title: Nimotuzumab, a humanized monoclonal antibody specific for the EGFR, in combination with temozolomide and radiation therapy for newly diagnosed glioblastoma multiforme: First results in Chinese patients.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of nimotuzumab, a humanized monoclonal antibody specific for the epidermal growth factor receptor (EGFR), in combination with temozolomide (TMZ) and radiation therapy (RT) in the treatment of newly diagnosed glioblastoma (GBM) in Chinese patients.
  
  
  METHODS
  Twenty-six patients with newly diagnosed GBM were enrolled. All patients received standard external beam RT after surgery, with a total dose of 60 Gy in 30 fractions. During RT, concurrent TMZ was given daily at 75 mg/m(2) for 40-42 days, combined with six weekly infusions of nimotuzumab at a 200 mg dose. After a 4-week interval upon completion of RT, six cycles of adjuvant TMZ (150 to 200 mg/m(2) for 5 days in each 28-day cycle) were given. The primary end point was 6-month progression-free survival (PFS) rate. EGFR expression in tumor tissues was analyzed by immunohistochemistry.
  
  
  RESULTS
  Treatment was well tolerated and no grade III or higher grade toxicity was observed. Median PFS and overall survival (OS) were 10.0 and 15.9 months, respectively, while the 6-month PFS and OS rates were 69.2% and 88.5%, respectively. No correlation between efficacy and EGFR expression was found.
  
  
  CONCLUSIONS
  Combination of Nimotuzumab with RT plus concomitant and adjuvant TMZ showed favorable safety and tolerability profiles in newly diagnosed GBM in Chinese patients. The survival times were similar to those seen in historical data of standard therapy.
authors.affiliation: Department of Radiation Oncology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Neurosurgery, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Li
authors.initials: L
authors.lastname: Pan
authors.affiliation: Department of Radiation Oncology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Xiao-fang
authors.initials: XF
authors.lastname: Sheng
authors.affiliation: Department of Radiation Oncology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Shu
authors.initials: S
authors.lastname: Chen
authors.affiliation: Department of Radiation Oncology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: Jia-zhong
authors.initials: JZ
authors.lastname: Dai
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000037:antagonists & inhibitors; D044466:Asian People; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality; D059248:Chemoradiotherapy / Q000379:methods*; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077204:Temozolomide; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C501466:nimotuzumab; D003606:Dacarbazine; C512478:EGFR protein, human; D066246:ErbB Receptors; D000077204:Temozolomide
keywords: chemotherapy; glioblastoma; nimotuzumab; radiotherapy