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

Breast Cancer Research

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

	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)
Unknown^a	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% CI^b	(9.0, 14.7)	(10.2, 18.6)	(9.7, 16.3)	(0, 10.9)
Clinical benefit rate (CR + PR + SD^c)	145 (27.2)	70 (24.6)	94 (22.2)	6 (18.8)
95% CI^b	(23.5, 31.2)	(19.7, 30.0)	(18.3, 26.4)	(7.2, 36.4)

^aPatients who had no baseline scans or only baseline scans
^bExact Clopper-Pearson 2-sided CI
^cFor clinical benefit, SD must be at least 6 months
Group A, no liver impairment; group B, increased AST and/or ALT only; group C, any abnormality except increased bilirubin; group D, increased bilirubin
ALT, alanine aminotransferase; AST, aspartate aminotransferase; CI, confidence interval; CR, complete response; PR, partial response; SD, stable disease

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