Table 2. Survival HRs according to EGFR gene copy number as assessed by FISH in phase III 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) | |||||
| FISH positive | 61 | 0.43 | 0.23–0.78 | 0.0042 | 0.12 |
| FISH negative | 98 | 0.80 | 0.49–1.29 | 0.3525 | |
| ISEL (Thatcher et al, 2005; Hirsch et al, 2006) | |||||
| FISH positive | 114 | 0.61 | 0.36–1.04 | 0.067 | 0.045 |
| FISH negative | 256 | 1.16 | 0.81–1.64 | 0.417 | |
| SATURN (Brugger et al, 2009; Cappuzzo et al, 2010b)a | |||||
| FISH positive | 0.69 | NR | 0.0001 | NR | |
| ATLAS (Johnson et al, 2009)a | |||||
| FISH positive | 87 | 0.66 | 0.39–1.13 | NR | NR |
| FISH negative | 109 | 1.40 | 0.86–2.28 | NR | |
| INTEREST (Kim et al, 2008; Douillard et al, 2010) | |||||
| FISH positive | 174 | 1.09 | 0.78–1.51 | 0.62 | 0.52 |
| FISH negative | 200 | 0.93 | 0.68–1.26 | 0.64 | |
| IPASS (Fukuoka et al, 2009; Mok et al, 2009)a | |||||
| FISH positive | 249 | 0.66 | 0.50–0.88 | 0.0050 | 0.0437 |
| FISH negative | 157 | 1.24 | 0.87–1.76 | 0.2368 | |
Abbreviations: ATLAS=Avastin and Tarceva or Avastin and pLAcebo in patients with NSCLC; CI=confidence interval; EGFR=epidermal growth factor receptor; FISH=fluorescence in situ hybridisation; 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; SATURN=Sequential Tarceva in Unresectable NSCLC.
a
HR for progression-free survival.