Cancers (Mar 2024)

A Real-World Study of Patient Characteristics and Clinical Outcomes in <i>EGFR</i> Mutated Lung Cancer Treated with First-Line Osimertinib: Expanding the FLAURA Trial Results into Routine Clinical Practice

  • Hollis Viray,
  • Andrew J. Piper-Vallillo,
  • Page Widick,
  • Emmeline Academia,
  • Meghan Shea,
  • Deepa Rangachari,
  • Paul A. VanderLaan,
  • Susumu S. Kobayashi,
  • Daniel B. Costa

DOI
https://doi.org/10.3390/cancers16061079
Journal volume & issue
Vol. 16, no. 6
p. 1079

Abstract

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Osimertinib is a tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR) that is used for first-line therapy in EGFR mutated non-small cell lung cancer (NSCLC) based on the results of the randomized FLAURA trial (ClinicalTrials.gov number NCT02296125). We performed a retrospective analysis of baseline characteristics and clinical outcomes in 56 real-world patients treated with osimertinib. In total, 45% of patients were determined to be FLAURA-eligible and 55% were FLAURA-ineligible based on the published inclusion/exclusion criteria of the aforementioned trial. For clinical outcomes, the median osimertinib time to treatment discontinuation (TTD) for all patients was 16.9 months (95% CI: 12.6–35.1), whereas the median TTD was 31.1 months (95% CI: 14.9–not reached) in the FLAURA-eligible cohort and the median TTD was 12.2 months (95% CI: 8.1–34.6 months) in the FLAURA-ineligible cohort. Re-biopsy at acquired resistance disclosed both on- and off-target mechanisms. The most common therapies following osimertinib included local therapies followed by post-progression osimertinib, platinum-doublet chemotherapy with or without osimertinib, and osimertinib combinatory targeted therapies. The median overall survival for all patients was 32.0 months (95% CI: 15.7–not reached), the median survival was not reached for the FLAURA-eligible cohort, and it was 16.5 months for the FLAURA-ineligible cohort. Our data support the use of osimertinib in real-word settings and highlight the need for designing registration trials that are more inclusive of patient/disease characteristics seen in routine clinical practice. It is yet to be determined if the use of evolving first-line EGFR inhibitor combination strategies (either platinum-doublet chemotherapy plus osimertinib or amivantamab plus lazertinib) will similarly translate from clinical trials to real-word settings.

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