Table 1. Patient characteristics and gene copy number characteristics of NEAT and BR9601 patients at randomisation.
| E-CMF, N (%) | CMF, N (%) | |
|---|---|---|
| Age (n=2391) | ||
| ⩽50 years old | 713 (60) | 699 (58) |
| >50 years old | 476 (40) | 503 (42) |
| Menopausal status (n=2265) | ||
| Pre-menopausal | 572 (51) | 562 (49) |
| Peri-menopausal | 103 (9) | 117 (10) |
| Post-menopausal | 444 (40) | 467 (41) |
| Performance status (n=2090) | ||
| 0 – Fully active | 837 (80) | 834 (79) |
| 1 – Restricted | 197 (19) | 211 (20) |
| 2 – Capable self-care | 5 (1) | 6 (1) |
| Type of surgery (n=2381) | ||
| Mastectomy | 615 (52) | 634 (53) |
| Breast conserving surgery | 569 (48) | 563 (47) |
| Surgery randomisation (n=2376) | ||
| N | 1181 | 1195 |
| Median (IQR) (days) | 26 (20–34) | 25 (19–33) |
| Nodal involvement (n=2391) | ||
| 0 Nodes involved | 336 (28) | 337 (28) |
| 1–3 Nodes involved | 564 (48) | 565 (47) |
| 4+ Nodes involved | 289 (24) | 300 (25) |
| Tumour typea (n=2376) | ||
| NST/NST with lobular features | 1010 (86) | 1015 (85) |
| Classical lobular/pleomorphic lobular | 80 (7) | 89 (7) |
| Mixed NST and lobular | 27 (2) | 24 (2) |
| Mixed NST and special type | 15 (1) | 13 (1) |
| Pure special type | 49 (4) | 54 (5) |
| Tumour size (n=2334) | ||
| ⩽2 cm | 504 (44) | 517 (44) |
| >2 and ⩽5 cm | 595 (51) | 594 (51) |
| >5 cm | 60 (5) | 64 (5) |
| VL invasion (n=2391) | ||
| Reported | 605 (51) | 615 (51) |
| Unreported | 584 (49) | 587 (49) |
| Tumour gradea (n=2379) | ||
| 1 – Well-differentiated | 39 (3) | 42 (4) |
| 2 – Mod. differentiated | 438 (37) | 419 (35) |
| 3 – Poorly differentiated | 707 (60) | 734 (61) |
| ER statusa (n=2280) | ||
| Negative (Allred score 0–2) | 465 (41) | 474 (41) |
| Positive (Allred score ⩾3) | 669 (59) | 672 (59) |
| PgR status (n=1801) | ||
| Negative (Allred score 0–2) | 387 (44) | 412 (45) |
| Positive (Allred score ⩾3) | 489 (56) | 513 (55) |
| HER2 (n=1907) | ||
| Negative | 746 (79) | 770 (80) |
| Positive | 197 (21) | 194 (20) |
| EGFR (n=1910) | ||
| Negative | 724 (77) | 749 (77) |
| Positive | 218 (23) | 219 (23) |
| HER3 (n=1897) | ||
| Negative | 669 (72) | 684 (71) |
| Positive | 266 (28) | 278 (29) |
| HER1–3 (n=1732) | ||
| Negative | 378 (44) | 375 (43) |
| Positive | 485 (56) | 494 (57) |
| Ki67 (n=1872) | ||
| Low (⩽13%) | 360 (39) | 376 (40) |
| High (>13%) | 571 (61) | 565 (60) |
| Triple negatives (n=1256) | ||
| ER neg, PR neg, HER2 neg | 190 (30) | 195 (31) |
| ER pos, HER2 neg | 433 (70) | 438 (69) |
| HER2 (n=1762) | ||
| Normal | 690 (78) | 705 (80) |
| Amplification | 192 (22) | 175 (20) |
| TOP2A (n=1762) | ||
| Normal | 792 (90) | 801 (91) |
| Amplification | 90 (10) | 79 (9) |
| TOP2A (n=1762) | ||
| Normal | 789 (89) | 782 (89) |
| Deletion | 93 (11) | 98 (11) |
| TOP2A (n=1762) | ||
| Normal | 699 (79) | 703 (80) |
| Altered (either amplified or deleted) | 183 (21) | 177 (20) |
| Ch17CEP (n=1762) | ||
| Normal | 692 (78) | 664 (75) |
| Duplication | 190 (22) | 216 (25) |
Abbreviations: IQR= interquartile range; NEAT=National Epirubicin Adjuvant Trial; CMF=cyclophosphamide, methotrexate and fluorouracil.
Unknowns not shown.
a
ER and tumour grade and type were analysed centrally in 84%, local values were used in 16%.