Xiao Shen Wang1, Hong Mei Ying1, Xia Yun He1, Zheng Rong Zhou2, Yong Ru Wu1, Chao Su Hu3. 1. Department of Radiation Oncology, Fudan University Shanghai Cancer Center, China; Department of Oncology, Shanghai Medical College of Fudan University, China. 2. Department of Diagnostic Radiology, Fudan University Shanghai Cancer Center, China; Department of Oncology, Shanghai Medical College of Fudan University, China. 3. Department of Radiation Oncology, Fudan University Shanghai Cancer Center, China; Department of Oncology, Shanghai Medical College of Fudan University, China. Electronic address: hucsu62@163.com.
Abstract
PURPOSE: A prospective, placebo controlled phase II trial was conducted to test the efficacy of Nerve Growth Factor (NGF) for the treatment of symptomatic temporal lobe necrosis (TLN). MATERIALS AND METHODS:Patients with progressive TLN were randomly assigned to either the control or the study group in a 1:1 ratio. The control group received corticosteroids with gradually reduced dosage. The study group received NGF with corticosteroids. NGF was dissolved in 2mL normal saline and injected intramuscularly at 18μg/time, once a day for 2months. The efficacy was evaluated by both the objective and subjective methods every 3-4months after treatment. The objective method compared volumes of the necrotic masses on MRI before and after treatment. The subjective method compared the neurocognitive score as evaluated by the mini-mental status examination (MMSE). RESULTS:Twenty-eight cases were enrolled into this study. The objective evaluation showed that the response rate (RR) in the study group was higher than the control group. The ratio was 10 versus 2 (p=0.006), and 12 versus 3 (p=0.002) at 3-4months and 6-8months after intervention, respectively. The subjective evaluation demonstrated both groups were effective in controlling the necrosis related symptoms in the first 6months after treatment. But NGF was more effective than corticosteroids at 9months (13 versus 4, p=0.001). The only observed side effect was mild pain at the injection site in 3 patients in the study group. CONCLUSIONS: Our results demonstrated that the process of TLN is not irreversible. NGF is more effective in recovering TLN than corticosteroids with little side effect. NGF has a longer duration in controlling the necrosis related symptoms than corticosteroids.
RCT Entities:
PURPOSE: A prospective, placebo controlled phase II trial was conducted to test the efficacy of Nerve Growth Factor (NGF) for the treatment of symptomatic temporal lobe necrosis (TLN). MATERIALS AND METHODS:Patients with progressive TLN were randomly assigned to either the control or the study group in a 1:1 ratio. The control group received corticosteroids with gradually reduced dosage. The study group received NGF with corticosteroids. NGF was dissolved in 2mL normal saline and injected intramuscularly at 18μg/time, once a day for 2months. The efficacy was evaluated by both the objective and subjective methods every 3-4months after treatment. The objective method compared volumes of the necrotic masses on MRI before and after treatment. The subjective method compared the neurocognitive score as evaluated by the mini-mental status examination (MMSE). RESULTS: Twenty-eight cases were enrolled into this study. The objective evaluation showed that the response rate (RR) in the study group was higher than the control group. The ratio was 10 versus 2 (p=0.006), and 12 versus 3 (p=0.002) at 3-4months and 6-8months after intervention, respectively. The subjective evaluation demonstrated both groups were effective in controlling the necrosis related symptoms in the first 6months after treatment. But NGF was more effective than corticosteroids at 9months (13 versus 4, p=0.001). The only observed side effect was mild pain at the injection site in 3 patients in the study group. CONCLUSIONS: Our results demonstrated that the process of TLN is not irreversible. NGF is more effective in recovering TLN than corticosteroids with little side effect. NGF has a longer duration in controlling the necrosis related symptoms than corticosteroids.
Authors: Eugene J Vaios; Kristen A Batich; Anne F Buckley; Anastasie Dunn-Pirio; Mallika P Patel; John P Kirkpatrick; Ranjit Goudar; Katherine B Peters Journal: Oncotarget Date: 2022-03-29