Epidoxorubicin versus no treatment as consolidation therapy in advanced ovarian cancer: results from a phase II study

Abstract.   Bolis G, Danese S, Tateo S, Rabaiotti E, D'Agostino G, Merisio C, Scarfone G, Polverino G, Parazzini F. Epidoxorubicin versus no treatment as consolidation therapy in advanced ovarian cancer: results from a phase II study. Int J Gynecol Cancer 2006; 16(Suppl. 1): 74–78.
To compare the effect of epidoxorubicin given for 4 months versus no treatment in the survival of patients with advanced ovarian cancer and complete pathologic response after first-line surgery and chemotherapy with platinum-based schedules, we conducted a multicenter randomized clinical trial. Patients with histologic diagnosis of epithelial ovarian cancer FIGO stage III or IV at first diagnosis; complete pathologic response at second-look laparotomy/laparoscopy or complete clinic response; and those who have had first-line therapy including surgery and one regimen containing cisplatin or carboplatinum were eligible for the study and were randomly allocated to epidoxorubicin 120 mg/sqm or no treatment. A total of 64 women were allocated to epidoxorubicin and 74 to no treatment. There were 20 and 19 deaths, respectively, in the epidoxorubicin and no-treatment groups. The 3-year percent overall survival was 79.0% and 78.7%, respectively, in the no-treatment and epidoxorubicin groups (log-rank test, P = 0.93).