title: Adjuvant therapy with cetuximab for locally advanced squamous cell carcinoma of the oropharynx: results from a randomized, phase II prospective trial.
abstract: BACKGROUND
  Cetuximab combined with radiotherapy (RT) is a treatment option for head and neck cancer. The objectives of this randomized, phase II trial were to evaluate the efficacy and safety of cetuximab maintenance therapy following definitive RT with concomitant cetuximab in patients with oropharyngeal cancer.
  
  
  METHODS
  Ninety-one patients with stage III-IV M0 oropharyngeal tumors were randomly assigned to the treatment with accelerated concomitant boost RT (69.9 Gy) + cetuximab or the same treatment with the addition of 12 consecutive weeks of cetuximab maintenance therapy. The primary end point was locoregional control (LRC) at 1 year.
  
  
  RESULTS
  LRC at 1 year was superior among patients in the experimental arm, treated with cetuximab maintenance (59% versus 47%). However, LRC was similar between both arms after 2 years of follow-up, as a result of increased locoregional recurrences after the first year in the maintenance group. Patients treated with adjuvant cetuximab do recover very soon from toxic effect after combined treatment.
  
  
  CONCLUSIONS
  Twelve weeks of cetuximab maintenance therapy after concomitant cetuximab + RT in locally advanced oropharyngeal carcinoma is feasible and improves clinical outcomes measured at 1 year. This improvement is not maintained after the second year suggesting that epidermal growth factor receptor blockade is not sufficient to completely eliminate the minimal residual disease.
authors.affiliation: Medical Oncology Department, IDIBELL, Institut Català d'Oncologia-L'Hospitalet, Barcelona. Electronic address: rmesia@iconcologia.net.
authors.forename: R
authors.initials: R
authors.lastname: Mesía
authors.affiliation: Medical Oncology Department, Complejo Hospitalario Virgen de la Victoria, Málaga.
authors.forename: A
authors.initials: A
authors.lastname: Rueda
authors.affiliation: Medical Oncology Department, Complejo Hospitalario de Navarra, Pamplona.
authors.forename: R
authors.initials: R
authors.lastname: Vera
authors.affiliation: Radiation Oncology Department, IDIBELL, Institut Català d'Oncologia-L'Hospitalet, Barcelona.
authors.forename: A
authors.initials: A
authors.lastname: Lozano
authors.affiliation: Radiation Oncology Department, Complejo Hospitalario Virgen de la Victoria, Málaga.
authors.forename: J A
authors.initials: JA
authors.lastname: Medina
authors.affiliation: Medical Oncology Department, Hospital General Dr Negrín, Las Palmas de Gran Canaria.
authors.forename: D
authors.initials: D
authors.lastname: Aguiar
authors.affiliation: Radiation Oncology Department, Complejo Hospitalario de Navarra, Pamplona.
authors.forename: F
authors.initials: F
authors.lastname: Árias
authors.affiliation: Radiation Oncology Department, Centro Oncológico Regional de Galicia, A Coruña.
authors.forename: G
authors.initials: G
authors.lastname: Triana
authors.affiliation: Medical Oncology Department, Hospital del Mar, Barcelona.
authors.forename: J
authors.initials: J
authors.lastname: Carles
authors.affiliation: Medical Oncology Department, Complejo Hospitalario Universitario de Santiago, Spain.
authors.forename: R
authors.initials: R
authors.lastname: López-López
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D000068818:Cetuximab; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068818:Cetuximab