title: Efficacy and cost of video-assisted thoracoscopic partial pleurectomy versus talc pleurodesis in patients with malignant pleural mesothelioma (MesoVATS): an open-label, randomised, controlled trial.
abstract: BACKGROUND
  Malignant pleural mesothelioma incidence continues to rise, with few available evidence-based therapeutic options. Results of previous non-randomised studies suggested that video-assisted thoracoscopic partial pleurectomy (VAT-PP) might improve symptom control and survival. We aimed to compare efficacy in terms of overall survival, and cost, of VAT-PP and talc pleurodesis in patients with malignant pleural mesothelioma.
  
  
  METHODS
  We undertook an open-label, parallel-group, randomised, controlled trial in patients aged 18 years or older with any subtype of confirmed or suspected mesothelioma with pleural effusion, recruited from 12 hospitals in the UK. Eligible patients were randomly assigned (1:1) to either VAT-PP or talc pleurodesis by computer-generated random numbers, stratified by European Organisation for Research and Treatment of Cancer risk category (high vs low). The primary outcome was overall survival at 1 year, analysed by intention to treat (all patients randomly assigned to a treatment group with a final diagnosis of mesothelioma). This trial is registered with ClinicalTrials.gov, number NCT00821860.
  
  
  RESULTS
  Between Oct 24, 2003, and Jan 24, 2012, we randomly assigned 196 patients, of whom 175 (88 assigned to talc pleurodesis, 87 assigned to VAT-PP) had confirmed mesothelioma. Overall survival at 1 year was 52% (95% CI 41-62) in the VAT-PP group and 57% (46-66) in the talc pleurodesis group (hazard ratio 1·04 [95% CI 0·76-1·42]; p=0·81). Surgical complications were significantly more common after VAT-PP than after talc pleurodesis, occurring in 24 (31%) of 78 patients who completed VAT-PP versus ten (14%) of 73 patients who completed talc pleurodesis (p=0·019), as were respiratory complications (19 [24%] vs 11 [15%]; p=0·22) and air-leak beyond 10 days (five [6%] vs one [1%]; p=0·21), although not significantly so. Median hospital stay was longer at 7 days (IQR 5-11) in patients who received VAT-PP compared with 3 days (2-5) for those who received talc pleurodesis (p<0·0001).
  
  
  CONCLUSIONS
  VAT-PP is not recommended to improve overall survival in patients with pleural effusion due to malignant pleural mesothelioma, and talc pleurodesis might be preferable considering the fewer complications and shorter hospital stay associated with this treatment.
  
  
  BACKGROUND
  BUPA Foundation.
authors.affiliation: Department of Thoracic Oncology, Papworth Hospital, Cambridge, UK.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Rintoul
authors.affiliation: Essex Cardiothoracic Centre, Basildon, UK.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Ritchie
authors.affiliation: Department of Cardiothoracic Surgery, Northern General Hospital, Sheffield, UK.
authors.forename: John G
authors.initials: JG
authors.lastname: Edwards
authors.affiliation: Department of Thoracic Surgery, Glenfield Hospital, Leicester, UK.
authors.forename: David A
authors.initials: DA
authors.lastname: Waller
authors.affiliation: Department of Thoracic Surgery, Papworth Hospital, Cambridge, UK.
authors.forename: Aman S
authors.initials: AS
authors.lastname: Coonar
authors.affiliation: MRC Biostatistics Unit, Cambridge, UK.
authors.forename: Maxine
authors.initials: M
authors.lastname: Bennett
authors.affiliation: Health Economics Research Group, Brunel University, Uxbridge, UK.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Lovato
authors.affiliation: Department of Thoracic Oncology, Papworth Hospital, Cambridge, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: Hughes
authors.affiliation: Health Economics Research Group, Brunel University, Uxbridge, UK.
authors.forename: Julia A
authors.initials: JA
authors.lastname: Fox-Rushby
authors.affiliation: Department of Thoracic Oncology, Papworth Hospital, Cambridge, UK; MRC Biostatistics Unit, Cambridge, UK; Clinical Trials Research Unit, University of Leeds, Leeds, UK. Electronic address: l.sharples@leeds.ac.uk.
authors.forename: Linda D
authors.initials: LD
authors.lastname: Sharples
mesh_terms: D000368:Aged; D003365:Costs and Cost Analysis; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000191:economics / Q000628:therapy*; D008297:Male; D008654:Mesothelioma / Q000191:economics / Q000628:therapy*; D000086002:Mesothelioma, Malignant; D010997:Pleural Neoplasms / Q000191:economics / Q000401:mortality / Q000628:therapy*; D018700:Pleurodesis / Q000191:economics / Q000379:methods* / Q000401:mortality; D019057:Quality-Adjusted Life Years; D013627:Talc / Q000008:administration & dosage* / Q000191:economics; D020775:Thoracic Surgery, Video-Assisted / Q000191:economics / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome
chemical_list: D013627:Talc