The molecular profiling of solid tumors by liquid biopsy: a position paper of the AIOM-SIAPEC-IAP-SIBioC-SIC-SIF Italian Scientific Societies.

The term liquid biopsy (LB) refers to the use of various biological fluids as a surrogate for neoplastic tissue to achieve information for diagnostic, prognostic and predictive purposes. In the current clinical practice, LB is used for the identification of driver mutations in circulating tumor DNA derived from both tumor tissue and circulating neoplastic cells. As suggested by a growing body of evidence, however, there are several clinical settings where biological samples other than tissue could be used in the routine practice to identify potentially predictive biomarkers of either response or resistance to targeted treatments. New applications are emerging as useful clinical tools, and other blood derivatives, such as circulating tumor cells, circulating tumor RNA, microRNAs, platelets, extracellular vesicles, as well as other biofluids such as urine and cerebrospinal fluid, may be adopted in the near future. Despite the evident advantages compared with tissue biopsy, LB still presents some limitations due to both biological and technological issues. In this context, the absence of harmonized procedures corresponds to an unmet clinical need, ultimately affecting the rapid implementation of LB in clinical practice. In this position paper, based on experts' opinions, the AIOM-SIAPEC-IAP-SIBIOC-SIF Italian Scientific Societies critically discuss the most relevant technical issues of LB, the current and emerging evidences, with the aim to optimizing the applications of LB in the clinical setting.

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Disclosure GB: Consulting fees: Lilly, Eisai, Incyte, Servier; honoraria for presentations: Clovis Oncology, Merck; support for attending meetings: Roche, Ipsen, Celgene, Servier, Sanofi; advisory board: Eisai. MF: Grants: QED Therapeutics, Astellas Pharma; consulting fees: Diaceutics, Tesaro-GSK, Astellas Pharma. UM: Personal fees from Boehringer Ingelheim, AstraZeneca, Roche, Merck Sharp & Dohme (MSD), Amgen, Merck, Eli Lilly, Thermo Fisher, Diaceutics for participation in a speaker bureau or for acting in an advisory role, outside the submitted work. NN: Grants: Merck, Sysmex, Thermo Fisher, QIAGEN, Roche, AstraZeneca, Biocartis, Illumina; honoraria for presentations: MSD, QIAGEN, Bayer, Biocartis, Illumina, Incyte, Roche, Bristol-Myers Squibb, Merck, Thermo Fisher, Boehringer Ingelheim, AstraZeneca, Sanofi, Eli Lilly; Other financial or non-financial interests: President, International Quality Network for Pathology (IQN Path); President, Italian Cancer Society (SIC). NS: Honoraria for presentations: MSD, Roche, Isheo, Iquvia. GR: honoraria for presentations: Pfizer, Novartis; advisory boards: Eli Lilly, Amgen, MSD. AR: Honorarium for advisory boards: Bristol, Pfizer, Bayer, Kyowa Kirin, Ambrosetti; Speaker honorarium: Roche Diagnostic. AS-B: Advisory Board: Amgen, Bayer, Sanofi, Servier, MSD. All other authors have declared no conflicts of interest.