Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer (GOG258)

Disease site

Uterus

Publication month/year

June 2019

Study question

To evaluate the use of chemoradiotherapy as compared with the use of chemotherapy alone in locally advanced endometrial cancer

Type of study

 Phase 3 RCT

Interventions compared

Chemoradiotherapy vs Chemotherapy

Experimental arm (Intervention)

Platinum-based chemotherapy plus radiation therapy (6 months duration)

Control arm

Chemotherapy alone (six cycles)

Primary outcome

Relapse-free survival

Secondary outcome
  • overall survival
  • acute and chronic toxic effects
  • quality of life
Inclusion criteria
  • 18 years of age or older and who had surgical stage III or IVA endometrial carcinoma
  • Any histologic subtype or had FIGO 2009 surgical stage I or II clear-cell or serous endometrial carcinoma and peritoneal washings that were positive for cancer cells
  • Hysterectomy and bilateral salpingo-oophorectomy performed within 8 weeks before trial entry
  • No single residual tumor mass could be larger than 2 cm in greatest dimension
  • Pelvic and paraaortic lymph-node biopsy or dissection was optional.
  • Normal organ function and a GOG performance status score of 2 or lower were required.
Exclusion criteria
  • Patients with carcinosarcoma or recurrent endometrial carcinoma were excluded
  • patients with peritoneal washings that were positive for cancer cells but with no evidence of extrauterine endometrioid tumor
Results
Intervention arm (Chemoradiotherapy) Control arm (Chemotherapy alone)
Randomised(n) 370 366
Received treatment(n) 346 361
Relapse -free 59% 58%
Adverse events (grade 3,4,5) 58% 63%
Cumulative incidence of vaginal disease recurrence 2% 7%
Cumulative incidence of distant recurrence 27% 21%
Coincident local and distant recurrences at first presentation 2.2% 4.9%
Cumulative incidence of pelvic or paraaortic node recurrence 11% 20%
Conclusions

Chemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma.

Study limitations

Reviewer name