Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World

Oncologist. 2024 Jul 5;29(7):596-608. doi: 10.1093/oncolo/oyae043.

Abstract

Introduction: The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients.

Methods: Herein, we report updated survival data, post-progression management, cost/effectiveness and budget impact (BI) of osimertinib compared with a RW population receiving gefitinib or erlotinib.

Results: Overall, 189 Caucasian patients receiving first-line osimertinib were included. After a follow-up of 20.7 months, 74(39.2%) patients discontinued osimertinib, median time-to-treatment discontinuation (mTTD) was 27.9 months, overall survival 36.8 months. At progression, tissue biopsy was performed in 29 (56.9%), liquid biopsy in 15 (29.4%) and both in 7 (13.7%) cases. The most frequent resistant mechanism was MET amplification (N = 14, 29.8%). At data cutoff, 13 (6.9%) patients were continuing osimertinib beyond progression; 52 (67.5%) received second-line treatment; no further treatments were administered in 25 (32.5%) cases. Thirty-three (63.4%) patients received chemotherapy, 12(23.1%) TKIs combination. Cost-effectiveness analysis showed a total cost per patient based on RW mTTD of 98,957.34€, 21,726.28€ and 19,637.83€ for osimertinib, erlotinib and gefitinib, respectively. The incremental cost-effectiveness ratio (ICER)/month for osimertinib was 359,806.0€/life-year-gained (LYG) and 197,789.77€/LYG compared to erlotinib and gefitinib. For osimertinib, the BI-gap between RW-TTD and theoretical-TTD was 16,501.0€ per patient.

Conclusions: This updated analysis confirms the effectiveness of osimertinib in RW. Although the ICER of osimertinib seems not cost-effective, additional costs for the management of disease progression to old generation TKIs were not considered in this study. The BI-gap suggests RW mTTD as a more reliable measure for expense estimation.

Keywords: cost effectiveness; epidermal growth factor receptor; non-small-cell lung cancer; osimertinib; real-world study.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Acrylamides* / economics
  • Acrylamides* / pharmacology
  • Acrylamides* / therapeutic use
  • Adult
  • Aged
  • Aged, 80 and over
  • Aniline Compounds* / economics
  • Aniline Compounds* / therapeutic use
  • Antineoplastic Agents / economics
  • Antineoplastic Agents / therapeutic use
  • Carcinoma, Non-Small-Cell Lung* / drug therapy
  • Carcinoma, Non-Small-Cell Lung* / economics
  • Carcinoma, Non-Small-Cell Lung* / genetics
  • Carcinoma, Non-Small-Cell Lung* / mortality
  • Carcinoma, Non-Small-Cell Lung* / pathology
  • Cost-Benefit Analysis
  • Disease Progression
  • ErbB Receptors* / genetics
  • Erlotinib Hydrochloride / economics
  • Erlotinib Hydrochloride / therapeutic use
  • Female
  • Gefitinib / economics
  • Gefitinib / therapeutic use
  • Humans
  • Indoles
  • Lung Neoplasms* / drug therapy
  • Lung Neoplasms* / economics
  • Lung Neoplasms* / genetics
  • Lung Neoplasms* / mortality
  • Lung Neoplasms* / pathology
  • Male
  • Middle Aged
  • Mutation
  • Prospective Studies
  • Pyrimidines

Substances

  • osimertinib
  • Aniline Compounds
  • Acrylamides
  • ErbB Receptors
  • EGFR protein, human
  • Erlotinib Hydrochloride
  • Gefitinib
  • Antineoplastic Agents
  • Indoles
  • Pyrimidines