<HashMap><database>biostudies-literature</database><scores/><additional><omics_type>Unknown</omics_type><volume>63(6)</volume><submitter>Raskin J</submitter><funding>Kom op tegen Kanker</funding><pubmed_abstract>&lt;h4>Background&lt;/h4>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.&lt;h4>Methods&lt;/h4>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.&lt;h4>Findings&lt;/h4>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.&lt;h4>Interpretation&lt;/h4>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_abstract><journal>The European respiratory journal</journal><pagination>2302114</pagination><full_dataset_link>https://www.ebi.ac.uk/biostudies/studies/S-EPMC11211697</full_dataset_link><repository>biostudies-literature</repository><pubmed_title>A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma: EORTC 1205.</pubmed_title><pmcid>PMC11211697</pmcid><pubmed_authors>Burgers SA</pubmed_authors><pubmed_authors>Klomp HM</pubmed_authors><pubmed_authors>Van Schil PEY</pubmed_authors><pubmed_authors>De Ryck F</pubmed_authors><pubmed_authors>Baas P</pubmed_authors><pubmed_authors>Oliveira A</pubmed_authors><pubmed_authors>Maat APWM</pubmed_authors><pubmed_authors>Marreaud S</pubmed_authors><pubmed_authors>Van Meerbeeck JP</pubmed_authors><pubmed_authors>Pretzenbacher Y</pubmed_authors><pubmed_authors>Cornelissen R</pubmed_authors><pubmed_authors>Raskin J</pubmed_authors><pubmed_authors>Aerts J</pubmed_authors><pubmed_authors>Surmont V</pubmed_authors><pubmed_authors>Yahia M</pubmed_authors></additional><is_claimable>false</is_claimable><name>A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma: EORTC 1205.</name><description>&lt;h4>Background&lt;/h4>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.&lt;h4>Methods&lt;/h4>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.&lt;h4>Findings&lt;/h4>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.&lt;h4>Interpretation&lt;/h4>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.</description><dates><release>2024-01-01T00:00:00Z</release><publication>2024 Jun</publication><modification>2026-06-30T03:11:35.876Z</modification><creation>2026-06-30T03:08:22.612Z</creation></dates><accession>S-EPMC11211697</accession><cross_references><pubmed>38843916</pubmed><doi>10.1183/13993003.02114-2023</doi></cross_references></HashMap>