Table 1. Results of phase III trials of anti-EGFR monoclonal antibodies and chemotherapy in advanced NSCLC in overall population and according to EGFR FISH status.
| Treatment | BMS 099 (8) | FLEX (6,7) | SQUIRE (10,17) | SWOG S0819 (15) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CBDCA/TXT or TXL | CBDCA/TXT or TXL + CET | HR and P | CDDP/VNR | CDDP/VNR + CET | HR and P | CDDP/GEM | CDDP/GEM/NEC | HR and P | CBDCA/TXL +/– BEVA | CBDCA/TXL +/– BEVA + CET | HR and P | ||||
| No. of pts | 338 | 338 | 568 | 557 | 548 [100] | 545 [100] | 657 | 656 | |||||||
| Squamous histology, N [%] | 65 [19] | 67 [20] | 187 [33] | 190 [34] | 161 [25] | 160 [249] | |||||||||
| Outcome in overall population | |||||||||||||||
| ORR, % | 25.7 | 30.7 | P=0.0066 | 29 | 36 | P=0.010 | 29 | 31 | P=0.40 | 36 | 42 | P=0.060 | |||
| PFS, months | 4.24 | 4.40 | HR, 0.9; P=0.2358 | 4.8 | 4.8 | HR, 0.943; P=0.39 | 5.5 | 5.7 | HR, 0.85; P=0.02 | 4.5 | 4.6 | HR, 0.99; P=0.83 | |||
| OS, months | 8.38 | 9.69 | HR, 0.89; P=0.1685 | 10.1 | 11.3 | HR, 0.871; P=0.044 | 9.9 | 11.5 | HR, 0.84; P=0.01 | 9.2 | 10.9 | HR, 0.93; P=0.22 | |||
| Outcome according to EGFR FISH status | |||||||||||||||
| EGFR FISH positive, N [%] | 27 [26] | 27 [25] | 53 [36] | 49 [37] | 97 [18] | 111 [20] | 201 [31] | 199 [30] | |||||||
| ORR, % | 22.0 | 37.0 | P=0.37 | 26.4 | 36.7 | P=0.26 | NR | NR | NR | 43 | 47 | P=0.48 | |||
| PFS, months | 5.4 | 5.4 | HR, 1.54; P=0.18 | 4.2 | 4.4 | HR, 0.80; P=0.33 | 5.1 | 6.1 | HR, 0.71 | 4.8 | 5.4 | HR, 0.92; P=0.40 | |||
| OS, months | 8.6 | 12.5 | HR, 1.92; P=0.03 | 9.9 | 11.6 | HR, 0.91; P=0.44 | 9.2 | 12.6 | HR, 0.70 | 9.8 | 13.4 | HR, 0.81; P=0.054 | |||
| EGFR FISH negative, N [%] | 24 [23] | 26 [25] | 95 [64] | 82 [63] | 178 [32] | 171 [31] | 293 [45] | 283 [43] | |||||||
| ORR, % | 16.7 | 30.8 | P=0.33 | 34.7 | 32.9 | P=0.80 | NR | NR | NR | 34 | 40 | P=0.069 | |||
| PFS, months | 4.3 | 3.8 | HR, 0.65; P=0.15 | 4.2 | 5.2 | HR, 1.05; P=0.77 | 5.5 | 5.6 | HR, 1.04 | 4.3 | 4.4 | HR, 1.01; P=0.50 | |||
| OS, months | 7.4 | 7.4 | HR, 0.84; P=0.57 | 10.0 | 10.6 | HR, 0.91; P=0.56 | 10.7 | 11.1 | HR, 1.02 | 8.9 | 9.5 | HR, 0.95; P=0.85 | |||
EGFR, epidermal growth factor receptor; FISH, fluorescent in situ hybridization; NSCLC, non-small-cell lung cancer; No. pts, number of patients; ORR, objective response rate; PFS, progression-free survival; OS, overall survival; HR, hazard ratio; NR, not reported; CBDCA, carboplatin; TXT, docetaxel; CET, cetuximab; CDDP, cisplatin; GEM, gemcitabine; VNR, vinorelbine; TXL, paclitaxel; NEC, necitumumab.