Perioperative anti-inflammatory to reduce breast cancer recurrence | Fonds Anticancer (FR)

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.

Status
Completed
 
Cancer types
  • Breast cancer
Trial phase
3

Funding

€251,595
ACF donation
€251,595
Total trial cost

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 drug?

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.

The poster can be found here. Full results to come soon.

Partners

Principal Investigator:

  • Dr Patrice Forget, previously at Cliniques Universitaires Saint-Luc, now at University Hospital Brussels, Brussels, Belgium

Sponsor:

  • Cliniques Universitaires Saint-Luc, Brussels, Belgium

Our role

financial support
Why we support this trial
Intervention has little or no commercial value
Expected survival benefit
No major hurdle for clinical implementation

Funding

€251,595
Total trial cost
€251,595
ACF donation
€4,053
ACF internal support (2015-2017)
Questions about participation?
Questions about this trial?
The Anticancer Fund
studies [at] anticancerfund.org

References

More info on clinicaltrials.gov: NCT01806259

Demaria, S., et al. (2010). Cancer and inflammation: promise for biologic therapy. Journal of Immunotherapy, 33(4), 335-51. doi:10.1097/CJI.0b013e3181d32e74

Forget, P., et al. (2010). Do intraoperative analgesics influence breast cancer recurrence after mastectomy? A retrospective analysis. Anesth Analg, 110(6):1630-5. doi:10.1213/ANE.0b013e3181d2ad0

Proctor, M.J., et al. (2011). A comparison of inflammation-based prognostic scores in patients with cancer. A Glasgow Inflammation Outcome Study. European Journal of Cancer, 47(17), 2633-41. doi:10.1016/j.ejca.2011.03.028

Rothwell, P.M., et al. (2012). Effect of daily aspirin on risk of cancer metastasis: a study of incident cancers during randomised controlled trials. Lancet, 379(9826):1591-601. doi:10.1016/S0140-6736(12)60209-8

Tomita, M., et al. (2011). Preoperative neutrophil to lymphocyte ratio as a prognostic predictor after curative resection for non-small cell lung cancer. Anticancer Research, 31(9):2995-8. Retrieved from http://ar.iiarjournals.org/

Author: Kristine Beckers (Trial Manager)

Last updated: December 2018.