|
TOP
|
|
Erbitux 5 mg/ml solution for infusioncetuximab(十三)
|
Hazard Ratio (95% CI)
|
0.401 (0.299, 0.536)
|
1.002 (0.732, 1.371)
|
|
p-value
|
<0.0001
|
0.9895
|
|
ORR
|
|
|
|
%
|
12.8
|
0
|
1.2
|
0
|
|
(95% CI)
|
(7.4, 20.3)
|
(-)
|
(0.0, 6.7)
|
(-)
|
|
p-value
|
<0.001
|
0.314
|
BSC = best supportive care, CI = confidence interval, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
Squamous cell cancer of the head and neck
Immunohistochemical detection of EGFR expression was not performed since more than 90% of patients with squamous cell cancer of the head and neck have tumours that express EGFR.
Cetuximab in combination with radiation therapy for locally advanced disease
• EMR 62 202-006: This randomised study compared the combination of cetuximab and radiation therapy (211 patients) with radiation therapy alone (213 patients) in patients with locally advanced squamous cell cancer of the head and neck. Cetuximab was started one week before radiation therapy and administered at the doses described in section 4.2 until the end of the radiation therapy period.
The efficacy data generated in this study are summarised in the table below:
|
Variable/ statistic
|
Radiation therapy + cetuximab
|
Radiation therapy alone
|
|
|
(N=211)
|
(N=213)
|
|
Locoregional control
|
|
|
|
|
|
months, median (95% CI)
|
24.4
|
(15.7, 45.1)
|
14.9
|
(11.8, 19.9)
|
|
Hazard Ratio (95% CI)
|
0.68 (0.52, 0.89)
|
|
p-value
|
0.005
|
|
OS
|
|
|
|
|
|
months, median (95% CI)
|
49.0
|
(32.8, 62.6+)
|
29.3
|
(20.6, 42.8)
|
|
Hazard Ratio (95% CI)
|
0.74 (0.56, 0.97)
|
|
p-value
|
0.032
|
CI = confidence interval, OS = overall survival time, a '+' denotes that the upper bound limit had not been reached at cut-off
Patients with a good prognosis as indicated by tumour stage, Karnofsky performance status (KPS) and age had a more pronounced benefit, when cetuximab was added to radiation therapy. No clinical benefit could be demonstrated in patients with KPS 80 who were 65 years |
