Table 1.
Baseline patient and tumor characteristics
| Characteristics | Control arm (n = 133) | GnRHa arm (n = 148) |
|---|---|---|
| Median age (range), y | 39 (25-45) | 39 (24-45) |
| Tumor size, No. (%) | ||
| pT1 | 75 (56.4) | 90 (60.8) |
| pT2-4 | 54 (40.6) | 56 (37.8) |
| Unknown | 4 (3.0) | 2 (1.4) |
| Axillary nodes, No. (%) | ||
| pN0 | 67 (50.4) | 61 (41.2) |
| pN1-2 | 62 (46.6) | 85 (57.4) |
| Unknown | 4 (3.0) | 2 (1.4) |
| Hormone receptor status, No. (%) | ||
| ER-negative and PR-negative | 22 (16.5) | 29 (19.6) |
| ER-positive, PR-positive, or both | 109 (82.0) | 117 (79.1) |
| Unknown | 2 (1.5) | 2 (1.4) |
| Timing of chemotherapy, No. (%) | ||
| Adjuvant therapy | 117 (88.0) | 133 (89.9) |
| Neoadjuvant therapy | 10 (7.5) | 13 (8.8) |
| Not begun | 6 (4.5) | 2 (1.4) |
| Type of chemotherapy, No. (%) | ||
| Anthracycline-based | 57 (42.9) | 56 (37.8) |
| Anthracycline- and taxane-based | 62 (46.6) | 86 (58.1) |
| CMF-based | 8 (6.0) | 4 (2.7) |
| Cumulative cyclophosphamide dose, median (IQR), mg/m2 | 4008 (3624-5550) | 4080 (3697-5400) |
| Duration of chemotherapy, median (IQR), wk | 16.9 (15.0-21.3) | 17.8 (15.0-21.3) |
| Treatment completed as planned, No. (%) | ||
| Chemotherapy | 121 (91.0) | 143 (96.6) |
| GnRHa during chemotherapy | NA | 142 (95.9) |
| Type of adjuvant endocrine therapy in patients with hormone receptor–positive diseasea, No. (%) | ||
| No treatment | 5 (4.6) | 5 (4.3) |
| GnRHa alone | 3 (2.8) | 6 (5.1) |
| GnRHa + tamoxifen | 65 (59.6) | 61 (52.1) |
| GnRHa + aromatase inhibitor | 2 (1.8) | 2 (1.7) |
| Tamoxifen | 22 (20.2) | 30 (25.6) |
| Tamoxifen followed by aromatase inhibitor | 12 (11.0) | 13 (11.1) |
| Median duration of endocrine therapy (IQR), yb | 5.00 (4.75-5.04) | 5.00 (4.94-5.08) |
| Median duration of adjuvant GnRHa (IQR), yc | 4.10 (2.08-5.04) | 4.08 (2.06-4.92) |
| Median interval between chemotherapy completion and adjuvant GnRHa initiation (IQR), moc | 1.28 (0.46-5.16) | 4.51 (2.96-8.16) |
a
Calculated on the total number of patients with hormone receptor–positive disease (117 in the GnRHa group and 109 in the control group). CMF = cyclophosphamide, methotrexate, fluorouracil; ER = estrogen receptor; GnRHa = gonadotropin–releasing hormone agonist; IQR = interquartile range; NA = not applicable; PR = progesterone receptor.
b
Calculated on the total number of patients with hormone receptor–positive disease receiving adjuvant endocrine therapy (112 in the GnRHa group and 104 in the control group).
c
Calculated on the total number of patients with hormone receptor–positive disease receiving adjuvant GnRHa (69 in the GnRHa group and 70 in the control group).