title: Effect of edaravone on radiation-induced brain necrosis in patients with nasopharyngeal carcinoma after radiotherapy: a randomized controlled trial.
abstract: Excessive generation of free radicals plays a critical role in the pathogenesis of radiation-induced brain injury. This study was designed to evaluate the protective effect of edaravone, a free radical scavenger, on radiation-induced brain necrosis in patients with nasopharyngeal carcinoma. Eligible patients were randomized 1:1 to the control group and the edaravone group (intravenous 30 mg twice per day for 2 weeks). Both groups received intravenous conventional steroid therapy and were monitored by brain MRI and LENT/SOMA scales prior to the entry of the trial and at 3-months after completing the trial. The primary end point was a 3-month response rate of the proportional changes determined by MRI. The trial is registered at Clinicaltrials.gov Identifier: NCT01865201. Between 2009 and 2012, we enrolled 154 patients. Of whom 137 were eligible for analysis. The volumes of necrosis estimated on T(2)-weighted image showed that 55.6 % edaravone-treated patients (40 out of 72) showed edema decreases ≥25 %, which was significantly higher than that in the control group (35.4 %, 23 out of 65, p = 0.025). Forty-four patients treated with edaravone (61.1 %) reported improvement in neurologic symptoms and signs evaluated by LENT/SOMA scales, while the rate was 38.5 % in the control group (p = 0.006). MRI of the edaravone group showed a significant decrease in area of T(1)-weighted contrast enhancement (1.67 ± 4.69 cm(2), p = 0.004) and the T(2)-weighted edema (5.08 ± 10.32 cm(2), p = 0.000). Moreover, compared with those in control group, patients with edaravone exhibited significantly better radiological improvement measured by T(2)-weighted image (p = 0.042). Administration of edaravone, in adjunct to steroid regimen, might provide a better outcome in patients with radiation-induced brain necrosis.
authors.affiliation: Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Number 107, Yan Jiang Xi Road, Guangzhou, 510120, Guangdong, China, yameitang@hotmail.com.
authors.forename: Yamei
authors.initials: Y
authors.lastname: Tang
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Rong
authors.forename: Weihan
authors.initials: W
authors.lastname: Hu
authors.forename: Guoqian
authors.initials: G
authors.lastname: Li
authors.forename: Xiaoxia
authors.initials: X
authors.lastname: Yang
authors.forename: Jianhua
authors.initials: J
authors.lastname: Yang
authors.forename: Pengfei
authors.initials: P
authors.lastname: Xu
authors.forename: Jinjun
authors.initials: J
authors.lastname: Luo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000983:Antipyrine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001930:Brain Injuries / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D002277:Carcinoma; D016022:Case-Control Studies; D000077553:Edaravone; D005260:Female; D005500:Follow-Up Studies; D016166:Free Radical Scavengers / Q000627:therapeutic use*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000150:complications* / Q000473:pathology / Q000532:radiotherapy; D009336:Necrosis; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D011832:Radiation Injuries / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D011878:Radiotherapy / Q000009:adverse effects*
chemical_list: D016166:Free Radical Scavengers; D000077553:Edaravone; D000983:Antipyrine