a phase ii study of capecitabine and oxaliplatin in the treatment of patients with advanced her2 negative breast cancer

1. Abstract 1.1. Background: There are many treatment options for patients with Metastatic Breast Cancer (MBC) although there is no standard chemotherapy after first line therapy. Capecitabine in combination with oxaliplatin (CapOx) is used in treatment of metastatic colorectal cancer and has shown divergent effect in patients with MBC. This phase II study was initiated to investigate the efficacy and toxicity of CapOx in patients with MBC, pretreated with anthracyclines and taxanes. 1.2. Patients and Method: Eighteen patients with HER-2 negative MBC, pretreated with anthracyclines and taxanes, were included. Capecitabine was administered orally continuously at 1300 mg/m 2 daily divided on two doses. Oxaliplatin was administered intravenously at 85 mg/m 2 every 2 weeks. The study was approved by the Regional Scientific Ethics Committee prior to start of the study. 1.3. Results: The best overall response rate was 28% with one CR and four PR’s. The Clinical Benefit Rate (CBR; complete response, partial remission and stable disease ≥ 6 months) was 50% and the CBR limit of ≥ 50% was thereby not met and the study was closed. The PFS and OS were 5.2 and 12.9 months, respectively. The treatment was tolerable with no grade 4 toxicity or any drug related deaths. The most common grade 2/3 toxicities were dysesthesia (55%) and sensory neuropathy (55%). 1.4. Conclusion: The efficacy of CapOx was not found superior to capecitabine monotherapy. The results from this study do not support the use of CapOx among patients with MBC. 2. Keywords: Breast Cancer; Capecitabine; Oxaliplatin; Phase II