title: A phase II study of combined chemotherapy with 5-week cycles of S-1 and CPT-11 plus bevacizumab in patients with metastatic colon cancer.
abstract: OBJECTIVE
  Combined chemotherapy with S-1 and irinotecan (IRIS) for metastatic colorectal cancer has been reported to be effective and safe. However, there are only a few studies on the effects of adding bevacizumab to IRIS. We conducted a clinical study to evaluate the efficacy and safety of IRIS plus bevacizumab as first-line therapy for metastatic colorectal cancer.
  
  
  METHODS
  Forty metastatic colorectal cancer patients were enrolled in this phase II study. All patients received irinotecan (80 mg/m(2)) and bevacizumab (7 mg/kg) on days 1 and 15 and S-1 (40-60 mg twice daily) on days 1-21 of a 5-week repeated cycle.
  
  
  RESULTS
  The response rate was 47.4% [95% confidence interval (CI) 31.5-63.2], progression-free survival was 11.9 months (95% CI 9.4-16.8), and overall survival was 23.4 months (95% CI 19.0-inf). The only grade 3 hematological toxicity was neutropenia (16%) and the incidences of grade 3 nonhematological toxicity were low at <10%, other than diarrhea (10.9%).
  
  
  CONCLUSIONS
  In this clinical study, we revealed IRIS plus bevacizumab to be a promising first-line regimen for metastatic colorectal cancer with a low incidence of serious toxicities, in which favorable response rates and extension of survival time can be expected.
authors.affiliation: Departments of Surgery at Osaka University Graduate School of Medicine, Suita, Japan.
authors.forename: Tsunekazu
authors.initials: T
authors.lastname: Mizushima
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Ide
authors.forename: Kohei
authors.initials: K
authors.lastname: Murata
authors.forename: Ichiro
authors.initials: I
authors.lastname: Ohashi
authors.forename: Keigo
authors.initials: K
authors.lastname: Yasumasa
authors.forename: Mutsumi
authors.initials: M
authors.lastname: Fukunaga
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Takemoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Tamagawa
authors.forename: Junichi
authors.initials: J
authors.lastname: Hasegawa
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: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010094:Oxonic Acid / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D000068258:Bevacizumab; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin