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Table 4 Response (ITT population)

From: Cetuximab in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) in the initial treatment of metastatic colorectal cancer: a multicentre two-part phase I/II study

 

LD 5-FU (n = 7)

HD 5-FU (n = 45)

Total (n = 52)

Response rate (%)

   

   Best overall response rate [95% CI]a

57

[18, 90]

47

[32, 62]

48

[34, 62]

   Stable disease

29

40

39

   Progressive disease

14

9

10

   Not assessable

0

4

4

Disease control rate (CR + PR + SD) (%) [95% CI]

86

[42, 100]

87

[73, 95]

87

[74, 94]

Median duration of response, days [95% CI]

7.7

[2.9, 12.2]

9.9

[8.1, 13.6]

9.9

[8.1, 11.4]

  1. aAll partial responses. LD = low-dose 5-FU; HD = high-dose 5-FU; CI = confidence intervals; CR = complete response; PR = partial response; SD = stable disease