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. 2019 Jan;8(Suppl 1):S23–S47. doi: 10.21037/tcr.2018.10.06

Table 8. Studies of first- and second-generation EGFR TKIs in early-stage EGFR-mutant NSCLC.

EGFR TKI Study Number of patients, population Design Primary endpoint Ref.
Gefitinib ADJUVANT, phase III 222, II–IIIA EGFR-mutant Gefitinib vs. platinum-based chemotherapy HR for DFS =0.60; P=0.0054 (149)
NCIC CTG BR19, phase III 503 stage IB–IIIA, unselected Gefitinib vs. placebo for 2 years HR for OS =1.24; P=0.14 (146)
Phase II, randomized 60, IIIA (N2), EGFR-mutant Platinum-based chemotherapy followed by gefitinib for 6 months vs. platinum-based chemotherapy HR for DFS =0.37; P=0.014 (148)
Erlotinib SELECT, phase II, non-randomised 100, IA–IIIA, EGFR-mutant Platinum-based chemotherapy followed by erlotinib for 2 years 2-year DFS rate =90% (150)
EVAN, phase II 100 IIIA EGFR-mutant Erlotinib (2 years) vs. platinum-based chemotherapy HR for DFS =0.26; P<0.001 (151)
RADIANT, phase III 973, IB–IIIA, EGFR overexpression (IHC or FISH) Erlotinib vs. placebo for 2 years HR for DFS =0.90; P=0.324 (147)
RECEL, phase II 41, unresectable stage III, EGFR-mutant Erlotinib + RT (erlotinib for 2 years) vs. cisplatin-etoposide + RT HR for PFS =0.053; P<0.001 (152)
Icotinib Phase II, randomized 41, IB–IIIA, EGFR-mutant Platinum-based chemotherapy followed by icotinib for 4–8 months vs. platinum-based chemotherapy 24 months DFS 90.5% vs. 66.7%; P=0. 066 (153)

EGFR, epidermal growth factor receptor; TKI, tyrosine kinase inhibitor; NSCLC, non-small cell lung cancer; DFS, disease-free survival; HR, hazard ratio; PFS, progression-free survival.