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 firstline 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 ¼ 0.93).
Epidoxorubicin versus no treatment as consolidation therapy in advanced ovarian cancer: results from a phase II study / G., Bolis; S., Danese; S., Tateo; E., Rabaiotti; G., D’Agostino; Merisio, Carla; G., Scarfone; G., Polverino; F., Parazzini. - In: INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER. - ISSN 1048-891X. - Suppl. 1 Jan-Feb(2006), pp. 74-78. [10.1111/j.1525-1438.2006.00313.x]