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Xeloda: the partner of choice for the treatment of metastatic CRC. Jim Cassidy Beatson Oncology Centre Glasgow, UK. Synergistic activity with Xeloda in preclinical models. 1 Sawada N et al. Clin Cancer Res 1999;5:2948–53 2 Cassidy J et al. J Clin Oncol 2004;22:2084–91
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Xeloda: the partner of choice for the treatment of metastatic CRC Jim Cassidy Beatson Oncology CentreGlasgow, UK
Synergistic activity withXeloda in preclinical models 1Sawada N et al. Clin Cancer Res 1999;5:2948–53 2Cassidy J et al. J Clin Oncol 2004;22:2084–91 3Tewes M et al. Ann Oncol 2003;14:1442-8 4Shen B-Q et al. Proc Am Assoc Cancer Res 2004;45 (Abst 2203) 5Ishitsuka H. Invest New Drugs 2000;18:343–54 6Tanaka Y et al. Proc Am Assoc Cancer Res 2003;44 (Abst 4678)
1 8 15 21 Day Oxaliplatin130mg/m2 (2-hour infusion) Xeloda1000mg/m2 twice daily Day 1 (pm)–15 (am) Rest Repeat cycle at day 22 Standard XELOX regimen • Developed from phase I and II trial program1,2 1Díaz-Rubio E et al. Ann Oncol 2002;13:558–65 2Cassidy J et al. J Clin Oncol 2004;22:2084–91
In MCRC, XELOX is comparable to 5-FU-based regimens: response rates Response (%) 60 50 40 30 20 10 0 XELOX (n=96)1 XELOX (n=45)2 DI XELOX (n=44)2 FOLFOX (n=267)3 FOLFOX (n=210)4 XELOX (n=35)5 FOLFOX (n=41)5 CAPOX (n=238)6 FUFOX (n=230)6 XELOX (n=128)7 Oxaliplatin/ 5-FU (TTD) (n=132)7 1Cassidy J et al. J Clin Oncol 2004;22:2084–91; 2Scheithauer W et al. J Clin Oncol 2003;21:1307–123Goldberg R et al. J Clin Oncol 2004;22:23–30; 4de Gramont A et al. J Clin Oncol 2000;18:2938–475Hochster HS et al. Proc ASCO 2005 (Abst 3515); 6Arkenau HT et al. Proc ASCO 2005 (Abst 3507) 7Sastre J et al. Proc ASCO 2005 (Abst 3524)
In MCRC, XELOX is comparable to 5-FU-based regimens: TTP Median TTP (months) 12 10 8 6 4 2 0 XELOX (n=96)1 XELOX (n=45)2 DI XELOX (n=44)2 FOLFOX (n=267)3 FOLFOX (n=210)4 CAPOX (n=238)5 FUFOX (n=230)5 1Cassidy J et al. J Clin Oncol 2004;22:2084–91; 2Scheithauer W et al. J Clin Oncol 2003;21:1307–123Goldberg R et al. J Clin Oncol 2004;22:23–30; 4de Gramont A et al. J Clin Oncol 2000;18:2938–475Arkenau HT et al. Proc ASCO 2005 (Abst 3507)
XELOX is well tolerated versus 5-FU-based regimens: phase III evaluation in MCRC 1Sastre J et al. Proc ASCO 2005 (Abst 3524) 2Arkenau HT et al. Proc ASCO 2005 (Abst 3507) 3Ducreux M et al. Proc ASCO 2005 (Abst 3596)
XELOX (n=48) FOLFOX (n=49) bFOL (n=50) XELOX-Avastin (n=72) FOLFOX-Avastin (n=71) bFOL-Avastin (n=70) Limited additional toxicities with Avastin (grade 3/4 adverse events*) Patients (%) TREE-1 TREE-2 HFS Diarrhea Neutropenia Neuro-toxicity Bleeding Venousthromboembolism Hypertension *First 12 weeks Hochster HS et al. Proc ASCO 2005 (Abst 3515)
3-weekly XELIRI regimen 1 8 15 21 Day Irinotecan250mg/m2 (90-minute infusion) Xeloda1000mg/m2 twice daily Day 1 (pm)–15 (am) Rest Repeat cycle at day 22 Patt YZ et al. Ann Oncol 2004;15(Suppl. 3):iii88 (Abst 238P)
30 25 20 15 10 5 0 Consistently high activity with first-line 3-weekly XELIRI Response rate (%) Median TTP (months) Median survival (months) 60 50 40 30 20 10 0 10 8 6 4 2 0 XELIRI (n=52)1 XELIRI (n=68)2 XELIRI (n=37)3 XELIRI (n=52)1 XELIRI (n=68)2 XELIRI (n=37)3 XELIRI (n=52)1 XELIRI (n=37)3 1Patt YZ et al. Ann Oncol 2004;15(Suppl. 3):iii88 (Abst 238P) 2Bajetta E et al. Cancer 2004;100:279–87; 3Borner MM et al. Ann Oncol 2005;16:282–8
Response rates: XELIRI compares favorably with 5-FU/LV/irinotecan Response (%) 60 50 40 30 20 10 0 XELIRI (n=52)1 XELIRI (n=68)2 XELIRI (n=37)3 XELIRI (n=36)4 XELIRI (n=45)5 XELIRI (n=38)6 FOLFIRI (n=145)7 FOLFIRI (n=109)8 1Patt YZ et al. Ann Oncol 2004;15(Suppl. 3):iii88 (Abst 238P); 2Bajetta E et al. Cancer 2004;100:279–87 3Borner MM et al. Ann Oncol 2005;16:282–8; 4Ahn J et al. Proc ASCO 2005 (Abst 3714)5Garcia-Alfonso P et al. Proc ASCO 2005 (Abst 3540); 6El Rayes BF et al Proc ASCO 2005 (Abst 3677) 7Douillard JY et al. Lancet 2000;355:1041–7; 8Tournigand C et al. J Clin Oncol 2004;22:229–37
Safety of Xeloda- and 5-FU-based combinations with irinotecan 1Patt YZ et al. Ann Oncol 2004;15(Suppl. 3):iii88 (Abst 238P); 2Borner M et al. Ann Oncol 2005;16:282–83Garcia-Alfonso P et al. Proc ASCO 2005 (Abst 3540); 4Ahn J et al. Proc ASCO 2005 (Abst 3714)5Köhne C et al. Proc ASCO 2005 (Abst 3525); 6Douillard JY et al. Lancet 2000;355:1041–7
Xeloda is an effective, well tolerated combination partner in MCRC • Xeloda is an effective combination partner • Xeloda is a safe combination partner • Xeloda-based combinations are more convenientand less complex than with 5-FU/LV • avoid the use of central venous devices and pumps • simplify increasingly complex regimens