Yongteng Xu1, Xiaoming Rong1, Weihan Hu2, Xiaolong Huang1, Yi Li1, Dong Zheng3, Zhaoxi Cai4, Zhiyi Zuo5, Yamei Tang6. 1. Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China. 2. Department of Radiation Oncology, Cancer Center of Sun Yat-sen University, Guangzhou, China. 3. Department of Neurology, Guangzhou Brain Hospital, Guangzhou, China. 4. Department of Radiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China. 5. Department of Anesthesiology, University of Virginia, Charlottesville, Virginia. 6. Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China; Guangdong Province Key Laboratary of Brain Function and Disease, Zhongshan School of Medicine, Sun Yat-Sen University, Gaungzhou, China. Electronic address: tangym@mail.sysu.edu.cn.
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 bevacizumab and 23 patients (42.6%) on corticosteroids demonstrated clinical improvement (P = .039). During the 6-month follow up, fourteen patients on bevacizumab and 13 patients on corticosteroids showed RN recurrence. The most frequent adverse event in the bevacizumab group was hypertension (20.6%). CONCLUSIONS: Our study indicate that compared with corticosteroids, bevacizumab offers improved symptomatic relief and radiographic response.
RCT Entities:
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 bevacizumab and 23 patients (42.6%) on corticosteroids demonstrated clinical improvement (P = .039). During the 6-month follow up, fourteen patients on bevacizumab and 13 patients on corticosteroids showed RN recurrence. The most frequent adverse event in the bevacizumab group was hypertension (20.6%). CONCLUSIONS: Our study indicate that compared with corticosteroids, bevacizumab offers improved symptomatic relief and radiographic response.
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