Table 1. Randomized controlled study of adjuvant EGFR-TKI for EGFR-mutated NSCLC.
| Study (reference) | Eligibility | Arm | No of EGFR-mutant | Effect of EGFR-TKI on DFS | Effect of EGFR-TKI on OS |
|---|---|---|---|---|---|
| EGFR-mutation-unselected | |||||
| BR.19 (Phase III) (7) | p-stage IB–IIIA | Gefitinib | 7/251 | HR =1.84 (0.44 to 7.73), P=0.40 | HR =3.16 (0.61 to 16.45), P=0.15 |
| Placebo | 8/252 | ||||
| RADIANT (Phase III) (8) | p-stage IB–IIIA EGFR-positive* | Erlotinib | 102/623 | HR =0.61 (0.38 to 0.98) | HR =1.09 (0.55 to 2.16) |
| mDFS, 46.4 m; 2 yr-DFS, 89% | |||||
| Placebo | 59/350 | mDFS, 28.5 m; 2 yr-DFS, 72% | |||
| EGFR-mutation-selected | |||||
| EVAN (Phase II) (9) | p-stage IIIA EGFR-mutant |
Erlotinib | 51 | 2 yr-DFS, 81.4% | |
| VP | 51 | 2 yr-DFS, 44.6%; HR =1.823 (1.194 to 2.784), P=0·0054 | |||
| CTONG1104 (Phase III) (10,11) | p-stage II–IIIA (N1–N2) EGFR-mutant |
Gefitinib | 111 | HR =0.60 (0.42 to 0.87), P=0.0054 | |
| mDFS, 28.7 m; 3 yr-DFS, 34% | |||||
| VP | 111 | mDFS, 18.0 m; 3 yr-DFS, 27% | |||
EGFR, epidermal growth factor receptor, TKI, tyrosine kinase inhibitor; NSCLC, non-small-cell lung cancer; DFS, disease-free survival; OS, overall survival; HR, hazard ratio; p-stage, pathologic stage; mDFS, median disease-free survival; 2-yr DFS, 2-year disease-free survival rate; VP, vinorelbine plus cisplatin. *EGFR protein expression by immunohistochemistry or EGFR amplification by fluorescence in situ hybridization.