Authors: Guilhem Roubaud, Marie Kostine, Raymond S. McDermott, Alice Bernard-Tessier, Xavier Maldonado, Marlon Silva, Aude Flechon, Dominik R. Berthold, Philippe Ronchin, Bertrand F. Tombal, Loic Mourey, Gwenaelle Gravis, Anne Escande, Sophie Abadie Lacourtoisie, Antoine Thiery-Vuillemin, Miguel Angel A. Climent Duran, Hélène Ribault, Alberto Bossi, Stéphanie Foulon, Karim Fizazi
Published: 2022-02-16
DOI: 10.1200/jco.2022.40.6_suppl.019
Source: Full article
19 Background: Addition of abiraterone plus prednisone (AAP) to androgen deprivation therapy (ADT) with or without docetaxel (D) improved overall survival in men with de novo metastatic castration sensitive prostate cancer in PEACE-1 trial. An analysis of bone mineral density (BMD) was planned by an amendment in the last randomized patients to assess whether addition of AAP increases bone loss. Methods: Patients (pts) were randomized to receive either ADT + D + AAP or ADT + D (and also randomized for radiotherapy given to the prostate). BMD (g/cm2) of the lumbar spine (L), femoral neck (F) and total hip (H) were measured by dual x-ray absorptiometry at baseline, M6, M12 and M24 in both arms. Mean percent change in BMD values from baseline to the different time points were calculated. T-Scores were also assessed. Results: Among the 210 pts with BMD data, 182 (87%) had available data at baseline, 109 (52%) at M6, 94 (45%) at M12, and 109 (52%) at M24: 97 pts were treated with AAP and 98 without. In both arms, the median age was 65 years and 69 pts (71%) were ECOG PS 0. Median body mass index (BMI) was 25.6 and 26.5 kg/m2 in pts treated with or without AAP, respectively. BMD, T score and mean percent change in BMD values are summarized in the Table. Conclusions: This is the first prospective assessment of BMD in a randomized trial, according to an experimental treatment with AAP. Despite a bone loss increase in both arms over time, addition of AAP to ADT+D was associated with no or modest difference in bone loss during the first 2 years, compared to ADT+D. Data including fractures will be presented. Main limitations include the difficulty to reliably assess BMD in men with bone metastases, the limited sample size and the short follow-up (i.e. 2 years). Clinical trial information: NCT01957436. [Table: see text]