Randomized, double-blind multicentre phase III study of bevacizumab in combination with cisplatin and gemcitabine in chemotherapy-na
Scientific Session: Randomized, double-blind multicentre phase III study of bevacizumab in combination with cisplatin and gemcitabine in chemotherapy-naïve patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC)
Bevacizumab (Avastin), a monoclonal antibody directed against the vascular endothelial growth factor receptor, has been shown to increase survival when used in combination with conventional chemotherapy in several types of cancer, including advanced non small cell lung cancer (NSCLC). Combination chemotherapy using cisplatin and gemcitabine is commonly used for treatment of advanced NSCLC in Europe . This study was carried out to evaluate effect on progression-free survival with the addition of bevacizumab to the cisplatin/ gemcitabine regimen used to treat NSCLC in Europe and in other regions outside of the United States .
1043 patients were treated with cisplatin (80 mg/m 2 ) and gemcitabine (1250 mg/m 2 ) on days 1 and 8 every 3 weeks for up to 6 cycles, and were then randomized to receive one of two doses of bevacizumab (7.5mg/kg or 15 mg/kg) or placebo every three weeks until disease progression. Progression free survival (that is the time until the disease progressed) was improved from 6.1 months in the placebo group to 6.7 and 6.5 months in the bevacizumab 7.5 mg/ kg group and the bevacizumab 15 mg/ kg group, respectively. Pulmonary hemorrhage is a complication of bevacizumab and this was seen in 4.9% of patients in the placebo group, 7.0% in the bevacizumab 7.5 mg/ kg group, and 9.7% in the bevacizumab 15 mg/ kg group. This was fatal in 0.3% of patients in the placebo group, 1.2% in the bevacizumab 7.5 mg/ kg group, and 0.9% in the bevacizumab 15 mg/ kg group. Other toxicities were similar in all three groups. Survival data is still pending. This study represents the second phase III clinical trial demonstrating a benefit in PFS with the addition of bevacizumab to established chemotherapy regimens, and confirms the results of ECOG 4955. However, this benefit is very modest overall.