Abstract
Background and 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 €s (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 (€2533 vs €231, respectively), but this difference was offset by the difference in mean chemotherapy administration costs per patient for FU+LV (€4338, compared with €152 for capecitabine). Mean total hospital days and medication costs for treatment-related adverse events were higher for FU+LV than for capecitabine (€352 vs €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 €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.
Similar content being viewed by others
Notes
The use of trade names is for product identification purposes only and does not imply endorsement.
References
International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) Investigators. Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. Lancet 1995; 345: 939–44
deGramont A, Bosset JF, Milan C, et al. Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study. J Clin Oncol 1997; 1: 808–15
Van Cutsem E, Hoff P, Harper P, et al. Oral capecitabine versus intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. Br J Cancer 2004; 90: 1190–7
Twelves C, Wong A, Nowacki MP, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 2005; 352: 2696–704
Scheithauer W, McKendrick J, Begbie S, et al. Oral capecitabine as an alternative to i.V. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial. Ann Oncol 2003; 14: 1735–43
National Institute for Health and Clinical Excellence [online]. Available from URL: http://www.nice.org.uk/nicemedia/pdf/TA094guidance.pdf [Accessed 2008 Aug 1]
Cassidy J, Douillard J-Y, Twelves C, et al. Pharmacoeconomic analysis of adjuvant oral capecitabine vs intravenous 5-FU+LV in Dukes’ C colon cancer: the X-ACT trial. Br J Cancer 2006; 94: 1122–9
Collett D. Modelling survival data in medical research. London: Chapman & Hall, 1994: 107–49
Ramsey S, Andersen MR, Etzioni R, et al. Quality of life in survivors of colorectal carcinoma. Cancer 2000; 88: 1294–303
Milano: L’informatore farmaceutico. Milano: OEMF 2005 [online]. Available from URL: http://www.informatorefarmaceutico.it [Accessed 2008 Aug 1]
Regione Lombardia. Aggiornamento delle tariffe delle prestazioni ospedaliere in regime di ricovero e attuazione del punto 3 del dispositivo della d.g.r. n. VI/34437 del 4 febbraio 1998
Lucioni C, Garancini MP, Massi-Benedetti M, et al. The social cost of type 2 diabetes in Italy: the CODE-2 study [in Italian]. PharmacoEcon Ital Res Artic 2000; 2(1): 1–21
Ministero della salute. Prestazioni di assistenza specialistica ambulatoriale erogabili nell’ambito del Servizio Sanitario Nazionale e relative tariffe. Decreto Ministeriale 22 luglio 1996, Supplemento ordinario alla Gazzetta Ufficiale n.216 del 14 settembre 1996
Data on file. Monza: Roche SpA
Drummond MF, O’Brien BJ, Stoddart GL, et al. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press, 2005
Andre T, Colin P, Louvet C, et al. Semimonthly versus monthly regimen of fluorouracil and leucovorin administered for 24 or 36 weeks as adjuvant therapy in stage II and III colon cancer: results of a randomized trial. J Clin Oncol 2003; 21: 2896–903
Andre T, Quinaux E, Louvet C, et al. Updated results at 6 year of the GERCOR C96.1 phase III study comparing LV5FU2 to monthly 5FU-leucovorin (mFufol) as adjuvant treatment for Dukes B2 and C colon cancer patients [abstract]. J Clin Oncol 2005; 23: 3522
Chau I, Norman AR, Cunningham D, et al. A randomised comparison between 6 months of bolus fluorouracil/leucovorin and 12 weeks of protracted venous infusion fluorouracil as adjuvant treatment in colorectal cancer. Ann Oncol 2005; 16: 549–57
Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 2000; 343: 905–14
De Gramont A, Figer A, Seymour M, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000; 18: 2938–47
André T, Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 1004; 350: 2343–51
Wolmark N, Wieand HS, Kuebler JP, et al. A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: results of NSABP Protocol C-07 [abstract no. dy3500]. J Clin Oncol 2005; 23: 246s
Schmoll H-J, Cartwright T, Tabernero J, et al. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J Clin Oncol 2007; 25(1): 102–9
Acknowledgements
This study was sponsored by Roche SpA, Monza, Italy. English language assistance for the preparation of this manuscript was provided by Tracey Hale, Wolters Kluwer Medical Communications. This assistance was funded by Roche SpA, Monza, Italy.
Co-contributors: Antimi Mauro, Ospedale S. Eugenio, Roma; Beretta Giordano, Ospedali Riuniti, Bergamo; Bertuccelli Maurizio, Azienda USL 6, Livorno; Biasco Guido, Policlinico S. Orsola Malpighi, Bologna; Brandi Giovanni, Policlinico S. Orsola Malpighi, Bologna; Bumma Cesare, Ospedale S. Giovanni AS, Torino; Cardarelli Nadia, Ospedale Vicenza, Vicenza; Ciuffreda Libero, Az. Sanitaria Ospedaliera Molinette, Torino; Comella Giuseppe, Istituto Tumori Fondazione Pascale, Napoli; Della Palma Maurizio, Ospedale Vicenza, Vicenza; Fosser Vinicio, Ospedale Vicenza, Vicenza; Frustaci Sergio, Centro Riferimento Oncologico, Aviano; Paccagnella Adriano, USL 6 Ospedale Civile, Venezia; Rabbi Carla, Az. Ospedaliera C. Poma, Poma; Ricci Sergio, Az. Ospedaliera S. Chiara, Pisa; Rosso Riccardo, Istituto Nazionale Ricerca Cancro, Genova; Scanni Alberto, Az. Ospedaliera Fatebenefratelli, Milano.
The authors have no conflicts of interest that are directly relevant to the content of this study.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Di Costanzo, F., Ravasio, R., Sobrero, A. et al. Capecitabine versus Bolus Fluorouracil plus Leucovorin (Folinic Acid) as Adjuvant Chemotherapy for Patients with Dukes’ C Colon Cancer. Clin. Drug Investig. 28, 645–655 (2008). https://doi.org/10.2165/00044011-200828100-00005
Published:
Issue Date:
DOI: https://doi.org/10.2165/00044011-200828100-00005