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Table 1 Eribulin mesylate exposure and dose modifications in patients with liver impairment (safety population)

From: Eribulin, Child-Pugh score, and liver-function tests: lessons from pivotal breast cancer studies 301 and 305

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)
  1. an = 33 for mean actual dose intensity analyses
  2. Group A, no liver impairment; group B, increased AST and/or ALT only; group C, any abnormality except increased bilirubin; group D, increased bilirubin
  3. ALT, alanine aminotransferase; AST, aspartate aminotransferase; SD, standard deviation