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Table 3 Response rates in patients with liver impairment (independent review)

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

  Normal Liver impairment
n (%) Group A
(n = 533)
Group B
(n = 285)
Group C
(n = 424)
Group D
(n = 32)
CR 3 (0.6) 1 (0.4) 1 (0.2) 0
PR 59 (11.1) 39 (13.7) 53 (12.5) 0
SD 275 (51.6) 141 (49.5) 199 (46.9) 24 (75.0)
Progressive disease 165 (31.0) 82 (28.8) 137 (32.3) 6 (18.8)
Not evaluable 6 (1.1) 10 (3.5) 16 (3.8) 1 (3.1)
Unknowna 25 (4.7) 12 (4.2) 18 (4.2) 1 (3.1)
Objective response rate (CR + PR) 62 (11.6) 40 (14.0) 54 (12.7) 0
95% CIb (9.0, 14.7) (10.2, 18.6) (9.7, 16.3) (0, 10.9)
Clinical benefit rate (CR + PR + SDc) 145 (27.2) 70 (24.6) 94 (22.2) 6 (18.8)
95% CIb (23.5, 31.2) (19.7, 30.0) (18.3, 26.4) (7.2, 36.4)
  1. aPatients who had no baseline scans or only baseline scans
  2. bExact Clopper-Pearson 2-sided CI
  3. cFor clinical benefit, SD must be at least 6 months
  4. Group A, no liver impairment; group B, increased AST and/or ALT only; group C, any abnormality except increased bilirubin; group D, increased bilirubin
  5. ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; CR, complete response; PR, partial response; SD, stable disease
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