Bevacizumab Monotherapy Reduces Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma Patients: A Randomized Controlled Trial
Abstract
PURPOSE
Studies have shown that addition of bevacizumab to corticosteroids improves outcome against radiation-induced brain necrosis (RN). Here, we aimed to evaluate the effectiveness and safety of bevacizumab monotherapy on RN in nasopharyngeal carcinoma (NPC) patients.
METHODS AND MATERIALS
In this multicenter open-label study, patients with RN were randomly assigned (1:1) into a bevacizumab group (5 mg/kg intravenously every 2 weeks, for 4 cycles) or a corticosteroid group (methylprednisolone 500 mg/day intravenously for 3 consecutive days and then gradually tapered, followed by 10 mg/day oral prednisone, for 2 months in total). Magnetic resonance imaging (MRI) was performed pre- and post-treatment to define the radiographic response. The primary outcome was a 2-month response rate as determined by MRI and clinical symptoms. All of the patients were followed up with for 6 months. The trial was registered at www.clinicaltrials.gov (NCT01621880).
RESULTS
Of 121 patients screened, 112 patients met the entry criteria. Thirty-eight (65.5%) patients in the bevacizumab group showed response, which was significantly higher than that in the corticosteroid group (65.5% vs 31.5%, P < .001). The mean percentage decrease in RN volume seen on T1 post-gadolinium and T2-weighted fluid-attenuated inversion recovery (FLAIR) MRI was 25.5% and 51.8%, respectively, in the bevacizumab group, versus 5.0% and 19.3%, respectively, in the corticosteroid group. Moreover, 36 patients (62.1%) on…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 121 participants or records.
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