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Divided Vinorelbine With Methotrexate/Fluorouracil Effective In Metastatic Breast Cancer

Combination regimens that include vinorelbine, divided between days 1 and 8 of a 3-week cycle, are comparable in efficacy to other modern first-line regimens in treating metastatic breast cancer.

In this 2-step study, Finnish researchers used 3 vinorelbine to determine the best tolerated dose to combine with methotrexate at 40 mg/m² on day 1 and fluorouracil at 600 mg/m² on days 1 and 8 in patients with evaluable metastases.

The first step involved 30 patients, randomly allocated to 1 of 3 vinorelbine groups: 20 mg/m² on days 1 and 8, 30 mg/m² on 1 and 10 mg/m² on day 8 or 40 mg/m² on day 1 but not exceeding 60 mg/m². In the second step of the study, the worst tolerated regimen was excluded, and the study was expanded to include 60 patients.

Objective response rates were seen in 50% of patients receiving 20 plus 20 mg/m² vinorelbine, 55% of those receiving 30 plus 10 mg/m² doses and 44% of those receiving 40 mg/m² doses.

Median time to survival was 26 months in the 20 plus 20 mg/m² vinorelbine group, 23 months in the 30 plus 10 mg/m² group and 16 months in the 40 mg/m² group. Median time to progression was 7 months in the 20 plus 20 mg/m² vinorelbine group, 10 months in the 30 plus 10 mg/m² group and eight months in the 40 mg/m² group.

Haematological toxicity was measured using World Health Organisation definitions. Grade 3 toxicity was seen in 23% of patients receiving the 20 plus 20 mg/m²doses, 36% of those receiving 30 plus 10 mg/m² doses and 50% of those receiving 40 mg/m² doses.
Annals of Oncology 2003;14:5:699-703. "Vinorelbine, methotrexate and fluorouracil (VMF) as first-line therapy in metastatic breast cancer: a randomized phase II trial"

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