Multicenter phase II clinical trial of nilotinib for patients with imatinib-resistant or -intolerant chronic myeloid leukemia from the East Japan CML study group evaluation of molecular response and the efficacy and safety of nilotinib

Table 3 Liver dysfunction and UGT1A1/1A9 polymorphisms

Liver test	Grades 2-4	*UGT1A1*			*UGT1A9* I399C > T
		Poor metabolizers	Extensive metabolizers	P-value	C/T + T/T	C/C	P-value
ALT	No	3	41	0.359	39	4	0.111
ALT	Yes	1	4	0.359	3	2	0.111
AST	No	3	44	0.158	41	5	0.237
AST	Yes	1	1	0.158	1	1	0.237
T.Bil	No	1	35	0.052	34	2	0.028
T.Bil	Yes	3	10	0.052	8	4	0.028
Nilotinib C₀	Median	687.6	1042.0	0.577	977.5	644.0	0.685
	Range (25–75)	(336.1-1906.6)	(614.9-1472.8)		(544.0-1473.0)	(623.0-2292.0)

Poor metabolizers, UGT1A1 *6/*28, *27/*28, or *28/*28; Extensive metabolizers, UGT1A1 *1/*1, *1/*6, *1/*27, or *1/*28; C₀, trough concentration.

ISSN: 2050-7771