A New Model for Bone Health Management in Postmenopausal Early Breast Cancer Patients Undergoing Adjuvant Endocrine Therapy-The Predict & Prevent Project.

Objective: The Italian Drug Agency (AIFA) Determination n. 589 of 2015 (Note 79) establishes that the use of bisphosphonates or denosumab is necessary for the primary prevention of bone fractures in postmenopausal patients with early breast cancer (EBC) undergoing adjuvant endocrine therapy (ET). Since adherence to the 2015 AIFA recommendation was still very low in 2019, a new bone health management model was identified to improve adherence to this recommendation. Methods: The aim of this project (Predict & Prevent) was to increase the percentage of patients with early breast cancer (EBC) with hormone receptor-positive (HR+) tumors treated. The project identified a new bone health model of management including the following: training of breast multidisciplinary teams and bone health specialists; presentation and implementation of this model in cancer centers; evaluation, at baseline and 12 months after the implementation of the project, of two key performance indicators (KPIs): rate of HR+ EBC patients assessed for bone health within 30 days from the start of adjuvant ET (KPI-1) and rate of HR+ breast cancer patients receiving bisphosphonates or denosumab within 90 days from the start of adjuvant ET (KPI-2). The primary endpoints of this study were the assessment of the rates of the two key performance indicators (KPIs) 12 months after the start of the project (T3) in comparison with the rates recorded at time 0 (T0) in each participating cancer center and the bone fracture rates at 5 years. In this first analysis, we reported the rates of two KPIs 12 months after the start of the new model (T3) and the comparison with the rates recorded at time 0 (T0) in each participating cancer center, to assess whether these percentages had increased after the implementation of the new organizational model. The rates of bone fractures will be evaluated after five years from implementation of this project in every cancer center. Results: From 2020 to 2022, 10 Italian cancer centers were involved in this project. As of September 2023, 9 cancer centers reported rates relative to two KPIs assessed in each hospital. In 6 hospitals (Negrar, Brescia, Bergamo, Aviano, Turin, Rome), the rates relative to KPI-1 and to KPI-2 increased progressively from time T0 (at baseline) to time T3 (after 12 months from the start of the project), due to training of multidisciplinary teams and implementation of a new bone health management model. In the other three cancer centers (Ancona, Genoa, Naples), where the rate of evaluation of bone health (KPI-1) and the indication for bisphosphonates/denosumab (KPI-2) in HR+ EBC patients were already high at time T0, the rates remained high even after 12 months from the start of this project. Conclusions: After 12 months from the implementation of this new organizational model of bone health management, an increase in the rate of postmenopausal HR+ EBC patients on adjuvant ET assessed for bone health and the rate of patients treated with bisphosphonate/denosumab were reported in six out of nine cancer centers. In the other three cancer centers, where the rates were high at baseline, the rates also remained high after 12 months from the new model implementation. This new model should be adopted in all cancer centers to allow adequate management of bone health in all postmenopausal HR+ EBC patients undergoing adjuvant ET, with the ultimate goal of reducing the rate of bone fractures in these patients in subsequent years.