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Radium-223 international early access program: results from the Spanish subset
Joan Carles1, Mª José Méndez2, Álvaro Pinto3
1Department of Medical Oncology, Hospital Universitario Vall d'Hebrón, Vall d'Hebron Institute of Oncology, 08035 Barcelona, Spain.
Aim:
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.
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%).
Conclusion:
Outcomes of the Spanish subset are consistent with the iEAP. Radium-223 was generally well tolerated with no safety concerns.
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