Performing nondiagnostic research biopsies in irradiated tissue: A review of scientific, clinical, and ethical considerations
Performing nondiagnostic research biopsies in irradiated tissue: A review of scientific, clinical, and ethical considerations
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DOI：
10.1200/jco.2008.16.9896
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发表时间：
2008-08-20
影响因子：
45.3
通讯作者：
Citrin, Deborah
中科院分区：
文献类型：
--
作者：
Brown, Aaron P.;Wendler, David S.;Citrin, Deborah
目的近年来，针对肿瘤特异性通路的药物的开发增加了研究药物对肿瘤组织作用的科学兴趣。因此，活检已成为许多早期临床试验的重要组成部分。进行非诊断性肿瘤活检引起了技术和伦理方面的担忧，主要与使用对患者没有潜在益处的潜在有害程序有关。这个问题是复杂的不确定性，是否在照射领域进行活检增加了显着的风险。本文回顾了临床，科学和伦理方面的考虑，在主管成人进行非诊断性肿瘤活检的研究目的，重点是活检中进行的治疗irradiation.MethodsClinical试验，活检期间或4个月内完成放疗被确定与文献综述。29项研究中有16项报告了不良事件（AE），但没有报告活检并发症的积极评价。10项研究在研究报告中未提及AE。至少有三项研究积极评价了患者的活检并发症。考虑到这一点，17（> 1%）的2,160例患者报告有活检并发症，虽然报告的AE是次优在大多数study.ConclusionLimited的数据表明，活检可以在辐照组织进行没有临床显着的过度风险。正在进行的和未来的试验（包括非诊断性研究活检）应记录和报告与该程序相关的AE，以提供有关安全性和毒性的额外数据。
PurposeRecent development of drugs that target specific pathways in tumors has increased scientific interest in studying drug effects on tumor tissue. As a result, biopsies have become an important part of many early-phase clinical trials. Performing nondiagnostic tumor biopsies raises technical and ethical concerns mostly related to the use of a potentially harmful procedure with no potential benefit to the patient. This issue is complicated by uncertainty about whether performing biopsies in irradiated fields adds significant risk. This article reviews the clinical, scientific, and ethical considerations involved in performing nondiagnostic tumor biopsies in competent adults for research purposes, with a focus on biopsies performed in the setting of therapeutic irradiation.MethodsClinical trials that performed biopsies during or within 4 months of the completion of radiotherapy were identified with a literature review.Results Twenty-nine studies with 2,160 patients were identified. Sixteen of 29 studies reported adverse events (AEs) but did not report active evaluation for biopsy complications. Ten studies did not mention AEs within the study report. At least three studies actively evaluated patients for biopsy complications. Taking this into consideration, 17 (> 1%) of 2,160 patients were reported to have biopsy complications, although reporting of AEs was suboptimal in most studies.ConclusionLimited data suggest that biopsies can be performed in irradiated tissues without clinically significant excess risk. Ongoing and future trials including nondiagnostic research biopsies should record and report AEs related to this procedure to provide additional data on safety and toxicity.