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Xeloda X -panding options in the adjuvant treatment of breast cancer

Xeloda X -panding options in the adjuvant treatment of breast cancer. Christopher J Poole Macmillan Senior Lecturer Medical Oncology University Hospital Birmingham, UK. Evaluation of Xeloda in adjuvant chemotherapy for women with early BC (n>20 000).

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Xeloda X -panding options in the adjuvant treatment of breast cancer

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  1. XelodaX-panding options in the adjuvant treatment of breast cancer Christopher J Poole Macmillan Senior Lecturer Medical OncologyUniversity HospitalBirmingham, UK

  2. Evaluation of Xeloda in adjuvant chemotherapy for women with early BC (n>20000) • Patients with HER2 positive tumors will receive Herceptin for 52 weeks

  3. Registration trial of Xeloda/Taxotere in sequential adjuvant treatment RANDO MIZ ATION T100 x4 AC x4 US Oncology n=2610 N+N0, tumor >2cmN0, ER-/PR– AC x4 X825 T75 x4 • Primary endpoint: disease-free survival at 5 years • Status: recruitment completed January 2006

  4. UK adjuvant study of sequential Xeloda monotherapy (TACT2) RANDO MIZ ATION n=4400 Medium-risk breast cancer with definite indication for adjuvant chemotherapy CMF x4 Epirubicin x4 2x2 bifactorial design: 3-weeky vs 2-weekly epirubicin/Neulasta Epirubicin x4 Xeloda x4 • Primary endpoint: disease-free survival at 5 years • Xeloda vs CMF comparison powered as non-inferiority study • Status: first patient recruited December 2005

  5. GEICAM: ET X vs EC Tin adjuvant BC RANDO MIZ ATION Taxotere100 x4 E90C600 x4 n=1302 N+ ER/PR +/- E90T75x4 Xeloda1250 bid x4 • Primary endpoint: relapse-free survival at 5 years • Status: 900 patients recruited

  6. GEICAM-CIBOMA trial: maintenance Xeloda after adjuvant anthracyclines RANDO MIZATION n=3538 Operable N+ ER/PR– Six prior cycles anthracycline-based adjuvant chemotherapy Xeloda8 cycles Observation • Primary endpoint: 14% increase in 5-year disease-free survival (HR 0.86) • Status: recruitment begins next month

  7. Primary endpoints • disease-free survival E PC versus ECXP • disease-free survival with or without Bondronat • Status: 700 patients recruited AGO GAIN: phase III study of adjuvant E P C versus EC XP RANDO MIZATION E P C n=3130 Primary BC N+ 2x2 ± Bondronat (daily for 2 years) 2x2 ± darbepoietin (during EPC and EC) EC XP

  8. CALGB: phase III adjuvant CMF or AC versus Xeloda in elderly patients RANDO MIZ ATION CMF or AC • n=600 • Stage I–IIIC disease • ³65 years • Tumor ³3cm, N0, M0 • or • T1–3, N1–3, M0 Xeloda • Primary endpoint: disease-free survival at 5 years • Status: 500 patients recruited

  9. BIG: Bondronat ± Xeloda in elderly patients with early BC (ICE) RANDO MIZ ATION n=1394 Stage II/III, high risk N+/– ³65 years Charlson Scale £2 score points ECOG PS £2 Bondronat oral or i.v. Bondronat+ Xeloda • Primary endpoint: increase in 5-year event-free survival from 61.0 to 71.5% • Status: >400 patients recruited

  10. Phase III adjuvant study (FinXX) of sequential Xeloda-based combinations n=1500 RANDO MIZATION FE75C x3 T80 x3 Risk of BC recurrence >25% in first 5 years or >35% in 10 years X900 T60 x3 CE75X900 x3 • Primary endpoint relapse-free survival • Recruitment complete end of 2006

  11. T XT Adjuvant XT versus T: less life-threatening toxicity with XT Patients (%) 50 40 30 20 10 0 Grade 3/4 adverse events Diarrhea Hand-footsyndrome Stomatitis Neuropathy Neutropenicfever/infection Non-neutropenicinfection Joensuu H et al. J Clin Oncol 2005;23:57s (Abst 719)

  12. Xeloda-based regimens:less grade 4 neutropenia Patients (%) 100 80 60 40 20 0 T XT FEC CEX Joensuu H et al. J Clin Oncol 2005;23:57s (Abst 719)

  13. FEC CEX Adjuvant CEX versus FEC:comparable side effect profiles Patients (%) Grade 3/4 adverse events 40 30 20 10 0 Neutropenicfever/infection Non-neutropenicinfection Neuropathy Joensuu H et al. J Clin Oncol 2005;23:57s (Abst 719)

  14. Double risk evaluation clinical-pathological and 70-gene signature Primary endpoint: 5-year DFS Status: launch summer 2006 EORTC-BIG MINDACT: AC vs XT in adjuvant node-negative BC n=5000 RISK EVALUATION AC Both risks high or either risk high X1000T75 Hormone therapyalone if required Both risks low

  15. Extensive adjuvant program with >20000 patients Proven efficacy in metastatic setting Well tolerated minimal myelosuppression and alopecia addition to Taxotere does not increase toxicity Dosing flexibility key to managing toxicity Xeloda – moving forward into early breast cancer

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