Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice
Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice
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DOI：
10.1007/s00259-019-4261-y
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发表时间：
2019-05-01
影响因子：
9.1
通讯作者：
Du, Yong
中科院分区：
文献类型：
--
作者：
Dizdarevic, Sabina;Petersen, Peter Meidahl;Du, Yong
目的Rasure是一项全球性、前瞻性、非干预性研究，旨在评估Re-223在骨转移去势抵抗前列腺癌患者中的长期安全性。在此，我们报告了一项根据既往化疗的患者的中期分析。方法在常规的临床实践中应用-223。在第一批600名患者入选后，计划进行中期安全性分析。对既往化疗(多西紫杉醇和/或卡巴紫杉醇)的患者特征和安全性数据进行调查。中位观察时间为7个月(范围0-20个月)。排除了19例同期接受化疗的患者，其中564例(97%)符合既往化疗使用情况的探索性分析；190例(34%)以前接受过并完成化疗，374例(66%)没有接受过化疗。在接受过化疗的患者中，有较高比例的患者具有东部合作肿瘤组的功能状态>；=2(22%对11%)和>；20个转移灶(26%对15%)，中位碱性磷酸酶(162.0对115.0 U/L)和前列腺特异性抗原(132.0对40.2 ng/ml)水平较高，完成6次-223注射的比例较低(45%对63%)。与药物相关的治疗-紧急不良事件(TEAE)的发生率分别为63%和48%，与血液系统药物相关的TEAE的发生率分别为21%和9%，这些患者以前是否接受过化疗。有4例药物相关死亡的报告，均在既往化疗组中。结论在常规临床实践中，Re-223的短期安全性与其他临床研究相当，与先前的化疗用法无关。血液学TEAE在先前的化疗组中发生得更频繁，可能是由于更晚期的疾病和先前暴露于细胞毒治疗的结果导致骨髓功能下降。在基线水平上，以前没有接受过化疗的患者似乎有较低的疾病负担，停止使用Re-223治疗的比例也较低。
Purpose REASSURE is a global, prospective, non-interventional study to assess long-term safety of radium-223 in patients with bone metastatic castration-resistant prostate cancer. Here we report an interim analysis of patients according to previous use of chemotherapy.Methods Radium-223 was administered in routine clinical practice. Interim safety analysis was planned after enrolment of the first 600 patients. Patient characteristics and safety data by previous administration of chemotherapy (docetaxel and/or cabazitaxel) were investigated.Results This interim analysis included 583 patients. Median duration of observation was 7 months (range, 0-20). Nineteen patients treated with concomitant chemotherapy were excluded, 564 (97%) were eligible for exploratory analysis according to prior use of chemotherapy; 190 (34%) had previously received and completed chemotherapy, and 374 (66%) had not. In the prior versus no prior chemotherapy group, a higher proportion of patients had an Eastern Cooperative Oncology Group performance status of >= 2 (22% vs 11%) and >20 metastatic lesions (26% vs 15%), median alkaline phosphatase (162.0 vs 115.0 U/L) and prostate-specific antigen (132.0 vs 40.2 ng/mL) levels were higher, and a lower proportion completed 6 radium-223 injections (45% vs 63%). Drug-related treatment-emergent adverse events (TEAEs) occurred in 63 and 48%, and haematological drug-related TEAEs in 21 and 9% of patients who had or had not previously received chemotherapy. Four drug-related deaths were reported, all in the prior chemotherapy group.Conclusions The short-term safety profile of radium-223 in routine clinical practice was comparable to other clinical studies, irrespective of prior chemotherapy use. Haematological TEAEs occurred more frequently in the prior chemotherapy group, presumably due to decreased bone marrow function as a consequence of more advanced disease and prior exposure to cytotoxic therapy. Patients who had not previously received chemotherapy appeared to have a lower burden of disease at baseline, and a lower proportion discontinued radium-223 treatment.