Intraoperative ketorolac in High-Risk Breast Cancer Patients. A Prospective, Randomized, Placebo-Controlled Clinical Trial.
Patrice Forget, Gauthier Bouche, Francois P. Duhoux, Pierre G. Coulie,Jan Decloedt, Alain Dekleermaker, Jean-Edouard Guillaume, Marc Ledent, Jean- Pascal Machiels, Véronique Mustin, Walter Swinnen, Aline van Maanen, Lionel Vander Essen, Jean-Christophe Verougstraete, Marc De Kock, Martine Berliere (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
Perioperative events may affect the risk of breast cancer recurrence. Ketorolac, a non-steroidal anti-inflammatory drug had been associated with better breast cancer outcomes in retrospective studies, but further research was necessary.
The clinical trial we supported, a multicenter, placebo-controlled, randomized phase III trial in high-risk breast cancer patients, revealed that a single administration of 30 mg of ketorolac before surgery did not increase disease-free survival in high risk breast cancer patients.
The overall survival difference between the ketorolac and placebo groups was not statistically significant. The study was however underpowered because of lower recurrence rates than initially anticipated.