title: An individual patient data meta-analysis of adjuvant therapy with carmofur in patients with curatively resected colon cancer.
abstract: BACKGROUND
  Oral carmofur, either as a single or in combination with other chemotherapeutic agents, has been used as adjuvant chemotherapy for curatively resected colon cancer patients. Past trials and meta-analyses indicate that it is somewhat effective in extending survival of patients with this cancer. The objective of this study was to perform a reappraisal of randomized clinical trials conducted in this regard.
  
  
  METHODS
  We designed an individual patient-based meta-analysis of relevant clinical trials to examine the benefit of oral carmofur for curatively resected colon cancer in terms of overall survival (OS) and disease-free survival (DFS).
  
  
  RESULTS
  We analyzed individual patient data of three randomized clinical trials, which met the predetermined inclusion criteria. These three trials had a combined total of 2152 patients, carmofur as adjuvant chemotherapy compared with surgery-alone, 5 years follow-up, intention-to-treat-based analytic strategy and similar end points (OS and DFS). In a pooled analysis, 5 year OS rates were 80.4 and 76.4%, and 5 year DFS rates 76.9 and 71.0%, respectively, in carmofur and surgery-alone group. Oral carmofur had significant advantage over surgery-alone in terms of both OS [pooled hazard ratio, 0.82; 95% confidence interval (CI) = 0.68-0.99; P = 0.043] and DFS (pooled hazard ratio, 0.77; 95% CI = 0.65-0.91; P = 0.003).
  
  
  CONCLUSIONS
  This individual patient-based meta-analysis demonstrated that oral carmofur significantly improves both OS and DFS in patients with curatively resected colon cancers.
authors.affiliation: Department of Epidemiological and Clinical Research Information Management, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto 606-8501, Japan. sakamoto@pbh.med.kyoto-u.ac.jp
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Chikuma
authors.initials: C
authors.lastname: Hamada
authors.forename: Mahbubur
authors.initials: M
authors.lastname: Rahman
authors.forename: Susumu
authors.initials: S
authors.lastname: Kodaira
authors.forename: Katsuki
authors.initials: K
authors.lastname: Ito
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nakazato
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Masayuki
authors.initials: M
authors.lastname: Yasutomi
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000601:surgery*; D013505:Digestive System Surgical Procedures; D018572:Disease-Free Survival; D005472:Fluorouracil / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D009364:Neoplasm Recurrence, Local; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; C017367:carmofur; D005472:Fluorouracil