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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Tuesday, March 1, 2022
According to research presented at the February 2022 American Society of Clinical Oncology (ASCO) Plenary Series (Abstract 360922), daily adjuvant aspirin use does not appear to improve invasive disease–free survival in patients with high-risk, HER2-negative breast cancer. Previous studies had reported a correlation between regular aspirin use and improved survival among this patient population.
“Although inflammation may still play a role in cancer progression, aspirin is not recommended for prevention of breast cancer recurrence,” concluded Wendy Chen, MD, of the Dana-Farber Cancer Institute, Boston, and colleagues.
Between January 2017 and December 2020, the double-blind study enrolled 3,021 participants who were randomly assigned 1:1 to receive either 300 mg of daily aspirin or daily placebo for 5 years. At a median follow-up of 20 months, the aspirin and placebo groups had experienced a total of 191 invasive disease–free survival events (n = 107 and n = 84, respectively). The resultant stratified hazard ratio of aspirin versus placebo was 1.27, exceeding the predetermined futility boundary of 1.03. For this reason, the study was unblinded in November 2021 following a recommendation from the data safety and monitoring board.
Grade 3 or 4 adverse event rates were comparable between groups. Both arms experienced similarly high rates of compliance. The rate of aspirin or nonsteroidal anti-inflammatory drug consumption outside the treatment protocol was less than 14% for both groups.
Disclosure: For full disclosures of the study authors, visit meetings.asco.org.
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