title: Safety and efficacy of modified FOLFOX6 for treatment of metastatic or locally advanced colorectal cancer. A single-institution outcome study.
abstract: BACKGROUND
  Although a variety of FOLFOX regimens (5-fluorouracil and L-leucovorin combined with oxaliplatin) are widely used for the treatment of advanced colorectal cancer, the neurotoxicity caused by oxaliplatin is often problematic. The aim of this observational study was to assess the safety and efficacy of a modified version of the FOLFOX6 regimen (mFOLFOX6) when administered using the 'stop-and-go' strategy.
  
  
  METHODS
  A total of 112 eligible patients treated between June 2005 and July 2007 were identified using the prospective cohort database system of Kyoto University Hospital.
  
  
  RESULTS
  The median follow-up was 16.3 months (range 1.6-33.9), and the response rate was 33.3% (95% CI 14.5-52.2), 40.0% (95% CI 22.5-57.5) and 14.0% (95% CI 3.6-24.3) for patients who received mFOLFOX6 as first-line therapy, second-line therapy and third- or later-line therapy, respectively. The estimated median progression-free survival was 8.7 months (95% CI 2.3-15.1) and 8.2 months (95% CI 7.3-9.1) for patients on first-line and second-line therapy, respectively. The median overall survival was not reached as of April 2008 for the patients on first-line therapy, while it was 27.1 months (95% CI 22.0-32.2) for those on second-line therapy. Severe neurotoxicity occurred in only 4 patients (3.6%).
  
  
  CONCLUSIONS
  mFOLFOX6 administered using the stop-and-go strategy significantly reduced oxaliplatin-induced neurotoxicity relative to conventional FOLFOX treatment, without compromising efficacy.
authors.affiliation: Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan. motocame@kuhp.kyoto-u.ac.jp
authors.forename: Shigemi
authors.initials: S
authors.lastname: Matsumoto
authors.forename: Takafumi
authors.initials: T
authors.lastname: Nishimura
authors.forename: Masashi
authors.initials: M
authors.lastname: Kanai
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Mori
authors.forename: Satoshi
authors.initials: S
authors.lastname: Nagayama
authors.forename: Jun'ichiro
authors.initials: J
authors.lastname: Kawamura
authors.forename: Akinari
authors.initials: A
authors.lastname: Nomura
authors.forename: Shin'ichi
authors.initials: S
authors.lastname: Miyamoto
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kitano
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ishiguro
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yanagihara
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.forename: Yoshiharu
authors.initials: Y
authors.lastname: Sakai
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Chiba
authors.forename: Masanori
authors.initials: M
authors.lastname: Fukushima
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil