Aspirin versus placebo in stage III or high-risk stage II colon cancer with PIK3CA mutation: A French randomised double-blind phase III trial (PRODIGE 50-ASPIK) |
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| Affiliation: | 1. Normandie Univ, UNIROUEN, Inserm 1245, IRON Group, Department of Hepato-Gastroenterology, Rouen University Hospital, Rouen, France;2. Department of Oncologic Medicine, Gustave Roussy, Villejuif, France;3. Department of Medical Oncology, Saint Antoine Hospital, Université Pierre et Marie Curie, Paris, France;4. Department of Gastroenterology and Digestive Oncology, Saint Louis Hospital, APHP, University Paris 7, Sorbonne Paris Cité, Paris, France;5. Department of Hepato-Gastroenterology and Digestive Oncology, Hôpital de la Pitié Salpetrière, APHP, University Paris 6, Paris, France;6. Department of Digestive Oncology, Aix-Marseille University–Assistance Publique Hôpitaux de Marseille, Marseille, France;7. Department of Medical Oncology, University Hospital Toulouse, Paul Sabatier University, Toulouse, France;8. Department of Hepatogastroenterology and Oncology Digestive, Burgundy Franche–Conté University, INSERM LNC UMR 1231 EPICAD, University Hospital of Dijon, Dijon, France;9. Gastroenterology Department of Hepatogastroenterology, Poitiers University Hospital, Poitiers, France;10. Department of Digestive Oncology, Université Paris Descartes, Hôpital Européen Georges Pompidou, Paris, France;11. Department of Pathology, University Hospital Toulouse, Paul Sabatier University, Toulouse, France;12. French Federation of Digestive Oncology (FFCD), INSERM LCN UMR 1231 EPICAD, Dijon, France;13. Normandie Univ, UNIROUEN, Inserm 1245, IRON Group, Department of Hepato-Gastroenterology, Rouen University Hospital, Department of Medical Oncology, Centre Henri Becquerel, Rouen, France |
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| Abstract: | Oxaliplatin-based adjuvant chemotherapy is standard of care for radically resected stage III colon cancer and an accepted option for high-risk stage II. Two recent retrospective studies strongly suggested that low-dose aspirin used (100 mg/d) after surgical resection of colorectal cancer with a PIK3CA mutation could act as a targeted therapy with a major protective effect on the risk of recurrence.We propose a double-blind randomized phase III study to evaluate aspirin (100 mg/d during 3 years or until recurrence) versus placebo. Main inclusion criteria are patients aged 18 or 20, stage III or high risk stage II.The primary endpoint of the study is 3-year disease-free survival (DFS). Hypotheses are to improve 3-years DFS from placebo: 72% to aspirin: 83% (HR = 0.56). 94 events and 264 patients with PIK3CA mutation are required. The secondary endpoints are DFS at 5 years, the overall survival rate at 5 years, grade 3–4 severe bleeding. |
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| Keywords: | Aspirin Colorectal cancer PI3KCA mutation |
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