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Background <p>The optimal treatment strategy for epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC)—sequential tyrosine kinase inhibitor (TKI) monotherapies versus upfront combination therapies—remains debated.</p> Objective <p>The Giotrif In Advanced NSCLC Taiwan (GIANT) study evaluated the real-world outcomes of sequential afatinib-based strategies.</p> Patients and Methods <p>This multicenter retrospective cohort study included 733 treatment-naïve patients with American Joint Committee on Cancer stage IIIB–IV NSCLC harboring Del19 or L858R EGFR mutations who received first-line afatinib across seven major Taiwanese medical centers between 2016 and 2024. Patients were stratified by second-line therapy into two groups: afatinib–osimertinib (<i>n</i> = 303) and afatinib–chemotherapy/other lines (<i>n</i> = 430). The primary outcome was overall survival (OS).</p> Results <p>Sequential afatinib–osimertinib therapy achieved a median OS of 55 months (95% confidence interval [CI] 53.2–66.4) compared to 32.3 months (95% CI 30.3–34.5) with alternative strategies (adjusted hazard ratio 0.43, <i>p</i> &lt; 0.001). Survival benefits were consistent across EGFR mutations and brain metastasis statuses.</p> Conclusion <p>Sequential afatinib-to-osimertinib therapy achieved remarkable OS exceeding 55 months in real-world practice, with outcomes appearing competitive with contemporary combination strategies. These findings support sequential TKI therapy as a durable and effective alternative that warrants prospective validation.</p>

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Real-World Outcomes of Sequential Afatinib and Osimertinib Versus Afatinib and Chemotherapy in EGFR-Mutant NSCLC: Taiwan Multicenter GIANT Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月20日

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  • How-Wen Ko,
  • Ying-Ting Liao,
  • Sheng-Kai Liang,
  • Yen-Hsiang Huang,
  • Yu-Ching Lin,
  • Ping-Chi Liu,
  • Chin-Chou Wang,
  • Jeng-Shiuan Tsai,
  • Yuh-Min Chen,
  • Jin-Yuan Shih,
  • Tsung-Ying Yang,
  • Cheng-Ta Yang

摘要

Background

The optimal treatment strategy for epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC)—sequential tyrosine kinase inhibitor (TKI) monotherapies versus upfront combination therapies—remains debated.

Objective

The Giotrif In Advanced NSCLC Taiwan (GIANT) study evaluated the real-world outcomes of sequential afatinib-based strategies.

Patients and Methods

This multicenter retrospective cohort study included 733 treatment-naïve patients with American Joint Committee on Cancer stage IIIB–IV NSCLC harboring Del19 or L858R EGFR mutations who received first-line afatinib across seven major Taiwanese medical centers between 2016 and 2024. Patients were stratified by second-line therapy into two groups: afatinib–osimertinib (n = 303) and afatinib–chemotherapy/other lines (n = 430). The primary outcome was overall survival (OS).

Results

Sequential afatinib–osimertinib therapy achieved a median OS of 55 months (95% confidence interval [CI] 53.2–66.4) compared to 32.3 months (95% CI 30.3–34.5) with alternative strategies (adjusted hazard ratio 0.43, p < 0.001). Survival benefits were consistent across EGFR mutations and brain metastasis statuses.

Conclusion

Sequential afatinib-to-osimertinib therapy achieved remarkable OS exceeding 55 months in real-world practice, with outcomes appearing competitive with contemporary combination strategies. These findings support sequential TKI therapy as a durable and effective alternative that warrants prospective validation.