Table 6.

Archival tumor biomarker analysis

Patient treatment data
FISH*
Immunohistochemistry
EGFR
PTEN
EGFR
p-S6
p-MAPK
p-AKT
Pt ID no.StratumDose levelBest responseTTP (months)Copy numberStatusCopy numberStatusIDIDIDID
102A1PR5.535.8Amplified1.7Loss4+1004+903+80170
103A1PD2.230.2Amplified1.8IndeterminateNDNDNDNDNDNDNDND
107A1PD1.83Intact1.7Indeterminate3+503+102+30NDND
113A2SD4.515.6Amplified1.1LossNDNDNDNDNDND380
114A2SD3.121.6Amplified1.3Loss4+1004+502+50NDND
115A2SD4.63.2Polysomy1.1LossNDNDNDNDNDND390
204B1SD6.03.3Polysomy1.8Intact2+352+103+80350
205B1PD2.050Amplified1.2Loss3+1003+252+50390
211B2PD1.050Amplified1.9Intact4+903+1Focal50370
212B2PD2.13.6Polysomy2.9Polysomy4+75%3+25Focal8011
221B3PD1.34.3Polysomy1.8Intact3+304+752+90350
225B3PD1.01.9Intact1.6LossNDNDNDNDNDNDNDND
226B3SD5.04.7Polysomy2.5Polysomy3+104+10Focal30370
222B3PD2.53.7Polysomy1.3Loss2+754+75Focal10370
  • Abbreviations: ND, not done; PR: partial response; SD: stable disease; PD: progressive disease; TTP: time to progression; I, intensity; D, distribution.

  • * FISH: amplified EGFR: EGFR/chromosome 7 ratio >2.0; polysomy EGFR: EGFR/chromosome 7 ratio 1-2; PTEN loss: <2 copies PTEN with 2 copies of CEP 2 control in ≥30% nuclei; PTEN indeterminate: <2 copies PTEN with 2 copies of CEP 2 control in 20% to 30% nuclei.

  • Immunohistochemistry: wild-type EGFR, p-S6 ribosomal protein, p-p44/42 MAPK, p-AKT. I, most common staining pattern present overall (0+, no staining; 1+, minimal cytoplasmic/membraneous staining; 2+, mild cytoplasmic/membraneous staining; 3+, moderate cytoplasmic/membraneous staining; 4+, strong cytoplasmic/membraneous staining). D, percent positive cells; focal refers to heterogeneous, regional, or sporadic staining of <25% of evaluated tumor cells.

  • Stratum A: no EIAEDs; stratum B, on EIAEDs.