title: Oxaliplatin/fluorouracil/leucovorin (FOLFOX4 and modified FOLFOX6) in patients with refractory or advanced colorectal cancer: post-approval Japanese population experience.
abstract: BACKGROUND
  The oxaliplatin/fluorouracil/leucovorin (FOL-FOX regimen) is an effective and generally well-tolerated regimen in Western clinical studies of advanced colorectal cancer. In Japan, oxaliplatin was approved in April 2005.
  
  
  METHODS
  To evaluate the objective tumor responses and feasibility (toxicities) of FOLFOX regimens (FOLFOX4 and modified FOLFOX6, mFOLFOX6) in a predominantly Japanese population with refractory or advanced colorectal cancer in Japan, 51 consecutive patients with histologically confirmed metastatic colon or rectum cancer who were treated between April 2005 and March 2006 were enrolled in a retrospective study. FOLFOX4 was used for treatment in 39% (first-line, 45%) of these patients, and mFOLFOX6 was used for treatment in 61% (first-line, 61%). Tumor responses were assessed radiologically, and toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 regarding toxicities other than peripheral sensory neuropathy.
  
  
  RESULTS
  The objective response rates (in those who underwent first- or second-line therapy) were 50.0% and 8.7%, respectively. The tumor control rate (partial response [PR] + stable disease [SD]) was 80.4%. There were no toxicity-related deaths. Neutropenia grade 3 was experienced in 20% of patients, and often caused delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 78% of patients. The incidence of hypersensitivity reactions to oxaliplatin in our study was lower than that in reported in Western countries.
  
  
  CONCLUSIONS
  Both FOLFOX regimens have good efficacy in refractory or advanced colorectal cancer in a Japanese population, with an acceptable overall toxicity profile.
authors.affiliation: Department of Medical Oncology, Kinki University Nara Hospital, 1248-1 Otoda-cho, Ikoma, Nara, 630-0293, Japan. tshimizu@nara.med.kindai.ac.jp
authors.forename: Toshio
authors.initials: T
authors.lastname: Shimizu
authors.forename: Taroh
authors.initials: T
authors.lastname: Satoh
authors.forename: Kenji
authors.initials: K
authors.lastname: Tamura
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Ozaki
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007564:Japan; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil