Switch-maintenance gemcitabine after first-line chemotherapy in patients with malignant mesothelioma (NVALT19): an investigator-initiated, randomised, open-label, phase 2 trial

Baas, 2015, Malignant pleural mesothelioma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Ann Oncol, 26, v31, 10.1093/annonc/mdv199 Damhuis, 2015, Treatment patterns and survival analysis in 9014 patients with malignant pleural mesothelioma from Belgium, the Netherlands and England, Lung Cancer, 89, 212, 10.1016/j.lungcan.2015.05.014 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 Ciuleanu, 2009, Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study, Lancet, 374, 1432, 10.1016/S0140-6736(09)61497-5 Pérol, 2012, Randomized, phase III study of gemcitabine or erlotinib maintenance therapy versus observation, with predefined second-line treatment, after cisplatin-gemcitabine induction chemotherapy in advanced non-small-cell lung cancer, J Clin Oncol, 30, 3516, 10.1200/JCO.2011.39.9782 Dudek, 2019, Randomized phase 2 study of maintenance pemetrexed (Pem) versus observation (Obs) for patients (pts) with malignant pleural mesothelioma (MPM) without progression after first-line chemotherapy, J Clin Oncol, 37 Scagliotti, 2019, Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial, Lancet Respir Med, 7, 569, 10.1016/S2213-2600(19)30139-0 Buikhuisen, 2013, Thalidomide versus active supportive care for maintenance in patients with malignant mesothelioma after first-line chemotherapy (NVALT 5): an open-label, multicentre, randomised phase 3 study, Lancet Oncol, 14, 543, 10.1016/S1470-2045(13)70125-6 Fennell, 2019, Maintenance defactinib versus placebo after first-line chemotherapy in patients with merlin-stratified pleural mesothelioma: COMMAND-a double-blind, randomized, phase II study, J Clin Oncol, 37, 790, 10.1200/JCO.2018.79.0543 Bischoff, 1998, Gemcitabine (Gemzar) may reduce tumor load and tumor associated symptoms in malignant pleural mesothelioma, Proc Am Soc Clin Oncol, 17, A464 van Meerbeeck, 1999, A phase II study of gemcitabine in patients with malignant pleural mesothelioma, Cancer, 85, 2577, 10.1002/(SICI)1097-0142(19990615)85:12<2577::AID-CNCR13>3.0.CO;2-S Rothman, 1990, No adjustments are needed for multiple comparisons, Epidemiology, 1, 43, 10.1097/00001648-199001000-00010 Toyokawa, 2014, Gemcitabine and vinorelbine as second-line or beyond treatment in patients with malignant pleural mesothelioma pretreated with platinum plus pemetrexed chemotherapy, Int J Clin Oncol, 19, 601, 10.1007/s10147-013-0619-5 Jänne, 2008, Phase II trial of pemetrexed and gemcitabine in chemotherapy-naive malignant pleural mesothelioma, J Clin Oncol, 26, 1465, 10.1200/JCO.2007.14.7611 Kovac, 2012, A phase II trial of low-dose gemcitabine in a prolonged infusion and cisplatin for malignant pleural mesothelioma, Anticancer Drugs, 23, 230, 10.1097/CAD.0b013e32834d7a1c Favaretto, 2003, Gemcitabine combined with carboplatin in patients with malignant pleural mesothelioma: a multicentric phase II study, Cancer, 97, 2791, 10.1002/cncr.11405 Dodd, 2008, Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?, J Clin Oncol, 26, 3791, 10.1200/JCO.2008.16.1711 Nowak, 2004, Assessing quality of life during chemotherapy for pleural mesothelioma: feasibility, validity, and results of using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and Lung Cancer Module, J Clin Oncol, 22, 3172, 10.1200/JCO.2004.09.147 Krug, 2011, Forced vital capacity (FVC) as a reproducible measure of pulmonary function (PF) in chemotherapy-pretreated patients with malignant pleural mesothelioma (MPM), J Clin Oncol, 29 Schwartz, 2017, The impact of surgical approach on quality of life for pleural malignant mesothelioma, Ann Transl Med, 5, 230, 10.21037/atm.2017.03.41