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<p>The efficacy, safety and ideal treatment duration of an adjuvant epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) for patients with resected EGFR-mutated non-small-cell lung cancer (NSCLC) were not known until 2014, when this study was initiated. In this phase 3 ICTAN trial (GASTO1002, NCT01996098), patients with completely resected, EGFR-mutated, stage II-IIIA NSCLC after adjuvant chemotherapy were assigned in a 1:1:1 ratio to receive icotinib (125 mg, three times daily) for 12 months, to receive icotinib for 6 months, or to undergo observation. The primary endpoint was disease-free survival (DFS). This trial was terminated early. A total of 251 patients were randomized. Adjuvant icotinib for 12 months significantly improved DFS (hazard ratio [HR]: 0.40, 95% confidence interval [CI], 0.27–0.61; <i>P</i> &lt; 0.001) and overall survival (OS; HR: 0.55, 95% CI, 0.32–0.96; <i>P</i> = 0.032) compared with observation. Adjuvant icotinib of 6 months also significantly improved DFS (HR: 0.41, 95% CI, 0.27–0.62; <i>P</i> &lt; 0.001) and OS (HR: 0.56, 95% CI, 0.32–0.98; <i>P</i> = 0.038) compared with observation. Adjuvant icotinib for 12 months did not improve DFS (HR: 0.97; <i>P</i> = 0.89) or OS (HR: 1.00; <i>P</i> = 0.99) compared with 6 months of this drug. Rates of adverse events of grade 3 or higher were 8.3%, 6.0% and 2.4% for the 12-month icotinib, 6-month icotinib, and observation groups, respectively. Adjuvant icotinib for 12 months or 6 months following adjuvant chemotherapy improved DFS and OS compared with observation in patients with resected EGFR-mutated stage II-IIIA NSCLC with a manageable safety profile, supporting it as a potential treatment option.</p>

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Adjuvant icotinib for resected EGFR-mutated stage II–IIIA non-small-cell lung cancer (ICTAN, GASTO1002): a randomized comparison study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月28日

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  • Ning Li,
  • Wei Ou,
  • Chao Cheng,
  • Jian You,
  • Lin Yang,
  • Feng-Xia Chen,
  • Yi Liang,
  • Zhixiong Yang,
  • Bao-Xiao Wang,
  • Zeng-Hao Chang,
  • Yao-Bin Lin,
  • Weixiong Yang,
  • Feng Xu,
  • Guanggui Ding,
  • Xian-Shan Chen,
  • Ronggui Hu,
  • Shujun Li,
  • Hao Jiang,
  • Xin-Xin Hu,
  • Hao Long,
  • Si-Yu Wang

摘要

The efficacy, safety and ideal treatment duration of an adjuvant epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) for patients with resected EGFR-mutated non-small-cell lung cancer (NSCLC) were not known until 2014, when this study was initiated. In this phase 3 ICTAN trial (GASTO1002, NCT01996098), patients with completely resected, EGFR-mutated, stage II-IIIA NSCLC after adjuvant chemotherapy were assigned in a 1:1:1 ratio to receive icotinib (125 mg, three times daily) for 12 months, to receive icotinib for 6 months, or to undergo observation. The primary endpoint was disease-free survival (DFS). This trial was terminated early. A total of 251 patients were randomized. Adjuvant icotinib for 12 months significantly improved DFS (hazard ratio [HR]: 0.40, 95% confidence interval [CI], 0.27–0.61; P < 0.001) and overall survival (OS; HR: 0.55, 95% CI, 0.32–0.96; P = 0.032) compared with observation. Adjuvant icotinib of 6 months also significantly improved DFS (HR: 0.41, 95% CI, 0.27–0.62; P < 0.001) and OS (HR: 0.56, 95% CI, 0.32–0.98; P = 0.038) compared with observation. Adjuvant icotinib for 12 months did not improve DFS (HR: 0.97; P = 0.89) or OS (HR: 1.00; P = 0.99) compared with 6 months of this drug. Rates of adverse events of grade 3 or higher were 8.3%, 6.0% and 2.4% for the 12-month icotinib, 6-month icotinib, and observation groups, respectively. Adjuvant icotinib for 12 months or 6 months following adjuvant chemotherapy improved DFS and OS compared with observation in patients with resected EGFR-mutated stage II-IIIA NSCLC with a manageable safety profile, supporting it as a potential treatment option.