Radium-223 therapy was registered in 2013 as a new life-prolonging therapeutic option for patients with symptomatic bone metastatic castration-resistant prostate cancer after the phase 3 ALSYMPCA study.
Postregistration reports on the use of radium-223 in real-world populations demonstrate that appropriate selection of patients for radium-223 therapy is challenging. While primarily retrospective and post hoc studies identified prognostic variables associated with overall survival, validated predictive biomarkers are still lacking. Important pretherapeutic prognostic variables include the number of prior therapies, baseline Eastern Cooperative Oncology Group performance status, baseline extent of bone metastatic disease, and baseline alkaline phosphatase, prostate-specific antigen, and lactate dehydrogenase levels. We reviewed the currently available literature to provide recommendations on patient selection for radium-223 therapy in patients with bone metastatic castration-resistant prostate cancer. In addition, the recent evidence from the report of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee regarding the restricted use of radium-223 after interim data analysis of the ERA-223 trial has been incorporated into our recommendations. Future perspectives are also discussed, including radium-223 re-treatment, the use of concomitant therapies, and the implementation of pretherapeutic molecular analysis for treatment stratification.
Clinical genitourinary cancer. 2018 Nov 22 [Epub ahead of print]
Maarten J van der Doelen, Niven Mehra, Rick Hermsen, Marcel J R Janssen, Winald R Gerritsen, Inge M van Oort
Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: ., Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands., Department of Radiology and Nuclear Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands., Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands., Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.