Oral vinorelbine in metastatic breast cancer

Excerpt

A new oral formulation of vinorelbine has been introduced in clinical studies since 1994, following increasing interest in the development of oral chemotherapy, driven by pharmacoeconomic issues, patient convenience and the potential for improved quality of life. A dose-finding study [1] established that 100 mg/m² was the MTD dose, limiting toxicities being neutropenia, nausea and vomiting, and neuroconstipation; the recommended dose was then defined at 80 mg/m² per week. The first phase II studies conducted in chemotherapy-naive NSCLC and as first-line chemotherapy in advanced breast cancer (ABC) showed an excessive rate of complicated neutropenia. This led to the formulation of a new schedule in which a lower dose of 60 mg/m² per week was administered for the first three courses with escalation to 80 mg/m², with a safety profile qualitatively comparable to that of intravenous vinorelbine at standard doses [2]. Equivalent blood concentrations were demonstrated between 80 mg/m² oral and 30 mg/m² intravenous, and between 60 mg/m² oral and 25 mg/m² intravenous [3]. …