Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
Prostate Cancer Prostatic Dis. 2023 Mar;26(1):142-150. doi: 10.1038/s41391-022-00569-8. Epub 2022 Jul 8.
Radium-223 is a registered treatment option for symptomatic bone metastatic castration-resistant prostate cancer (mCRPC). Aim of this multicenter, prospective observational cohort study was to evaluate health-related quality of life (HR-QoL), psychological distress and fatigue in mCRPC patients treated with radium-223.
Primary endpoint was cancer-specific and bone metastases-related HR-QoL, as measured by the EORTC QLQ-C30 and BM-22 questionnaires. Secondary endpoints were psychological distress and fatigue, evaluated by the HADS and CIS-Fatigue questionnaires. Outcomes were analyzed for the total cohort and between subgroups (1-3 versus 4-5 versus 6 radium-223 injections). A trajectory analysis was performed to explore HR-QoL patterns over time.
In total, 122 patients were included for analysis. Baseline HR-QoL, pain intensity, psychological distress and fatigue were worse in patients who did not complete radium-223 therapy. In patients who completed therapy, stabilization of HR-QoL was perceived and psychological distress and fatigue remained stable, whereas clinically meaningful and statistically significant deterioration of HR-QoL, psychological distress and fatigue over time was observed in patients who discontinued radium-223 therapy. Trajectory analysis revealed that HR-QoL deterioration over time was more likely in patients with baseline opioid use, low hemoglobin and high alkaline phosphatase levels.
Patients who discontinued radium-223 therapy showed worse HR-QoL, psychological distress and fatigue at baseline and more frequent deterioration of HR-QoL, psychological distress and fatigue over time when compared to patients who completed therapy. Specific attention with regard to HR-QoL during follow-up is indicated in patients with opioid use, low hemoglobin and high alkaline phosphatase levels before radium-223 therapy initiation.
NCT04995614.
镭-223 是一种已注册的治疗选择，用于治疗有症状的骨转移去势抵抗性前列腺癌（mCRPC）。本多中心、前瞻性观察队列研究旨在评估镭-223 治疗的 mCRPC 患者的健康相关生活质量（HR-QoL）、心理困扰和疲劳。
主要终点是通过 EORTC QLQ-C30 和 BM-22 问卷评估的癌症特异性和骨转移相关的 HR-QoL。次要终点是通过 HADS 和 CIS-Fatigue 问卷评估的心理困扰和疲劳。对总队列和亚组（1-3 次 versus 4-5 次 versus 6 次镭-223 注射）进行了分析。进行轨迹分析以探索随时间变化的 HR-QoL 模式。
共有 122 名患者被纳入分析。未完成镭-223 治疗的患者基线 HR-QoL、疼痛强度、心理困扰和疲劳更严重。在完成治疗的患者中，HR-QoL 稳定，心理困扰和疲劳保持稳定，而停止镭-223 治疗的患者则观察到 HR-QoL、心理困扰和疲劳随时间出现具有临床意义和统计学意义的恶化。轨迹分析显示，基线时使用阿片类药物、低血红蛋白和高碱性磷酸酶水平的患者更有可能随时间出现 HR-QoL 恶化。
与完成治疗的患者相比，停止镭-223 治疗的患者在基线时 HR-QoL、心理困扰和疲劳较差，随时间推移 HR-QoL、心理困扰和疲劳恶化的频率更高。在开始镭-223 治疗之前，对于阿片类药物使用、低血红蛋白和高碱性磷酸酶水平的患者，在随访期间应特别注意 HR-QoL。
NCT04995614。
