A phase II study evaluating the cisplatin and epirubicin combination in patients with unresectable malignant pleural mesothelioma - For the European Lung Cancer Working Party (ELCWP)

Few chemotherapeutic agents have demonstrated their efficacy in malignant mesothelioma. The cisplatin plus doxorubicin combination has one of the highest response rates. Epirubicin is an anthracyclin, analogous to doxorubicin, with a different toxicologic pattern. As there are no data on the activity of the combination cisplatin plus epirubicin in malignant mesotheliorna, the European Lung Cancer Working Party (ELCWP) designed a phase II study with response rate as primary objective. Sixty-nine eligible patients with malignant pleural mesothelioma were centrally registered. The majority of the patients were mate (n = 59), had a Karnofsky performance status of 80 or more (n = 62) and presented with an epitheliat histologic subtype (n=43). Median age was 62 years. In nine patients, metastases were documented at the initial work-up, mainly in bone, lung and skin. Three hundred and twenty-four cycles of chemotherapy were administered. The main toxicities were nausea and vomiting, neutropenia and alopecia. Among 63 assessable patients, response rate was 19.0% (95% confidence interval [CI] 9-29%). Median survival was 13.3 months. In multivariate analysis, poor prognostic factors for survival were neutrophil count and CALGB groups 4-6. In conclusion, cisptatin plus epirubicin appears as an effective regimen in malignant mesothetioma, with a favourable toxicity profile. However, it does not demonstrate superior activity to other active regimens in this disease. (c) 2005 Elsevier Ireland Ltd. Alt rights reserved.