|
TOP
|
|
Erbitux 5 mg/ml solution for infusioncetuximab(九)
|
|
0.7549
|
|
PFS
|
|
|
|
months, median
|
9.9
|
8.4
|
7.4
|
7.7
|
|
(95% CI)
|
(9.0, 11.3)
|
(7.4, 9.2)
|
(6.1, 8.0)
|
(7.3, 9.2)
|
|
Hazard Ratio (95% CI)
|
0.696 (0.558, 0.867)
|
1.171 (0.887, 1.544)
|
|
p-value
|
0.0012
|
0.2648
|
|
ORR
|
|
|
|
%
|
57.3
|
39.7
|
31.3
|
36.1
|
|
(95% CI)
|
(51.6, 62.8)
|
(34.6, 45.1)
|
(25.2, 38.0)
|
(29.1, 43.5)
|
|
Odds Ratio (95% CI)
|
2.069 (1.515, 2.826)
|
0.822 (0.544, 1.242)
|
|
p-value
|
<0.0001
|
0.3475
|
CI = confidence interval, FOLFIRI = irinotecan plus infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
• EMR 62 202-047: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and oxaliplatin plus continuous infusional 5-fluorouracil/folinic acid (FOLFOX4) (169 patients) to the same chemotherapy alone (168 patients). The proportion of patients with KRAS wild-type tumours from the patient population eva luable for KRAS status comprised 57%.
The efficacy data generated in this study are summarised in the table below:
|
KRAS wild-type population
|
KRAS mutant population
|
|
Variable/ statistic
|
Cetuximab plus FOLFOX4
|
FOLFOX4
|
Cetuximab plus FOLFOX4
|
FOLFOX4
|
|
|
(N=82)
|
(N=97)
|
(N=77)
|
(N=59)
|
|
OS
|
|
|
|
months, median
|
22.8
|
18.5
|
13.4
|
17.5
|
|
(95% CI)
|
(19.3, 25.9)
|
(16.4, 22.6)
|
(10.5, 17.7)
|
(14.7, 24.8)
|
|
Hazard Ratio (95% CI)
|
0.855 (0.599, 1.219)
|
1.290 (0.873, 1.906)
|
|
p-value
|
0.3854
|
0.2004
|
|
|
|
