title: Capecitabine versus bolus fluorouracil plus leucovorin (folinic acid) as adjuvant chemotherapy for patients with Dukes' C colon cancer : economic evaluation in an Italian NHS setting.
abstract: OBJECTIVE
  In the recent X-ACT (Xeloda in Adjuvant Colon cancer Therapy) trial, oral capecitabine (Xeloda) demonstrated superior efficacy and an improved safety profile compared with infused fluorouracil + leucovorin (folinic acid) [FU+LV] in patients with Dukes' C colorectal cancer. We used the X-ACT results to determine the cost effectiveness of capecitabine compared with FU+LV from the perspective of the Italian National Health Service (NHS).
  
  
  METHODS
  Medical resource use data were collected throughout the treatment period. Unit costs for drug administration, hospitalization, emergency room visits and concomitant medications were obtained using Italian published sources. A health-state transition model was used to estimate the incremental cost-effectiveness ratio per quality-adjusted life-month (QALM) gains in the intent-to-treat population (1004 and 983 patients in the capecitabine and FU+LV arms, respectively). Costs and effectiveness were discounted at 3.5%. Costs were calculated in euros (2005 values).
  
  
  RESULTS
  Administration of capecitabine required fewer clinic visits per patient than FU+LV (7.35 vs 28.0, respectively). Mean acquisition costs per patient for capecitabine were higher than for FU+LV (euro 2533 vs euro 231, respectively), but this difference was offset by the difference in mean chemotherapy administration costs per patient for FU+LV (euro 4338, compared with euro 152 for capecitabine). Mean total hospital days and medication costs for treatment-related adverse events were higher for FU+LV than for capecitabine (euro 352 vs euro 78, respectively). The cost of emergency room visits for the treatment of adverse events did not differ between the treatment groups. With respect to the lifetime horizon, compared with FU+LV, capecitabine is projected to increase QALMs by a mean 6.5 months, with overall cost savings of euro 2234 over the treatment period. These findings show that capecitabine is an economically dominant treatment in this setting.
  
  
  CONCLUSIONS
  Adjuvant capecitabine for patients with Dukes' C colon cancer has the same activity in terms of outcome when compared with FU+LV but is a lower cost option from the economic perspective of the Italian NHS.
authors.affiliation: Unità Complessa di Oncologia Medica, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy. dicostanzofrancesco@fiscali.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Costanzo
authors.forename: Roberto
authors.initials: R
authors.lastname: Ravasio
authors.forename: Alberto
authors.initials: A
authors.lastname: Sobrero
authors.forename: Oscar
authors.initials: O
authors.lastname: Bertetto
authors.forename: Orazio
authors.initials: O
authors.lastname: Vinante
authors.forename: Gabriele
authors.initials: G
authors.lastname: Luppi
authors.forename: Roberto
authors.initials: R
authors.lastname: Labianca
authors.forename: Dino
authors.initials: D
authors.lastname: Amadori
authors.forename: Carlo
authors.initials: C
authors.lastname: Barone
authors.forename: Marco
authors.initials: M
authors.lastname: Carlo Merlano
authors.forename: Flavia
authors.initials: F
authors.lastname: Longo
authors.forename: Giovanni
authors.initials: G
authors.lastname: Mansueto
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Antonuzzo
authors.forename: Silvia
authors.initials: S
authors.lastname: Gasperoni
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant / Q000191:economics / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000191:economics / Q000379:methods; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003362:Cost-Benefit Analysis; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D017048:Health Care Costs; D006801:Humans; D007263:Infusions, Parenteral / Q000191:economics; D007558:Italy; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009313:National Health Programs / Q000191:economics; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D002955:Leucovorin; D005472:Fluorouracil
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