title: Prophylactic cranial irradiation in extensive small-cell lung cancer.
abstract: BACKGROUND
  We conducted a randomized trial of prophylactic cranial irradiation in patients with extensive small-cell lung cancer who had had a response to chemotherapy.
  
  
  METHODS
  Patients between the ages of 18 and 75 years with extensive small-cell lung cancer were randomly assigned to undergo prophylactic cranial irradiation (irradiation group) or receive no further therapy (control group). The primary end point was the time to symptomatic brain metastases. Computed tomography or magnetic resonance imaging of the brain was performed when any predefined key symptom suggestive of brain metastases was present.
  
  
  RESULTS
  The two groups (each with 143 patients) were well balanced regarding baseline characteristics. Patients in the irradiation group had a lower risk of symptomatic brain metastases (hazard ratio, 0.27; 95% confidence interval [CI], 0.16 to 0.44; P<0.001). The cumulative risk of brain metastases within 1 year was 14.6% in the irradiation group (95% CI, 8.3 to 20.9) and 40.4% in the control group (95% CI, 32.1 to 48.6). Irradiation was associated with an increase in median disease-free survival from 12.0 weeks to 14.7 weeks and in median overall survival from 5.4 months to 6.7 months after randomization. The 1-year survival rate was 27.1% (95% CI, 19.4 to 35.5) in the irradiation group and 13.3% (95% CI, 8.1 to 19.9) in the control group. Irradiation had side effects but did not have a clinically significant effect on global health status.
  
  
  CONCLUSIONS
  Prophylactic cranial irradiation reduces the incidence of symptomatic brain metastases and prolongs disease-free and overall survival. (ClinicalTrials.gov number, NCT00016211 [ClinicalTrials.gov].).
authors: Department of Radiation Oncology, VU University Medical Center, Amsterdam, The Netherlands. bj.slotman@vumc.nl
authors: Ben
authors: B
authors: Slotman
authors: Corinne
authors: C
authors: Faivre-Finn
authors: Gijs
authors: G
authors: Kramer
authors: Elaine
authors: E
authors: Rankin
authors: Michael
authors: M
authors: Snee
authors: Matthew
authors: M
authors: Hatton
authors: Pieter
authors: P
authors: Postmus
authors: Laurence
authors: L
authors: Collette
authors: Elena
authors: E
authors: Musat
authors: Suresh
authors: S
authors: Senan
mesh_terms: D000328:Adult; D000368:Aged; D001932:Brain Neoplasms / Q000453:epidemiology / Q000517:prevention & control* / Q000556:secondary; D018288:Carcinoma, Small Cell / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary; D003131:Combined Modality Therapy; D016371:Cranial Irradiation; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012306:Risk; D016019:Survival Analysis