Four retrospective studies were recently published on aspirin efficacy in patients with surgically resected colorectal cancer (CRC). Two of these studies strongly suggest that low-dose aspirin (100 mg/d) after resection of CRC with PIK3CA mutation could act as a targeted therapy with a major protective effect in terms of cancer specific survival. The other two studies did not confirm the benefit of aspirin in this setting. These retrospective studies provide an insufficient level of evidence to demonstrate the benefit of low-dose aspirin as adjuvant therapy for CRC with PIK3CA mutation (approximately 12% of all CRC). Therefore, as recommended in the conclusion of these studies and meta-analyses, prospective studies addressing this issue are warranted.
PRODIGE 50 is a double blind randomized phase III study comparing aspirin and placebo in patients with curative resection of stage III or high-risk stage II colon cancer with PIK3CA mutation. The primary end point is 3-year disease-free survival (DFS). Among secondary endpoints Disease-free survival at 5 years, Overall survival at 5 years, Compliance to aspirin (comptability of containers) will be evaluated. Randomization (1:1 ratio) is stratified according to center, stage (II vs III), RAS mutation and chemotherapy (oxaliplatin vs no oxaliplatin). The treatment is planned for 3 years (1 tablet 100 mg/day). Abdominal ultrasound/or CT-scan and CEA is performed every 3 to 6 months during 3 years then every 6 months during the two next years. Hypotheses (α two-sided=5%, power= 80%) are to improve 3-year DFS from placebo: 72% to aspirin: 83% (HR = 0.56). 94 events and 264 patients with PIK3CA mutation are required. 2200 patients will be screened. Patient blood and tumor tissues will be collected in order to establish a large biobank as a basis for translational research projects including identification and quantification of circulating tumour DNA and evaluating Cox2 expression. Inclusion start is planned on September 2017 until 2019.
Clinical trial identification
Legal entity responsible for the study
Bayer scientific, PHRC K 2015, FFCD
V. Boige: Bayer, Sanofi, Merck Serono, Novartis, Roche, Daiichi Sankyo, Prestizia, Amgen. T. Aparicio: Roche, Novartis, Sanofi, Pfizer, Ipsen, Pierre Fabre, HalioDX, BMS, Hospira. J-B. Bachet: Fees: Amgen, Bayer, Celgène, Merck Serono, Sanofi. Consultant: Amgen, Bayer, Merck Serono, Servier. R. Guimbaud: Roche, Novartis, Ipsen, Sanofi, Lilly. D. Tougeron: Sanofi, Celgene, Amgen, Ipsen. J. Taieb: Abbvie, Amgen, Baxalta, Celgene, Lilly, Merck, Roche, Merck, Roche. All other authors have declared no conflicts of interest.