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
Dr. Lucio Gordan's Thoughts
Many of us have used platinum/paclitaxel in this setting but this study helps to corroborate the clinical practice.
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.
Author Affiliations
1Washington University School of Medicine, St Louis, MO; 2NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY; 3Memorial Sloan-Kettering Cancer Center, New York, NY; 4The Peggy and Charles Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK; 5University of California, Irvine, Division of Gynecologic Oncology, Orange, CA; 6Ohio State University, Columbus, OH; 7Duke Cancer Institute, Durham, NC; 8Washington University, St Louis, MO; 9Yale University, Obstetrics and Gynecology, Division of Gynecologic Oncology, New Haven, CT; 10Cooper Hospital University Medical Center, Camden, NJ; 11Women’s Cancer Center, Las Vegas, NV; 12Women and Infants Hospital, Providence, RI; 13University of Maryland Medical Center, Baltimore, MD; 14UT Southwestern Medical Center at Dallas, Dallas, TXRelated Articles
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