Table 1.
Demographic and Clinical Characteristics of the Hormone Receptor–Positive Cohort and All Patients at baseline.*
| Hormone Receptor–Positive Cohort | All Patients | |||
|---|---|---|---|---|
| Characteristic | T-DXd (N = 331) | Physician’s Choice (N = 163) | T-DXd (N = 373) | Physician’s Choice (N = 184) |
| Median age, (range) — yr | 56.8 (31.5-80.2) | 55.7 (28.4-80.0) | 57.5 (31.5-80.2) | 55.9 (28.4-80.5) |
| Female sex — no. (%) | 329 (99.4) | 163 (100) | 371 (99.5) | 184 (100) |
| Region — no. (%) | ||||
| Europe or Israel | 149 (45.0) | 73 (44.8) | 166 (44.5) | 85 (46.2) |
| Asia | 128 (38.7) | 60 (36.8) | 147 (39.4) | 66 (35.9) |
| North America | 54 (16.3) | 30 (18.4) | 60 (16.1) | 33 (17.9) |
| Race — no. (%) † | ||||
| White | 156 (47.1) | 78 (47.9) | 176 (47.2) | 91 (49.5) |
| Black | 7 (2.1) | 2 (1.2) | 7 (1.9) | 3 (1.6) |
| Asian | 131 (39.6) | 66 (40.5) | 151 (40.5) | 72 (39.1) |
| Other | 37 (11.2) | 16 (9.8) | 39 (10.5) | 17 (9.2) |
| Missing data | 0 | 1 (0.6) | 0 | 1 (0.5) |
| Ethnic group — no. (%) † | ||||
| Hispanic or Latino | 14 (4.2) | 5 (3.1) | 14 (3.8) | 7 (3.8) |
| Non-Hispanic or Non-Latino | 267 (80.7) | 137 (84.0) | 308 (82.6) | 153 (83.2) |
| Unknown | 9 (2.7) | 4 (2.5) | 9 (2.4) | 7 (3.8) |
| Not applicable | 41 (12.4) | 17 (10.4) | 42 (11.3) | 17 (9.2) |
| HER2-low status — no. (%) ‡ | ||||
| IHC 1+ | 193 (58.3) | 95 (58.3) | 215 (57.6) | 106 (57.6) |
| IHC 2+ and ISH-negative | 138 (41.7) | 68 (41.7) | 158 (42.4) | 78 (42.4) |
| ECOG performance status score — no. (%) § | ||||
| 0 | 187 (56.5) | 95 (58.3) | 200 (53.6) | 105 (57.1) |
| 1 | 144 (43.5) | 68 (41.7) | 173 (46.4) | 79 (42.9) |
| Hormone receptor–positive — no. (%) ¶ | 328 (99.1) | 162 (99.4) | 333 (89.3) | 166 (90.2) |
| Metastases — no. (%) | ||||
| Brain | 18 (5.4) | 7 (4.3) | 24 (6.4) | 8 (4.3) |
| Liver | 247 (74.6) | 116 (71.2) | 266 (71.3) | 123 (66.8) |
| Lung | 98 (29.6) | 58 (35.6) | 120 (32.2) | 63 (34.2) |
| Previous cancer therapy — no. (%) | ||||
| Targeted therapy | 259 (78.2) | 132 (81.0) | 279 (74.8) | 140 (76.1) |
| CDK4/6 inhibitor | 233 (70.4) | 115 (70.6) | 239 (64.1) | 119 (64.7) |
| Immunotherapy | 10 (3.0) | 8 (4.9) | 20 (5.4) | 12 (6.5) |
| Other | 128 (38.7) | 70 (42.9) | 140 (37.5) | 76 (41.3) |
| Endocrine therapy | 330 (99.7) | 160 (98.2) | 347 (93.0) | 165 (89.7) |
| Chemotherapy | 331 (100) | 162 (99.4) | 373 (100) | 183 (99.5) |
| Lines of therapy for metastatic disease | ||||
| Median no. of lines (range) | 3 (1-9) | 3 (1-8) | 3 (1-9) | 3 (1-8) |
| No. of lines —no. of patients (%) | ||||
| 1 | 23 (6.9) | 14 (8.6) | 39 (10.5) | 19 (10.3) |
| 2 | 85 (25.7) | 41 (25.2) | 100 (26.8) | 53 (28.8) |
| ≥3 | 223 (67.4) | 108 (66.3) | 234 (62.7) | 112 (60.9) |
Percentages may not total 100 because of rounding. CDK4/6 denotes cyclin-dependent kinases 4 and 6.
Race and ethnic group were reported by the patients. For available options, see the methods section in the Supplementary Appendix.
Low expression of human epidermal growth factor receptor (HER2) was defined as a score of 1+ on immunohistochemical (IHC) analysis or as an IHC score of 2+ and negative results on in situ hybridization (ISH).
Performance-status scores on the Eastern Cooperative Oncology Group (ECOG) scale range from 0 (no disability) to 5 (death).
For the intention-to-treat analyses in the hormone receptor–positive cohort, hormone-receptor status is based on data collected with the use of the interactive Web-response and voice-response system at the time of randomization, which includes patients who were mis-stratified.