Table 1 Trial Characteristics
| Â | Irinotecan-based | Oxaliplati n-based | Fluorouracil alone | Â | ||
|---|---|---|---|---|---|---|
Study | Hurwitz, 2004 (AVF2107) [26] | Stathopoulos, 2010 [24] | Saltz, 2008 (NO16966) [25] | Kabinnavar, 2003 [21] | Kabinnavar, 2005 [22] | Tebutt, 2010 (MAX) [23] |
No. of patients (placebo/bev) | 411/402 | 108/114 | 701/699 | 36/68 | 105/104 | 156/156 |
Phase | III | III | III | II | II | III |
Randomization | Adequate | Adequate | Adequate | Adequate | Adequate | Unclear |
Study Population | First-line | First-line | First-line | First-line | First-line, elderly | First-line, elderly |
ITT Analysis | Yes | No | Yes | No | Yes | Yes |
Blinding | Yes | No | Yes | No | Yes | Yes |
Multicentric | Yes | No | Yes | Yes | Yes | Yes |
Alpha error | Yes | Yes | Yes | NS | Yes | Yes |
Beta error | Yes | Yes | Yes | NS | Yes | Yes |
Withdrawals | NS | Described | Described | Described | Described | Described |
Regimens | Saltz IFL | Irino 135 mg/m2 + 5 FU 500 mg/m2 + LV 200 mg/m2 every 21 d | XELOX or FOLFOX4 | Roswell- Park | Roswell- Park | Capecitabine |
Bev schedule | 5 mg/kg every 14 d | 7.5 mg/kg every 21 d | 7.5 mg/kg every 21 d (XELOX) or 5 mg/kg every 14 d (FOLFOX4) | 10 mg/kg every 14 d (32 patients) 5 mg/kg every 14 d (33 patients) | 5 mg/kg every 14 d | 7.5 mg/kg every 21 d |
Maintenance | Until Progression | Until Progression | Until Progression | 48 Weeks | Until Progression | Until Progression |
Sponsor | Industry | NS | Industry | NS | Public | Public/Industry |