154E An evaluations of the incidence of proteinuria and hypertension in patients receiving shorter infusions of bevacizumab

Wednesday, October 24, 2012
Westin Diplomat Resort
Sachin R. Shah, PharmD, BCOP1 and Sarah M. Gressett Ussery, Pharm.D., BCOP2
1Texas Tech University Health Sciences Center School of Pharmacy/ VA North Texas Health Care System;, Dallas, TX
2Bristol Myers Squibb, Waxahachie, TX
Abstract AN EVALUATION OF THE INCIDENCE OF PROTEINURIA AND HYPERTENSION IN PATIENTS RECEIVING SHORTER INFUSIONS OF BEVACIZUMAB

Purpose: The FDA approved minimum duration for bevacizumab administration is a 30 minute intravenous infusion. A previous study has shown that shorter, 0.5 mg/kg/min, bevacizumab infusions can be safely administered without increasing the risk for infusion-related hypersensitivity reactions. However, the risk of proteinuria and hypertension in patients receiving shorter infusion of bevacizumab is undetermined. Purpose of this study was to evaluate the incidence of proteinuria (primary objective) and hypertension in patients receiving shorter infusions of bevacizumab.

Methods: This is a multicenter, prospective, observational study in patients receiving less than 10 mg/kg dose of bevacizumab infused over 0.5 mg/kg/min. Patients with prior bevacizumab exposure were excluded from the study. Patients were observed on this trial until discontinuation of bevacizumab for progression of cancer or toxicity.

Results: Sixty three patients received a total of 392 doses of shorter bevacizumab infusions. Of these, 22 patients received bevacizumab at a dose of 5 mg/kg and 41 patients received a dose of 7.5 mg/kg. Nineteen (30.2%) patients experienced proteinuria while receiving bevacizumab. Out of 19 patients, 13 had grade 1 and 6 had grade 2 proteinuria. None of the patients experienced grade 3 or 4 proteinuria. Hypertension was reported in 32 (50.8%) patients receiving bevacizumab. Twelve (19%) patients developed grade 3 or greater hypertension on bevacizumab.

Conclusion: A shorter, 0.5 mg/kg/min bevacizumab infusions does not increase the risk of proteinuria and hypertension. The incidences of proteinuria and hypertension are similar to that previously reported with the standard infusion rate of bevacizumab.