title: Prophylactic cranial irradiation in extensive disease small-cell lung cancer: short-term health-related quality of life and patient reported symptoms: results of an international Phase III randomized controlled trial by the EORTC Radiation Oncology and Lung Cancer Groups.
abstract: OBJECTIVE
  Prophylactic cranial irradiation (PCI) in patients with extensive-disease small-cell lung cancer (ED-SCLC) leads to significantly fewer symptomatic brain metastases and improved survival. Detailed effects of PCI on health-related quality of life (HRQOL) are reported here.
  
  
  METHODS
  Patients (age, 18 to 75 years; WHO < or = 2) with ED-SCLC, and any response to chemotherapy, were randomly assigned to either observation or PCI. Health-related quality of life (HRQOL) and patient-reported symptoms were secondary end points. The European Organisation for the Research and Treatment of Cancer core HRQOL tool (Quality of Life Questionnaire C30) and brain module (Quality of Life Questionnaire Brain Cancer Module) were used to collect self-reported patient data. Six HRQOL scales were selected as primary HRQOL end points: global health status; hair loss; fatigue; and role, cognitive and emotional functioning. Assessments were performed at random assignment, 6 weeks, 3 months, and then 3-monthly up to 1 year and 6-monthly thereafter.
  
  
  RESULTS
  Compliance with the HRQOL assessment was 93.7% at baseline and dropped to 60% at 6 weeks. Short-term results up to 3 months showed that there was a negative impact of PCI on selected HRQOL scales. The largest mean difference between the two arms was observed for fatigue and hair loss. The impact of PCI on global health status as well as on functioning scores was more limited. For global health status, the observed mean difference was eight points on a scale 0 to 100 at 6 weeks (P = .018) and 3 months (P = .055).
  
  
  CONCLUSIONS
  PCI should be offered to all responding ED SCLC patients. Patients should be informed of the potential adverse effects from PCI. Clinicians should be alert to these; monitor their patients; and offer appropriate support, clinical, and psychosocial care.
authors.affiliation: Department of Radiation Oncology, VU University Medical Center, Amsterdam, The Netherlands. bj.slotman@vumc.nl
authors.forename: Berend J
authors.initials: BJ
authors.lastname: Slotman
authors.forename: Murielle E
authors.initials: ME
authors.lastname: Mauer
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
authors.forename: Corinne
authors.initials: C
authors.lastname: Faivre-Finn
authors.forename: Gijs W P M
authors.initials: GW
authors.lastname: Kramer
authors.forename: Elaine M
authors.initials: EM
authors.lastname: Rankin
authors.forename: Michael
authors.initials: M
authors.lastname: Snee
authors.forename: Matthew
authors.initials: M
authors.lastname: Hatton
authors.forename: Pieter E
authors.initials: PE
authors.lastname: Postmus
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.forename: Suresh
authors.initials: S
authors.lastname: Senan
mesh_terms: D016371:Cranial Irradiation; D006801:Humans; D008175:Lung Neoplasms / Q000523:psychology / Q000532:radiotherapy*; D011788:Quality of Life; D055752:Small Cell Lung Carcinoma / Q000523:psychology / Q000532:radiotherapy*