Fosbøl Marie Øbro, Petersen Peter Meidahl, Daugaard Gedske, Holm Søren, Kjaer Andreas, Mortensen Jann
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.
Ann Nucl Med. 2018 Jan;32(1):16-21. doi: 10.1007/s12149-017-1212-1. Epub 2017 Oct 3.
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.
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.
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.
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.
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。
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。
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.
