Efficacy and Side Effects of Generic (Osloda®) and Brand-Name (Xeloda®) Capecitabine in Metastatic Breast Cancer

Purpose: To compare the efficacy and side effects of brand-name capecitabine (Xeloda®) vs. generic (Osloda®) in metastatic breast cancer. Methods: In this non-randomized clinical trial, 39 patients with metastatic breast cancer were included and divide into Xeloda® (19 patients, mean age of 49.5 years) or Osloda® (20 patients, mean age of 51.7 years) groups. A total of six 3-week cycles (1250 mg/m2 daily) were administered. Efficacy and side effects were documented in a three-year follow-up period. Results: The four most common treatment-related adverse events did not differ significantly in Xeloda group vs. Osloda group including hand-foot syndrome (68.4% vs. 65%, P= 0.82), Anorexia (47.4% vs. 50%, P= 0.86), pain (57.9% vs. 40%; P= 0.26), and nausea (52.6% vs. 35%; P= 0.26). Most patients in both groups (25 subjects) showed partial response. Nine patients in each group died (47.4% in Xeloda group and 45% in Osloda group, P= 0.88). Mean overall survival was 20.13 months in Xeloda group and 25.82 months in Osloda group (P= 0.47). Conclusion: Xeloda and Osloda had comparable efficacy and side effects in metastatic breast cancer. Considering the lower cost of Osloda, this agent can be used instead of Xeloda.