Table 1. Patient, Tumor, and Treatment Characteristics of the mFAS and PPS Populations.
| Characteristic | Patients in the category, No. (%) | |||||
|---|---|---|---|---|---|---|
| mFAS | PPS | |||||
| HD201 | Referent trastuzumab | Total | HD201 | Referent trastuzumab | Total | |
| Patient population, No. | 250 | 252 | 502 | 238 | 236 | 474 |
| Age, median (range), y | 53.7 (26.3-79.4) | 54.2 (28.0-82.1) | 54.1 (26.3-82.1) | 53.7 (26.3-79.4) | 53.6 (28.0-77.9) | 53.6 (26.3-79.4) |
| Region | ||||||
| Asia | 20 (8.0) | 19 (7.5) | 39 (7.8) | 19 (8.0) | 17 (7.2) | 36 (7.6) |
| Western Europea | 14 (5.6) | 14 (5.6) | 28 (5.6) | 10 (4.2) | 8 (3.3) | 18 (3.8) |
| Eastern Europe | 216 (86.4) | 219 (86.9) | 435 (86.7) | 209 (87.8) | 211 (89.4) | 420 (88.6) |
| Weight, median (range), kg | 69 (43-125) | 71 (45-122) | 70 (43-125) | 69 (43-125) | 71 (45-122) | 70 (43-125) |
| ECOG performance status | ||||||
| 0 | 205 (82.0) | 191 (75.8) | 396 (78.9) | 196 (82.4) | 182 (77.1) | 378 (79.7) |
| 1 | 45 (18.0) | 61 (24.2) | 106 (21.1) | 42 (17.6) | 54 (22.9) | 96 (20.3) |
| Left ventricular ejection fraction at baseline, median (range), % | 65.5 (52-77) | 66.0 (51-80) | 66.0 (51-80) | 66.0 (52-77) | 66.0 (52-80) | 66.0 (52-80) |
| Clinical stage | ||||||
| I B | 0 | 1 (0.4) | 1 (0.2) | 0 | 1 (0.4) | 1 (0.2) |
| II A | 64 (25.6) | 70 (27.8) | 134 (26.7) | 61 (25.6) | 65 (27.5) | 126 (26.6) |
| II B | 80 (32.0) | 74 (29.4) | 154 (30.7) | 76 (31.9) | 68 (28.8) | 144 (30.4) |
| III A | 37 (14.8) | 29 (11.5) | 66 (13.1) | 34 (14.3) | 27 (11.4) | 61 (12.9) |
| III B | 50 (20.0) | 53 (21.0) | 103 (20.5) | 48 (20.2) | 51 (21.6) | 99 (20.9) |
| III C | 19 (7.6) | 25 (9.9) | 44 (8.8) | 19 (8.0) | 24 (10.2) | 43 (9.1) |
| Axillary clinical nodal status | ||||||
| N0 | 64 (25.6) | 71(28.2) | 135 (26.9) | 61 (25.6) | 66 (27.9) | 127 (26.8) |
| N1-N2-N3 | 186 (74.4) | 181 (71.8) | 367 (73.1) | 177 (74.4) | 170 (72.1) | 347 (73.2) |
| Hormone receptor status | ||||||
| ER+ or PR+ | 155 (62.0) | 152 (60.3) | 307 (61.2) | 152 (63.9) | 144 (61.0) | 296 (62.4) |
| ER−/PR− | 95 (38.0) | 100 (39.7) | 195 (38.8) | 86 (36.1) | 92 (39.0) | 178 (37.6) |
| ERBB2 status | ||||||
| Positive | 250 (100) | 252 (100) | 502 (100) | 238 (100) | 236 (100.0) | 474 (100) |
| Histological grade | ||||||
| I | 6 (3.3) | 6 (3.1) | 12 (3.2) | 6 (3.6) | 6 (3.4) | 12 (3.4) |
| II | 109 (60.6) | 105 (54.7) | 214 (57.5) | 101 (59.8) | 99 (55.3) | 200 (57.5) |
| III | 65 (36.1) | 81 (42.2) | 146 (39.2) | 62 (36.7) | 74 (41.3) | 136 (39.1) |
| Inflammatory breast | 32 (12.8) | 38 (15.1) | 70 (13.9) | 30 (12.6) | 36 (15.3) | 66 (13.9) |
| Sentinel node biopsy | 9 (3.6) | 7 (2.8) | 16 (3.2) | 8 (3.4) | 4 (1.7) | 12 (2.5) |
| Negative sentinel node | 2 (0.8) | 1 (0.4) | 3 (0.6) | 1 (0.4) | 1 (0.4) | 2 (0.4) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; mFAS, modified full analysis set; PPS, per-protocol set; PR, progesterone receptor.
a
Central Europe was pooled with Western Europe for the analysis.