title: Retrospective analysis on the efficacy of bevacizumab with FOLFOX as a first-line treatment in Japanese patients with metastatic colorectal cancer.
abstract: OBJECTIVE
  Past reports have suggested that the addition of bevacizumab (BV) to oxaliplatin combined with 5-fluorouracil (5-FU) and folinic acid (leucovorin) (FOLFOX4) provides a limited survival benefit in metastatic colorectal cancer (mCRC). Our study aimed to evaluate the survival benefits of a FOLFOX4 + BV regimen.
  
  
  METHODS
  Patients with mCRC who started treatment between April 2005 and July 2008 were evaluated in this retrospective cohort study. Patients received FOLFOX4, or FOLFOX4 + BV after the approval of BV in 2007. The two cohorts treated before and after BV approval were compared. Primary end-points were progression-free survival (PFS), overall survival (OS) and response rate (RR).
  
  
  RESULTS
  A total of 213 patients received either FOLFOX4 (n = 128) or FOLFOX4 + BV (n = 85). For FOLFOX4 and FOLFOX4 + BV respectively, median PFS was 9.9 and 17.0 months (HR, 0.58; 95% CI, 0.42-0.82; P = 0.002), median OS was 20.5 and 38.8 months (HR, 0.49; 95% CI, 0.34-0.71; P < 0.001), respectively. Patients who received 5-fluorouracil plus leucovorin (FL) as maintenance therapy during oxaliplatin suspension in both FOLFOX4 (n = 6) and FOLFOX4 + BV (n = 46) groups showed a trend to improved median PFS and median OS.
  
  
  CONCLUSIONS
  The additive effect and potential survival benefits of adding BV to the FOLFOX4 regimen in first-line treatment of mCRC were demonstrated. Maintenance FL during suspension of oxaliplatin appeared to be an important factor in better survival.
authors.affiliation: Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Mitsukuni
authors.initials: M
authors.lastname: Suenaga
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Mizunuma
authors.forename: Satoshi
authors.initials: S
authors.lastname: Matsusaka
authors.forename: Eiji
authors.initials: E
authors.lastname: Shinozaki
authors.forename: Masashi
authors.initials: M
authors.lastname: Ueno
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Yamaguchi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D057286:Electronic Health Records; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007564:Japan; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D000068258:Bevacizumab; D002955:Leucovorin; D005472:Fluorouracil
keywords: FOLFOX4; bevacizumab; metastatic colorectal cancer; overall survival; progression-free survival