OBJECTIVES: To conduct an economic evaluation of an open label, phase III randomized trial involving centers in North America and Europe. METHODS: There were 239 and 235 patients in the liposomal doxorubicin (50mg/m2 every 4 weeks) and topotecan (1.5mg/m2 for 5 days every 3 weeks) arms, respectively. Overall median survival was 420 days and 397 days for liposomal doxorubicin and topotecan, respectively (hazard ratio=1.12 (90% CI 0.92,1.37; p=.34)). Because the outcomes were not clinically different for the 2 groups, a cost minimization analysis was performed. Costs included were: study drug; drug administration; and management of adverse events. Actual mg of drug administered and frequency and severity of adverse events were obtained from the clinical trial. Expert opinion was used to estimate the resources used in the treating adverse events, and unit costs were based on UK practice data. Further validation of the expert opinion is currently underway. RESULTS: Severe (Grade III/IV) toxicities were more frequent for liposomal doxorubicin versus topotecan in terms of palmar-plantar erythrodysesthesia (PPE) (n=64 vs. 0), and stomatitis/pharyngitis (n=32 vs. 2) but less frequent for thrombocytopenia (n=3 vs. 238), anemia (n=19 vs. 146), neutropenia (n=55 vs. 764) and fever (n=2 vs. 13). The average cost per patient was estimated to be EUR16,230 (95% CI 14,780 to 17,680) and EUR20,554 (95% CI 18,764 to 22,344) for liposomal doxorubicin and topotecan, respectively. Per patient cost for drug + administration were similar between the two groups, (EUR14,974 and EUR15,073); the main differential in cost was management of anemia (EUR407 and EUR2,219) and neutropenia (EUR57 and EUR1,454) for the liposomal doxorubicin and topotecan groups, respectively. CONCLUSIONS: In settings where the current standard of care for platinum refractory or resistant ovarian cancer is topotecan, liposomal doxorubicin offers the potential for savings through reduction in cost of adverse event management.