title: Treatment of malignant, non-resectable, epithelial origin esophageal tumours with the humanized anti-epidermal growth factor antibody nimotuzumab combined with radiation therapy and chemotherapy.
abstract: BACKGROUND
  Over-expression of epidermal growth factor receptor in esophageal cancer is associated with poor prognosis. The present study was conducted to evaluate safety and preliminary efficacy of nimotuzumab, a humanized anti-EGFR antibody in combination with radiation and chemotherapy in advanced esophageal tumours.
  
  
  METHODS
  A Phase II clinical trial was conducted, where patients received cisplatin, 5-fluorouracil, and radiotherapy, either alone or combined with six weekly infusions of nimotuzumab at the dose of 200 mg. Safety was the primary endpoint. The antitumoral objective response rate was the secondary endpoint. Epidermal growth factor receptor expression, KRAS mutation status and anti-idiotypic response were also evaluated.
  
  
  RESULTS
  Sixty-three patients were included in the study. Thirty patients were entered into the control group, and thirty-three patients received the treatment with nimotuzumab. The antibody was very well tolerated. Objective response rate was 47.8 % (nimotuzumab group) and 15.4 % (control group). Disease control rate was 60.9 % (nimotuzumab group) and 26.9 % (control group). Response and disease control rate were higher in patients with EGFR overexpressing tumors.
  
  
  CONCLUSIONS
  Nimotuzumab plus chemoradiotherapy was safe and provided statistically significant objective response. A Phase III in patients with similar characteristics will be launched.
authors.affiliation: Center of Molecular Immunology, Havana, Cuba. mayra@cim.sld.cu
authors.forename: Mayra
authors.initials: M
authors.lastname: Ramos-Suzarte
authors.forename: Patricia
authors.initials: P
authors.lastname: Lorenzo-Luaces
authors.forename: Nery Gonzalez
authors.initials: NG
authors.lastname: Lazo
authors.forename: Mayte Lima
authors.initials: ML
authors.lastname: Perez
authors.forename: Jorge Luis
authors.initials: JL
authors.lastname: Soriano
authors.forename: Carmen Elena Viada
authors.initials: CE
authors.lastname: Gonzalez
authors.forename: Ivis Mendoza
authors.initials: IM
authors.lastname: Hernadez
authors.forename: Yisel Ávila
authors.initials: YÁ
authors.lastname: Albuerne
authors.forename: Beatriz Paredes
authors.initials: BP
authors.lastname: Moreno
authors.forename: Eduardo Santiesteban
authors.initials: ES
authors.lastname: Alvarez
authors.forename: Idael Pineda
authors.initials: IP
authors.lastname: Callejo
authors.forename: José
authors.initials: J
authors.lastname: Alert
authors.forename: Juan Antonio
authors.initials: JA
authors.lastname: Martell
authors.forename: Yanela Santiesteban
authors.initials: YS
authors.lastname: Gonzalez
authors.forename: Yulainis Santiesteban
authors.initials: YS
authors.lastname: Gonzalez
authors.forename: Horacio
authors.initials: H
authors.lastname: Astudillo de la Vega
authors.forename: Erika Betzabe
authors.initials: EB
authors.lastname: Ruiz-Garcia
authors.forename: Tania Crombet
authors.initials: TC
authors.lastname: Ramos
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000235:genetics; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C501466:nimotuzumab; D066246:ErbB Receptors