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      Management of Aromatase Inhibitor-Associated Bone Loss (AIBL) in postmenopausal women with hormone sensitive breast cancer: Joint position statement of the IOF, CABS, ECTS, IEG, ESCEO IMS, and SIOG

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          Abstract

          Background

          Several guidelines have been reported for bone-directed treatment in women with early breast cancer (EBC) for averting fractures, particularly during aromatase inhibitor (AI) therapy. Recently, a number of studies on additional fracture related risk factors, new treatment options as well as real world studies demonstrating a much higher fracture rate than suggested by randomized clinical controlled trials (RCTs). Therefore, this updated algorithm was developed to better assess fracture risk and direct treatment as a position statement of several interdisciplinary cancer and bone societies involved in the management of AI-associated bone loss (AIBL).

          Patients and methods

          A systematic literature review identified recent advances in the management of AIBL. Results with individual agents were assessed based on trial design, size, follow-up, and safety.

          Results

          Several fracture related risk factors in patients with EBC were identified. Although, the FRAX algorithm includes fracture risk factors (RF) in addition to BMD, it does not seem to adequately address the effects of AIBL. Several antiresorptive agents can prevent and treat AIBL. However, concerns regarding compliance and long-term safety remain. Overall, the evidence for fracture prevention is strongest for denosumab 60 mg s.c. every 6 months. Additionally, recent studies as well as an individual patient data meta-analysis of all available randomized trial data support additional anticancer benefits from adjuvant bisphosphonate treatment in postmenopausal women with a 34% relative risk reduction in bone metastasis and 17% relative risk decrease in breast cancer mortality that needs to be taken into account when advising on management of AIBL.

          Conclusions

          In all patients initiating AI treatment, fracture risk should be assessed and recommendation with regard to exercise and calcium/vitamin D supplementation given. Bone-directed therapy should be given to all patients with a T-score<−2.0 or with a T-score of <–1.5 SD with one additional RF, or with ≥2 risk factors (without BMD) for the duration of AI treatment. Patients with T-score>−1.5 SD and no risk factors should be managed based on BMD loss during the first year and the local guidelines for postmenopausal osteoporosis. Compliance should be regularly assessed as well as BMD on treatment after 12 - 24 months. Furthermore, because of the decreased incidence of bone recurrence and breast cancer specific mortality, adjuvant bisphosphonates are recommended for all postmenopausal women at significant risk of disease recurrence.

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          Most cited references98

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          Thresholds for therapies: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2009

          The 11th St Gallen (Switzerland) expert consensus meeting on the primary treatment of early breast cancer in March 2009 maintained an emphasis on targeting adjuvant systemic therapies according to subgroups defined by predictive markers. Any positive level of estrogen receptor (ER) expression is considered sufficient to justify the use of endocrine adjuvant therapy in almost all patients. Overexpression or amplification of HER2 by standard criteria is an indication for anti-HER2 therapy for all but the very lowest risk invasive tumours. The corollary is that ER and HER2 must be reliably and accurately measured. Indications for cytotoxic adjuvant therapy were refined, acknowledging the role of risk factors with the caveat that risk per se is not a target. Proliferation markers, including those identified in multigene array analyses, were recognised as important in this regard. The threshold for indication of each systemic treatment modality thus depends on different criteria which have been separately listed to clarify the therapeutic decision-making algorithm.
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            Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures.

            To determine the ability of measurements of bone density in women to predict later fractures. Meta-analysis of prospective cohort studies published between 1985 and end of 1994 with a baseline measurement of bone density in women and subsequent follow up for fractures. For comparative purposes, we also reviewed case control studies of hip fractures published between 1990 and 1994. Eleven separate study populations with about 90,000 person years of observation time and over 2000 fractures. Relative risk of fracture for a decrease in bone mineral density of one standard deviation below age adjusted mean. All measuring sites had similar predictive abilities (relative risk 1.5 (95% confidence interval 1.4 to 1.6)) for decrease in bone mineral density except for measurement at spine for predicting vertebral fractures (relative risk 2.3 (1.9 to 2.8)) and measurement at hip for hip fractures (2.6 (2.0 to 3.5)). These results are in accordance with results of case-control studies. Predictive ability of decrease in bone mass was roughly similar to (or, for hip or spine measurements, better than) that of a 1 SD increase in blood pressure for stroke and better than a 1 SD increase in serum cholesterol concentration for cardiovascular disease. Measurements of bone mineral density can predict fracture risk but cannot identify individuals who will have a fracture. We do not recommend a programme of screening menopausal women for osteoporosis by measuring bone density.
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              A meta-analysis of previous fracture and subsequent fracture risk.

              Previous fracture is a well-documented risk factor for future fracture. The aim of this study was to quantify this risk on an international basis and to explore the relationship of this risk with age, sex, and bone mineral density (BMD). We studied 15259 men and 44902 women from 11 cohorts comprising EVOS/EPOS, OFELY, CaMos, Rochester, Sheffield, Rotterdam, Kuopio, DOES, Hiroshima, and two cohorts from Gothenburg. Cohorts were followed for a total of 250000 person-years. The effect of a prior history of fracture on the risk of any fracture, any osteoporotic fracture, and hip fracture alone was examined using a Poisson model for each sex from each cohort. Covariates examined were age, sex, and BMD. The results of the different studies were merged by using the weighted beta-coefficients. A previous fracture history was associated with a significantly increased risk of any fracture compared with individuals without a prior fracture (RR = 1.86; 95% CI = 1.75-1.98). The risk ratio was similar for the outcome of osteoporotic fracture or for hip fracture. There was no significant difference in risk ratio between men and women. Risk ratio (RR) was marginally downward adjusted when account was taken of BMD. Low BMD explained a minority of the risk for any fracture (8%) and for hip fracture (22%). The risk ratio was stable with age except in the case of hip fracture outcome where the risk ratio decreased significantly with age. We conclude that previous history of fracture confers an increased risk of fracture of substantial importance beyond that explained by measurement of BMD. Its validation on an international basis permits the use of this risk factor in case finding strategies.
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                Author and article information

                Contributors
                Journal
                J Bone Oncol
                J Bone Oncol
                Journal of Bone Oncology
                Elsevier
                2212-1366
                2212-1374
                23 March 2017
                June 2017
                23 March 2017
                : 7
                : 1-12
                Affiliations
                [a ]Krankenhaus Nordwest, Frankfurt, Germany
                [b ]Genolier Cancer Center, Switzerland
                [c ]CHU Brugmann, Université Libre de Bruxelles, Belgium
                [d ]Medical University of Vienna, Austria
                [e ]University of Florence, Italy
                [f ]University of Liège, Belgium
                [g ]Erasmus MC, Rotterdam, Netherlands
                [h ]Univeristy of Kiel, Germany
                [i ]University of Stellenbosch, Cape Town, South Africa
                [j ]University of Sydney, Australia
                [k ]Indiana University School of Medicine, USA
                [l ]University of Southampton, UK
                [m ]Aarhus University, Denmark
                [n ]Instituto Palacios Madrid, Spain
                [o ]Catholic University of Australia, Melbourne, Australia and University of Sheffield, UK
                [p ]University of Riyadh, Saudi Arabia
                [q ]Autonomous University of Barcelona, Spain
                [r ]University of Oslo, Norway
                [s ]Klinikum Birkenwerder, Germany
                [t ]Geneva University, Switzerland
                [u ]University of Sheffield, UK
                Author notes
                [* ]Correspondence to: Prof. Dr. med. P. Hadji, Philipps-University of Marburg Krankenhaus Nordwest Dept. of Bone Oncology, Endocrinology and Reproductive Medicine, Steinbacher Hohl Frankfurt, Germany. hadji.peyman@ 123456khnw.de
                [1]

                IOF: International Osteoporosis Foundation * ( *International Osteoporosis Foundation Committee of Scientific Advisors Working Group on Cancer-Induced Bone Disease: JJ Body, mL Brandi, J Cannata-Andia, D Chappard, PR Ebeling, C Glüer, G El Hajj Fuleihan, A El Maghraoui, G Guglielmi, P Hadji, DL Kendler, N Napoli, A Papaioannou, DD Pierroz, R Rizzoli, TJ de Villiers).

                [2]

                CABS: Cancer and Bone Society.

                [3]

                ECTS: European Calcified Tissue Society.

                [4]

                IEG: International Expert Group for AIBL.

                [5]

                ESCEO: European Society for Clinical and Economics Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.

                [6]

                IMS: International Menopause Society.

                [7]

                SIOG: International Society for Geriattric Oncology.

                Article
                S2212-1374(17)30025-8
                10.1016/j.jbo.2017.03.001
                5384888
                28413771
                6c01c2e6-993d-41dd-bc3b-4c8c2fe80791
                © 2017 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 9 March 2017
                : 10 March 2017
                Categories
                Review Article

                breast cancer,osteoporosis,endocrine treatment,fracture,bisphosphonate,denosumab

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