A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma : EORTC 1205
- Author
- Jo Raskin, Veerle Surmont (UGent) , Alexander P.W.M. Maat, Maha Yahia, Sjaak A. Burgers, Yassin Pretzenbacher, Frederic De Ryck (UGent) , Robin Cornelissen, Houke M. Klomp, Ana Oliveira, Joachim Aerts, Paul Baas, Sandrine Marreaud, Jan Van Meerbeeck (UGent) and Paul E.Y. Van Schil
- Organization
- 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-na & iuml;ve, 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.
- Keywords
- EXTRAPLEURAL PNEUMONECTOMY, TRIMODALITY THERAPY, SURGICAL TECHNIQUES, PLEURECTOMY/DECORTICATION, MULTICENTER, OUTCOMES, TRENDS
Downloads
-
ERJ-02114-2023.pdf
- full text (Published version)
- |
- open access
- |
- |
- 780.75 KB
Citation
Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-01JKTDZ16JZ6VZMW3RP376Y18V
- MLA
- Raskin, Jo, et al. “A Randomised Phase II Study of Extended Pleurectomy/Decortication Preceded or Followed by Chemotherapy in Patients with Early-Stage Pleural Mesothelioma : EORTC 1205.” EUROPEAN RESPIRATORY JOURNAL, vol. 63, no. 6, 2024, doi:10.1183/13993003.02114-2023.
- APA
- Raskin, J., Surmont, V., Maat, A. P. W. M., Yahia, M., Burgers, S. A., Pretzenbacher, Y., … Van Schil, P. E. Y. (2024). A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma : EORTC 1205. EUROPEAN RESPIRATORY JOURNAL, 63(6). https://doi.org/10.1183/13993003.02114-2023
- Chicago author-date
- Raskin, Jo, Veerle Surmont, Alexander P.W.M. Maat, Maha Yahia, Sjaak A. Burgers, Yassin Pretzenbacher, Frederic De Ryck, et al. 2024. “A Randomised Phase II Study of Extended Pleurectomy/Decortication Preceded or Followed by Chemotherapy in Patients with Early-Stage Pleural Mesothelioma : EORTC 1205.” EUROPEAN RESPIRATORY JOURNAL 63 (6). https://doi.org/10.1183/13993003.02114-2023.
- Chicago author-date (all authors)
- Raskin, Jo, Veerle Surmont, Alexander P.W.M. Maat, Maha Yahia, Sjaak A. Burgers, Yassin Pretzenbacher, Frederic De Ryck, Robin Cornelissen, Houke M. Klomp, Ana Oliveira, Joachim Aerts, Paul Baas, Sandrine Marreaud, Jan Van Meerbeeck, and Paul E.Y. Van Schil. 2024. “A Randomised Phase II Study of Extended Pleurectomy/Decortication Preceded or Followed by Chemotherapy in Patients with Early-Stage Pleural Mesothelioma : EORTC 1205.” EUROPEAN RESPIRATORY JOURNAL 63 (6). doi:10.1183/13993003.02114-2023.
- Vancouver
- 1.Raskin J, Surmont V, Maat APWM, Yahia M, Burgers SA, Pretzenbacher Y, et al. A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma : EORTC 1205. EUROPEAN RESPIRATORY JOURNAL. 2024;63(6).
- IEEE
- [1]J. Raskin et al., “A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma : EORTC 1205,” EUROPEAN RESPIRATORY JOURNAL, vol. 63, no. 6, 2024.
@article{01JKTDZ16JZ6VZMW3RP376Y18V,
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-na & iuml;ve, 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.}},
articleno = {{2302114}},
author = {{Raskin, Jo and Surmont, Veerle and Maat, Alexander P.W.M. and Yahia, Maha and Burgers, Sjaak A. and Pretzenbacher, Yassin and De Ryck, Frederic and Cornelissen, Robin and Klomp, Houke M. and Oliveira, Ana and Aerts, Joachim and Baas, Paul and Marreaud, Sandrine and Van Meerbeeck, Jan and Van Schil, Paul E.Y.}},
issn = {{0903-1936}},
journal = {{EUROPEAN RESPIRATORY JOURNAL}},
keywords = {{EXTRAPLEURAL PNEUMONECTOMY,TRIMODALITY THERAPY,SURGICAL TECHNIQUES,PLEURECTOMY/DECORTICATION,MULTICENTER,OUTCOMES,TRENDS}},
language = {{eng}},
number = {{6}},
pages = {{12}},
title = {{A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma : EORTC 1205}},
url = {{http://doi.org/10.1183/13993003.02114-2023}},
volume = {{63}},
year = {{2024}},
}
- Altmetric
- View in Altmetric
- Web of Science
- Times cited: