Capecitabine: expanding options for the treatment of patients with early or locally advanced breast cancer.

Capecitabine has proven efficacy in metastatic breast cancer, extending survival in combination with docetaxel and offering a favorable safety profile, including minimal myelosuppression and alopecia, as a single agent. It is therefore logical that capecitabine could build on the improved outcomes achieved with taxanes in early breast cancer. In the neoadjuvant setting, a phase III trial of capecitabine and docetaxel (XT) versus doxorubicin and cyclophosphamide (AC) showed that XT was more effective than AC in terms of clinical response rate and pathologic complete response rate, with a manageable safety profile. Other studies, including a phase III trial of capecitabine, epirubicin, and docetaxel, a phase III trial of capecitabine and vinorelbine, and several phase II studies of different regimens with capecitabine, have confirmed the high activity of neoadjuvant capecitabine, with acceptable safety. In the adjuvant setting, a Finnish phase III study (FinXX) of sequential XT followed by cyclophosphamide, epirubicin, and capecitabine versus docetaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide has shown favorable safety with lower doses of both capecitabine and docetaxel in the XT combination. Efficacy results from that trial are eagerly awaited. A large, ongoing trial program is continuing to explore the potential for capecitabine in the treatment of early breast cancer, looking at capecitabine-taxane combinations, capecitabine maintenance therapy, capecitabine for elderly patients, and sequential versus combination therapy, involving >20,000 patients.