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

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Presentation on theme: "Bevacizumab in MBC 1 Breast Cancer Take home message Sabino De Placido."— Presentation transcript:

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

2 Survival of Patients with Metastatic Breast Cancer

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 recommendations reflect consensus expert opinion and represent level 5 clinical evidence.

4 4 Metastatic Breast Cancer Take home message No single «gold standard» in metastatic breast cancer 1/5

5 Bevacizumab in first line MBC 5 Breast Cancer

6 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. Comparison of the Studies (1/2) E2100AVADO*RIBBON-1* No. of patients GeographyUS (90%)Ex-USUS (50%) Randomization ratio (BV:PL) 1:1 2:1 Primary EndpointPFS Independent review RetrospectiveNoProspective

7 Comparison of the Studies (2/2) E AVADO 2 RIBBON-1 3 Placebo controlled NoYes ChemotherapyWeekly paclitaxel 3-weekly docetaxel Capecitabine Taxane or anthracycline Bevacizumab dose 10 mg/kg q2w7.5 or 15 mg/kg q3w15 mg/kg q3w Key Secondary Endpoints OS, ORR OS, ORR, 1-yr survival OS, ORR, 1-yr survival 1. Miller, et al. NEJM 2007; 2. Miles, et al. ASCO 2008; 3. Robert, et al. ASCO 2009

8 8 Metastatic Breast Cancer Take home message Remarkable consistency in all study results Study Results 2/5

9 Consistent Benefit with Bevacizumab-Based Therapy: Significant Improvement in PFS E2100AVADO RIBBON-1 (Cape) RIBBON-1 (Tax/Anthra) Non- BV BV Non- BV BV* Non- BV BV Non- BV BV Median PFS, mo Stratified HR (95% CI) 0.48 (0.39–0.61) 0.62 (0.48–0.79) 0.69 (0.56–0.84) 0.64 (0.52–0.80) p-valuesp<0.0001p=0.0003p=0.0002p< BV=bevacizumab, Cape=capecitabine, Tax/Anthra=taxane/anthracycline. * 15 mg/kg cohort.

10 E2100AVADO RIBBON-1 (Cape) RIBBON-1 (Tax/Anthra) Non- BV BV Non- BV BV* Non- BV BV Non- BV BV ORR (%) p-valuesp<0.0001p=0.0003p=0.0097p< BV=bevacizumab, Cape=capecitabine, Tax/Anthra=taxane/anthracycline. * 15 mg/kg cohort. Consistent Benefit with Bevacizumab-Based Therapy: Significant Improvement in ORR

11 E2100AVADO RIBBON-1 (Cape) RIBBON-1 (Tax/Anthra) Non- BV BV Non- BV BV*Non-BV BV Non-BV BV Median OS, mo Stratified HR (95% CI) p-valuesP=0.14P=0.85P=0.87P= year rate (%) p-valuesP=0.017P=0.02P=0.076P=0.44 BV=bevacizumab, Cape=capecitabine, Tax/Anthra=taxane/anthracycline. * 15 mg/kg cohort. No Statistically Significant Difference in OS

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 OShaughnessy, 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 Optional Second-line Chemo + BV ( AVADO and RIBBON-1 only ) Chemo + No BV Chemo + BV Treat until PD RANDOMIZE Previously Untreated MBC RIBBON-1 Capecitabine, Taxane, or Anthracycline AVADO Docetaxel E2100 Paclitaxel

14 Progression-Free Survival, Pooled Population Non-BV (n=1008) BV (n=1439) Median, mo HR (95% CI)0.64 (0.57–0.71)

15 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 Summary of Pooled Efficacy Analysis

16 16 Metastatic Breast Cancer Clinical Relevance

17 Is 2.5 month improvement in median PFS a clinically relevant result ? PFS Bevacizumab + Paclitaxel vs Paclitaxel2.5 mos Anthracyclines + Taxanes vs Taxanes0.8 mos Capecitabine + Docetaxel vs Docetaxel1.9 mos Gemcitabine + Paclitaxel vs Paclitaxel2.1 mos Clinical Relevance

18 18 Metastatic Breast Cancer Take home message The improvement in PFS is similar to that of most other first line studies Clinical Relevance 3/5

19 19 Metastatic Breast Cancer Adverse Events

20 20 E2100, AVADO & RIBBON1 Metanalysis Grade 3 Selected Adverse Events (Aes)

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

22 22 Metastatic Breast Cancer Improvements across key clinical subpopulations

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27 27 Metastatic Breast Cancer Improvements across key clinical subpopulations Take home message 5/5 The advantage may be relevant in triple negative breast cancer

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