Table 2.

Clinical use of predicting survival benefit according to EGFR protein expression by immunohistochemistry, EGFR copy number by FISH, and EGFR mutation status in large, placebo-controlled trials with EGFR TKIs

Author (reference)Study descriptionEGFR protein, percentage positive; HRs in positive vs. negative subsetsEGFR copy number by FISH, percentage positive; HRs in positive vs. negative subsetsEGFR mutations, percentage positive; HRs in positive vs. negative subsets
Tsao (2)BR.21, phase III trial comparing erlotinib to placebo in second or third-line treatment; trial result positive57%; 0.68 vs. 0.9345%; 0.44 vs. 0.8522.6%; 0.77 vs. 0.73
Hirsch (17) and Holloway (31)ISEL, phase III trial comparing gefitinib to placebo in second or third-line treatment; trial result negative68%; NR31%; 0.61 vs. 1.1412%; NR*
Bell (21) and Bailey (16)INTACT 1 and 2, phase III trials comparing addition of gefitinib or placebo to chemotherapy in first-line treatment; trials results negativeNSND10%; 1.77 vs. 0.91
Eberhard (30) and Herbst (35)TRIBUTE, phase III trial comparing addition of erlotinib or placebo to chemotherapy in first-line treatment; trial result negativeNR; 1.00 vs. 1.02ND13%; NS
  • NOTE: HR comparing EGFR TKI versus placebo.

    Abbreviations: ND, not done; NS, not significant [exact value(s) not reported].

  • * Not reported due to too few events.