Daily aspirin use fails to reduce risk for breast cancer recurrence
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Use of aspirin failed to prolong invasive DFS among patients with breast cancer, according to results of a randomized phase 3 study presented during the ASCO Plenary Series.
"Although inflammation may still play a role in cancer progression, aspirin is not recommended for prevention of breast cancer recurrence,” Wendy Y. Chen, MD, MPH, medical oncologist and senior physician at Dana Farber Cancer Institute and assistant professor of medicine at Harvard Medical School, said in a press release.
Background
Researchers initiated the double-blind, placebo-controlled Aspirin after Breast Cancer (ABC) trial to determine the true benefits and risks associated with adjuvant aspirin therapy for breast cancer survivors.
In vitro and in vivo evidence suggested aspirin may have an antitumor effect, and several epidemiologic studies showed longer survival among patients with breast cancer who used aspirin regularly compared with nonusers. In addition, pooled data from randomized trials of aspirin for cardiovascular disease showed a decreased risk for metastatic cancer among aspirin users.
Methodology
The analysis included 3,021 participants aged 18 to 70 years diagnosed with primary invasive HER2-negative breast cancer and enrolled between January 2017 and December 2020.
Tumors of those with hormone receptor-positive disease had to be node-positive and diagnosed within the past 10 years; tumors of those with hormone receptor-negative disease could be node-positive or T2-4N0 and diagnosed within the past 18 months.
Researchers randomly assigned patients 1:1 to 300 mg daily aspirin (n = 1,511; 82.1% white) or placebo (n = 1,510; 81.5% white) for 5 years. Investigators stratified according to hormone receptor status, BMI (< or 30 kg/m2) and stage (II vs. III).
A comparison of the effect of aspirin vs. placebo on invasive DFS served as the primary objective. Secondary objectives included effects on OS, cardiovascular disease, toxicity and adherence.
Key findings
Results showed 191 invasive DFS events (107 with aspirin, 84 with placebo) at median follow-up of 20 months. Researchers reported a stratified HR of 1.27 (z-score, 1.64) comparing aspirin to placebo, which exceeded the prespecified HR for futility (1.03; z-score, 0.19).
“The follow-up was short,” Chen said during the presentation, “but the futility bound was clearly crossed.”
Additionally, researchers found no difference in the frequency of grade 3 to grade 4 events among the two groups.
The investigators reported high compliance across both groups and similar, nonprotocol use of aspirin or other nonsteroidal anti-inflammatory drugs (less than 14%), consistent with prior randomized aspirin trials.
In further research, the authors plan to conduct additional analyses of tumor and blood samples collected from participants at baseline and on repeat blood samples collected at 2 years.
“Although inflammation may still play a key role in cancer, it’s also important to remember that aspirin may have different effects in other cancer, such as colon, or in different settings, such as primary vs. secondary prevention,” Chen said to conclude her presentation.
References:
Chen WY, et al. Abstract 360922. Presented at: ASCO Plenary Series; Feb. 15, 2022.
Daily aspirin does not prevent breast cancer recurrence. https://www.asco.org/about-asco/press-center/news-releases/daily-aspirin-does-not-prevent-breast-cancer-recurrence. Published Feb. 15, 2022. Accessed Feb. 15, 2022.
Perspective
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Angela DeMichele, MD, MSCE
The well-designed, well-conducted ABC trial enrolled the right study population given the underlying mechanism of action of the intervention, and patients received adequate study drug, with minimal contamination. Nonetheless, the trial was stopped early for futility. The direction and magnitude highly preclude the possibility that there would have been a benefit with more follow-up. Although it was not statistically significant, we cannot rule out the possibility of a potential increase in breast cancer recurrence from the use of aspirin.
What can we take home from this study? For patients and providers, at this time aspirin should not be used simply to prevent breast cancer recurrence. And for situations in which there are other options, decisions about aspirin use for other indications should definitely include an individualized risk-benefit discussion between physician and patient.
This study is important to our field overall. It underscores the needs for prospective randomized trials that are essential to isolate the effects of interventions identified in observational studies. And we’ve seen this time and again, with a classic example of hormone replacement therapy for cardiovascular disease prevention.
It’s important to underscore that negative trials are valuable, particularly when there has been meticulous biospecimen collection such as in the ABC trial. These analyses will be helpful in gaining knowledge about the role of inflammation recurrence and other interventions regardless of this trial’s outcomes.
University of Pennsylvania
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Chen WY, et al. Abstract 360922. Presented at: ASCO Plenary Series; Feb. 15, 2022.
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