Assessment and management of bone health in women with early breast cancer receiving endocrine treatment in the DATA study

• Published in: International journal of cancer Vol. 145; no. 5; pp. 1325 - 1333
• Main Authors: Hellemond, Irene E.G., Smorenburg, Carolien H., Peer, Petronella G.M., Swinkels, Astrid C.P., Seynaeve, Caroline M., Sangen, Maurice J.C., Kroep, Judith R., de Graaf, Hiltje, Honkoop, Aafke H., Erdkamp, Frans L.G., Berkmortel, Franchette W.P.J., Boer, Maaike, Roos, Wilfred K., Linn, Sabine C., Imholz, Alexander L.T., Tjan‐Heijnen, Vivianne C.G.
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 01.09.2019; Wiley Subscription Services, Inc
• Subjects: adjuvant; Anastrozole; Anastrozole - administration & dosage; Anastrozole - adverse effects; Antineoplastic Agents, Hormonal - administration & dosage; Antineoplastic Agents, Hormonal - adverse effects; aromatase inhibitors; Bisphosphonates; Bone Density - drug effects; bone health; Bone mineral density; Breast cancer; Breast Neoplasms - drug therapy; Cancer; Cancer Therapy and Prevention; endocrine therapy; Female; Fractures, Bone; Humans; Medical research; Middle Aged; Osteopenia; Osteoporosis; Osteoporosis, Postmenopausal - diagnosis; Osteoporosis, Postmenopausal - therapy; Post-menopause; Prospective Studies; Randomization; Spine; Spine (lumbar); Tamoxifen; Tamoxifen - administration & dosage; Tamoxifen - adverse effects; osteopenia; bone mineral density; adjuvant; bone health; breast cancer; aromatase inhibitors; anastrozole; osteoporosis; tamoxifen; endocrine therapy
• ISSN: 0020-7136; 1097-0215; 1097-0215
• DOI: 10.1002/ijc.32205

The phase III DATA study investigates the efficacy of adjuvant anastrozole (6 vs. 3 year) in postmenopausal women with breast cancer previously treated with 2–3 years of tamoxifen. This planned side‐study assessed patterns of care regarding detection and treatment of osteopenia/osteoporosis, and trends in bone mineral density (BMD) during and after therapy. We registered all BMD measurements and bisphosphonate‐use. Time to osteopenia/osteoporosis was analysed by Kaplan Meier methodology. For the trend in T‐scores we used linear mixed models with random patients effects. Of 1860 eligible DATA patients, 910 (48.9%) had a baseline BMD measurement. Among patients with a normal baseline BMD (n = 417), osteopenia was observed in 53.5% and 55.4% in the 6‐ and 3‐year group respectively (p = 0.18), during follow‐up. Only two patients (3‐year group) developed osteoporosis. Of the patients with osteopenia at baseline (n = 408), 24.4% and 20.4% developed osteoporosis respectively (p = 0.89). Three years after randomisation 18.3% and 18.2% used bisphosphonates in the 6‐ and 3‐year groups respectively and 6 years after randomisation this was 23.7% and 20.9% respectively (p = 0.90) of which the majority used oral bisphosphonates. The yearly mean BMD‐change during anastrozole in the lumbar spine showed a T‐score decline of 0.075. After bisphosphonate addition the decline became less prominent (0.047 (p < 0.001)) and after anastrozole cessation, while continuing bisphosphonates, the mean BMD yearly increased (0.047 (p < 0.001)). In conclusion, extended anastrozole therapy was not associated with a higher incidence of osteoporosis. Anastrozole‐use was associated with a BMD decrease; however, the decline was modest and partially reversible after anastrozole cessation. What's new? Loss of bone mineral density (BMD) is a side effect of aromatase inhibitor treatment, a class of drugs that stops estrogen production in postmenopausal women with breast cancer. Here the authors examined BMD loss during and after extended adjuvant endocrine therapy, following a 2‐3 year treatment with tamoxifen, subsequent aromatase inhibitor treatment was associated with BMD decrease, but the decline was modest and partially reversible after treatment cessation. The authors concluded that extended endocrine therapy was not associated with a higher incidence of osteoporosis.