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Annals of Oncology 12:497-499, 2001
© 2001 European Society for Medical Oncology

research-article

Phase II trial of liposomal daunorubicin in malignant pleural mesothelioma

J. P. C. Steele1,, C. A. O'Doherty1, J. Shamash1, M. T. Evans1, N. H. Gower2, M. D. Tischkowitz1 and R. M. Rudd1

1Department of Medical Oncology, St Bartholomew's Hospital London, UK
2London Lung Cancer Group, Royal Free and University College Medical School London, UK

Correspondence to: J P C Steele, MD, MRCP, Department of Medical Oncology, St Bartholomew's Hospital, London EC1A 7BE, UK, E-mail Jeremy.steele{at}virgin.net

Background To assess the response rate, toxicity and survival in patients with malignant pleural mesothelioma treated with liposomal daunorubicin. The study design allowed for dose escalation pending toxicity

Patients and methods Liposomal daunorubicin (Dauno-Xome, Nexstar, USA) 120 mg/m2 was administered every 21 days to a maximum of 6 cycles Patients had to have histologically-proven malignant pleural mesothelioma Patients were all chemotherapy-naive with ECOG performance status 0–2

Results: Fourteen patients were enrolled There were no objective or symptomatic responses though nine patients (64%) had stable disease on therapy Myelosuppression was the major toxicity with 9 of 11 patients evaluable for toxicity experiencing grade 3 or 4 neutropenia Other toxicities seen in at least 30% of patients included grade 3 infection and grade 2 nausea and vomiting The median overall survival by intention-to-treat analysis was 6 1 months from the time of first treatment. The median duration of stable disease from time of first treatment for patients not progressing on therapy was 5 1 months

Conclusions Liposomal daunorubicin 120 mg/m2 has no useful clinical activity in patients with malignant pleural meso-thelioma Toxicity was substantial with most patients experiencing at least one episode of grade 3 or 4 neutropenia Liposomal daunorubicin cannot be recommended for patients with malignant pleural mesothelioma

liposomal daunorubicin, malignant pleural mesothelioma, phase II trial


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