Feasibility and safety of sequential research-related tumor core biopsies in clinical trials
Feasibility and safety of sequential research-related tumor core biopsies in clinical trials
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DOI：
10.1002/cncr.27916
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发表时间：
2013-04-01
期刊：
影响因子：
6.2
通讯作者：
Kohn, Elise C.
中科院分区：
文献类型：
--
作者：
Lee, Jung-min;Hays, John L.;Kohn, Elise C.
背景：在靶向治疗研究中，人们对系列研究活检的兴趣越来越大。在抗血管生成和靶向药物时代，需要定义患者特征和安全研究肿瘤活检的最佳靶组织。方法：这项机构审查委员会批准的回顾性研究包括来自国家癌症研究所6项1/2期研究的图表和介入放射学病例审查。结果：150例方案患者中有142例同意进行研究性活检。患者的中位年龄为56岁（范围：27-78岁），中位体重指数为25.8 kg/m2（范围：14.4-46.2 kg/m2），东部肿瘤协作组体能状态评分为0或1，终末器官功能正常。从142例患者中的138例（97%）中采集了基线活检标本，从96例（70%）中采集了配对标本。大多数患者患有转移性妇科癌症（85%），78%的目标疾病位于膈下，中位尺寸为2.7 cm（范围，1-14.5 cm）。方案治疗包括激酶抑制剂（35%）、血管生成抑制剂（54%）和奥拉帕尼/卡铂（11%）;活检未中断治疗。所有不良事件均无并发症，在4例患者中观察到（1例患者为肝包膜下血肿，2例患者为血管迷走性晕厥，1例患者为气胸）。肥胖患者的并发症发生率与非肥胖患者相似（分别为3/108例患者vs 1/34例患者）。67例患者（48%）在随后的活检时接受贝伐单抗治疗。接受和未接受贝伐珠单抗治疗的患者之间的并发症发生率没有差异（分别为67例患者中的3例vs 71例患者中的1例）。95%的活组织检查产生了可用的材料。结论：可以安全地获得连续经皮芯针活检，并产生适用于多种平移应用的材料。肥胖和/或伴随的抗血管生成治疗和疾病的深度不会增加风险或妨碍有用组织的成功采集。癌症2013年。(c)2012年美国癌症协会
BACKGROUND: There has been increasing interest in serial research biopsies in studies of targeted therapies. Definition of patient characteristics and optimal target tissue for safe research tumor biopsy in the era of antiangiogenic and targeted agents is needed. METHODS: This institutional review board-approved, retrospective study included chart and interventional radiology case review from 6 phase 1/2 studies at the National Cancer Institute. RESULTS: One hundred forty-two of 150 protocol patients who were approached gave consent for research biopsies. Patients' median age was 56 years (range, 27-78 years), their median body mass index was 25.8 kg/m2 (range, 14.4-46.2 kg/m2), they had an Eastern Cooperative Oncology Group performance status of 0 or 1, and they had normal end-organ function. Baseline biopsies were collected from 138 of 142 patients (97%), and paired specimens were collected from 96 (70%). Most patients had metastatic gynecologic cancers (85%), and 78% had target disease below the diaphragm with a median size of 2.7 cm (range, 1-14.5 cm). Protocol therapies included kinase inhibitors (35%), angiogenesis inhibitors (54%), and olaparib/carboplatin (11%); therapy was not interrupted for biopsies. All adverse events were uncomplicated and were observed in 4 patients (liver subcapsular hematoma in 1 patient, vasovagal syncope in 2 patients, and pneumothorax in 1 patient). The complication rate in obese patients was similar to that in nonobese patients (3 of 108 patients vs 1 of 34 patients, respectively). Sixty-seven patients (48%) were receiving bevacizumab at the time of subsequent biopsies. The complication rate was not different between patients who were and were not receiving bevacizumab (3 of 67 patients vs 1 of 71 patients, respectively). Ninety-five percent of biopsies yielded useable material. CONCLUSIONS: Serial percutaneous core-needle biopsies can be obtained safely and yield material applicable for multiple translational applications. Obesity and/or concomitant antiangiogenic therapy and depth of disease did not increase the risk or preclude the successful acquisition of useful tissue. Cancer 2013. (c) 2012 American Cancer Society.