title: Cost-effectiveness analysis of first-line chemotherapies in metastatic colorectal cancer. Results of the Fédération Francophone de Cancérologie Digestive (FFCD) 9601 randomized trial.
abstract: BACKGROUND
  The De Gramont regimen (or high-dose LV5FU2, HD-LV5FU2) is considered a standard treatment for metastatic colorectal cancer. The aim of the study was to evaluate the efficacy and the costs of three regimens as compared to HD-LV5FU2: raltitrexed (R), LV5FU2 with a lower dose of folinic acid (LD-LV5FU2), and weekly infusional 5FU (WI-FU).
  
  
  METHODS
  An economic analysis was performed prospectively as part of a randomized trial comparing first-line chemotherapy regimens in 294 patients with unresectable metastatic colorectal cancer. The primary endpoint was event-free survival (EFS). Direct medical costs were computed from the health system viewpoint using 2001 unit costs.
  
  
  RESULTS
  None of the three regimens improved EFS as compared to HD-LV5FU2. R was less effective and more toxic. The mean total cost per patient was euro 15,970 for HD-LV5FU2. The cost of R (10,687 euro) was lower than that of HD-LV5FU2 (p = 0.008). The cost of LD-LV5FU2 (14,888 euro) and of WI-FU (13,760 euro) was not significantly different from that of HD-LV5FU2.
  
  
  CONCLUSIONS
  The lower efficacy and increased toxicity of R made it a clinically inferior regimen despite its easy administration and lower cost. The HD-LV5FU2 protocol remains a better treatment. LD-LV5FU2 appeared a good alternative regimen because it reduced costs without jeopardizing its efficacy. The WI-FU regimen did not show a significant difference in terms of efficacy, but suggested toxicity to be slightly increased.
authors.affiliation: Gustave Roussy Institute, Villejuif, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Borget
authors.forename: Anne
authors.initials: A
authors.lastname: Aupérin
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Pignon
authors.forename: Moncef
authors.initials: M
authors.lastname: Abbas
authors.forename: Olivier
authors.initials: O
authors.lastname: Bouché
authors.forename: Mireille
authors.initials: M
authors.lastname: Mousseau
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Raoul
authors.forename: Laurent
authors.initials: L
authors.lastname: Bedenne
authors.forename: Philippe
authors.initials: P
authors.lastname: Cassan
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Clavero-Fabri
authors.forename: Noël
authors.initials: N
authors.lastname: Stremsdoerfer
authors.forename: Salvador
authors.initials: S
authors.lastname: Nasca
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Queuniet
authors.forename: Michel
authors.initials: M
authors.lastname: Ducreux
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000191:economics*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000191:economics*; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000191:economics*; D005602:France; D017048:Health Care Costs; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate; D013876:Thiophenes / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D011799:Quinazolines; D013876:Thiophenes; C068874:raltitrexed; D002955:Leucovorin; D005472:Fluorouracil