A phase II study of vinorelbine (VNR) and letrozole (LTZ) in aged women with metastatic breast cancer (MBC)

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Abstract
756 Background: To evaluate the efficacy and toxicity profile of VNR and LTZ in aged women with MBC. Methods: Between April 2001 and August 2003, fifty-three women with measurable MBC, no prior chemotherapy for advanced disease, ECOG performance status (PS) 0–1, and adequate bone marrow, renal and hepatic function were included. Twenty-four pts had been treated with neo/adjuvant therapy, 16 of them with chemotherapy. Only five patients had received hormonal therapy as first line treatment for MBC. Treatment consists in VNR 30 mg/m2 i.v. on days 1 and 8 every 21 days for a maximum of 8 cycles, and LTZ 2.5 mg/day continuous. Tumor evaluation was done every 3 cycles. Results: : Of 53 pts included, 48 are fully evaluable for response and toxicity. Median age was 73.0 years (range 56–82); ECOG PS 0/1: 26/22 pts; patients had metastases in bone (14 pts), liver (12 pts), lung (9 pts), nodes (12 pts), cutaneous (11 pts), other sites (3 pts). Fourteen pts have two o more metastatic localization. A total of 279 cycles of VNR were administered (median 6, range 2–8). Toxicity was generally mild: grade 3–4 toxicity consisted of leukopenia in 3 pts (2.2% cycles), neutropenia in 12 pts (7,2% cycles), anemia in 3 pts (1.1% cycles), asthenia in 4 pts (1.8% cycles) and liver toxicity in 1 pt (0,7% cycles). Efficacy: To date, 4 (8%) pts achieved a complete response and 20 (42%) pts a partial response, 16 (33%) pts had stable disease and 8 (17%) pts had progressive disease. The median time to progression was 11.6 months. Conclusions: The combination of VNR and LTZ in aged women with MBC appears to be active regimen with a favorable toxicity profile. No significant financial relationships to disclose.

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