|
Irinotecan-based
|
Oxaliplati n-based
|
Fluorouracil alone
| |
---|
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
|
- Description of the main trials' characteristics and details prompt to bias.
- Abbreviations: 5FU: fluorouracil; bev: Bevacizumab; d: days; Irino: Irinotecan; ITT: Intention to Treat; LV: leucovorin; NS: not stated.