1. Satya Shanbhag Waikato Cardiothoracic Unit
Meso-VATS Trial
Satya Shanbhag
Waikato Cardiothoracic Unit

3. Introduction
Malignant pleural mesothelioma (MPM) has consistent worse prognosis
Treatment modalities limited: chemo, EPP and combined therapy
VATS debulking with partial pleurectomy emerging option
Usual symptom control through talc pleurodesis

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

5. Methods
Patients randomly assigned to undergo VAT-PP or talc pleurodesis(June 2003 –Dec 2012)
Study in 12 centers from UK (Main center: Papworth)
F/U period up to 1 year (1,3,6 and 12 months)
Primary Outcome: Overall survival after 1yr after randomisation
Secondary Outcome: Pleural effusion, quality of life, exercise tolerance and cost to health service

6. Methods
Pts randomised in 1:1 fashion by computer generated block of 10pts
Randomisation stratified according to risk score ( high WCC, non-epitheloid cell type & male sex)
Staging determined by 2 radiologists using IMIG score
Estimated 1yr survival to be 37 with TP and 59% with VATS-PP respectively (80% power- 196 pts)

9. Survival

12. Quality of Life post procedure

13. Cost per procedure

14. Author Conclusions
First RT study about VAT-PP and talc pleurodesis for MPM
At 1yr no difference in primary outcome between the two group
VATs-PP resulted in more complications, longer hospital stay and was expensive

15. Study strengths Well conducted multi institutional randomised study
The study met the required number of patients
Some amount of blinding performed for selection
Published in a reputed journal

16. Study weakness
Very few patients to compare at 1 yr, logical conclusion cannot be drawn
Combination therapy not standardised, left to the treating Hospital
Because of diminishing number of patients, secondary endpoints could be deducted from about 40% of patients

17. Study weakness
Overall survival chosen as primary endpoint for an operation where the tumour remained
Varying degree of debulking introduced heterogeneity to the study
Additional confounders: neoadjuvant therapy in some and also change in method of talc introduction
Treatment not stratified for tumour stage or volume

18. Mesothelioma & Radical Surgery (MARS Trial)
UK Trial from with 50 patients randomised (24 EPP and 26 no EPP)
Three early mortality in EPP group with a HR of 2.75 compared to non EPP group
Weakness: Small study, very far reaching conclusions
Investigator Conclusion: In view of the high morbidity associated with EPP in this trial and in other non-randomised studies a larger study is not feasible. These data, although limited, suggest that radical surgery in the form of EPP within trimodal therapy offers no benefit and possibly harms patients

19. MARS2 Trial
Randomisation between chemotherapy only and extended pleural decortication (EPD)
Trial still ongoing recruiting total of 50 patients.
Completion by end of this year
Early results favour surgery over chemotherapy arm

22. What are the evidence/guidelines?

23. Future Progress

24. Conclusions
EPP has a role in mesothelioma patients who have a favourable early stage tumour
These should be offered for the ideal candidate patients
Multi-modal therapy has better outcome compared to monotherapy/surgery
Talc pleurodesis is adequate for advanced stage cancer for symptom relief
Newer treatment modalities/surgery devised for prolonging life and quality