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The future for elderly patients: adjuvant Xeloda

The future for elderly patients: adjuvant Xeloda. Alberto Sobrero Ospedale San Martino Genoa, Italy. <55 years 55–74 years ³ 75 years. Adjuvant 5-FU-based therapy received by colon cancer patients by age at diagnosis (n=4 706). Patients (%). 100 80 60 40 20 0.

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The future for elderly patients: adjuvant Xeloda

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  1. The future for elderly patients: adjuvant Xeloda Alberto Sobrero Ospedale San Martino Genoa, Italy

  2. <55 years 55–74 years ³75 years Adjuvant 5-FU-based therapy received by colon cancer patients by age at diagnosis (n=4 706) Patients (%) 100 80 60 40 20 0 1987 1989 1991 1993 1995 Year Potosky AL et al. J Clin Oncol 2002;20:1192–202 Stage III (n=1010)

  3. Factors affecting clinical decisions Commonsense Scientificevidence Personalexperience

  4. Life expectancy in the elderly: longer than we might think! Arias E. United States Life Tables 2002, National Vital Statistics Reports 2004;53

  5. Time to relapse shorter than we might think! • Median time to relapse: 1.5 years • Median overall survival of stage IV: 1.5 years • Overall survival from radical surgery: 3 years

  6. Pooled analysis of seven studies including 3 351 elderly patients with stage II / III colon cancer Adjuvant therapy Surgery only Adjuvant chemotherapy is effective in elderly patients (>70 years): OS Age £70 years Age >70 years Patients (%) Patients (%) 100 80 60 40 100 80 60 40 71 69 64 62 0 12 24 36 48 60 72 84 96 0 12 24 36 48 60 72 84 96 Months Months Sargent DJ et al. N Engl J Med 2001;345:1091–7

  7. Adjuvant therapy Surgery only Adjuvant chemotherapy is effective in elderly patients (>70 years): DFS Age £70 years Age >70 years Patients (%) Patients (%) 100 80 60 40 100 80 60 40 n=2 745 n=506 0 12 24 36 48 60 72 84 96 0 12 24 36 48 60 72 84 96 Months Months • Pooled analysis of seven studies including 3 351 elderly patients with stage II / III colon cancer Sargent DJ et al. N Engl J Med 2001;345:1091–7

  8. Incidence of toxicity is not increased among elderly patients Sargent DJ et al. N Engl J Med 2001;345:1091–7

  9. X-ACT: one in five patients >70 years X-ACT specifically allowed enrollment of patients >70 years to assess efficacy and safety of Xeloda in this subgroup 396/1987 (191 randomized to receive Xeloda)

  10. Xeloda consistent benefit in DFS maintained in younger and older patients n Xeloda better Bolus 5-FU/LV better ITT population Male Female <40 40–69years old 70 N1 (1–3 nodes) N2 (³4 nodes) Baseline CEA <ULN Baseline CEA >ULN 1987 1074 912 76 1543 396 1389 593 1672 155 Cassidy J et al. J Clin Oncol Proc ASCO Late-breaking Abstract Book 2004;23:14 (Abst 3509) 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 Hazard ratio and 95% CI

  11. Improved tolerability profile of Xeloda maintained in elderly *Grade 3/4 Díaz-Rubio E et al. J Clin Oncol Proc ASCO 2004;23:304 (Abst 3737)

  12. Xeloda (n=995) 5-FU/LV (n=974) Xeloda: only nine ambulatory consultations versus 30 with 5-FU/LV Mean visits per patient 30 20 10 0 AE treatment Drug administration Total McKendrick JJ et al. J Clin Oncol Proc ASCO 2004;23:265 (Abst 3578; poster update)

  13. Scientific evidence supports treatment in the elderly Scientificevidence Commonsense • Long life expectancy: 15 years • Short time to relapse: 1.5 years • Same benefit: 10% Personalexperience

  14. Xeloda expands options for adjuvant treatment in the elderly • Whenever appropriate (common sense), elderly patients should receive adjuvant chemotherapy • Xeloda monotherapy • not inferior to 5-FU/LV perhaps more efficacious • better tolerated • more convenient

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