Table 1.
Characteristics of Patients in TEXT and SOFT, Overall and According to Trial and Chemotherapy Stratum.*
| Characteristic | No-Chemotherapy Cohorts | Chemotherapy Cohorts† | Overall (N = 4690) | ||
|---|---|---|---|---|---|
| TEXT (N = 1053) | SOFT (N = 943) | TEXT (N = 1607) | SOFT (N = 1087) | ||
| Age at randomization — no. (%) | |||||
|
| |||||
| <35 yr | 41 (3.9) | 14 (1.5) | 191 (11.9) | 224 (20.6) | 470 (10.0) |
|
| |||||
| 35–39 yr | 123 (11.7) | 68 (7.2) | 289 (18.0) | 312 (28.7) | 792 (16.9) |
|
| |||||
| 40–49 yr | 768 (72.9) | 690 (73.2) | 1048 (65.2) | 515 (47.4) | 3021 (64.4) |
|
| |||||
| ≥50 yr | 121 (11.5) | 171 (18.1) | 79 (4.9) | 36 (3.3) | 407 (8.7) |
|
| |||||
| Lymph-node status — no. (%) | |||||
|
| |||||
| Negative | 835 (79.3) | 865 (91.7) | 542 (33.7) | 470 (43.2) | 2712 (57.8) |
|
| |||||
| Positive | 218 (20.7) | 78 (8.3) | 1065 (66.3) | 617 (56.8) | 1978 (42.2) |
|
| |||||
| Tumor size — no. (%)‡ | |||||
|
| |||||
| ≤2 cm | 847 (80.4) | 800 (84.8) | 738 (45.9) | 537 (49.4) | 2922 (62.3) |
|
| |||||
| >2 cm | 203 (19.3) | 139 (14.7) | 844 (52.5) | 508 (46.7) | 1694 (36.1) |
|
| |||||
| HER2 positive — no. (%) | 54 (5.1) | 30 (3.2) | 272 (16.9) | 211 (19.4) | 567 (12.1) |
|
| |||||
| Interval from surgery to randomization — mo | |||||
|
| |||||
| Median | 1.5 | 1.8 | 1.2 | 8.0 | 1.6 |
|
| |||||
| Interquartile range | 1.1–1.9 | 1.3–2.4 | 0.9–1.6 | 5.7–10.1 | 1.1–2.7 |
|
| |||||
| Endocrine therapy before randomization — no. (%)§ | — | 44 (4.7) | — | 453 (41.7) | — |
A more complete summary of characteristics is provided in Table S1 in the Supplementary Appendix. Characteristics were well balanced according to treatment assignment (Table S2 in the Supplementary Appendix). The statistical analysis plan did not specify hypothesis testing regarding comparisons between these groups. HER2 denotes human epidermal growth factor receptor 2, SOFT Suppression of Ovarian Function Trial, and TEXT Tamoxifen and Exemestane Trial.
Among patients who received chemotherapy, patients in TEXT received chemotherapy during the trial, and those in SOFT had received chemotherapy before enrollment.
Data were missing for 3 patients in TEXT who did not receive chemotherapy, for 4 in SOFT who did not receive chemotherapy, for 25 in TEXT who received chemotherapy, and for 42 in SOFT who had received chemotherapy previously.
Oral endocrine therapy before randomization was allowed in SOFT while premenopausal status was established or reestablished; it was not allowed in TEXT.