A phase II study of high-dose epirubicin plus cisplatinum in advanced non-small-cell lung cancer (NSCLC).

Thirty-seven patients with unresectable NSCLC received epirubicin (EPI) as i.v. bolus at the dose of 120 mg/sm+cisplatinum (CP) at the dose of 60 mg/sm every 28 days up to the maximum cumulative dose of 840 mg/sm of EPI. Of 35 evaluable patients, 19 (54%) (95% confidence limits: 37%-71%) achieved PR for a median duration of 10 months (range: 2-21). The majority of responsive patients experienced improvement in performance status, related-disease symptoms and body weight. Grades 3-4 leukopenia occurred in 42% of the patients. In five patients there was a > 10% reduction in the left ventricular ejection fraction as calculated by radionuclide angiocardiography. None of these patients suffered from cardiac symptoms. The median survival was 9 months (range 2-26). This study shows that inclusion of HD-EPI in a combination regimen contributes to obtaining a high remission rate in advanced NSCLC.