Rationale for Trials Studying Pegylated Liposomal Doxorubicin in Metastatic Breast Cancer

Breast cancer is second only to lung cancer as a leading cause of cancer mortality in women. In women with metastatic, hence, essentially incurable disease, we strive to find effective chemotherapeutic regimens that offer a higher quality of life free of the many toxicities associated with standard therapies. We have treated a small group of patients who were heavily pretreated for metastatic breast cancer with pegylated liposomal doxorubicin (PEG-LD) (Doxil) and demonstrated clinical benefit without the usual concomitant toxicity of traditional doxorubicin (Adriamycin). We have initiated trials of combination chemotherapy with PEG-LD with agents designed to improve clinical efficacy, while maintaining or improving patients' quality of life. We believe that optimal schedules for use of PEG-LD, and its combination with other agents, will provide promising options for treating patients with metastatic breast cancer.