|
TOP
|
|
Erbitux 5 mg/ml solution for infusioncetuximab(十一)
|
(N=101)
|
(N=78)
|
|
OS
|
|
|
|
months, median
|
16.3
|
18.2
|
13.1
|
14.6
|
|
(95% CI)
|
(10.3, 32.2)
|
(9.8, 27.5)
|
(8.0, 23.9)
|
(9.5, 22.0)
|
|
Hazard Ratio (95% CI)
|
0.93 (0.72, 1.19)
|
0.99 (0.75, 1.30)
|
|
p-value
|
0.617
|
0.931
|
|
PFS
|
|
|
|
months, median
|
9.0
|
9.2
|
6.8
|
8.5
|
|
(95% CI)
|
(5.8, 15.5)
|
(5.8, 12.7)
|
(5.0, 10.7)
|
(3.4, 10.8)
|
|
Hazard Ratio (95% CI)
|
0.77 (0.59, 1.01)
|
1.05 (0.77, 1.41)
|
|
p-value
|
0.056
|
0.78
|
|
Best overall response rate
|
|
|
|
%
|
68
|
59
|
47
|
51
|
|
(95% CI)
|
(58, 76)
|
(50, 68)
|
(37, 57)
|
(40, 63)
|
|
Odds Ratio (95% CI)
|
1.44 (0.85, 2.43)
|
0.83 (0.46, 1.49)
|
|
p-value
|
0.171
|
0.529
|
CI = confidence interval, OxMdG = oxaliplatin plus infusional 5-FU/FA, OS = overall survival time, PFS = progression-free survival time
In time related endpoints no trends indicating clinical benefit could be shown for patients who received cetuximab in combination with the XELOX regimen.
There were significant dose reductions and delays of capecitabine or oxaliplatin administration mainly due to higher frequency of diarrhoea in the cetuximab containing arm. In addition, significantly fewer patients treated with cetuximab received second-line therapy.
• CA225006: This randomised study in patients with metastatic colorectal cancer who had received initial combination treatment with oxaliplatin plus fluoropyrimidine for metastatic disease compared the combination of cetuximab and irinotecan (648 patients) with irinotecan alone (650 patients). Following disease progression, treatment with EGFR-targeting agents was initiated in 50% of patients in the irinotecan-alone arm.
In the overall population, irrespective of KRAS status, the results reported for cetuximab plus irinotecan (648 patients) vs. irinotecan alone (650 patients) were: median overall survival time (OS) 10.71 vs. 9.99 months (HR 0.98), median progression free survival time (PFS) 4.0 vs. 2.6 months (HR 0.69), and objecti |
