Table 1. Baseline Characteristics of Patients in the Tumor-Infiltrating Lymphocyte (TIL) Cohort Compared With the Entire NeoALTTO Trial Population.
| Characteristic | Cohort | P Value Between TILs and No-TILs Cohorts | ||
|---|---|---|---|---|
| All NeoALTTO (N = 455) | TILs (n = 387) | No TILs (n = 68) | ||
| Age, median (range), y | 50 (23-80) | 50 (23-80) | 49 (23-72) | .65 |
| Tumor size, median (range), cm | 4.0 (2.1-9.5) | 4.0 (2.1-9.0) | 4.8 (2.1-9.5) | .09 |
| Nodal status, No. (%) | ||||
| N > 2, Nx, or missing | 72 (16) | 63 (16) | 9 (13) | .53 |
| N0 or N1 | 383 (84) | 324 (84) | 59 (87) | |
| Hormone receptor status, No. (%) | ||||
| Positive (>1%) | 232 (51) | 195 (50) | 37 (54) | .54 |
| Negative | 223 (49) | 192 (50) | 31 (46) | |
| Treatment group, No. | ||||
| Trastuzumab | 154 | 130 | 24 | .46 |
| Lapatinib | 149 | 131 | 18 | |
| Trastuzumab + lapatinib | 152 | 126 | 26 | |
| Clinical outcome, No. | ||||
| pCR events | 138 | 120 | 18 | .50 |
| EFS events | 105 | 90 | 15 | .83 |
| Deaths | 54 | 43 | 11 | .24 |
| Outcome for trastuzumab + lapatinib vs trastuzumab alone, odds ratio (95% CI)a | ||||
| pCR benefit | 2.40 (1.44-4.00) | 2.88 (1.65-5.02) | 0.84 (0.22-3.20) | .72 |
| EFS difference | 0.78 (0.49-1.28) | 0.75 (0.43-1.30) | 0.97 (0.28-3.44) | .32 |
Abbreviations: EFS, event-free survival; pCR, pathological complete response.
a
The odds ratio for the whole cohort does not match that of Baselga et al9 because we used a stratified analysis to be consistent with the analyses used for EFS rather than putting in the factors as covariates.