Table 1.
Baseline patients’ characteristics and pathological complete response rates of the NeoALTTO and CALGB 40601 RNA sequencing cohorts
| NeoALTTO (N = 254) | CALGB 40601 (N = 264) | P value | |
|---|---|---|---|
| Age | 0.735a | ||
| - Median (Q1, Q3) | 49.0 (41.2, 56.8) | 49.0 (41, 56) | |
| Racial or ethnic group | 1.11 × 10−12b | ||
| - Asian | 69 (27.2%) | 16 (6.1%) | |
| - Black | 4 (1.6%) | 21 (8.0%) | |
| - White | 158 (62.2%) | 213 (80.7%) | |
| - Other | 23 (9.1%) | 14 (5.3%) | |
| Tumor size | 1.75 × 10–9b | ||
| - Not available | 0 | 16 | |
| - cT1 | 0 (0.0%) | 24 (9.7%) | |
| - cT2 | 151 (59.4%) | 161 (64.9%) | |
| - ≥ cT3 | 103 (40.6%) | 63 (25.4%) | |
| Nodal stage | 9.05 × 10−8b | ||
| - cN0 | 67 (26.4%) | 113 (42.8%) | |
| - cN1 | 149 (58.7%) | 110 (41.7%) | |
| - cN2 | 24 (9.4%) | 23 (8.7%) | |
| - cN3 | 13 (5.1%) | 3 (1.1%) | |
| - cNx | 1 (0.4%) | 15 (5.7%) | |
| HR status | 0.331b | ||
| - Negative | 117 (46.1%) | 110 (41.7%) | |
| - Positive | 137 (53.9%) | 154 (58.3%) | |
| ER status | 0.113b | ||
| - Negative | 128 (50.4%) | 114 (43.2%) | |
| - Positive | 126 (49.6%) | 150 (56.8%) | |
| pCR breast (ypT0/is) | 0.007b | ||
| - No | 166 (65.4%) | 141 (53.4%) | |
| - Yes | 88 (34.6%) | 123 (46.6%) | |
| pCR breast + axilla (ypT0/is ypN0) | 0.008b | ||
| - Not available | 10 | 0 | |
| - No | 169 (69.3%) | 152 (57.6%) | |
| - Yes | 75 (30.7%) | 112 (42.4%) | |
| Treatment Arm | 0.003b | ||
| - Lapatinib (L) | 89 (35.0%) | 57 (21.6%) | |
| - Trastuzumab (T) | 79 (31.1%) | 104 (39.4%) | |
| - T + L | 86 (33.9%) | 103 (39.0%) | |
| TILs (%)c | 6.79 × 10−10a | ||
| - Median (Q1, Q3) | 12.5 (5, 32.5) | 20 (13.125, 45) | |
| PAM50 | 0.302b | ||
| - HER2-Enriched | 151 (59.4%) | 146 (55.3%) | |
| - Basal-like | 21 (8.3%) | 22 (8.3%) | |
| - Luminal B | 41 (16.1%) | 35 (13.3%) | |
| - Luminal A | 22 (8.7%) | 28 (10.6%) | |
| - Normal-like | 19 (7.5%) | 33 (12.5%) |
P values are two-sided.
BCR B cell receptor, ER estrogen receptor, HR hormone receptor, pCR pathological complete response, Q1 quartile 1, Q3 quartile 3, TILs tumor-infiltrating lymphocytes.
aWilcoxon rank sum test.
bFisher’s Exact Test.
cTILs data were available for 233 patients in NeoALTTO and 230 patients in CALGB 40601.