Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2024 Jun 28;63(6):2302114.
doi: 10.1183/13993003.02114-2023. Print 2024 Jun.

A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma: EORTC 1205

Jo Raskin  1   2 , Veerle Surmont  3 , Alexander P W M Maat  2   4 , Maha Yahia  5 , Sjaak A Burgers  6 , Yassin Pretzenbacher  7 , Frederic De Ryck  8 , Robin Cornelissen  2   9 , Houke M Klomp  10 , Ana Oliveira  7 , Joachim Aerts  2   9 , Paul Baas  6 , Sandrine Marreaud  7 , Jan P Van Meerbeeck  11   2   12   13 , Paul E Y Van Schil  12   14   13
Affiliations
Clinical Trial

A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma: EORTC 1205

Jo Raskin et al. Eur Respir J. .

Abstract

Background: The role of surgery in pleural mesothelioma remains controversial. It may be appropriate in highly selected patients as part of a multimodality treatment including chemotherapy. Recent years have seen a shift from extrapleural pleuropneumonectomy toward extended pleurectomy/decortication. The most optimal sequence of surgery and chemotherapy remains unknown.

Methods: EORTC-1205-LCG was a multicentric, noncomparative phase 2 trial, 1:1 randomising between immediate (arm A) and deferred surgery (arm B), followed or preceded by chemotherapy. Eligible patients (Eastern Cooperative Oncology Group 0-1) had treatment-naïve, borderline resectable T1-3 N0-1 M0 mesothelioma of any histology. Primary outcome was rate of success at 20 weeks, a composite end-point including 1) successfully completing both treatments within 20 weeks; 2) being alive with no signs of progressive disease; and 3) no residual grade 3-4 toxicity. Secondary end-points were toxicity, overall survival, progression-free survival and process indicators of surgical quality.

Findings: 69 patients were included in this trial. 56 (81%) patients completed three cycles of chemotherapy and 58 (84%) patients underwent surgery. Of the 64 patients in the primary analysis, 21 out of 30 patients in arm A (70.0%; 80% CI 56.8-81.0%) and 17 out of 34 patients (50.0%; 80% CI 37.8-62.2%) in arm B reached the statistical end-point for rate of success. Median progression-free survival and overall survival were 10.8 (95% CI 8.5-17.2) months and 27.1 (95% CI 22.6-64.3) months in arm A, and 8.0 (95% CI 7.2-21.9) months and 33.8 (95% CI 23.8-44.6) months in arm B. Macroscopic complete resection was obtained in 82.8% of patients. 30- and 90-day mortality were both 1.7%. No new safety signals were found, but treatment-related morbidity was high.

Interpretation: EORTC 1205 did not succeed in selecting a preferred sequence of pre- or post-operative chemotherapy. Either procedure is feasible with a low mortality, albeit consistent morbidity. A shared informed decision between surgeon and patient remains essential.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: The authors have no potential conflicts of interest to disclose.

Figures

None
Overview of the study findings. mOS: median overall survival.
FIGURE 1
FIGURE 1
Overview of the consort flow chart. COVID-19: coronavirus disease 2019; PET: positron emission tomography; CT: computed tomography.
FIGURE 2
FIGURE 2
Kaplan–Meier analysis of overall survival in both treatment arms.
FIGURE 3
FIGURE 3
Kaplan–Meier analysis of overall survival in both treatment arms per histology. NE: not evaluable.
See this image and copyright information in PMC

Comment in

References

    1. Milano MT, Zhang H. Malignant pleural mesothelioma: a population-based study of survival. J Thorac Oncol 2010; 5: 1841–1848. doi:10.1097/JTO.0b013e3181f1cf2b - DOI - PubMed
    1. Raskin J, Van Schil PE, Meerbeeck JPV. Surgical series in mesothelioma: navigating between biases. Transl Lung Cancer Res 2023; 12: 184–186. doi:10.21037/tlcr-23-34 - DOI - PMC - PubMed
    1. Saddoughi SA, Abdelsattar ZM, Blackmon SH. National trends in the epidemiology of malignant pleural mesothelioma: a National Cancer Data Base study. Ann Thorac Surg 2018; 105: 432–437. doi:10.1016/j.athoracsur.2017.09.036 - DOI - PubMed
    1. Nelson DB, Rice DC, Niu J, et al. . Predictors of trimodality therapy and trends in therapy for malignant pleural mesothelioma. Eur J Cardiothorac Surg 2018; 53: 960–966. doi:10.1093/ejcts/ezx427 - DOI - PubMed
    1. Treasure T, Lang-Lazdunski L, Waller D, et al. . Extra-pleural pneumonectomy versus no extra-pleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study. Lancet Oncol 2011; 12: 763–772. doi:10.1016/S1470-2045(11)70149-8 - DOI - PMC - PubMed

Publication types

MeSH terms