Table 3.
Response rates in subset of patients with measureable disease (per RECIST) at baseline
Analysis Group | Outcome | All Patients | EGFR FISH-Positive | EGFR FISH Non-Positive |
---|---|---|---|---|
All Patients | Cetuximab Arm RR, 95% CI | 257/617 = 42% (38% – 46%) | 87/187 = 47% (39% – 54%) | 170/430 = 40% (35% – 44%) |
Control Arm RR, 95% CI | 227/623 = 36% (33% – 40%) | 82/191 = 43% (36% – 50%) | 145/432 = 34% (29% – 38%) | |
p-value | 0.06 | 0.48 | 0.07 | |
Bevacizumab | Cetuximab Arm RR, 95% CI | 126/266 = 47% (41% – 53%) | 44/83 = 53% (42% – 64%) | 82/183 = 45% (38% – 52%) |
Control Arm RR, 95% CI | 118/255 = 46% (40% – 52%) | 46/75 = 61% (50% – 72%) | 72/180 = 40% (33% – 47%) | |
p-value | 0.80 | 0.29 | 0.35 | |
No Bevacizumab | Cetuximab Arm RR, 95% CI | 131/351 = 37% (32% – 42%) | 43/104 = 41% (32% – 51%) | 88/247 = 36% (30% – 42%) |
Control Arm RR, 95% CI | 109/368 = 30% (25% – 34%) | 36/116 = 31% (23% – 39%) | 73/252 = 29% (23% – 35%) | |
p-value | 0.03 | 0.11 | 0.11 | |
Squamous Cell Histology | Cetuximab Arm RR, 95% CI | 59/150 = 39% (32% – 47%) | 23/50 = 46% (32% – 60%) | 36/100 = 36% (27% – 45%) |
Control Arm RR, 95% CI | 54/155 = 35% (27% – 42%) | 21/54 = 39% (26% – 52%) | 33/101 = 33% (24% – 42%) | |
p-value | 0.42 | 0.46 | 0.62 | |
Non-Squamous Histology | Cetuximab Arm RR, 95% CI | 198/467 = 42% (38% – 47%) | 64/137 = 47% (38% – 55%) | 134/330 = 41% (35% – 46%) |
Control Arm RR, 95% CI | 173/468 = 37% (33% – 41%) | 61/137 = 45% (36% – 53%) | 112/331 = 34% (29% – 39%) | |
p-value | 0.09 | 0.72 | 0.07 |
Footnote: RR = Response rate; CI = Confidence Interval