DCE-MRI assessment of the effect of vandetanib on tumor vasculature in patients with advanced colorectal cancer and liver metastases: a randomized phase I study

Table 2 Mean % change from baseline in MRI parameters (full analysis set)

	Mean % change from baseline (95% confidence interval)		Pvalue* (300 mg vs. 100 mg)
	Vandetanib 100 mg	Vandetanib 300 mg
Primary variables
iAUC₆₀	--3.4 (--13.6, 8.1)	--4.6 (--13.4, 5.0)	0.429 (one-sided)
K^trans	--4.6 (--22.4, 17.4)	--2.7 (--18.4, 16.2)	0.558 (one-sided)
Exploratory variables
T2*	--2.2 (--7.1, 2.9)	7.3 (3.1, 11.7)	0.006 (two-sided)
LD_DCE-MRI	16.1 (9.7, 22.9)	8.0 (2.9, 13.4)	0.029 (one-sided)

iAUC₆₀ initial area under the DCE-MRI contrast agent concentration--time curve after 60 s
K^trans volume transfer constant between blood plasma and extravascular extracellular space
T2* effective magnetic transverse relaxation time
LD_DCE-MRI length of longest diameter of target lesion measured as part of the DCE-MRI acquisition protocol
*The effect of vandetanib on MRI parameters was assessed using repeated measures ANOVA, which was fitted to the log-transformed baseline as a covariate and dose as a factor. Point and interval estimates were exponentially back transformed to provide the estimates of the % differences. The preplanned statistical comparisons were between the dose levels and not within dose levels. Only the least squares mean (95% CI) changes are reported within dose. See 'Statistical analyses' section for full details

ISSN: 2045-824X