GOG 249 Study
Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer

Disease site

Uterus

Publication month/year

July 2019

Study question

To determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival compared with pelvic radiation therapy (RT) in high-risk early-stage endometrial carcinoma

Type of study

Randomised controlled trial (RCT)

Interventions compared

Radiation therapy vs Vaginal cuff brachytherapy and chemotherapy

Experimental arm (Intervention)

Vaginal cuff brachytherapy followed by IV paclitaxel 175mg/m2 (3 hours) plus carboplatin every 21 days for three cycles

Control arm

Radiation therapy (45 to 50.4 Gy over 5 weeks)

Primary outcome

Recurrence free survival

Secondary outcome
  • Overall survival 
  • Pelvic or para-aortic nodal recurrences
  • Acute and late toxicity
Inclusion criteria
  • Stage I endometrial cancer of endmetrioid adenocarcinoma histology meeting the following criteria:
      • Age 70 years or older with one uterine risk factor
      • Age 50 years or older with two risk factors
      • Age 18 years or older with three risk factor
  • Uterine risk factors included:
        • Grade 2 or 3 tumor
        • Outer half depth of invasion
        • Lymphovascular invasion 
  • Positive or negative peritoneal cytology were allowed (endometroid)
  • Patients with serous or clear cell tumors with stage I or II with negative peritoneal cytology
Exclusion criteria
  • Wrong stage  
  • Wrong cell type
  • Wrong primary
  • Inadequate pathological materials
  • Risk criteria not met
  • No tumor at entry
Results
VCB/C RT
Randomised (n)
300
301
Received treatment (n)
290
283
60-month recurrence free survival
76%
76%
60-month overall survival
85%
87%
Pelvic or para-aortic nodal recurrences
4%
9%
Other results
  • Vaginal and distal recurrence rates were similar between arms.
  • Acute toxicity was more frequent and severe in the vaginal cuff brachytherapy with chemotherapy arm.
  • Late toxicity was similar.
Conclusions

Pelvic radiotherapy remains the standard of care. It is effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinoma of all histologies.

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