Phase II Study of Oral Tegafur/Uracil and Leucovorin plus Bevacizumab as a First-Line Therapy for Elderly Patients with Advanced or Metastatic Colorectal Cancer

作者：Mizushima Tsunekazu^*; Tamagawa Hiroshi; Matsuda Chu; Murata Kohei; Fukunaga Mutsumi; Ota Hirofumi; Hasegawa Junichi; Tsujie Masaki; Fukuzaki Takayuki; Hata Taishi; Takemasa Ichiro; Ikeda Masataka; Yamamoto Hirofumi; Sekimoto Mitsugu; Nezu Riichiro; Doki Yuichiro; Mori Masaki

来源：Oncology, 2015, 89(3): 152-158.

DOI：10.1159/000381718

• Tegafur/uracil
• Leucovorin
• Bevacizumab
• Colorectal cancer
• Elderly patients
• Phase II study

Background/Objective: Oral tegafur/uracil and leucovorin (UFT/LV) therapy is effective and safe for elderly patients with advanced or metastatic colorectal cancer (CRC). However, there are few studies on the combination of bevacizumab with UFT/LV. This clinical study evaluated the efficacy and safety of UFT/LV plus bevacizumab as a first-line therapy for elderly patients with advanced or metastatic CRC. Methods: Forty patients with advanced or metastatic CRC aged >= 75 years were enrolled in this multicenter, open-label, single-arm phase II study. All patients received oral UFT (300600 mg) and LV (50 mg) twice daily on days 1-21 and intravenous bevacizumab (5 mg/kg) on days 1 and 15 of a 4-week cycle (University Hospital Medical Information Network No. UMIN000003447). Results: The median follow-up period was 14.7 months. The response rate was 20.0% [95% confidence interval (CI): 9.1-35.6], median progression-free survival was 8.9 months (95% CI: 5.3-11), and median overall survival was 21.7 months (95% CI: 13.7-23.4). The only grade 3 hematological toxicity was neutropenia (3.0%), and the incidence rates of grade 3 nonhematological toxicity were low at <= 10%. Conclusion: UFT/LV plus bevacizumab is a promising first-line regimen for elderly patients with advanced or metastatic CRC. The combination is well tolerated and efficacious.

• 出版日期2015