Questionable oncologic benefits of degarelix.

ABSTRACT

INTRODUCTION: Luteinizing hormone releasing hormone (LhRh) antagonist degarelix has been approved by the Food and Drug Administration (FDA) for the treatment of advanced prostate cancer in 2008. However, the studies that followed such initial approval have several limitations. OBJECTIVE: To make a critical review of those publications. METHODS: Literature search on degarelix. RESULTS: The studies supporting the use of degarelix are criticized on the basis of selection bias in regards to the heterogeneous populations described, ad hoc analyses with low statistical merit, and the presentation of selected data that would appear to be favorable to the evaluated medication. In addition, those studies still have not shown that any of the data that they point out have any association with clinical benefit. CONCLUSION: The flawed methodology of these publications makes the evidence to support the use of degarelix rather weak.