Xeloda in the treatment of metastatic breast cancer.

There are few treatment options available for patients with metastatic breast cancer who have failed anthracycline- and paclitaxel-based chemotherapy. Xeloda (capecitabine) is a novel selectively tumoractivated fluoropyrimidine carbamate producing clinically active levels of 5-fluorouracil (5-FU) at the tumor site. Xeloda is active in breast cancer and is administered orally. It is the only registered treatment for patients in whom anthracycline and taxoid treatment has failed. In a phase II trial of 163 paclitaxel-refractory patients with metastatic breast cancer, the overall response rate with Xeloda was 20%, with three complete responses, and the median survival was 12.8 months. A total of 20% of patients experienced a Clinical Benefit Response (a composite assessment of clinical benefit). Furthermore, Xeloda was well tolerated; the most common treatment-related adverse events were hand-foot syndrome, diarrhea, nausea, vomiting, and fatigue. Two additional studies of Xeloda in patients with metastatic breast cancer have also been completed. In the first study, patients with anthracycline-resistant metastatic breast cancer received either Xeloda or paclitaxel; the response rates were 36 and 26%, respectively. In the second study, women aged >/=55 years received first-line treatment with either Xeloda or cyclophosphamide/methotrexate/5-FU. The response rates were 25 and 16%, respectively. These studies show that Xeloda is an active agent in the treatment of metastatic breast cancer with the additional advantage of oral administration.