Table 3.
Randomized trials that compare oxaliplatin plus capecitabine with oxaliplatin plus 5-fluorouracil ± folinic acid in metastatic colorectal cancer
| Trial | Arms | Patients No. | PFS (mo) | OS (mo) | RR (%) | Severe toxicity ≥ grade 3 |
| FOCA trial[31] | XELOX: (oxaliplatin 130 mg/m2 on day 1 and capecitabine 2000 mg/m2 per day for 14 d, repeating every 21 d) pviFOX: (protracted fluorouracil intravenous infusion plus oxaliplatin) | 62 56 | 7 9 | NR NR | 43 48 | Less diarrhea (8 vs 18%) and stomatitis (19 vs 29 %) in XELOX arm |
| US TREE-1[32] | XELOX: as above bFOL: (oxaliplatin 85 mg/m2 on day 1 and fluorouracil 500 mg/m2 plus folinic acid 20 mg/m2 intravenously on days 1 and 8, every 2 wk) mFOLFOX: (oxaliplatin 85 mg/m2, folinic acid 350 mg/m2, fluorouracil 400 mg/m2 bolus and 2400 mg/m2 46-h infusion on day 1) | 49 50 49 | 5.9 6.9 8.7 | 17.2 17.9 17.6 | 27 20 41 | Less neutropenia (15%) but more dehydration (27%) with XELOX |
| German trial[33] | CAPOX: (oxaliplatin 70 mg/m2 on days 1 and 8, and capecitabine 2000 mg/m2 per day for 2 wk, recycling every 3 wk) FUFOX: (fluorouracil 2000 mg/m2 infused over 24 h, folinic acid 500 mg/m2 and oxaliplatin 50 mg/m2 infused over 2 h) | 241 233 | 7.1 8.0 | 16.8 18.8 | 48 54 | More skin toxicity (10% vs 4%) with CAPOX |
| Spanish trial[34] | XELOX: as above FUOX: (fluorouracil 2250 mg/m2 infused over 48 h once a week plus oxaliplatin 85 mg/m2 twice a week) | 171 171 | 8.9 9.5 | 18.1 20.8 | 37 46 | Less diarrhea (14% vs 24%) with XELOX |
| French trial[35] | XELOX: as above FOLFOX6: (oxaliplatin 100 mg/m2, folinic acid 200 mg/m2 infused over 2, fluorouracil 400 mg/m2 bolus and 2400 mg/m2 infused over 48 h) | 156 150 | 8.8 9.3 | 19.9 20.5 | 39 46 | Less neutropenia (5% vs 47%), febrile neutropenia (0% vs 6%) and neuropathy (11% vs 25%) with XELOX |
| NO16966 trial[36] | XELOX: as above FOLFOX4: (oxaliplatin 85 mg/m2 on day 1, folinic acid 100 mg/m2, fluorouracil 400 mg/m2 bolus and 600 mg/m2 infused over 22 h) | 317 317 | 7.3 7.7 | NR NR | 37 39 | Less neutropenia (7% vs 43%) but more diarrhea (20% vs 11%) and Hand Foot Syndrome (6% vs 1%) with XELOX |
| COFFEE trial[38] | OXXEL: (oxaliplatin 100 mg/m2 on day 1 and capecitabine 2000 mg/m2 per day from day 1 to day 11 every 2 wk) OXAFAFU: (oxaliplatin 85 mg/m2 infused over 2 h on day 1, folinic acid 250 mg/m2 infused over 2 h on day 1, fluorouracil 850 mg/m2 bolus on day 2) | 158 164 | 6.2 6.3 | 16.0 17.1 | 34 33 | Less neutropenia (10% vs 27%) and febrile neutropenia (6% vs 13%), more gastric symptoms (8% vs 3%) and diarrhea (13% vs 8%) with OXXEL |
PFS: Progression free survival; OS: Overall survival; RR: Response rate; NR: Not recorded.