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: Journal Of Clinical Oncology : Official Journal Of The American Society Of Clinical Oncology
Treatment Used: Paclitaxel and Carboplatin vs. Paclitaxel and Ifosfamide
Number of Patients: 536
MediFind Summary

Summary: This study compared paclitaxel and carboplatin (PC) versus paclitaxel and ifosfamide (PI) in the treatment of patients with uterine carcinosarcoma (UCS).

Conclusion: For patients with uterine carcinosarcoma, treatment with paclitaxel and carboplatin should be standard.


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; P < .01 for noninferiority, P > .1 for superiority). The median progression-free survival was 16 versus 12 months (HR = 0.73; P = < 0.01 for noninferiority, P < .01 for superiority). Toxicities were similar, except that more patients in the PC arm had hematologic toxicity and more patients in the PI arm had confusion and genitourinary hemorrhage. Among 90 eligible patients with OCS, those in the PC arm had longer OS (30 v 25 months) and progression-free survival (15 v 10 months) than those in the PI arm, but with limited precision, these differences were not statistically significant.

Conclusion: PC was not inferior to the active regimen PI and should be standard treatment for UCS.

Matthew Powell, Virginia Filiaci, Martee Hensley, Helen Huang, Kathleen Moore, Krishnansu Tewari, Larry Copeland, Angeles Secord, David Mutch, Alessandro Santin, David Warshal, Nick Spirtos, Paul Disilvestro, Olga Ioffe, David Miller

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