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Phase III Trial of Ifosfamide With or Without Paclitaxel in Advanced Uterine Carcinosarcoma: A Gynecologic Oncology Group Study

Howard D. Homesley, Virginia Filiaci, Maurie Markman, Pincas Bitterman, Lynne Eaton, Larry C. Kilgore, Bradley J. Monk, Frederick R. Ueland

From the Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Brody School of Medicine, Greenville, NC; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Department of Pathology, Rush University Medical Center, Chicago, IL; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Ohio State University/James Cancer Hospital, Columbus, OH; Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL; Division of Gynecologic Oncology, University of California-Irvine, Chao Family Comprehensive Cancer Center, Orange, CA; and the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Kentucky, Lexington, KY

Address reprint requests to Denise Mackey, Gynecologic Oncology Group, Administrative Office, Four Penn Center, 1600 JFK Blvd, Suite 1020, Philadelphia, PA 19103; e-mail: dmackey{at}gog.org

Purpose: To determine if paclitaxel added to ifosfamide as first-line treatment for advanced uterine carcinosarcoma (CS) improves overall survival (OS), progression-free survival (PFS), response, and toxicity.

Patients and Methods: Eligible patients had measurable stage III or IV, persistent, or recurrent uterine CS. Random assignment to treatment was between ifosfamide 2.0 g/m² intravenously (IV) daily for 3 days (arm 1) or ifosfamide 1.6 g/m² IV daily for 3 days plus paclitaxel 135 mg/m² by 3-hour infusion day 1 (arm 2). Mesna was administered similarly (both arms); filgrastim began on day 4 (arm 2). Cycles were repeated every 21 days up to eight cycles.

Results: Of 214 patients enrolled, 179 were eligible (arm 1, 91 patients; arm 2, 88 patients). Arm 2 patients experienced more frequent and severe sensory neuropathy (grade 1 to 4; 8% v 30%). The crude response rate was 29% (arm 1) and 45% (arm 2). The odds of response stratified by performance status were 2.21 greater in arm 2 (P = .017). Median PFS and OS, respectively, for arm 1 compared with arm 2 were 3.6 v 5.8 months and 8.4 v 13.5 months, respectively. There was a 31% decrease in the hazard of death (hazard ratio [HR], 0.69; 95% CI, 0.49 to 0.97; P = .03) and a 29% decrease in the hazard of progression (HR, 0.71; 95% CI, 0.51 to 0.97; P = .03) relative to arm 1 when stratifying by performance status.

Conclusion: OS was significantly improved in arm 2, and toxicities were as expected and manageable. However, the need for active new agents persists, given that OS remains relatively poor in this disease.

Supported by National Cancer Institute grants to the Gynecologic Oncology Group (GOG) Administrative Office (Grant No. CA 27469) and the GOG Statistical and Data Center (Grant No. CA 37517).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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