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X-tending the horizons of Xeloda into early breast cancer (BC)

X-tending the horizons of Xeloda into early breast cancer (BC). Wolfgang Janni Ludwig Maximilians University of Munich Munich, Germany. Rationale for integrating Xeloda into the treatment of early BC. High single-agent efficacy in metastatic BC

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X-tending the horizons of Xeloda into early breast cancer (BC)

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  1. X-tending the horizons of Xeloda into early breast cancer (BC) Wolfgang Janni Ludwig Maximilians University of MunichMunich, Germany

  2. Rationale for integrating Xeloda into the treatment of early BC • High single-agent efficacy in metastatic BC • Favorable safety profile, with minimal myelosuppression and alopecia • Highly active in combination regimens • Xeloda extends overall survival when combined with Taxotere1 • logical partner to build upon the improved outcomes achieved with taxanes in early BC treatment2,3 1O’Shaughnessy J et al. J Clin Oncol 2002;20:2812–232Bear HD et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S16 (Abst 26)3Martin M et al. Breast Cancer Res Treat 2003 (Abst 43)

  3. Intensive evaluation in the adjuvant treatment of early BC (N=21244)

  4. Trial evaluating benefits of adding Xelodato Taxotere in sequential adjuvant treatment RANDO MIZ ATION T x 4 (100mg/m2) AC x 4 US Oncology n=2410 Eligibility criteriaN1–2N0, tumor >2cmN0, ER/PR– XT x 4 (825*/75mg/m2) AC x 4 • Primary endpoint: disease-free survival (DFS) at 5 years • Patients with ER+ or PR+ tumors will receive tamoxifen or anastrozole for 5 years *Xeloda dose: twice daily, days 1–14, every 21 days

  5. Ongoing Finnish, phase III adjuvant study of sequential Xeloda-based combinations RANDO MIZATION Taxotere x 3 (80mg/m2) FE75C x 3 n=1500 XT x 3 (900*/60mg/m2) CE75X900* x 3 • Primary endpoint: relapse-free survival (RFS) • Patients with ER+ or PR+ tumors will receive tamoxifen or anastrozole for 5 years *Xeloda dose: twice daily, days 1–14, every 21 days

  6. UK adjuvant study of sequential Xeloda monotherapy (TACT2 ) RANDO MIZATION CMF x 4 Epirubicin x 4 n=4400 Medium-risk BC Epirubicin x 4 Xeloda x 4 • Primary endpoint: 5-year DFS • 2 x 2 factorial design; accelerated epirubicin with G-CSF C = cyclophosphamide, M = methotrexate, F = 5-FU Xeloda 1250mg/m2 twice daily, days 1–14 every 21 days

  7. GEICAM 2003-10: Spanish adjuvant study evaluating sequential ETXeloda RANDO MIZATION EC x 4 (90/600mg/m2) Taxotere100 x 4 n=1302 ET x 4 (900/75mg/m2) Xeloda1250 x 4 • Primary endpoint: 5-year RFS (H1: 79% vs 72%) • Tamoxifen (or anastrozole where indicated) for 5 years, as appropriate

  8. Intensive ongoing evaluation of Xeloda as primary systemic therapy (PST) for BC

  9. Primary objective: pathological (pCR) and clinical complete response (cCR) of PST Phase III Korean trial: XT versus AC as PST for early BC RANDO MIZ ATION SURGERY AC x 4 (60/600) XT x 4 (1000/75) Eligibility criteriaECOG PS £1 Stage II/III BC Axillary lymph node involvement No prior treatment Primary Adjuvant AC x 4 (60/600) XT x 4 (1000/75) Ro J et al. presented at St Gallen 2005

  10. Phase III Korean trial interim analysis: treatment arms well balanced Lymph node status determined by PET or by ultrasound-guided biopsy Ro J et al. presented at St Gallen 2005

  11. XT (n=81) AC (n=79) XT increases pCR versus AC inprimary tumors and lymph nodes Patients (%) 50 40 30 20 10 0 Tumor Lymph nodes Ro J et al. presented at St Gallen 2005

  12. PST with XT: highly effective versus AC Ro J et al. presented at St Gallen 2005

  13. Hand-foot Stomatitis Desquamation syndrome Low incidence of grade 3/4 adverse events with neoadjuvant XT versus AC Patients (%) 100 80 60 40 20 0 AC (n=79) XT (n=81) Neutropenia Vomiting Ro J et al. Presented at St Gallen 2005

  14. Ongoing French study evaluating PST with CEX as an alternative to FEC RANDO MIZATION FEC x 4 SURGERY T x 4 (500/100/500) n=200 Stage T2/T3N0–1 CEX x 4 T x 4 (900/100/500) • Primary endpoint: non-inferiority pCR • Appropriate endocrine therapy for ER+/PR+ tumors allowed • Adjuvant radiotherapy administered after T, if required F = 5-FU; E = epirubicin; C = cyclophosphamideX = XelodaT = Taxotere

  15. Taxotere (100 q3w) RANDO MIZ ATION RAND AC (4 cycles q3w) XT (825/75) n=1200 Operable BC Palpable disease on examination T1c–T3, N0–1, M0 GT (1000/75) Taxotere (100 q3w) RAND XT (825/75) AC (4 cycles q3w) GT (1000/75) Primary objective: pCR/cCR NSABP B-40: phase III study of XT as PST for BC All followed by Tamoxifen x 5 years

  16. Xeloda: potential to improve outcomes in early breast cancer • The extensive multinational clinical trial program is confirming the potential of Xeloda to improve outcomes in early BC • pre-operative XT improves pCR rate compared with AC1 • Results of ongoing trials evaluating Xeloda as adjuvant and primary systemic therapy are eagerly awaited 1Ro J et al. Presented at St Gallen 2005

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