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      Divided Vinorelbine With Methotrexate/Fluorouracil Effective In Metastatic Breast Cancer

      A DGReview of :"Vinorelbine, methotrexate and fluorouracil (VMF) as first-line therapy in metastatic breast cancer: a randomized phase II trial"
      Annals of Oncology

      04/29/2003
      By Elda Hauschildt


      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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