Safety of image guided research biopsies in patients with thoracic malignancies.

A common opportunity to collect research samples is during image-guided percutaneous core needle biopsies (CNBs) performed when clinically indicated or for assessing clinical trial eligibility. The relative safety of extra CNBs collected for research is undefined. Patients who underwent CNB for research purposes only [RO], as clinically indicated [CI], or as part of a clinical trial [CT] were identified. 30-day post-procedure adverse events (AEs) among the cohorts were examined and compared to the 2020 Society of Interventional Radiology QI guidelines. 236 patients with thoracic cancers (90 % NSCLC, 5 % SCLC, 4 % mesothelioma, and 1 % thymic) had 292 CNBs (63 RO, 229 CI + CT). AEs occurred in 13 % of both the RO and CI + CT groups. Compared to the CI + CT group, the RO group did not have a higher pneumothorax incidence (RO: 5/29 [17 %], CI + CT: 18/114 [16 %], p = 0.79); both were below the suggested QI threshold of 45 % for pneumothorax. There was a negative association between number of cores obtained and risk of AE (AE vs no AE mean cores = 3.5 vs 4.8). After adjusting for the number of cores and smoking history, RO vs CI + CT lung biopsies had a higher risk of AEs (adjusted relative risk [aRR] = 2.44, 1.08-5.55, p = 0.03 vs non-lung aRR = 0.86, 0.10-7.09, p = 0.89). CNBs performed for research purposes do not have a significantly increased risk of AEs when compared to those performed for clinical trials and/or when clinically indicated. However, AEs were most frequent in lung biopsies. When performing research biopsies, a target other than lung may be preferred when clinically appropriate.

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Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: C.B. reports personal fees from Takeda. P.A.J. reports grants from The Mark Foundation for Cancer Research, grants from American Cancer Society, during the conduct of the study; grants and personal fees from AstraZeneca, grants and personal fees from Boehringer Ingelheim, personal fees from Pfizer, personal fees from Roche/Genentech, personal fees from Chugai Pharmaceuticals, personal fees from Ignyta, personal fees from LOXO Oncology, grants and personal fees from Eli Lilly, personal fees from SFJ Pharmaceuticals, personal fees from Voronoi, grants and personal fees from Daiichi Sankyo, personal fees from Biocartis, personal fees from Novartis, personal fees from Sanofi, grants and personal fees from Takeda Oncology, personal fees from Transcenta, personal fees from Silicon Therapeutics, personal fees from Syndax, personal fees from Nuvalent, personal fees from Bayer, personal fees from Esai, grants from PUMA, grants from Astellas Pharmaceuticals, grants from Revolution Medicines, personal fees from Mirati Therapeutics, outside the submitted work. J.L has received honoraria from Targeted Oncology and Physicians’ Education Resource; and personal fees from Erasca, Blueprint Medicines, and Daiichi Sankyo. B.E.J reports personal fees from Novartis, Boston Pharmaceuticals, Checkpoint Therapeutics, Chugai, Daiichi Sankyo, AstraZeneca, Foundation Medicine, G1 Therapeutics, Genentech, GlaxoSmithKline, Hengrui Therapeutics, Janssen, Jazz Pharmaceuticals, and Eli Lilly outside the submitted work; in addition, B.E. Johnson has a patent for EGFR Mutation Testing licensed and with royalties paid from DFCI and MGH.