medwireNews: Updated safety data from the EORTC 1333/PEACE-3 trial show a marked reduction in the risk for fractures with the use of bone protecting agents (BPA) in men with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases.
These findings follow on from an earlier analysis reported in 2019 and confirm “the importance of complying to international recommendations and give BPA when treating mCRPC patients with bone metastases to prevent skeletal complications,” said Silke Gillessen (Oncology Institute of Southern Switzerland, Bellinzona) at the 2021 ASCO Annual Meeting.
She explained that following the reports of high fracture rates in the ERA 223 trial of radium-223 plus abiraterone in men with bone-predominant mCRPC, the use of BPA was mandated in the PEACE-3 study, which is evaluating the addition of radium-223 to enzalutamide in a very similar patient population.
Prior to this mandate, nearly half (45.2%) of the 115 enrolled participants had no use of BPA such as denosumab or bisphosphonates, compared with just 2.9% of the 136 who were recruited after the mandate was issued. The corresponding rates of BPA use during treatment were 46.1% and 96.3%.
Among men with no BPA use, the cumulative incidence of fractures at 12 months was 37.1% in the enzalutamide plus radium group and 15.6% in the enzalutamide only group, with 18-month rates of 45.9% and 21.9%, respectively.
The rates were “much lower” with BPA use, reported Gillessen, at 2.7% in the combination group and 2.6% in the enzalutamide only group at 12 months, while the respective rates at 18 months were 4.3% and 2.6%.
This analysis shows that “the risk of fractures is well controlled in both arms when patients receive a bone protecting agent,” she summarized, adding that the trial’s Independent Data Monitoring Committee “will continue to closely monitor the study at regular intervals.”
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