Rationale and objectives

The purpose of this study was to quantify the degree of imaging-histologic discordance in a cohort of patients undergoing computed tomography (CT)-guided lung biopsy for focal lung disease.

Materials and methods

A retrospective review was performed of 186 patients who underwent percutaneous lung biopsy of a parenchymal lesion at our institution between January and December 2009. Diagnostic radiology reports of CT or positron emission tomography-CTs performed before biopsy were used to classify the lesion as malignant or benign by five readers. Pathology reports of the biopsied lesions were classified by three readers. Inter-reader agreement and imaging-histologic concordance were quantified using kappa statistics. Discordant benign cases were then revisited to determine downstream effects.

Results

Inter-reader agreement on report content was substantial or almost perfect with kappas >0.783. Kappas for concordance were as follows: malignant (0.448), primary lung cancer (0.517), metastatic disease to lung (0.449), benign (0.510), and overall agreement (0.381). Of the twelve discordant benign cases that were revisited, four were found to be false negatives, resulting in a delay in diagnosis.

Conclusions

Our study of imaging-histologic discordance in percutaneous biopsy of lung lesions supports the need for imaging report standardization and improved integration and communication between the fields of radiology and pathology.

Background

Clinical trials in lung cancer increasingly require patients to provide fresh tumor tissue as a prerequisite to enrollment. The effects of this requirement on enrollment rates, enrollment durations, and patient selection have not been fully elucidated.

Methods

The authors retrospectively reviewed data generated by patients who consented to 1 or more interventional lung cancer clinical trials at the University of California-Los Angeles Jonsson Comprehensive Cancer Center between January 2013 and December 2014. Trials were considered to require a biopsy when enrollment was conditional on the procurement of tissue without intervening therapy between procurement and enrollment.

Results

In total, 311 patients underwent 368 screening incidents for 1 or more of 19 trials. Trials that required a new biopsy had a longer median screening duration (34 vs 14 days) than trials that did not require a biopsy (P < .001). Trials that required a biopsy had a greater screen failure rate (49.1% vs 26.5%; P < .001), which was largely driven by patients who did not undergo the required biopsy or lacked the required biomarker. Worsening performance status led to the majority of screen failures (56.5%) among biomarker-eligible patients.

Conclusions

Although the scientific benefits of obtaining a new biopsy and requiring specific results for trial enrollment are clear, these requirements lead to a lengthening of the screening period, which, in some patients, is associated with clinical decline before enrollment. Implications for the interpretation of data from studies of this design should be explored. Cancer 2017;123:4800-7. © 2017 American Cancer Society.