Xeloda (R) in the treatment of metastatic breast cancer

There are few treatment options available for patients with metastatic brea st cancer who have failed anthracycline- and paclitaxel-based chemotherapy. Xeloda(R) (capecitabine) is a novel selectively tumoractivated(TM) fluorop yrimidine carbamate producing clinically active levels of 5-fluorouracil (5 -FU) at the tumor site. Xeloda is active in breast cancer and is administer ed orally. It is the only registered treatment for patients in whom anthrac ycline and taxoid treatment has failed. In a phase II trial of 163 paclitax el-refractory patients with metastatic breast cancer, the overall response rate with Xeloda was 20%, with three complete responses, and the median sur vival was 12.8 months. A total of 20% of patients experienced a Clinical Be nefit Response (a composite assessment of clinical benefit). Furthermore, X eloda was well tolerated; the most common treatment-related adverse events were hand-foot syndrome, diarrhea, nausea, vomiting, and fatigue. Two addit ional 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 great er than or equal to 55 years received first-line treatment with either Xelo da or cyclophosphamide/methotrexate/5-FU. The response rates were 25 and 16 %, respectively. These studies show that Xeloda is an active agent in the t reatment of metastatic breast cancer with the additional advantage of oral administration.