Table 2 Efficacy outcome measures: OxCap vs OxFU

From: Oxaliplatin/capecitabine vs oxaliplatin/infusional 5-FU in advanced colorectal cancer: the MRC COIN trial

  

Regimen

  
  

OxCap

OxFU

Measure of association (unadjusted)

Measure of association (adjusteda)

Outcome measure

Subgroup

Median survival (months)

HR (95% CI)

P -value

HR (95% CI)

P -value

OS

Arms A and C

15.4

14.9

1.02 (0.90, 1.15)

0.80

0.92 (0.78, 1.09)

0.33

 

Arm A

16.0

15.8

1.00 (0.84, 1.19)

0.99

0.95 (0.80, 1.14)

0.58

 

Arm B

15.0

14.9

1.01 (0.86, 1.20)

0.87

0.94 (0.79, 1.12)

0.51

 

Arm C

13.8

13.8

1.03 (0.87, 1.23)

0.72

1.05 (0.88, 1.25)

0.59

PFS

Arm A

7.4

8.8

0.93 (0.79, 1.08)

0.34

0.90 (0.77, 1.06)

0.20

 

Arm B

7.4

8.5

0.82 (0.70, 0.96)

0.011

0.79 (0.67, 0.93)

0.004

  

% Rate

OR (95% CI)

P -value

OR (95% CI)

P -value

RR at 12 weeks

Arms A and C

45%

47%

1.05 (0.85, 1.30)

0.65

1.06 (0.85, 1.32)

0.61

 

Arm B

47%

46%

0.95 (0.71, 1.29)

0.76

0.99 (0.72, 1.36)

0.95

ORR

Arms A and C

51%

54%

1.16 (0.94, 1.44)

0.17

1.18 (0.94, 1.47)

0.15

 

Arm A

51%

55%

1.16 (0.86, 1.58)

0.33

1.18 (0.86, 1.62)

0.30

 

Arm B

51%

57%

1.26 (0.93, 1.70)

0.14

1.35 (0.98, 1.86)

0.069

 

Arm C

50%

54%

1.16 (0.86, 1.57)

0.34

1.16 (0.85, 1.59)

0.36

RRS

Arms A and C

3.5%

6.5%

1.96 (1.21, 3.20)

0.006

1.96 (1.18, 3.23)

0.009

 

Arm A

4.2%

9.6%

2.44 (1.34, 4.45)

0.003

2.43 (1.30, 4.54)

0.005

 

Arm B

6.4%

7.3%

1.17 (0.65, 2.09)

0.61

1.27 (0.69, 2.33)

0.44

 

Arm C

2.8%

4.0%

1.45 (0.65, 3.25)

0.38

1.25 (0.53, 2.96)

0.61

  1. Abbreviations: CI=confidence interval; HR=hazard ratio; ORR=overall response rate; OR=odds ratio; OS=overall survival; PS=performance status; RRS=rate of radical surgeries; OxCap=oxaliplatin/capecitabine; OxFU=oxaliplatin/leucovorin (LV)/infusional 5-FU.
  2. aMultiple imputation was used for ‘any mutation’.