Paclitaxel Plus Vinorelbine in Metastatic Breast Ca Patients With Contraindications to Receive Anthracyclines

Metastatic breast cancer belongs to the group of moderately sensitive malignant tumors. Classic combination chemotherapy regimens, especially those containing anthracyclines (FAC, FEC, AC, and others) result in objective responses in 50% to 80% of patients, including complete responses in nearly 15%.[1] However, in spite of the important research conducted over the past two decades, metastatic breast cancer remains essentially an incurable disease, with the vast majority of patients presenting with a recurrence of disease after initial chemotherapy. In particular, the prognosis of metastatic breast cancer patients who are not candidates for the new anthracycline therapy (because of prior anthracycline resistance, prior anthracycline cumulative dose reaching the maximum recommended dose, or medical contraindications to receive anthracyclines) has been considered extremely poor. Over the past decade, a few new drugs, such as the taxanes (paclitaxel [Taxol]/ and docetaxel [Taxotere]) and vinorelbine (Navelbine), have been shown to be partially non-cross resistant with anthracyclines in metastatic breast cancer. The availability of these drugs may give patients with contraindications to receive anthracyclines the opportunity to receive new chemotherapy regimens able to induce a substantial rate of objective responses. The encouraging antitumor activity of paclitaxel (21% to 22% response rate) and vinorelbine (16% response rate), as single agents in metastatic breast cancer patients refractory to anthracyclines,[2-4] prompted us to evaluate the antitumor activity of the combination of these two drugs in patients with contraindications to receiving anthracycline therapy. This article presents the preliminary results of our cooperative phase II study using this combination.