GOG 258 Study
Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer
Disease site
Uterus
Pubmed link
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.