Table 3.
Pathological outcomes according to blinded independent pathological review in the ITT population
| Variables | Cam+nab-TP (n = 132) | Cam+TP (n = 130) | TP (n = 129) |
|---|---|---|---|
| pCR | |||
| Rate, % (95%CI)a | 28.0 (20.6, 36.5) | 15.4 (9.7, 22.8) | 4.7 (1.7, 9.8) |
| Difference (vs TP group), % (95%CI)b | 23.5 (15.1, 32.0) | 10.9 (3.7, 18.1) | |
| OR (vs TP group) (95%CI)b | 8.11 (3.28, 20.06) | 3.81 (1.48, 9.80) | |
| P value (vs TP group)c | <0.0001 | 0.0034 | |
| MPR | |||
| Rate, % (95%CI)a | 59.1 (50.2, 67.6) | 36.2 (27.9, 45.0) | 20.9 (14.3, 29.0) |
| Difference (vs TP group), % (95%CI)b | 38.3 (27.4, 49.3) | 15.4 (4.7, 26.2) | |
| OR (vs. TP group) (95%CI)b | 5.51 (3.18, 9.56) | 2.19 (1.25, 3.84) | |
a95%CI were calculated based on the Clopper-Pearson method.
b95%CI for the stratification factor-adjusted rate differences were derived using the Mantel-Haenszel method.
cThe Cochran-Mantel-Haenszel test, stratified by clinical stage (I/II versus III/IVA), was used to compare between groups.
MPR, major pathological response.