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    Adjuvant EGFR-TKI Therapy in Resected Stage I EGFR-Mutated Lung Adenocarcinoma

    Cao et alTranslational lung cancer research

    Adjuvant EGFR-TKI Therapy in Resected Stage I EGFR-Mutated Lung Adenocarcinoma
    This retrospective cohort study found that in patients with completely resected stage I invasive lung adenocarcinoma (LUAD) (tumors ≤3 cm) harboring sensitizing EGFR mutations (exon 19 deletion or exon 21 L858R) and pathological high-risk features, adjuvant EGFR-tyrosine kinase inhibitor (TKI) therapy was associated with a significant reduction in the hazard of disease recurrence, although it did not confer an overall survival benefit. Adjuvant EGFR-TKI therapy is not standard in stage IA disease; these results describe an association and should not be read as establishing standard care for that stage.
    This retrospective cohort study evaluated 357 patients who underwent complete resection for stage I invasive LUAD between January 2011 and May 2024. All eligible patients had sensitizing EGFR mutations and at least one high-risk pathological characteristic, defined as lymphovascular invasion, visceral pleural invasion, spread through air spaces (STAS), high-grade histological patterns (micropapillary, solid, or complex glandular), or poor differentiation. Outcomes assessed were relapse-free survival (RFS) and overall survival (OS). The primary evaluation employed a 90-day landmark analysis with stabilized inverse probability of treatment weighting (IPTW) to adjust for baseline imbalances between groups.
    At the 90-day landmark, 354 patients were alive and recurrence-free, with 104 initiating adjuvant EGFR-TKI therapy and 250 remaining unexposed. Adjuvant EGFR-TKI was associated with improved RFS in both the unweighted model (HR = 0.27, 95% CI: 0.13–0.56; P = 0.004) and the IPTW-adjusted model (HR = 0.28, 95% CI: 0.11–0.68; P = 0.009). A time-dependent Cox regression similarly reported a lower hazard of recurrence (HR = 0.27, 95% CI: 0.14–0.52; P < 0.001), and a 120-day landmark sensitivity analysis supported these findings. Conversely, no significant difference in OS was observed in unweighted (HR = 0.93, 95% CI: 0.33–2.63; P = 0.91), IPTW-weighted (HR = 1.34, 95% CI: 0.50–3.61; P = 0.38), or time-dependent models (HR = 1.14, 95% CI: 0.41–3.19; P = 0.49).

    Key Takeaways

    • This was a retrospective analysis reporting associations, not causation. Adjuvant EGFR-TKI therapy is not standard in stage IA disease.
    • Adjuvant EGFR-TKI therapy was associated with significantly improved relapse-free survival in patients with completely resected stage I (≤3 cm) EGFR-mutated lung adenocarcinoma harboring high-risk pathological features on both unweighted analysis (HR = 0.27, 95% CI: 0.13–0.56; P = 0.004) and IPTW-adjusted analysis (HR = 0.28, 95% CI: 0.11–0.68; P = 0.009).
    • No significant overall survival benefit was observed with adjuvant EGFR-TKI exposure in either unweighted (HR = 0.93, 95% CI: 0.33–2.63; P = 0.91), IPTW-weighted (HR = 1.34, 95% CI: 0.50–3.61; P = 0.38), or time-dependent analyses (HR = 1.14, 95% CI: 0.41–3.19; P = 0.49).
    Read the original sourceTranslational lung cancer research