title: Treatment of cerebral radiation necrosis with nerve growth factor: A prospective, randomized, controlled phase II study.
abstract: OBJECTIVE
  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).
  
  
  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.affiliation: Department of Radiation Oncology, Fudan University Shanghai Cancer Center, China; Department of Oncology, Shanghai Medical College of Fudan University, China.
authors.forename: Xiao Shen
authors.initials: XS
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, Fudan University Shanghai Cancer Center, China; Department of Oncology, Shanghai Medical College of Fudan University, China.
authors.forename: Hong Mei
authors.initials: HM
authors.lastname: Ying
authors.affiliation: Department of Radiation Oncology, Fudan University Shanghai Cancer Center, China; Department of Oncology, Shanghai Medical College of Fudan University, China.
authors.forename: Xia Yun
authors.initials: XY
authors.lastname: He
authors.affiliation: Department of Diagnostic Radiology, Fudan University Shanghai Cancer Center, China; Department of Oncology, Shanghai Medical College of Fudan University, China.
authors.forename: Zheng Rong
authors.initials: ZR
authors.lastname: Zhou
authors.affiliation: Department of Radiation Oncology, Fudan University Shanghai Cancer Center, China; Department of Oncology, Shanghai Medical College of Fudan University, China.
authors.forename: Yong Ru
authors.initials: YR
authors.lastname: Wu
authors.affiliation: 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.
authors.forename: Chao Su
authors.initials: CS
authors.lastname: Hu
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009336:Necrosis; D020932:Nerve Growth Factor / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011832:Radiation Injuries / Q000188:drug therapy*; D013702:Temporal Lobe / Q000473:pathology / Q000528:radiation effects*
chemical_list: D020932:Nerve Growth Factor
keywords: Corticosteroids; Nasopharyngeal carcinoma; Nerve growth factor; Temporal lobe necrosis