GOG 258

GOG 258
Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer - PubMed
Chemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00942357.).

Year of Publication

  • 2019

Hypothesis

  • Six months of platinum-based chemotherapy plus radiation therapy improves relapse-free survival compared to chemotherapy alone in stage III or IVA endometrial carcinoma.

Inclusion Criteria

  • Women aged ≥18 years with surgical stage III or IVA endometrial carcinoma of any histologic subtype or FIGO 2009 surgical stage I or II clear-cell or serous endometrial carcinoma with positive peritoneal washings.

Exclusion Criteria

  • Patients with carcinosarcoma or recurrent endometrial carcinoma.

Primary Endpoint

  • Relapse-free survival.

Experimental Arm(s)

  • Chemoradiotherapy: Cisplatin (50 mg/m² on days 1 and 29) plus volume-directed external-beam radiation therapy, followed by carboplatin (AUC 5-6) plus paclitaxel (175 mg/m²) every 21 days for four cycles with G-CSF support.

Control Arm (or Standard Therapy)

  • Chemotherapy-only: Carboplatin (AUC 6) plus paclitaxel (175 mg/m²) every 21 days for six cycles.

Results

Metric Chemoradiotherapy Chemotherapy-only p-value Hazard Ratio
Relapse-free survival at 60 months 59% (95% CI 53-65) 58% (95% CI 53-64) 0.20 0.90 (90% CI 0.74-1.10)
Vaginal recurrence (5-year) 2% 7% - 0.36 (95% CI 0.16-0.82)
Pelvic/paraaortic lymph-node recurrence (5-year) 11% 20% - 0.43 (95% CI 0.28-0.66)
Distant recurrence (5-year) 27% 21% - 1.36 (95% CI 1.00-1.86)
Grade 3-5 adverse events 58% 63% - -

Conclusions

  • Chemotherapy plus radiation did not significantly improve relapse-free survival compared to chemotherapy alone for stage III or IVA endometrial carcinoma, though it reduced the incidence of vaginal and pelvic/paraaortic lymph-node recurrences.

Limitations

  • The study did not demonstrate an overall survival benefit at the time of analysis and had a higher-than-expected frequency of distant metastases in the chemoradiotherapy group.