272P - Primary prevention of bone fractures in patients (pts) with hormone receptor (HR)+ early breast cancer (EBC) during adjuvant hormonal therapy (HT): The predict & prevent project (P&P)

Background

High rate of clinical fractures was reported during adjuvant HT trials (9-14% in BIG 1-98, ATAC, IES). Since 2015, in Italy, bisphosphonates and denosumab are reimbursed for prevention of bone fractures in EBC HR+ postmenopausal pts receiving HT, regardless of T-score values (Note 79 of AIFA-Agenzia Italiana del Farmaco). In 2019, these drugs were administered only in 25% of potentially beneficiary pts. The P&P is a nationwide Bone Health (BH) management project designed to improve adherence to recommendations regarding fracture risk assessment and risk prevention measures in pts receiving HT for HR+ EBC.

Methods

The BH management model P&P was developed in 10 Italian cancer centres and includes: 1- training of multidisciplinary team and presentation of a BH management model by the oncologist (with referral to the Bone Specialist if osteoporosis); 2- implementation of this model in every centre; 3- evaluation, after 12 months, of rate of EBC HR+ pts in postmenopausal status (natural, surgical, secondary to chemotherapy or hormonal blockage) assessed for BH within 30 days from the start of adjuvant HT; 4- evaluation, after 12 months, of rate of EBC HR+ pts receiving therapy within 90 days from the start of adjuvant HT, according to the criteria for reimbursement by AIFA.

Results

At 12 months after implementation of P&P, data are available from 6 centres (IRCCS Negrar, Ancona Hospital, IRCCS San Martino Genova, Poliambulanza Brescia, Cardarelli Napoli, Papa Giovanni XXIII Bergamo) in 1,551 postmenopausal EBC HR+ pts. The first analysis reports that 83% of EBC HR+ patients who started adjuvant HT were assessed for BH within 30 days compared to 43% in the 2019 national survey and 68% of pts started bisphosphonates/denosumab compared to 25% in the 2019 national survey.

Conclusions

Implementation of the P&P model has been shown to increase the rate of postmenopausal EBC HR+ pts on adjuvant HT assessed for BH and treated with bisphosphonate/denosumab to reduce the risk of bone fractures. A new project is ongoing to assess the rate of fractures in Italian pts after the approval of Note 79 by AIFA.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

S. Gori.

Funding

Amgen.

Disclosure

C. Bighin: Financial Interests, Personal, Research Grant: Novartis, Roche, Lilly, Eisai, Gilead, Italfarmaco. F. Puglisi: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Daiichi Sankyo, Celgene, Eisai, Eli Lilly, Exact Sciences, Gilead, Ipsen, Menarini, MSD, Novartis, Pierre Fabre, Roche, Pfizer, Seagen, Takeda, Viatris; Financial Interests, Personal, Research Grant: AstraZeneca, Eisai, Roche. A. Fabi: Financial Interests, Personal, Advisory Board: Roche, Pfizer, Novartis, Lilly, Seagen, Gilead, Exact Science, Dompè Biotech. All other authors have declared no conflicts of interest.