Table 5.
Analysis of endometrial thickness (ET), bone mineral density (BMD), bone metabolism markers (BMMs), serum lipids, and endocrine hormones in postmenopausal Japanese women with breast cancer treated with TAS‐108
| Variable | n | Baseline (median) | 8a or 24b weeks (median) | Change or percentage changec from baseline to 8a or 24b weeks | ||
|---|---|---|---|---|---|---|
| Median | Range | P d | ||||
| ET, mm | 37 | 3.30 | 4.00 | 0.00 | −6.00–13.10 | 0.0850 |
| BMD, g/cm2 | 20 | 0.83 | 0.84 | −0.30 | −10.74–8.79 | 0.5220 |
| BMMs | ||||||
| Serum Osteocalcin, ng/mL | 50 | 9.50 | 9.20 | −0.62 | −38.75–85.42 | 0.8420 |
| Serum I‐CTP, ng/mL | 51 | 3.40 | 3.40 | −3.03 | −52.86–105.26 | 0.4120 |
| Serum lipids | ||||||
| Total‐cho, mg/dL | 93 | 208.00 | 212.00 | 0.00 | −78.00–94.00 | 0.4410 |
| HDL‐cho, mg/dL | 92 | 62.00 | 63.90 | 0.00 | −28.00–51.00 | 0.1960 |
| LDL‐cho, mg/dL | 91 | 121.00 | 127.00 | 3.00 | −57.00–81.00 | 0.0830 |
| Triglycerides, mg/dL | 93 | 104.00 | 86.00 | −13.00 | −217.00–301.00 | <0.0001 |
| APO‐A1, mg/dL | 93 | 147.00 | 151.00 | 4.00 | −45.00–59.00 | 0.1810 |
| APO‐B, mg/dL | 93 | 99.00 | 99.00 | 1.00 | −33.00–42.00 | 0.6680 |
| Endocrine hormones | ||||||
| E2, pg/mL | 93 | 10.00 | 11.00 | 0.00 | −11.00–33.00 | 0.1310 |
| FSH, mIU/mL | 93 | 44.49 | 44.80 | −2.60 | −24.27–26.88 | 0.3210 |
| Prolactin, ng/mL | 93 | 8.33 | 8.45 | 0.42 | −41.12–40.79 | 0.0280 |
| Testosterone, ng/dL | 93 | 0.21 | 0.22 | 0.02 | −0.23–0.31 | 0.0190 |
| TSH, μIU/mL | 93 | 2.58 | 2.51 | 0.00 | −5.90–94.30 | 0.6350 |
| Cortisol, μg/dL | 93 | 13.60 | 13.20 | 0.20 | −16.30–22.10 | 0.7540 |
| SHBG, nmol/L | 93 | 71.40 | 91.90 | 14.00 | −110.00–133.40 | <0.0001 |
Bone metabolism markers, serum lipids, and endocrine hormones were assessed at the 8‐week point in patients who received TAS‐108 for 8 weeks or more.
Endometrial thickness and BMD were assessed at the 24‐week point in patients who received TAS‐108 for 24 weeks or more.
Data are presented as change from baseline, except BMD and BMMs as percentage change from baseline.
P‐values based on the Wilcoxon signed‐rank test. APO‐A1, apolipoprotein A‐I; APO‐B, apolipoprotein B; HDL‐cho, high‐density lipoprotein cholesterol; I‐CTP, cross‐linked carboxy‐terminal telopeptide of type I collagen; LDL‐cho, low‐density lipoprotein cholesterol; SHBG, sex hormone‐binding globulin; Total‐cho, total cholesterol; TSH, thyroid‐stimulating hormone.