Background: Ovarian cancer is the most prevalent gynecologic cancer in women. Unfortunately for patients whose cancer is resistant to first-line therapies (platinum and paclitaxel), only a few second-line regimens have both significant efficacy and minimal treatment-related toxicity. Furthermore, the use of these agents increases treatment costs due to adverse events (AEs) related to tolerability and toxicity. Objective: The aim of the present study was to assess the comparative patient-specific treatment costs associated with 2 second-line therapies, both benchmark therapies used to treat ovarian cancer patients in Italy: pegylated liposomal doxorubicin (PLD) and topotecan, which appear to have similar efficacy but different tolerability and toxicity profiles. Methods: A cost-minimization analysis was performed in line with the point of view of Italy's National Health Service. Data on treatment efficacy and the number and types of AEs associated with drug toxicity were taken from a recent Phase III clinical trial comparing PLD with topotecan for the treatment of ovarian cancer. Resource-use estimates for each AE were based on the opinions of a panel of experts (Delphi method). Unit costs were drawn from national sources and a sensitivity analysis was performed. Results: The mean total per-patient cost in the PLD arm was Euro8812 (minimum, Euro8281; maximum, Euro9314) compared with Euro15,788 in the topotecan arm (minimum Euro12,014; maximum Euro18,847), The higher acquisition cost of PLD offset the higher cost of managing the AEs related to treatment with topotecan. Conclusions: The present analysis suggested the net cost-saving capability of PLD compared with topotecan. PLD required fewer ambulatory care-center visits for treatment administration and was associated with fewer severe AEs than topotecan. Copyright (C) 2003 Excerpta Medica, Inc.