Capecitabine as adjuvant treatment for stage III colon cancer

New England Journal of Medicine

Volumn 352, Issue 26, 2005, Pages 2696-2704

  Twelves, Chris ^a,b,aa   Wong, Alfred ^c   Nowacki, Marek P ^d   Abt, Markus ^e   Burris III, Howard ^f   Carrato, Alfredo ^g   Cassidy, Jim ^b,h   Cervantes, Andrés ⁱ   Fagerberg, Jan ^e   Georgoulias, Vassilis ^j   Husseini, Fares ^k   Jodrell, Duncan ^l   Koralewski, Piotr ^m   Kröning, Hendrik ⁿ   Maroun, Jean ^o   Marschner, Norbert ^p   McKendrick, Joseph ^q   Pawlicki, Marek ^r   Rosso, Riccardo ^s   Schüller, Johannes ^t   Seitz, Jean François ^u   Stabuc, Borut ^v   Tujakowski, Jerzy ^w   Van Hazel, Guy ^x   Zaluski, Jerzy ^y   Scheithauer, Werner ^z   more..

^a UNIVERSITY OF LEEDS   (United Kingdom)

^b UNIVERSITY OF GLASGOW   (United Kingdom)

^c TOM BAKER CANCER CENTRE   (Canada)

^d INSTITUTE OF ONCOLOGY   (Poland)

^e F HOFFMANN LA ROCHE LTD   (Switzerland)

^f Sarah Cannon Cancer Center   (United States)

^g HOSPITAL GENERAL UNIVERSITARIO DE ELCHE   (Spain)

^h UNIVERSITY OF ABERDEEN   (United Kingdom)

ⁱ HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

^j UNIVERSITY HOSPITAL OF HERAKLION   (Greece)

^k Pasteur Hospital   (France)

^l UNIVERSITY OF EDINBURGH   (United Kingdom)

^m Rydygier Memorial Hospital   (Poland)

ⁿ Stadisches Klinikum Magdeburg   (Germany)

^o OTTAWA REGIONAL CANCER CENTRE   (Canada)

^p Outpatient Cancer Center   (Germany)

^q BOX HILL HOSPITAL   (Australia)

^r Cancer Institute   (Poland)

^s UNIVERSITY OF GENOA   (Italy)

^t KRANKENANSTALT RUDOLFSTIFTUNG   (Austria)

^u TIMONE HOSPITAL   (France)

^v UNIVERSITY MEDICAL CENTRE LJUBLJANA   (Slovenia)

^w Regional Oncology Centre Bydgoszcz   (Poland)

^x Mount Hospital   (Australia)

^y Greatpoland Cancer Center   (Poland)

^z UNIVERSITY OF VIENNA   (Austria)

^aa UNIVERSITY OF BRADFORD   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; FLUOROPYRIMIDINE; FLUOROURACIL; FOLINIC ACID; ANTINEOPLASTIC ANTIMETABOLITE; DEOXYCYTIDINE; DRUG DERIVATIVE;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANOREXIA; ARTICLE; ASTHENIA; CANCER ADJUVANT THERAPY; CANCER RELAPSE; CANCER STAGING; CANCER SURGERY; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COLON CARCINOMA; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPERBILIRUBINEMIA; INCIDENCE; LETHARGY; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUTROPENIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMATITIS; TOXICITY; ADJUVANT CHEMOTHERAPY; COLON TUMOR; DISEASE FREE SURVIVAL; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; MULTIVARIATE ANALYSIS; SURVIVAL;

ADULT; AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; CHEMOTHERAPY, ADJUVANT; COLONIC NEOPLASMS; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; NEOPLASM STAGING; SURVIVAL ANALYSIS;

EID: 21244497388     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa043116     Document Type: Article

References (29)

1. Stewart BW, Kleihues P, eds. World cancer report. Lyon, France: IARC Press, 2003: 198.
2. Ayanian JZ, Zaslavsky AM, Fuchs CS, et al. Use of adjuvant chemotherapy and radiation therapy for colorectal cancer in a population-based cohort. J Clin Oncol 2003;21: 1293-300.
3. Benson AB III, Schrag D, Somerfield MR, et al. American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol 2004;22:3408-19.
4. Moertel CG, Fleming TR, Macdonald JS, et al. Fluorouracil plus levamisole as effective adjuvant therapy after resection of stage III colon carcinoma: a final report. Ann Intern Med 1995;122:321-6.
5. O'Connell MJ, Mailliard JA, Kahn MJ, et al. Controlled trial of fluorouracil and lowdose leucovorin given for 6 months as postoperative adjuvant therapy for colon cancer. J Clin Oncol 1997;15:246-50.
6. 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.
7. Wolmark N, Rockette H, Mamounas E, et al. Clinical trial to assess the relative efficacy of fluorouracil and leucovorin, fluorouracil and levamisole in patients with Dukes' B and C carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project C-04. J Clin Oncol 1999;17:3553-9.
8. Haller DG, Catalano PJ, Macdonald JS, Mayer RJ. Fluorouracil (FU), leucovorin (LV) and levamisole (LEV) adjuvant therapy for colon cancer: five-year final report of INT-0089. Prog Proc Am Soc Clin Oncol 1998; 17:256a. abstract.
9. Arkenau HT, Bermann A, Rettig K, Stohmeyer G, Porschen R. 5-Fluorouracil plus leucovorin is an effective adjuvant chemotherapy in curatively resected stage III colon cancer: long-term follow-up results of the adjCCA-01 trial. Ann Oncol 2003;14:395-9.
10. Porschen R, Bermann A, Loffler T, et al. Fluorouracil plus leucovorin as effective adjuvant chemotherapy in curatively resected stage III colon cancer: results of the trial adjCCA-01. J Clin Oncol 2001;19:1787-94.
11. André 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.
12. Saini A, Norman AR, Cunningham D, et al. Twelve weeks of protracted venous infusion of fluorouracil (5-FU) is as effective as 6 months of bolus 5-FU and folinic acid as adjuvant treatment in colorectal cancer. Br J Cancer 2003;88:1859-65.
13. Poplin E, Benedetti J, Estes NC, et al. Phase III randomized trial of bolus 5-FU/ leucovorin/levamisole versus 5-FU continuous infusion/levamisole as adjuvant therapy for high risk colon cancer (SWOG 9415/ INT-0153). Prog Proc Am Soc Clin Oncol 2000;19:240a. abstract.
14. Van Cutsem E, Dicato M, Wils J, et al. Adjuvant treatment of colorectal cancer (current expert opinion derived from the Third International Conference: Perspectives in Colorectal Cancer, Dublin, 2001). Eur J Cancer 2002;38:1429-36.
15. Du XL, Key CR, Osborne C, Mahnken JD, Goodwin JS. Discrepancy between consensus recommendations and actual community use of adjuvant chemotherapy in women with breast cancer. Ann Intern Med 2003;138:90-7. [Erratum, Ann Intern Med 2003;139:873.]
16. Grothey A, Kellermann L, Schmoll HJ. Deficits in management of patients with colorectal carcinoma in Germany: results of multicenter documentation of therapy algorithms. Med Klin (Munich) 2002;97:270-7. (In German.)
17. Hensley Alford S, Ulcickas-Yood M, Jankowski M, Fortman K, Rolnick S, Johnson CC. Stage III colon cancer in the elderly: adjuvant therapy and survival. Prog Proc Am Soc Clin Oncol 2003;22:748. abstract.
18. Edwards BK, Howe HL, Ries LA, et al. Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on U.S. cancer burden. Cancer 2002;94:2766-92.
19. Borner MM, Schöffski P, de Wit R, et al. 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;38:349-58.
20. Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997;15:110-5.
21. Miwa M, Ura M, Nishida M, et al. 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;34:1274-81.
22. Schüller J, Cassidy J, Dumont E, et al. Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 2000;45:291-7.
23. 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.
24. Cassidy J, Twelves C, Van Cutsem E, et al. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol 2002; 13:566-75.
25. Twelves C, Boyer M, Findlay M, et al. Capecitabine (Xeloda) improves medical resource use compared with 5-fluorouracil plus leucovorin in a phase III trial conducted in patients with advanced colorectal cancer. Eur J Cancer 2001;37:597-604.
26. 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.
27. André T, Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 2004;350:2343-51.
28. Sargent DJ, Wieand S, Benedetti J, et al. Disease-free survival (DFS) vs. overall survival (OS) as a primary endpoint for adjuvant colon cancer studies: individual patient data from 12,915 patients on 15 randomized trials. Prog Proc Am Soc Clin Oncol 2004;23: 246.
29. Díaz-Rubio E, Burris H, Douillard JY, et al. Safety of capecitabine (X) compared to fluorouracil/leucovorin (5-FU/LV) for the adjuvant treatment of elderly colon cancer patients (pts). Prog Proc Am Soc Clin Oncol 2004;23:304.