Table 1. Selected trials of gefitinib, erlotinib, icotinib and afatinib, compared to chemotherapy as first-line therapy for EGFR-mutant NSCLC patients.
| Study name | Design | Population (N of patients) | Median PFS (months) | Median OS (months) | ORR (%) | Ref. |
|---|---|---|---|---|---|---|
| IPASS | Gefitinib vs. carboplatin-paclitaxel in pulmonary adenocarcinoma; phase 3 | 261 EGFR mutant (1,217 total) | 9.5 (gefitinib) vs. 6.3 (chemotherapy); P<0.001 | 21.6 (gefitinib) vs. 21.9 (chemotherapy); ns | 71.2% (gefitinib) vs. 47.3% (chemotherapy); P<0.001 | (21,22) |
| WJTOG3405 | Gefitinib vs. cisplatin plus docetaxel in EGFR mutant NSCLC patients; phase 3 | 117 | 9.2 (gefitinib) vs. 6.3 (chemotherapy); P<0.0001 | 34.8 (gefitinib) vs. 37.3 (chemotherapy); ns | 62.1% (gefitinib) vs. 32.2% (chemotherapy); P<0.0001 | (23,24) |
| NEJ002 | Gefitinib vs. chemotherapy in EGFR mutant NSCLC patients; phase 3 | 230 | 10.8 (gefitinib) vs. 5.4 (chemotherapy); P<0.001 | 30.5 (gefitinib) vs. 23.6 (chemotherapy); ns | 73.7% (gefitinib) vs. 30.7% (chemotherapy); P<0.001 | (25) |
| NEJ009 | Gefitinib plus chemotherapy vs. gefitinib in EGFR mutant NSCLC patients; phase 3 |
334 | 20.9 (gefitinib plus chemotherapy) vs. 11.2 (gefitinib); P<0.001 PFS21, 20.9 (gefitinib plus chemotherapy) vs. 20.7 (gefitinib); P=0.0774 |
52.2 (gefitinib plus chemotherapy) vs. 38.8 (gefitinib); P=0.013 | 84.0 (gefitinib plus chemotherapy) vs. 76.4 (gefitinib) | (26) |
| EURTAC | Erlotinib vs. chemotherapy in EGFR mutant NSCLC patients; phase 3 | 173 | 9.4 (erlotinib) vs. 5.2 (chemotherapy); P<0.0001 | 19.3 (erlotinib) vs. 19.5 (chemotherapy); ns | 64% (erlotinib) vs. 18% (chemotherapy); P<0.0001 | (27) |
| OPTIMAL | Erlotinib vs. chemotherapy in EGFR mutant NSCLC patients; phase 3 | 165 | 13.1 (erlotinib) vs. 4.6 (chemotherapy); P<0.0001 | 22.8 (erlotinib) vs. 27.2 (chemotherapy); ns | 83% (erlotinib) vs. 36% (chemotherapy); P<0.0001 | (28,29) |
| ENSURE | Erlotinib vs. chemotherapy in EGFR mutant NSCLC patients; phase 3 | 217 | 11 (erlotinib) vs. 5.5 (chemotherapy); P<0.0001 | 26.3 (erlotinib) vs. 22.5 (chemotherapy); ns | 62.7% (erlotinib) vs. 33.6% (chemotherapy); P<0.0001 | (30) |
| CONVINCE | Icotinib vs. chemotherapy in EGFR mutant NSCLC patients; phase 3 | 217 | 11.2 (icotinib) vs. 7.9 (chemotherapy); P=0.006 | 30.5 (icotinib) vs. 32.1 (chemotherapy); ns | – | (31) |
| LUX-Lung 3 | Afatinib vs. chemotherapy in EGFR mutant NSCLC patients; phase 3 | 345 | 11.1 (afatinib) vs. 6.9 (chemotherapy); P=0.001 | Overall: 28.2 (afatinib) vs. 28.2 (chemotherapy); ns. Exon 19 deletion: 33.3 (afatinib) vs. 21.1 months; P=0.0015. L858R mutation: 27.6 (afatinib) vs. 40.3 months; ns | 56% (afatinib) vs. 23% (chemotherapy); P=0.001 | (32,33) |
| LUX-Lung 6 | Afatinib vs. chemotherapy in EGFR mutant NSCLC patients; phase 3 | 345 (Asiatic) | 11.0 (afatinib) vs. 5.6 (chemotherapy); P<0.0001 | Overall: 23.1 (afatinib) vs. 23.5 (chemotherapy); ns Exon 19 deletion: 31.4 (afatinib) vs. 18.4 (chemotherapy); P=0.023 L858R mutation: 19.6 (afatinib) vs. 24.3 (chemotherapy); ns |
66.9% (afatinib) vs. 23% (chemotherapy); P<0.0001 | (33,34) |
| LUX-Lung 3 and LUX-Lung 6 | – | – | – | Exon 19 deletion: 31.7 (afatinib) vs. 20.7 (chemotherapy); P<0.0001 L858R mutation: 22.1 (afatinib) vs. 26.9 (chemotherapy); ns |
– | (33) |
ns, not significant; 1PFS2, progression after the next line of therapy; EGFR, epidermal growth factor receptor; NSCLC, non-small cell lung cancer; PFS, progression-free survival; OS, overall survival; ORR, objective response rate.