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The emerging role of paclitaxel in breast cancer therapy.

Introduction Multiple chemotherapeutic agents and regimens exist with documented antitumor activity against breast cancer; however, less than one in five patients with stage IV breast cancer are alive 5 years from the first detection of distant metastases (1). Although improved response proportions have been observed, overall survival for patients with metastatic breast cancer has not been significantly improved by the progress of the past three decades. Furthermore, despite the proven magnitude of benefit of adjuvant systemic therapy in reducing the risk of recurrence (2), a significant fraction of patients with early stage breast cancer still will relapse and ultimately die of metastatic disease. Clearly new active agents and strategies are needed to improve upon this situation. The development of paclitaxel (Taxol#{174}), the prototype taxane, as an anticancer agent accelerated after the elucidation of its unique mechanism of action (3) and by the initial demonstration of its activity in refractory advanced ovarian carcinoma (4). Multidisciplinary efforts to procure sufficient quantities of this agent have allowed a rapid expansion of clinical trials. This review will address the development of paclitaxel for use in breast cancer, the clinical results noted thus far in the treatment of metastatic disease, the design of presently ongoing trials, and examine avenues of future investigation.