Table 3. Event-Free Survival According to Levels of Stromal Tumor-Infiltrating Lymphocytes (TILs): Univariate and Multivariate Analyses With and Without Including Pathological Complete Response (pCR) in the Model.
| Characteristic | P Value | Hazard Ratio (95% CI) |
|---|---|---|
| Univariate Effect Without pCR (n = 387)a | ||
| Stromal TILs, per unit increase, % | <.001 | 0.97 (0.96-0.99) |
| Positive hormone receptor status | .16 | 0.74 (0.48-1.12) |
| Nodal statusb | .09 | 1.57 (0.91-2.58) |
| Tumor sizec | .39 | 1.20 (0.79-1.83) |
| Planned conservative surgeryd | .02 | 0.56 (0.33-0.91) |
| Combination treatmente | .26 | 0.74 (0.43-1.24) |
| Multivariate Effect Without pCR (n = 257)a | ||
| Stromal TILs, per unit increase, % | .002 | 0.97 (0.95-0.99) |
| Positive hormone receptor status | .66 | 0.89 (0.52-1.51) |
| Nodal statusb | .67 | 0.85 (0.37-1.71) |
| Tumor sizec | .85 | 1.05 (0.60-1.81) |
| Planned conservative surgeryd | .04 | 0.46 (0.21-0.91) |
| Combination treatmente | .53 | 0.84 (0.49-1.44) |
| Univariate Effect Including pCR (n = 257)f | ||
| Stromal TILs, per unit increase, % | <.001 | 0.97 (0.96-0.99) |
| Positive hormone receptor status | .24 | 0.78 (0.51-1.18) |
| Nodal statusb | .11 | 1.53 (0.89-2.51) |
| Tumor sizec | .53 | 1.14 (0.74-1.74) |
| Planned conservative surgeryd | .04 | 0.57 (0.33-0.94) |
| Combination treatmente | .21 | 0.71 (0.41-1.21) |
| pCR | .001 | 0.42 (0.24-0.70) |
| Multivariate Effect Including pCR (n = 250)f | ||
| Stromal TILs, per unit increase, % | .005 | 0.97 (0.95-0.99) |
| Positive hormone receptor status | .50 | 0.83 (0.48-1.44) |
| Nodal statusb | .78 | 0.90 (0.39-1.82) |
| Tumor sizec | .96 | 0.99 (0.56-1.70) |
| Planned conservative surgeryd | .048 | 0.46 (0.20-0.94) |
| Combination treatmente | .79 | 0.93 (0.53-1.61) |
| pCR | .04 | 0.51 (0.25-0.96) |
a
Using baseline characteristics (as TILs were assessed at baseline; lapatinib-alone patients were excluded from multivariate analysis).
b
Compared with reference status of N0 or N1.
c
Compared with reference size of T2.
d
Compared with reference status of not a candidate for breast-conserving surgery.
e
Compared with reference group of trastuzumab single-agent therapy.
f
Landmark analyses including pCR (lapatinib-alone patients were excluded from multivariate analysis; see eTable in the Supplement).