Table 1.

Patient cohorts according to liver function

				Initial paclitaxel dose (mg m−2)
Cohort	ALAT/ASAT	Bilirubin	Dose level	Predefined	Model-derived recommendation
I		<2.6 × ULN	= 1.25 × ULN	0	175*
II	2.6–10 × ULN	= 1.25 × ULN	0	175	175†
III	<10 × ULN	1.26–2.0 × ULN	0	175	115
IV	<10 × ULN	2.1–3.5 × ULN	−1	135	100
V	<10 × ULN	= 3.6–10 × ULN	−2	110	70

ULN, Upper limit of normal. ULN for aspartate aminotransferase (ASAT) = 25 U l⁻¹. ULN for alanine aminotransferase (ALAT) = 35 U l⁻¹. ULN for total bilirubin = 20 µmol l⁻¹.

^*ANC nadir from cohort I used as a base for dose recommendations cohorts II–V.

^†As cohort II is identical to cohort I with respect to total bilirubin concentration, the presented model does not predict increased toxicity in cohort II when administering the same dose of paclitaxel (175 mg m⁻²).