Table 3 Summary of outcomes in phase II trial
Outcome | Erlotinib | Dalotuzumab 10 mg/kg plus erlotinib | |
|---|---|---|---|
N = 38 | N = 37 | ||
Response | Difference in rates: -0.052 (95% CI: -0.069-0.185); p = 0.317 | ||
Partial response | 3 (7.9%) | 1 (2.7%) | |
Complete response | 0 | 0 | |
Overall response | 3 (7.9%) | 1 (2.7%) | |
Not evaluable | 1 (2.6%) | 4 (10.8%) | |
Progressive disease | 14 (36.8%) | 11 (29.7%) | |
Stable disease | 21 (55.3%) | 21 (56.7%) | |
Stable disease ≤3 months | 11 (28.9%) | 10 (27%) | |
Stable disease 4-12 months | 7 (18.42%) | 7 (18.9%) | |
Stable disease >12 months | 3 (7.9%) | 2 (5.4%) | |
Progression-free survival (months) | 1.6 | 2.5 | HR, 0.86 (95% CI: 0.47-1.57); p = 0.268 |
Overall survival (months) | 10.2 | 6.6 | HR, 1.80 (95% CI: 0.87-3.72); p = 0.946 |