What is Cardiotoxicity and How Does this Impact Clinicians and Their Patients?
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1 Klinik und Poliklinik für Kinderchirurgie What is Cardiotoxicity and How Does this Impact Clinicians and Their Patients? How can Cardiology help in the development & cunduct of a clinical trial for Oncology Thomas M. Suter, M.D. Cardiology Bern University Hospital / Mayo Clinic Jacksonville FL
2 Trial Involvement Trial Cancer Compound N Patients CRC Location HERA ALTTO BACH BEATRICE BO22857/ TDM4874g Aphinity SAKK 24/06 Breast Cancer Breast Cancer Breast Cancer Breast Cancer Breast Cancer Breast Cancer Breast Cancer Trastuzumab 4500 BIG / Roche Lapatinib 8000 Liposomal Doxirubicin 180 Bevacizumab 2500 BIG, NCCTG / GSK Independent / Schering Independent / Roche World, except US World Europe World, except US T-DM1 150 Roche World Pertuzumab 3800 BIG / Roche World Bevacizumab, Liposomal Doxirubicin 40 SAKK Switzerland Cardiology help for Oncology suter.thomas@mayo.edu 2
3 CardiOncology - Cardio-Oncology Onco-Cardiology Cardiology help for Oncology suter.thomas@mayo.edu 3
4 Cardiovascular Side Effects of Cancer Therapy QT-Prolongation Arrhythmia QT-Prolong Johnson, J. N., & Ackerman, M. J. (2009). British journal of sports medicine, 43(9), Cardiology help for Oncology 4
5 Cardiovascular Side Effects of Cancer Therapy Blood Pressure Hypertension < 140 / 90 mmhg Cardiology help for Oncology suter.thomas@mayo.edu 5
6 Blood Pressure JNC7 ESH Common Terminology Criteria for Adverse Events CTCAE 2.0 CTCAE 3.0 CTCAE)Version 4.0 Cardiology help for Oncology 6
7 Cardiovascular Side Effects of Cancer Therapy Cardiac Dysfunction Heart Failure Cardiac Dysfunction Greenberg B, Kahn AW: Braunwald's Heart Disease - A Textbook of Cardiovascular Medicine, 9th ed. Cardiology help for Oncology suter.thomas@mayo.edu 7
8 Cardiology help for Oncology 8
9 Cardiovascular Side Effects of Cancer Therapy Cardiac Dysfunction Heart Failure CTCAE 3.0 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Cardiology help for Oncology 9
10 Cardiology help for Oncology 10
11 Cardiovascular Side Effects of Cancer Therapy Cardiac Dysfunction Heart Failure Cardiac Dysfunction Echocardiography MUGA Cardiology help for Oncology 11
12 Cardiovascular Side Effects of Cancer Therapy Cardiac Dysfunction Heart Failure Central Review If LVEF < 50%: repeat after 3 weeks Cardiac Dysfunction Echocardiography Suter TM, Procter M et al. JCO 2007; 25 Cardiology help for Oncology suter.thomas@mayo.edu 12
13 Cardiovascular Side Effects of Cancer Therapy Cardiac Dysfunction Heart Failure Cardiac Dysfunction Cardiology help for Oncology 13
14 Cardiovascular Side Effects of Cancer Therapy Cardiac Dysfunction Heart Failure Cardiac Dysfunction Cardiology help for Oncology 14
15 Cardiovascular Side Effects of Cancer Therapy Cardiac Dysfunction Heart Failure Cardiac Dysfunction Suter TM, Procter M et al. JCO 2007; 25 Cardiology help for Oncology suter.thomas@mayo.edu 15
16 How can Cardiology help in Clinical Oncology Trials? Surrogate Markers Cardiac Biomarkers New Imaging Long-term follow-up Treatment Trials Cardiology help for Oncology 16
17 How can Cardiology help in Clinical Oncology Trials? Cardiac Dysfunction Procter M, Suter TM et al. JCO 2010; 29 Cardiology help for Oncology 17
18 How can Cardiology help in Clinical Oncology Trials? Collaborations Clinical Endpoints Common Definitions Surrogate Markers Long-term follow-up Treatment Trials Cardiology help for Oncology 18
19 Klinik und Poliklinik für Kinderchirurgie Innovation in Collecting Safety Data via Novel Randomized Trial Approaches or Other Techniques Academinc Viewpoint Thomas M. Suter, M.D. Cardiology Bern University Hospital / Mayo Clinic Jacksonville FL
20 Collecting Safety Data via Novel Randomized Trial Approaches Cardiology help for Oncology 20
21 Collecting Safety Data via Novel Randomized Trial Approaches Cardiology help for Oncology 21
22 Collecting Safety Data via Novel Randomized Trial Approaches Cardiology help for Oncology 22
23 Collecting Safety Data via Novel Randomized Trial Approaches Academic Challenge Collaborations Clinical Endpoints Long-term follow-up Surrogate Markers Cardiac Biomarkers New Imaging Cardiology help for Oncology 23
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