Abstract
Abstract Background Personalized medicine and related health technologies are growing rapidly. In this context, health technology assessment methodologies must be prepared and adapted. Evaluating liquid biopsy (LB) for the diagnosis, treatment indication and prognosis of lung cancer is an example of the challenges in the personalized medicine assessment. Methods A systematic review and metanalysis based on EUnetHTA CoreModel. Review question: What is the effectiveness of LB for the diagnosis, therapeutic adequacy and prognosis of lung cancer versus tissue biopsy? The Covidence software was used for the systematic review and MetaDiSC software for the meta-analysis. The quality of the included systematic reviews was assessed with AMSTAR-2 and the quality of the clinical studies with QUADAS-II. Results 69 systematic reviews corresponding to different therapeutic purposes: 12 for treatment adequacy, 47 for diagnosis and 13 for prognosis. Also 24 clinical trials were included. The omics alterations analysed were: punctual mutations in EGFR, BRAF, KRAS and ALK, methylation patterns, lncRNA expression, detection of circulating tumour cells, quantification of circulating DNA, NGS analysis of point mutations, miRNA expression and analysis of exosome content. Conclusions Use of LB tests at different disease stages and need of individual validation for the biomolecules and mutations analysed, are the main challenges. An evaluation framework that includes the specificities of these technologies is necessary for their proper assessment. Key messages • Liquid biopsy may be an alternative to tissue biopsy. The evaluation of the biomolecules analysed should be disaggregated. • The particularities of personalised medicine technologies require assessment methodologies adapted to them.
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