Department of Medical Oncology, Hospital Universitario Vall d'Hebrón, Vall d'Hebron Institute of Oncology, 08035 Barcelona, Spain.
Department of Medical Oncology, Maimonides Institute of Biomedical Research (IMIBIC), Reina Sofía Hospital, University of Córdoba, 14004 Córdoba, Spain.
Future Oncol. 2018 Jan;14(1):41-50. doi: 10.2217/fon-2017-0297. Epub 2017 Dec 13.
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.
报告镭-223 国际早期准入计划（iEAP）中西班牙亚组的结果。
90 例去势抵抗性前列腺癌和骨转移患者每 4 周接受镭-223 55kBq/kg，共 6 个周期。
疾病进展的中位时间为 8 个月，前列腺特异性抗原进展的中位时间为 4 个月。前列腺特异性抗原确认下降≥50%的患者比例为 9%。中位总生存期为 14 个月。34%的患者出现 3 级或 4 级治疗突发不良事件（TEAEs）（严重 TEAEs 28%，导致停药的 TEAEs 27%）。
西班牙亚组的结果与 iEAP 一致。镭-223 总体耐受性良好，无安全性问题。
