Abstract P1-20-01: Intraoperative ketorolac in high-risk breast cancer patients with and without inflammation. A prospective, randomized, placebo-controlled clinical trial

Introduction: Perioperative events may affect the risk of breast cancer recurrence after surgery. Ketorolac, a non-steroidal anti-inflammatory drug routinely used to improve pain control postoperatively has been associated with better breast cancer outcome in retrospective studies. However, it is still unknown whether a single dose of pre-incisional ketorolac may be sufficient to prolong recurrence-free survival. Patients and methods: The KBCt trial (NCT01806259) is a national, multicenter, prospective, double-blind, placebo-controlled, randomized phase III trial in high risk breast cancer patients. Each patient was assigned to the ketorolac or the placebo group. Patients were given one dose of ketorolac tromethamine (Taradyl®, N.V. Roche S.A., Belgium) or a matching placebo 30 minutes before surgery. Eligible patients were ≥18 and ≤75 years old with histologically or cytologically confirmed, invasive ductal or lobular breast carcinoma planned for curative breast cancer surgery, and with at least one of these 3 criteria: a Neutrophil-to-Lymphocyte Ratio ≥4, node-positive disease (cN1-N3) or a triple-negative histology. The primary endpoint of the study was Disease-Free Survival (DFS). Secondary endpoints included safety, pain assessment and overall survival. Results: Two hundred and three patients were assigned to ketorolac (n=96) or placebo (n=107). Baseline characteristics were similar between arms. Patients had a mean age of 55.7 (SD 14) years. Both intra- and post-operative blood losses were not different between groups and there was no difference in pain at day 1 after surgery. There was no difference between the 2 arms for DFS (p=0.52) nor for OS (p=0.88). Discussion and conclusion: This study shows that a single administration of 30 mg of ketorolac tromethamine before surgery does not increase disease-free survival in high risk breast cancer patients. Overall survival is also comparable. No safety concerns were observed in this study. Citation Format: Berliere M, Bouche G, Duhoux F, Coulie P, De Cloedt J, Dekleermaker A, Guillaume J-E, Ledent M, Machiels J-P, Mustin V, Swinnen W, Vander Essen L, Van Maanen A, Verougstraete J-C, De Kock M, Forget P. Intraoperative ketorolac in high-risk breast cancer patients with and without inflammation. A prospective, randomized, placebo-controlled clinical trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-20-01.