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Annals of Oncology 15:1173-1178, 2004
© 2004 European Society for Medical Oncology

Phase III randomized trial of doxorubicin + cisplatin versus doxorubicin + 24-h paclitaxel + 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-naïve patients were randomly assigned to doxorubicin 60 mg/m2 intravenously (i.v.) followed by cisplatin 50 mg/m2 i.v. (arm 1, n=157) or doxorubicin 50 mg/m2 i.v. followed 4 h later by paclitaxel 150 mg/m2 i.v. over 24 h plus filgrastim 5 µg/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 1 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.

G. F. Fleming1,*, V. L. Filiaci2, R. C. Bentley3, T. Herzog4, J. Sorosky5, L. Vaccarello6 and H. Gallion7,{dagger}

1 Section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, IL; 2 Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; 3 Pathology Department, Duke University Medical Center, Durham, NC; 4 Department of Obstetrics & Gynecology, Division of Gynecologic Oncology, Washington University School of Medicine, St Louis, MO; 5 Division of Gynecologic Oncology, University of Iowa Hospitals and Clinics, Iowa City, IA; 6 Division of Gynecologic Oncology, Department of Obstetrics & Gynecology, Arthur James Cancer Hospital and Research Institute, Ohio State University, Columbus, OH; 7 Division of Gynecologic Oncology, University of Kentucky, Lexington, KY, USA

* Correspondence to: Dr G. F. Fleming, Section of Medical Oncology (MC2115), University of Chicago, 5841 S. Maryland Avenue (Room I-211), Chicago, IL 60637, USA. Tel: +1-773-702-6712; Fax: +1-773-702-0963; Email: gfleming{at}medicine.bsd.uchicago.edu

Key words: chemotherapy, cisplatin, doxorubicin, endometrial cancer, paclitaxel


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