1 / 23

Xeloda Combination Therapy For MCRC

Xeloda Combination Therapy For MCRC. Xeloda plus oxaliplatin (XELOX): a solid construction. XELOX international phase II trial: first-line in MCRC (n=96). 1. 8. 15. 21. Day. Oxaliplatin 130mg/m 2 (2-hour infusion).

unity-munoz
Download Presentation

Xeloda Combination Therapy For MCRC

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Xeloda Combination Therapy For MCRC

  2. Xeloda plus oxaliplatin (XELOX): a solid construction

  3. XELOX international phase II trial:first-line in MCRC (n=96) 1 8 15 21 Day Oxaliplatin130mg/m2 (2-hour infusion) Xeloda1,000mg/m2 twice daily Day 1 (pm)–15 (am) Rest Repeat cycle at day 22 • Regimen recommended from phase I trial1 • Male/female (%) = 64/36; median age = 64 years2 • 28% prior (neo)adjuvant therapy 1Díaz-Rubio E et al. Ann Oncol 2002;13:558–65 2Sawada N et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 303)

  4. XELOX produces consistently high response rates across subgroups Patients (%) 80 60 40 20 0 61 60 60 56 55 55 55 54 53 50 Overall Liver Lung Yes No £80 >80 <60 ³60 Metastases (Neo)adjuvant KPS Age chemotherapy Sawada N et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 303)

  5. XELOX: median progression-freesurvival of 7.7 months (n=96) 1.0 0.8 0.6 0.4 0.2 0.0 7.7 months(95% CI: 6.4–8.6) Estimated probability 0 2 4 6 8 10 12 14 16 18 20 22 Months Sawada N et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 303)

  6. XELOX: median overall survival of 19.5 months (n=96) 1.0 0.8 0.6 0.4 0.2 0.0 19.5 months (95% CI: 15.3–21.6) Estimated probability 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 Months Sawada N et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 303)

  7. XELOX efficacy comparesfavourably with FOLFOX4 1Sawada N et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 303) 2Goldberg R et al. Proc Am Soc Clin Oncol 2003;22:252 (Abst 1009)3de Gramont A et al. J Clin Oncol 2000;18:2938–47

  8. Low incidence of grade 3/4 treatment-related adverse events with XELOX Patients (%) 50 40 30 20 10 0 Grade 3 Grade 4 Laryngo-spasm* Nausea/ vomiting Fatigue/ asthenia Thrombo-cytopenia Hand-foot syndrome Sensory neuropathy Diarrhoea Neutropenia *Includes laryngopharyngeal dysesthesia Sawada N et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 303)

  9. XELOX: favourable safetyprofile compared with FOLFOX4 1Sawada N et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 303) 2Goldberg R et al. Proc Am Soc Clin Oncol 2003;22:252 (Abst 1009)3de Gramont A et al. J Clin Oncol 2000;18:2938–47

  10. Improved patient benefit of XELOX Days/patient 70 60 50 40 30 20 10 0 TTP gain with FOLFOX Days in hospital/clinic Days in hospital/clinic versus 5-FU/LV1 with FOLFOX1 with XELOX2 1de Gramont A et al. J Clin Oncol 2000;18:2938–47 2Sawada N et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 303)

  11. XELOX: highly effective first-line treatment for MCRC • High efficacy • overall response rate: 55% • median PFS: 7.7 months • median OS: 19.5 months • compares favourably with FOLFOX4 • Favourable safety compared with FOLFOX4 • reduced incidence of neutropenia (7% vs 42–47%) • Simplified regimen with improved convenienceover FOLFOX4

  12. Xeloda plus irinotecan (XELIRI): another solid construction

  13. XELIRI in first-line MCRC:US phase II study (n=52) • Male/female (%) = 56/44; median age = 58 years • Primary tumour = 84% colon, 12% rectum, 4% both • 14 patients 65treated at 200/750 1 8 15 21 Day Irinotecan250mg/m2i.v. Xeloda1000mg/m2 twice daily Day 1 (pm)–15 (am) Rest Repeat cycle at day 22 Patt YZ et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 304)

  14. Consistently high response rates with XELIRI (n=52) Patients (%) 60 50 40 30 20 10 0 52 51 50 45 42 32 30 Overall Yes No £80 >80 <60 ³60 (Neo)adjuvant KPS Age chemotherapy Patt YZ et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 304)

  15. Time to disease progression 7.1 months 1.0 0.8 0.6 0.4 0.2 0.0 7.1 months(95% CI: 5.0–11.1) Estimated probability 0 2 4 6 8 10 12 14 16 18 20 Months Patt YZ et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 304)

  16. XELIRI and FOLFIRI or IFL regimens appear to have similar efficacy 1Patt YZ et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 304)2Goldberg R et al. Proc Am Soc Clin Oncol 2003;22:252 (Abst 1009)3Douillard JY et al. Lancet 2000;355:1041–7

  17. XELIRI: low incidence ofgrade 3/4 adverse events Patients (%) 100 80 60 40 20 0 • No treatment-related deaths Nausea/ Diarrhoea* Hand-foot Abdominal Neutropenia vomiting syndrome* pain* *No grade 4 events Patt YZ et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 304)

  18. Similar safety profile in older and younger patients Patients (%) 100 80 60 40 20 0 <65 years (n=37) 65 years (n=14) Neutropenia Diarrhoea Nausea/ Abdominal Hand-foot vomiting pain syndrome Patt YZ et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 304)

  19. XELIRI: favourable safety profile compared with FOLFIRI or IFL regimens 1Patt YZ et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 304) 2Goldberg R et al. Proc Am Soc Clin Oncol 2003;22:252 (Abst 1009);3Douillard JY et al. Lancet 2000;355:1041–7

  20. XELIRI: highly active first-line treatment for MCRC • Xeloda plus 3-weekly irinotecan is highly active in first-line MCRC • response rate: 46% • median TTP: 7.1 months • median OS: 16 months • Efficacy and safety compare favourably with IFL and FOLFIRI • XELIRI is more convenient than either IFL or FOLFIRI

  21. Randomised trial evaluating two Xeloda combinations in first-line MCRC • Xeloda days 1–14 every 3 weeks plus • irinotecan days 1, 8 (CAPIRI) • oxaliplatin days 1, 8 (CAPOX) • Similar antitumour activity (144 evaluable patients) • 41% overall response rate with CAPIRI • 51% with CAPOX • Similar median progression-free (7.1 and 7.2 months) and overall survival (>17 months) • Favourable safety profiles with typical toxicity of oxaliplatin and irinotecan Grothey A et al. Eur J Cancer 2003;1(Suppl. 5):S90 (Abst 295)

  22. Oral Xeloda: the keystone of CRC therapy • Xeloda is a highly effective, tolerable and more convenient combination partner than 5-FU/LV • Xeloda is replacing 5-FU/LV as the backbone of CRC therapy

  23. Xeloda1 5-FU/LV (Saltz) 5-FU/LV (Douillard) 5-FU/LV (de Gramont) XELIRI2 IFL (Goldberg) IFL (Saltz) FOLFIRI (Douillard) XELOX3 FOLFOX (de Gramont) FOLFOX (Goldberg) IFL+ Avastin 1Twelves C. Eur J Cancer 2002;38(Suppl. 2):S15–S20 2Patt YZ et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 304) 3Sawada N et al. Eur J Cancer 2003;1(Suppl. 5):S93 (Abst 303) Overall survival: first-line fluoropyrimidine combination regimens ? XELOX + Avastin 0 5 10 15 20 25 Median OS (months)

More Related