The effect of denosumab in breast cancer patients receiving adjuvant aromatase inhibitors: 36-month results

• Published in: Journal of bone and mineral metabolism 2021-03, Vol.39 (2), p.224-229
• Main Authors: Ouchi, Yoshimi, Nakatsukasa, Katsuhiko, Sakaguchi, Koichi, Morita, Midori, Koyama, Hiroshi, Matsuda, Takayuki, Kato, Makoto, Konishi, Eiichi, Ono, Hisako, Taguchi, Tetsuya
• Format: Article
• Language: English
• Subjects: Acid phosphatase (tartrate-resistant); Adjuvants, Pharmaceutic - pharmacology; Adjuvants, Pharmaceutic - therapeutic use; Adverse events; Aged; Aged, 80 and over; Alkaline phosphatase; Alkaline Phosphatase - blood; Aromatase; Aromatase Inhibitors - pharmacology; Aromatase Inhibitors - therapeutic use; Biomarkers - blood; Bone density; Bone Density - drug effects; Bone Density Conservation Agents - therapeutic use; Bone loss; Bone mineral density; Bone Remodeling - drug effects; Bone turnover; Breast cancer; Breast Neoplasms - blood; Breast Neoplasms - drug therapy; Calcium; Denosumab - adverse effects; Denosumab - pharmacology; Denosumab - therapeutic use; Female; Femur; Fractures; Fractures, Bone - blood; Fractures, Bone - drug therapy; Humans; Immunotherapy; Medicine; Medicine & Public Health; Metabolic Diseases; Middle Aged; Monoclonal antibodies; Original Article; Orthopedics; Osteopenia; Patients; Phosphatase; Prospective Studies; Quality of life; Spine (lumbar); Targeted cancer therapy; Tartrate-Resistant Acid Phosphatase - blood; Vitamin D
• ISSN: 0914-8779; 1435-5604
• DOI: 10.1007/s00774-020-01138-6

Introduction Aromatase inhibitor (AI)-associated bone loss increases the risk of bone fracture and reduces patients’ quality of life, making it a critical issue worldwide. We conducted a prospective non-randomized clinical trial (UMIN-CTR, UMIN 000016173) to assess the effect of denosumab on bone loss in patients treated with adjuvant AI and have previously reported the results at 12 and 24 months. This study aimed to present the results at 36 months of treatment with denosumab for osteopenia in breast cancer patients who were undergoing treatment with adjuvant AI; 36 months is the longest denosumab treatment period reported so far. Materials and methods Patients received 60-mg denosumab subcutaneously every 6 months. Daily supplements containing 500-mg elemental calcium and at least 400 international units of vitamin D were highly recommended throughout the study period. The levels of bone mineral density (BMD) and bone turnover markers, serum tartrate-resistant acid phosphatase isoform 5b, and bone alkaline phosphatase were determined at baseline and 6, 12, 18, 24, and 36 months. Results At 36 months, the bone mineral density of the lumbar spine, right femoral neck, and left femoral neck were found to increase by 8.8% (95% confidence interval CI 7.6–10.1), 4.3% (95% CI 3.0–5.5), and 3.1% (95% CI 2.1–4.1), respectively. No non-traumatic clinical fractures occurred in patients receiving AI and denosumab. Conclusion Twice-yearly administration of denosumab to the breast cancer patients treated with adjuvant AI, regardless of the skeletal site, resulted in consistent increases in BMD without severe adverse events at 36 months.