Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2018 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
Effect of denosumab on bone mineral density in postmenopausal Japanese women with osteopenia receiving adjuvant aromatase inhibitors for non-metastatic breast cancer: 24-month results.
2018 ASCO Annual Meeting
J Clin Oncol 36, 2018 (suppl; abstr e12536)
Author(s): Katsuhiko Nakatsukasa, Takayuki Matsuda, Tetsuya Taguchi; Dept. of Endocrine & Breast Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan; Saiseikai Kyoto Hospital, Kyoto, Japan
Background: Patients receiving aromatase inhibitor (AI) are at increased risk for bone fracture, which can reduce their quality of life. Efforts to prevent BMD loss are thus needed. Thus far, in Japan, the efficacy of denosumab in the treatment of AI-associated bone loss has not been evaluated in a prospective study. We previously reported the results of a 12-month, nonrandomized prospective study, which demonstrated that denosumab, a fully human monoclonal antibody against receptor activator of nuclear-factor kappa-B ligand (RANKL), increased the bone mineral Density (BMD) at the lumbar spine and femoral necks in patients with hormone receptor-positive breast cancer who were receiving adjuvant AI therapy and had evidence of low bone mass. Herein, we present the results of these therapeutic effects of 24-month denosumab therapy on the percentage change in BMD from baseline at the lumber spine and femoral necks. Methods: This non-randomized prospective study was conducted in Japan. we prospectively evaluated the BMD of the lumbar spine and bilateral femoral neck in hormone-receptor positive clinical stageⅠ–ⅢA, postoperative postmenopausal breast cancer patients who were scheduled for treatment with AI as adjuvant endocrine therapy or during AI adjuvant therapy. They received supplemental calcium, vitamin D and subcutaneous denosumab 60mg (n = 103) every six months. At enrollment, all patients were required to have evidence of low bone mass, excluding osteoporosis. The secondary endpoint was percentage change from baseline in lumbar spine BMD at 24 months. Results: We enrolled 103 patients between November, 2014 to October, 2016. At 24 months, lumber spine BMD increased by 7.0 %. The patients who were administered prior AI therapy (n = 62) had a 7.0 % increase, and the patients without prior AI therapy (n = 29) had a 6.8 % increase. At 24 months, the right and left femoral neck BMD increased by 3.4 % and 3.6 %. Conclusions: Twice-yearly treatment with denosumab was associated with consistently greater gains in BMD among Japanese women receiving adjuvant AI therapy, regardless of whether prior AI therapy was administered. Clinical trial information: UMIN000022256.
1. TAILORx: Phase III trial of chemoendocrine therapy versus endocrine therapy alone in hormone receptor-positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score.