- Vaginal cuff brachytherapy (VCB) with chemotherapy (C) is not superior to adjuvant pelvic radiation therapy (RT) in patients with high-intermediate-risk and high-risk early-stage endometrial carcinoma with respect to recurrence-free survival (RFS) and OS.
- The incidences of vaginal and distant cumulative recurrences were similar between groups, but pelvic and para-aortic nodal failures were significantly higher in the VCB+C group.
Why this matters
- Pelvic RT remains an appropriate treatment for high-risk early-stage endometrial carcinoma.
- Phase 3 GOG-0249 study.
- 601 patients with high-intermediate-risk and high-risk early-stage endometrial carcinoma were randomly assigned to adjuvant pelvic RT or VCB, followed by paclitaxel+carboplatin.
- Primary outcome: RFS (time from study entry until disease recurrence or death or date of last contact).
- Funding: National Cancer Institute; others.
- Median follow-up was 53 months.
- At 60 months, RT vs VCB+C showed no significant difference in:
- RFS: 0.76 vs 0.76 (HR, 0.92; 90% CI, 0.69-1.23);
- OS: 0.87 vs 0.85 (HR, 1.04; 90% CI, 0.71-1.52);
- vaginal recurrences (HR, 1.0; 95% CI, 0.33-3.16); or
- distant recurrences (HR, 1.0; 95% CI, 0.68-1.52).
- Cumulative incidence of para-aortic nodal or pelvic recurrences was 4% with RT vs 9% with VCB+C.
- Patients in the VCB+C group experienced increased neurotoxicity.
- Open-label design.