Safety of bevacizumab in clinical practice for recurrent ovarian cancer: A retrospective cohort study

open access

 The primary aim of the present study was to describe the safety profile of bevacizumab in routine practice. The most common AEs observed were hypertension, proteinuria and epistaxis (open access), which are known side effects of bevacizumab treatment. The risk of the occurrence of such events may be dose-associated, as indicated by the multivariate Cox regression analysis and by previously published data (35–37).

Endpoints assessment (n=156)

The safety profile of bevacizumab was the primary endpoint of the study. Secondary endpoints included the usage conditions of bevacizumab (e.g., dose schedule, concurrent chemotherapy) and survival rates. During bevacizumab therapy, AEs potentially attributable to the monoclonal antibody were described according to the Common Terminology Criteria for Adverse Events, Version 3.0 (31). The AEs of particular interest in the present study were defined prior to data collection, and focused on the following: Hypertension, proteinuria, epistaxis, bleeding or hemorrhage, venous thromboembolic event, arterial thromboembolic event, wound healing complication, intestinal perforation, gastrointestinal (GI) fistula, reversible posterior leak-encephalopathy syndrome and pulmonary hypertension.
Overall survival (OS) was determined from the time of bevacizumab introduction to the time of the mortality of the patients (due to any cause). Progression-free survival (PFS) was determined from the time of bevacizumab introduction to disease progression or patient mortality. The data for patients who were alive without undergoing disease progression were censored at the date of their last assessment.
During bevacizumab treatment, disease progression was evaluated by each treating physician through clinical examination and/or carbohydrate antigen 125 (CA125) levels and/or radiological examination. Biological progression was defined, according to the Gynecological Cancer Intergroup criteria (32), as an increase of CA125 levels. Determination of radiological and clinical progression relied on physician judgement.