Phase II trial of liposomal daunorubicin in malignant pleural mesothelioma

Background: To assess the response rate, toxicity and survival in patients with malignant pleural mesothelioma treated with liposomal daunorubicin. Th e study design allowed for dose escalation pending toxicity. Patients and methods: Liposomal daunorubicin (DaunoXome, Nexstar, USA) 120 mg/m(2) was administered every 21 days to a maximum of 6 cycles. Patients h ad to have histologically-proven malignant pleural mesothelioma. Patients w ere all chemotherapy-naive with ECOG performance status 0-2. Results: Fourteen patients were enrolled. There were no objective or sympto matic responses though nine patients (64%) had stable disease on therapy. M yelosuppression 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 vo miting. The median overall survival by intention-to-treat analysis was 6.1 months from the time of first treatment. The median duration of stable dise ase from time of first treatment for patients not progressing on therapy wa s 5.1 months. Conclusions: Liposomal daunorubicin 120 mg/m(2) has no useful clinical acti vity in patients with malignant pleural mesothelioma. Toxicity was substant ial with most patients experiencing at least one episode of grade 3 or 4 ne utropenia. Liposomal daunorubicin cannot be recommended for patients with m alignant pleural mesothelioma.