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Multicenter Study
. 2020 Sep;21(5):e464-e473.
doi: 10.1016/j.cllc.2020.02.021. Epub 2020 Mar 9.

Detection of EGFR-Activating and T790M Mutations Using Liquid Biopsy in Patients With EGFR-Mutated Non-Small-Cell Lung Cancer Whose Disease Has Progressed During Treatment With First- and Second-Generation Tyrosine Kinase Inhibitors: A Multicenter Real-Life Retrospective Study

Roberta Minari  1 , Giulia Mazzaschi  2 , Paola Bordi  2 , Letizia Gnetti  3 , Giorgia Alberti  4 , Annalisa Altimari  5 , Elisa Gruppioni  5 , Francesca Sperandi  6 , Claudia Parisi  7 , Giorgia Guaitoli  8 , Stefania Bettelli  9 , Lucia Longo  10 , Federica Bertolini  8 , Maria Pagano  11 , Candida Bonelli  11 , Elena Tagliavini  12 , Davide Nicoli  13 , Alessandro Ubiali  14 , Adriano Zangrandi  14 , Serena Trubini  14 , Manuela Proietto  15 , Michelangelo Fiorentino  16 , Marcello Tiseo  17 ; DETECTION Study Group
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Multicenter Study

Detection of EGFR-Activating and T790M Mutations Using Liquid Biopsy in Patients With EGFR-Mutated Non-Small-Cell Lung Cancer Whose Disease Has Progressed During Treatment With First- and Second-Generation Tyrosine Kinase Inhibitors: A Multicenter Real-Life Retrospective Study

Roberta Minari et al. Clin Lung Cancer. 2020 Sep.

Abstract

Background: In advanced epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC) patients whose disease has progressed during treatment with first- and second-generation tyrosine kinase inhibitors (TKIs), liquid biopsy (LB) is routinely used to evaluate the presence of EGFR T790M as an acquired resistance mechanism. The objective of this study was to assess a real-life picture of EGFR T790M detection in LB.

Materials and methods: Liquid biopsies performed between June 2016 and October 2018 for advanced EGFR-mutated NSCLC at disease progression during treatment with first- and second-generation TKIs were retrospectively evaluated in 5 Italian centers. Circulating tumor DNA was extracted from plasma and tested with different commercial kits. The detection rate in LBs and the patients' characteristics were correlated.

Results: We enrolled 120 consecutive patients. The overall T790M detection rate observed using LB was 25.8%. Fifty-four of 89 (60.7%) patients with negative LB results underwent tissue rebiopsy, and 56% were positive for T790M. The overall rate of T790M positivity in the study cohort was 49.2%. LB performed before formal tumor progression according to Response Evaluation Criteria In Solid Tumors criteria was negative for T790M in all patients (n = 21; P = .012). T790M positivity was statistically significantly higher in cases of disease progression at extrathoracic metastatic sites (P = .008) and, specifically, in the case of worsening bone disease (P = .003).

Conclusion: Our study shows that the detection of T790M-positive patients whose disease progressed during treatment with first- and second-generation TKIs in real life was according to the literature. However, this result was obtained with a specific clinical course (repeat LBs and tissue rebiopsy), thus implying the necessity for multidisciplinary management.

Keywords: Clinical practice; Detection rate; NSCLC; Osimertinib; cfDNA.

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