The value of interventional radiology in clinical trial teams: experience from the BATTLE lung cancer trials.

Abstract

AIM:

To report on the multidisciplinary approach, focusing specifically on the role of the interventional radiologist (IR), used to support the Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) and BATTLE-2 trials.

MATERIALS AND METHODS:

Patients who underwent percutaneous image-guided biopsy for the BATTLE and BATTLE-2 trials were reviewed. A radiology-based, three-point, lesion-scoring system was developed and used by two IRs. Lesions were given a score of 3 (most likely to yield sufficient material for biomarker analysis) if they met the following criteria: size >2 cm, solid mass, demonstrated imaging evidence of viability, and were technically easy to sample. Lesions not meeting all four criteria were scored 2 with the missing criteria noted as negative factors. Lesions considered to have risks that outweighed potential benefits receive a score of 1 and were not biopsied. Univariate and multivariate analyses were performed to evaluate the score's ability to predict successful yield for biomarker adequacy.

RESULTS:

A total of 555 biopsies were performed. The overall yield for analysis of the required biomarkers was 86.1% (478/555), and 84% (268/319) and 88.9% (210/236) for BATTLE and BATTLE-2, respectively (p=0.09). Lesions receiving a score of 3 were adequate for biomarker analysis in 89% of cases. Lesions receiving a score of 2 with more than two negative factors were adequate for molecular analysis in 69.2% (IR1, p=0.03) and 74% (IR2, p=0.04) of cases. The two IRs scored 78.4% of the lesions the same indicating moderate agreement (kappa=0.55; 95% confidence interval [CI]: 0.48, 0.61).

CONCLUSIONS:

IRs add value to clinical trial teams by optimising lesions selected for biopsy and biomarker analysis.

• Authors: A L Tam, V Papadimitrakopoulou, I I Wistuba, J J Lee, J E Ensor, E S Kim, N Kalhor, G R Blumenschein Jr, A S Tsao, J V Heymach, R S Herbst, M E Hicks, W K Hong, S Gupta
• Journal: Clinical radiology (Clin Radiol) Vol. 76 Issue 2 Pg. 155.e25-155.e34 (Feb 2021) ISSN: 1365-229X [Electronic] England
• PMID: 33268083 (Publication Type: Journal Article)
• Copyright: Copyright © 2020 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Topics

• Aged
• Biopsy, Fine-Needle
• Carcinoma, Non-Small-Cell Lung (diagnostic imaging, pathology)
• Clinical Trials as Topic
• Female
• Humans
• Image-Guided Biopsy
• Lung (diagnostic imaging, pathology)
• Lung Neoplasms (diagnostic imaging, pathology)
• Male
• Middle Aged
• Patient Care Team
• Radiology, Interventional (methods)