Feasibility of image-guided transthoracic core-needle biopsy in the BATTLE lung trial

Abstract

Background: As therapy for non-small-cell lung cancer (NSCLC) patients becomes more personalized, additional tissue in the form of core-needle biopsies (CNBs) for biomarker analysis is increasingly required for determining appropriate treatment and for enrollment into clinical trials. We report our experience with small-caliber percutaneous transthoracic (PT) CNBs for the evaluation of multiple molecular biomarkers in BATTLE (biomarker-integrated approaches of targeted therapy for lung cancer elimination), a personalized, targeted therapy NSCLC clinical trial.

Methods: The medical records of patients who underwent PTCNB for consideration of enrollment in BATTLE were reviewed for diagnostic yield of 11 predetermined molecular markers and procedural complications. Univariate and multivariate analyses of factors related to patient and lesion characteristics were performed to determine possible influences on diagnostic yield.

Results: One hundred and seventy PTCNBs were performed using 20-gauge biopsy needles in 151 NSCLC patients screened for the trial. The biopsy specimens of 82.9% of the patients were found to have adequate tumor tissue for analysis of the required biomarkers. On multivariate analysis, metastatic lesions were 5.4 times more likely to yield diagnostic tissue as compared with primary tumors (p = 0.0079). Pneumothorax and chest tube insertion rates were 15.3% and 9.4%, respectively.

Conclusions: Image-guided 20-gauge PTCNB is safe and provides adequate tissue for analysis of multiple biomarkers in the majority of patients being considered for enrollment into a personalized, targeted therapy NSCLC clinical trial. Metastatic lesions are more likely to yield diagnostic tissue as compared with primary tumors.

Trial registration: ClinicalTrials.gov NCT00409968 NCT00410059 NCT00410189 NCT00411632 NCT00411671.

Figure 1

Case of sampling error resulting in insufficient tissue for biomarker analysis. Axial fused PET/CT image demonstrates FDG activity (arrows) within the mediastinal nodes and the inferior, medial border of the left upper lobe lung mass (A). Axial CT image during lung biopsy to acquire tumor tissue for enrollment into BATTLE demonstrates a coaxial technique with the tip of the 19-gauge guide needle located at the periphery of the lesion (arrowhead) and the 20-gauge core biopsy needle located in the lateral edge of the cavitary mass (arrow), an area which does not correspond to the highest area of FDG uptake on the pre-biopsy diagnostic PET/CT (B).