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

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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 mutated colon cancer patients Prof. Dr. med. Ulrich Güller, MD, MHS, FEBS PD Dr. med. et phil. Markus Jörger, MD, PhD

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

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

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

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

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

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

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

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

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