Early endometrial cancer: vaginal brachytherapy+chemo no better than pelvic RT

  • Randall ME & al.
  • J Clin Oncol
  • 17 Apr 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Open-label design.