MANHASSET, NYAn open-label study of vinorelbine
(Navelbine) followed by paclitaxel (Taxol) in patients with
metastatic breast cancer has yielded an active dosing schedule for
this regimen for use in phase II testing, Daniel R. Budman, MD, said
at a poster session of the San Antonio Breast Cancer Symposium.
Dr. Budman, of North Shore University Hospital, said that vinorelbine
and paclitaxel have been shown to have a synergistic effect when
combined in animal models and cultured cell lines. Our
preclinical studies suggested that vinorelbine must be given prior to
paclitaxel for a synergistic effect, Dr. Budman said.
The combination was tested in 28 patients, 79% of whom had received
prior anthracyclines. Profound neutropenia occurred at the first dose
level but was avoided by the use of G-CSF (Neupogen) at subsequent levels.
Responses were seen in 12 of 25 evaluable patients (48%) and in 10 of
22 patients (45%) treated with prior anthracyclines. Based on this
dose escalation trial, the recommended phase II schedule is
vinorelbine 13 mg/m² daily for 3 days followed by paclitaxel 175
mg/m2 over 3 hours on day 3.