GOG-249

In early-stage high-intermediate/high-risk endometrial cancer, does vaginal brachytherapy plus chemotherapy improve outcomes vs pelvic RT?

Population and treatment

601 patients with high-intermediate/high-risk early-stage endometrial cancer.

Intervention vs comparator: Vaginal cuff brachytherapy plus 3 cycles carboplatin/paclitaxel vs pelvic external-beam RT.

Registry: https://pubmed.ncbi.nlm.nih.gov/?term=GOG-249+vaginal+brachytherapy+chemotherapy+pelvic+radiotherapy

Results

Five-year RFS was approximately 76% in both arms; OS approximately 85% vs 87%, with no significant superiority for brachytherapy plus chemotherapy. Pelvic/para-aortic nodal recurrence was higher with brachytherapy plus chemotherapy; acute toxicity was greater.

Recurrence-free survival · 5 years

NNT: NCT00807768

NNH not calculated without defensible fixed-time excess-harm risk. Never derive NNT from median survival or HR alone.

Toxicity and treatment burden

76

Full grade 3–5 toxicity, discontinuation, QoL and treatment exposure require primary-report/supplement extraction before full clinical signoff. Missing rates are not imputed.

Interpretation and limitations

No demonstrated RFS/OS superiority for brachytherapy plus chemotherapy. Pelvic RT gave better nodal control with less systemic toxicity; consider patient risk and treatment burden.

Distinguish prespecified from exploratory subgroups, mature from immature endpoints, and superiority from non-inferiority. Verify current guidelines and eligibility.

Primary source

Primary publication / authoritative source ↗

Source-level QoL, discontinuation, full toxicity and guideline currency audit remains a QC requirement.