@article{2263e885d45a4bf1bc49ab455ed75390,
title = "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.",
author = "Tam, {A. L.} and V. Papadimitrakopoulou and Wistuba, {I. I.} and Lee, {J. J.} and Ensor, {J. E.} and Kim, {E. S.} and N. Kalhor and Blumenschein, {G. R.} and Tsao, {A. S.} and Heymach, {J. V.} and Herbst, {R. S.} and Hicks, {M. E.} and Hong, {W. K.} and S. Gupta",
note = "Funding Information: Dr. Blumenschein reports personal fees from Abbvie, Adicet, Amgen, Ariad, Bayer, Clovis Oncology, grants from Adaptimmune, grants from Elelixis, grants from GlaxoSmithKline, grants from Immatics, grants from Immunocore, grants from Incyte, grants from Kite Pharma, grants from Macrogenics, grants from Torque, grants and personal fees from AstraZenaca, grants and personal fees from Bristol-Myers Squibb, grants and personal fees from Celgene, grants and personal fees from Genetech, grants and personal fees from MedImmune, grants and personal fees from Merck, grants and personal fees from Novartis, grants and personal fees from Roche, grants and personal fees from Xcovery, personal fees from Virogin Biotech, personal fees from Johnson & Johnson, personal fees from Maverick Therapeutics, outside the submitted work. Funding Information: Dr. Wistuba reports grants and personal fees from Genentech/Roche, grants and personal fees from Bayer, grants and personal fees from Bristol-Myers Squibb, grants and personal fees from AstraZeneca/Medimmune, grants and personal fees from Pfizer, grants and personal fees from HTG Molecular, grants and personal fees from Merck, personal fees from GlaxoSmithKline, grants and personal fees from Guardant Health, personal fees from MSD, grants from Oncoplex, grants from DepArray, grants from Adaptive, grants from Adaptimmune, grants from EMD Serono, grants from Takeda, grants from Amgen, grants from Karus, grants from Johnson & Johnson, grants from Iovance, grants from 4D, grants from Novartis, grants from Oncocyte, grants from Akoya, personal fees from Flame, outside the submitted work. Funding Information: Dr. Papadimitrakopoulou is currently an employee of Pfizer. During the conduct of the study, Dr. Papadimitrakopoulou reports grants from Merck, grants from Bayer, during the conduct of the study; personal fees from Merck, outside the submitted work; and Advisory Board: Nektar Therapeutics, Astra Zeneca Pharmaceuticals, Arrys Therapeutics, Merck&Co, LOXO Oncology, Araxes Pharma, F.Hoffman-LaRoche Ltd, Janssen Research Foundation, Bristol-Myers Squibb, Clovis Oncology, Eli Lilly &Co, Novartis Pharmaceuticals Corp. Takeda Pharmaceuticals, Abbvie, TRM Oncology, Tesaro, Exelixis, Gritstone, Leeds Biolabs, Ideaya, Bolt Therapeutics, G2 Innovation {\DH}esearch/Grant : Eli Lilly &Co, Novartis, Merck, Astra Zeneca Pharmaceuticals, F Hoffman-La Roche, Nektar Therapeutics, Janssen, Bristol-Myers Squibb, Checkmate, Incyte. {\DH}peaker fees: F.Hoffman- LaRoche. Funding Information: Dr. Tsao reports grants and personal fees from BMS, grants and personal fees from AZ, grants and personal fees from Roche, grants and personal fees from Millenium/Takeda, grants and personal fees from Boehringer-Ingelheim, grants and personal fees from Ariad, grants and personal fees from Seattle Genetics, grants from Polaris, grants and personal fees from Epizyme, grants from Merck, personal fees from Huron, grants from Lilly outside the submitted work. Funding Information: This research was supported in part by the Department of Defense Grant W81XWH-6-1-0303 ; the National Institutes of Health through MD Anderson Cancer Center Support Grant P30 CA01667 and RO1 CA155196-01A1 ; and research grants from Merck Research Laboratories and Bayer Healthcare Pharmaceuticals (No. 15660 ) Publisher Copyright: {\textcopyright} 2020 The Royal College of Radiologists",
year = "2021",
month = feb,
doi = "10.1016/j.crad.2020.09.024",
language = "English (US)",
volume = "76",
pages = "155.e25--155.e34",
journal = "Clinical Radiology",
issn = "0009-9260",
publisher = "W.B. Saunders Ltd",
number = "2",
}