Table 1 Eribulin mesylate exposure and dose modifications in patients with liver impairment (safety population)
Parameter | Normal | Liver impairment | ||
|---|---|---|---|---|
Group A (n = 540) | Group B (n = 292) | Group C (n = 440) | Group D (n = 34a) | |
Bilirubin, μmol/L, median (range) | 8.55 (1.6, 19.9) | 8.55 (1.7, 21.0) | 8.55 (1.7, 23.9) | 22.70 (16.0, 75.2) |
AST, U/L, median (range) | 23.0 (2.6, 48.0) | 51.0 (9.6, 323.0) | 47.0 (9.2, 369.0) | 55.0 (16.0, 474.0) |
ALT, U/L, median (range) | 19.0 (1.3, 51.0) | 45.5 (5.0, 407.0) | 39.0 (5.0, 407.0) | 36.0 (12.0, 220.0) |
Albumin, g/L, median (range) | 42.0 (29.0, 66.0) | 41.2 (31.0, 58.9) | 39.0 (18.0, 58.9) | 42.0 (28.0, 63.3) |
Mean duration of treatment, days (SD) | 166.12 (163.44) | 151.65 (122.50) | 140.26 (113.30) | 128.76 (75.90) |
Median number of cycles completed on study (range) | 6.0 (1.0, 65.0) | 6.0 (1.0, 38.0) | 5.0 (1.0, 38.0) | 4.5 (1.0, 15.0) |
Mean actual dose intensity of eribulin mesylate, mg/m2/week (SD) | 0.82 (0.14) | 0.78 (0.16) | 0.78 (0.16) | 0.65 (0.18) |
Patients with a dose delay, n (%) | 223 (41.3) | 141 (48.3) | 212 (48.2) | 23 (67.7) |
Patients with a dose reduction, n (%) | 141 (26.1) | 101 (34.6) | 153 (34.8) | 21 (61.8) |