MARS-2
Trial question
What is the role of extended pleurectomy decortication in patients with resectable pleural mesothelioma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
13.0% female
87.0% male
N = 335
335 patients (44 female, 291 male)
Inclusion criteria: patients with resectable pleural mesothelioma
Key exclusion criteria: severe comorbidities precluding surgery; severe shortness of breath; severe HF; ESRD requiring dialysis; liver failure
Interventions
N=169 chemotherapy with surgery (pleurectomy decortication or extended pleurectomy decortication, followed by 2-4 further cycles of chemotherapy)
N=166 chemotherapy alone (2-4 cycles of chemotherapy)
Primary outcome
Median overall survival
19.3
24.8
24.8 months
18.6 months
12.4 months
6.2 months
0.0 months
Chemotherapy with
surgery
Chemotherapy
alone
Significant
decrease ▼
Significant decrease in median overall survival (19.3 months vs. 24.8 months; AD -1.9 months, 95% CI -3.4 to -0.3)
Secondary outcomes
No significant difference in median progression-free survival (10.6 months vs. 11 months; HR 0.9, 95% CI 0.72 to 1.11)
Safety outcomes
Significant difference in median serious adverse event per person (1 vs. 0).
Conclusion
In patients with resectable pleural mesothelioma, chemotherapy with surgery was inferior to chemotherapy alone with respect to median overall survival.
Reference
Eric Lim, David Waller, Kelvin Lau et al. Extended pleurectomy decortication and chemotherapy versus chemotherapy alone for pleural mesothelioma (MARS 2): a phase 3 randomised controlled trial. Lancet Respir Med. 2024 Jun;12(6):457-466.
Open reference URL