GOG-99
Surgery with or without adjunctive external pelvic radiation therapy in intermediate-risk endometrial adenocarcinoma (Gynecologic Oncology Group study 99)
Phase 3N = 448
- Population
- Intermediate-risk endometrial adenocarcinoma, FIGO stages IB, IC and II (occult disease), after surgery; 392 of 448 randomised patients were eligible and are analysed
- Design
- Phase 3 randomised trial: 448 consenting patients with intermediate-risk endometrial adenocarcinoma (FIGO stages IB, IC and II occult disease) were randomised after surgery to no additional therapy or whole pelvic radiation therapy; 392 met all eligibility requirements (202 and 190). Median follow-up 69 months. A high-intermediate-risk (HIR) subgroup was defined by tumour grade, lymphovascular invasion, outer-third myometrial invasion and age; all other eligible participants formed the low-intermediate-risk subgroup.
- Arms
- No additional therapy (control, n = 202): Surgery alone
- Whole pelvic radiation therapy (experimental, n = 190): Whole pelvic radiation therapy after surgery
- People
- Keys HM, Gynecologic Oncology Group
Δ 24-month Cumulative incidence of recurrence−9 pointsΔ 24-month Cumulative incidence of recurrence−20 pointsΔ 48-month OS+6 points
Show the numbers
| Endpoint | Analysis | Whole pelvic radiation therapy | No additional therapy | Effect |
|---|---|---|---|---|
| Cumulative incidence of recurrenceEligible patients (392)Estimated 2-year cumulative incidence of recurrence; the abstract reports a relative hazard (RH) | primarymedian follow-up 69 monthsKeys 2004 | 3% at 2 y | 12% at 2 y | P=0.007The abstract also gives a relative hazard (RH) of 0.42 with no confidence interval and does not state the reference arm, so it is not entered as a hazard ratio. 44 recurrences and 66 deaths (32 disease- or treatment-related) in the whole study population. |
| Cumulative incidence of recurrenceHigh-intermediate-risk subgroup of eligible patientsEstimated 2-year cumulative incidence of recurrence in the high-intermediate-risk (HIR) subgroup | exploratoryKeys 2004 | 6% at 2 y | 26% at 2 y | The abstract also gives RH 0.42 for this subgroup with no confidence interval, p-value or reference arm (not entered as a hazard ratio). Subgroup size is not stated in the abstract. |
| OSEligible patients (392)Estimated 4-year overall survival; the abstract reports a relative hazard (RH) | primarymedian follow-up 69 monthsKeys 2004 | 92% at 4 y | 86% at 4 y | P=0.557The abstract also gives RH 0.86 with no confidence interval and does not state the reference arm (not entered as a hazard ratio). The abstract describes the difference as not significant. |
| Endpoint | Analysis | Whole pelvic radiation therapy | No additional therapy | Effect |
|---|---|---|---|---|
| Cumulative incidence of recurrenceEligible patients (392)Estimated 2-year cumulative incidence of recurrence; the abstract reports a relative hazard (RH) | primarymedian follow-up 69 monthsKeys 2004 | 3% at 2 y | 12% at 2 y | P=0.007The abstract also gives a relative hazard (RH) of 0.42 with no confidence interval and does not state the reference arm, so it is not entered as a hazard ratio. 44 recurrences and 66 deaths (32 disease- or treatment-related) in the whole study population. |
| Cumulative incidence of recurrenceHigh-intermediate-risk subgroup of eligible patientsEstimated 2-year cumulative incidence of recurrence in the high-intermediate-risk (HIR) subgroup | exploratoryKeys 2004 | 6% at 2 y | 26% at 2 y | The abstract also gives RH 0.42 for this subgroup with no confidence interval, p-value or reference arm (not entered as a hazard ratio). Subgroup size is not stated in the abstract. |
| OSEligible patients (392)Estimated 4-year overall survival; the abstract reports a relative hazard (RH) | primarymedian follow-up 69 monthsKeys 2004 | 92% at 4 y | 86% at 4 y | P=0.557The abstract also gives RH 0.86 with no confidence interval and does not state the reference arm (not entered as a hazard ratio). The abstract describes the difference as not significant. |