We recruited patients aged older than 18 years with unresectable malignant mesothelioma with no evidence of disease progression after at least four cycles of first-line chemotherapy (with platinum and pemetrexed), who had a WHO performance status of 0-2, adequate organ function, and measurable or evaluable disease. We did a randomised, open-label, phase 2 trial in 18 hospitals in the Netherlands (NVALT19). We aimed to assess the efficacy and safety of switch-maintenance gemcitabine in patients with malignant mesothelioma without disease progression after first-line chemotherapy. Previous studies have investigated maintenance therapy, but none has shown a great effect. Electronic address: all patients with malignant mesothelioma eventually have disease progression after first-line therapy. 13 Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.Electronic address: 1 Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands. 12 Department of Radiology, Netherlands Cancer Institute, Amsterdam, Netherlands.11 Department of Pulmonary Diseases, Zuyderland Medical Centre, Heerlen, Netherlands.10 Department of Pulmonary Diseases, Ziekenhuis groep Twente, Almelo, Netherlands.9 Department of Pulmonary Diseases, University of Groningen and University Medical Center Groningen, Groningen, Netherlands.8 Department of Lung Oncology, Maxima Medical Centre, Eindhoven, Netherlands.7 Department of Pulmonary Diseases, Deventer Hospital, Deventer, Netherlands.6 Department of Pulmonary Diseases, Amphia Hospital, Breda, Netherlands.5 Department of Pulmonary Diseases, Erasmus MC Cancer Institute, Rotterdam, Netherlands.4 Department of Pulmonary Diseases, Jeroen Bosch Hospital, Den Bosch, Netherlands.3 Department of Pulmonary Diseases, Isala Hospital, Zwolle, Netherlands.2 Department of Biometrics, Netherlands Cancer Institute, Amsterdam, Netherlands.1 Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.
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