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) - Université de Bourgogne Accéder directement au contenu
Article Dans Une Revue Digestive and Liver Disease Année : 2018

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)

Valérie Boige
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Thierry André
Rosine Guimbaud
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Résumé

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.

Domaines

Cancer
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Dates et versions

hal-01704109 , version 1 (08-02-2018)

Identifiants

Citer

Pierre Michel, Valérie Boige, Thierry André, Thomas Aparicio, Jean Baptiste Bachet, et al.. 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). Digestive and Liver Disease, 2018, 50 (3), pp.305-307. ⟨10.1016/j.dld.2017.12.023⟩. ⟨hal-01704109⟩
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