2018 ASCO Annual Meeting!
Session: Breast Cancer—Local/Regional/Adjuvant
Type: Poster Session
Time: Saturday June 2, 8:00 AM to 11:30 AM
Location: Hall A
Assessment and management of bone health in women treated with adjuvant anastrozole in the DATA study.
2018 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #26)
J Clin Oncol 36, 2018 (suppl; abstr 534)
Author(s): Irene Van Hellemond, Carolien H. Smorenburg, Petronella Peer, Astrid Swinkels, Caroline M. Seynaeve, Maurice Van Der Sangen, Judith R. Kroep, Hiltje de Graaf, Aafke H. Honkoop, Frans Erdkamp, Franchette van den Berkmortel, Maaike De Boer, Wilfred de Roos, Sabine C. Linn, Alexander Imholz, Vivianne C. Tjan-Heijnen; Maastricht University Medical Centre, Maastricht, Netherlands; Antoni van Leeuwenhoek, Amsterdam, Netherlands; Radboud University Medical Center, Nijmegen, Netherlands; Comprehensive Cancer Organization Netherlands, Nijmegen, Netherlands; Erasmus MC Cancer Institute, Department of Medical Oncology and Cancer Genomics, Rotterdam, Netherlands; Catharina Hospital, Eindhoven, Netherlands; Leiden University Medical Center, Leiden, Netherlands; Medical Center Leeuwarden, Leeuwarden, Netherlands; Isala Klinieken, Zwolle, Netherlands; Zuyderland Hospital, Sittard, Netherlands; Zuyderland Hospital, Heerlen, Netherlands; Gelderse Vallei Hospital, Ede, Netherlands; Department of Medical Oncology- Antoni van Leeuwenhoek Hospital, Netherlands Cancer Institute, Amsterdam, Netherlands; Deventer Hospital, Deventer, Netherlands
Background: The phase III DATA study (NCT00301457) investigates the efficacy of 6 versus 3 years of adjuvant anastrozole (AI) after an initial 2-3 year treatment with tamoxifen in postmenopausal women with breast cancer. In a planned side study, we assessed patterns of care in detection and treatment of osteopenia/osteoporosis and linear trends over time in bone mineral density (BMD). Methods: BMD measurements and bisphosphonate use in the DATA study were left to the treating physician. We registered all BMD measurements and start of bisphosphonate-use. BMD was measured by a dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine and/or the hip and transformed to a T-score. Time to osteopenia or osteoporosis was analysed by reverse Kaplan Meier methodology. For the linear trend in BMD T-score, linear mixed models with random effects for patient were used. Results: Of the 1860 eligible patients in the DATA study, 910 (48.9%) had a BMD measurement at the start of anastrozole (baseline). In 417 (45.8%) patients the baseline measurement indicated a normal BMD, in 408 (44.8%) osteopenia, and in 85 (9.3%) osteoporosis. In patients with a normal baseline BMD, osteopenia was observed in 53.5% of patients in the 6-year group, and 55.4 % in the 3-year group (p = 0.18), while none developed osteoporosis within 6 years after randomization. Of the patients with osteopenia at baseline, 24.4 % developed osteoporosis in the 6-year group and 20.4% in the 3-year group (p = 0.89). The yearly BMD change in the lumbar spine showed a decline of the mean T score of 0.075. When bisphosphonates were added the decline became 0.047 per year (p < 0.001), and when the AI was stopped and bisphosphonates continued the BMD increased yearly with 0.047. Conclusions: In postmenopausal women who had been treated with 2-3 years of adjuvant tamoxifen, BMD measurement showed osteopenia in 44.8% of women and osteoporosis in 9.3%. Although subsequent AI-use was associated with a further decrease of BMD, none of the patients with a normal BMD at baseline developed osteoporosis regardless of treatment arm. Clinical trial information: NCT00301457
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.