Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

A Real-World, Observational, Prospective Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations upon Progression on or after First-Line Therapy with a First or Second Generation EGFR Tyrosine Kinase Inhibitor in EGFR Mutation-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer: The ‘LUNGFUL’ Study

Version 1 : Received: 25 April 2021 / Approved: 28 April 2021 / Online: 28 April 2021 (07:55:22 CEST)

A peer-reviewed article of this Preprint also exists.

Mountzios, G.; Koumarianou, A.; Bokas, A.; Mavroudis, D.; Samantas, E.; Fergadis, E.G.; Linardou, H.; Katsaounis, P.; Athanasiadis, E.; Karamouzis, M.V.; Pentheroudakis, G.; Lampaki, S.; Froudarakis, M.E.; Perdikouri, E.-I.A.; Somarakis, A.; Papageorgiou, F.; Paparepa, Z.; Nikolaou, A.; Syrigos, K.N. A Real-World, Observational, Prospective Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations upon Progression on or after First-Line Therapy with a First- or Second-Generation EGFR Tyrosine Kinase Inhibitor in EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer: The ‘LUNGFUL’ Study. Cancers 2021, 13, 3172. Mountzios, G.; Koumarianou, A.; Bokas, A.; Mavroudis, D.; Samantas, E.; Fergadis, E.G.; Linardou, H.; Katsaounis, P.; Athanasiadis, E.; Karamouzis, M.V.; Pentheroudakis, G.; Lampaki, S.; Froudarakis, M.E.; Perdikouri, E.-I.A.; Somarakis, A.; Papageorgiou, F.; Paparepa, Z.; Nikolaou, A.; Syrigos, K.N. A Real-World, Observational, Prospective Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations upon Progression on or after First-Line Therapy with a First- or Second-Generation EGFR Tyrosine Kinase Inhibitor in EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer: The ‘LUNGFUL’ Study. Cancers 2021, 13, 3172.

Journal reference: Cancers 2021, 13, 3172
DOI: 10.3390/cancers13133172

Abstract

Background: Real-world data on the molecular epidemiology of EGFR resistance mutations at or after progression with first- or second-generation EGFR-TKIs in patients with advanced NSCLC are lacking. Methods: This ongoing observational study was carried out by 23 hospital-based physicians in Greece. The decision to perform Cobas® EGFR Mutation Test v2 in tissue and/or plasma at disease progression was made before enrollment. For patients with negative/inconclusive T790M plasma-based results, tissue re-biopsy could be performed. Results: Ninety-six (96) eligible patients were consecutively enrolled (median age: 67.8 years) between July-2017 and September-2019. Of the patients, 98% were tested upon progression using plasma and 2% using tissue/cytology biopsy. The T790M mutation was detected in 16.0% of liquid biopsies. Tissue re-biopsy was performed in 22.8% of patients with a T790M-negative plasma result. In total, the T790M positivity rate was 21.9%, not differing between patients on first- or second-generation EGFR-TKI. Higher (≥2) ECOG performance status and longer (≥10 months) time to disease progression following EGFR-TKI treatment initiation were associated with T790M positivity. Conclusions: Results from plasma/tissue-cytology samples in a real-world setting, yielded a T790M positivity rate lower than previous reports. Fewer than one in four patients with negative plasma-based testing underwent tissue re-biopsy, indicating the challenges in routine care settings.

Keywords

Epidermal Growth Factor Receptor (EGFR); mutations, EGFR tyrosine kinase inhibitor; molecular epidemiology; Non-small-cell lung cancer

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