Chiyoe Kitagawa1, Masahide Mori2, Masao Ichiki3, Noriaki Sukoh4, Akiko Kada5, Akiko M Saito5, Yukito Ichinose6. 1. Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan kitagawc@nnh.hosp.go.jp. 2. Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, Toyonaka, Japan. 3. Department of Respiratory Medicine, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. 4. Department of Respiratory Medicine, National Hospital Organization Hokkaido Medical Center, Sapporo, Japan. 5. Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan. 6. Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Abstract
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. Copyright
RCT Entities:
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. Copyright