title: Multicenter safety study of mFOLFOX6 for unresectable advanced/recurrent colorectal cancer in elderly patients.
abstract: BACKGROUND
  Combination chemotherapy with oxaliplatin plus 5-fluorouracil/leucovorin (FOLFOX) has become a standard regimen for colorectal cancer. An increase of adverse events with combination chemotherapy is predicted in elderly patients, and it remains controversial whether they should receive the same chemotherapy as younger patients. Accordingly, this study of modified FOLFOX6 (mFOLFOX6) therapy was performed to compare its safety between elderly and non-elderly patients.
  
  
  METHODS
  We prospectively studies 14 non-elderly patients aged <70 years old and 8 elderly patients aged >or= 70 years with unresectable advanced/recurrent colorectal cancer who received mFOLFOX6 therapy during the period from March 2006 to March 2007. Adverse events and the response to treatment were compared between the elderly and non-elderly groups.
  
  
  RESULTS
  The main adverse events were neutropenia and peripheral neuropathy, which occurred in 62.5% (>or= grade 3) and 87.5% (>or= grade 1) of elderly patients. The grade and frequency of adverse events were similar in the elderly and non-elderly groups. In some patients with neutropenia, treatment could be continued without reducing the dose of oxaliplatin by deleting bolus 5-fluorouracil. A correlation was found between the cumulative dose of oxaliplatin and the severity of neuropathy, and there were 2 elderly and 3 younger patients in whom discontinuation of treatment was necessary due to peripheral neuropathy. The median number of treatment cycles was 10.0 and 9.5 in the non-elderly and elderly groups, respectively. The response rate was 60.0% in the non-elderly and 50.0% in the elderly group, while the disease control rate was 100% and 83.3% respectively, showing no age-related difference.
  
  
  CONCLUSIONS
  mFOLFOX6 therapy was well-tolerated and effective in both non-elderly and elderly patients. However, discontinuation of treatment was sometimes necessary due to peripheral neuropathy, which is dose-limiting toxicity of this therapy.
authors: Department of Surgery, Shimane Prefectural Central Hospital, Izumo, Japan. shin1028@spch.izumo.shimane.jp
authors: Shinichi
authors: S
authors: Sugimoto
authors: Kuniyuki
authors: K
authors: Katano
authors: Akiyoshi
authors: A
authors: Kanazawa
authors: Hiroshi
authors: H
authors: Yoshimura
authors: Akihiko
authors: A
authors: Kidani
authors: Hiroshi
authors: H
authors: Takeda
authors: Masato
authors: M
authors: Makino
authors: Nobuhiro
authors: N
authors: Ozaki
authors: Tsuneo
authors: T
authors: Tanaka
authors: Masahide
authors: M
authors: Ikeguchi
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000517:prevention & control; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil