title: [Multicenter randomized controlled study of temozolomide versus semustine in the treatment of recurrent malignant glioma].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of temozolomide (TMZ) versus semustine (Me-CCNU) in the treatment of recurrent glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).
  
  
  METHODS
  A total of 151 patients with recurrent GBM or AA were enrolled into this randomized, multicentre and open-label study. And 144 patients (intent-to-treat (ITT) population) were assigned randomly into 2 groups. TMZ was given orally at 200 or 150 mg×m(-2)d(-1) (prior chemotherapy) for 5 days, repeated every 28 days. Me-CCNU was given orally at 150 mg×m(-2)×d(-1) once, repeated every 28 days. The treatment periods were within 2 - 6 months and the follow-up period was 6 months. Gadopentetate dimeglumine-magnetic resonance imaging (GD-MRI) or contrast-enhanced computed tomography was performed at 2, 3 and 6 months after treatment to evaluate the image-based progression. Progression-free survival (PFS), overall survival rates at the end of follow-up period and adverse events rates were evaluated.
  
  
  RESULTS
  PFS at 6 months was 78.87% in TMZ group and 55.88% in Me-CCNU group (P < 0.05). Overall survival rates at the end of follow-up period were 96.89% in TMZ group and 97.30% in Me-CCNU group (P > 0.05). The objective response rate of TMZ and Me-CCNU groups were complete response (CR) (19.44% vs 6.38%), partial response (PR) (26.39% vs 14.89%), stable disease (SD) (26.39% vs 34.03%) and progressive disease (PD) (27.78% vs 44.68%, P < 0.01). Adverse events rates of TMZ and Me-CCNU were 29.11% and 45.15% respectively (P < 0.05).
  
  
  CONCLUSIONS
  The efficacy of TMZ for patients with recurrent GBM or AA is better than that of Me-CCNU. And TMZ has an acceptable safety profile and its adverse events are mostly mild.
authors.affiliation: Department of Neurosurgery, General Hospital, Tianjin Medical University, Tianjin, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Sun
authors.forename: Xue-jun
authors.initials: XJ
authors.lastname: Yang
authors.forename: Shu-yuan
authors.initials: SY
authors.lastname: Yang
mesh_terms: D000328:Adult; D001254:Astrocytoma / Q000188:drug therapy; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy; D005910:Glioma / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D012673:Semustine / Q000009:adverse effects / Q000627:therapeutic use; D000077204:Temozolomide
chemical_list: D012673:Semustine; D003606:Dacarbazine; D000077204:Temozolomide