title: Additional 5-FU-LV significantly increases survival in gastrointestinal cancer.
abstract: Metastatic colorectal and other locally advanced gastrointestinal (G.I.) cancers often recur after curative resection. Many mechanisms of tumor growth and/or immune escape by residual cancer cells may provoke tumor progression. Long-term, cytostatic action with repeated post-adjuvant administration of 5-fluorouracil (FU)-leucovorin (LV) cycles may interrupt or downregulate these mechanisms and favor the recovery and/or increase the immune system activity. Seventy patients were considered. An active prospective cohort including 21 patients (study group) was matched in a 1:1 ratio with a retrospective parallel control group of 21 patients. The study group received long-term repeated post-adjuvant administration of 5-FU-LV cycles, while the matched control group was conventionally treated. Statistical analysis was performed by Kaplan-Meier method and Cox's proportional hazard regression model. The five-year disease-free survival (DFS) was 77.0 + 10.1 % and 31.7 + 10.6 % (p = 0.001; hazard ratio (HR) 5.3, 95 % C.I.: 1.7-16.1, p = 0.003), while the five-year overall survival (OS) was 88.0 + 8.1 % and 37.0 + 10.7 % (p = 0.001; HR 8.9, 95 % C.I.: 2.0-39.9, p = 0.004) in the study group and in matched controls respectively. These findings suggest a relevant improvement in the outcome of this population by an intermittent and prolonged cytostatic effect with 5-FU-LV.
authors.affiliation: Department of Internal Medicine, University of Pisa, Pisa, Italy. a.nicolini@int.med.unipi.it
authors.forename: Andrea
authors.initials: A
authors.lastname: Nicolini
authors.forename: Massimo
authors.initials: M
authors.lastname: Conte
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rossi
authors.forename: Paola
authors.initials: P
authors.lastname: Ferrari
authors.forename: Michael
authors.initials: M
authors.lastname: Duffy
authors.forename: Vivian
authors.initials: V
authors.lastname: Barak
authors.forename: Angelo
authors.initials: A
authors.lastname: Carpi
authors.forename: Paolo
authors.initials: P
authors.lastname: Miccoli
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
chemical_list: D002955:Leucovorin; D005472:Fluorouracil