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Xeloda X-panding options in the adjuvant treatment of breast cancer Christopher J Poole Macmillan Senior Lecturer Medical Oncology University Hospital.

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Presentation on theme: "Xeloda X-panding options in the adjuvant treatment of breast cancer Christopher J Poole Macmillan Senior Lecturer Medical Oncology University Hospital."— Presentation transcript:

1 Xeloda X-panding options in the adjuvant treatment of breast cancer Christopher J Poole Macmillan Senior Lecturer Medical Oncology University Hospital Birmingham, UK

2 Evaluation of Xeloda in adjuvant chemotherapy for women with early BC (n>20 000)  Patients with HER2 positive tumors will receive Herceptin for 52 weeks

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4 Registration trial of Xeloda/Taxotere in sequential adjuvant treatment US Oncology n=2 610 N+ N 0, tumor >2cm N 0, ER-/PR– X 825 T 75 x4 RANDOMIZATIONRANDOMIZATION AC x4 T 100 x4 AC x4  Primary endpoint: disease-free survival at 5 years  Status: recruitment completed January 2006

5 UK adjuvant study of sequential Xeloda monotherapy (TACT2) Xeloda x4 RANDOMIZATIONRANDOMIZATION Epirubicin x4 CMF x4 Epirubicin x4  Primary endpoint: disease-free survival at 5 years  Xeloda vs CMF comparison powered as non-inferiority study  Status: first patient recruited December 2005 n=4 400 Medium-risk breast cancer with definite indication for adjuvant chemotherapy 2x2 bifactorial design: 3-weeky vs 2-weekly epirubicin/Neulasta

6 GEICAM: ET X vs EC T in adjuvant BC n=1 302 N+ ER/PR +/-  Primary endpoint: relapse-free survival at 5 years  Status: 900 patients recruited RANDOMIZATIONRANDOMIZATION Xeloda 1250 bid x4 E 90 T 75 x4 Taxotere 100 x4 E 90 C 600 x4

7 GEICAM-CIBOMA trial: maintenance Xeloda after adjuvant anthracyclines n=3 538 Operable N+ ER/PR – Six prior cycles anthracycline-based adjuvant chemotherapy Xeloda 8 cycles Observation  Primary endpoint: 14% increase in 5-year disease-free survival (HR 0.86)  Status: recruitment begins next month RANDOMIZATIONRANDOMIZATION

8 E P C AGO GAIN: phase III study of adjuvant E P C versus EC XP RANDOMIZATIONRANDOMIZATION n=3 130 Primary BC N+ EC XP 2x2 ± Bondronat (daily for 2 years) 2x2 ± darbepoietin (during EPC and EC)  Primary endpoints – disease-free survival E P C versus EC XP – disease-free survival with or without Bondronat  Status: 700 patients recruited

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10 CALGB: phase III adjuvant CMF or AC versus Xeloda in elderly patients n=600 Stage I–IIIC disease  65 years Tumor  3cm, N0, M0 or T1–3, N1–3, M0 RANDOMIZATIONRANDOMIZATION Xeloda CMF or AC  Primary endpoint: disease-free survival at 5 years  Status: 500 patients recruited

11 BIG: Bondronat ± Xeloda in elderly patients with early BC (ICE) n=1 394 Stage II/III, high risk N+/–  65 years Charlson Scale  2 score points ECOG PS  2 RANDOMIZATIONRANDOMIZATION Bondronat + Xeloda Bondronat oral or i.v.  Primary endpoint: increase in 5-year event-free survival from 61.0 to 71.5%  Status: >400 patients recruited

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13 Phase III adjuvant study (FinXX) of sequential Xeloda-based combinations X 900 T 60 x3 n=1 500 CE 75 X 900 x3 T 80 x3 FE 75 C x3  Primary endpoint relapse-free survival  Recruitment complete end of 2006 RANDOMIZATIONRANDOMIZATION Risk of BC recurrence >25% in first 5 years or >35% in 10 years

14 Adjuvant XT versus T: less life-threatening toxicity with XT Patients (%) Grade 3/4 adverse events Neutropenic fever/infection Non-neutropenic infection Diarrhea Stomatitis Hand-foot syndrome Neuropathy Joensuu H et al. J Clin Oncol 2005;23:57s (Abst 719) T XT

15 Xeloda-based regimens: less grade 4 neutropenia Patients (%) TXTFECCEX Joensuu H et al. J Clin Oncol 2005;23:57s (Abst 719)

16 Adjuvant CEX versus FEC: comparable side effect profiles Patients (%) Neutropenic fever/infection Non-neutropenic infection Neuropathy Joensuu H et al. J Clin Oncol 2005;23:57s (Abst 719) Grade 3/4 adverse events FEC CEX

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18 EORTC-BIG MINDACT: AC vs XT in adjuvant node-negative BC  Double risk evaluation clinical-pathological and 70-gene signature  Primary endpoint: 5-year DFS  Status: launch summer 2006 n=5000 Both risks high or either risk high AC RISKEVALUATIONRISKEVALUATION X 1000 T 75 Both risks low Hormone therapy alone if required

19 Xeloda – moving forward into early breast cancer  Extensive adjuvant program with > 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

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