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What can Xeloda add to neoadjuvant chemotherapy?

What can Xeloda add to neoadjuvant chemotherapy?. Marjorie Green MD Anderson Cancer Center University of Texas Texas, USA. Rationale for integrating Xeloda into the treatment of early BC. Highly effective in metastatic BC Favorable safety profile minimal myelosuppression and alopecia

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What can Xeloda add to neoadjuvant chemotherapy?

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  1. What can Xeloda add to neoadjuvant chemotherapy? Marjorie Green MD Anderson Cancer CenterUniversity of TexasTexas, USA

  2. Rationale for integrating Xeloda into the treatment of early BC • Highly effective in metastatic BC • Favorable safety profile • minimal myelosuppression and alopecia • Highly active in combinations • Xeloda extends overall survival when combined with Taxotere1 • logical partner to build on improved outcomes achieved with taxanes in early BC2,3 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. N Engl J Med 2005;352:2302–13

  3. Primary objective: pathological complete response (pCR) Phase III Korean trial:neoadjuvant XT versus AC RANDO MIZ ATION SURGERY n=204 ECOG PS £1 Stage II/IIIbreast cancer Axillary lymph node involvement No prior treatment A60C600 x4 X1000T75 x4 X1000T75 x4 A60C600 x4 Lee KS et al. Breast Cancer Res Treat 2005;94(Suppl. 1):S224 (Abst 5052)

  4. Phase III Korean trial: treatment arms well balanced Lee KS et al. Breast Cancer Res Treat 2005;94(Suppl. 1):S224 (Abst 5052)

  5. XT (n=103) AC (n=101) Neoadjuvant XT vs AC: comparable tolerability (all-grade adverse events) Patients (%) 100 80 60 40 20 0 HFS Nausea Myalgia Alopecia Diarrhea Vomiting Anorexia Stomatitis Nail changes Desquamation Lee KS et al. Breast Cancer Res Treat 2005;94(Suppl. 1):S224 (Abst 5052)

  6. Neoadjuvant XT: highly effective versus AC pCR in breast tumor only Lee KS et al. Breast Cancer Res Treat 2005;94(Suppl. 1):S224 (Abst 5052)

  7. XT (n=103) AC (n=101) XT increases pCR versus AC inprimary tumors and lymph nodes Patients (%) 50 40 30 20 10 0 Tumor Lymph nodes Lee KS et al. Breast Cancer Res Treat 2005;94(Suppl. 1):S224 (Abst 5052)

  8. XT achieves high response rates in neoadjuvant BC 1Bellet M et al. J Clin Oncol 2005;23:61s (Abst 735) 2Lybaert W et al. Eur J Cancer Suppl 2005;3:105 (Abst 375) 3Lebowitz PF et al. Clin Cancer Res 2004;10:6764–9 *In breast and lymph nodes

  9. Xeloda added to ET does not increase the incidence of grade 3/4 adverse events1 Xeloda improves combinations in neoadjuvant BC *In breast 1Mansutti M et al. Ann Oncol 2004;15(Suppl. 3):iii42 (Abst 157P)

  10. Xeloda-based combinations achieve high response rates in neoadjuvant BC 1Franco SX et al. J Clin Oncol 2005;23:96s (Abst 876) 2Lu YS et al. J Clin Oncol 2005;23:92s (Abst 861) 3Perez-Manga G et al. Eur J Cancer Suppl 2005;3:133 (Abst 477) 4Ahlgren J et al. Proc Am Soc Clin Oncol 2003;22:27 (Abst 107) *In breast and lymph nodes

  11. GEPARTRIO (TAC TAC or XN): non-responders should switch to XN • XN vs TAC (after no response to 2x neoadjuvant TAC) • substantially less grade 3/4 toxicity, particularly febrile neutropenia • no need for prophylactic G-CSF Von Minckwitz G et al. Breast Cancer ResTreat 2005;94(Suppl. 1):S19 (Abst 38) *In breast and lymph nodes

  12. Neoadjuvant Xeloda/radiation: highly effective for anthracycline-resistant BC • Xeloda 850mg/m2 twice daily, days 1–14, every 3 weeks (n=28) • Tumor size at baseline: 80cm2 (range: 36–357) • after neoadjuvant chemoradiation: 49cm2(range: 6–126) • 82% of patients operable after chemoradiation • median positive nodes: 2 (range: 0–27) • pCR* in 11% Gaui MF et al. Breast Cancer Res Treat 2005;94(Suppl. 1):S227 (Abst 5060) *In breast

  13. No grade 3/4 adverse events Neoadjuvant Xeloda chemoradiation: well tolerated Patients (%) 50 40 30 20 10 0 Grade 1 Grade 2 Nausea Vomiting Diarrhea Mucositis Gaui MF et al. Breast Cancer Res Treat 2005;94(Suppl. 1):S227 (Abst 5060)

  14. Ongoing evaluation ofneoadjuvant Xeloda (n>5000)

  15. Several randomized studies are exploring alternative doses of XT CHAT = Capecitabine, Herceptin and Taxotere Trial (multinational)USO = US Oncology, USA

  16. GEPARQUATTRO: phase III study of EC sequential or combination XT RAND O M I Z A T I O N n=1600 HER2 2+/– Operable tumors T100 x4 24w EC x 4 T75X900 x4 24w T75 x4 X900x4 36w • Primary endpoint: pCR

  17. Xeloda: potential to improve outcomes in early BC • Large trial program of Xeloda in early BC • Neoadjuvant XT improves pCR rate versus AC • Efficacy of XT confirmed by numerous studies • Other Xeloda combinations also show high activity • XT survival benefit should translate to neoadjuvant setting

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