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

• DOI: 10.1200/jco.2006.06.4907
• Publication Date: 2007-02-09T00:33:47Z
• Authors: Howard D. Homesley; Virginia Filiaci; Maurie Markman; Pincas Bitterman; Lynne Eaton; Larry C. Kilgore; Bradley J. Monk; Frederick R. Ueland
• Keywords: Gynecologic oncology; Carcinosarcoma; Clinical Oncology

To determine if paclitaxel added to ifosfamide as first-line treatment for advanced uterine carcinosarcoma (CS) improves overall survival (OS), progression-free (PFS), response, and toxicity.Eligible patients had measurable stage III or IV, persistent, recurrent CS. Random assignment was between 2.0 g/m2 intravenously (IV) daily 3 days (arm 1) 1.6 IV plus 135 mg/m2 by 3-hour infusion day 1 2). Mesna administered similarly (both arms); filgrastim began on 4 Cycles were repeated every 21 up eight cycles.Of 214 enrolled, 179 eligible 1, 91 patients; arm 2, 88 patients). Arm 2 experienced more frequent severe sensory neuropathy (grade 4; 8% v 30%). The crude response rate 29% 45% odds of stratified performance status 2.21 greater in (P = .017). Median PFS OS, respectively, compared with 3.6 5.8 months 8.4 13.5 months, respectively. There a 31% decrease the hazard death (hazard ratio [HR], 0.69; 95% CI, 0.49 0.97; P .03) progression (HR, 0.71; 0.51 relative when stratifying status.OS significantly improved toxicities expected manageable. However, need active new agents persists, given that OS remains relatively poor this disease.