How was Avastin studied in MCRC?
The clinical benefits of Avastin have been evaluated across several randomized clinical trials and in combination with multiple IV 5-FU–containing regimens, including: • IFL: 923 patients with previously untreated MCRC were evaluated in Study 2107 (a Phase III trial). Patients in the study received placebo plus IFL (Arm 1), Avastin 5 mg/kg IV every 2 weeks (q2w) plus IFL (Arm 2), or Avastin 5 mg/kg IV q2w plus IV 5-FU/LV (Arm 3). As prespecified, Arm 3 was discontinued when the relative safety of Avastin plus IFL was established in an interim analysis. The primary endpoint in this rigorous Phase III trial was overall survival1-3 • IV 5-FU/LV: A combined analysis (N=490) of 3 randomized clinical trials, which included patients from studies 0780, 2192, and 2107, examined the addition of Avastin to IV 5-FU/LV chemotherapy in previously untreated patients with MCRC. These 3 studies were combined into a single analysis evaluating the efficacy of Avastin plus IV 5-FU/LV vs a “combined contro