title: Phase II study of combined chemotherapy with irinotecan and S-1 (IRIS) plus bevacizumab in patients with inoperable recurrent or advanced colorectal cancer.
abstract: BACKGROUND
  In Japan, a study comparing the effectiveness and safety of irinotecan plus S-1 (IRIS) with those of a combination of 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) as second-line treatment in patients with advanced or recurrent colorectal cancer demonstrated that IRIS was non-inferior to FOLFIRI. We previously reported that IRIS is also effective as first-line treatment.
  
  
  METHODS
  Eligibility criteria included inoperable recurrent colorectal cancer with a confirmed diagnosis of adenocarcinoma, age ≥20 years, and no history of prior chemotherapy. S-1 (40-60 mg twice daily) was given orally on Days 1 to 14, and irinotecan (100 mg/m(2)) and bevacizumab (5 mg/kg) were given intravenously on Days 1 and 15 of a 28-day cycle. The primary endpoint was safety. The secondary endpoints included overall response (OR), progression-free survival (PFS), and overall survival (OS).
  
  
  RESULTS
  A total of 52 eligible patients were enrolled from October 2007 through March 2009. In safety analysis, the incidences of grade 3 or 4 adverse reactions were as follows: neutropenia, 27%; hypertension, 21%; and diarrhea, 17%. The overall response rate was 57.7%. Median progression-free survival was 16.7 months.
  
  
  CONCLUSIONS
  IRIS plus bevacizumab is a well-tolerated, highly effective chemotherapeutic regimen that is easy to administer.
authors.affiliation: Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan. ykomatsu@med.hokudai.ac.jp
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yuki
authors.forename: Susumu
authors.initials: S
authors.lastname: Sogabe
authors.forename: Hiraku
authors.initials: H
authors.lastname: Fukushima
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nakatsumi
authors.forename: Yoshimitsu
authors.initials: Y
authors.lastname: Kobayashi
authors.forename: Ichiro
authors.initials: I
authors.lastname: Iwanaga
authors.forename: Michio
authors.initials: M
authors.lastname: Nakamura
authors.forename: Kazuteru
authors.initials: K
authors.lastname: Hatanaka
authors.forename: Takuto
authors.initials: T
authors.lastname: Miyagishima
authors.forename: Mineo
authors.initials: M
authors.lastname: Kudo
authors.forename: Masaki
authors.initials: M
authors.lastname: Munakata
authors.forename: Takashi
authors.initials: T
authors.lastname: Meguro
authors.forename: Miki
authors.initials: M
authors.lastname: Tateyama
authors.forename: Yuh
authors.initials: Y
authors.lastname: Sakata
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; 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; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D000077146:Irinotecan; D007564:Japan / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000008:administration & dosage; D012720:Severity of Illness Index; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D000068258:Bevacizumab; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin