Proposing Trastuzumab as an Essential Medicine to Treat Cancer: Insight on Methodologies, Processes and Outcomes. Lorenzo Moja
|
|
- Morris Griffin
- 5 years ago
- Views:
Transcription
1 Proposing Trastuzumab as an Essential Medicine to Treat Cancer: Insight on Methodologies, Processes and Outcomes Lorenzo Moja Essen%al Medicines List Secretariat Essen%al Medicines and Health Products Department Who is asking for a name: a window to understand the drugs of the future (R.Balocco) Contrast in Pharmacology 2.0 Turin, May, 2015
2 Outline l The difficult job of an Expert Committee l How to balance desirable and undesirable effects of medicines - cancer 2
3 WHO EML May,
4 4
5 EML 2015: 77 applications and a few big challenges l Cancer drugs: a large comprehensive review (29 applications) l New highly effective HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens) l TB drugs (4+1) l New oral anticoagulants l a tight Agenda 5
6 EML 2015: 16 new cancer medicines included l Some of these medicines produce relevant survival benefits for cancers with high incidence, such as trastuzumab for breast cancer, explained Dr Kees De Joncheere, WHO Director of Essential Medicines. l Other treatment regimens for rare cancers such as leukemia and lymphoma, which can cure up to 90% of patients, were added to set a global standard. Kees De Joncheere, Director Essential Medicines Department, WHO 6
7 EML Cancer medicines update
8 Trastuzumab (Herceptin) ü An antibody blocking HER-2, which is over-expressed in 20 to 25% of women with breast cancer. ü Rapidly approved by regulatory agencies for the treatment of women with MBC. ü Open debate and great attention by the media Approvation for MBC and EBC 8
9 Trastuzumab (Herceptin) Population: Interventions: Comparator: Outcom es: Type of studies: Women with HER2 positive metastatic or operable early breast cancer, of any age, menopausal status or hormone receptor status. alone, following or in combination with chemotherapy. The same chemotherapy regimen or placebo. Primary: overall survival, progression free survival Randomised controlled clinical trials. 9
10 Trastuzumab in early breast cancer Disease-free survival (censored) - Median FU 2 yrs Patients(%) year trastuzumab 19.4% Not effective 80 Observation 6.6% Necessary & effective year Events DFS HR 95% CI p value 74% Not necessary Effectiveness on disease relapse , 0.78 < Months from randomisation No at risk Conte, Oncologia, Modena 10
11 Explanations of EML decisions Assumed control group risk (without the intervention) is based on median control group risks reported in the included studies, or on epidemiological data from country registers. 11
12 Explanations of EML decisions Baseline (control group) risk: low risk 100 per 1000 High risk: 500 per 1000 Most important outcomes for someone making a decision. These include potential benefits and harms. 12
13 Explanations of EML decisions Corresponding treatment (trastuzumab) group risk. It is the risk of an outcome occurring in the group receiving the intervention (i.e. anticancer medicine). 13
14 Explanations of EML decisions The relative effect is derived by dividing the two risks, with the intervention risk being divided by the control risk: = Usually the absolute effect is different for groups that are at high and low risk, whereas the relative effect often is the same. 14
15 Explanations of EML decisions Trastuzumab absolute effect 50/100 Without Trastuzumab 15 Deaths
16 Explanations of EML decisions Trastuzumab absolute effect 50/100 37/100 = 13 13% absolute difference With Trastuzumab 16 Deaths Deaths avoided
17 Explanations of EML decisions With Trastuzumab Deaths Deaths avoided $ $ $ $ $ $ 17
18 Explanations of EML decisions With Trastuzumab Deaths Deaths avoided $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ $ Without trastuzumab 1 year treatment costs about With trastuzumab 1 year treatment costs about All cohort NNT = 7 =
19 SoF death 19
20 SoF DFS 20
21 SoF harm 21
22 EML comprehensive cancer review: methodology l The cancer WG discussed thresholds for clinical benefits and acknowledged their importance but did not endorse an explicit threshold l The EC discussed the application and the importance of magnitude of benefit as the main criterion to include a medicines in EML but was out of its mandate to define a threshold for clinical benefit l Some medicines included in EML are cost effective AND unaffordable: this will require actions to increase access to these essential medicines 22
23 EML cancer update 2015: an overview Discussed as showing a large benefit: to be considered at next EC The application did not present the evidence supporting their use as second line agents: to be evaluated again at next EC 23
24 24
25 EML 2015: Le Monde (13 May 2015): change of paradigm 25
26 EM Model List Team l Nicola Magrini l Jeanne-Marie Scott l Bernadette Cappello l Lorenzo Moja l Gilles Forte l Kees De Joncheere 26
Proposing Trastuzumab as an Essential Medicine to Treat Cancer: Insight on Methodologies, Processes and Outcomes. Lorenzo Moja
Proposing Trastuzumab as an Essential Medicine to Treat Cancer: Insight on Methodologies, Processes and Outcomes Lorenzo Moja Essential Medicines List Secretariat Essential Medicines and Health Products
More informationAn introduction to the Essential Medicines concept: balancing innovation with public health priorities
An introduction to the Essential Medicines concept: balancing innovation with public health priorities World Oncology Forum Lugano 20 October 2017 Nicola Magrini Secretary, WHO Expert Committee on the
More informationSystemic Management of Breast Cancer
Systemic Management of Breast Cancer Why Who When What How long Etc. Vernon Harvey Rotorua, June 2014 Systemic Management of Breast Cancer Metastatic Disease Adjuvant Therapy Aims of therapy Quality of
More informationXII Michelangelo Foundation Seminar
XII Michelangelo Foundation Seminar Paradigm shift? The Food and Drug Administration collaborative project P. Cortazar, Silver Spring, USA FDA Perspective: Moving from Adjuvant to Neoadjuvant Trials in
More informationWilliam J. Gradishar MD
Northwestern University Feinberg School of Medicine Adjuvant Endocrine Therapy For Postmenopausal Women SOBO 2013 William J. Gradishar MD Betsy Bramsen Professor of Breast Oncology Director, Maggie Daley
More informationMedia Release. FDA grants Priority Review for Roche s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer
Media Release Basel, 29 September 2017 FDA grants Priority Review for Roche s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced
More informationTRIALs of CDK4/6 inhibitor in women with hormone-receptor-positive metastatic breast cancer
TRIALs of CDK4/6 inhibitor in women with hormone-receptor-positive metastatic breast cancer Marta Bonotto Department of Oncology University Hospital of Udine TRIALs of CDK4/6 inhibitor in women with hormone-receptor-positive
More informationUpdate on the WHO EML 2017 process: focus on the selection of antibiotics
Update on the WHO EML 2017 process: focus on the selection of antibiotics IPC Seminar, Geneva 9 th December 2016 Nicola Magrini EML Secretary, Policy, Access and Use - Essential Medicines Department Who
More informationHealth Industry Forum October 2, 2007 Scott Howell, MD Senior Director, Channel and Contracting Strategy Genentech
1 Cost Effectiveness & Pricing/Reimbursement A Biotech Case Study Health Industry Forum October 2, 2007 Scott Howell, MD Senior Director, Channel and Contracting Strategy Genentech Disclaimer 2 The views
More informationPatient Leader Education Summit. Precision Medicine: Today and Tomorrow March 31, 2017
Patient Leader Education Summit Precision Medicine: Today and Tomorrow March 31, 2017 Precision Medicine: Presentation Outline Agenda What is a Precision Medicine What is its clinical value Overview of
More informationATAC Trial. 10 year median follow-up data. Approval Code: AZT-ARIM-10005
ATAC Trial 10 year median follow-up data Approval Code: AZT-ARIM-10005 Background FDA post-approval commitment analysis to update DFS, TTR, OS and Safety Prof. Jack Cuzick on behalf of ATAC/LATTE Trialists
More informationAccelerated approval of Perjeta for neoadjuvant use also converted to full approval
Media Release Basel, 21 December 2017 FDA approves Roche s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer Accelerated approval of Perjeta for neoadjuvant use also converted
More informationSession Breast Cancer. Alessandra Fabi Il punto di vista dell esperto
Session Breast Cancer Alessandra Fabi Il punto di vista dell esperto Roma 6-7.10.2017 The Importance of Understanding What Disease to Treat Cejalvo et al, Cancer Res 2017 Skyline Chaging at evolution of
More informationExtended Hormonal Therapy
Extended Hormonal Therapy Dr. Caroline Lohrisch, Medical Oncologist, BC Cancer Agency Vancouver Centre November 1, 2014 www.fpon.ca Optimal Endocrine Therapy for Women with Hormone Receptor Positive Early
More informationExiste-t-il un sous groupe à risque qui pourrait bénéficier d une modification de la durée de traitement par trastuzumab? X. Pivot CHRU De Besançon
Existe-t-il un sous groupe à risque qui pourrait bénéficier d une modification de la durée de traitement par trastuzumab? X. Pivot CHRU De Besançon In 25 results of 4 Adjuvant Herceptin trials have definitively
More informationChemotherapy for Isolated Locoregional Recurrence
Chemotherapy for Isolated Locoregional Recurrence Michelle Melisko MD Assistant Clinical Professor UCSF Helen Diller Family Comprehensive Cancer Center MBC and Improved Median Survival with New Therapies
More informationThe Three Ages of Systemic Adjuvant Therapy for EBC
The Three Ages of Systemic Adjuvant Therapy for EBC 1896-2018 Nicholas Wilcken Westmead Hospital Petersham Institute University of Sydney Questions to be answered (concentrating on chemotherapy) Why should
More informationPolicy No: dru281. Medication Policy Manual. Date of Origin: September 24, Topic: Perjeta, pertuzumab. Next Review Date: May 2015
Medication Policy Manual Topic: Perjeta, pertuzumab Committee Approval Date: May 9, 2014 Policy No: dru281 Date of Origin: September 24, 2012 Next Review Date: May 2015 Effective Date: June 1, 2014 IMPORTANT
More informationBisphosphonates and other bone agents for breast cancer(review)
Cochrane Database of Systematic Reviews Bisphosphonates and other bone agents for breast cancer (Review) O Carrigan B, Wong MHF, Willson ML, Stockler MR, Pavlakis N, Goodwin A O Carrigan B, Wong MHF, Willson
More informationBREAST CANCER RISK REDUCTION (PREVENTION)
BREAST CANCER RISK REDUCTION (PREVENTION) Articles Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled
More informationFDA Briefing Document Oncologic Drugs Advisory Committee Meeting. September 12, sbla /51 Pertuzumab (PERJETA ) Applicant: Genentech, Inc.
/51 FDA Briefing Document Oncologic Drugs Advisory Committee Meeting September 12, 2013 /51 Pertuzumab (PERJETA ) Applicant: Genentech, Inc. Disclaimer: The attached package contains background information
More informationTargeted Agents In Breast Cancer. Wonderful Music With New Instruments
Targeted Agents In Breast Cancer Wonderful Music With New Instruments 1 Trends In Cancer Mortality In Women in US At This Rate We Will Beat Breast Cancer In 2040 Is the cause screening?? Is the cause better
More informationHR 95% Confidence Interval. *no DFS events occurred in AJCC 7 stage I/II TNBC patients treated with NPS plus trastuzumab.
NEWS RELEASE SELLAS Life Sciences Announces Additional Positive Triple Negative Breast Cancer (TNBC) Subgroup Data from Phase 2b Study of Nelipepimut-S Plus Trastuzumab at the 2018 San Antonio Breast Cancer
More informationHer 2 Positive Metastatic Breast Cancer
Her 2 Positive Metastatic Breast Cancer Alison Jones November 2013 Mrs Hermione Positive (then and now!) Diagnosed 2007 T2 N1 Mo ER ve; Her2 ve Mastectomy ANC; FEC/T Herceptin (12months) August 2010metastatic
More informationA Slow Starvation: Adjuvant Endocrine Therapy of Breast Cancer
A Slow Starvation: Adjuvant Endocrine Therapy of Breast Cancer Dr. Susan Ellard Surgical Oncology Update October 24, 2009 Disclosure slide Participant in various meetings or advisory boards sponsored by
More informationOPTIMAL ENDOCRINE THERAPY IN EARLY BREAST CANCER
OPTIMAL ENDOCRINE THERAPY IN EARLY BREAST CANCER STEPHEN E. JONES, M.D. US ONCOLOGY RESEARCH THE WOODLANDS, TX TOPICS PREMENOPAUSAL BREAST CANCER POSTMENOPAUSAL BREAST CANCER THE FUTURE TOPICS PREMENOPAUSAL
More information8/8/2011. PONDERing the Need to TAILOR Adjuvant Chemotherapy in ER+ Node Positive Breast Cancer. Overview
Overview PONDERing the Need to TAILOR Adjuvant in ER+ Node Positive Breast Cancer Jennifer K. Litton, M.D. Assistant Professor The University of Texas M. D. Anderson Cancer Center Using multigene assay
More informationEstimating and explaining survival time in metastatic breast cancer
Estimating and explaining survival time in metastatic breast cancer Dr Belinda Kiely Medical Oncologist Concord and Campbelltown Hospitals NHMRC Clinical Trials Centre, University of Sydney Clinic this
More informationSustained benefits for women with HER2-positive early breast cancer JORGE MADRID BIG GOCCHI PROTOCOLO HERA
Sustained benefits for women with HER2-positive early breast cancer JORGE MADRID BIG GOCCHI PROTOCOLO HERA The fascinating history of Herceptin 1981 1985 1987 1990 1992 1998 2000 2005 2006 2008 2011 Murine
More informationImproving outcomes as rapidly as possible for patients. Multi-arm, multi stage platform, umbrella and basket protocols
Improving outcomes as rapidly as possible for patients Multi-arm, multi stage platform, umbrella and basket protocols Mahesh Parmar MRC Clinical Trials Unit at UCL Institute of Clinical Trials and Methdology
More informationJules Bordet Institute, Brussels, Belgium Université Libre de Bruxelles Breast International Group (BIG aisbl), Chair ESMO President
Symposium «Evaluation of the Belgian Cancer Plan» Brussels, November 26th, 2012 Personalized oncology in Europe: only a dream if national health systems do not get involved in diagnostics and pivotal cancer
More informationSesiones interhospitalarias de cáncer de mama. Revisión bibliográfica 4º trimestre 2015
Sesiones interhospitalarias de cáncer de mama Revisión bibliográfica 4º trimestre 2015 Selected papers Prospective Validation of a 21-Gene Expression Assay in Breast Cancer TAILORx. NEJM 2015 OS for fulvestrant
More informationUpdate in the treatment of Her2- overexpressing breast cancers. Fabrice ANDRE Institut Gustave Roussy Villejuif, France
Update in the treatment of Her2- overexpressing breast cancers Fabrice ANDRE Institut Gustave Roussy Villejuif, France Questions Should tumors
More informationWorld Health Organization: Essential Medicines and Devices for Cancer:
World Health Organization: Essential Medicines and Devices for Cancer: Principles, Methodologies, and Outcomes Lawrence N. Shulman, MD Abramson Cancer Center, University of Pennsylvania Partners In Health
More informationSYSTEMIC THERAPY OPTIONS FOR BREAST CANCER IN 2014
SYSTEMIC THERAPY OPTIONS FOR BREAST Oncology Day 2014 CANCER IN 2014 Dr. Katherine Enright, M.D., M.P.H., F.R.C.P.(C) Katherine.enright@Trilliumhealthpartners.ca OBJECTIVES 1. Outline an approach to the
More informationAdjuvant Systemic Therapy in Early Stage Breast Cancer
Adjuvant Systemic Therapy in Early Stage Breast Cancer Julie R. Gralow, M.D. Director, Breast Medical Oncology Jill Bennett Endowed Professor of Breast Cancer Professor, Global Health University of Washington
More informationGSK Medicine: Study Number: Title: Rationale: Study Period: Objectives: Indication: Study Investigators/Centers: Research Methods: Data Source
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationNon-Anthracycline Adjuvant Therapy: When to Use?
Northwestern University Feinberg School of Medicine Non-Anthracycline Adjuvant Therapy: When to Use? William J. Gradishar MD Betsy Bramsen Professor of Breast Oncology Director, Maggie Daley Center for
More informationCancer du sein métastatique et amélioration de la survie Pr. X. Pivot
Cancer du sein métastatique et amélioration de la survie Pr. X. Pivot Date of preparation: November 2015. EU0250i TTP/PFS Comparaisons First line metastatic breast cancer Monotherapy Docetaxel Chan 1999
More informationCerebel trial Any impact on the clinical practice? Antonio Frassoldati Oncologia Clinica - Ferrara
Cerebel trial Any impact on the clinical practice? Antonio Frassoldati Oncologia Clinica - Ferrara CNS metastases in HER2+ BC The proportion of patients with HER2+ advanced breast cancer who have CNS metastases
More informationNadia Harbeck Breast Center University of Cologne, Germany
Evidence in Favor of Taxane Based Combinations and No Anthracycline in Adjuvant and Metastatic Settings Nadia Harbeck Breast Center University of Cologne, Germany Evidence in Favor of Taxane Based Combinations
More informationAdjuvant Endocrine Therapy: How Long is Long Enough?
Adjuvant Endocrine Therapy: How Long is Long Enough? Harold J. Burstein, MD, PhD Dana-Farber Cancer Institute Harvard Medical School Boston, Massachusetts hburstein@partners.org I have no conflicts to
More informationReal World Cost-Effectiveness of Cancer Drugs
1 Real World Cost-Effectiveness of Cancer Drugs Sara Khor, MASc, Cancer Care Ontario Li Ka Shing Knowledge Institute, St. Michael s Hospital Canadian Centre for Applied Research in Cancer Control April
More informationCommon disease 175,000 new cases/year 44,000 deaths/year Less than 10% with newly diagnosed at presentation have stage IV disease Chronic disease,
Chemotherapy for Metastatic Breast Cancer: Recent Results HARMESH R. NAIK, MD. Karmanos Cancer Institute and St. Mary Hospital Metastatic breast cancer (MBC) Common disease 175,000 new cases/year 44,000
More informationJonathan Dickinson, LCL Xeloda
Xeloda A blockbuster in the making Jonathan Dickinson, LCL Xeloda Xeloda unique tumor-activated mechanism Delivering more cancer-killing agent straight into cancer Highly effective comparable efficacy
More informationTRANSPARENCY COMMITTEE OPINION. 15 February 2006
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 15 February 2006 Taxotere 20 mg, concentrate and solvent for solution for infusion B/1 vial of Taxotere and 1 vial
More informationGeneral Information, efficacy and safety data
Horizon Scanning in Oncology Horizon Scanning in Oncology 29 th Prioritization 4 th quarter 2016 General Information, efficacy and safety data Nicole Grössmann Sarah Wolf Claudia Wild Please note: Within
More informationRationale For & Design of TAILORx. Joseph A. Sparano, MD Albert Einstein College of Medicine Montefiore-Einstein Cancer Center Bronx, New York
Rationale For & Design of TAILORx Joseph A. Sparano, MD Albert Einstein College of Medicine Montefiore-Einstein Cancer Center Bronx, New York Declining Breast Cancer Mortality & Event Rates in Adjuvant
More informationThe 22nd SEC (Oncology& hematology) meeting deliberated the proposals on and recommended the following:- volunteers.
:- The 22nd SEC (Oncology& hematology) meeting deliberated the proposals on 14-01-2015 and recommended the following:- Agenda 1 peg-gcsf 4-270/Biocon Ltd./14 BD 2 Trastuzumab 4-237/Dr. Reddy/14-BD 3 GCSF
More informationChoosing between different hormonal therapies. Rudy Van den Broecke UZ Ghent
Choosing between different hormonal therapies Rudy Van den Broecke UZ Ghent What is the golden standard in premenopausal hormonal sensitive early breast cancer? Ovarian Suppression alone 5 years Tamoxifen
More informationRoche s Perjeta regimen approved in Europe for use before surgery in early stage aggressive breast cancer
Media Release Basel, 31 July, 2015 Roche s Perjeta regimen approved in Europe for use before surgery in early stage aggressive breast cancer The approval is based on the benefit seen with the Perjeta regimen
More informationMammaPrint, the story of the 70-gene profile
MammaPrint, the story of the 70-gene profile René Bernards Professor of Molecular Carcinogenesis The Netherlands Cancer Institute Amsterdam Chief Scientific Officer Agendia Amsterdam The breast cancer
More informationORMONOTERAPIA ADIUVANTE: QUALE LA DURATA OTTIMALE? MARIANTONIETTA COLOZZA
ORMONOTERAPIA ADIUVANTE: QUALE LA DURATA OTTIMALE? MARIANTONIETTA COLOZZA THE NATURAL HISTORY OF HORMONE RECEPTOR- POSITIVE BREAST CANCER IS VERY LONG Recurrence hazard rate 0.3 0.2 0.1 0 ER+ (n=2,257)
More informationSystemic Therapy of HER2-positive Breast Cancer
Systemic Therapy of HER2-positive Breast Cancer Tanja Cufer, MD, PhD University Clinic Golnik, Medical Faculty Ljubljana, Slovenia ESO ESMO Masterclass, Belgrade 2017 Relative Risk HER2-positive Breast
More informationS u p p o r t e d b y a n i n d e p e n d e n t E d u c a t i o n a l G r a n t f r o m B a y e r
EXPERTS KNOWLEDGE SHARE with Prof. Köhne, Dr. Modest and Dr. Vecchione Madrid (Spain) Sunday September 10 th 2017 S u p p o r t e d b y a n i n d e p e n d e n t E d u c a t i o n a l G r a n t f r o m
More informationMedia Release. Basel, 5 June 2017
Media Release Basel, 5 June 2017 APHINITY study shows Roche s Perjeta-based regimen reduced the risk of invasive cancer returning compared to Herceptin and chemotherapy in HER2- positive early breast cancer
More informationIn the Clinic: Annals Sweta Kakaraparthi 1/23/15
In the Clinic: Annals Sweta Kakaraparthi 1/23/15 Case Scenerio 56 year old female with breast cancer presents to the clinic for her 3 month followup! She is concerned about blood clots and asks you about
More informationUK Interdisciplinary Breast Cancer Symposium. Should lobular phenotype be considered when deciding treatment? Michael J Kerin
UK Interdisciplinary Breast Cancer Symposium Should lobular phenotype be considered when deciding treatment? Michael J Kerin Professor of Surgery National University of Ireland, Galway and Galway University
More informationThe Current Status of Immune Checkpoint Inhibitors: Arvin Yang, MD PhD Oncology Global Clinical Research Bristol-Myers Squibb
The Current Status of Immune Checkpoint Inhibitors: A Global Overview of the Field Arvin Yang, MD PhD Oncology Global Clinical Research Bristol-Myers Squibb Immune Checkpoint Inhibitors Conference, March
More informationCáncer de mama HER2+/RE+ vs HER2+/RE : Una misma enfermedad? Dra E. Ciruelos Departamento de Oncología Médica Hospital Universitario 12 de Octubre
Cáncer de mama HER2+/RE+ vs HER2+/RE : Una misma enfermedad? Dra E. Ciruelos Departamento de Oncología Médica Hospital Universitario 12 de Octubre Recurrence of HER2-positive breast cancer (A) Time to
More informationImmunoconjugates in Both the Adjuvant and Metastatic Setting
Immunoconjugates in Both the Adjuvant and Metastatic Setting Mark Pegram, M.D. Director, Stanford Breast Oncology Program Co-Director, Molecular Therapeutics Program Trastuzumab Treatment of Breast Tumor
More informationEndocrine Therapy in Premenopausal Breast Cancer. Joyce O Shaughnessy, MD Baylor Sammons Cancer Center Texas Oncology, PA US Oncology
Endocrine Therapy in Premenopausal Breast Cancer Joyce O Shaughnessy, MD Baylor Sammons Cancer Center Texas Oncology, PA US Oncology Ovarian Ablation or Suppression vs. Not in ER + or ER UK Breast Cancer
More informationNational Institute for Health and Care Excellence (NICE)
National Institute for Health and Care Excellence (NICE) What is the cost-effectiveness of latent tuberculosis infection (LTBI) treatment with different regimens? Addendum to report of April 2015 August
More informationTarge:ng HER2 in Metasta:c Breast Cancer in 2014
Targe:ng HER2 in Metasta:c Breast Cancer in 2014 Kimberly L. Blackwell MD Professor Department of Medicine and Radia:on Oncology Duke University Medical Center Director, Breast Cancer Program Duke Cancer
More informationUpdate on the Management of HER2+ Breast Cancer. Christian Jackisch, MD, PhD Sana Klinikum Offenbach Offenbach, Germany
Update on the Management of HER2+ Breast Cancer Christian Jackisch, MD, PhD Sana Klinikum Offenbach Offenbach, Germany Outline Treatment strategies for HER2-positive metastatic breast cancer since First
More informationSURROGATE ENDPOINTS IN ONCOLOGY: OBJECTIVES, METHODOLOGICAL OVERVIEW, AND CURRENT STATUS
SURROGATE ENDPOINTS IN ONCOLOGY: OBJECTIVES, METHODOLOGICAL OVERVIEW, AND CURRENT STATUS Everardo D. Saad, MD Medical Director, IDDI everardo.saad@iddi.com Acknowledgement to Marc Buyse 1 The ideal endpoint
More informationWhat is new in HR+ Breast Cancer? Olivia Pagani Breast Unit and Institute of oncology of Southern Switzerland
What is new in HR+ Breast Cancer? Olivia Pagani Breast Unit and Institute of oncology of Southern Switzerland Outline Early breast cancer Advanced breast cancer Open questions Outline Early breast cancer
More informationGuidelines for clinical management of severe influenza infection. Aeron Hurt
Guidelines for clinical management of severe influenza infection Aeron Hurt Current WHO guidelines WHO guidance documents for the clinical management of influenza virus infection were published in 2007
More informationA Step Forward in Cancer Patient Care:
Hong Kong Pharmacy Conference 2018 A Step Forward in Cancer Patient Care: The Experience of Oncology Pharmacist-Managed Trastuzumab Clinic in Queen Mary Hospital Amy Yuen Clinical Pharmacist 24 Oct 2017.
More informationHow to carry out health technology appraisals and guidance. Learning from the Scottish experience Richard Clark, Principal Pharmaceutical
The Managed Introduction of New Medicines How to carry out health technology appraisals and guidance. Learning from the Scottish experience Richard Clark, Principal Pharmaceutical Analyst July 10 th 2009,
More informationLA MALATTIA METASTATICA. La malattia HR positiva/her2 negativa: quale terapia di I linea? Come scegliere? Jennifer Foglietta P.O.
LA MALATTIA METASTATICA La malattia HR positiva/her2 negativa: quale terapia di I linea? Come scegliere? Jennifer Foglietta P.O. Narni-Amelia (TR) Outline Re-testing metastatic disease Chemo- vs endocrine-therapy
More informationAdjuvant bisphosphonates: our recommendations
Adjuvant bisphosphonates: our recommendations Andreas Makris Mount Vernon Cancer Centre OPTIMA launch meeting, 27 April 2017 Breast Cancer Metastasis Tumour cell colonisation of bone Tumour cell proliferation
More informationLung Cancer Non-small Cell Local, Regional, Small Cell, Other Thoracic Cancers: The Question Isn t Can We, but Should We
Lung Cancer Non-small Cell Local, Regional, Small Cell, Other Thoracic Cancers: The Question Isn t Can We, but Should We Edward Garon, MD, MS Associate Professor Director- Thoracic Oncology Program David
More informationLa preservazione della fertilità in oncologia: il carcinoma mammario come paradigma. Olivia Pagani Centro di Senologia dellasvizzera Italiana
La preservazione della fertilità in oncologia: il carcinoma mammario come paradigma Olivia Pagani Centro di Senologia dellasvizzera Italiana Centro di Senologia della Svizzera Italiana Pregnancy rate after
More informationPertuzumab for the adjuvant treatment of HER2-positive breast cancer
Lead team presentation Pertuzumab for the adjuvant treatment of HER2-positive breast cancer 1 st Appraisal Committee meeting Background and clinical effectiveness Committee A Lead team: John McMurray,
More informationOpen Clinical Trials: What s Out There Now Paula D. Ryan, MD, PhD
Open Clinical Trials: What s Out There Now Paula D. Ryan, MD, PhD Hanahan and Weinberg, 2000 Acquired Capabilities of Cancer Clinical Trials When should I consider a clinical trial? How do I find the right
More informationHow can a STRONG recommendation be based on VERY LOW quality evidence?
How can a STRONG recommendation be based on VERY LOW quality evidence? Background Grading of Recommendations, Assessment, Development and Evaluation (GRADE) is a widely used rating system Several COG-endorsed
More informationGiuseppe Viale for the BIG 1 98 Collaborative and International Breast Cancer Study Groups
Central Review of ER, PgR and HER2 in BIG 1 98 Evaluating Letrozole vs. Letrozole Tamoxifen vs. Tamoxifen Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women with Hormone Receptor Positive
More informationAnthracyclines in the elderly breast cancer patients
Anthracyclines in the elderly breast cancer patients Etienne GC Brain, MD PhD Medical Oncology Centre René Huguenin, Saint-Cloud & Group GERICO, FNCLCC, Paris Centre René Huguenin - Saint-Cloud Facts about
More informationPossible causes of difference among regions How to look at the results from MRCT Non-compliance with GCP and/or protocol Apparent Differences (Play of
Outline ICH E17 General Principles for Planning and Design of Multi-Regional Clinical Trials Future MRCTs Based on E17 Guideline Background and Key Principles in E17 Some case studies of Gastric Cancer
More informationLong term survival study of de-novo metastatic breast cancers with or without primary tumor resection
Long term survival study of de-novo metastatic breast cancers with or without primary tumor resection Dr. Michael Co Division of Breast Surgery Queen Mary Hospital The University of Hong Kong Conflicts
More informationLuminal early breast cancer: (neo-) adjuvant endocrine therapy
CAMPUS GROSSHADERN CAMPUS INNENSTADT KLINIK UND POLIKLINIK FÜR FRAUENHEILKUNDE UND GEBURTSHILFE DIREKTOR: PROF. DR. MED. SVEN MAHNER Luminal early breast cancer: (neo-) adjuvant endocrine therapy Nadia
More informationPage. Objectives: Hormone Therapy Resistance: Challenges and Opportunities. Research Support From Merck
Hormone Therapy Resistance: Challenges and Opportunities Pamela. N. Munster, MD University of California, San Francisco Financial Disclosures Research Support From Merck Objectives: Understanding the current
More informationPost-ESMO 2012: Tamara Rordorf Klinik für Onkologie UniversitätsSpital Zürich T.Rordorf, SAMO Luzern 1
Post-ESMO 2012: Breast Cancer Tamara Rordorf Klinik für Onkologie UniversitätsSpital Zürich 1 Neoadjuvant treatment (in Her-2 positive disease) neoadjuvant trials abstracts: breast sparing surgery, biomarkers,
More informationGRADE. Grading of Recommendations Assessment, Development and Evaluation. British Association of Dermatologists April 2014
GRADE Grading of Recommendations Assessment, Development and Evaluation British Association of Dermatologists April 2014 Previous grading system Level of evidence Strength of recommendation Level of evidence
More informationImmunotherapy in the Adjuvant Setting for Melanoma: What You Need to Know
Immunotherapy in the Adjuvant Setting for Melanoma: What You Need to Know Jeffrey Weber, MD, PhD Laura and Isaac Perlmutter Cancer Center NYU Langone Medical Center New York, New York What Is the Current
More informationEmerging Approaches for (Neo)Adjuvant Therapy for ER+ Breast Cancer
Emerging Approaches for (Neo)Adjuvant Therapy for E+ Breast Cancer Cynthia X. Ma, M.D., Ph.D. Associate Professor of Medicine Washington University in St. Louis Outline Current status of adjuvant endocrine
More informationBest of San Antonio 2008
Best of San Antonio 2008 Ellie Guardino, MD/PhD Assistant Professor Stanford University BIG 1 98: a randomized double blind phase III study evaluating letrozole and tamoxifen given in sequence as adjuvant
More informationExtended Adjuvant Endocrine Therapy
Extended Adjuvant Endocrine Therapy After all, 5 years Tamoxifen works.. For women with ER+ primary breast cancer, previous studies have shown that treatment with tamoxifen for 5 years has a carry-over
More informationRole of Primary Resection for Patients with Oligometastatic Disease
GBCC 2018, April 6, Songdo ConvensiA, Incheon, Korea Panel Discussion 4, How Can We Better Treat Patients with Metastatic Disease? Role of Primary Resection for Patients with Oligometastatic Disease Tadahiko
More informationTo Maintain or Not to Maintain? Lymphoma and Myeloma 2015 Waldorf Astoria Hotel, New York
To Maintain or Not to Maintain? Lymphoma and Myeloma 2015 Waldorf Astoria Hotel, New York Sundar Jagannath Director, Multiple Myeloma Program Tisch Cancer Institute Mount Sinai Medical Center Maintenance
More informationDear doctor, what about a baby? Myths and facts
Dear doctor, what about a baby? Myths and facts OLIVIA PAGANI BREAST UNIT AND INSTITUTE OF ONCOLOGY OF SOUTHERN SWITZERLAND IBCSG Background About 15% of patients with BC are diagnosed during their reproductive
More informationThe questions are changing in early phase cancer clinical trials: Opportunities for novel statistical designs
The questions are changing in early phase cancer clinical trials: Opportunities for novel statistical designs Elizabeth Garrett-Mayer, PhD Associate Professor Director of Biostatistics, Hollings Cancer
More informationBreast cancer. Prof Arlene Chan Medical Oncologist Director Breast Clinical Trials Unit, Mount Hospital Vice-Chair Breast Cancer Research Centre - WA
Breast cancer rof Arlene Chan Medical Oncologist Director Breast Clinical Trials Unit, Mount Hospital Vice-Chair Breast Cancer Research Centre - WA Breast cancer Incidence of Breast Cancer by Stage at
More informationBREAST CANCER. Dawn Hershman, MD MS. Medicine and Epidemiology Co-Director, Breast Program HICCC Columbia University Medical Center.
BREAST CANCER Dawn Hershman, MD MS Florence Irving Assistant Professor of Medicine and Epidemiology Co-Director, Breast Program HICCC Columbia University Medical Center Background Breast cancer is the
More informationPERJETA (pertuzumab) FOR TREATMENT OF MALIGNANCIES
PERJETA (pertuzumab) FOR TREATMENT OF MALIGNANCIES Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures,
More informationNeo-adjuvant and adjuvant treatment for HER-2+ breast cancer
Neo-adjuvant and adjuvant treatment for HER-2+ breast cancer Angelo Di Leo «Sandro Pitigliani» Medical Oncology Unit Hospital of Prato Istituto Toscano Tumori Prato, Italy NOAH: Phase III, Open-Label Trial
More informationSystemic Therapy of HER2-positive Breast Cancer
Systemic Therapy of HER2-positive Breast Cancer Tanja Cufer, MD, PhD University Clinic Golnik, Medical Faculty Ljubljana, Slovenia ESO ESMO Masterclass, Belgrade 2018 HER2-positive Breast Cancer Adjuvant
More informationThe next wave of successful drug therapy strategies in HER2-positive breast cancer. Hans Wildiers University Hospitals Leuven Belgium
The next wave of successful drug therapy strategies in HER2-positive breast cancer Hans Wildiers University Hospitals Leuven Belgium Trastuzumab in 1st Line significantly improved the prognosis of HER2-positive
More informationNeoadjuvant therapy a new pathway to registration?
Neoadjuvant therapy a new pathway to registration? Graham Ross, FFPM Clinical Science Leader Roche Products Ltd Welwyn Garden City, UK (full time employee) Themes Neoadjuvant therapy Pathological Complete
More information