Background Many drugs are prescribed outside the terms of the marketing authorization (off-label), especially in oncology.
Purpose To describe the use of bevacizumab in metastatic breast cancer (MCB), evaluating its suitability after the extension of the indications in 2011 by the European Medicines Agency (EMA).
Materials and Methods Retrospective and descriptive monitoring study carried out between January and December of 2011 on the use of bevacizumab in MBC in a 446-bed tertiary care hospital. Demographic data, regimens, types of treatment, dose, number and frequency of cycles and indications were examined. During the study it was considered according to technical data that treatment regimens with bevacizumab combined with paclitaxel or capecitabine were among the best for metastatic illnesses.
Results The total number of patients with MBC in treatment during 2011 was 96, 40.6% (39 patients) of whom were being treated with bevacizumab with an average age of 62 (ranging 45–79). 40 treatments were reviewed (one patient received two different bevacizumab regimens during the monitoring process), 42.5% of which followed the indications authorised by the EMA. The regimens that didn’t fit to the technical data (57. 5%) were as follows: 46% bevacizumab in monotherapy 15 mg/kg/21 days, 54% bevacizumab associated with other cytostatics different from paclitaxel or capecitabine. Combinations with bevacizumab not indicated in the technical data were: 37% bevacizumab 15 mg/kg + liposomal doxorubicin 75 mg/m²/21 days, 37% bevacizumab 15 mg/kg/ 21 days + vinorelbine 25 mg/m² days 1 and 8, 10% bevacizumab 15 mg/kg/21 days, 10% bevacizumab 10 mg/kg +irinotecan to 125 mg/m²/15 days and 6% bevacizumab 15 mg/kg +docetaxel 100 mg/m²/21 days.
Conclusions Despite the extension of the bevacizumab indications in 2011 by the European Medicines Agency (EMA) the off-label use of bevacizumab remains high, probably due to the clinical evidence with bevacizumab, which has evolved rapidly in recent years. In this sense, the importance of pharmacists’ role should be stressed in evaluating the use of medicine in relation to the recent evidence of the MBC.
No conflict of interest.
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