Background/Aims: To compare the cost consequences of oral capecitabine and two different intravenous regimens of 5-fluorouracil/folinic acid (de Gramont and Mayo Clinic regimens) as adjuvant therapy in stage III colon cancer in France. Methods: Clinical efficacy and safety data were taken from published clinical trials. Medical resource use was estimated from published data and expert opinion. Direct costs (drug acquisition, inpatient and home drug administration, laboratory tests, transportation, and management of adverse events) were considered over a time horizon of 46 months (3.8 years). The perspective taken was that of the French Sickness Funds. Results: In patients treated with capecitabine, relapse-free survival was 1.3 months longer than with the Mayo Clinic regimen, which has been shown to be as effective as the de Gramont regimen. In the base case analysis, capecitabine was less costly (3,654 EUR/patient) than the Mayo Clinic (10,481 EUR/ patient) and de Gramont (7,204 EUR/patient) regimens. In the sensitivity analysis, capecitabine remained dominant except when the intravenous regimens were assumed to be administered at home in all patients. Conclusions: In France, capecitabine is more effective and less costly than both the Mayo Clinic and de Gramont regimens as adjuvant therapy for colon cancer.

Keywords:
Colon cancer, Adjuvant therapy, Cost-effectiveness, Capecitabine, 5-Fluorouracil, Mayo Clinic regimen, de Gramont regimen
1.
Bouvier AM: Cancer du côlon-rectum; in Remontet L, Buemi A, Velten M, Jougla E, Esteve J: Evolution de l’incidence et de la mortalité par cancer en France de 1978 à 2000. Rapport, 2003. http://www.invs.sante.fr.
2.
Remontet L, Esteve J, Bouvier AM: Cancer incidence and mortality over the period 1978–2000. Rev Epidémiol Santé Publique 2003;51:3–30.
3.
Colonna M, Grosclaude P, Launoy G, Arveux P, Buemi A, Raverdy N, Schaffer P, Tretarre B, Exbrayat C, Faivre J: Estimation de la prévalence régionale des tumeurs colorectales en France. Rev Epidémiol Santé Publique 2002;50:243–251.
4.
Gatta G, Ciccolallo L, Capocaccia R, Coleman M, Hakulinen T, Moller H, Berrino F; Eurocare Working Group: Differences in colorectal cancer survival between European and US populations: the importance of sub-site and morphology. Eur J Cancer 2003;39:2214–2222.
5.
TNS Health Care – Cancérologie 2005, vol II: Les indications (recueil des données mars–juin 2005).
6.
Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, Shimma N, Umeda, Ishitsuka H: Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 1998;34:1274–1281.
7.
Schüller J, Cassidy J, Dumont E, Roos B, Durston S, Banken L, Utoh M, Mori K, Weidekamm E, Reigner B: Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 2000;45:291–297.
8.
Van Cutsem E, Twelves C, Cassidy J, Allman D, Bajetta E, Boyer M, Bugat R, Findlay M, Frings S, Jahn M, McKendrick J, Osterwalder B, Perez-Manga G, Rosso R, Rougier P, Schmiegel WH, Seitz JF, Thompson P, Vieitez JM, Weitzel C, Harper P; Xeloda Colorectal Cancer Study Group: Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol 2001;19:4097–4106.
9.
Van Cutsem E, Hoff PM, Harper P, Bukowski RM, Cunningham D, Dufour P, Graeven U, Lokich J, Madajewicz S, Maroun JA, Marshall JL, Mitchell EP, Perez-Manga G, Rougier P, Schmiegel W, Schoelmerich J, Sobrero A, Schilsky RL: Oral capecitabine vs. intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomized, phase III trials. Br J Cancer 2004;90:1190–1197.
10.
Hoff PM, Ansari R, Batist G, Cox J, Kocha W, Kuperminc M, Maroun J, Walde D, Weaver C, Harrison E, Burger HU, Osterwalder B, Wong AO, Wong R: Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol 2001;19:2282–2292.
11.
O’Neill VJ, Cassidy J: Capecitabine in the treatment of colorectal cancer. Future Oncol 2005;1:183–190.
12.
Twelves C, Wong A, Nowacki MP, Abt M, Burris H 3rd, Carrato A, Cassidy J, Cervantes A, Fagerberg J, Georgoulias V, Husseini F, Jodrell D, Koralewski P, Kroning H, Maroun J, Marschner N, McKendrick J, Pawlicki M, Rosso R, Schuller J, Seitz JF, Stabuc B, Tujakowski J, Van Hazel G, Zaluski J, Scheithauer W: Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 2005;352:2696–2704.
13.
Scheithauer W, McKendrick J, Begbie S, Borner M, Burns WI, Burris HA, Cassidy J, Jodrell D, Koralewski P, Levine EL, Marschner N, Maroun J, Garcia-Alfonso P, Tujakowski J, Van Hazel G, Wong A, Zaluski J, Twelves C; X-ACT Study Group: 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;12:1735–1743.
14.
Cassidy J, Douillard JY, Twelves C, McKendrick JJ, Scheithauer W, Bustova I, Johnston PG, Lesniewski-Kmak K, Jelic S, Fountzilas G, Coxon F, Diaz-Rubio E, Maughan TS, Malzyner A, Bertetto O, Beham A, Figer A, Dufour P, Patel KK, Cowell W, Garrison LP: Pharmacoeconomic analysis of adjuvant oral capecitabine vs intravenous 5-FU/LV in Dukes’ C colon cancer: the X-ACT trial. Br J Cancer 2006;94:1122–1129.
15.
André T, Colin P, Louvet C, Gamelin E, Bouche O, Achille E, Colbert N, Boaziz C, Piedbois P, Tubiana-Mathieu N, Boutan-Laroze A, Flesch M, Buyse M, de Gramont A: 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;21:2896–2903.
16.
Collège des Economistes de la Santé. Guide méthodologique pour l’évaluation économique des stratégies de santé, 2003. http://www.ces-asso.org/Pages/reco.html.
17.
URCAMIF: Prise en charge du cancer du côlon en Ile-de-France. Synthèse, 2004. http://www.urcamif.assurance–maladie.fr.
18.
Com-Ruelle L, Lucas-Gabrielli V, Renaud T: Le coût du cancer du colon en Ile de France, Questions d’économie de la santé, 2005, vol 98, pp 1–8. http://www.irdes.fr/Publications/Bulletins/QuestEco/2005.htm#n98.
21.
Service évaluation médico-économique et santé publique: analyse comparée de la chimiothérapie anticancéreuse administrée à l’hôpital ou prise en charge à domicile: aspects économiques et organisationnels. Paris, Haute Autorité de Santé, Juin 2005. http://www.has-sante.fr/anaes/Publications.nsf/nPDFFile/RA_LFAL-6HGH86/$File/chimio_rap.pdf?OpenElement.
23.
Le Lay K, Riou-Franca L, Launois R: Coût efficacité des chimiothérapie par voie orale en médecine de ville: le cas de la vinorelbine. J Econ Méd 2002;20:379–400.
24.
Plan cancer 2003–2007: Mission interministérielle pour la lutte contre le cancer. http://www.e-cancer.fr/v1/fichiers/public/plancancerbase.pdf.
25.
Liu G, Franssen E, Fitch MI, Warner E: Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997;15:110–115.
26.
Borner MM, Schoffski P, de Wit R, Caponigro F, Comella G, Sulkes A, Greim G, Peters GJ, van der Born K, Wanders J, de Boer RF, Martin C, Fumoleau P: Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer 2002;38:349–358.
© 2008 S. Karger AG, Basel
2008
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.