title: A European Organisation for Research and Treatment of Cancer phase III trial of adjuvant whole-brain radiotherapy versus observation in patients with one to three brain metastases from solid tumors after surgical resection or radiosurgery: quality-of-life results.
abstract: OBJECTIVE
  This phase III trial compared adjuvant whole-brain radiotherapy (WBRT) with observation after either surgery or radiosurgery of a limited number of brain metastases in patients with stable solid tumors. Here, we report the health-related quality-of-life (HRQOL) results.
  
  
  METHODS
  HRQOL was a secondary end point in the trial. HRQOL was assessed at baseline, at 8 weeks, and then every 3 months for 3 years with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and Brain Cancer Module. The following six primary HRQOL scales were considered: global health status; physical, cognitive, role, and emotional functioning; and fatigue. Statistical significance required P ≤ .05, and clinical relevance required a ≥ 10-point difference.
  
  
  RESULTS
  Compliance was 88.3% at baseline and dropped to 45.0% at 1 year; thus, only the first year was analyzed. Overall, patients in the observation only arm reported better HRQOL scores than did patients who received WBRT. The differences were statistically significant and clinically relevant mostly during the early follow-up period (for global health status at 9 months, physical functioning at 8 weeks, cognitive functioning at 12 months, and fatigue at 8 weeks). Exploratory analysis of all other HRQOL scales suggested worse scores for the WBRT group, but none was clinically relevant.
  
  
  CONCLUSIONS
  This study shows that adjuvant WBRT after surgery or radiosurgery of a limited number of brain metastases from solid tumors may negatively impact some aspects of HRQOL, even if these effects are transitory. Consequently, observation with close monitoring with magnetic resonance imaging (as done in the EORTC trial) is not detrimental for HRQOL.
authors.affiliation: University of Torino and San Giovanni Battista Hospital, Turin, Italy. riccardo.soffietti@unito.it
authors.forename: Riccardo
authors.initials: R
authors.lastname: Soffietti
authors.forename: Martin
authors.initials: M
authors.lastname: Kocher
authors.forename: Ufuk M
authors.initials: UM
authors.lastname: Abacioglu
authors.forename: Salvador
authors.initials: S
authors.lastname: Villa
authors.forename: François
authors.initials: F
authors.lastname: Fauchon
authors.forename: Brigitta G
authors.initials: BG
authors.lastname: Baumert
authors.forename: Laura
authors.initials: L
authors.lastname: Fariselli
authors.forename: Tzahala
authors.initials: T
authors.lastname: Tzuk-Shina
authors.forename: Rolf-Dieter
authors.initials: RD
authors.lastname: Kortmann
authors.forename: Christian
authors.initials: C
authors.lastname: Carrie
authors.forename: Mohamed
authors.initials: M
authors.lastname: Ben Hassel
authors.forename: Mauri
authors.initials: M
authors.lastname: Kouri
authors.forename: Egils
authors.initials: E
authors.lastname: Valeinis
authors.forename: Dirk
authors.initials: D
authors.lastname: van den Berge
authors.forename: Rolf-Peter
authors.initials: RP
authors.lastname: Mueller
authors.forename: Gloria
authors.initials: G
authors.lastname: Tridello
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
mesh_terms: D001932:Brain Neoplasms / Q000532:radiotherapy* / Q000556:secondary; D016371:Cranial Irradiation; D005060:Europe; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D007390:International Agencies; D009367:Neoplasm Staging; D009369:Neoplasms / Q000150:complications* / Q000473:pathology / Q000601:surgery; D010349:Patient Compliance; D011183:Postoperative Complications; D011379:Prognosis; D011788:Quality of Life; D016634:Radiosurgery / Q000009:adverse effects*; D018714:Radiotherapy, Adjuvant; D015996:Survival Rate