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Xeloda: a first choice in metastatic breast cancer

Xeloda: a first choice in metastatic breast cancer. Marjorie Green MD Anderson Cancer Center University of Texas Texas, USA. Xeloda: consistently high front-line activity in metastatic breast cancer (MBC). Response rate (%). 60 40 20 0. O’Shaughnessy (n=93) 1. Talbot (n=41) 2.

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Xeloda: a first choice in metastatic breast cancer

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  1. Xeloda: a first choice in metastatic breast cancer Marjorie Green MD Anderson Cancer CenterUniversity of TexasTexas, USA

  2. Xeloda: consistently high front-line activity in metastatic breast cancer (MBC) Response rate (%) 60 40 20 0 O’Shaughnessy(n=93)1 Talbot(n=41)2 Bajetta(n=73)3 Torrecillas(n=62)4 1O’Shaughnessy J et al. Ann Oncol 2001;12:1247–54 2Talbot D et al. Br J Cancer 2002;86:1367–72; 3Bajetta E et al. J Clin Oncol 2005;23:2155–61 4Torrecillas L et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S200 (Abst 5048)

  3. Xeloda is an ideal combination partner • Consistently high activity • Low incidence of non-hematologic grade 3/4 events • minimal alopecia, myelosuppression • no cumulative toxicity • no treatment-related deaths • Patients prefer oral chemotherapy1,2 • Home-based treatment: patients lead more normal life • Xeloda combinations are rationally designed • preclinical synergy between Xeloda andmultiple cytotoxic agents 1Liu G et al. J Clin Oncol 1997;15:425–32 2Borner M et al. Eur J Cancer 2002;38:349–58

  4. XT (n=255) Taxotere (n=255) Addition of Xeloda to Taxotere (XT) extends survival Survival probability 1.0 0.8 0.6 0.4 0.2 0.0 Hazard ratio = 0.77 Log-rank p = 0.013 11.5 14.5 0 2 4 6 8 10 12 14 16 18 20 22 24 26 Months 1O’Shaughnessy J et al. J Clin Oncol 2002;20:2812–23

  5. XT survival advantage maintainedeven with 74% cross-over Survival probability 1.0 0.8 0.6 0.4 0.2 0.0 Hazard ratio = 0.53 p = 0.006 XT (n=50) T X (n=50) 19.0 22.0 0 5 10 15 20 25 30 35 40 Months Beslija S et al. Eur J Cancer Suppl 2005;3:118 (Abst 407)

  6. Xeloda plus 3-weekly paclitaxel (XP): high activity in front-line MBC 1Batista N et al. Br J Cancer 2004;90:1740–6 2Gradishar W et al. J Clin Oncol 2004;22:2321–7 *94% treated in first line

  7. Xeloda plus weekly paclitaxel (XP): consistently high activity, favorable safety 1Uhlmann C et al. Oncology 2004;67:117–22; 2Blum J et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S202 (Abst 5053); 3Susnjar S et al. J Clin Oncol 2005;23:90s (Abst 851)

  8. First-line Xeloda-based combinations: highly effective, monotherapy an option Saturday December 10 Abstract 5039 N REYNOSO et al. Economic evaluation of sequential capecitabine (X) and taxanes vs the combinations in patients with advanced/metastatic breast cancer: a Mexican Oncology Study Group (MOSG) trial 17:00–19:00 Poster session 5 Exhibit Hall B Torrecillas L et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S200 (Abst 5048)

  9. New data with XT in first-line MBC Sunday December 11 Abstract 6089 D MAVROUDIS et al. A multicenter phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine asfirst-line treatment in patients with locally advanced and metastatic breast cancer. Preliminary report 07:00–09:00 Poster session 6 Exhibit Hall B

  10. Xeloda improvescombinations in first-line MBC • Xeloda added to ET does not increase the incidence of grade 3/4 adverse events Mansutti M et al. Ann Oncol 2004;15(Suppl. 3):iii42 (Abst 157P)

  11. XN: consistently high activity in MBC 1Ghosn M et al. J Clin Oncol 2005;23:46s (Abst 673); 2Stuart N et al. Proc Am Soc Clin Oncol 2003;22:46 (Abst 183) 3Ahn J et al. Proc Am Soc Clin Oncol 2003;22:54 (Abst 216);4Welt A et al. Ann Oncol 2005;16:64–95Estevez L et al. Ann Oncol 2004;15(Suppl. 3):iii44 (Abst 166P)

  12. Xeloda + Herceptin (XH): high first-line activity in HER2-positive MBC • Favorable safety (n=43) • only grade 3 adverse events HFS 10%, leucopenia 2%; no grade 4 Xu L et al. Eur J Cancer Suppl 2005;3:125 (Abst 446)

  13. Xeloda/Herceptin: highly active in patients with pretreated HER2+ MBC • No significant additional toxicity with addition of Herceptin to Xeloda monotherapy 1Yamamoto D et al. J Clin Oncol 2005;23:78s (Abst 802) 2Schaller G et al. J Clin Oncol 2005;23:57s (Abst 717) *Dose intensity 25% less than standard

  14. Xeloda/Herceptin/Taxoterecombination is feasible Sunday December 11 Abstract 6094 A WARDLEY et al. CHAT – an open-label, randomized phase II studyof trastuzumab plus docetaxel with or withoutcapecitabine in patients with advanced and/or metastatic, HER2-positive breast cancer: second interim safety analysis 07:00–09:00 Poster session 6 Exhibit Hall B

  15. Xeloda/Avastin: active and well tolerated in heavily pretreated MBC • Only increased toxicity with addition of Avastin was hypertension (<1 vs 18%) Miller K et al. J Clin Oncol 2005;23:792–9

  16. Proposed first-line registrationtrial for Xeloda/Avastin in MBC Choice of chemotherapy: RANDO MIZATION n=900 First-line MBC Stratificationby prior adjuvant therapy HER2-negative Anthracycline-containing (n=300) Avastin Xeloda (n=300) Placebo • Primary endpoint: TTP

  17. Xeloda: an essential component of breast cancer treatment • Favorable safety profile with minimal myelosuppression and alopecia • Allows treatment to be tailored to patients’ needs • Highly effective first-line treatment • Flexible combination partner • Extends overall survival beyond Taxotere

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