GOG 258: Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer
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.).
Daniela Matei
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.