title: 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.
abstract: 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 (300-600 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%.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Tsunekazu
authors.initials: T
authors.lastname: Mizushima
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tamagawa
authors.forename: Chu
authors.initials: C
authors.lastname: Matsuda
authors.forename: Kohei
authors.initials: K
authors.lastname: Murata
authors.forename: Mutsumi
authors.initials: M
authors.lastname: Fukunaga
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Ota
authors.forename: Junichi
authors.initials: J
authors.lastname: Hasegawa
authors.forename: Masaki
authors.initials: M
authors.lastname: Tsujie
authors.forename: Takayuki
authors.initials: T
authors.lastname: Fukuzaki
authors.forename: Taishi
authors.initials: T
authors.lastname: Hata
authors.forename: Ichiro
authors.initials: I
authors.lastname: Takemasa
authors.forename: Masataka
authors.initials: M
authors.lastname: Ikeda
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yamamoto
authors.forename: Mitsugu
authors.initials: M
authors.lastname: Sekimoto
authors.forename: Riichiro
authors.initials: R
authors.lastname: Nezu
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
mesh_terms: D000284:Administration, Oral; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D009503:Neutropenia / Q000139:chemically induced; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005641:Tegafur; D000068258:Bevacizumab; D014498:Uracil; D002955:Leucovorin