Alkaline phosphatase (ALP) declines and pain responses can occur during radium-223 (223Ra) treatment, but their association with treatment outcomes is unclear.
For patients with metastatic castration-resistant prostate cancer treated with 223Ra in the REASSURE study, we investigated whether ALP decline (Week 12) and/or pain response (during treatment) are associated with improved overall survival (OS). The Brief Pain Inventory-Short Form (BPI-SF) was used to assess pain at baseline and pain response (in patients with baseline BPI-SF score ≥2).
Of 785 patients with baseline and Week 12 ALP measurements, 779 were eligible for the OS analyses. Overall, 80% of patients had an ALP decline. Median OS was longer in patients with than without an ALP decline (18.1 versus 14.2 months; HR 0.74; 95% CI 0.60-0.92). In patients with an ALP decline, there was no clear OS difference between those with versus without a pain response. For patients without ALP decline, median OS was longer in those with versus without a pain response (16.2 versus 10.9 months; HR 0.50; 95% CI 0.32-0.77).
Decreases in ALP and/or pain during 223Ra treatment are associated with improved OS. This may help support clinical decisions.
ClinicalTrials.gov identifier NCT02141438. Analyses from the radium-223 REASSURE global study suggest that declines in alkaline phosphatase and pain during treatment may predict longer survival in patients with advanced prostate cancer and may help doctors make decisions with their patients.
British journal of cancer. 2025 Jan 09 [Epub ahead of print]
Joe M O'Sullivan, Daniel Heinrich, Elena Castro, Saby George, Sabina Dizdarevic, Sergio Baldari, Markus Essler, Igle Jan de Jong, Secondo Lastoria, Peter G Hammerer, Bertrand Tombal, Nicholas D James, Jeff Meltzer, Per Sandström, Oliver Sartor
Patrick G. Johnston Centre for Cancer Research, Queen's University Belfast and Northern Ireland Cancer Centre, Belfast, UK. ., Department of Medical and Radiation Oncology, Innlandet Hospital Trust, Gjøvik, Norway., Hospital Universitario 12 de Octubre, Madrid, Spain., Roswell Park Cancer Institute, Buffalo, NY, USA., University Hospitals Sussex NHS Foundation Trust, Clinical Imaging Science Centre, Brighton & Sussex Medical School, University of Sussex and Brighton, Brighton, UK., Nuclear Medicine Unit, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy., Department of Nuclear Medicine, University Hospital Bonn, Bonn, Germany., Department of Urology, University Medical Center Groningen, Groningen, The Netherlands., IRCCS National Cancer Institute, Fondazione Senatore G. Pascale, Naples, Italy., Department of Urology, Academic Hospital, Braunschweig, Germany., Cliniques Universitaires Saint Luc, Brussels, Belgium., The Institute of Cancer Research, London, UK., Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA., Bayer A/S, Copenhagen, Denmark., Mayo Clinic, Rochester, MN, USA.