title: Safety verification trials of mFOLFIRI and sequential IRIS + bevacizumab as first- or second-line therapies for metastatic colorectal cancer in Japanese patients.
abstract: OBJECTIVE
  S-1 is effective in sequential combination with irinotecan (IRIS) in treating metastatic colorectal cancer. We conducted a randomized phase II trial of modified leucovorin, fluorouracil and irinotecan (mFOLFIRI) + bevacizumab and sequential IRIS + bevacizumab as first- or second-line therapies.
  
  
  METHODS
  Sixty metastatic colorectal cancer patients were randomly assigned to receive mFOLFIRI + bevacizumab or sequential IRIS + bevacizumab (7.5 mg/kg of bevacizumab and 150 mg/m(2) of irinitecan, and 80 mg/m(2)/day of S-1 orally from day 3 until day 16 as a 3-week course). The primary endpoint was the safety of each method until week 12, with the secondary endpoint being the comparison of the safety and efficacy of the two methods.
  
  
  RESULTS
  The safety of the two treatments was comparable, except that G3 anorexia and diarrhoea were less frequent with sequential IRIS + bevacizumab. The overall response rate was 62% [95% confidence interval (CI) 40.1-79.8] versus 72% (95% CI 50.6-86.2), and progression-free survival was 324 days (95% CI 247-475) versus 345 days (95% CI 312-594) with mFOLFIRI + bevacizumab versus IRIS + bevacizumab, respectively.
  
  
  CONCLUSIONS
  Sequential IRIS + bevacizumab is a safe and effective method of systemic chemotherapy against metastatic colorectal cancer and is compatible with mFOLFIRI + bevacizumab.
authors: Institute of Development, Department of Clinical Oncology, Aging and Cancer, Tohoku University, Sendai, Japan.
authors: Shunsuke
authors: S
authors: Kato
authors: Hideaki
authors: H
authors: Andoh
authors: Makio
authors: M
authors: Gamoh
authors: Takuhiro
authors: T
authors: Yamaguchi
authors: Yasuko
authors: Y
authors: Murakawa
authors: Hideki
authors: H
authors: Shimodaira
authors: Shin
authors: S
authors: Takahashi
authors: Takahiro
authors: T
authors: Mori
authors: Hisatsugu
authors: H
authors: Ohori
authors: Shun-ichi
authors: S
authors: Maeda
authors: Takao
authors: T
authors: Suzuki
authors: Satoshi
authors: S
authors: Kato
authors: Shoko
authors: S
authors: Akiyama
authors: Yuka
authors: Y
authors: Sasaki
authors: Takashi
authors: T
authors: Yoshioka
authors: Chikashi
authors: C
authors: Ishioka
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D000068258:Bevacizumab; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin