Abstract

The recent emergence of novel neoadjuvant and/or adjuvant therapies for early stage (I-IIIA) non-small cell lung carcinoma (NSCLC), mainly tyrosine kinase inhibitors (TKIs) targeting EGFR mutations and immunotherapy or chemo-immunotherapy, has suddenly required the evaluation of biomarkers predictive of the efficacy of different treatments in these patients. Currently, the choice of one or another of these treatments mainly depends on the results of immunohistochemistry for PD-L1 and of the status of EGFR and ALK. This new development has led to the setup of different analyses for clinical and molecular pathology laboratories, which have had to rapidly integrate a number of new challenges into daily practice and to establish new organization for decision making. This review outlines the impact of the management of biological samples in laboratories and discusses perspectives for pathologists within the framework of EGFR TKIs in early stage NSCLC.

Highlights

  • Developments in the treatment of patients with advanced stage non-small cell lung carcinoma (NSCLC) have improved the overall quality of life and the life expectancy of these patients [1,2]

  • The recent results of adjuvant therapy targeting activating mutations in EGFR and of preoperative immunotherapies of early stage (I-IIIA) NSCLC open up great perspectives for the prevention of relapse and/or post-operative tumor progression [6,7,8,9,10,11,12,13,14]

  • PD-L1 IHC was used as a predictive biomarker in clinical trial development for early stage NSCLC treated with immune checkpoint inhibitors (ICIs) [11,12,13]

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Summary

Introduction

Developments in the treatment of patients with advanced stage non-small cell lung carcinoma (NSCLC) have improved the overall quality of life and the life expectancy of these patients [1,2]. The recent results of adjuvant therapy targeting activating mutations in EGFR (exon 19 deletion and L858R mutation) and of preoperative immunotherapies of early stage (I-IIIA) NSCLC open up great perspectives for the prevention of relapse and/or post-operative tumor progression [6,7,8,9,10,11,12,13,14] In this context, laboratories of pathology have been required to meet new challenges in developing a number of analyses to assure optimal care of patients in a routine clinical practice. When the status of genomic alterations is known at diagnosis, it is possible to consider this information at recurrence or tumor progression, which reduces the delay to administration of a therapeutic, in particular if it is not possible to perform an additional re-biopsy on a patient at that time These analyses by NGS can be done on preoperative biopsies and/or surgical specimens.

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