Table 1.
Patient and Treatment Characteristics and Baseline (Pretreatment) Hormone Levels in the Analytic Cohort, Overall and According to Treatment Assignment
| Characteristic | No. of Patients (%)* | ||
|---|---|---|---|
| Exemestane Plus Triptorelin (n = 86) | Tamoxifen Plus Triptorelin (n = 30) | All Patients (N = 116) | |
| Age at random assignment, years | |||
| Median (IQR) | 44 (40-48) | 44 (41-48) | 44 (41-48) |
| < 35 | 8 (9.3) | 0 (0.0) | 8 (6.9) |
| 35-39 | 10 (11.6) | 6 (20.0) | 16 (13.8) |
| 40-44 | 27 (31.4) | 9 (30.0) | 36 (31.0) |
| 45-49 | 31 (36.0) | 12 (40.0) | 43 (37.1) |
| Menstruation | |||
| Normal | 39 (45.3) | 18 (60.0) | 57 (49.1) |
| Irregular | 14 (16.3) | 3 (10.0) | 17 (14.7) |
| Amenorrhea | 33 (38.4) | 9 (30.0) | 42 (36.2) |
| Hysterectomy, yes | 2 (2.3) | 0 (0.0) | 2 (1.7) |
| BMI, kg/m2 | |||
| Median (IQR) | 24 (22-28) | 23 (22-26) | 24 (22-28) |
| Normal (< 25) | 45 (52.3) | 19 (63.3) | 64 (55.2) |
| Overweight (25 to < 30) | 26 (30.2) | 5 (16.7) | 31 (26.7) |
| Obese (≥ 30) | 13 (15.1) | 4 (13.3) | 17 (14.7) |
| Unknown | 2 (2.3) | 2 (6.7) | 4 (3.4) |
| Smoking history | |||
| Currently smokes | 25 (29.1) | 3 (10.0) | 28 (24.1) |
| Stopped smoking | 11 (12.8) | 9 (30.0) | 20 (17.2) |
| Never smoked | 48 (55.8) | 18 (60.0) | 66 (56.9) |
| Unknown | 2 (2.3) | 0 (0.0) | 2 (1.7) |
| Prior chemotherapy | |||
| No | 39 (45.3) | 13 (43.3) | 52 (44.8) |
| Yes | 47 (54.7) | 17 (56.7) | 64 (55.2) |
| Chemotherapy regimen | |||
| Anthracycline plus taxane | 34 (72.3) | 10 (58.8) | 44 (68.8) |
| Anthracycline based | 11 (23.4) | 4 (23.5) | 15 (23.4) |
| Taxane based | 2 (4.3) | 3 (17.6) | 5 (7.8) |
| Months from last chemotherapy dose to random assignment, median (IQR) | 4 (2-6) | 4 (2-6) | 4 (2-6) |
| Prior tamoxifen | |||
| No | 58 (67.4) | 22 (73.3) | 80 (69.0) |
| Yes | 28 (32.6) | 8 (26.7) | 36 (31.0) |
| Prior tamoxifen duration, weeks, median (IQR) | 16 (9-20) | 21 (10-23) | 18 (9-21) |
| Hormone levels | |||
| Estradiol, pg/mL | |||
| Median (IQR) | 49.9 (6.8-110.0) | 72.5 (6.2-199.0) | 50.6 (6.5-124.0) |
| No. of missing samples | 3 | 0 | 3 |
| Estrone, pg/mL | |||
| Median (IQR) | 43.6 (24.0-70.0) | 39.2 (24.8-102.2) | 41.8 (24.1-71.3) |
| No. of missing samples | 3 | 0 | 3 |
| Estrone sulfate, pg/mL | |||
| Median (IQR) | 784.0 (315.0-1,320.0) | 1,000.0 (272.2-1,620.0) | 894.0 (307.0-1,380.0) |
| No. of missing samples | 3 | 0 | 3 |
| FSH, IU/L | |||
| Median (IQR) | 19.6 (7.6-47.9) | 13.7 (6.4-41.8) | 15.5 (6.9-46.8) |
| No. of missing samples | 6 | 1 | 7 |
| LH, IU/L | |||
| Median (IQR) | 15.9 (5.9-26.8) | 10.3 (6.9-30.4) | 13.7 (6.0-27.7) |
| No. of missing samples | 5 | 1 | 6 |
Abbreviations: BMI, body mass index; FSH, follicle-stimulating hormone; IQR, interquartile range; LH, luteinizing hormone.
*
Values are numbers and percentages of patients, unless noted otherwise.