title: A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients.
abstract: BACKGROUND
  Adjuvant chemotherapy is standard treatment for patients with resected colon cancer who are at high risk for recurrence, but the efficacy and toxicity of such treatment in patients more than 70 years of age are controversial.
  
  
  METHODS
  We performed a pooled analysis, based on the intention to treat, of individual patient data from seven phase 3 randomized trials (involving 3351 patients) in which the effects of postoperative fluorouracil plus leucovorin (five trials) or fluorouracil plus levamisole (two trials) were compared with the effects of surgery alone in patients with stage II or III colon cancer. The patients were grouped into four age categories of equal size, and analyses were repeated with 10-year age ranges (< or =50, 51 to 60, 61 to 70, and >70 years), with the same conclusions. The toxic effects measured in all trials were nausea or vomiting, diarrhea, stomatitis, and leukopenia. Patients in the fluorouracil-plus-leucovorin and fluorouracil-plus-levamisole groups were combined for the efficacy analysis but kept separate for toxicity analyses.
  
  
  RESULTS
  Adjuvant treatment had a significant positive effect on both overall survival and time to tumor recurrence (P<0.001 for each, with hazard ratios of death and recurrence of 0.76 [95 percent confidence interval, 0.68 to 0.85] and 0.68 [95 percent confidence interval, 0.60 to 0.76], respectively). The five-year overall survival was 71 percent for those who received adjuvant therapy, as compared with 64 percent for those untreated. No significant interaction was observed between age and the efficacy of treatment. The incidence of toxic effects was not increased among the elderly (age >70 years), except for leukopenia in one study.
  
  
  CONCLUSIONS
  Selected elderly patients with colon cancer can receive the same benefit from fluorouracil-based adjuvant therapy as their younger counterparts, without a significant increase in toxic effects.
authors.affiliation: Mayo Clinic, Rochester, Minn 55905, USA.
authors.forename: D J
authors.initials: DJ
authors.lastname: Sargent
authors.forename: R M
authors.initials: RM
authors.lastname: Goldberg
authors.forename: S D
authors.initials: SD
authors.lastname: Jacobson
authors.forename: J S
authors.initials: JS
authors.lastname: Macdonald
authors.forename: R
authors.initials: R
authors.lastname: Labianca
authors.forename: D G
authors.initials: DG
authors.lastname: Haller
authors.forename: L E
authors.initials: LE
authors.lastname: Shepherd
authors.forename: J F
authors.initials: JF
authors.lastname: Seitz
authors.forename: G
authors.initials: G
authors.lastname: Francini
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D007978:Levamisole / Q000008:administration & dosage; D015999:Multivariate Analysis; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis
chemical_list: D007978:Levamisole; D002955:Leucovorin; D005472:Fluorouracil