Assessment of Effectiveness of Maintenance Capecitabine among Triple Negative Breast Cancer Patients Attending Suez Canal University Hospital

Background: Triple Negative Breast Cancer (TNBC) accounts for approximately 15% of breast cancer cases. TNBC has a poor prognosis and worse survival. The addition of adjuvant capecitabine for TNBC with non-pathological complete response (non-PCR) after neoadjuvant chemotherapy (NACT) has been recommended in most guidelines. However, for those early TNBC patients without NACT the effectiveness of adding capecitabine is still controversial.Aim:To assess the effectiveness & and tolerability of maintenance Capecitabine among TNBC patients. Objectives:The primary objectives were to evaluate the tolerability and DFS of maintenance Capecitabine in TNBC patients in comparison to those who received the standard of care. Meanwhile, the Secondary Objective was to compare the OS. Patients and Methods:A randomized controlled two parallel groups study design was conducted among TNBC patients attending the Clinical Oncology and Nuclear Medicine Department at Suez Canal University Hospital during the period from January2019 to January 2022. A total of 120 patients were randomly allocated into control or intervention groups with 60 patients in each group. Patients in the intervention group received oral capecitabine at a dose of 500 mg BID monthly. Treatment continued for 2 years or until disease progression or emergence of intolerable toxicity. Kaplan-Meier method and log-rank test were used for survival analysis. Results:The mean age of patients was 46.5 years in the control group compared to 48.2 years in the Capecitabine group. In the Capecitabine group DFS significantly longer (76.7 %) than in the control group (30%), OS 90 % compared to 82.2 % in the control group. 23% of patients who received Capecitabine experienced adverse effects, the most frequent adverse effects were gastritis (17%) followed by dermatitis (3%), neuropathy (2%), and Hand-Foot syndrome (1%). Conclusion: Adjuvant maintenance capecitabine was well tolerated and efficacious in improving the DFS& and OS in TNBC.