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.