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Phase II study of vinorelbine (NVB) and UFT in patients with metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes.

751 Background: To assess the efficacy and safety of the combination of NVB and UFT as first or second line treatment in patients with MBC previously treated with anthracyclines and taxanes.


METHODS
Patients with histologically confirmed breast cancer, measurable disease, no more of one prior regimen of chemotherapy for metastatic disease, ECOG PS<2, and adequate bone marrow, renal and liver function were eligible. Patients received NVB 30 mgrs/m2 on day 1 and UFT 250 mgrs/m2 daily, q2w, until progression or unacceptable toxicity. Toxicity was evaluated every cycle and objective response every six cycles.


RESULTS
Between 2/2001 and 8/2003, 37 patients have been included, all evaluables for toxicity, and 36 for response: median age 62 years (range 37-80; median PS 1. Twenty eight patients (76%) received neo/adjuvant therapy, and twenty nine patients (78%) received one prior chemotherapy regimen for metastasic disease. Patients had metastasis in bone (18 pts), liver (18 pts), lung (13 pts), nodes (7 pts), other sites (8 pts) and 23 (62%) had two or more metastatic sites. A total of 301 cycles were administered (median 7 cycles, range 1-19). Toxicity was generally mild; grade 3-4 toxicity consisted of neutropenia in 14 pts (10% cycles), thrombocytopenia in 1 pts (0,4% cycles), asthenia 3 pts (2% cycles), mucositis in 1 pt (0,4% cycles), neuropathy in 1 pt (0,4% cycles), and constipation in 1 pt (0,4% cycles).


EFFICACY
To date, 13 pts (36%) achieved partial response, 7 patients (19%) had stable disease, 12 patients (33%) had progressive disease, and 4 patients (11%) were no evaluables. Median time to progression was 18 weeks range (5-47.2).


CONCLUSIONS
The combination of NVB and UFT in patients with MBC previously treated is a well-tolerated an effective regimen, and achieved disease control in 55% in this group of patients. No significant financial relationships to disclose.