Radium-223 international early access program: results from the Spanish subset.

Authors :: Carles J
Méndez MJ
Pinto Á
Sáez MI
Arranz JA
Maroto P
López-Criado P
Mellado B
Donas JG
Hernando S
León L
Del Alba AG
Laínez N
Esteban E
Reynés G
Pérez-Gracia JL
Germà JR
López-Brea M
Pérez-Valderrama B
Moretones C
Castellano D
Source :: Future oncology (London, England) [Future Oncol] 2018 Jan; Vol. 14 (1), pp. 41-50. Date of Electronic Publication: 2017 Dec 13.
Publication Year :: 2018
Abstract: Aim: To report results from the Spanish subset included in the radium-223 international early access program (iEAP).<br />Patients & Methods: Ninety patients with castration-resistant prostate cancer and bone metastases received radium-223 55 kBq/kg every 4 weeks for six cycles.<br />Results: The median time to disease progression was 8 months and to prostate-specific antigen progression was 4 months. The percentage of patients with ≥50% confirmed declines in prostate-specific antigen was 9%. The median overall survival was 14 months. Grade 3 or 4 treatment emergent adverse events (TEAEs) occurred in 34% of patients (serious TEAEs 28%, TEAEs leading to discontinuation 27%).<br />Conclusion: Outcomes of the Spanish subset are consistent with the iEAP. Radium-223 was generally well tolerated with no safety concerns.