Table 2.
Summary table of CNS best response by composite criteria among evaluable patients
| Response | All (n = 38) | Cohort 1 (HER2-negative) (n = 9) | Cohort 2 (HER2-positive) (n = 29) |
|---|---|---|---|
| No. of patients (%) | No. of patients (%) | No. of patients (%) | |
| CR | 0 (0) | 0 (0) | 0 (0) |
| PR | 24 (63)a | 5 (56) | 19 (66) |
| SD > 24 weeks | 2 (5) | 0 (0) | 2 (7) |
| SD < 24 weeks | 5 (13) | 0 (0) | 5 (17) |
| PDb | 7 (18) | 4 (44) | 3 (10) |
| PD in CNS by radiographic criteria | 1 (3) | 0 (0) | 1 (3) |
| Symptomatic deterioration | 2 (5) | 1 (11) | 1 (3) |
| PD in non-CNS site(s) | 4 (11) | 3 (33) | 1 (3) |
aTaking into account the two-stage design, the 95% CI for CNS ORR (n = 38) is 47 to 77%
bPatients were considered to have progressed if any of the PD criteria were met. Each patient could also have been taken off study for meeting multiple PD criteria simultaneously
Abbreviations: CNS central nervous system, CR complete response, HER2 human epidermal growth factor receptor 2, PD progression of disease, PR partial response, SD stable disease