Table 1.
Baseline patients' characteristics.
| Characteristics | Chemotherapy + simvastatin (n = 41) | Chemotherapy + placebo (n = 41) | P value | Total (n = 82) | |
|---|---|---|---|---|---|
| N (%) | n (%) | ||||
| Age (years) | |||||
| Median | 47 | 49 | 0.73 | 47.5 | |
| Range | 28–74 | 24–71 | 24–74 | ||
|
| |||||
| BMI (kg/m2) | |||||
| <18.5 | 1 (2.44) | 0 (0) | 0.46 | 1 (1.21) | |
| 18.5–24.9 | 9 (21.95) | 11 (26.83) | 20 (24.39) | ||
| 25–29.9 | 15 (36.59) | 19 (46.34) | 34 (41.46) | ||
| ≥30 | 16 (39.02) | 11 (26.83) | 27 (32.92) | ||
|
| |||||
| No. of metastatic sites | |||||
| 1 | 23 (56.10) | 17 (41.46) | 0.23 | 40 (48.78) | |
| 2 | 17 (41.46) | 20 (48.78) | 37 (45.12) | ||
| 3 | 1 (2.44) | 4 (9.75) | 5 (6.09) | ||
|
| |||||
| Site of metastases | |||||
| Bone | 5 (12.20) | 6 (14.63) | 0.54 | 11 (13.41) | |
| Liver | 8 (19.51) | 3 (7.32) | 11 (13.41) | ||
| Lung | 4 (9.76) | 3 (7.32) | 7 (8.54) | ||
| Brain | 0 (0) | 1 (2.44) | 1 (1.22) | ||
| Skin/chest wall | 2 (4.88) | 2 (4.88) | 4 (4.88) | ||
| Lymph node | 4 (9.76) | 2 (4.88) | 6 (7.32) | ||
| Multiple sites | 18 (43.9) | 24 (58.54) | 42 (51.22) | ||
|
| |||||
| ECOG-PS | |||||
| 0 | 4 (9.75) | 4 (9.75) | 0.84 | 8 (9.75) | |
| 1 | 29 (70.73) | 31 (75.61) | 60 (73.17) | ||
| 2 | 8 (19.50) | 6 (14.63) | 14 (17.07) | ||
|
| |||||
| Hormone receptor | |||||
| ER+ PR+ | 14 (34.15) | 13 (31.71) | 0.46 | 27 (32.92) | |
| ER− PR− | 18 (43.90) | 21 (51.22) | 39 (47.56) | ||
| ER+ PR− | 2 (4.88) | 4 (9.76) | 6 (7.32) | ||
| ER− PR+ | 5 (12.20) | 1 (2.44) | 6 (7.32) | ||
| Unknown | 2 (4.88) | 2 (4.88) | 4 (4.88) | ||
|
| |||||
| HER 2 | |||||
| HER+ | 30 (73.17) | 26 (63.41) | 0.6 | 56 (68.29) | |
| HER− | 9 (21.95) | 13 (31.71) | 22 (26.82) | ||
| Unknown | 2 (4.88) | 2 (4.88) | 4 (4.88) | ||
|
| |||||
| Chemotherapy line | |||||
| 1st line | 18 (43.90) | 19 (46.34) | 0.37 | 37 (45.12) | |
| 2nd line | 17 (41.46) | 19 (46.34) | 36 (43.90) | ||
| ≥3rd line | 6 (14.63) | 3 (7.32) | 9 (10.97) | ||