Gefitinib Plus Bevacizumab vs . Gefitinib Alone for EGFR Mutant Non-squamous Non-small Cell Lung Cancer.

Background/Aim: A phase II trial was conducted to assess the efficacy and safety of gefitinib plus bevacizumab for EGFR mutation positive non-small cell lung cancer (NSCLC). Patients and Methods: Patients were randomly assigned to receive either gefitinib at 250 mg/day alone or with bevacizumab at 15 mg/kg every 3 weeks. Results: Ten patients were allocated to the gefitinib group (group A) and 6 to the gefitinib plus bevacizumab group (group B). Median survival time (80%CI) for progression free survival (PFS) was 15.1 months for group A, and 5.4 months for group B. Overall survival probability at 1 year (95%CI) was 0.750 for group A, and 0.667 for group B. The response rate was 44 % for group A and 50 % for group B. Adverse events occurred at a similar frequency in both groups. Conclusion: PFS was shorter in group B than group A, and therefore there was no basis to proceed to a phase III trial.