medwireNews: In patients undergoing radical therapy for cancer, an 8-week run-in period of aspirin is acceptable and well tolerated, and could reduce the risk for nonadherence and participant attrition in adjuvant and prevention trials, say researchers.
These findings are based on the prespecified feasibility analysis of the Add-Aspirin trial, which comprises four phase III trials assessing the effect of aspirin after radical therapy in patients with early-stage breast, prostate, colorectal, and gastroesophageal cancer. In the initial phase of the trial, all participants took aspirin 100 mg/day for an 8-week run-in period, after which they were randomly assigned to receive aspirin at either the 100 or 300 mg/day dose or placebo for at least 5 years.
At the 2018 NCRI Conference in Glasgow, UK, presenting author Nalinie Joharatnam (University College London, UK) explained that although there is evidence to support the use of aspirin as a chemopreventive agent, concerns regarding adherence and tolerability have limited its use.
She noted, however, that the data from the initial 2253 participants of the Add-Aspirin trial who had completed the run-in period showed “good adherence,” with 95% of participants taking six or seven tablets every week and 85% proceeding to the randomization stage.
Furthermore, grade 3 or worse adverse events occurred in 0.6% of patients during the run-in phase, including one incidence of a lower gastrointestinal tract bleed in a patient with prostate cancer, and 0.7% of participants discontinued as a result of toxicity, most commonly in the colorectal and prostate cancer cohorts.
She noted that trial recruitment is ongoing, with more than 5700 individuals enrolled thus far from the UK, Ireland, and India.
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