Ketorolac in Breast Cancer Trial
Location: Cliniques Saint-Luc, Brussels, Belgium
Collaboration: Dr Patrice Forget
There has been recent interest in the possible impact of the perioperative period on cancer outcomes. Several observations suggest that physiological changes induced by surgery and anesthesia may have an impact on the growth of tumor cells in breast cancer. It is well documented that anesthesia and surgery induce a change in immunity and an inflammatory response. Local inflammation and angiogenesis required for wound healing may also influence roles in the process. Though cancer surgery is key in the management of many types of cancer, research on the perioperative period and possible consequences on cancer outcomes is scarce.
Recently, Patrice Forget et al. evaluated all drugs used during anesthesia and surgery of breast cancer in women treated with removal of the whole breast (mastectomy) performed at the Cliniques Saint-Luc in Brussels. They found that cancer patients who received ketorolac, a non-steroidal anti-inflammatory drug, during surgery had a lower risk of breast cancer recurrence. Ketorolac is sometimes used by anesthesiologists to prevent postoperative pain. Other anesthesiologists use other drugs instead of ketorolac to demonstrate preferences. The link between injection of ketorolac during surgery and lower risk of breast cancer recurrence suggests important factors to affect the risk of recurrence. The same finding was observed in another center in Belgium (although not statistically significant due to a low number of recurrences). Within the Cliniques Saint-Luc, the same phenomenon was observed in patients operated for lung cancer, but not in patients operated for prostate cancer.
In order to verify if an injection of ketorolac is responsible of the risk reduction of breast cancer recurrence, this hypothesis must be tested in a randomized clinical trial. The Anticancer Fund decided to support this breast cancer clinical trial that started in February 2013 at the Cliniques Saint-Luc in Brussels. The study will involve 4 additional Belgian centers, and ultimately include 200 women diagnosed with breast cancer. These cancer patients must have a moderate to high risk of cancer recurrence and will be randomized in 2 arms: ketorolac or placebo. Cancer patients and doctors will not know whether placebo or ketorolac had been administered. Recruitment is planned over 2 years and results should be available by the end of 2016. Dr Patrice FORGET is the principal investigator, in collaboration with Prof Marc DE KOCK, Prof Martine BERLIERE, Prof Jean-Pascal MACHIELS, Dr François DUHOUX, Prof Pierre COULIE and Dr Aline VANMAANEN.
You can send an email to Alain Dekleermaker, study coordinator, at kbctrial@gmail [dot] com for more information.
More details about this study (NCT01806259) at www.clinicaltrials.gov.