Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham, Vincent Drive, Edgbaston, Birmingham B15 2TT, United Kingdom.
Department of Oncology, University College London Hospitals NHS Foundation Trust, 250 Euston Road, London NW1 2PG, United Kingdom.
Eur J Cancer. 2014 Mar;50(4):801-15. doi: 10.1016/j.ejca.2013.11.016. Epub 2013 Dec 12.
The optimal use and effectiveness of (131)I-meta iodobenzylguanidine ((131)I-mIBG) molecular radiotherapy for neuroblastoma remain unclear despite extensive clinical experience. This systematic review aimed to improve understanding of the current data and define uncertainties for future clinical trials. Bibliographic databases were searched for neuroblastoma and (131)I-mIBG. Clinical trials and non-comparative case series of (131)I-mIBG therapy for neuroblastoma were included. Two reviewers assessed papers for inclusion using the title and abstract with consensus achieved by discussion. Data were extracted by one reviewer and checked by a second. Studies with multiple publications were reported as a single study. The searches yielded 1216 citations, of which 51 publications reporting 30 studies met our inclusion criteria. No randomised controlled trials (RCTs) were identified. In two studies (131)I-mIBG had been used as induction therapy and in one study it had been used as consolidation therapy. Twenty-seven studies for relapsed and refractory disease were identified. Publication dates ranged from 1987 to 2012. Total number of patients was 1121 with study sizes ranging from 10 to 164. There was a large amount of heterogeneity between the studies with regard to patient population, treatment schedule and response assessment. Study quality was highly variable. The objective tumour response rate reported in 25 studies ranged from 0% to 75%, mean 32%. We conclude that (131)I-mIBG is an active treatment for neuroblastoma, but its place in the management of neuroblastoma remains unclear. Prospective randomised trials are essential to strengthen the evidence base.
尽管已有广泛的临床经验，但（131）I-间碘苄胍（（131）I-mIBG）分子放射疗法在神经母细胞瘤中的最佳应用和疗效仍不明确。本系统评价旨在增进对现有数据的了解，并为未来的临床试验确定不确定性。检索了神经母细胞瘤和（131）I-mIBG 的文献数据库。纳入了（131）I-mIBG 治疗神经母细胞瘤的临床试验和非对照病例系列研究。两位审稿人使用标题和摘要进行评估，如有分歧则通过讨论达成共识。一位审稿人提取数据，另一位审稿人核对。有多个出版物的研究报告为单个研究。检索共得到 1216 条引文，其中 51 篇文献报道的 30 项研究符合纳入标准。未发现随机对照试验（RCT）。两项研究将（131）I-mIBG 用于诱导治疗，一项研究将其用于巩固治疗。确定了 27 项用于复发和难治性疾病的研究。出版物日期范围为 1987 年至 2012 年。总患者人数为 1121 人，研究规模从 10 例到 164 例不等。由于患者人群、治疗方案和反应评估方面的差异，研究之间存在很大的异质性。研究质量差异很大。25 项研究报告的客观肿瘤缓解率从 0%到 75%不等，平均值为 32%。我们的结论是，（131）I-mIBG 是神经母细胞瘤的一种有效治疗方法，但在神经母细胞瘤的治疗管理中的地位仍不明确。前瞻性随机试验对于加强证据基础至关重要。
