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镭-223治疗转移性去势抵抗性前列腺癌患者时治疗延迟的影响。

Impact of treatment delay in Radium-223 therapy of metastatic castration-resistant prostate cancer patients.

作者信息

Fosbøl Marie Øbro, Petersen Peter Meidahl, Daugaard Gedske, Holm Søren, Kjaer Andreas, Mortensen Jann

机构信息

Department of Clinical Physiology, Nuclear Medicine & PET and Cluster for Molecular Imaging, Rigshospitalet and University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.

Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

出版信息

Ann Nucl Med. 2018 Jan;32(1):16-21. doi: 10.1007/s12149-017-1212-1. Epub 2017 Oct 3.

Abstract

BACKGROUND

Radium-223-dichloride (Ra-223) is an alpha-emitting, bone seeking radionuclide therapy approved for patients with metastatic castration-resistant prostate cancer (mCRPC). In the fall of 2014, a global temporary shortage of Ra-223 occurred for 2 months due to production irregularities. The aim of this study was to assess whether prolonged interval between Ra-223 cycles to non-disease related causes had a negative impact on clinical outcome of therapy.

MATERIALS AND METHODS

Retrospective single-center study of mCRPC patients who initiated Ra-223 therapy in the period from March 2014 to February 2015. End points were number of completed Ra-223 cycles, overall survival (OS) and radiographic progression-free survival (rPFS). Bone scintigraphy, CT of thorax and abdomen, hematological status, PSA and alkaline phosphatase were evaluated prior to first dose and after 3rd and 6th treatment, respectively. Follow-up period was 18 months after first Ra-223 cycle.

RESULTS

A total of 50 consecutive patients initiated Ra-223 therapy in the time period. Seventeen of 50 patients (34%) had prolonged interval between cycles due to delivery problems. Median delay was 4 weeks (range 3-9 weeks). Patients with delayed treatment had significantly longer median rPFS [delayed patients: 7.1 months (95% CI 4.9-9.3) vs. 4.5 months (95% CI 2.8-6.3)]. There was no significant difference in number of completed cycles or median OS.

CONCLUSION

We find no negative impact of prolonged interval between Ra-223 cycles due to non-disease related reasons on OS, rPFS or number of completed treatment cycles.

摘要

背景

二氯化镭-223(Ra-223)是一种发射α粒子、亲骨性放射性核素疗法,已被批准用于转移性去势抵抗性前列腺癌(mCRPC)患者。2014年秋季,由于生产异常,全球出现了为期2个月的Ra-223临时短缺。本研究的目的是评估因非疾病相关原因导致的Ra-223治疗周期延长是否会对治疗的临床结果产生负面影响。

材料与方法

对2014年3月至2015年2月期间开始接受Ra-223治疗的mCRPC患者进行回顾性单中心研究。终点指标为完成的Ra-223治疗周期数、总生存期(OS)和影像学无进展生存期(rPFS)。分别在首次给药前以及第3次和第6次治疗后评估骨闪烁显像、胸部和腹部CT、血液学状态、前列腺特异性抗原(PSA)和碱性磷酸酶。随访期为首次Ra-223治疗周期后的18个月。

结果

在此期间共有50例连续患者开始接受Ra-223治疗。50例患者中有17例(34%)因给药问题导致治疗周期延长。中位延迟时间为4周(范围3-9周)。治疗延迟的患者中位rPFS显著更长[延迟治疗患者:7.1个月(95%CI 4.9-9.

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