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Int J Cancer. 2019 Feb 12. doi: 10.1002/ijc.32205. [Epub ahead of print]

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

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Department of Medical Oncology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.
Department of Internal Medicine, Medical Centre Alkmaar, Alkmaar, the Netherlands.
Biostatistics, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, the Netherlands.
Clinical research department, Netherlands Comprehensive Cancer Organisation IKNL, Utrecht, the Netherlands.
Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Department of Radiation Oncology, Catharina Hospital, Eindhoven, the Netherlands.
Department of Medical Oncology, Leiden University Medical Centre, Leiden, the Netherlands.
Department of Medical Oncology, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.
Department of Medical Oncology, Isala Clinics, Zwolle, the Netherlands.
Department of Medical Oncology, Zuyderland Medical Centre, Sittard, the Netherlands.
Department of Surgery, Gelderse Vallei Hospital, Ede, the Netherlands.
Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Department of Medical Oncology, Deventer Hospital, Deventer, the Netherlands.


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.


adjuvant; anastrozole; aromatase inhibitors; bone health; bone mineral density; breast cancer; endocrine therapy; osteopenia; osteoporosis; tamoxifen


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