Clinical Study
A Prospective, Randomized, Placebo-Controlled Study of a Combination of Simvastatin and Chemotherapy in Metastatic Breast Cancer
Table 1
Baseline patients’ characteristics.
| | Characteristics | Chemotherapy + simvastatin (n = 41) | Chemotherapy + placebo (n = 41) | 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) |
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