Table 1. Studies investigating MD changes in response to use of SERMs.
| Study | Subjects | Protocol | Results (PMD Change) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mammography | Agent and dose | Time | N | PMD (%) | p value | ||||||
| Reference | Trial Type | Age (yr) | On | Baseline | Finish | versus baseline | versus control | ||||
| Clinical Scenario | Measure | Post-Start | Therapy | ||||||||
| Tamoxifen | |||||||||||
| Brisson 2000[28] |
RCT | ≥35 Prevention |
PMD, Wolfe |
41 m | Placebo Tamoxifen 20mg |
60 m | 33 36 |
60.5 60.3 |
51.1 56.7 |
NR NR |
NA 0.01 |
| Chow 2000[29] |
RCT | 36-74 Prevention |
PMD Boyd, BIRADS |
22 m | Control Tamoxifen 20mg |
24 m | 20 27 |
29.7 31.9 |
29.6 29.2 |
0.88 0.0007 |
NA NR |
| Konez 2001[31] |
Retro cohort |
31-81 Adjuvant post-BC |
MD Category |
60 m | Tamoxifen 20mg | 60 m | 24 | 20.8%* | 0.06 | NA | |
| Cuzick 2004[27] |
RCT | 35-70 Prevention |
PMD, Boyd |
54 m | Placebo Tamoxifen 20mg |
60 m | 430 388 |
42.6 41.9 |
35.3 28.2 |
<0.001 <0.001 |
NA <0.001 |
| Meggiorini 2008[30] |
Retro cohort |
41-78 Adjuvant post-BC |
BIRADS | 12 m | Control Tamoxifen 20mg |
60 m | 80 68 |
30%* 50% * |
NR NR |
NA 0.021 |
|
| Howell 2015[33] |
Retro cohort |
33-46 Prevention |
PMD | 12 m | Tamoxifen | 12m | 105 | 49%† | NR | NA | |
| Engman 2016[32] |
Retro cohort |
45-60 Adjuvant post-BC |
VPD, DV |
annually | Tamoxifen | 36 m | 379 | 11.6 64.7 |
17%** 0,90** |
NR NR |
NR NR |
| Raloxifene | |||||||||||
| Freedman 2001[39] |
RCT | 45-60 Prevention Post-menopause |
PMD | 24m | Placebo Raloxifene 60mg Raloxifene 150mg |
24 m | 45 45 42 |
9.8 9.3 8.1 |
8.5 7.7 6.4 |
<0.02 <0.02 <0.02 |
NA NS NS |
| Christo- doulakos 2002[38] |
RCT | 41-67 Risk of osteoporosis |
Wolfe | 12m | Placebo Raloxifene 60 mg Tibilone 2.5mg |
12 m | 27 48 56 |
25.9 † 18.8† 10.7† |
0 †† 6.3 †† 10.7 †† |
NR NR NR |
NA 0.47 0.07 |
| Cirpan 2006[37] |
Retro cohort |
43-58 Osteoporosis |
BIRADS | 12m | Raloxifene 60mg | 12 m | 55 | MD category increase in one patient. Otherwise, no change | 0.32 | NA | |
| Eng-Wong 2008[40] |
CT | 35-47 Prevention |
PMD | 24 m | Raloxifene 60mg | 24 m | 27 | 38 | 41.5 | NS | NA |
| Eilertsen 2008[36] |
RCT | 45-65 Prevention |
PMD (volume) | 12 week | Raloxifene 60 mg Low dose HRT Standard dose HRT |
12 week | 44 44 45 |
7.7 8.6 8.3 |
8.1 11.2 10.6 |
0.09 <0.0001 <0.0001 |
NA NA NA |
| Nielsen 2009[35] |
RCT | 55-80 Risk of osteoporosis |
PMD BIRADS |
24m | Tibolone Raloxifene 60 mg Estradiol 0.014 wk, |
24 m | 45 135 135 |
7.5 16 16 |
8.1 18 20 |
0.9 NS <0.05 |
NA NA NA |
| Harvey 2013[34] |
RCT | 40-75 Risk of osteoporosis |
PMD | 24m | Placebo BZA 20mg/E 0.45mg BZA 20mg/E0.625 mg Raloxifene 60 mg |
24 m | 126 129 105 125 |
26.1 26.5 25.3 27.2 |
25.7 26.1 25.2 27 |
significant significant NS NS |
NA NS NS NS |
*
% pts with MD category reduction, † % pts with MD decrease, **annualized MD reduction, †† % pts with MD increase
RCT: Randomised Controlled Trial, Retro cohort: Retrospective cohort, BC: Breast Cancer, PMD: Percent Mammographic Density, BIRADS: Breast Imaging-Reporting and Data System, VPD: Volumetric Percent Density, DV: Dense Volume, m: month, HRT: Hormone Replacement Therapy, BZA: Bazedoxifene, NS: Not Significant, NR: Not Reported, NA: Not Applicable