Table 1

EGFR FISH status and impact on survival in selected randomised NSCLC trials with EGFR TKIs

Study/authorTreatment armNo. of patients with EGFR FISH resultNo. of patients with EGFR FISH-positive status*HR for survival in EGFR FISH-positive patients†Cut-off values for EGFR FISH-positive status
BR.21/Tsao et al16 17Erlotinib (150 mg) versus placebo15956 (45)0.43 (0.004)High degrees of polysomy or EGFR gene amplification using Colorado scoring criteria
ISEL/Hirsch et al18Gefitinib (250 mg) versus placebo370114 (31)0.61 (0.067)High polysomy (⩾4 copies of EGFR in ⩾40% of cells) or EGFR gene amplification
INVITE/Crino et al22Gefitinib (250 mg) versus vinorelbine15854 (34)2.88NR
INTEREST/Kim et al24 25Gefitinib (250 mg) versus docetaxel374174 (47)1.09 (0.52)High polysomy (⩾4 copies of EGFR in ⩾40% of cells) or EGFR gene amplification
TRIBUTE/Hirsch et al26Carboplatin/paclitaxel+erlotinib (150 mg) versus carboplatin/paclitaxel+placebo245100 (41)1.52 (0.083)High polysomy (⩾4 copies of EGFR in ⩾40% of cells) or EGFR gene amplification
  • *Values in parentheses are percentages; †values in parentheses are p values.

  • EGFR, epidermal growth factor receptor; FISH, fluorescence in situ hybridisation; HR, hazard ratio; NR, not reported in manuscript; NSCLC, non-small-cell lung cancer; TKI, tyrosine kinase inhibitor.