Phase III randomized trial of doxorubicin plus cisplatin versus doxorubicin+24-h paclitaxel plus filgrastim in endometrial carcinoma: a Gynecologic Oncology Group study

Background: This study was performed to determine whether 24-h paclitaxel plus doxorubicin and filgrastim was superior to cisplatin plus doxorubicin in patients with endometrial cancer with respect to response, progression-free survival (PFS) and overall survival (OS). Patients and methods: Eligible chemotherapy-naive patients were randomly assigned to doxorubicin 60 mg/m(2) intravenously (i.v.) followed by cisplatin 50 mg/m(2) i.v. (arm 1, n = 157) or doxorubicin 50 mg/m(2) i.V. followed 4 h later by paclitaxel 150 mg/m(2) i.v. over 24 h plus filgrastim 5 mug/kg on days 3-12 (arm 2, n = 160). Starting doses were reduced for prior pelvic radiotherapy and age >65 years. Both regimens were to be repeated every 3 weeks for a maximum of seven cycles. Results: There was no significant difference in response rate (40% versus 43%), PFS (median 7.2 versus 6 months) or OS (median 12.6 versus 13.6 months) for arm I and arm 2, respectively. Toxicities were primarily hematological, with 54% (arm 1) and 50% (arm 2) of patients experiencing grade 4 granulocytopenia. Gastrointestinal toxicities were similar in both arms. Conclusions: Doxorubicin and 24-h paclitaxel plus filgrastim was not superior to doxorubicin and cisplatin in terms of response, PFS or survival in advanced endometrial cancer.