Long-Term Follow-Up and Overall Survival in NRG258, a Randomized Phase III Trial of Chemoradiation Versus Chemotherapy for Locally Advanced Endometrial Carcinoma
Abstract
This randomized phase III trial aimed to determine whether treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for four cycles (chemoradiotherapy [C-RT]) increased recurrence-free survival (RFS) and overall survival (OS) when compared with carboplatin and paclitaxel for six cycles (chemotherapy [CT]) in locally advanced endometrial cancer (UC). Previously reported results showed that C-RT did not improve RFS compared with CT. Here we report the final OS analysis. Patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage III-IVA UC or stage I/II serous or clear cell UC and positive cytology were enrolled. The primary objective was RFS. Secondary objectives were OS, toxicity, and quality of life. Cumulative probabilities of OS were estimated using the Kaplan-Meier method. Subgroup analyses of treatment effect for FIGO stage, age, race, gross residual disease, histology, lymph-vascular space invasion, and body mass index were performed. In total, 813 patients were randomly assigned (407 C-RT and 406 CT). The median follow-up was 112 months. Median OS was not achieved in either arm. The stratified hazard ratio for death comparing C-RT versus CT was 1.05 (95% CI, 0.82 to 1.34, log-rank two-sided P value = .72). None of the factors analyzed predicted OS benefit from C-RT. Although C-RT reduced the rate of local recurrence compared with CT, it did not increase OS or RFS in stage III/IVA UC.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (24)
Daniela E. Matei
Northwestern University, Chicago, IL
Danielle M. Enserro
NRG Oncology Statistical and Data Center, Buffalo, NY
Marcus E. Randall
University of Kentucky, Lexington, KY
David Mutch
Washington University School of Medicine, Siteman Cancer Center, St Louis, MO
William Small
Paul A. DiSilvestro
Women and Infants Hospital in Rhode Island/The Warren Alpert Medical School of Brown University, Providence, RI
Nick M. Spirtos
Women's Cancer Center of Nevada, Las Vegas, NV
David M. O’Malley
The Ohio State University and the James Comprehensive Cancer Center, Columbus, OH
Guilherme H. Cantuaria
University Gynecologic Oncology—Atlanta, Atlanta, GA
David Michelin
Cowell Family Cancer Center, Traverse City, MI
Steven Waggoner
Cleveland Clinic, Cleveland, OH
Mark Shahin
Abington Hospital, Jefferson Health, Sidney Kimmel Medical College of Thomas Jefferson University, Abington, PA
Saketh Guntupalli
UCHealth CU Cancer Center, Anshultz Medical Campus, Aurora
Olivia Lara
University of North Carolina, Raleigh, NC
Frederick R. Ueland
University of Kentucky, Lexington, KY
David Warshal
Cooper University Health Care, Philadelphia, PA
Albert Bonebrake
CoxHealth, Springfield, MO
Krishnansu S. Tewari
Annie Tan
Matthew A. Powell
Washington University in St. Louis, St. Louis, MO
Joan L. Walker
The University of Oklahoma and Stephenson Cancer Center, Oklahoma City, OK
Alessandro D. Santin
Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine
Jong Hyeok Kim
College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Korea
David S. Miller
University of Texas Southwestern Medical Center, Dallas, TX