Table 2.
Phase II clinical trials of neoadjuvant-targeted therapy.
| Trial | Stage | Size | Intervention Used | ORR | Complete Resection | MPR | pCR | Survival |
|---|---|---|---|---|---|---|---|---|
| CTONG1103 [7] | IIIA, N2 | 72 | Erlotinib vs. Gemcitabine + Cisplatin | 54.1% vs. 34.3% | 73% vs. 62.9% | 9.7% vs. 0% | 0% vs. 0% | mPFS: 21.5 months vs. 11.4 months mOS: 45.8 months vs. 39.2 months * |
| Zhang, Y. [23] | II- IIIA | 33 | Gefitinib | 54.5% | NR | 24.2% | NR | mDFS: 33.5 months OS at 48 months: 54.5% |
| Xiong, L. [24] | IIIA | 19 | Erlotinib | 42.1% | 68.4% | NR | NR | mOS: 51.6 months |
| Lv, C. [25] | I–IIIA | 134 | EGFR-TKI vs. Pemetrexed + Cisplatin | 55.8% vs. 38.5% | 95.3% vs. 95.6% | NR | 0% vs. 2.2% | mDFS: 15.0 months vs. 14.1 months † OS at 36 months: 76.6% vs. 66.8% |
| ASCENT [26] | 19 | Afatinib + CRT | 69% | NR | 57.1% | 14.3% | OS at 24 months: 85% mPFS: 34.6 months |
|
| Bao, Y. [27] | IB-IIIC | 42 | EGFR-TKIs | 47.6% | NR | 23.8% | NR | mRFS: 19.8 months |
* HR, 0.77; 95% CI, 0.41–1.45; p = 0.417, not significant; † 0.895 95% CI, 0.402–1.993; p = 0.871 not significant; EGFR-TKI, epidermal growth factor receptor–tyrosine kinase inhibitor; ORR, objective response rate; MPR, major pathological response; mPFS, median progress-free survival; mRFS, median recurrence-free survival; mDFS, median disease-free survival; OS, overall survival; CRT, chemoradiotherapy; NR, not reported.