Results From a Large, Multicenter, Retrospective Analysis On Radium223 Use in Metastatic Castration-resistant Prostate Cancer (mCRPC) in the Triveneto Italian Region

Background: Radium 223 was introduced for metastatic castration-resistant prostate cancer based on the results of a randomized controlled trial showing risk reduction for death and skeletal events. Our aim was to evaluate the outcome of patients receiving radium 223 in a real-world setting. Patients and Methods: We conducted a multicenter retrospective analysis in the Triveneto region of Italy. Results: One hundred fifty-eight patients received radium 223 in our region. After a median follow-up of 9.5 months, 75 patients died. The median overall survival (OS) was 14.2 months, and the median progression-free survival (PFS) was 6.2 months. Seventy-one (45%) patients achieved progression as best response. Thirty-seven (23%) patients stopped the treatment early because of progression. Eastern Cooperative Oncology Group performance status was prognostic for OS (18.4 vs. 12.3 vs. 7.5 months; 0 vs. 1, P =.0062; 0 vs. 2, P =.0002), whereas previous prostatectomy or docetaxel exposure were not. A neutrophil to lymphocytes ratio ≥ 3 significantly impacted OS (18.1 vs. 9.7 months; P <.001) and slightly impacted PFS (6.6 vs. 5.6 months; P =.05). Patients with a baseline alkaline phosphatase (ALP) value ≥ 220 U/L had worse OS and PFS (24.1 vs. 10.5 months; 7.2 vs. 5.5 months; P <.001). Patients with changes in ALP value achieved better OS (P =.029) and PFS (P =.002). There was no difference according to the line of therapy (0 vs. ≥ 1; P =.490). The main grade 3/4 toxicities were anemia, asthenia, and thrombocytopenia. Conclusion: This large real-world report confirms comparable OS and PFS data when compared with the pivotal study, as well as the predictive role of ALP and neutrophil to lymphocytes ratio. The definition of the optimal position of radium 223 in the treatment of metastatic castration-resistant prostate cancer has still to be defined. One hundred fifty-eight patients have been treated in the Triveneto region with radium 223 since its introduction. The median overall survival and progression-free survival was 14.2 and 6.2 months, respectively. Eastern Cooperative Oncology Group performance status, increased alkaline phosphatase, and alkaline phosphatase changes were prognostic for survival. Comparable outcome with a pivotal study and similar reports were confirmed. The high progression rate at first assessment (62%) shows that only some patients obtained a clear benefit.