Current status of vinorelbine for breast cancer.

Vinorelbine tartrate (Navelbine) is a new semisynthetic vinca alkaloid with efficacy against a variety of solid tumors, including non-small-cell lung cancer, breast cancer, head and neck cancer, and Hodgkin's lymphoma. Recently approved by the FDA for the first-line treatment of advanced non-small-cell lung cancer, vinorelbine is also under review by the FDA for use in patients with metastatic breast cancer. There is now extensive data confirming the activity of vinorelbine in metastatic breast cancer, with second-line response rates of 17% to 36% and first-line response rates of 40% to 44%. Investigators have combined vinorelbine with other active drugs against breast cancer to produce response rates exceeding 50% for first-line therapy. Numerous centers are now conducting randomized trials comparing vinorelbine to established second-line therapies for advanced breast cancer, such as paclitaxel (Taxol). Future research is needed to further define the precise role of vinorelbine as a component of combination therapy for metastatic breast cancer.