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

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Tác giả: Albert Bonebrake, Guilherme H Cantuaria, Paul A DiSilvestro, Danielle M Enserro, Saketh Guntupalli, Jong Hyeok Kim, Olivia Lara, Daniela E Matei, David Michelin, David S Miller, David Mutch, David M O'Malley, Matthew A Powell, Marcus E Randall, Alessandro D Santin, Mark Shahin, William Small, Nick M Spirtos, Annie Tan, Krishnansu S Tewari, Frederick R Ueland, Steven Waggoner, Joan L Walker, David Warshal

Ngôn ngữ: eng

Ký hiệu phân loại:

Thông tin xuất bản: United States : Journal of clinical oncology : official journal of the American Society of Clinical Oncology , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 700452

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
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