Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
PURPOSE: This phase III randomized trial (NCT00954174) tested the null hypothesis that paclitaxel and carboplatin (PC) is inferior to paclitaxel and ifosfamide (PI) for treating uterine carcinosarcoma (UCS).
PATIENTS AND METHODS: Adults with chemotherapy-naïve UCS or ovarian carcinosarcoma (OCS) were randomly assigned to PC or PI with 3-week cycles for 6-10 cycles. With 264 events in patients with UCS, the power for an overall survival (OS) hybrid noninferiority design was 80% for a null hazard ratio (HR) of 1.2 against a 13% greater death rate on PI with a type I error of 5% for a one-tailed test.
RESULTS: The study enrolled 536 patients with UCS and 101 patients with OCS, with 449 and 90 eligible, respectively. Primary analysis was on patients with UCS, distributed as follows: 40% stage I, 6% stage II, 31% stage III, 15% stage IV, and 8% recurrent. Among eligible patients with UCS, PC was assigned to 228 and PI to 221. PC was not inferior to PI. The median OS was 37 versus 29 months (HR = 0.87; 90% CI, 0.70 to 1.075;
CONCLUSION: PC was not inferior to the active regimen PI and should be standard treatment for UCS.
Women & Children
Obstetrics & Gynecology
Powell, Matthew A; Filiaci, Virginia L; Hensley, Martee L; Huang, Helen Q; Moore, Kathleen N; Tewari, Krishnansu S; Copeland, Larry J; Secord, Angeles A; Mutch, David G; Santin, Alessandro; Warshal, David P; Spirtos, Nick M; DiSilvestro, Paul A; Ioffe, Olga B; and Miller, David S, "Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial." (2022). Articles, Abstracts, and Reports. 5774.