Table 2. Biomarker results of women with previously treated hormone receptor-negative breast cancer randomised to Polyphenon E (Poly E) or placebo (n = 34).
| Biomarker | Poly E (n = 26) | Placebo (n = 8) | ||||||
|---|---|---|---|---|---|---|---|---|
| Baseline | 2 months | 4 months | 6 months | Baseline | 2 months | 4 months | 6 months | |
| Total urinary tea polyphenols (mmol g−1 Cr) | ||||||||
| Mean (SD) | 18.3 (31.2) | 191.0 (189.6) | 165.5 (131.0) | 163.8 (176.8) | 8.1 (7.0) | 29.3 (44.4) | 16.2 (30.8) | 19.9 (18.6) |
| Mean absolute change from baseline (SD) | +179.1 (186.9) | +153.5 (132.6) | +152.1 (186.4) | +21.2 (43.1) | +8.1 (25.2) | +11.8 (13.7) | ||
| Percentage change from baseline | +979 | +838 | +831 | +262 | +100 | +146 | ||
| P-value (within-group comparison)* | <0.001 | <0.001 | <0.001 | 0.207 | 0.392 | 0.046 | ||
| P-value (between-group comparison)** | <0.001 | <0.001 | <0.001 | |||||
| P-value (baseline-adjusted)*** | 0.032 | 0.003 | 0.017 | |||||
| Serum HGF (pg mL−1) | ||||||||
| Mean (SD) | 1441.2 (530.2) | 1296.4 (524.4) | 1387.9 (466.1) | 1352.4 (466.0) | 1568.5 (931.4) | 1667.1 (1088.2) | 1530.6 (925.4) | 1579.0 (1030.4) |
| Mean absolute change from baseline (SD) | −183.0 (347.0) | −99.4 (394.4) | −88.7 (296.4) | +98.5 (189.8) | -37.9 (521.1) | +10.4 (542.6) | ||
| Percentage change from baseline | −12.7 | −6.9 | −6.2 | +6.3 | −2.4 | +0.7 | ||
| P-value (within-group comparison)* | 0.013 | 0.211 | 0.140 | 0.185 | 0.843 | 0.958 | ||
| P-value (between-group comparison)** | 0.037 | 0.723 | 0.634 | |||||
| P-value (baseline-adjusted)*** | 0.037 | 0.602 | 0.405 | |||||
| Serum VEGF (pg mL−1) | ||||||||
| Mean (SD) | 1973.1 (1439.9) | 1786.8 (1330.5) | 1747.5 (1537.1) | 1861.8 (1438.5) | 921.1 (498.3) | 836.4 (460.1) | 863.0 (559.9) | 1038.9 (657.2) |
| Mean absolute change from baseline (SD) | −227.5 (478.2) | −273.5 (670.8) | −111.3 (458.0) | −84.7 (165.6) | −58.1 (418.3) | +117.8 (438.6) | ||
| Percentage change from baseline | −11.5 | −13.9 | −5.6 | −9.2 | −6.3 | +12.8 | ||
| P-value (within-group comparison)* | 0.023 | 0.048 | 0.227 | 0.191 | 0.706 | 0.472 | ||
| P-value (between-group comparison)** | 0.206 | 0.400 | 0.221 | |||||
| P-value (baseline-adjusted)*** | 0.942 | 0.508 | 0.375 | |||||
| Serum cholesterol (mg dL−1) | ||||||||
| Mean (SD) | 209.5 (43.4) | 194.6 (41.6) | 195.5 (41.4) | 200.7 (41.3) | 183.1 (27.6) | 182.1 (24.9) | 183.3 (15.8) | 191.4 (28.8) |
| Mean absolute change from baseline (SD) | −12.6 (31.7) | −8.3 (23.4) | −6.8 (20.3) | −2.3 (18.3) | +3.0 (30.4) | +9.7 (31.1) | ||
| Percentage change from baseline | −6.0 | −4.0 | −3.2 | −1.3 | +1.6 | +5.3 | ||
| P-value (within-group comparison)* | 0.076 | 0.112 | 0.139 | 0.767 | 0.803 | 0.441 | ||
| P-value (between-group comparison)** | 0.457 | 0.310 | 0.115 | |||||
| P-value (baseline-adjusted)*** | 0.760 | 0.713 | 0.255 | |||||
| Serum triglycerides (mg dL−1) | ||||||||
| Mean (SD) | 123.8 (70.8) | 125.9 (75.3) | 124.1 (71.8) | 119.2 (67.3) | 124.6 (42.1) | 132.8 (67.3) | 123.4 (78.0) | 128.3 (81.9) |
| Mean absolute change from baseline (SD) | +9.2 (72.1) | +8.2 (65.5) | −0.9 (52.6) | +15.9 (52.0) | +7.6 (59.4) | +17.5 (66.7) | ||
| Percentage change from baseline | +7.4 | +6.6 | −0.7 | +12.8 | +6.1 | +14.0 | ||
| P-value (within-group comparison)* | 0.566 | 0.554 | 0.936 | 0.450 | 0.747 | 0.549 | ||
| P-value (between-group comparison)** | 0.824 | 0.982 | 0.478 | |||||
| P-value (baseline-adjusted)*** | 0.749 | 0.991 | 0.501 | |||||
| Urine 8-oxodG (nmol mmol−1 Cr) | ||||||||
| Mean (SD) | 6.8 (8.0) | 5.9 (6.0) | 6.0 (4.8) | 5.6 (4.2) | 4.9 (2.3) | 11.8 (21.5) | 9.5 (15.4) | 11.2 (18.3) |
| Mean absolute change from baseline (SD) | −1.1 (9.0) | −0.9 (6.2) | −1.3 (8.3) | +6.9 (20.3) | +4.5 (14.1) | +6.2 (17.0) | ||
| Percentage change from baseline | −16.2 | −13.2 | −19.1 | +141 | +91.8 | +127 | ||
| P-value (within-group comparison)* | 0.525 | 0.472 | 0.440 | 0.371 | 0.392 | 0.334 | ||
| P-value (between-group comparison)** | 0.311 | 0.322 | 0.261 | |||||
| P-value (baseline-adjusted)*** | 0.178 | 0.175 | 0.130 | |||||
| Urine 15-F2t-lsoP (nmol mmol−1 Cr) | ||||||||
| Mean (SD) | 0.773 (0.386) | 0.697 (0.306) | 0.750 (0.414) | 0.757 (0.372) | 0.655 (0.345) | 0.841 (0.831) | 1.042 (0.913) | 0.748 (0.420) |
| Mean absolute change from baseline (SD) | −0.033 (0.387) | −0.028 (0.384) | −0.047 (0.341) | +0.146 (0.616) | +0.347 (0.704) | +0.053 (0.469) | ||
| Percentage change from baseline | −4.3 | −3.6 | −6.1 | +22.3 | +53.0 | +8.1 | ||
| P-value (within-group comparison)* | 0.669 | 0.709 | 0.500 | 0.524 | 0.206 | 0.757 | ||
| P-value (between-group comparison)** | 0.330 | 0.185 | 0.515 | |||||
| P-value (baseline-adjusted)*** | 0.356 | 0.069 | 0.721 | |||||
| Plasma protein carbonyls (nmol mg−1) | ||||||||
| Mean (SD) | 0.251 (0.061) | 0.256 (0.035) | 0.262 (0.029) | 0.260 (0.038) | 0.260 (0.045) | 0.250 (0.034) | 0.254 (0.024) | 0.242 (0.035) |
| Mean absolute change from baseline (SD) | +0.003 (0.062) | +0.012 (0.059) | +0.011 (0.060) | −0.010 (0.015) | −0.006 (0.028) | −0.017 (0.021) | ||
| Percentage change from baseline | +1.2 | +4.8 | +4.4 | −3.8 | −2.3 | −6.5 | ||
| P-value (within-group comparison)* | 0.808 | 0.304 | 0.356 | 0.109 | 0.589 | 0.057 | ||
| P-value (between-group comparison)** | 0.350 | 0.254 | 0.052 | |||||
| P-value (baseline-adjusted)*** | 0.575 | 0.374 | 0.161 | |||||
| hsCRP (ng mL−1) | ||||||||
| Mean (SD) | 3.0 (4.0) | 4.1 (7.4) | 4.5 (11.0) | 5.9 (13.9) | 2.9 (2.1) | 3.2 (3.7) | 2.3 (2.6) | 2.0 (1.2) |
| Mean absolute change from baseline (SD) | +1.2 (8.0) | +1.4 (11.9) | +2.8 (14.8) | +0.3 (2.8) | −0.6 (1.9) | −0.9 (2.5) | ||
| Percentage change from baseline | +40.0 | +46.7 | +93.3 | +10.3 | −20.7 | −31.0 | ||
| P-value (within-group comparison)* | 0.440 | 0.542 | 0.341 | 0.764 | 0.373 | 0.329 | ||
| P-value (between-group comparison)** | 0.621 | 0.397 | 0.226 | |||||
| P-value (baseline-adjusted)*** | 0.750 | 0.586 | 0.445 | |||||
| Urine PGE-M (ng mg−1 Cr) | ||||||||
| Mean (SD) | 5.7 (5.2) | 4.6 (3.1) | 6.7 (9.3) | 5.6 (4.0) | 5.9 (3.2) | 5.2 (4.3) | 6.1 (3.1) | 4.8 (2.8) |
| Mean absolute change from baseline (SD) | −1.0 (5.0) | +1.1 (10.2) | −0.2 (4.8) | −0.4 (3.3) | +0.2 (2.7) | −1.2 (5.7) | ||
| Percentage change from baseline | −17.5 | +19.3 | −3.5 | −6.8 | +3.4 | −20.3 | ||
| P-value (within-group comparison)* | 0.305 | 0.581 | 0.860 | 0.770 | 0.861 | 0.582 | ||
| P-value (between-group comparison)** | 0.750 | 0.675 | 0.623 | |||||
| P-value (baseline-adjusted)*** | 0.649 | 0.848 | 0.566 | |||||
Cr, creatinine; HGF, hepatocyte growth factor; hsCRP, high-sensitivity C-reactive protein; PGE-M, prostaglandin E2 metabolite; VEGF, vascular endothelial growth factor; 8-oxodG, 8-oxo-7,8-di-hydrodeoxyguanosine; 15-F2t-lsoP, 15-F2-isoprostanes.
*
Comparing the absolute change from baseline within the Poly E and placebo groups using a paired t-test.
**
Comparing the mean absolute change from baseline at 2, 4 and 6 months in the Poly E versus placebo groups using a two-sample t-test.
***
Comparing the mean absolute change from baseline at 2, 4 and 6 months in the Poly E versus placebo groups using linear regression adjusting for baseline biomarker values.