title: Mature Results of a Prospective Randomized Trial Comparing 5-Flourouracil with Leucovorin to 5-Flourouracil with Levamisole as Adjuvant Therapy of Stage II and III Colorectal Cancer- The Israel Cooperative Oncology Group (ICOG) Study.
abstract: OBJECTIVE
  Survival benefit with adjuvant therapy was shown in patients with Stage III colorectal cancer (CRC). This study evaluates long-term (10-year) outcome in patients with CRC randomly assigned to adjuvant 5-Fluorouracil/Leucovorin (5FU+LV) or 5-FU/Levamisole (5FU+LEV).
  
  
  METHODS
  Between 1990 and 1995, 398 patients with curatively resected Stage II-III CRC were randomly assigned to adjuvant 5FU+LV or 5FU+LEV for 12 months.
  
  
  RESULTS
  No difference was evident in 10-year relapse-free or overall survival between study groups. Grade III toxicity was similar between groups; however, neurotoxicity was significantly greater with 5FU+LEV (p=0.02) and gastrointestinal toxicity with 5FU+LV (p=0.03). Female patients treated with 5FU+LEV had improved overall survival.
  
  
  CONCLUSIONS
  Adjuvant treatment of CRC is still based on leucovorin modulated fluorouracil. The long-term follow-up results of this trial indicate that the adjuvant treatment of Stage II-III CRC with 5FU+LV or 5FU+LEV is equally effective. The finding of improved survival in female subjects treated with 5FU+LEV warrants further study to determine if Levamisole is a better modulator of 5-FU than Leucovorin in this patient subset.
authors.affiliation: 1. Department of Oncology, Tel Aviv-Souraski Medical Center, Tel Aviv, Israel.
authors.forename: Arie
authors.initials: A
authors.lastname: Figer
authors.forename: Aviram
authors.initials: A
authors.lastname: Nissan
authors.forename: Adi
authors.initials: A
authors.lastname: Shani
authors.forename: Riva
authors.initials: R
authors.lastname: Borovick
authors.forename: Mariana
authors.initials: M
authors.lastname: Stiener
authors.forename: Mario
authors.initials: M
authors.lastname: Baras
authors.forename: Herbert R
authors.initials: HR
authors.lastname: Freund
authors.forename: Aaron
authors.initials: A
authors.lastname: Sulkes
authors.forename: Alexander
authors.initials: A
authors.lastname: Stojadinovic
authors.forename: Tamar
authors.initials: T
authors.lastname: Peretz