GOG-258
Cisplatin and tumour-volume-directed irradiation followed by carboplatin and paclitaxel versus carboplatin and paclitaxel for advanced endometrial carcinoma (GOG-258)
Phase 3N = 813NCT00942357
- Population
- Stage III or IVA endometrial carcinoma (NEJM); the 2025 report describes eligibility as FIGO 2009 stage III-IVA, or stage I/II serous or clear-cell cancer with positive cytology
- Design
- Randomised phase 3 trial of 6 months of platinum-based chemotherapy plus radiation (cisplatin with volume-directed radiation, then four cycles of carboplatin and paclitaxel) versus six cycles of carboplatin and paclitaxel alone. 813 patients enrolled (407 chemoradiotherapy, 406 chemotherapy); 736 eligible and included in the relapse-free survival analysis, of whom 707 received the randomly assigned intervention (346 and 361). Primary endpoint relapse-free survival; secondary endpoints included overall survival, toxicity and quality of life. Median follow-up 47 months (primary report) and 112 months (final overall survival report).
- Primary endpoint
- RFS
- Arms
- Chemotherapy alone (control, n = 406): Carboplatin and paclitaxel, six cycles
- Chemoradiotherapy (experimental, n = 407): Cisplatin with volume-directed radiation, followed by four cycles of carboplatin and paclitaxel
- People
- Matei D
RFSHR 0.9Δ 60-month RFS+1 pointsVaginal recurrenceHR 0.36 (95% CI 0.16–0.82)Δ 60-month Vaginal recurrence−5 pointsPelvic and para-aortic lymph-node recurrenceHR 0.43 (95% CI 0.28–0.66)Δ 60-month Pelvic and para-aortic lymph-node recurrence−9 points
Show the numbers
| Endpoint | Analysis | Chemoradiotherapy | Chemotherapy alone | Effect |
|---|---|---|---|---|
| RFSEligible patients included in the relapse-free survival analysis (736 of 813 enrolled)Relapse-free survival (primary endpoint): Kaplan-Meier estimate of the percentage alive and relapse-free at 60 months | primarymedian follow-up 47 monthsMatei 2019 | 59% at 5 y (53–65%) | 58% at 5 y (53–64%) | HR 0.9Hazard ratio 0.90 with a 90% confidence interval of 0.74 to 1.10 (as published; not a 95% interval). 707 of the 736 received the randomly assigned intervention (346 chemoradiotherapy, 361 chemotherapy only). |
| Vaginal recurrenceEligible patients included in the relapse-free survival analysis (736 of 813 enrolled)5-year incidence of vaginal recurrence | primarymedian follow-up 47 monthsMatei 2019 | 2% at 5 y | 7% at 5 y | HR 0.36 (95% CI 0.16–0.82) |
| Pelvic and para-aortic lymph-node recurrenceEligible patients included in the relapse-free survival analysis (736 of 813 enrolled)5-year incidence of pelvic and para-aortic lymph-node recurrence | primarymedian follow-up 47 monthsMatei 2019 | 11% at 5 y | 20% at 5 y | HR 0.43 (95% CI 0.28–0.66) |
| Distant recurrenceEligible patients included in the relapse-free survival analysis (736 of 813 enrolled)5-year incidence of distant recurrence | primarymedian follow-up 47 monthsMatei 2019 | 27% at 5 y | 21% at 5 y | HR 1.36 (95% CI 1.00–1.86)Distant recurrence was more common with chemoradiotherapy. |
| Grade 3 or worse adverse eventsPatients who received the randomly assigned intervention (707)Grade 3, 4 or 5 adverse events | primaryMatei 2019 | 58% | 63% | 202 patients with chemoradiotherapy and 227 with chemotherapy only. |
| OSEligible patients, intention-to-treat analysis of eligible patients (813 randomly assigned: 407 chemoradiotherapy, 406 chemotherapy; 733 eligible per the 2025 report)Overall survival; final analysis. Median overall survival was not achieved in either arm | finalmedian follow-up 112 monthsMatei 2025 | — | — | HR 1.05 (95% CI 0.82–1.34)P=0.72Stratified hazard ratio for death comparing chemoradiotherapy with chemotherapy; two-sided log-rank P. The abstract states that none of the factors analysed predicted an overall survival benefit from chemoradiotherapy. The analysis population is stated in the full-text Methods (intention-to-treat analysis of eligible patients), not in the abstract; the 2025 report counts 733 eligible patients, the 2019 report 736. |
| Endpoint | Analysis | Chemoradiotherapy | Chemotherapy alone | Effect |
|---|---|---|---|---|
| RFSEligible patients included in the relapse-free survival analysis (736 of 813 enrolled)Relapse-free survival (primary endpoint): Kaplan-Meier estimate of the percentage alive and relapse-free at 60 months | primarymedian follow-up 47 monthsMatei 2019 | 59% at 5 y (53–65%) | 58% at 5 y (53–64%) | HR 0.9Hazard ratio 0.90 with a 90% confidence interval of 0.74 to 1.10 (as published; not a 95% interval). 707 of the 736 received the randomly assigned intervention (346 chemoradiotherapy, 361 chemotherapy only). |
| Vaginal recurrenceEligible patients included in the relapse-free survival analysis (736 of 813 enrolled)5-year incidence of vaginal recurrence | primarymedian follow-up 47 monthsMatei 2019 | 2% at 5 y | 7% at 5 y | HR 0.36 (95% CI 0.16–0.82) |
| Pelvic and para-aortic lymph-node recurrenceEligible patients included in the relapse-free survival analysis (736 of 813 enrolled)5-year incidence of pelvic and para-aortic lymph-node recurrence | primarymedian follow-up 47 monthsMatei 2019 | 11% at 5 y | 20% at 5 y | HR 0.43 (95% CI 0.28–0.66) |
| Distant recurrenceEligible patients included in the relapse-free survival analysis (736 of 813 enrolled)5-year incidence of distant recurrence | primarymedian follow-up 47 monthsMatei 2019 | 27% at 5 y | 21% at 5 y | HR 1.36 (95% CI 1.00–1.86)Distant recurrence was more common with chemoradiotherapy. |
| Grade 3 or worse adverse eventsPatients who received the randomly assigned intervention (707)Grade 3, 4 or 5 adverse events | primaryMatei 2019 | 58% | 63% | 202 patients with chemoradiotherapy and 227 with chemotherapy only. |
| OSEligible patients, intention-to-treat analysis of eligible patients (813 randomly assigned: 407 chemoradiotherapy, 406 chemotherapy; 733 eligible per the 2025 report)Overall survival; final analysis. Median overall survival was not achieved in either arm | finalmedian follow-up 112 monthsMatei 2025 | — | — | HR 1.05 (95% CI 0.82–1.34)P=0.72Stratified hazard ratio for death comparing chemoradiotherapy with chemotherapy; two-sided log-rank P. The abstract states that none of the factors analysed predicted an overall survival benefit from chemoradiotherapy. The analysis population is stated in the full-text Methods (intention-to-treat analysis of eligible patients), not in the abstract; the 2025 report counts 733 eligible patients, the 2019 report 736. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| Vaginal recurrence | 0.36 | 0.16–0.82 |
| Pelvic and para-aortic lymph-node recurrence | 0.43 | 0.28–0.66 |
| Distant recurrence | 1.36 | 1–1.86 |
| OS | 1.05 | 0.82–1.34 |
Appears in
Sources
Matei D, Filiaci V, Randall ME, Mutch D, Steinhoff MM, DiSilvestro PA, et al. Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer. N Engl J Med. 2019;380(24):2317-2326.
Matei DE, Enserro DM, Randall ME, Mutch D, Small W, DiSilvestro PA, et al. Long-Term Follow-Up and Overall Survival in NRG258, a Randomized Phase III Trial of Chemoradiation Versus Chemotherapy for Locally Advanced Endometrial Carcinoma. J Clin Oncol. 2025;43(9):1055-1060.