Table 3.
Characteristics of Patients Randomly Assigned to Exemestane Plus Triptorelin Who Had at Least One Postbaseline Sample Analyzed, According to Occurrence of E2 Level Greater Than 2.72 pg/mL During at Least One Time Point
| Characteristic | No. of Patients (%)* | P | ||
|---|---|---|---|---|
| Postbaseline E2 | All Patients (N = 79) | |||
| All Assay Values < 2.72 pg/mL (n = 52) | At Least One Assay Value > 2.72 pg/mL (n = 27) | |||
| Age at random assignment, years | ||||
| Median (IQR) | 44 (40-48) | 45 (40-48) | 44 (40-48) | .792 |
| < 35 | 4 (7.7) | 4 (14.8) | 8 (10.1) | |
| Menstruation | ||||
| Normal | 12 (23.1) | 2 (7.4) | 14 (17.7) | .162 |
| Irregular | 20 (38.5) | 10 (37.0) | 30 (38.0) | |
| Amenorrhea | 20 (38.5) | 15 (55.6) | 35 (44.3) | |
| BMI, kg/m2, median (IQR) | 24 (22-27) | 27 (23-29) | 24 (22-28) | .054 |
| Smoking history | .926 | |||
| Currently smokes | 15 (28.8) | 9 (33.3) | 24 (30.4) | |
| Stopped smoking | 7 (13.5) | 3 (11.1) | 10 (12.7) | |
| Never smoked | 29 (55.8) | 14 (51.9) | 43 (54.4) | |
| Unknown | 1 (1.9) | 1 (3.7) | 2 (2.5) | |
| Prior chemotherapy | .061 | |||
| No | 19 (36.5) | 16 (59.3) | 35 (44.3) | |
| Yes | 33 (63.5) | 11 (40.7) | 44 (55.7) | |
| Chemotherapy regimen | .788 | |||
| Anthracycline plus taxane | 25 (75.8) | 8 (72.7) | 33 (75.0) | |
| Anthracycline-based | 7 (21.2) | 3 (27.3) | 10 (22.7) | |
| Taxane-based | 1 (3.0) | 0 (0.0) | 1 (2.3) | |
| Prior chemotherapy duration, weeks, median (IQR) | 21 (18-24) | 20 (18-24) | 20 (18-24) | ND |
| Prior tamoxifen | .207 | |||
| No | 32 (61.5) | 21 (77.8) | 53 (67.1) | |
| Yes | 20 (38.5) | 6 (22.2) | 26 (32.9) | |
| Prior tamoxifen duration, weeks, median (IQR) | 18 (12-20) | 12 (10-12) | 16 (10-20) | ND |
| Baseline hormone levels | ||||
| E2, pg/mL, median (IQR) | 41 (5-110) | 65 (27-115) | 50 (6-110) | .183 |
| Estrone, pg/mL, median (IQR) | 41 (24-72) | 47 (22-61) | 42 (24-70) | .780 |
| Estrone sulfate, pg/mL | ||||
| Median (IQR) | 637 (303-1,278) | 854 (490-1,282) | 712 (306-1,288) | .669 |
| FSH, IU/L, median (IQR) | 34 (12-58) | 8 (5-34) | 21 (8-51) | .002 |
| LH, IU/L, median (IQR) | 21 (7-32) | 7 (4-20) | 16 (6-28) | .004 |
Abbreviations: BMI, body mass index; E2, estradiol; FSH, follicle-stimulating hormone; IQR, interquartile range; LH, luteinizing hormone; ND, not done.
*
Values are numbers and percentages of patients, unless noted otherwise.