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Randall ME , Filiaci V , McMeekin DS , von Gruenigen V , Huang H , Yashar CM , Mannel RS , Kim JW , Salani R , DiSilvestro PA , Burke JJ , Rutherford T , Spirtos NM , Terada K , Anderson PR , Brewster WR , Small W , Aghajanian CA , Miller DS
Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer
J Clin Oncol. 2019 Jul 20;37(21) :1810-1818
PMID: 30995174    PMCID: PMC6804858    URL: https://www.ncbi.nlm.nih.gov/pubmed/30995174
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Abstract
PURPOSE: The primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma. PATIENTS AND METHODS: A randomized phase III trial was performed in eligible patients with endometrial cancer. Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage I endometrioid histology with Gynecologic Oncology Group protocol 33-based high-intermediate-risk criteria, stage II disease, or stage I to II serous or clear cell tumors. Treatment was randomly assigned between RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m(2) (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles. RESULTS: The median age of the 601 patients was 63 years, and 74% had stage I disease. Histologies included endometrioid (71%), serous (15%), and clear cell (5%). With a median follow-up of 53 months, the 60-month RFS was 0.76 (95% CI, 0.70 to 0.81) for RT and 0.76 (95% CI, 0.70 to 0.81) for VCB/C (hazard ratio, 0.92; 90% confidence limit, 0.69 to 1.23). The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52). Vaginal and distant recurrence rates were similar between arms. Pelvic or para-aortic nodal recurrences were more common with VCB/C (9% v 4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated. CONCLUSION: Superiority of VCB/C compared with pelvic RT was not demonstrated. Acute toxicity was greater with VCB/C; late toxicity was similar. Pelvic RT alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.
Notes
1527-7755 Randall, Marcus E Filiaci, Virginia McMeekin, D Scott von Gruenigen, Vivian Huang, Helen Yashar, Catheryn M Mannel, Robert S Kim, Jae-Weon Salani, Ritu DiSilvestro, Paul A Burke, James J Rutherford, Thomas Spirtos, Nick M Terada, Keith Anderson, Penny R Brewster, Wendy R Small, William Aghajanian, Carol A Miller, David S U10 CA180868/CA/NCI NIH HHS/United States U10 CA027469/CA/NCI NIH HHS/United States P30 CA008748/CA/NCI NIH HHS/United States UG1 CA233302/CA/NCI NIH HHS/United States UG1 CA233191/CA/NCI NIH HHS/United States U10 CA180838/CA/NCI NIH HHS/United States U10 CA180822/CA/NCI NIH HHS/United States UG1 CA233290/CA/NCI NIH HHS/United States UG1 CA189867/CA/NCI NIH HHS/United States UG1 CA233331/CA/NCI NIH HHS/United States UG1 CA233193/CA/NCI NIH HHS/United States U10 CA037517/CA/NCI NIH HHS/United States Clinical Trial, Phase III Journal Article Research Support, N.I.H., Extramural United States J Clin Oncol. 2019 Jul 20;37(21):1810-1818. doi: 10.1200/JCO.18.01575. Epub 2019 Apr 17.