Role of COX-2 inhibitors as maintenance therapy in non-metastatic triple negative breast cancer Egyptian patients, single institution study

Abstract

Author(s): Fatma Gharib, Yomna Zamzam, Lamiss Mohamed sad

Objective: In comparison to other breast subtypes, Triple Negative Breast Cancer (TNBC) has worst prognosis. In this study, we evaluate the role of maintenance COX-2 inhibitors in non-metastatic TNBC patients. Methods: This study was a prospective, open-label, 1:1-ratio, randomized trial. Eighty-six patients diagnosed with non-metastatic TNBC and proved to have positive COX-2 expression by immunohistochemically staining were enrolled in this trial. The patients were treated and followed up at Tanta University Hospitals in the period from January 2014 to October 2019. Patients randomized to receive COX-2 inhibitors (Celecoxib 200 mg once daily) as maintenance therapy after completion of adjuvant therapy till progression or toxicity (arm A) or observation without maintenance therapy (arm B) in ratio of 1 to 1. The primary endpoint was Disease Free Survival (DFS). Positive COX-2 expression was defined as more than 10% cytoplasmic staining. Results: With median follow up of 59 months, the 4-year DFS rate was significantly higher for patients received celecoxib compared to patients who didn’t receive maintenance therapy (66% and 41.9% respectively) p<0.001). Worse DFS were associated with conservative breast surgery, high Ki-67 and positive family history of breast cancer respectively (p<0.001, 0.016 and 0.002respectively). Surgical approach and use of Cox-2 inhibitors remained statistically significant with DFS in multivariate analysis [P=0.001; 95%CI (0.071-0.508); HR=0.190) and P=0.006; 95%CI (1.466-10.27); HR=3.880) respectively]. Conclusion: This study showed that use of COX-2 inhibitors as maintenance therapy based on COX-2 expression may be associated with better DFS for non-metastatic TNBC patients. So, targeting COX-2 may have a role in this aggressive disease.

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