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Breast Cancer

Take home message. Breast Cancer. Bevacizumab in MBC. Sabino De Placido. 1. Survival of Patients with Metastatic Breast Cancer 1974 - 2000. International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy

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Breast Cancer

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  1. Take home message Breast Cancer Bevacizumab in MBC Sabino De Placido 1

  2. Survival of Patients with Metastatic Breast Cancer 1974 - 2000

  3. International Guidelines for Management of Metastatic Breast Cancer: Combination vs Sequential Single-Agent Chemotherapy Fatima Cardoso , Philippe L. Bedard , Eric P. Winer , Olivia Pagani , Elzbieta Senkus-Konefka , Lesley J. Fallowfield , Stella Kyriakides , Alberto Costa , Tanja Cufer , Kathy S. Albain ; on behalf of the ESO-MBC Task Force J Natl Cancer Inst 2009;101:1174–1181 In the absence of evidence to guide daily clinical decision making in MBC, both combination and sequential single agent chemotherapy are reasonable options as first-line systemic therapy. An important question for future research is the clear definition of patients who may benefit from a combination approach. Until such data are available, the ESO-MBC Task Force believes that sequential single-agent therapy should be the preferred choice for most MBC patients, in the absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control. These recommendationsreflectconsensus expert opinion and representlevel 5 clinical evidence.

  4. 1/5 Take home message Metastatic Breast Cancer No single «gold standard» in metastaticbreastcancer 4

  5. Breast Cancer Bevacizumab in first line MBC 5

  6. Comparison of the Studies (1/2) BV=bevacizumab, PL=placebo, PFS=progression-free survival, ORR=objective response rate, OS=overall survival. * Permitted continuing on BV or crossing over to BV. †Analyses based on IRF assessments.

  7. Comparison of the Studies (2/2) 1. Miller, et al. NEJM 2007; 2. Miles, et al. ASCO 2008; 3. Robert, et al. ASCO 2009

  8. 2/5 Take home message Metastatic Breast Cancer Study Results Remarkableconsistency in allstudyresults 8

  9. Consistent Benefit with Bevacizumab-Based Therapy: Significant Improvement in PFS BV=bevacizumab, Cape=capecitabine, Tax/Anthra=taxane/anthracycline. * 15 mg/kg cohort.

  10. Consistent Benefit with Bevacizumab-Based Therapy: Significant Improvement in ORR BV=bevacizumab, Cape=capecitabine, Tax/Anthra=taxane/anthracycline. * 15 mg/kg cohort.

  11. No Statistically Significant Difference in OS BV=bevacizumab, Cape=capecitabine, Tax/Anthra=taxane/anthracycline. * 15 mg/kg cohort.

  12. A Meta-Analysis of Overall Survival Data from Three Trials of Bevacizumab and First-Line Chemotherapy as Treatment for Patients with Metastatic Breast Cancer • Baylor-Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, TX; Mount Vernon Cancer Centre, London, England; Dana-Farber Cancer Institute, Boston, MA; Institut Curie, Paris, France; Mayo Clinic, Jacksonville, Florida; Michiana Hematology Oncology, South Bend, IN; Vall d'Hebron University Hospital, Barcelona, Spain; BioOncology, Genentech, S San Francisco, CA; Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN Joyce O’Shaughnessy, David Miles, Robert Gray, Véronique Diéras, Edith A. Perez, Robin Zon, Javier Cortés, Xian Zhou, See-Chun Phan,Kathy Miller ASCO, 2010

  13. General Study Designs OptionalSecond-line Chemo + BV(AVADO and RIBBON-1 only) E2100Paclitaxel Chemo +No BV Treat until PD Previously Untreated MBC AVADO Docetaxel RANDOMIZE Chemo +BV RIBBON-1 Capecitabine, Taxane,orAnthracycline

  14. Progression-Free Survival, Pooled Population

  15. Summary of Pooled Efficacy Analysis • PFS • HR=0.64, 36% reduction in risk of PD or death • 2.5 month improvement in median PFS • Improvements across key clinical subpopulations • ORR • 17% increase vs controls • OS • No statistically significant difference

  16. Metastatic Breast Cancer Clinical Relevance 16

  17. Clinical Relevance • Is 2.5 month improvement in median PFS a clinically relevant result ? • PFS • Bevacizumab + Paclitaxel vs Paclitaxel 2.5 mos • Anthracyclines + TaxanesvsTaxanes0.8 mos • Capecitabine + DocetaxelvsDocetaxel1.9 mos • Gemcitabine + Paclitaxel vs Paclitaxel 2.1 mos

  18. 3/5 Take home message Metastatic Breast Cancer Clinical Relevance The improvement in PFS issimilar to that of mostother first line studies 18

  19. Metastatic Breast Cancer Adverse Events 19

  20. E2100, AVADO & RIBBON1 MetanalysisGrade ≥3 SelectedAdverseEvents (Aes) 20

  21. 4/5 Take home message Metastatic Breast Cancer Adverse Events Well tolerated in MBC patients and AE are fairly manageable 21

  22. Metastatic Breast Cancer Improvements across key clinical subpopulations 22

  23. 5/5 Take home message Metastatic Breast Cancer Improvements across key clinical subpopulations The advantagemay be relevant in triple negative breastcancer 27

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