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Purpose <p>We aimed to evaluate the effectiveness and safety of osimertinib as a first-line therapy in patients with advanced <i>EGFR-mutated</i> non-small cell lung cancer (aNSCLC) in a Spanish real-world setting.</p> Methods <p>This retrospective observational study was conducted at eight centers. The primary objective was to assess the effect of osimertinib on progression-free survival (PFS). The secondary objective was to evaluate the objective response rate (ORR), disease control rate (DCR), overall survival (OS), and drug toxicity.</p> Results <p>A total of 181 patients with aNSCLC were included in this study. The median PFS and OS were 15.8 (95% CI 12.5–19.0) and 29.3 (95% CI 21.1–37.5) months, respectively. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ≥ 2 was associated with shorter PFS, whereas the presence of common EGFR mutations (exon 19 deletion and exon 21 L858R) was associated with longer PFS. Similarly, the age ≥ 70&#xa0;years and an ECOG PS ≥ 2 were associated with a shorter OS, whereas the exon 19 deletion was associated with a longer OS. In addition, the overall ORR was 71.3% (CI 95% 64.7–77.9%), and the DCR was 87.8% (CI 95% 83.1–92.6%), with exon 19 deletion associated with a greater treatment response. Finally, 77% of the patients reported mild adverse reactions. Severe toxicity was not observed.</p> Conclusions <p>This study supports the effectiveness and tolerable safety profile of osimertinib as first-line treatment for patients with aNSCLC in a real-world setting. Exon 19 deletion appears to be a strong predictor of greater effectiveness in patients with aNSCLC.</p>

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Real-world clinical experience with osimertinib in advanced EGFR-mutated non-small cell lung cancer

  • 期刊论文

  • 发表日期：

    2025年8月12日

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  • María Carmen Areses Manrique,
  • Luis León-Mateos,
  • Sofia Silva-Díaz,
  • Ana Alonso,
  • Martín Lázaro-Quintela,
  • Natalia Fernández Núñez,
  • Francisco Javier Afonso-Afonso,
  • Pablo Freijido-Álvarez,
  • Manuel Fernández-Bruno,
  • Soledad Cameselle-García,
  • Clara González-Ojea,
  • Gerardo Huidobro,
  • Blanca Távara-Silva,
  • Carme García-Lorenzo,
  • Javier Álvarez,
  • Patricia Cordeiro González,
  • Jesús García Mata,
  • Cristina Azpitarte-Raposeiras,
  • Luis Ruiz de Almirón Lomo,
  • Víctor Cebey-López,
  • Joaquín Mosquera Martínez,
  • Jorge García-González ,
  • Lucía Santomé,
  • Margarita Amenedo,
  • José Luis Fírvida-Pérez

摘要

Purpose

We aimed to evaluate the effectiveness and safety of osimertinib as a first-line therapy in patients with advanced EGFR-mutated non-small cell lung cancer (aNSCLC) in a Spanish real-world setting.

Methods

This retrospective observational study was conducted at eight centers. The primary objective was to assess the effect of osimertinib on progression-free survival (PFS). The secondary objective was to evaluate the objective response rate (ORR), disease control rate (DCR), overall survival (OS), and drug toxicity.

Results

A total of 181 patients with aNSCLC were included in this study. The median PFS and OS were 15.8 (95% CI 12.5–19.0) and 29.3 (95% CI 21.1–37.5) months, respectively. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ≥ 2 was associated with shorter PFS, whereas the presence of common EGFR mutations (exon 19 deletion and exon 21 L858R) was associated with longer PFS. Similarly, the age ≥ 70 years and an ECOG PS ≥ 2 were associated with a shorter OS, whereas the exon 19 deletion was associated with a longer OS. In addition, the overall ORR was 71.3% (CI 95% 64.7–77.9%), and the DCR was 87.8% (CI 95% 83.1–92.6%), with exon 19 deletion associated with a greater treatment response. Finally, 77% of the patients reported mild adverse reactions. Severe toxicity was not observed.

Conclusions

This study supports the effectiveness and tolerable safety profile of osimertinib as first-line treatment for patients with aNSCLC in a real-world setting. Exon 19 deletion appears to be a strong predictor of greater effectiveness in patients with aNSCLC.