title: Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab.
abstract: OBJECTIVE
  In this randomized, phase III study, quality of life (QoL) was assessed in patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN) after high-dose radiotherapy alone or in combination with cetuximab.
  
  
  METHODS
  Patients with stage III or IV nonmetastatic and measurable squamous cell carcinoma of the oropharynx, hypopharynx, or larynx were eligible. QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and EORTC QLQ Head and Neck Cancer-Specific Module at baseline, week 4, and at months 4, 8, and 12 postbaseline.
  
  
  RESULTS
  In this study, one of the largest conducted in a population of patients with locoregionally advanced SCCHN, 424 patients received radiotherapy alone (213 patients) or radiotherapy plus cetuximab (211 patients). Radiotherapy/cetuximab significantly improved locoregional control (P = .005) and overall survival (P = .03) compared with radiotherapy alone, without significantly increasing radiotherapy-associated adverse events. The current analysis focused on the impact of cetuximab on the QoL. Compliance with completion of QoL questionnaires was high in both arms. QoL worsened during treatment and improved after cessation of treatment, reaching baseline levels at 12 months. There were no significant differences in QoL scores between the treatment arms. This was particularly notable for global health status/QoL, social functioning, social eating, and social contact. Pretreatment global health status/QoL was identified as a significant prognostic variable in these patients.
  
  
  CONCLUSIONS
  The addition of cetuximab to radiotherapy significantly improved locoregional control and increased overall survival without adversely affecting QoL.
authors.affiliation: Omega Research, Dublin, Ireland. descurran@omega-research.eu.com
authors.forename: Desmond
authors.initials: D
authors.lastname: Curran
authors.forename: Jordi
authors.initials: J
authors.lastname: Giralt
authors.forename: Paul M
authors.initials: PM
authors.lastname: Harari
authors.forename: K Kian
authors.initials: KK
authors.lastname: Ang
authors.forename: Roger B
authors.initials: RB
authors.lastname: Cohen
authors.forename: Merrill S
authors.initials: MS
authors.lastname: Kies
authors.forename: Jacek
authors.initials: J
authors.lastname: Jassem
authors.forename: José
authors.initials: J
authors.lastname: Baselga
authors.forename: Eric K
authors.initials: EK
authors.lastname: Rowinsky
authors.forename: Nadia
authors.initials: N
authors.lastname: Amellal
authors.forename: Sylvie
authors.initials: S
authors.lastname: Comte
authors.forename: James A
authors.initials: JA
authors.lastname: Bonner
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000523:psychology* / Q000532:radiotherapy; D000068818:Cetuximab; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000523:psychology* / Q000532:radiotherapy; D006304:Health Status; D006801:Humans; D011379:Prognosis; D011788:Quality of Life
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D066246:ErbB Receptors; D000068818:Cetuximab