Ketorolac in Breast Cancer Surgery

Info

Location: Cliniques Saint-Luc, Brussels, Belgium
Collaboration: Dr Patrice Forget

 

Status: Recruitment finalized. This study is ongoing (follow-up of patients during 2 years)

 

Surgery is a significant step in the treatment process of many forms of cancer. In the case of breast cancer, an operation also frequently provides the best results. What happens in the body of a patient under general anaesthesia, now also appears to have an effect on the further course of the cancer.

Long-term effect of an anti-inflammatory agent

Patrice Forget’s team investigated the drugs used when anaesthetising a patient for the full surgical removal of a breast (a mastectomy). One of these drugs, an anti-inflammatory agent, should immediately demonstrate its efficacy during and after the surgery. But Patrice Forget and his team determined that it also had a longer-term effect. Women who were administered Ketorolac (a non-steroidal anti-inflammatory agent and painkiller) were less likely to relapse – in some cases by up to nearly 50%. This observation was an indication, but was not decisive enough to serve as evidence.

Evidence provided by a clinical study with a control group

In order to exclude all distorting factors and to determine that the Ketorolac injection is indeed responsible for reducing the rate of relapses amongst breast cancer patients, the hypothesis is being investigated in a clinical study with a control group. The researchers examine whether or not Ketorolac affects the course of the disease. Breast cancer frequently recurs in high-risk patients within two years and five years after surgery. Patrice Forget and his team aim to demonstrate that Ketorolac reduces the chances of an ‘early’ relapse (after two years).

200 patients with a moderate to high risk of recurrence

The study (no. NCT01806259) was launched in February 2013 at the Cliniques universitaires Saint-Luc in Brussels, with four other Belgian institutions also participating in the research project. A total of 200 breast cancer patients were examined, each patient with a moderate to high risk of cancer recurrence. They were divided into two groups, with one group receiving Ketorolac and the other a placebo. Neither the patients nor their doctors knew who was being administered the drug and who was receiving the placebo. During the operation, only the tumour, a quarter of the breast or the entire breast (either including or excluding lymph node curettage) is surgically removed. The results of this study are expected in the fourth quarter of 2017.

Professional info

Location: Cliniques Saint-Luc, Brussels, Belgium
Collaboration: Dr Patrice Forget

 

Status: Recruitment finalized. This study is ongoing (follow-up of patients during 2 years)

 

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 is 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 involved 4 additional Belgian centers, and included 200 women diagnosed with breast cancer. These cancer patients had a moderate to high risk of cancer recurrence and were randomized in 2 arms: ketorolac or placebo. Cancer patients and doctors didl not know whether placebo or ketorolac had been administered. Recruitment has taken  2 years and results should be available in the fourth quarter of 2017. 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.