TABLE III.
Alternative dosing trials with cetuximaba
| Parameter | Cetuximab dosing |
|||
|---|---|---|---|---|
| 250 mg/m2 weeklyb |
500 mg/m2 every 2 weeksc |
|||
| bond11 | mabel6 | Danish study 8 | Danish study 8 | |
| Patients (n) | 329 | 1147 | 65 | 74 |
| Response rate (%) | 22.9 | 20 | 18.5 | 25.7 |
| Median ttp (months) | 4.1 | nr | 5.4d | 5.4d |
| Median os (months) | 8.6 | 9.2 | 10.4 | 8.9 |
The main irinotecan regimens were 180 mg/m2 every 2 weeks and 350 mg/m2 every 3 weeks.
Preceded by an initial dose of 400 mg/m2 (according to the approved dosing regimen).
The first course is infused over 120 minutes, followed 1 hour later by irinotecan at a dose of 180 mg/m2 as a 30-minute infusion. Subsequent courses of cetuximab are infused over 60 minutes, immediately followed by irinotecan, resulting in a total treatment time of only 90 minutes.
In the Danish study, the values were reported as median progression-free survival.
bond = Bowel Oncology with Cetuximab Antibody; mabel = Monoclonal Antibody Erbitux in European Pre-License; ttp = time to progression; nr = not reported; os = overall survival.