Table 6. Randomised trials of oxaliplatin-infused 5-FU/leucovorin vs oxaliplatin/capecitabine.
| Study | Treatment arms | Number of patients | Objective response rates (%) | Median PFS/TTP (months) | Median overall survival (months) | Comments |
|---|---|---|---|---|---|---|
| First line | ||||||
| Porschen et al (2007) German AIO | FUFOX | 234 | 54 | 8.0 | 18.8 | Primary end point=PFS |
| CAPOX | 242 | 48 | 7.1 | 16.8 | Non-inferiority margin for 95% CI <1.29. | |
| HR: 1.17; 95% CI: 0.96–1.43, therefore 1° end point not met | ||||||
| Diaz-Rubio et al (2007) Spanish TTD | FUOX | 174 | 46 | 9.5 | 20.8 | Primary end point=TTP |
| CAPOX | 174 | 37 | 8.9 | 18.1 | Non-inferiority margin for 95% CI <1.27. | |
| HR: 1.18; 95% CI: 0.9–1.5, therefore 1° end point not met | ||||||
| Ducreux et al (2007) French | FOLFOX 6 | 150 | 46 | 9.3 | 20.5 | Primary end point=best response rate |
| CAPOX | 156 | 42 | 8.8 | 19.9 | Non-inferiority margin for 95% CI <15%. | |
| Difference in response rate=4.7% upper limit of 95% CI=14.4%, therefore 1° end point just met | ||||||
| Cassidy et al (2008) XELOX -1 | FOLFOX 4 | 1017 | 39 | 8.5 | 19.6 | Primary end point=PFS |
| CAPOX | 1017 | 37 | 7.9 | 19.8 | Non-inferiority margin for 97.5% CI < 1.23. | |
| HR: 1.05; 97.5% CI: 0.94–1.18, therefore 1° end point met | ||||||
| Second line | ||||||
| Rothenberg et al (2008) XELOX -2 | FOLFOX 4 | 314 | 12.4 | 5.5 | 13.2 | Primary end point=PFS |
| CAPOX | 313 | 15.3 | 5.1 | 12.7 | Non-inferiority margin for 95% CI <1.30. | |
| HR: 1.03; 97.5% CI: 0.87–1.24, therefore 1° end point met | ||||||
FUFOX, FUOX and FOLFOX=different dose schedules of oxaliplatin/infused 5-FU/LV; PFS=progression free survival; TTP=time to tumour progression; HR=hazard ratio; CI=confidence interval.