Table 1. Randomised trials evaluating EGFR-TKIs in EGFR-mutation positive patients with NSCLC.
Study/phase | Treatment arms | No. patients; region | RR (%); P | PFS (months) | HR; P | OS (months) | HR; P |
---|---|---|---|---|---|---|---|
IPASS/III (9,10) | Gefitinib vs. carboplatin-taxol | 261; Asia | 71.2 vs. 47.3; <0.001 | 9.5 vs. 6.3 | 0.48; <0.001 | 21.6 vs. 21.9 | 1; 0.990 |
First-SIGNAL/III (11) | Gefitinib vs. cisplatin-gemcitabine | 96; Korea | 84.6 vs. 37.5; 0.002 | 8.5 vs. 6.7 | 0.54; 0.086 | 27.2 vs. 25.6 | 1.043; 0.428 |
WJTOC 3405/III (12,13) | Gefitinib vs. cisplatin-docetaxel | 177; Japan | 62.1 vs. 32.2; <0.0001 | 9.2 vs. 6.3 | 0.488; <0.0001 | 36.0 vs. 39.0 | 1.19; 0.443 |
NEJ002/III (14,15) | Gefitinib vs. carboplatin-taxol | 230; Japan | 73.7 vs. 30.7; <0.001 | 10.4 vs. 5.4 | 0.30; <0.001 | 27.7 vs. 26.6 | 0.887; 0.483 |
OPTIMAL/III (16,17) | Erlotinib vs. carboplatin-gemcitabine | 154; China | 83.0 vs. 36.0; <0.0001 | 13.1 vs. 4.6 | 0.16; <0.0001 | 22.8 vs. 27.2 | 1.19; 0.2663 |
EURTAC/III (18) | Erlotinib vs. cisplatin-docetaxel | 174; Europe | 58.0 vs. 15.0; <0.0001 | 9.7 vs. 5.2 | 0.37; <0.0001 | 19.3 vs. 19.5 | 1.04; 0.87 |
ENSURE/III (19) | Erlotinib vs. cisplatin-gemcitabine | 148; Asia | 62.7 vs. 33.6; <0.0001 | 11.0 vs. 5.3 | 0.34; <0.0001 | 26.3 vs. 25.5 | 0.91; 0.607 |
LUX-LUNG 3/III (20,21) | Afatinib vs. cisplatin-pemetrexed | 345; Global | 56.0 vs s. 23.0; 0.001 | 11.1 vs. 6.9 | 0.58; 0.001 | 28.2 vs. 28.2 | 0.88; 0.39 |
LUX-LUNG 6/III (21,22) | Afatinib vs. cisplatin-gemcitabine | 364; China | 67.0 vs. 23.0; <0.0001 | 11.0 vs. 5.6 | 0.28; <0.001 | 23.1 vs. 23.5 | 0.93; 0.61 |
LUX-LUNG 7/II (23,24) | Afatinib vs. gefitinib | 319; Global | 70.0 vs. 56.0; 0.0083 | 11.0 vs. 10.9 | 0.73; <0.017 | 27.9 vs. 24.5 | 0.86; 0.258 |
JO25567/II (25) | Erlotinib + bevacizumab vs. erlotinib | 154; Japan | 69.3 vs. 63.6; 0.4951 | 16.0 vs. 9.7 | 0.54; 0.0015 | NR | NR |
EGFR-TKIs, epidermal growth factor receptor-tyrosine kinase inhibitors; HR, hazard ratio; NR, not reached; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival; RR, response rate.