Bevacizumab (Avastin; Genentech) received FDA approval on January 23, 2013, for use in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy for treating patients with metastatic colorectal cancer (mCRC) with disease that has progressed on a regimen containing first-line bevacizumab.
The FDA approval was granted based on the results of a randomized, open-label, multinational clinical trial that enrolled patients with mCRC whose disease progressed during or within 3 months of discontinuation of first-line bevacizumab-based combination chemotherapy. The 820 patients accrued for the trial were randomized to receive chemotherapy alone or chemotherapy in combination with bevacizumab. Depending on their prior treatment, patients received either fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy, with treatment cycles for both groups repeated every 2 or 3 weeks. For those patients in the chemotherapy plus bevacizumab arm, bevacizumab was administered by intravenous infusion at a dose of 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks. Patients received bevacizumab until disease progression or unacceptable toxicity.
Overall survival (OS) was the primary end point, with a statistically significant improvement in OS observed in patients who received chemotherapy plus bevacizumab compared with those who received chemotherapy alone. Median OS was 11.2 months for patients in the chemotherapy plus bevacizumab arm and 9.8 months for patients in the chemotherapy-alone arm.