[Primary chemotherapy of metastatic breast carcinoma with bendamustine hydrochloride, methotrexate and fluorouracil versus cyclophosphamide, methotrexate and fluorouracil].

The combination bendamustine/methotrexate/fluorouracil (BMF) was proven versus cyclophosphomide/methotrexate/fluorouracil (CMF) in a stratified randomized pilot study as primary chemotherapy in 61 patients with metastatic breast cancer. Bendamustine was given in a dose of 240 mg/m2 and cyclophosphamide in a dose of 960 mg/m2 per therapy-cycle. The doses of methotrexate (40 mg/m2 i.v., day 1 and 8) and fluorouracil (500 mg/m2 i.v., day 1 and 8) were identical in both groups. 25 patients in the BMF- and 24 patients in the CMF-group were evaluable. The remission rates were 52% vs. 46%. The median duration of remission was 15.2 months (ranging from 8.1 to 19.7 months) in the BMF-group and 6.2 months (ranging from 1.9 to 11.1 months) in the CMF-group. The aim of this study was to identify the main criterion for further randomized studies. The results of this pilot study indicate, that it is possible to prolong the median duration of remission without changing the antineoplastic activity by replacing cyclophosphamide with bendamustine.

RCT Entities:   Population Interventions Outcomes