Table 4. Summary of randomized phase II/III trials of EGFR tyrosine kinase inhibitors in the adjuvant setting.
Trial | Phase | Population | Arms | N | mDFS (months) | HR | mOS (months) | HR |
---|---|---|---|---|---|---|---|---|
RADIANT | III | IB–IIIA EGFR+ | Erlotinib for 2 years | 623 | 50.5 | 0.9 | NR | 1.09 |
Placebo | 250 | 48.2 | NR | |||||
BR19 | III | IB–IIIA EGFR+ | Gefitinib for 2 years | 251 | 50.4 | 1.22 | 5.1 | 1.24 |
Placebo | 252 | NR | NR | |||||
CTONG1104/ADJUVANT | III | II–IIIA EGFR+ | Gefitinib for 2 years | 111 | 30.8 | 0.56 | 75.5 | 0.92 |
Cisplatin/vinorelbine | 111 | 19.8 | 62.8 | |||||
EVAN | II | IIIA EGFR+ | Erlotinib for 2 years | 51 | 42.4 | 0.268 | NR | 0.165 |
Cisplatin/vinorelbine | 51 | 21 | NR | |||||
ADAURA | III | IB–IIIA EGFR+ | Osimertinib for 3 years | 339 | NR | 0.17 | NR | 0.4 |
Placebo | 343 | 20.4 | NR | |||||
EVIDENCE | III | II–IIIA EGFR+ | Icotinib for 2 years | 151 | 47.0 | 0.36 | NR | 0.91 |
Intravenous chemotherapy | 132 | 22.1 | NR |
HR, hazard ratio; EGFR+, EGFR-mutated; mDFS, median disease-free survival; mOS, median overall survival; NR, not reached.