Joan Carles1, Mª José Méndez2, Álvaro Pinto3, Mª Isabel Sáez4, José A Arranz5, Pablo Maroto6, Pilar López-Criado7, Begoña Mellado8, Jesús García Donas9, Susana Hernando10, Luís León11, Aránzazu González Del Alba12, Núria Laínez13, Emilio Esteban14, Gaspar Reynés15, José L Pérez-Gracia16, Josep R Germà17, Marta López-Brea18, Begoña Pérez-Valderrama19, Cristina Moretones20, Daniel Castellano21. 1. Department of Medical Oncology, Hospital Universitario Vall d'Hebrón, Vall d'Hebron Institute of Oncology, 08035 Barcelona, Spain. 2. Department of Medical Oncology, Maimonides Institute of Biomedical Research (IMIBIC), Reina Sofía Hospital, University of Córdoba, 14004 Córdoba, Spain. 3. Department of Medical Oncology, Hospital Universitario la Paz, 28046 Madrid, Spain. 4. Department of Medical Oncology, Hospital Universitario Virgen de la Victoria, 29010 Málaga, Spain. 5. Department of Medical Oncology, Hospital General Universitario Gregorio Marañón, 28007 Madrid, Spain. 6. Department of Medical Oncology, Hospital de la Santa Cruz y San Pablo, 08041 Barcelona, Spain. 7. Department of Medical Oncology, MD Anderson Cancer Center, 28033 Madrid, Spain. 8. Department of Medical Oncology, Hospital Clínico y Provincial, 08036 Barcelona, Spain. 9. Department of Medical Oncology, CIOCC, 28050 Madrid, Spain. 10. Department of Medical Oncology, Hospital Universitario Fundación Alcorcón, 28922 Madrid, Spain. 11. Department of Medical Oncology, Complejo Hospitalario Universitario de Santiago, 15706 Santiago de Compostela, Spain. 12. Department of Medical Oncology, Hospital Universitario Son Espases, 07120 Palma de Mallorca, Spain. 13. Department of Medical Oncology, Complejo Hospitalario de Navarra, 31008 Pamplona, Spain. 14. Department of Medical Oncology, Hospital Universitario Central de Asturias, 33011 Oviedo, Spain. 15. Department of Medical Oncology, Hospital Universitario y Politécnico la Fe, 46026 Valencia, Spain. 16. Department of Medical Oncology, Clínica Universidad de Navarra, 31008 Pamplona, Spain. 17. Department of Medical Oncology, Instituto Catalán de Oncología, 08908 Hospitalet de Llobregat, Spain. 18. Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, 39008 Santander, Spain. 19. Department of Medical Oncology, Hospital Universitario Virgen del Rocío, 41013 Sevilla, Spain. 20. Bayer Hispania SL, 08970 Barcelona, Spain. 21. Department of Medical Oncology, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain.
Abstract
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.
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.
Entities:
Keywords:
bone metastasis; castration-resistant prostate cancer; radium-223; safety; survival