Seminars in Oncology
Volume 32, Issue 1 , Pages 43-51 , February 2005

Oral capecitabine: Bridging the Atlantic divide in colon cancer treatment

  • Eric Van Cutsem

      Affiliations

    • University Hospital Gasthuisberg, Department of Internal Medicine, Digestive Oncology Unit, Leuven, Belgium.
    • Corresponding Author InformationAddress reprint requests to Eric Van Cutsem, MD, PhD, University Hospital Gasthuisberg, Department of Internal Medicine, Herestraat 49, Leuven 3000, Belgium.
    • ,
  • Chris Verslype

      Affiliations

    • University Hospital Gasthuisberg, Department of Internal Medicine, Digestive Oncology Unit, Leuven, Belgium.
    • ,
  • Sabine Tejpar

      Affiliations

    • University Hospital Gasthuisberg, Department of Internal Medicine, Digestive Oncology Unit, Leuven, Belgium.

References 

  1. Saltz LB , Cox JV , Blanke C , et al.  Irinotecan Study Group   Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer . N Engl J Med . 2000;343:905–914
  2. Hurwitz H , Fehrenbacher L , Cartwright T , et al.   Bevacizumab (a monoclonal antibody to vascular endothelial growth factor) prolongs survival in first-line colorectal cancer (CRC) (Results of a phase III trial of bevacizumab in combination with bolus IFL (irinotecan, 5-fluorouracil, leucovorin) as first-line therapy in subjects with metastatic CRC) . Proc Am Soc Clin Oncol . 2003;22:906i; (abstr 3646)
  3. Douillard JY , Cunningham D , Roth AD , et al.   Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer (A multicentre randomised trial) . Lancet . 2000;355:1041–1047
  4. 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;18:2938–2947
  5. 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;34:1274–1281
  6. 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;45:291–297
  7. 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;38:349–358
  8. Liu G , Franssen E , Fitch M , et al.   Patient preferences for oral versus intravenous palliative chemotherapy . J Clin Oncol . 1997;15:110–115
  9. Van Cutsem E , Findlay M , Osterwalder B , et al.   Capecitabine, an oral fluoropyrimidine carbamate with substantial activity in advanced colorectal cancer (Results of a randomized phase II study) . J Clin Oncol . 2000;18:1337–1345
  10. Van Cutsem E , Twelves C , Cassidy J , et al.   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
  11. Hoff P , Ansari R , Batist G , et al.   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
  12. 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;90:1190–1197
  13. Meta-analysis Group in Cancer . Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer . J Clin Oncol . 1998;16:301–308
  14. de Gramont 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;15:808–815
  15. Köhne CH , Wils J , Lorenz M , et al.   Randomized phase III study of high-dose fluorouracil given as a weekly 24-hour infusion with or without leucovorin versus bolus fluorouracil plus leucovorin in advanced colorectal cancer (European Organization of Research and Treatment of Cancer Gastrointestinal Group study 40952) . J Clin Oncol . 2003;21:3721–3728
  16. 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;13:566–575
  17. IMPACT: Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators. Lancet 345:939–9441, 995
  18. 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;38:1429–1436
  19. Arkenau HT , Bermann A , Rettig K , et al.   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;14:395–399
  20. 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;21:2896–2903
  21. Haller DG , Catalano P , Macdonald JS , et al.   Fluorouracil (FU), leucovorin (LV) and levamisole (LEV) adjuvant therapy for colon cancer (Five-year final report of int-0089) . Proc Am Soc Clin Oncol . 1998;17:256a; (abstr 982)
  22. Haydon A . Adjuvant chemotherapy in colon cancer (What is the evidence?) . Int Med J . 2003;33:119–124
  23. 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;97:270–277
  24. Hensley Alford S , Ulcickas-Yood M , Jankowski M , et al.   Stage III colon cancer in the elderly (Adjuvant therapy and survival) . Proc Am Soc Clin Oncol . 2003;22:748; (abstr 3008)
  25. Cassidy J , Scheithauer W , McKendrick J , et al.   Capecitabine vs bolus 5-FU/leucovorin (LV) as adjuvant therapy for colon cancer (the X-act study) (Positive efficacy results of a phase III trial) . Proc Am Soc Clin Oncol . 2004;22:247; (abstr 3509)
  26. Scheithauer W , McKendrick J , Begbie S , et al.   Oral capecitabine as an alternative to i.v. 5-FU-based adjuvant therapy for colon cancer: Safety results of a randomized, phase III trial . Ann Oncol . 2003;14:1735–1743
  27. Hickish T , Boni C , Tabernero J , et al.   Oxaliplatin/5-fluorouracil/leucovorin in stage II and III colon cancer (Updated results of the international randomized “MOSAIC” trial) . Proc Am Soc Clin Oncol GI Cancer Symp . 2004;46: (abstr 211)
  28. Rothenberg ML , Meropol NJ , Poplin EA , et al.   Mortality associated with irinotecan plus bolus fluorouracil/leucovorin (summary findings of an independent panel) . J Clin Oncol . 2001;19:3801–3807
  29. Morton RF , Goldberg RM , Sargent DJ , et al.   Oxaliplatin (OXAL) or CPT-11 combined with 5FU/leucovorin (LV) in advanced colorectal cancer (CRC) (An NCCTG/CALGB study) . Proc Am Soc Clin Oncol . 2001;20:125a; (abstr 495)
  30. Goldberg RM , Sargent DJ , Morton RF , et al.   A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer . J Clin Oncol . 2004;22:23–30
  31. Cassidy J , Tabernero J , Twelves C , et al.   XELOX (capecitabine plus oxaliplatin) (Active first-line therapy for patients with metastatic colorectal cancer) . J Clin Oncol . 2004;22:2084–2091
  32. Van Cutsem E , Twelves C , Tabernero J , et al.   XELOX (mature results of a mulitnational, phase II trial of capecitabine plus oxaliplatin, an effective first-line option for patients with metastatic colorectal cancer) . Proc Am Soc Clin Oncol . 2003;22:255; (abstr 1023)
  33. Dìaz-Rubio E , Evans TR , Tabernero J , et al.   Capecitabine (Xeloda) in combination with oxaliplatin (A phase I, dose-escalation study in patients with advanced or metastatic solid tumors) . Ann Oncol . 2002;13:558–565
  34. Shields AF , Zalupski MM , Marshall JL , et al.   Treatment of advanced colorectal carcinoma with oxaliplatin and capecitabine . Cancer . 2004;100:531–537
  35. Borner MM , Dietrich D , Stupp R , et al.   Phase II study of capecitabine and oxaliplatin in first- and second-line treatment of advanced or metastatic colorectal cancer . J Clin Oncol . 2002;20:1759–1766
  36. Chu E , Diaz-Rubio E , Marshall J , et al.   Economic analysis of potential medical cost savings of XELOX (capecitabine and oxaliplatin combination) in metastatic colorectal cancer (MCRC) . Proc Am Soc Clin Oncol . 2003;22:269; (abstr 1080)
  37. Van Cutsem E , Beale P , Delord JP , et al.   Tarceva (erlotinib) in combination with Xeloda (capecitabine) and oxaliplatin in patients with metastatic colorectal cancer (CRC) (A phase I dose-escalation trial) . Clin Cancer Res . 2003;9(suppl):6095s; (abstr 109)
  38. Hapke G , Cao S , Rustum YM . Enhanced antitumour activity of Xeloda by irinotecan in nude mice bearing human A253 and FaDu head and neck xenografts . Proc Am Assoc Cancer Res . 2001;42:86; (abstr 464)
  39. Tewes M , Schleucher N , Achterrath W , et al.   Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer (Results of an extended phase I study dagger) . Ann Oncol . 2003;14:1442–1448
  40. Kerr D , Ten Bokkel Huinink WW , Ferry D , et al.   A phase I/II study of CPT-11 in combination with capecitabine as first line chemotherapy for metastatic colorectal cancer (MCRC) . Proc Am Soc Clin Oncol . 2002;21:161a; (abstr 643)
  41. Delord JP , Pierga J , Bertheaut-Cvitkovic F , et al.   Dose escalation and pharmacokinetic study of capecitabine and irinotecan (CPT-11) in gastro-intestinal (GI) tumours . Eur J Cancer . 2001;37(suppl 6):76; (abstr 272)
  42. Patt YZ , Leibmann J , Diamandidis D , et al.   Capecitabine plus irinotecan (XELIRI) in first-line metastatic colorectal cancer (MCRC) (Update on a phase II trial) . Eur J Cancer . 2003;1(suppl 5):S93; (abstr 304)
  43. Munoz A , Salut A , Escudero P , et al.   Irinotecan (CPT-11) and capecitabine (C) as first-line treatment of locally advanced or metastatic colorectal cancer (CRC) . Proc Am Soc Clin Oncol . 2003;22:317; (abstr 1271)
  44. Borner MM , Dietrich D , Popescu R , et al.   A randomized phase II trial of capecitabine (CAP) and two different schedules of irinotecan (IRI) in first-line treatment of metastatic colorectal cancer (MCC) . Proc Am Soc Clin Oncol . 2003;22:266; (abstr 1068)
  45. Gold P , Godfrey T , Dhami M , et al.   Capecitabine and irinotecan as 1st line therapy for patients with metastatic colorectal cancer (MCRC) (Phase II study preliminary results) . Proc Am Soc Clin Oncol . 2003;22:288; (abstr 1158)
  46. Meropol N , Gold P , Diasio B , et al.   Correlation of thymidine phosphorylase (TP), thymidylate synthase (TS) and dihydropyrimidine dehydrogenase (DPD) expression in primary and metastatic sites with response to capecitabine plus irinotecan in patients with colorectal cancer . Proc Am Soc Clin Oncol . 2004;23:250; (abstr 3520)
  47. Yanagisawa M , Ouchi KF , Tanaka Y . Optimal dosing schedule for combination therapy with capecitabine and irinotecan in a human colorectal cancer (CRC) xenograft model . Eur J Cancer . 2003;1(suppl 5):S81; (abstr 264)
  48. Grothey A , Jordan K , Kellner O , et al.   Capecitabine plus irinotecan (CAPIRI) vs capecitabine plus oxaliplatin (CAPOX) as first-line therapy of advanced colorectal cancer (ACRC) (Updated results of a randomized phase II trial) . Eur J Cancer . 2003;1(suppl 5):S90; (abstr 295)
  49. Sawada N , Ishikawa T , Sekiguchi F , et al.   X-ray irradiation induces thymidine phosphorylase and enhances the efficacy of capecitabine (Xeloda) in human cancer xenografts . Clin Cancer Res . 1999;5:2948–2953
  50. Dunst J , Reese T , Hoelscher T , et al.   Preoperative radiochemotherapy with capecitabine (Xeloda) in locally advanced rectal cancer (A phase II study) . Eur J Cancer . 2003;1(suppl 5):S86; (abstr 282)
  51. Lin E , Skibber J , Rodriguez M , et al.   A phase II study of capecitabine and radiotherapy plus concomitant boost in patients (pts) with locally advanced rectal cancer (LARC) (Preliminary safety analysis) . Proc Am Soc Clin Oncol . 2003;22:287; (abstr 1152)
  52. Kocakova I , Spelda S , Svoboda M , et al.   Combined therapy of locally advanced rectal adenocarcinoma with capecitabine and concurrent radiotherapy . Proc Am Soc Clin Oncol . 2003;22:322; (abstr 1295)
  53. Glynne-Jones R , Sebag-Montefiore D , McDonald A , et al.   Phase I/II study of preoperative radiation and capecitabine in combination with oxaliplatin in locally advanced rectal cancer (The SOCRATES study) . Proc Am Soc Clin Oncol . 2003;22:292; (abstr 1174)
  54. Rodel C , Grabenbauer GG , Papadopoulos T , et al.   Phase I/II trial of capecitabine, oxaliplatin, and radiation for rectal cancer . J Clin Oncol . 2003;21:3098–3104
  55. Kennedy A , Kwok Y , Batko-Yovino S , et al.   A phase I study of preoperative capecitabine, irinotecan concurrent with radiation therapy for resectable rectal cancer . Proc Am Soc Clin Oncol GI Cancer Symp . 2004;173: (abstr 268)

PII: S0093-7754(04)00457-9

doi: 10.1053/j.seminoncol.2004.09.028

Seminars in Oncology
Volume 32, Issue 1 , Pages 43-51 , February 2005

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