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Management choices in breast cancer: maximizing survival with Xeloda

Management choices in breast cancer: maximizing survival with Xeloda. Laura Biganzoli Sandro Pitigliani Medical Oncology Unit Hospital of Prato Prato, Italy Andrew Wardley Christie Hospital and South Manchester University Hospital Manchester, UK. Clinical case history 1.

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Management choices in breast cancer: maximizing survival with Xeloda

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  1. Management choices in breast cancer: maximizing survival with Xeloda Laura Biganzoli Sandro Pitigliani Medical Oncology UnitHospital of PratoPrato, Italy Andrew Wardley Christie Hospital and South Manchester University HospitalManchester, UK

  2. Clinical case history 1 • 42-year-old woman diagnosed with right breast cancer • wide local excision with axillary clearance • Tumor 2.2cm, grade 3 • ER/PR negative • HER2 negative by IHC • 2/16 nodes positive

  3. Neoadjuvant XT highly effectiveversus AC • Xeloda/Taxotere vs doxorubicin/cyclophosphamide • less grade 3/4 neutropenia and vomiting • more hand-foot syndrome and stomatitis Ro J et al. Breast 2005;14(Suppl. 1):S40 (Abst P89)

  4. Adjuvant X900T60 and CEX are feasible and safe Joensuu H et al. J Clin Oncol 2005;23:57s (Abst 719)

  5. Patient experienced recurrence within 2 years following adjuvant treatment • Patient received six cycles of FEC • Relapsed after 18 months • fatigue, mild cough, bone pain, ECOG PS 1 • Bone lesions in left sacrum, L5, right second rib • Pelvic CT: sacral lesion with soft tissue extension • Chest and abdominal CT: lung metastases • CA-27.29 elevated at 160U/L

  6. Addition of Xeloda to Taxotere extends survival Similar survival benefit in patients relapsing within 2 years after adjuvant anthracyclines XT (n=255) Taxotere (n=255) Overall population1 XT Taxotere Relapse ≤2 years2 Hazard ratio = 0.77 Log-rank p=0.013 11.5 14.5 2Leonard R et al. Semin Oncol 2004;31(Suppl. 10):21–8 Estimated probability 1.0 0.8 0.6 0.4 0.2 0.0 XT Taxotere 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

  7. XT: superior response rate and TTP Estimated probability 1.0 0.8 0.6 0.4 0.2 0.0 Response rate XT (n=255) 42% Taxotere (n=256) 30% p=0.006 Log-rank p=0.0001 4.2 6.1 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 Months O’Shaughnessy J et al. J Clin Oncol 2002;20:2812–23

  8. XT (n=251) Taxotere (n=255) XT: a manageable safety profile Patients (%) 30 20 10 0 Grade 3/4 adverse events Hand-foot syndrome Fatigue/ asthenia Diarrhea Neutropenic fever Stomatitis Nausea O’Shaughnessy J et al. J Clin Oncol 2002;20:2812–23

  9. Both full dose(X 1250 T 75; 670 cycles) Both reduced dose(X 1000 T 60; 405 cycles) Fewer grade 3/4 adverse events afterTaxotere and Xeloda doses are reduced Cycles (%) 20 16 12 8 4 0 Diarrhea Stomatitis Hand-foot Neutropenic syndrome fever Leonard R et al. Semin Oncol 2004;31(Suppl. 10):21–8

  10. XT dose reduction does not compromise efficacy: TTP Estimated probability 1.0 0.8 0.6 0.4 0.2 0.0 Both reduced, X1000T60 Both full, X1250T75 6.4 6.7 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 Months From cycle 2 Leonard R et al. Semin Oncol 2004;31(Suppl. 10):21–8

  11. Xeloda, the best option after Taxotere: insights from the phase III XT trial Overall survival Single-agent Xeloda (n=28) All other chemotherapy (n=128) 1.0 0.8 0.6 0.4 0.2 0.0 Log-rankp=0.0046 12.3 21.0 0 4 8 12 16 20 24 28 32 36 40 Months Miles D et al. Clin Breast Cancer 2004;5:273–8

  12. Poster:XT versus sequential T X • Breast cancer poster session: Level 2 – Foyer Hall • Monday, 31 October 2005; 08:00–18:00 • Discussion: Bordeaux Amphitheatre • Monday, 31 October 2005; 11:30–12:15 • Abstract 407; Beslija SA single institution randomized trial of Taxotere (T) and Xeloda (X) given in combination vs Taxotere (T) followed by Xeloda (X) after progression as first line chemotherapy (CT) for metastatic breast cancer (MBC)

  13. Clinical outcome: rapid, effective disease control with XT • Patient received XT: Xeloda 1250mg/m2, twice daily, days 1–14 + Taxotere 75mg/m2, day 1, every 3 weeks • Partial response after two cycles • bone pain resolved; CA-27.29 decreased to 46U/L • Grade 2 stomatitis • cycle 3, treatment interrupted until resolution • recurred cycle 5; both agents reduced by 25%

  14. Successful completionof treatment course • After six cycles • patient asymptomatic • CT scan: sclerotic lesion in sacral region • bone scan: reduced uptake • CA-27.29 level 40U/L

  15. Xeloda monotherapy in MBC: low incidenceof grade 3/4 adverse events (n=713) Patients (%) 40 30 20 10 0 • Minimal alopecia and myelosuppression • No cumulative toxicity • No treatment-related deaths Hand-foot Diarrhea Fatigue Stomatitis Nausea Dehydration syndrome Blum JL et al. Eur J Cancer 2001;37(Suppl. 6):S190 (Abst 693)Blum JL et al. Cancer 2001;92:1759–68; Reichardt P et al. Ann Oncol 2003;14:1227–33 Fumoleau P et al. Eur J Cancer 2004;40:536–42; Miller K et al. J Clin Oncol 2005;23:792–9

  16. Xeloda treatment improves QoL in women with MBC (n=1125) • Overall QoL stable or improved in 70% of patients Maintained Improved (p<0.01) Patients (%) 80 60 40 20 0 Physical Role Emotional Social Cognitive Function: Oliveira C et al. J Clin Oncol 2005;23:738s (Abst 8036)

  17. Case summary: XT followed by single-agent Xeloda maintenance • Following relapse <2 years after adjuvant FEC, patient treated with XT • rapid response and symptom relief • XT well tolerated with active side-effect management • After six cycles of XT, changed to Xeloda monotherapy • CA-27.29 levels fell further to 19U/L • patient remained stable for 1 year • performance status improved

  18. How would you treat this patient in the following situation? • Patient had 12 positive nodes • Tumor was hormone-receptor and HER2 negative • She received adjuvant TAC • She is at high risk of recurrence; would maintenance therapy with Xeloda be appropriate?

  19. GEICAM-CIBOMA trial: maintenance Xeloda after adjuvant chemotherapy RANDO MIZATION n=3538 Operable Node+ ER/PR– Six prior cycles anthracycline-based adjuvant chemotherapy Xeloda8 cycles Observation • Primary endpoint: 14% increase in 5-year DFS (HR 0.86)

  20. How would you treat this patient in the following situation? • 75-year-old woman with right breast cancer • wide local excision with axillary clearance • Tumor 2.2cm, grade 3 • ER/PR negative • HER2 negative by IHC • 2/16 nodes positive

  21. CALGB-49907: phase III study of 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: 5-year DFS

  22. Bondronat ± Xeloda in elderly patients with early BC (ICE) n=1394 Stage II/III, high risk N+ or N– ≥65 years Charlson Scale ≤2 score points VES13 Score ECOG PS ≤2 RANDO MIZ ATION Bondronat oral or i.v. Bondronat+ Xeloda • Primary endpoint: increase in 5-year EFS from 61.0 to 71.5%

  23. How would you treat this patient in the following situation? • Relapsed after 18 months • fatigue, mild cough, bone pain, ECOG PS 1 • Bone lesions in left sacrum, L5, right second rib • Pelvic CT: sacral lesion with soft tissue extension • Chest and abdominal CT negative • CA-27.29 elevated at 160U/L • You prefer to use a different combination than XT

  24. Xeloda + paclitaxel:consistently high activity in MBC 1Batista N et al. Br J Cancer 2004;90:1740–6 2Gradishar W et al. J Clin Oncol 2004;22:2321–7 3Blum J et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S202 (Abst 5053)

  25. Xeloda/vinorelbine: consistently high activity in MBC 1Ghosn M et al. J Clin Oncol 2005;23:46s (Abst 673); 2Estevez L et al. Ann Oncol 2004;15(Suppl. 3):iii44 (Abst 166P)3Welt A et al. Ann Oncol 2005;16:64–9; 4Ahn J et al. Proc Am Soc Clin Oncol 2003;22:54 (Abst 216) 5Stuart N et al. Proc Am Soc Clin Oncol 2003;22:46 (Abst 183)

  26. How would you treat this patient in the following situation? • She has HER2-positive disease • She did not receive adjuvant Herceptin

  27. Xeloda + Herceptin (XH): high first-line activity in HER2-positive MBC • Favorable safety (n=41) • only grade 3/4 adverse event HFS 10% Xu L et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S128 (Abst 3049)

  28. Xeloda: an essential component of breast cancer treatment • Consistently high activity in MBC • Extends overall survival beyond Taxotere • Favorable safety profile with minimal myelosuppression and alopecia • Flexible combination partner • Ongoing trials establishing XT as an effective and safe option in early breast cancer

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