Long-Term Follow-Up and Overall Survival in NRG258, a Randomized Phase III Trial of Chemoradiation Versus Chemotherapy for Locally Advanced Endometrial Carcinoma

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 <i>P</i> 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.

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Publication Details

Journal
Journal of Clinical Oncology
Published
2024-12-19
DOI
https://doi.org/10.1200/jco.24.01121
Citations
6
Primary Topic
Endometrial and Cervical Cancer Treatments
Type
article
Field-Weighted Citation Impact
3.50
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article

Long-Term Follow-Up and Overall Survival in NRG258, a Randomized Phase III Trial of Chemoradiation Versus Chemotherapy for Locally Advanced Endometrial Carcinoma

Guilherme Cantuaria, Alessandro Davide Santin, Marcus E. Randall, David M. O’Malley et al.
6 citations
Journal of Clinical Oncology
Endometrial and Cervical Cancer Treatments
3.50
article

Long-Term Follow-Up and Overall Survival in NRG258, a Randomized Phase III Trial of Chemoradiation Versus Chemotherapy for Locally Advanced Endometrial Carcinoma

Guilherme Cantuaria, Alessandro Davide Santin, Marcus E. Randall, David M. O’Malley, David Warshal, William C. Small, Paul DiSilvestro, David Scott Miller, Steven Waggoner, Jong Hyeok Kim, Joan L. Walker, Danielle M. Enserro, Saketh R. Guntupalli, Krishnansu S. Tewari, Albert J. Bonebrake, Daniela Matei, Frederick R. Ueland, David G. Mutch, Matthew A. Powell, Nick M. Spirtos, Mark S. Shahin, Olivia D. Lara, Annie Tan
article en
6 citations

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 <i>P</i> 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.

Journal of Clinical OncologyVol. 43(9)
Northwestern University (US), University of Minnesota (US), Cleveland Clinic (US), North Carolina State University (US), University of Kentucky (US), Thomas Jefferson University (US), Loyola University Chicago (US), Washington University in St. Louis (US), Brown University (US), Asan Medical Center (KR), Abington Memorial Hospital (US), Yale University (US), University of Ulsan (KR), University of California, Irvine Medical Center (US), Women's Cancer Center of Nevada (US), Women & Infants Hospital of Rhode Island (US), University of Colorado Cancer Center (US), Jefferson Hospital (US), CoxHealth (US), Cooper University Health Care (US), NRG Oncology (US), University of Oklahoma Health Sciences Center (US), The Ohio State University (US), The University of Texas Southwestern Medical Center (US), University of Colorado Denver (US)
Good health and well-being
Openalex Percentile: Top 7%
Endometrial and Cervical Cancer Treatments
3.50
DOIOpen Access PDFOpenAlex
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