Aspirin Found Ineffective in Improving Recurrence Risk or Survival Rate of Breast Cancer Patients

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Aspirin Found Ineffective in Improving Recurrence Risk or Survival Rate of Breast Cancer Patients

Aspirin Found Ineffective in Improving Recurrence Risk or Survival Rate of Breast Cancer Patients

There have been numerous observational and retrospective scientific studies that found a reduced risk of cancer progression or death associated with taking aspirin.

Many types of cancer were involved in these studies, including breast cancer, which ranks second globally in terms of incidence. If aspirin’s efficacy against breast cancer were as found in retrospective studies, it would undoubtedly be good news for the millions of breast cancer patients newly diagnosed each year worldwide. However, there is currently no placebo-controlled randomized clinical trial that can confirm aspirin’s anti-cancer effects on breast cancer.

Unfortunately, the “myth” created by aspirin in retrospective studies has been shattered in the world’s first placebo-controlled randomized clinical trial for breast cancer.

Recently, a groundbreaking study led by Wendy Y. Chen from the Dana-Farber Cancer Institute was published in the top medical journal, JAMA.

They initiated a randomized, placebo-controlled, double-blind phase 3 clinical trial, originally planned to last for 5 years. However, at the midpoint analysis with a median follow-up time of 33.8 months, they found that the number of events such as death and invasive progression in the group taking 300mg of aspirin daily was actually higher (without statistical significance) compared to the placebo group. Therefore, this clinical trial was forced to terminate.

Aspirin Found Ineffective in Improving Recurrence Risk or Survival Rate of Breast Cancer Patients

Chen et al. believe that in high-risk non-metastatic breast cancer patients, daily aspirin intake does not improve the recurrence risk or survival rate of breast cancer and should not be recommended as an adjuvant therapy for breast cancer.

To clarify the true clinical effect of aspirin, oncologist Chen and her team recruited 3,020 high-risk non-metastatic breast cancer patients aged 23-69 (median age 53), including 16 male patients, from 534 research institutions in the United States and Canada, between January 6, 2017, and December 4, 2020.

All participants were randomly assigned to the aspirin group (300mg daily) or the placebo group in a 1:1 ratio, with the trial planned to last for 5 years. The primary endpoint of the study was invasive disease-free survival (IDFS), defined as the time from randomization to the first occurrence of any of the following: distant recurrence, local recurrence, contralateral or ipsilateral breast cancer, second primary (non-breast) invasive cancer, or death from any cause. The secondary endpoint was overall survival (OS).

Looking at the primary endpoint, at the median follow-up time of 33.8 months, a total of 253 IDFS events occurred, with 141 in the aspirin group and 112 in the placebo group, representing a 27% increased risk in the aspirin group, but without statistical significance (HR, 1.27; P=0.06). Except for contralateral breast cancer, all IDFS events in the aspirin group, including death, invasive progression (distant and local), and new primary cancer events, were more frequent, but the differences were not statistically significant.

Looking at the secondary endpoint, 63 patients in the aspirin group died, with 46 deaths due to breast cancer; in the placebo group, 52 patients died, with 35 deaths due to breast cancer, but again, the differences were not statistically significant (HR, 1.19; P=0.36).

From the above data, it is clear that daily oral intake of 300mg of aspirin does not benefit breast cancer IDFS in high-risk early breast cancer patients. Chen and her colleagues believe that although the follow-up time was short, it had crossed the predefined futility boundary, making it very unlikely that additional follow-up would show a benefit.

It is worth noting that while this study suggests no benefit of aspirin for breast cancer patients, aspirin may still play an important role in preventing and treating other cancers.

For example, a double-blind, randomized, placebo-controlled study published in The Lancet in 2020 found that in individuals at high risk of hereditary colorectal cancer (Lynch syndrome), taking aspirin for over 2 years reduced the incidence of colorectal cancer by 50%; even more remarkable, this protective effect of aspirin could last up to 20 years.

Therefore, the effectiveness of aspirin in cancer treatment depends on randomized controlled clinical trials conducted in specific cancers.

Aspirin Found Ineffective in Improving Recurrence Risk or Survival Rate of Breast Cancer Patients

References:

[1].Rothwell PM, Wilson M, Price JF, Belch JF, Meade TW, Mehta Z. Effect of daily aspirin on risk of cancer metastasis: a study of incident cancers during randomised controlled trials. Lancet. 2012;379(9826):1591-1601. doi:10.1016/S0140-6736(12)60209-8

[2].Chen WY, Ballman KV, Partridge AH, et al. Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer: The Alliance A011502 Randomized Trial. JAMA. Published online April 29, 2024. doi:10.1001/jama.2024.4840

[3].Burn J, Sheth H, Elliott F, et al. Cancer prevention with aspirin in hereditary colorectal cancer (Lynch syndrome), 10-year follow-up and registry-based 20-year data in the CAPP2 study: a double-blind, randomised, placebo-controlled trial. Lancet. 2020;395(10240):1855-1863. doi:10.1016/S0140-6736(20)30366-4

(source:internet, reference only)

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