Table 4.
Median values and median percentage change from baseline for plasma concentrations of estrogens (mITT population)
Estrogen | Exemestane (n = 20) | Letrozole (n = 20) | Anastrozole (n = 18) | Placebo (n = 20) |
E1 | ||||
Baseline, median (min., max.) | 31 (11, 72) | 28 (13, 51) | 29 (14, 61) | 26 (9.9, 61) |
Week 12, median (min., max.) | 2.0 (1.8, 10) | 1.8 (1.8, 20) | 1.8 (1.8, 84) | 31 (8.4, 58) |
% baseline, median (95% CI*) | 7.8 (6.9, 9.3) | 6.6 (5.5, 8.1) | 7.6 (6.4, 11) | 101 (89, 110) |
Week 24, median (min., max.) | 1.8 (1.8, 63) | 1.8 (1.8, 33) | 1.8 (1.8, 44) | 26 (7.2, 56) |
% baseline, median (95% CI) | 6.7 (5.3, 8.6) | 6.6 (5.1, 8.1) | 7.9 (7.1, 11) | 94 (76, 108) |
Week 36, median (min., max.) | 23 (10, 62) | 19 (10, 44) | 25 (8.4, 158) | 22 (13, 46) |
% baseline, median (95% CI) | 72 (63, 86) | 76 (61, 93) | 70 (66, 121) | 89 (72, 95) |
E2 | ||||
Baseline, median (min., max.) | 4.4 (1.1, 13) | 4.2 (1.8, 8.6) | 3.8 (1.9, 32) | 3.9 (1.9, 8.8) |
Week 12, median (min., max.) | 0.70 (0.70, 2.5) | 0.70 (0.70, 2.7) | 0.70 (0.70, 104) | 3.8 (1.6, 15) |
% baseline, median (95% CI) | 18 (14, 22) | 19 (14, 24) | 20 (18, 31) | 102 (87, 115) |
Week 24, median (min., max.) | 0.70 (0.70, 29) | 0.70 (0.70, 7.3) | 0.72 (0.70, 84) | 4.4 (1.9, 12) |
% baseline, median (95% CI) | 19 (13, 22) | 18 (13, 24) | 22 (19, 31) | 128 (95, 139) |
Week 36, median (min., max.) | 4.5 (1.6, 36) | 4.2 (1.9, 15) | 4.2 (1.4, 136) | 4.0 (1.6, 11) |
% baseline, median (95% CI) | 103 (89, 134) | 109 (81, 119) | 106 (92, 130) | 105 (90, 130) |
E1S | ||||
Baseline, median (min., max.) | 192 (58, 757) | 193 (79, 1075) | 202 (64, 896) | 200 (62, 1156) |
Week 12, median (min., max.) | 13 (8.7, 246) | 8.7 (6.0, 62) | 15 (6.6, 3260) | 209 (58, 876) |
% baseline, median (95% CI) | 9.1 (6.1, 11) | 4.5 (3.3, 6.0) | 11 (6.7, 13) | 110 (91, 146) |
Week 24, median (min., max.) | 16 (6.1, 839) | 10 (6.0, 254) | 18 (8.8, 1440) | 195 (64, 802) |
% baseline, median (95% CI) | 11 (7.2, 13) | 4.7 (3.0, 7.2) | 10 (8.6, 20) | 105 (69, 123) |
Week 36, median (min., max.) | 223 (7.4, 2100) | 222 (115, 932) | 296 (58, 4890) | 205 (68, 864) |
% baseline, median (95% CI) | 114 (90, 152) | 121 (105, 135) | 131 (109, 147) | 125 (91, 143) |
*95% CI, bias-corrected and adjusted 95% bootstrap CI for median.
CI, confidence interval; E1, estrone; E1S, estrone sulfate; E2, estradiol; max; min; mITT, modified intent to treat.