Table 3 Parameters associated with time to disease progression by uni- and multivariate analysis (Cox proportional hazards model)

From: Sorafenib in advanced melanoma: a critical role for pharmacokinetics?

 

N

Univariate HR

95% CI

P -value

Multivariate HR

95% CI

P -value

WHO PS

       

 0–1

22

1

     

 2–3

6

1.77

0.62–4.35

0.26

   

Time from metastatic diagnosis

       

15 Months

9

1

     

 >15 Months

19

0.47

0.18–1.17

0.10a

NS

Early hypertension

       

 Grade<2

17

1

     

 Grade2

11

0.92

0.28–1.49

0.31

   

Early HFSR

       

 Grade<2

14

1

     

 Grade2

14

0.65

0.32–1.75

0.49

   

Early rash

       

 Grade<2

7

1

     

 Grade2

21

0.44

0.10–1.37

0.17a

NS

Early diarrhoea

       

 Grade<2

19

1

     

 Grade2

9

0.51

0.19–1.23

0.13a

NS

Early toxicities

       

 Grade<2

8

1

     

 Grade2

20

0.38

0.15–0.98

0.045 a

NS

AUC max

       

 <100

12

1

  

1

  

100

15

0.28

0.11–0.72

0.009 a

0.28

0.11–0.72

0.009 a

  1. Abbreviations: AUC=area under the plasma concentration–time curve over 12 h; CI=confidence interval; HFSR=hand-foot skin reaction; HR=hazard ratio; N=number of patients; NS=variables not selected by the stepwise multivariate model; PS=performance status.
  2. Early toxicities included: hypertension, HFSR and diarrhoea during the first 2 months.
  3. aVariables included in the stepwise multivariate model. P-values <0.05 are in bold.