Table 1 Phase III Studies Investigating the efficacy of EGFR inhibition alone or as part of the 1 st line treatment for stage IIIB-IV NSCLC
From: EGFR inhibition in non-small cell lung cancer: current evidence and future directions
Study | Stage | Study Arms | # Pts | ORR | Median PFS | Median OS |
|---|---|---|---|---|---|---|
TKI | ||||||
INTACT 1 [15] | IIIB-IV | Cisplatin + Gemcitabine (CG) vs. CG + Gefitinib 250 mg/d vs. CG + Gefitinib 500 mg/d | 363 vs. 365 vs. 365 | 47.20% vs. 51.20% vs. 50.30%, p = ns | 6.0 mo vs. 5.8 mo vs. 5.5 mo, p = 0.7633 | 10.9 mo vs. 9.9 mo vs. 9.9 mo, p = 0.4560 |
INTACT 2 [16] | III-IV | Carboplatin + Paclitaxel (CP) vs. CP + Gefitinib 250 mg/d vs. CP + Gefitinib 500 mg/d | 345 vs. 345 vs. 347 | 28.70% vs. 30.40% vs. 30.00%, p = ns | 5.0 mo vs. 5.3 mo vs. 4.6 mo, p = 0.0562 | 9.9 mo vs. 9.8 mo vs. 8.7 mo, p = 0.6385 |
TRIBUTE [17] | IIIB-IV | Carboplatin + Paclitaxel (CP) vs. CP + Erlotinib; followed by Erlotinib maintenance | 540 vs. 539 | 19.30% vs. 21.50%, p = 0.36 | 4.9 mo vs. 5.1 mo, p = 0.36 | 10.5 mo vs. 10.6 mo, p = 0.95 |
IPASS [18] Non smokers or former light smokers with adenocarcinoma | IIIB-IV | Carboplatin + Paclitaxel vs. Gefitinib | 608 vs. 609 | 32.20% vs. 43.00%, p <0.001 | 6.7% vs. 24.9% at 1 year, p <0.001 | 17.3 mo vs. 18.6 mo |
WJTOG3405 [19] Sensitive EGFR mutation + only | IIIB-IV, postoperative recurrent | Gefitinib vs. Cisplatin + Docetaxel | 86 vs. 86 | 62.10% vs. 32.20%, p <0.0001 | 9.2 mo vs. 6.3 mo, p <0.0001 | 30.9 mo vs. not reached, p = 0.211 |
OPTIMAL [20] Sensitive EGFR mutation + only | IIIB-IV | Erlotinib vs. Carboplatin + Gemcitabine | 82 vs. 72 | 83% vs. 36%, p <0.0001 | 13.1 mo vs. 4.6 mo, p <0.0001 |  |
NEJ002 [21] Sensitive EGFR mutation + only | IIIB-IV, postoperative recurrent | Gefitinib vs. Carboplatin/ Paclitaxel | 114 vs. 114 | 73.7% vs. 30.7%, p <0.001 | 10.8 mo vs. 5.4 mo, p <0.001 | 27.7 mo vs. 26.6 mo, p = 0.483 |
EURTAC [22] Sensitive EGFR mutation + only | IIIB-IV | Erlotinib v s. Platinum based chemotherapy | 86 vs. 87 | 63% vs. 18%, p <0.001 | 9.7 mo vs. 5.2 mo, p <0.0001 | 19.3 mo vs. 19.5 mo, p = 0.87 |
TORCH [23] | IIIB-IV | Erlotinib vs. Cisplatin/ Gemcitabine as 1st line treatment, and the opposite as 2nd line therapy | 373 vs. 371 | 20.3% vs. 32.6%; 2nd line Erlotinib vs. 2nd line chemo: 4.7% vs. 10.5%; p <0.001 | 6.4 mo vs. 8.9 mo | 8.7 mo vs. 11.6 mo |
Cetuximab | ||||||
FLEX [33] | IIIB-IV | Cisplatin + Vinorelbine (CV) vs. CV + Cetuximab | 568 vs. 557 | 29% vs. 35%, p = 0.010 | 4.8 mo vs. 4.8 mo, p = 0.39 | 10.1 mo vs. 11.3 mo, p = 0.044 |
BMS099 [34] | IIIB-IV | Carboplatin + Taxane (CT) vs. CT + Cetuximab | 338 vs. 338 | 17.20% vs. 25.70%, p = 0.007 | 4.24 mo vs. 4.40 mo, p = 0.2358 | 8.38 mo vs. 9.69 mo, p = 0.169 |