Bin-Chi Liao1, Ya-Ying Bai2, Jih-Hsiang Lee3, Chia-Chi Lin4, Shu-Yung Lin5, Yee-Fan Lee6, Chao-Chi Ho7, Jin-Yuan Shih7, Yeun-Chung Chang8, Chong-Jen Yu7, James Chih-Hsin Yang9, Pan-Chyr Yang7. 1. 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. 2. Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan. 3. Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan. 4. Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; Department of Urology, College of Medicine, National Taiwan University, Taipei, Taiwan. 5. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital Jinshan Branch, New Taipei City, Taiwan. 6. Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan. 7. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. 8. Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: ycc5566@ntu.edu.tw. 9. Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Oncology, College of Medicine, National Taiwan University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
Abstract
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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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). METHODS: We searched the medical records of NSCLCpatients 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. RESULTS: 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. CONCLUSION: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.