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SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Prospective, double-blinded, placebo- controlled randomized trial of adjuvant aspirin treatment in PIK3CA.

Published byMohamed Blackhurst Modified over 9 years ago

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Presentation on theme: "SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Prospective, double-blinded, placebo- controlled randomized trial of adjuvant aspirin treatment in PIK3CA."— Presentation transcript:

1 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Prospective, double-blinded, placebo- controlled randomized trial of adjuvant aspirin treatment in PIK3CA mutated colon cancer patients Prof. Dr. med. Ulrich Güller, MD, MHS, FEBS PD Dr. med. et phil. Markus Jörger, MD, PhD

2 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Rationale Aspirin inhibits cyclo-oxygenase-2 Inhibition of cyclo-oxygenase-2 results in down-regulation phosphatidylinositol 3-kinase (PI3K) signaling activity Güller/Horber

3 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Güller/Horber

4 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Background Retrospective analysis Data from the Nurses` Health Study and the Health Professionals Follow-up Study 964 patients with colorectal cancer 17% PIK3 mutations Data containing aspirin use (325mg/day) and PIK3CA mutation Güller/Horber

5 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Güller/Horber Cancer-Specific Survival

6 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Güller/Horber Overall Survival

7 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Study Proposal: Inclusion Criteria Patients aged 18 – 85 years Histologically proven colon adenocarcinoma Complete (R0) Resection Stage II and III Life expectancy > 3 years Willing to consent No medical conditions requiring aspirin or NSAIDS No upper GI-bleeding within the past 12 months PIK3CA mutation Güller/Horber

8 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Study Proposal PIK3CA testing 2:1 Randomization Aspirin 300mg daily/ Standard Chemo if indicated Follow-up PIK3CA mutated patients Güller/Horber Potentially eligible colon cancer patients Placebo daily/ Standard Chemo if indicated

9 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Strengths Relevant public health problem Feasibility: Simple intervention Novelty Enthusisam in Medical Oncology Community Güller/Horber Large number needed to screen (n= 1088) Funding Critical Issues

10 SAKK 41/13: PIK3CA-Mutations Aspirin Colon Cancer Acknowledgements Dr. med. et sc. D. Horber Dr. phil. Ch. Pilop, Head Trial Coordinator SAKK Dr. phil. Stefanie Hayoz, SAKK Statistician Mr. Severin Strasky, Funding Specialist SAKK Prof. Dr. med. A. Roth Prof. Dr. W. Jochum Prof. B. Thürlimann, President SAKK Dr. med. M. Montemurro, President SAKK GI Group Prof. Th. Cerny Güller/Horber

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