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 kno...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.展开更多
基金sponsored by Betta Pharmaceuticals Co.,Ltdsupported by the Basic and Applied Basic Research Foundation of Guangdong Province(2024A1515030227,Ning Li).
文摘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.
