Treatment of patients with ovarian carcinoma with pegylated liposomal doxorubicin - Analysis of toxicities and predictors of outcome

BACKGROUND. Pegylated liposomal doxorubicin is a new formulation with activ ity against epithelial ovarian carcinoma (EOC). The authors sought to deter mine patient characteristics that may predict for response to this treatmen t and favorable time to failure as well as survival. METHODS. Eight patients in a Phase I study and 44 patients ill two consecut ive Phase II studies who were treated with pegylated liposomal doxorubicin (40-60 mg/m(2) every 3 weeks for the first two cycles and 40 mg/m(2) every 4 weeks thereafter) after failing initial platinum-based chemotherapies for ovarian carcinoma were analyzed. Associations were sought for response, ti me to failure (TTF), and survival after the treatment and various pretreatm ent characteristics. RESULTS. Treatment with pegylated liposomal doxorubicin yielded 23% objecti ve responses in measurable disease and 31% overall responses, including ser um CA 125-defined responses. The median TTF was 5.2 months (95% confidence interval, 4.1-6.9 months) in all patients, and the median response duration in all responders was 13.2 months (95% confidence interval, 11.9-18.5 mont hs). The overall median survival was 15 months (95% confidence interval, 11 -40 months). The main predictive factors were tumor size and baseline hemog lobin level for TTF, and these plus Karnofsky performance status were the m ain predictive factors for survival. CONCLUSIONS. Pegylated liposomal doxorubicin is an effective drug when it i s given as secondary therapy to patients with EOC. Lack of bulky disease is the major predictor for a favorable response, TTF, and survival. The role of this treatment in combination with other effective drugs should be explo red in both previously treated and untreated patients with ovarian carcinom a. Cancer 2001;91:90-100. (C) 2001 American Cancer Society.