Phase I study of vinorelbine (VRL) alternating i.v. and oral in combination with docetaxel (DTX) as 1st line chemotherapy (CT) of metastatic breast cancer (MBC)

783 Background: VRL and DTX are targeting tubulin-microtubule system, either inhibiting tubulin polymerisation (VRL) or microtubule depolymerisation (DTX). Both agents have proven activity in MBC. Methods: This study was designed to evaluate the efficacy and the tolerance of the combination of i.v. VRL 20 mg/m2 with DTX 60 mg/m2 on day 1 and oral VRL 60 mg/m2 on day 15 of a three-week cycle in first line treatment MBC for a maximum of 6 cycles. Prior adjuvant CT was allowed if completed at least 12 months before study entry. At least one bidimensionally measurable lesion (WHO criteria) should be present. Results on the first 23 treated patients are as follows: median age was 56(y), 16 pts (69.6%) had received prior adjuvant chemotherapy, 22 pts (95.7%) had a KPS ≥80%, and 10 pts (43.5%) had ≥3 sites involved. All patients were eligible and evaluable for efficacy. A total of 129 cycles were given (median 6). Median relative dose intensities (RDI) of i.v.VRL and DTX were over 99% and median RDI of oral VRL ...