Add-Aspirin trial: A phase III, double blind, placebo-controlled, randomized trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common nonmetastatic solid tumors.

• DOI: 10.1200/jco.2014.32.15_suppl.tps1617
• Publication Date: 2019-01-03T22:26:40Z
• Authors: Ruth E Langley; Richard H. Wilson; Alistair E. Ring; Howard Gordon Kyn...; David A. Cameron; Christopher Coyle; Duncan Charles Gi...; Carlo Patrono; Sam Rowley; Claire Murphy; David Adlam; Richard Hubner; Tim Iveson; Robert J Steele; Anne L. Thomas; Timothy J Underwood; Janusz Jankowski; Sudeep Gupta; Conjeevaram S Pra...; Mahesh Parmar
• Keywords: Tolerability

TPS1617 Background: Pre-clinical data demonstrate that aspirin inhibits tumour growth and prevents metastases. Meta-analyses of individual patient from randomized trials evaluating cardiovascular (CV) effects show reduced metastases cancer deaths for those on aspirin. Toxicity concerns have limited use as a primary anti-cancer prevention agent. In the adjuvant setting, risk:benefit ratio differs, with higher morbidity mortality recurrence potentially outweighing risks. Aspirin, an inexpensive drug potential therapeutic role in several common cancers, could large impact global burden. The Add-Aspirin trial investigates if after curative treatment non-metastatic solid tumours prolongs survival. Methods: is double blind, placebo-controlled, multicentre, international trial. Eligible participants (n=9,920) UK India will had cancer. There are 4 separate cohorts – breast (BC), colorectal (CRC), gastro-oesophageal (GOC) prostate (PC). Following 8 week active run-in period 100mg daily to assess adherence tolerability, randomised 100mg, 300mg or placebo > 5 years. Each specific cohort individually powered has disease-specific outcome measure: BC (n = 3,100) invasive disease-free survival (DFS); CRC 2,600) DFS; GOC 2,100) overall (OS); PC 2,120) biochemical recurrence-free Secondary measures include adherence, toxicity CV events. OS across co-primary measure. Sub-studies assessment thromboxane B2 compliance methodological work utility long-term passive follow up. Blood/tissue specimens collected at enrolment allow tumour-specific mutations be used stratification factors. Recruitment commence by May 2014. Funder CRUK; Sponsor University College UK. Clinical information: 2013-004398-28.