VIDEO: Trial finds no benefit to aspirin in breast cancer
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CHICAGO — Aspirin was not linked to a benefit in invasive disease-free survival, according to updated study results presented at ASCO Annual Meeting.
“I want to remind everyone that there’s strong biologic rationale for a randomized trial of aspirin, looking at the epidemiologic data, laboratory data and, most importantly, data from randomized control trials of aspirin for other endpoints, which showed a decreased risk of metastatic carcinoma, especially metastatic adenocarcinoma,” Wendy Y. Chen, MD, MPH, assistant professor of medicine at Harvard Medical School and Dana-Farber Cancer Institute’sBreast Oncology Center, told Healio.
These previous findings, Chen explained, led researchers to create the randomized A011502 trial that enrolled breast cancer survivors aged less than 70 years, were HER2-negative and were HR-positive and node positive or HR-negative and high risk.
According to Chen, the patients were randomly assigned to receive 300 mg aspirin daily or placebo.
The trial was suspended after the Data and Safety Monitoring Board recommended stopping the trial after the researchers reached their prespecified futility boundary.
Chen noted she presented results on invasive disease-free survival, which had an HR of approximately 1.2, meaning it “was not statistically significant, but was worse for aspirin.”
Additional results on overall survival were similar and “were numerically worse for aspirin, although not statistically significant,” she said.
Chen explained that while some have questioned whether continuing aspirin would have changed the results, the prespecified analysis included approximately 50% of patients, so there would need to be a “complete flip” in results for the next 50% of patients that demonstrated a significantly decreased relative risk.
“In conclusion, A011502 did not show a benefit of aspirin in terms of improving invasive disease-free survival for breast cancer,” she said. “Therefore, we would not recommend the use of aspirin for breast cancer survivors for breast cancer prevention.”
She stressed, however, that this result does not apply to other cancers.
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