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Moving forward with adjuvant chemotherapy: combination or single-agent?

Moving forward with adjuvant chemotherapy: combination or single-agent?. Jean-Yves Douillard Centre Ren é Gauducheau/CHU Laennec Nantes, France. Adjuvant 5-FU-based chemotherapy reduces risk of recurrence and death versus observation 1–3 Roswell Park non-inferior to Mayo Clinic (DFS, OS)

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Moving forward with adjuvant chemotherapy: combination or single-agent?

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  1. Moving forward with adjuvant chemotherapy: combination or single-agent? Jean-Yves Douillard Centre René Gauducheau/CHU LaennecNantes, France

  2. Adjuvant 5-FU-based chemotherapy reduces risk of recurrence and death versus observation1–3 Roswell Park non-inferior to Mayo Clinic (DFS, OS) but one-third of patients had grade 3/4 diarrhea4 No benefit of infusional versus bolus 5-FU no improvement in relapse-free or overall survival5,6 Adjuvant treatment:the past 1Buyse M et al. JAMA 1988;259:3571–8; 2Laurie JA et al. J Clin Oncol 1989;7:1447–56 3Moertel CG et al. Ann Intern Med 1995;122:321–64Haller DG et al. Proc Am Soc Clin Oncol 1998;17:256a (Abstract 982)5Saini A et al. Br J Cancer 2003;88:1859–656Poplin E et al. Proc Am Soc Clin Oncol 2000;19:240a (Abstract 931)

  3. Adjuvant treatment:recent milestones • IFL demonstrated no clinical benefit versus Roswell Park1 • FOLFOX significantly improves DFS versus LV5FU2 but has shown no survival advantage yet2 • Xeloda has a strong trend towards superior DFS versus Mayo Clinic, a trend towards improved OS and fewer serious grade 3/4 toxicities3,4 1Saltz LB et al. Proc Am Soc Clin Oncol 2004;23:246 (Abst 3500) 2de Gramont A et al. Proc ASCO GI Cancers Symposium 2005 (Abst 167)3Cassidy J et al. Proc Am Soc Clin Oncol Late-breaking Abstract Book 2004;14: (Abst 3509) 4Scheithauer W et al. Ann Oncol 2003;14:1735–43

  4. Improved adjuvant treatment is now a reality • With a range of effective options, which is best for our patients? • patients must be informed about the reality of treatment and associated risks/benefits

  5. Benefits Proven efficacy Risks Toxicity Mayo Clinic regimen vs observation in adjuvant treatment

  6. Roswell Park versus Mayo Clinic regimen in adjuvant treatment Benefits • Equivalent efficacy •  stomatitis Risks •  diarrhea

  7. LV5FU2 vs bolus 5-FU/LV in adjuvant treatment Benefits • Efficacy may be similar •  toxicity Risks • Central venous access complications

  8. Xeloda versus Mayo Clinic regimen in adjuvant treatment Benefits • At least equivalent efficacy • Trend to improved DFS + OS •  toxicity • Convenience • Cost savings Risks •  hand-foot syndrome

  9. Improved outcomes Toxicity Monotherapy:risk/benefit considerations Benefits Risks Mayo Clinic regimen vs observation Roswell Park vs Mayo Clinic • Equivalent efficacy •  stomatitis •  diarrhea LV5FU2 vs bolus 5-FU/LV • Efficacy may be similar •  toxicity • Central venous access complications Xeloda vs Mayo Clinic • At least equivalent efficacy • Trend to improved DFS + OS •  toxicity • Convenience • Cost savings •  hand-foot syndrome

  10. Combination treatment: one positive and one negative trial

  11. Benefits Significantly improved DFS in stage III 23% reduction in risk of recurrence Not yet in overall survival Risks Neurotoxicity FOLFOX versus LV5FU2

  12. Benefits Nil Risks  toxicity  early mortality No clinical benefit; DFS curve tracks slightly below 5-FU/LV IFL versus Roswell Park regimen

  13. Landmark trials: recent evidence 1Cassidy J et al. Proc Am Soc Clin Oncol 2004;23:14 (Abst 3509) 2de Gramont A et al. Proc ASCO GI Cancers Symposium 2005 (Abst 167) 3Saltz LB et al. Proc Am Soc Clin Oncol 2004;23:246 (Abst 3500)

  14. Landmark trials: upcoming evidence

  15. How to choose in the current landscape? 1Cassidy J et al. Proc Am Soc Clin Oncol 2004;23:14 (Abstract 3509) 2André T et al. N Engl J Med 2004;350:2343–51

  16. Factors influencing treatment decisions with adjuvant chemotherapy • Treatment outcomes • efficacy • toxicity • Patient characteristics • disease stage • age • comorbidities Benefit to risk ratio Burden • Patients • convenience • impact on lifestyle • Healthcare providers • treatment costs • resource use

  17. Favorable benefit/risk ratio with Xeloda • At least as effective as 5-FU/LV, with strong trend to superior DFS and fewer grade 3/4 toxicities • proven benefits in stage III • can be considered for stage II patients • efficacy and safety benefits maintained in older patients • allows patients to lead a more normal lifestyle • cost savings with improved outcomes • The single-agent fluoropyrimidine of choice in the adjuvant treatment of colon cancer • Xeloda-based combinations may provide improved outcomes, safety and convenience versus 5-FU-based combinations

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