Table 1.
Score | Observation | N# of patients (%) | EGFR signal features | FISH result Patients (%) | ||
---|---|---|---|---|---|---|
Arm A | Arm B | Overall | ||||
1 | Disomy | 11 (3.9%) | 13 (4.7%) | 24 (4.3%) | < 40% of cells displaying ≥ 4 copies of the EGFR signal AND EGFR/CEP7 ratio < 2 AND absence of gene clusters AND < 10% of cells displaying ≥ 15 copies of EGFR |
Negative
349 (62.7%) |
2 | Low trisomy | 61 (21.6%) | 56 (20.4%) | 117 (21.0%) | ||
3 | High trisomy | 10 (3.5%) | 13 (4.7%) | 23 (4.1%) | ||
4 | Low polysomy | 89 (31.6%) | 96 (34.9%) | 185 (33.2%) | ||
5 | High polysomy | 89 (31.6%) | 78 (28.4%) | 167 (30.0%) | ≥ 40% of cells displaying ≥ 4 copies of the EGFR signal* |
Positive
208 (37.3%) |
6 | Gene amplification | 22 (7.8%) | 19 (6.9%) | 41 (7.4%) | EGFR/CEP7 ratio ≥ 2 OR presence of gene clusters (≥ 4 spots) OR ≥ 10% of cells displaying ≥ 15 copies of EGFR* |
|
TOTAL | 282 (50.6%) | 275 (49.4%) | 557 (100%) |
Arm A: cisplatin-gemcitabine-necitumumab; Arm B: cisplatin-gemcitabine.
If a sample met the critieria for both high polysomy and gene amplification, the sample was categorized as score=6.