Preliminary findings of this retrospective study indicate that treatment with bevacizumab reference product may be associated with a higher risk for hypertension and proteinuria, whereas treatment with bevacizumab biosimilars correlated with shorter onset of these adverse events.
Comparative safety analysis of the bevacizumab biosimilars and the reference product is limited. Therefore, a retrospective study sought to evaluate the incidence of hypertension and proteinuria and their associated risk factors in patients treated with reference versus biosimilar bevacizumab.
This retrospective study identified patients with gastrointestinal cancer who were treated with either reference bevacizumab or biosimilar bevacizumab between January 2019 and July 2020 at Roswell Park Comprehensive Cancer Center. In the analysis, electronic health records were searched for the presence or absence of hypertension and proteinuria and time to event. To assess the risk association with hypertension and proteinuria, information including demographics, hypertension- and proteinuria-related risk factors, bevacizumab-containing chemotherapy regimen, and bevacizumab dosing were identified.
A total of 75 patients were included in the analysis; of these, 42 patients received bevacizumab and 33 patients received bevacizumab biosimilars. Hypertension occurred more frequently in the bevacizumab reference group versus the biosimilar group (52.4% vs 36.4%; P = .242); however, the difference was not statistically significant. After treatment initiation, the median time to hypertension was significantly longer in the bevacizumab reference group versus the biosimilar group (84 days vs 24.5 days; P = .0064). A slightly higher proportion of patients in the bevacizumab reference group developed proteinuria (35.7% vs 30%; P = .7193). The median onset of proteinuria was significantly longer in the bevacizumab reference group than in the biosimilar group (213 days vs 53.5 days; P = .0022). Risk assessments showed that a history of hypertension was associated with increased risk for further hypertension, whereas underlying renal dysfunction increased the risk for proteinuria.
These results suggest a higher risk for hypertension and proteinuria with the bevacizumab reference product, although the differences did not reach statistical significance and indicate a shorter onset of these adverse events with the bevacizumab biosimilars. Further studies in larger cohorts are warranted to confirm these results.
Source: Man Y, Han Y, Mukherjee S, et al. Incidence of hypertension and proteinuria in patients treated with bevacizumab versus bevacizumab biosimilar. J Clin Oncol. 2021;39(suppl_3):83.
