A multicentre randomised phase III trial comparing pembrolizumab versus single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial

Annals of Oncology - Tập 31 Số 12 - Trang 1734-1745 - 2020
Sanjay Popat1, Alessandra Curioni‐Fontecedro2, Urania Dafni3, R. Shah4, Mary O’Brien5, A. Pope6, P.M. Fisher7, James Spicer8, A. Roy9, David Gilligan10, Oliver Gautschi11,12, Ernest Nadal13, Wolf-Dieter Janthur14,11, Rafael López Castro15, Rosario García Campelo16, Sylvie Rusakiewicz17, Igor Letovanec18, Varvara Polydoropoulou19, Heidi Roschitzki‐Voser20, Barbara Ruepp20, A. Gasca-Ruchti20, Solange Peters21, Rolf A. Stahel2
1Royal Marsden Hospital, Fulham Road, London, UK
2University Hospital Zürich, Department of Medical Oncology and Hematology, Zürich, Switzerland
3National and Kapodistrian University of Athens & Frontier Science Foundation-Hellas, Athens, Greece
4Kent Oncology Centre, Maidstone, UK
5Royal Marsden Hospital Sutton, London, UK
6Clatterbridge Cancer Centre, Liverpool, UK
7Weston Park Hospital, Sheffield, UK
8King’s College London, Guy’s Hospital, London, UK
9University Hospital Plymouth, Plymouth, UK
10Addenbrooke's Hospital, Cambridge, UK
11Swiss Group for Clinical Cancer Research, Switzerland (SAKK), Bern
12University of Bern and Cantonal Hospital Luzern, Luzern Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland
13Catalan Institute of Oncology (ICO), L'Hospitalet, Barcelona, Spain
14Cantonal Hospital Aarau, Aarau, Switzerland
15Hospital Clínico Universitario de Valladolid, Valladolid, Spain
16Hospital Teresa Herrera, La Coruña, Spain
17Centre Hospitalier Universitaire Vaudois CHUV, Centre of Experimental Therapies and Department of Oncology, Lausanne, Switzerland
18Centre Hospitalier Universitaire Vaudois CHUV, Institute of Pathology, Lausanne, Switzerland
19Frontier Science Foundation-Hellas, Athens, Greece
20European Thoracic Oncology Platform (ETOP), Bern, Switzerland
21Centre Hospitalier Universitaire Vaudois, Department of Oncology, Lausanne, Switzerland

Tóm tắt

Từ khóa


Tài liệu tham khảo

van Meerbeeck, 2005, J Clin Oncol, 23, 6881, 10.1200/JCO.20005.14.589

Vogelzang, 2003, Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma, J Clin Oncol, 21, 2636, 10.1200/JCO.2003.11.136

Zalcman, 2016, Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial, Lancet, 387, 1405, 10.1016/S0140-6736(15)01238-6

Kindler, 2018, Treatment of malignant pleural mesothelioma: American Society of Clinical Oncology clinical practice guideline, J Clin Oncol, 36, 1343, 10.1200/JCO.2017.76.6394

Ceresoli, 2015, Vinca alkaloids in the therapeutic management of malignant pleural mesothelioma, Cancer Treat Rev, 41, 853, 10.1016/j.ctrv.2015.10.006

Yap, 2017, Novel insights into mesothelioma biology and implications for therapy, Nat Rev Cancer, 17, 475, 10.1038/nrc.2017.42

Mansfield, 2014, B7-H1 expression in malignant pleural mesothelioma is associated with sarcomatoid histology and poor prognosis, J Thorac Oncol, 9, 1036, 10.1097/JTO.0000000000000177

Alley, 2017, Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial, Lancet Oncol, 18, 623, 10.1016/S1470-2045(17)30169-9

Curran, 1998, Prognostic factors in patients with pleural mesothelioma: the European Organization for Research and Treatment of Cancer experience, J Clin Oncol, 16, 145, 10.1200/JCO.1998.16.1.145

Robins, 2000, Correcting for noncompliance and dependent censoring in an AIDS Clinical Trial with inverse probability of censoring weighted (IPCW) log-rank tests, Biometrics, 56, 779, 10.1111/j.0006-341X.2000.00779.x

Mok, 2019, Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial, Lancet, 393, 1819, 10.1016/S0140-6736(18)32409-7

Kindler, 2017, OA 02.01 Randomized phase II study of anetumab ravtansine or vinorelbine in patients with metastatic pleural mesothelioma, J Thorac Oncol, 12, S1746, 10.1016/j.jtho.2017.09.328

Metaxas, 2018, Pembrolizumab as palliative immunotherapy in malignant pleural mesothelioma, J Thorac Oncol, 13, 1784, 10.1016/j.jtho.2018.08.007

Cheng, 2015, Response evaluation in mesothelioma: beyond RECIST, Lung Cancer, 90, 433, 10.1016/j.lungcan.2015.08.012

Hasan, 2014, Eur J Cancer, 50, 2771, 10.1016/j.ejca.2014.07.020

Okada, 2019, Clinical efficacy and safety of nivolumab: results of a multicenter, open-label, single-arm, Japanese phase II study in malignant pleural mesothelioma (MERIT), Clin Cancer Res, 25, 5485, 10.1158/1078-0432.CCR-19-0103

Quispel-Janssen, 2018, Programmed death 1 blockade with nivolumab in patients with recurrent malignant pleural mesothelioma, J Thorac Oncol, 13, 1569, 10.1016/j.jtho.2018.05.038

Bueno, 2016, Comprehensive genomic analysis of malignant pleural mesothelioma identifies recurrent mutations, gene fusions and splicing alterations, Nat Genet, 48, 407, 10.1038/ng.3520

Calabro, 2013, Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: an open-label, single-arm, phase 2 trial, Lancet Oncol, 14, 1104, 10.1016/S1470-2045(13)70381-4

Calabro, 2015, Efficacy and safety of an intensified schedule of tremelimumab for chemotherapy-resistant malignant mesothelioma: an open-label, single-arm, phase 2 study, Lancet Respir Med, 3, 301, 10.1016/S2213-2600(15)00092-2

Hassan, 2019, Efficacy and safety of avelumab treatment in patients with advanced unresectable mesothelioma: phase 1b results from the JAVELIN solid tumor trial, JAMA Oncol, 5, 351, 10.1001/jamaoncol.2018.5428

Scherpereel, 2019, Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial, Lancet Oncol, 20, 239, 10.1016/S1470-2045(18)30765-4

Calabro, 2018, Tremelimumab combined with durvalumab in patients with mesothelioma (NIBIT-MESO-1): an open-label, non-randomised, phase 2 study, Lancet Respir Med, 6, 451, 10.1016/S2213-2600(18)30151-6

Disselhorst, 2019, Ipilimumab and nivolumab in the treatment of recurrent malignant pleural mesothelioma (INITIATE): results of a prospective, single-arm, phase 2 trial, Lancet Respir Med, 7, 260, 10.1016/S2213-2600(18)30420-X