Ipilimumab and nivolumab in the treatment of recurrent malignant pleural mesothelioma (INITIATE): results of a prospective, single-arm, phase 2 trial

Lancet Respiratory Medicine,The - Tập 7 Số 3 - Trang 260-270 - 2019
Maria Disselhorst1, Josine M.M.F. Quispel-Janssen1, Ferry Lalezari2, Kim Monkhorst3, Jeltje F. de Vries4, Vincent van der Noort4, Emmy Harms1, Sjaak Burgers1, Paul Baas1
1Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands
2Department of Radiology, Netherlands Cancer Institute, Amsterdam, Netherlands
3Department of Pathology, Netherlands Cancer Institute, Amsterdam, Netherlands
4Biometrics Department, Netherlands Cancer Institute, Amsterdam, Netherlands

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Wagner, 1960, Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province, Br J Ind Med, 17, 260

McDonald, 2010, Epidemiology of malignant mesothelioma—an outline, Ann Occup Hyg, 54, 851

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

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

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

Jassem, 2008, Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma, J Clin Oncol, 26, 1698, 10.1200/JCO.2006.09.9887

Zucali, 2012, Second-line chemotherapy in malignant pleural mesothelioma: results of a retrospective multicenter survey, Lung Cancer, 75, 360, 10.1016/j.lungcan.2011.08.011

Stebbing, 2009, The efficacy and safety of weekly vinorelbine in relapsed malignant pleural mesothelioma, Lung Cancer, 63, 94, 10.1016/j.lungcan.2008.04.001

Zauderer, 2014, Vinorelbine and gemcitabine as second- or third-line therapy for malignant pleural mesothelioma, Lung Cancer, 84, 271, 10.1016/j.lungcan.2014.03.006

Ceresoli, 2010, Second-line treatment for malignant pleural mesothelioma, Cancer Treat Rev, 36, 24, 10.1016/j.ctrv.2009.09.003

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

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

Hassan, 2016, Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced unresectable mesothelioma from the JAVELIN solid tumor phase Ib trial: safety, clinical activity, and PD-L1 expression, J Clin Oncol, 34, 8503, 10.1200/JCO.2016.34.15_suppl.8503

Maio, 2017, Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial, Lancet Oncol, 18, 1261, 10.1016/S1470-2045(17)30446-1

Selby, 2016, Preclinical development of ipilimumab and nivolumab combination immunotherapy: mouse tumor models, in vitro functional studies, and cynomolgus macaque toxicology, PLoS One, 11, e0161779, 10.1371/journal.pone.0161779

Calabrò, 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

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, 10.1016/S1470-2045(18)30765-4

Cedrés, 2015, Analysis of expression of programmed cell death 1 ligand 1 (PD-L1) in malignant pleural mesothelioma (MPM), PLoS One, 10, e0121071, 10.1371/journal.pone.0121071

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

Thapa, 2017, The immune microenvironment, genome-wide copy number aberrations, and survival in mesothelioma, J Thorac Oncol, 12, 850, 10.1016/j.jtho.2017.02.013

Awad, 2016, Cytotoxic T cells in PD-L1-positive malignant pleural mesotheliomas are counterbalanced by distinct immunosuppressive factors, Cancer Immunol Res, 4, 1038, 10.1158/2326-6066.CIR-16-0171

Tsao, 2011, A practical guide of the Southwest Oncology Group to measure malignant pleural mesothelioma tumors by RECIST and modified RECIST criteria, J Thorac Oncol, 6, 598, 10.1097/JTO.0b013e318208c83d

Byrne, 2004, Modified RECIST criteria for assessment of response in malignant pleural mesothelioma, Ann Oncol, 15, 257, 10.1093/annonc/mdh059

Simon, 1989, Optimal two-stage designs for phase II clinical trials, Controlled Clin Trials, 10, 1, 10.1016/0197-2456(89)90015-9

Calabrò, 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

Calabrò, 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

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

de Gooijer, 2018, Treat it or leave it: immuno-oncology in mesothelioma observed by the eyes of Argus, J Thorac Oncol, 13, 1619, 10.1016/j.jtho.2018.08.2024

Borghaei, 2015, Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer, N Engl J Med, 373, 1627, 10.1056/NEJMoa1507643

Gassenmaier, 2018, Safety of shortened infusion times for combined ipilimumab and nivolumab, Cancer Immunol Immunother, 67, 135, 10.1007/s00262-017-2075-y

Waterhouse, 2018, Safety profile of nivolumab administered as 30-min infusion: analysis of data from CheckMate 153, Cancer Chemother Pharmacol, 81, 679, 10.1007/s00280-018-3527-6

Kiyotani, 2017, Integrated analysis of somatic mutations and immune microenvironment in malignant pleural mesothelioma, Oncoimmunology, 6, e1278330, 10.1080/2162402X.2016.1278330

Omori, 2018, Changes in programmed death ligand 1 expression in non-small cell lung cancer patients who received anticancer treatments, Int J Clin Oncol, 23, 1052, 10.1007/s10147-018-1305-4

Zhao, 2017, Prognostic value of PD-L1 expression in tumor infiltrating immune cells in cancers: A meta-analysis, PLoS One, 12, e0176822, 10.1371/journal.pone.0176822