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. The study design allowed for dose escalation pending toxicity. PATIENTS AND METHODS Liposomal daunorubicin (DaunoXome, 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-naïve 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 mesothelioma. 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.