Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomised trial

摘要: Summary Background Malignant pleural mesothelioma is almost always fatal, and few treatment options are available. Although active symptom control (ASC) has been recommended for the management of this disease, no consensus exists role chemotherapy. We investigated whether addition chemotherapy to ASC improved survival quality life. Methods 409 patients with malignant mesothelioma, from 76 centres in UK two Australia, were randomly assigned alone (treatment could include steroids, analgesic drugs, bronchodilators, palliative radiotherapy [n=136]); plus MVP (four cycles mitomycin 6 mg/m 2 , vinblastine cisplatin 50 every 3 weeks [n=137]); or vinorelbine (one injection 30 week 12 [n=136]). Randomisation was done by minimisation, stratification WHO performance status, histology, centre. Follow-up 21 after randomisation, 8 thereafter. Because slow accrual, groups combined compared primary outcome overall survival. Analysis intention treat. This study registered, number ISRCTN54469112. Findings At time analysis, 393 (96%) had died (ASC 132 [97%], [96%], 129 [95%]). Compared alone, we noted a small, non-significant benefit (hazard ratio [HR] 0·89 [95% CI 0·72–1·10]; p=0·29). Median 7·6 months group 8·5 group. Exploratory analyses suggested advantage (HR 0·80 [0·63–1·02]; p=0·08), median 9·5 months. There evidence 0·99 [0·78–1·27]; p=0·95). observed between-group differences four predefined quality-of-life subscales (physical functioning, pain, dyspnoea, global health status) at any assessments first Interpretation The offers significant benefits terms However, exploratory that merits further investigation. Funding Cancer Research Medical Council (UK).