Abstract
Simple SummaryThe clinical relevance of tumor genotyping through analysis of ctDNA is now widely recognized at all steps of the clinical evaluation process in metastatic non-small cell lung cancer (NSCLC) patients. ctDNA analysis through liquid biopsy has recently gained increasing attention as well in the management of early and locally advanced, not oncogene-addicted, NSCLC. The aim of this review is to summarize the landscape of liquid biopsies in clinical practice and also to provide an overview of the potential perspectives of development focusing on early detection and screening, the assessment of minimal residual disease, and its potential role in predicting response to immunotherapy.Tumor genomic profiling has a dramatic impact on the selection of targeted treatment and for the identification of resistance mechanisms at the time of progression. Solid tissue biopsies are sometimes challenging, and liquid biopsies are used as a non-invasive alternative when tissue is limiting. The clinical relevance of tumor genotyping through analysis of ctDNA is now widely recognized at all steps of the clinical evaluation process in metastatic non-small cell lung cancer (NSCLC) patients. ctDNA analysis through liquid biopsy has recently gained increasing attention as well in the management of early and locally advanced, not oncogene-addicted, NSCLC. Its potential applications in early disease detection and the response evaluation to radical treatments are promising. The aim of this review is to summarize the landscape of liquid biopsies in clinical practice and also to provide an overview of the potential perspectives of development focusing on early detection and screening, the assessment of minimal residual disease, and its potential role in predicting response to immunotherapy. In addition to available studies demonstrating the clinical relevance of liquid biopsies, there is a need for standardization and well-designed clinical trials to demonstrate its clinical utility.
Highlights
The utility of tumor genotyping is widely recognized at all stages of the clinical evaluation process in non-small-cell lung cancer (NSCLC) [1]
While tissue-based molecular analysis is the gold standard for precision medicine, liquid biopsies have recently gained increasing attention due to the approval of EGFR tyrosine kinase inhibitors administration on ctDNA-based mutation detection. ctDNA analysis has been shown to be feasible to evaluate the amount of molecular alterations characterizing the tumor by the so-called blood tumor mutational burden. bTMB has recently been approved by the US Food and
Targeted therapies typically result in a high response rate and durable responses; some patients experience disease progression earlier than expected, probably due to primary or acquired resistance mechanisms. ctDNA dynamics has been evaluated as a predictive biomarker to identify these patients
Summary
The utility of tumor genotyping is widely recognized at all stages of the clinical evaluation process in non-small-cell lung cancer (NSCLC) [1]. The deeper understanding of specific genomic alterations driving NSCLC development led to novel therapeutics with a dramatic impact on patients’. Approved drugs will certainly have a further impact on outcomes in the near future. While tissue-based molecular analysis is the gold standard for precision medicine, liquid biopsies have recently gained increasing attention due to the approval of EGFR tyrosine kinase inhibitors administration on ctDNA-based mutation detection. CtDNA analysis has been shown to be feasible to evaluate the amount of molecular alterations characterizing the tumor by the so-called blood tumor mutational burden (bTMB). BTMB has recently been approved by the US Food and. Drug Administration (FDA) as a first-line predictive biomarker of response to the combination of chemotherapy and immunotherapy. Despite its questionable positive predictive value, bTMB remains an important variable to consider in exploratory studies designed to identify integrated predictive biomarkers in the immuno-oncology field
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