• N. Engl. J. Med. · Jun 2019

    Randomized Controlled Trial Multicenter Study

    Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer.

    • Daniela Matei, Virginia Filiaci, Marcus E Randall, David Mutch, Margaret M Steinhoff, Paul A DiSilvestro, Katherine M Moxley, Yong M Kim, Matthew A Powell, David M O'Malley, Nick M Spirtos, William Small, Krishnansu S Tewari, William E Richards, John Nakayama, Ursula A Matulonis, Helen Q Huang, and David S Miller.
    • From Northwestern University (D. Matei) and Loyola University (W.S.) - both in Chicago; NRG Oncology Statistical and Data Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY (V.F., H.Q.H.); University of Kentucky, Lexington (M.E.R.); Washington University School of Medicine, Siteman Cancer Center, St. Louis (D. Mutch, M.A.P.); Women and Infants Hospital in Rhode Island-The Warren Alpert Medical School of Brown University, Providence (M.M.S., P.A.D.); Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City (K.M.M.); Asan Medical Center, University of Ulsan, Songpa-gu, Seoul, South Korea (Y.M.K.); Ohio State University, Columbus (D.M.O.); Women's Cancer Center of Nevada, Las Vegas (N.M.S.); University of California Irvine Medical Center, Irvine (K.S.T.); Lewis Cancer and Research Pavilion at St. Joseph's-Candler, Savannah, GA (W.E.R.); Case Western Reserve University Hospital, Cleveland (J.N.); Dana-Farber Cancer Institute, Boston (U.A.M.); and the University of Texas Southwestern Medical Center, Dallas (D.S.M.).
    • N. Engl. J. Med. 2019 Jun 13; 380 (24): 231723262317-2326.

    BackgroundStage III or IVA endometrial cancer carries a significant risk of systemic and locoregional recurrence.MethodsIn this randomized phase 3 trial, we tested whether 6 months of platinum-based chemotherapy plus radiation therapy (chemoradiotherapy) is associated with longer relapse-free survival (primary end point) than six cycles of combination chemotherapy alone in patients with stage III or IVA endometrial carcinoma. Secondary end points included overall survival, acute and chronic toxic effects, and quality of life.ResultsOf the 813 patients enrolled, 736 were eligible and were included in the analysis of relapse-free survival; of those patients, 707 received the randomly assigned intervention (346 received chemoradiotherapy and 361 received chemotherapy only). The median follow-up period was 47 months. At 60 months, the Kaplan-Meier estimate of the percentage of patients alive and relapse-free was 59% (95% confidence interval [CI], 53 to 65) in the chemoradiotherapy group and 58% (95% CI, 53 to 64) in the chemotherapy-only group (hazard ratio, 0.90; 90% CI, 0.74 to 1.10). Chemoradiotherapy was associated with a lower 5-year incidence of vaginal recurrence (2% vs. 7%; hazard ratio, 0.36; 95% CI, 0.16 to 0.82) and pelvic and paraaortic lymph-node recurrence (11% vs. 20%; hazard ratio, 0.43; 95% CI, 0.28 to 0.66) than chemotherapy alone, but distant recurrence was more common in association with chemoradiotherapy (27% vs. 21%; hazard ratio, 1.36; 95% CI, 1.00 to 1.86). Grade 3, 4, or 5 adverse events were reported in 202 patients (58%) in the chemoradiotherapy group and 227 patients (63%) in the chemotherapy-only group.ConclusionsChemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00942357.).Copyright © 2019 Massachusetts Medical Society.

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