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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.

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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.
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References

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