medwireNews: Daily aspirin therapy does not reduce the risk for recurrence or improve survival in patients with high-risk nonmetastatic breast cancer, the Alliance A011502 trial has found.
“Despite its promise and wide availability, aspirin should not be recommended as an adjuvant breast cancer treatment,” write Wendy Chen (Dana-Farber Cancer Institute, Boston, Massachusetts, USA) and associates in JAMA.
Outlining the rationale for the trial, they explain that “[o]bservational studies of survivors of breast cancer and prospective trials of aspirin for cardiovascular disease suggest improved breast cancer survival among aspirin users,” but prospective studies are lacking.
The team therefore initiated the phase 3 trial that enrolled 3020 patients with HER2-negative breast cancer treated with standard therapy, and randomly assigned them, in a double-blind manner, to receive either adjuvant aspirin 300 mg/day or placebo. Most of the participants were postmenopausal (81.1%), had hormone receptor-positive (88.6%) and node-positive (88.9%) disease, and had received chemotherapy (83.2%).
The first interim analysis, conducted when 191 invasive disease events had occurred, gave a stratified hazard ratio (HR) of 1.27 for the comparison of aspirin versus placebo, “which crossed the prespecified futility boundary of 1.03,” report the researchers.
“The Alliance data and safety monitoring board therefore recommended that the trial be unblinded and study treatments terminated,” they continue.
Chen and colleagues also report the findings from an analysis conducted at a median follow-up of 33.8 months, when 253 invasive disease events had occurred. This revealed an identical stratified HR of 1.27. The median invasive disease-free survival (IDFS) time was 68.8 months in the aspirin arm and unreached in the placebo arm.
They note that all invasive disease events other than contralateral breast cancer, including invasive locoregional and distant progression, new primary events, and death, were numerically more frequent in the aspirin than placebo group, but the differences were not statistically significant.
Overall survival (OS) also did not differ significantly between the aspirin and placebo treatment arms (HR=1.19), and adjustment for adherence did not substantially change the HRs for IDFS or OS.
“Although follow-up was short, the prespecified futility bound was crossed, rendering very low likelihood that additional follow-up would demonstrate a benefit,” say the investigators.
But they continue: “Despite our findings for breast cancer, aspirin may still have an important role in prevention and treatment of other cancers.”
The authors of a related editorial express a similar view, saying that “despite the reasonably definitive result that aspirin use did not improve [IDFS] among survivors of breast cancer, oncology and primary care clinicians may still consider discussing with one another and their patients the potential benefits and harms of aspirin used for other reasons.”
Such purposes could include “effects on other cancers, management of comorbid diseases, and improvements in patient-reported outcomes such as pain and cognitive function,” write Jeanne Mandelblatt and colleagues from the Lombardi Comprehensive Cancer Center in Washington, DC, USA.
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JAMA 2024; doi:10.1001/jama.2024.4840
JAMA 2024; doi:10.1001/jama.2024.4828