ABSTRACT

I. INTRODUCTION Metastatic breast cancer is an incurable disease that is typically associated with a median survival of approximately 18 to 24 months. The goals of systemic therapy include palliation of symptoms, prolongation of survival, and in rare cases prolongation of disease-free survival beyond 5 years. Current options for systemic therapy include hormonal therapy for those with estrogen and/or progesterone receptor-positive disease, trastuzumab for those with disease that overexpresses Her2/neu, and cytotoxic chemotherapy. Cytotoxic therapy is generally reserved for patients with hormone-sensitive disease who have failed one or more hormonal regimens or those with who have symptomatic disease that requires prompt symptom relief. This chapter focuses on the efficacy of cytotoxic therapy and other nonhormonal approaches for the treatment of patients with metastatic breast cancer. The emphasis is on clinical trials that have been reported within the past decade-either randomized Phase III trials or selected Phase II trials that have had a substantial impact on the field. Endpoints reviewed for selected studies include response rate, median time to disease progression (or treatment failure), median survival, and the incidence of severe (grade 3) and life-threatening (grade 4) toxicities.