|
TOP
|
|
Erbitux 5 mg/ml solution for infusioncetuximab(十)
|
PFS
|
|
|
|
months, median
|
8.3
|
7.2
|
5.5
|
8.6
|
|
(95% CI)
|
(7.2, 12.0)
|
(5.6, 7.4)
|
(4.0, 7.3)
|
(6.5, 9.4)
|
|
Hazard Ratio (95% CI)
|
0.567 (0.375, 0.856)
|
1.720 (1.104, 2.679)
|
|
p-value
|
0.0064
|
0.0153
|
|
ORR
|
|
|
|
%
|
57.3
|
34.0
|
33.8
|
52.5
|
|
(95% CI)
|
(45.9, 68.2)
|
(24.7, 44.3)
|
(23.4, 45.5)
|
(39.1, 65.7)
|
|
Odds Ratio (95% CI)
|
2.551 (1.380, 4.717)
|
0.459 (0.228, 0.924)
|
|
p-value
|
0.0027
|
0.0290
|
CI = confidence interval, FOLFOX4 = oxaliplatin plus continuous infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
In particular a negative effect of cetuximab add-on in the KRAS mutant population was observed.
• COIN: This was an open-label, 3-arm, randomised study in 2445 patients with inoperable metastatic or locoregional colorectal cancer who had not received prior treatment for metastatic disease and compared oxaliplatin plus fluoropyrimidines (infusional 5-fluorouracil/folinic acid [OxMdG] or capecitabine [XELOX]) in combination with cetuximab to the same chemotherapy regimen alone. The third experimental arm used an intermittent OxMdG or XELOX regimen without cetuximab. Data for the XELOX regimen and the third experimental arm are not presented.
Tumour samples from approximately 81% of patients were analysed retrospectively for KRAS expression, of which 55% were KRAS wild-type. Of these, 362 patients received cetuximab and oxaliplatin plus fluoropyrimidines (117 patients OxMdG and 245 patients XELOX) and 367 patients received oxaliplatin plus fluoropyrimidines alone (127 patients OxMdG and 240 patients XELOX). Of the KRAS mutant population, 297 patients received cetuximab and oxaliplatin plus fluoropyrimidines (101 patients OxMdG and 196 patients XELOX) and 268 patients received oxaliplatin plus fluoropyrimidines alone (78 patients OxMdG and 190 patients XELOX).
The efficacy data on the OxMdG regimen generated in this study are summarised in the table below:
|
KRAS wild-type population
|
KRAS mutant population
|
|
Variable/ statistic
|
Cetuximab plus OxMdG
|
OxMdG
|
Cetuximab plus OxMdG
|
OxMdG
|
|
|
(N=117)
|
(N=127)
|
|
|
