Table 1 Biomarker status at baseline among patients in the intent-to-treat population of the MARIANNE study
Trastuzumab + taxane (Control) (N = 365)a | T-DM1 (T-DM1) (N = 367)a | T-DM1 + pertuzumab (T-DM1 + P) (N = 363)a | |
|---|---|---|---|
HER2 mRNA | |||
n (%) | 330 (90) | 339 (92) | 330 (91) |
Median (range) | 57.28 (1.9–4182.1) | 56.89 (0.9–3615.6) | 61.61 (2.1–3281.2) |
HER2 status, n (%) | |||
ISH-positive/IHC 3+ | 294 (81) | 305 (83) | 295 (81) |
ISH-positive/IHC 2+ | 27 (7) | 25 (7) | 27 (7) |
ISH-positive/IHC 1+, 0 or unknown | 5 (1) | 2 (1) | 3 (1) |
ISH-negative/IHC 3+ | 7 (2) | 5 (1) | 7 (2) |
ISH-negative or unknown/IHC 2+ | 0 | 0 | 2 (1) |
ISH unknown/IHC 3+ | 32 (9) | 30 (8) | 29 (8) |
HER3 mRNA | |||
n (%) | 331 (91) | 342 (93) | 332 (91) |
Median (range) | 1.88 (0.1–33.1) | 1.57 (0.1–52.7) | 1.71 (0.1–26.0) |
PIK3CA status | |||
n (%) | 326 (89) | 332 (90) | 328 (90) |
Mutated, n (%) | 83 (25) | 92 (28) | 88 (27) |
Non-mutated, n (%) | 243 (75) | 240 (72) | 240 (73) |
PTEN H-score | |||
n (%) | 182 (50) | 181 (49) | 179 (49) |
Median (range) | 135.0 (0.0–310.0) | 180.0 (0.0–370.0) | 160.0 (0.0–380.0) |
HER2 distribution | |||
n (%)b | 360 (99) | 365 (99) | 360 (99) |
Focal (10–29%), n (%) | 14 (4) | 12 (3) | 15 (4) |
Heterogeneous (30–79%), n (%) | 35 (10) | 37 (10) | 33 (9) |
Homogeneous (≥80%), n (%) | 311 (86) | 316 (87) | 312 (87) |