Table 1 Characteristics of the eligible clinical trials
Author and Year | Study phase | Country | Study design | Stage | N | EGFRm+ (%) | Adjuvant CT (%) | Intervention | Duration (months) | Endpoints | Follow-up (months) | mDFS (months) | DFS rate | DFS HR (95% CI) | OS HR (95% CI) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
N | Regimes | |||||||||||||||
Tada 2022 (IMPACT) | Phase 3 | Japan | RCT | II-III | 232 | 100% | 0% | 116 | Gefitinib | 24 | DFS | 70 | 35.9 | 31.8%(5y) | 0.92 (0.67–1.28) | 1.03 (0.65–1.65) |
100% | 100% | 116 | NP | Â | Â | 25.1 | 34.1%(5y) | |||||||||
He 2021 (EVIDENCE) | Phase 3 | China | RCT | II-IIIA | 283 | 100% | 0% | 151 | Icotinib | 22.2 | DFS | 24.9 | 47 | 63.9%(3y) | 0.36 (0.24–0.55) | 0.91 (0.42–1.94) |
100% | 100% | 132 | NP/PP | Â | 22.1 | 32.5%(3y) | ||||||||||
Wu 2020 (ADAURA) | Phase 3 | International | RCT | IB-IIIA | 682 | 100% | 76% (II-IIA), 26%(IB) | 339 | Osimertnib | 36 | DFS in II-IIIA | 22.1 | NR | 90%(2y) | 0.17 (0.11–0.26) | 0.40 (0.09–1.83) |
100% | 343 | Placebo | Â | Â | 19.6 | 44%(2y) | ||||||||||
Zhong 2018/2021 (ADJUVANT) | Phase 3 | China | RCT | II-IIIA | 222 | 100% | 0% | 111 | Gefitinib | 24 | DFS, OS | 80.0 | 30.8 | 39.6%(3y) 22.6%(5y) | 0.56 (0.40–0.79) | 0.92 (0.62–1.36) |
100% | 100% | 111 | NP | Â | 19.8 | 32.5%(3y) 23.2%(5y) | ||||||||||
Yue 2018 (EVAN) | Phase 2 | China | RCT | IIIA | 102 | 100% | 0% | 51 | Erlotinib | 24 | DFS, OS | 33 | 42.4 | 81.4%(2y) 54.2%(3y) | 0.27 (0.14–0.53) | 0.165 (0.047–0.579) |
100% | 100% | 51 | NP | Â | 21 | 44.6%(2y) 19.8%(3y) | ||||||||||
Kelly 2015 (RADIANT) | Phase 3 | International | RCT | IB-IIIA express EGFR | 973 | 16.4% | 50.6% | 623 | Erlotinib | 24 | DFS, OS in ITT | 47 | 50.5 | 67.2%(2y) | 0.90 (0.74–1.10) | 1.13 (0.881–1.448) |
16.9% | 57.1% | 350 | Placebo | Â | 48.2 | 62.4%(2y) | ||||||||||
161 | 100% | 45.1% | 102 | Erlotinib | 24 | DFS, OS in EGFRm+ | 47 | 46.4 | 75%(2y) | 0.61 (0.384–0.981) | 1.09 (0.555–2.161) | |||||
100% | 55.9% | 59 | Placebo | Â | 28.5 | 54%(2y) | ||||||||||
Feng 2015 | NA | China | RCT | IB-IIIA EGFRm+ | 41 | 100% | 100% | 21 | PTX + NDP/LP + Icotinib | 4–8 | DFS | 24 | NA | 90.5%(2y) | 0.45 (0.05–3.81) | NA |
100% | 100% | 20 | PTX + NDP/LP |  | 66.7%(2y) | |||||||||||
Li 2014 | Phase 2 | China | RCT | IIIA-N2 | 60 | 100% | 100% | 30 | PC + gefitinib | 6 | DFS, OS | 30.6 | 39.8 | 78.9%(2y) | 0.37 (0.16–0.85) | 0.37 (0.12–1.11) |
100% | 100% | 30 | PC | Â | 27 | 54.2%(2y) | ||||||||||
Goss 2013 (NCIC CTGBR19) | Phase 3 | North American | RCT | IB-IIIA | 503 | 4% | 17% | 251 | Gefitinib | 24 | OS, DFS | 4.7 years | 4.2 years | 50.2%(4y) | 1.22 (0.93–1.61); 1.84 (0.44–7.73) (EGFRm+) | 1.24 (0.94–1.64); 3.16 (0.61–16.45) EGFRm+ |
4.3% | 17% | 252 | Placebo | NR | 57.6%(4y) | |||||||||||