Table 1.
Results of phase III trials comparing epidermal growth-factor receptor (EGFR)-tyrosine kinase inhibitors with chemotherapy as first-line treatment in non-small-cell lung cancer patients with EGFR mutations
| Authors | Trial | Regimens | Patients | Method to detect EGFR mutation | ORR (%) | PFS
|
OS
|
||
|---|---|---|---|---|---|---|---|---|---|
| Months | HR (95% CI) | Months | HR (95% CI) | ||||||
| Mok et al,22 Fukuoka et al23 | IPASS | Gefitinib | 132 | SARMS | 71.2 | 9.5 | 0.48 | 21.6 | 1.00 |
| CBDCA plus PAC | 129 | 47.3 | 6.3 | (0.34–0.67) P < 0.001 |
21.9 | (0.76–1.33) P = 0.990 |
|||
| Han et al21 | First-SIGNAL | Gefitinib | 26 | Direct sequencing | 84.6 | 8.0 | 0.54 | 27.2 | 1.043 |
| CDDP plus GEM | 16 | 37.5 | 6.3 | (0.269–1.100) P = 0.086 |
25.6 | (0.498–2.182) – |
|||
| Mitsudomi et al25,26 | WJTOG3405 | Gefitinib | 86 | Various methods | 62.1 | 9.6 | 0.520 | 38.8 | 1.185 |
| CDDP plus DOC |
86 | 32.1 | 6.6 | (0.378–0.715) P < 0.001 |
35.5 | (0.767–1.829) P = 0.443 |
|||
| Maemondo et al27 | NEJ002 | Gefitinib | 114 | PNA-LNA | 73.7 | 10.8 | 0.322 | 27.7 | 0.887 |
| Inoue et al28 | CBDCA plus PAC |
114 | PCR clamp | 30.7 | 5.4 | (0.236–0.438) P < 0.001 |
26.6 | (0.634–1.241) P = 0.483 |
|
| Zhou et al30 | OPTIMAL | Erlotinib | 82 | Direct sequencing | 83.0 | 13.1 | 0.16 | 22.7 | 1.04 |
| CBDCA plus GEM |
72 | 36.0 | 4.6 | (0.10–0.26) P < 0.0001 |
28.8 | (0.69–1.58) P = 0.691 |
|||
| Rosell et al32 | EUROTAC | Erlotinib | 86 | Various methods | 64.0 | 9.7 | 0.37 | 19.3 | 1.04 |
| CDDP-based | 87 | 15.0 | 5.2 | (0.25–0.54) P < 0.0001 |
19.5 | (0.65–1.68) P = 0.870 |
|||
Abbreviations: CBDCA, carboplatin; PAC, paclitaxel; CDDP, cisplatin; GEM, gemcitabine; DOC, docetaxel; ORR, objective response rate; PFS, progression-free survival; OS, overall survival; HR, hazard ratio; CI, confidence interval; SARMS, Scorpion amplification-refractory mutation system; PNA-LNA PCR, peptide nucleic acid-locked nucleic acid polymerase chain reaction.