Table 4 Univariate and multivariate analyses of clinical determinants and toxicities

From: Toxicity associated with capecitabine plus oxaliplatin in colorectal cancer before and after an institutional policy of capecitabine dose reduction

  

Univariate analyses

Multivariate analyses

Clinical factors

No. of patients

Risk ratio

95% confidence interval

P

Risk ratio

95% confidence interval

P

Grades 3 and 4 diarrhoea

 Treatment groups

       

CAPOX 2000

200

1

     

CAPOX 1700

200

0.88

0.53–1.45

0.61

NA

  

 Disease extent

       

Metastatic

284

1

     

(Neo)adjuvant

116

1.65

0.97–2.80

0.07

NA

  

 Gender

       

Male

239

1

  

1

  

Female

161

1.74

1.05–2.90

0.03

1.69

1.01–2.83

0.047

 Race

       

White

363

1

     

Non-white

37

0.67

0.25–1.77

0.42

NA

  

 Age

       

<70 years old

262

1

     

70 years old

138

0.77

0.44–1.32

0.34

NA

  

 Baseline eGFR

       

>70 ml min–1

296

1

  

1

  

50–70 ml min–1

93

2.34

1.36–4.03

0.002

2.27

1.31–3.92

0.003

<50 ml min–1a

11

      

All grades diarrhoea

 Treatment groups

       

CAPOX 2000

200

1

     

CAPOX 1700

200

0.74

0.50–1.10

0.13

NA

  

 Disease extent

       

Metastatic

284

1

     

(Neo)adjuvant

116

1.31

0.85–2.03

0.23

NA

  

 Gender

       

Male

239

1

     

Female

161

1.23

0.82–1.84

0.32

NA

  

 Race

       

White

363

1

     

Non-white

37

0.41

0.20–0.84

0.01

NA

  

 Age

       

<70 years old

262

1

     

70 years old

138

1.46

0.96–2.23

0.08

NA

  

 Baseline eGFR

       

>70 ml min–1

296

1

     

50–70 ml min–1

93

1.42

0.88–2.29

0.15

NA

  

<50 ml min–1

11

1.08

0.32–3.61

0.90

   

All grades stomatitis

 Treatment groups

       

CAPOX 2000

200

1

     

CAPOX 1700

200

1.09

0.62–1.91

0.77

NA

  

 Disease extent

       

Metastatic

284

1

     

(Neo)adjuvant

116

1.88

1.05–3.37

0.03

NA

  

 Gender

       

Male

239

1

     

Female

161

1.34

0.76–2.37

0.31

NA

  

 Race

       

White

363

1

     

Non-white

37

1.05

0.39–2.81

0.93

NA

  

 Age

       

<70 years old

262

1

     

70 years old

138

0.73

0.39–1.35

0.32

NA

  

 Baseline eGFR

       

>70 ml min–1

296

1

     

50–70 ml min–1

93

0.60

0.28–1.28

0.18

NA

  

<50 ml min–1

11

1.24

0.26–5.93

0.79

   

Grades 2–4 hand foot syndrome

 Treatment groups

       

CAPOX 2000

200

1

     

CAPOX 1700

200

0.64

0.35–1.16

0.14

NA

  

 Disease extent

       

Metastatic

284

1

  

1

  

(Neo)adjuvant

116

2.62

1.44–4.74

0.002

2.52

1.39–4.59

0.002

 Gender

       

Male

239

1

     

Female

161

1.01

0.56–1.82

0.98

NA

  

 Race

       

White

363

1

     

Non-white

37

0.50

0.22–1.16

0.11

NA

  

 Age

       

<70 years old

262

1

  

1

  

70 years old

138

0.47

0.23–0.94

0.03

0.49

0.24–1.00

0.05

 Baseline eGFR

       

>70 ml min–1

296

1

     

50–70 ml min–1

93

1.50

0.79–2.85

0.22

NA

  

<50 ml min–1a

11

      

Grades 3–4 neutropenia

 Treatment groups

       

 CAPOX 2000

200

1

     

 CAPOX 1700

200

0.35

0.14–0.84

0.02

NA

  

 Disease extent

       

Metastatic

284

1

     

(Neo)adjuvant

116

1.58

0.70–3.59

0.28

NA

  

 Gender

       

Male

239

1

     

Female

161

2.13

0.95–4.76

0.07

NA

  

 Race

       

White

363

1

     

Non-white

37

1.30

0.37–4.57

0.68

NA

  

 Age

       

<70 years old

262

1

     

70 years old

138

0.68

0.28–1.67

0.40

NA

  

 Baseline eGFR

       

>70 ml min–1

296

1

     

50–70 ml min–1

93

0.74

0.27–2.03

0.56

NA

  

<50 ml min–1a

11

      

All grades neutropenia

 Treatment groups

       

CAPOX 2000

200

1

     

CAPOX 1700

200

0.53

0.30–0.93

0.03

NA

  

 Disease extent

       

Metastatic

284

1

     

(Neo)adjuvant

116

1.39

0.78–2.48

0.27

NA

  

 Gender

       

Male

239

1

     

Female

161

1.47

0.85–2.56

0.17

NA

  

 Race

       

White

363

1

     

Non-white

37

0.61

0.26–1.40

0.24

NA

  

 Age

       

<70 years old

262

1

     

70 years old

138

0.79

0.43–1.42

0.43

NA

  

 Baseline eGFR

       

>70 ml min–1

296

1

     

50–70 ml min–1

93

0.69

0.34–1.40

0.31

NA

  

<50 ml min–1

11

0.52

0.06–4.13

0.53

   

All grades elevated serum bilirubin

 Treatment groups

       

CAPOX 2000

200

1

  

1

  

CAPOX 1700

200

0.44

0.29–0.66

<0.001

0.43

0.29–0.64

<0.001

 Disease extent

       

Metastatic

284

1

     

(Neo)adjuvant

116

1.02

0.66–1.57

0.92

NA

  

 Gender

       

Male

239

1

  

1

  

Female

161

0.61

0.41–0.91

0.02

0.59

0.39–0.88

0.01

 Race

       

White

363

1

     

Non-white

37

1.08

0.55–2.12

0.83

NA

  

 Age

       

<70 years old

262

1

     

70 years old

138

0.92

0.61–1.39

0.68

NA

  

 Baseline eGFR

       

>70 ml min–1

296

1

     

50–70 ml min–1

93

1.48

0.91–2.32

0.12

NA

  

<50 ml min–1

11

0.62

0.18–2.18

0.46

   

All grades elevated serum ALT

 Treatment groups

       

CAPOX 2000

200

1

  

1

  

CAPOX 1700

200

0.60

0.40–0.89

0.01

0.62

0.41–0.93

0.02

 Disease extent

       

Metastatic

284

1

  

1

  

(Neo)adjuvant

116

1.77

1.14–2.73

0.01

1.63

1.05–2.54

0.03

 Gender

       

Male

239

1

     

Female

161

1.43

0.96–2.14

0.08

NA

  

 Race

       

White

363

1

     

Non-white

37

0.85

0.43–1.68

0.64

NA

  

 Age

       

<70 years old

262

1

  

1

  

70 years old

138

0.58

0.38–0.88

0.01

0.58

0.38–0.90

0.01

 Baseline eGFR

       

>70 ml min–1

296

1

     

50–70 ml min–1

93

0.91

0.57–1.46

0.70

NA

  

<50 ml min–1

11

0.92

0.28–3.09

0.90

   

All grades elevated serum alkaline phosphatase

 Treatment groups

       

CAPOX 2000

200

1

     

CAPOX 1700

200

1.35

0.91–2.01

0.14

NA

  

 Disease extent

       

Metastatic

284

1

     

(Neo)adjuvant

116

0.43

0.27–0.69

<0.001

NA

  

 Gender

       

Male

239

1

     

Female

161

1.23

0.82–1.84

0.32

NA

  

 Race

       

White

363

1

     

Non-white

37

0.81

0.41–1.63

0.56

NA

  

 Age

       

<70 years old

262

1

     

70 years old

138

0.72

0.47–1.10

0.13

NA

  

 Baseline eGFR

       

>70 ml min–1

296

1

     

50–70 ml min–1

93

0.80

0.50–1.29

0.36

NA

  

<50 ml min–1

11

2.32

0.66–8.08

0.19

   
  1. Abbreviations: ALT=alanine transferase; CAPOX=capecitabine plus oxaliplatin; eGFR=estimated glomerular filtration rate; NA=not applicable.
  2. These factors were non-significant in univariate analyses and, therefore, not entered into multivariate regression models. When less than 2 factors was significant in univariate analyses, no multivariate analysis was performed.
  3. aBaseline eGFR <50 ml min–1 had too few events in the category to perform meaningful statistical analyses.