Radium-223 international early access program: results from the Spanish subset
Carles J (1), Méndez MJ (2), Pinto Á (3), Sáez MI (4), Arranz JA (5), Maroto P (6), López-Criado P (7), Mellado B (8), Donas JG (9), Hernando S (10), León L (11), Del Alba AG (12), Laínez N (13), Esteban E (14), Reynés G (15), Pérez-Gracia JL (16), Germà JR (17), López-Brea M (18), Pérez-Valderrama B (19), Moretones C (20), Castellano D (21).
To report results from the Spanish subset included in the radium-223 international early access program (iEAP).
PATIENTS & METHODS:
Ninety patients with castration-resistant prostate cancer and bone metastases received radium-223 55 kBq/kg every 4 weeks for six cycles.
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%).
Outcomes of the Spanish subset are consistent with the iEAP. Radium-223 was generally well tolerated with no safety concerns.