Surgery, National Hospital Organization Chiba Medical Center, Yokohama City University Medical Center, Tokyo, Japan., Narui K; Department of Breast and Thyroid Surgery, Yokohama City University Medical Center, Yokohama, 232-0024, Japan., Niikura N; Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Tokyo, Japan., Hasegawa Y; Department of Breast Surgical Oncology, Hirosaki Municipal Hospital, Hirosaki, Japan., Miura D; Akasaka Miura Clinic, Tokyo, Japan., Konishi E; Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan., Taguchi T; Department of Endocrine and Breast Surgery, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan. ttaguchi@koto.kpu-m.ac.jp.
Jazyk: angličtina
Zdroj: Breast cancer (Tokyo, Japan) [Breast Cancer] 2019 Jan; Vol. 26 (1), pp. 106-112. Date of Electronic Publication: 2018 Jul 27.
DOI: 10.1007/s12282-018-0896-y
Abstrakt: 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.
Databáze: MEDLINE