Elsevier

The Lancet

Volume 384, Issue 9948, 20–26 September 2014, Pages 1118-1127
The Lancet

Articles
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

https://doi.org/10.1016/S0140-6736(14)60418-9Get rights and content

Summary

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.

Findings

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).

Interpretation

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.

Funding

BUPA Foundation.

Introduction

The incidence of malignant pleural mesothelioma continues to rise;1, 2, 3 however, few evidence-based therapeutic options are available. Cisplatin plus pemetrexed chemotherapy has been shown to confer a slight survival advantage.4, 5 The role of surgical resection is uncertain, but several operative approaches have been described.6 Extrapleural pneumonectomy (EPP) has been assessed in several studies—most recently in the MARS trial7 as part of trimodality therapy. Lung-sparing approaches, including (extended) pleurectomy with decortication8, 9, 10 and video-assisted thoracoscopic partial pleurectomy (VAT-PP), have also been assessed,11, 12 and might be particularly appropriate for patients with more advanced disease or comorbidities.

VAT-PP involves thoracoscopic debulking of the parietal pleura and visceral pleurectomy with decortication to release trapped lung.6 Results of non-randomised studies examining VAT-PP suggest that VAT-PP improved symptom control compared with EPP11 and possibly increased survival compared with biopsy alone.12 The standard approach to control pleural effusion in patients with malignant pleural mesothelioma is talc pleurodesis, either via a chest tube or, more recently, by thoracoscopy.

The MesoVATS trial was designed to establish whether VAT-PP improves survival in patients with pleural effusion secondary to malignant pleural mesothelioma when compared with talc pleurodesis, to provide a full economic analysis of these treatments, and to compare symptom control and quality-of-life outcomes.

Section snippets

Study design and participants

MesoVATS was an open-label, parallel-group, multicentre, randomised, controlled trial that recruited patients from 12 secondary or tertiary care hospitals in the UK. Eligible patients were those aged 18 years or older with confirmed (any subtype) or suspected (working diagnosis) malignant pleural mesothelioma who had a pleural effusion. Participants had to be fit enough to undergo VAT-PP and provide informed consent. Exclusion criteria were previous attempted pleurodesis and previous primary

Results

As planned, we recruited 196 patients between Oct 24, 2003, and Jan 24, 2012 (figure 1), and followed them up until Jan 31, 2013, with a further survival update on June 17, 2013. At randomisation, 120 (61%) of 196 patients had confirmed malignant pleural mesothelioma and 76 (39%) had suspected (working diagnosis) malignant pleural mesothelioma (appendix). 11 (11%) of 98 patients assigned to VAT-PP and 10 (10%) of 98 patients assigned to talc pleurodesis with suspected malignant pleural

Discussion

To our knowledge, our study is the first randomised controlled trial to compare VAT-PP and talc pleurodesis in patients with suspected or confirmed malignant pleural mesothelioma. Our results showed that overall survival was not improved by VAT-PP, and that this approach resulted in more complications, longer hospital stays, and was more expensive than was talc pleurodesis.

A study in a similar population of patients—the Mesothelioma and Radical Surgery (MARS) trial7—compared extrapleural

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