Table 2.
Primary study endpoint: breast duct cytology pre- and post-treatment with lovastatin
| ID | Entry criterion | Pre-treatment cytology (Masood score)a | Post-treatment cytology (Masood score)a | Change in cytology |
|---|---|---|---|---|
| 1 | BRCA1 mutation carrier | Non-proliferative (10) | Non-proliferative (9) | Unchanged |
| 2 | BRCA1 mutation carrier | Non-proliferative (10) | Non-proliferative (9) | Unchanged |
| 3 | BRCA1 mutation carrier | Non-proliferative (10) | Non-proliferative (9) | Unchanged |
| 4 | BRCA2 mutation carrier | Non-proliferative (10) | Non-proliferative (10) | Unchanged |
| 5 | BRCA2 mutation carrier | Proliferative without atypia (11) | Proliferative without atypia (12) | Unchanged |
| 6 | BRCA2 mutation carrier | Proliferative without atypia (11) | Proliferative without atypia (12) | Unchanged |
| 7 | BRCA1 mutation carrier | Proliferative without atypia (11) | Non-proliferative (9) | Favorable |
| 8 | BRCA1 mutation carrier | Proliferative without atypia (12) | Non-proliferative (10) | Favorable |
| 9 | BRCA2 mutation carrier | Proliferative without atypia (13) | Non-proliferative (9) | Favorable |
| 10 | BRCA1 mutation carrier | Non-proliferative (9) | Proliferative without atypia (11) | Unfavorable |
| 11 | BRCA1 and BRCA2 mutation carrier | Non-proliferative (8) | Acellular | Equivocal |
| 12 | Lifetime risk ≥20 %, Claus model | Non-proliferative (9) | Non-proliferative (10) | Unchanged |
| 13 | Lifetime risk ≥20 %, Claus model | Proliferative without atypia (13) | Proliferative without atypia (14) | Unchanged |
| 14 | Lifetime risk ≥20 %, Claus model | Proliferative without atypia (12) | Proliferative without atypia (12) | Unchanged |
| 15 | Lifetime risk ≥20 %, Claus model | Non-proliferative (9) | Non-proliferative (10) | Unchanged |
| 16 | Lifetime risk ≥20 %, Claus model | Proliferative without atypia (12) | Proliferative without atypia (11) | Unchanged |
| 17 | Lifetime risk ≥20 %, Claus model | Proliferative without atypia (13) | Non-proliferative (10) | Favorable |
| 18 | Lifetime risk ≥20 %, Claus model | Non-proliferative (10) | Proliferative without atypia (12) | Unfavorable |
| 19 | Lifetime risk ≥20 %, Claus model | Non-proliferative (8) | Acellular | Equivocal |
| 20 | Personal history of breast cancer | Non-proliferative (10) | Non-proliferative (9) | Unchanged |
| 21 | TP53 mutation carrier | Proliferative without atypia (11) | Proliferative without atypia (12) | Unchanged |
| 22 | ER/PR-negative breast cancer | Proliferative without atypia (12) | Proliferative without atypia (11) | Unchanged |
| 23 | ER/PR-negative breast cancer | Non-proliferative (8) | Non-proliferative (8) | Unchanged |
| 24 | ER/PR-negative breast cancer | Proliferative without atypia (11) | Non-proliferative (10) | Favorable |
| 25 | ER/PR-negative breast cancer | Non-proliferative (9) | Acellular | Equivocal |
| 26 | ER/PR-negative breast cancer | Acellular | Non-proliferative (9) | Equivocal |
| Summary of cytology change, comparing post-treatment to pre-treatment cytology category | ||||
|---|---|---|---|---|
|
| ||||
| Change | Number of participants (percentage, 95 % CI) | |||
| Unchanged | 15/26 (57.7 %, 38.9–74.5 %) | |||
| Favorable | 5/26 (19.2 %, 8.1–38.3 %) | |||
| Unfavorable | 2/26 (7.7 %, 1.0–25.3 %) | |||
| Equivocal | 4/26 (15.4 %, 5.5–34.2 %) | |||
a
Masood scale: non-proliferative breast disease, 6–10; proliferative breast disease without atypia, 11–14; proliferative breast disease with atypia, 15–18; and carcinoma in situ and invasive cancer, 19–24 [25]