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First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor

Akira Inoue1, Kunihiko Kobayashi, Kazuhiro Usui

  • 1Tohoku University, Graduate School of Medicine and School of Medicine, Japan.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|February 20, 2009
PubMed
Abstract

Insights

First-line gefitinib shows efficacy in advanced non-small-cell lung cancer (NSCLC) patients with poor performance status and EGFR mutations. This treatment improved performance status and survival rates, offering a new option beyond supportive care.

Area of Science:

  • Oncology
  • Medical Genetics

Background:

  • Advanced non-small-cell lung cancer (NSCLC) often presents challenges in treatment selection for patients with poor performance status (PS).
  • Epidermal growth factor receptor (EGFR) mutations are key drivers in a subset of NSCLC, influencing treatment response.

Purpose of the Study:

  • To evaluate the efficacy and feasibility of gefitinib as a first-line treatment for advanced NSCLC patients with EGFR mutations and poor PS.
  • To assess gefitinib's impact on performance status and survival outcomes in this specific patient group.

Main Methods:

  • A multicenter phase II study enrolled chemotherapy-naïve NSCLC patients with poor PS (ECOG PS 1-4 depending on age).
  • EGFR mutations were confirmed using the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method.
  • Patients received gefitinib (250 mg/d) as monotherapy.

Main Results:

  • Thirty patients with NSCLC and poor PS were enrolled; 22 had PS 3-4.
  • The overall response rate was 66% (90% CI, 51% to 80%), with a disease control rate of 90%.
  • A significant PS improvement rate of 79% was observed, with 68% of PS 3-4 patients improving to PS 1 or less. Median progression-free survival was 6.5 months, median survival time was 17.8 months, and the 1-year survival rate was 63%.

Conclusions:

  • First-line gefitinib is effective and feasible in advanced NSCLC patients with EGFR mutations and extremely poor PS.
  • EGFR mutation testing is recommended for this patient population, as gefitinib offers a viable treatment option beyond best supportive care.
  • No treatment-related deaths were reported, indicating a favorable safety profile.

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