Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; National Taiwan University Cancer Center, College of Medicine, National Taiwan University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
J Formos Med Assoc. 2018 Apr;117(4):326-331. doi: 10.1016/j.jfma.2017.04.018. Epub 2017 May 9.
BACKGROUND/PURPOSE: Research biopsies (RBs) are crucial for developing novel molecular targeted agents. However, the safety and diagnostic yields of RBs have not been investigated in EGFR mutation-positive non-small cell lung cancer (NSCLC) patients pretreated with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs).
We searched the medical records of NSCLC patients who participated in lung cancer clinical trials and underwent mandatory RBs between 2012 and 2014 at our institution. Only patients with EGFR mutation-positive NSCLC pretreated with at least 1 EGFR-TKI were enrolled.
Of 140 enrolled patients, 73 (52.1%) and 59 (42.1%) had exon 19 deletions and exon 21 L858R mutation, respectively. Before RBs, 108 (77.1%), 83 (59.3%), and 36 (25.7%) patients had been treated with gefitinib, erlotinib, and afatinib, respectively. Computed tomography-guided percutaneous core needle biopsy was the most frequently used modality among 181 RBs performed (50.8%), followed by ultrasonography-guided (32.0%) and endoscopic RBs (16.0%). The most common RB sites were the lung (69.6%), pleura (8.8%), and liver (6.1%). Pathologic examinations revealed malignant cells in most RB specimens (72.9%). Complications due to RBs included pneumothorax (11.6%), bleeding (6.1%), and infection (1.1%). Only 1 patient required chest tube placement for pneumothorax, and 2 patients underwent endotracheal intubation because of bleeding.
RBs in this patient population were generally safe. Pneumothorax was the most frequent complication; bleeding, while infrequent, increased the risk of severe events. The diagnostic yields and complications of any particular modality should therefore be discussed with prospective clinical trial participants.
背景/目的：研究性活检（RB）对于开发新型分子靶向药物至关重要。然而，在接受表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗的 EGFR 突变阳性非小细胞肺癌（NSCLC）患者中，RB 的安全性和诊断效果尚未得到研究。
我们检索了 2012 年至 2014 年在我们机构参与肺癌临床试验并接受强制性 RB 的 NSCLC 患者的病历。仅纳入接受至少 1 种 EGFR-TKI 治疗的 EGFR 突变阳性 NSCLC 患者。
在纳入的 140 名患者中，分别有 73 名（52.1%）和 59 名（42.1%）患者存在外显子 19 缺失和外显子 21 L858R 突变。在进行 RB 之前，分别有 108 名（77.1%）、83 名（59.3%）和 36 名（25.7%）患者接受了吉非替尼、厄洛替尼和阿法替尼治疗。在进行的 181 次 RB 中，最常使用的方法是计算机断层扫描引导下经皮穿刺芯活检（50.8%），其次是超声引导（32.0%）和内镜 RB（16.0%）。最常见的 RB 部位是肺（69.6%）、胸膜（8.8%）和肝脏（6.1%）。大多数 RB 标本的病理检查均显示恶性细胞（72.9%）。RB 相关并发症包括气胸（11.6%）、出血（6.1%）和感染（1.1%）。仅有 1 名患者因气胸需要放置胸腔引流管，2 名患者因出血需要气管插管。
在该患者人群中，RB 通常是安全的。气胸是最常见的并发症；虽然出血不常见，但增加了严重事件的风险。因此，应与前瞻性临床试验参与者讨论任何特定方式的诊断效果和并发症。
