Table 3. Survival HRs according to EGFR mutation status in phase III clinical trials with EGFR tyrosine kinase inhibitors.
| Trial | N | HR | 95% CI | P-value | Biomarker by treatment interaction P-value |
|---|---|---|---|---|---|
| BR.21 (Shepherd et al, 2005; Tsao et al, 2005; Zhu et al, 2008) | |||||
| EGFR mutated | 30 | 0.55 | 0.25–1.19 | 0.1217 | 0.47 |
| EGFR wild-type | 176 | 0.74 | 0.52–1.05 | 0.0924 | |
| ISEL (Thatcher et al, 2005; Hirsch et al, 2006) | |||||
| EGFR mutated | 26 | NR | NR | NR | NR |
| EGFR wild-type | 189 | ||||
| SATURN (Brugger et al, 2009; Cappuzzo et al, 2010b)a | |||||
| EGFR mutated | 22 | 0.10 | 0.04–0.25 | <0.0001 | |
| EGFR wild-type | 199 | 0.78 | 0.63–0.96 | 0.0195 | |
| ATLAS (Johnson et al, 2009)a | |||||
| EGFR mutated | 52 | 0.44 | 0.22–0.86 | NR | NR |
| EGFR wild-type | 295 | 0.85 | 0.64–1.13 | NR | |
| INTEREST (Kim et al, 2008; Douillard et al, 2010) | |||||
| EGFR mutated | 0.83 | 0.41–1.67 | 0.60 | 0.59 | |
| EGFR wild-type | NR | 1.02 | 0.78–1.33 | 0.91 | |
| IPASS (Fukuoka et al, 2009; Mok et al, 2009)a | |||||
| EGFR mutated | 261 | 0.48 | 0.36–0.64 | <0.001 | <0.0001 |
| EGFR wild-type | 176 | 2.85 | 2.05–3.98 | <0.001 | |
| WJTOG3405 (Mitsudomi et al, 2010)a,b | 177 | 0.489 | 0.336–0.710 | <0.0001 | NA |
| NEJ002 (Maemondo et al, 2010)a,c | 230 | 0.36 | 0.25–0.51 | <0.001 | NA |
| CTONG 0802 (Zhou et al, 2010) | 154 | 0.16 | 0.10–0.26 | <0.0001 | NA |
Abbreviations: ATLAS=Avastin and Tarceva or Avastin and pLAcebo in patients with NSCLC; CI=confidence interval; EGFR=epidermal growth factor receptor; HR=hazard ratio; ISEL=Iressa Survival Evaluation in Lung Cancer; INTEREST=Iressa NSCLC Trial Evaluating Response and Survival versus Taxotere; IPASS=Iressa Pan-Asian Study; NR=not reported; NA=not applicable; SATURN=Sequential Tarceva in Unresectable NSCLC; TKI=tyrosine kinase inhibitor.
HR for progression-free survival.
Gefitinib vs cisplatin/docetaxel.
Gefitinib vs paclitaxel/carboplatin.