GOG 258 Study
Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer

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
CT + RT CT alone
Randomised (n)
370
366
Received treatment
346
361
Relapse -free rate
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.

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