Biomarker | TCH + P N = 221 | T-DM1 + P N = 223 |
---|---|---|
HER2, n (%) | 221 (100.0) | 223 (100.0) |
ISH+/IHC3+ | 184 (83.3) | 185 (83.0) |
ISH+/IHC2+ | 25 (11.3) | 26 (11.7) |
ISH+/IHC0 or 1+ | 2 (0.9) | 0 (0) |
ISH−/IHC3+ | 1 (0.5) | 2 (0.9) |
ISH−/IHC2+ | 0 (0) | 1 (0.4)a |
ISH unknown/IHC3+ | 9 (4.1) | 8 (3.6) |
ISH unknown/IHC2+ | 0 (0) | 1 (0.4)a |
HER2/CEP17 gene ratio, n (%) | 211 (95.5) | 210 (94.2) |
≥ 2 to < 4 | 45 (21.3) | 52 (24.8) |
≥ 4 | 166 (78.7) | 158 (75.2) |
HER2 staining fraction, n (%) | 221 (100.0) | 223 (100.0) |
Focal (< 30%) | 15 (6.8)b | 16 (7.2) |
Heterogeneous (30–79%) | 27 (12.2) | 27 (12.1) |
Homogeneous (≥ 80%) | 179 (81.0) | 180 (80.7) |
HER2 mRNA expressionc | 213 (96.4) | 217 (97.3) |
Median (range) | 36.3 (1.7–1606.8) | 35.3 (2.0–548.8) |
≤ median, n (%) | 106 (49.8) | 109 (50.2) |
> median, n (%) | 107 (50.2) | 108 (49.8) |
HER3 mRNA expressionc | 212 (95.9) | 218 (97.8) |
Median (range) | 0.3 (0–2.0) | 0.3 (0–2.4) |
≤ median, n (%) | 101 (47.6) | 116 (53.2) |
> median, n (%) | 111 (52.4) | 102 (46.8) |
PIK3CA mutation status, n (%) | 213 (96.4) | 212 (95.1) |
Mutated | 53 (24.9) | 61 (28.8) |
Non-mutated | 160 (75.1) | 151 (71.2) |
PAM50 subtype, n (%) | 171 (77.4) | 183 (82.1) |
HER2-E | 104 (60.8) | 90 (49.2) |
Luminal A | 25 (14.6) | 35 (19.1) |
Luminal B | 32 (18.7) | 42 (23.0) |
Basal-like | 10 (5.8) | 16 (8.7) |
PD-L1, n (%) | 200 (90.5) | 196 (87.9) |
IC 0 | 117 (58.5) | 106 (54.1) |
IC 1, 2, 3 | 83 (41.5) | 90 (45.9) |