Outcomes of Research Biopsies in Phase I Clinical Trials: The MD Anderson Cancer Center Experience
Outcomes of Research Biopsies in Phase I Clinical Trials: The MD Anderson Cancer Center Experience
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DOI：
10.1634/theoncologist.2011-0043
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发表时间：
2011-09-01
期刊：
影响因子：
5.8
通讯作者：
Kurzrock, Razelle
中科院分区：
文献类型：
--
作者：
El-Osta, Hazem;Hong, David;Kurzrock, Razelle
背景研究性活检对于探索新药对假定靶点的影响至关重要。目前的研究评估的安全性和成功率与执行这样的活检。我们回顾了2004年9月至2009年10月期间作为I期试验一部分的155例连续患者的医疗记录，这些患者接受了一次或多次研究性活检。在进行的281例研究活检中，118例在治疗前后配对活检（总计= 236例活检）。活检部位以浅表淋巴结最多（19.9%），其次为肝脏（16.4%），最后为软组织（15.7%）。超声引导活检是最常见的类型（53.7%）。在142名同意进行强制性活检的患者中，86.6%的患者进行了活检，而911名患者中有4.4%的患者提供了可选的活检（p <0.0001）。活检最常在行业赞助的试验中获得;非行业试验缺乏资金是未获得活检的最常见原因。在281例单次活检中，仅4例（1.4%）发生并发症：气胸需要放置胸管（n = 2），感染需要住院（n = 1），心律失常伴低血压（n = 1）。除一次活检外，所有活检均成功获得组织。无一例死亡可归因于活检。我们的经验表明，早期临床试验中的研究性活检是安全的（严重并发症风险为1.4%），与选择性活检的患者（4.4%）相比，接受强制性活检的患者比例更高（86.6%）。肿瘤学家2011;16：1292-1298
Background. Research biopsies are crucial for exploring the impact of novel agents on putative targets. The current study assesses the safety and success rate associated with performing such biopsies.Methods. We reviewed the medical records of 155 consecutive patients who had one or more research biopsies as part of a phase I trial from September 2004 to October 2009.Results. Of 281 research biopsies performed, 118 were paired before and after treatment biopsies (total = 236 biopsies). The most common sites of biopsy were superficial lymph node (19.9%), followed by liver (16.4%), and then soft tissue (15.7%). Ultrasound-guided biopsies were the most frequent type (53.7%). Among 142 patients who consented for mandatory biopsy, 86.6% had the biopsy performed, compared with 4.4% of 911 patients offered a biopsy on an optional basis (p < .0001). Biopsy was obtained most frequently on industry-sponsored trials; lack of funding on nonindustry trials was the most common reason that biopsies were not obtained. Of 281 single biopsies, only 4 (1.4%) had complications: pneumothorax requiring chest tube placement (n = 2), infection requiring admission (n = 1), and arrhythmia with hypotension (n = 1). All but one biopsy was successful in obtaining tissue. No deaths were attributable to biopsy.Conclusions. Our experience demonstrates that research biopsies in early phase clinical trials are safe (1.4% risk of serious complications), and a higher percentage of patients underwent mandatory biopsies (86.6%) compared with that of the patients with optional biopsies (4.4%). The Oncologist 2011;16:1292-1298