223Ra-chloride therapy in men with hormone-refractory prostate cancer and skeletal metastases: Real-world experience

• Published in: Tumori 2018-03, Vol.104 (2), p.128-136
• Main Authors: Boni, Giuseppe, Mazzarri, Sara, Cianci, Claudia, Galli, Luca, Farnesi, Azzurra, Borsatti, Eugenio, Bortolus, Roberto, Fratino, Lucia, Gobitti, Carlo, Lamaj, Elda, Ghedini, Pietro, Rizzini, Elisa Lodi, Massari, Francesco, Dionisi, Valeria, Fanti, Stefano, Volterrani, Duccio, Monari, Fabio
• Format: Article
• Language: English
• ISSN: 0300-8916; 2038-2529
• DOI: 10.1177/0300891618765571

Background: Radium-223 (223Ra) chloride, an alpha emitter, has been shown to improve overall survival (OS) and pain control, and to delay skeletal-related events, in patients with castration-resistant prostate cancer (CRPC) and bone metastases. Our retrospective observational study presents the first Italian experience on the efficacy and safety of 223Ra therapy in routine clinical practice. Methods: A total of 83 patients with metastatic CRPC were treated with 223Ra at 3 Italian centers between August 2013 and August 2016. 223Ra-chloride (55 kBq/kg) was administered every 4 weeks for a total of 6 cycles. Primary endpoints were OS and progression-free survival (PFS). Secondary endpoints included toxicity, pain evaluation using numeric rating scale (NRS), symptomatic skeletal-related events and biomarkers response. Results: Patients had a median age of 75 (range 53–89) years. The majority of men showed a Gleason score of 7, 8, or 9. Forty-one patients completed 6 treatment cycles; 33 stopped treatment before completing 6 cycles. Nine were still receiving therapy at the time of data collection. At the end of therapy, NRS pain scores significantly improved (p < .000001). OS was a mean of 10.1 months, while median OS had not been attained. According to Kaplan-Meier estimation, OS and PFS were 17.5 and 7.7 months, respectively. There was a significant correlation between OS and PFS with the number of 223Ra cycles; patients receiving all 6 cycles experienced the major benefit from the therapy. 223Ra was well-tolerated. Conclusions: 223Ra alpha therapy is an important therapeutic option for men with CRPC and symptomatic skeletal metastases.