Perioperative anti-inflammatory to reduce breast cancer recurrence
Perioperative ketorolac in high risk breast cancer patients with and without inflammation – a prospective randomised placebo-controlled trial.
- Breast cancer
Funding
Why this trial?
Surgery is an important step in the treatment of many cancers, and leads to the best outcomes in breast cancer. Several observations suggest that physiological changes induced by surgery and anaesthesia may have an impact on the growth of tumour cells in breast cancer.
Anaesthesia and surgery induce major physiological changes in patients. Immune changes, inflammation, and angiogenesis necessary for wound healing may also promote the growth of cancer cells, possibly making the surgery less effective.
To counter these effects, it has been hypothesised that the use of nonsteroidal anti-inflammatory drugs (NSAIDs) at the time of surgery may improve cancer patient outcomes. However, only clinical trials will be able to confirm these findings.
Why this intervention?
The researchers involved in this trial have previously shown that intra-operative ketorolac, an NSAID routinely used after surgery but rarely during, is associated with a lower risk of breast cancer recurrence.
The link between injection of ketorolac during surgery and lower risk of breast cancer was found by other researchers as well. In order to assess whether an injection of ketorolac is responsible of the risk reduction of breast cancer recurrence, the hypothesis is tested in a randomised clinical trial.
Trial design
This is a prospective, randomised, placebo-controlled, double-blind study with an inclusion period of 2 years and a 5-year follow-up period. 200 patients will be recruited and treated by 4 Belgian centres.
Breast cancer patients with a moderate to high risk of cancer recurrence are randomly placed into 2 arms, ketorolac or placebo, to find out if perioperative administration of ketorolac during breast cancer surgery has an effect on survival rates.
Results
A poster was presented at the San Antonio Breast Cancer Symposium (SABCS), held December 4-8, 2018. A single injection of ketorolac - a NSAID - just before breast cancer surgery does not improve DFS. Trial is underpowered but the KM curves are very similar.
Partners
Principal Investigator:
- Dr Patrice Forget, previously at Cliniques Universitaires Saint-Luc
Sponsor:
- Cliniques Universitaires Saint-Luc, Brussels, Belgium
Our role
Funding
References
More info on clinicaltrials.gov: NCT01806259
Forget, P., et al (2019). Intraoperative ketorolac in high-risk breast cancer patients. A prospective, randomized, placebo-controlled clinical trial. PLoS ONE ,14(12): e0225748. https://doi.org/10.1371/journal.pone.0225748
Last updated: January 2020.