P-275 - Phase II study of oral tegafur/uracil and leucovorin plus bevacizumab as a first line therapy for elderly patients with advanced or metastatic color...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anticancer agents
Geriatric Oncology
Colon and Rectal Cancer
Biological therapy
Presenter H. Tamagawa
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors H. Tamagawa1, T. Mizushima2, C. Matsuda3, K. Murata4, M. Fukunaga5, H. Ohta6, J. Hasegawa7, M. Tsujie8, T. Fukuzaki9, T. Hata10, I. Takemasa2, M. Ikeda11, H. Yamamoto2, M. Sekimoto11, R. Nezu12, Y. Doki2, M. Mori2
  • 1Otemae Hospital, Osaka/JP
  • 2Osaka University Graduate School of Medicine, Suita/JP
  • 3Osaka General Medical Center, Osaka/JP
  • 4Suita Municipal Hospital, Suita/JP
  • 5Hyogo Prefectural Nishinomiya Hospital, Nishinomiya/JP
  • 6Ikeda Municipal Hospital, Ikeda/JP
  • 7Osaka Rosai Hospital, Sakai/JP
  • 8Dept of Surgery, Sakai/JP
  • 9Saiseikai Senri Hospital, Suita/JP
  • 10Dept of Gastroenterological Surgery, Suita/JP
  • 11Osaka National Hospital, Osaka/JP
  • 12Nishinomiya Municipal Central Hospital, Nishinomiya/JP



Oral tegafur/uracil and leucovorin (UFT/LV) therapy is effective and safe for elderly patients with advanced or metastatic colorectal cancer (CRC). However, there have been few studies on the combination of bevacizumab with UFT/LV. This clinical study is aimed to evaluate the efficacy and safety of UFT/LV plus bevacizumab as a first line therapy for elderly patients with advanced or metastatic CRC.


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 tegafur/uracil (300–600 mg) and leucovorin (50 mg) twice daily on days 1–21, and intravenous bevacizumab (5 mg/kg) on days 1 and 15 of a 4-week cycle. (UMIN000003447)


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 months), and median overall survival was 21.7 months (95% CI: 13.7–23.4 months). The grade-3 hematological toxicity included just neutropenia (3.0%), and the incidences of grade-3 non-hematological toxicity were less than 10%.


UFT/LV plus bevacizumab was a promising first-line regimen for elderly patients with advanced or metastatic CRC. This combination therapy was well tolerated and efficacious.