GOG-81
Oral medroxyprogesterone acetate in advanced or recurrent endometrial carcinoma: a dose-response study by the Gynecologic Oncology Group
N = 299
- Population
- Eligible women with advanced or recurrent endometrial carcinoma (299 randomised)
- Design
- Randomised dose-response study: oral medroxyprogesterone acetate (MPA) 200 mg/day or 1000 mg/day until unacceptable toxicity or progression.
- Arms
- MPA 200 mg/day (control, n = 145): Oral medroxyprogesterone acetate 200 mg/day
- MPA 1000 mg/day (experimental, n = 154): Oral medroxyprogesterone acetate 1000 mg/day
- People
- Thigpen JT, Gynecologic Oncology Group
Δ ORR−10 pointsΔ median PFS−0.7 monthsΔ median OS−4.1 months
Show the numbers
| Endpoint | Analysis | MPA 1000 mg/day | MPA 200 mg/day | Effect |
|---|---|---|---|---|
| ORREligible women (N = 299) | finalThigpen 1999 | 15% | 25% | Complete responses 17% and partial 8% with the low dose; complete 9% and partial 6% with the high dose. Adjusted relative odds of responding to the high dose compared with the low dose 0.61 (90% CI 0.36 to 1.04). |
| PFSEligible women (N = 299) | finalThigpen 1999 | median 2.5 months | median 3.2 months | — |
| OSEligible women (N = 299) | finalThigpen 1999 | median 7 months | median 11.1 months | — |
| Endpoint | Analysis | MPA 1000 mg/day | MPA 200 mg/day | Effect |
|---|---|---|---|---|
| ORREligible women (N = 299) | finalThigpen 1999 | 15% | 25% | Complete responses 17% and partial 8% with the low dose; complete 9% and partial 6% with the high dose. Adjusted relative odds of responding to the high dose compared with the low dose 0.61 (90% CI 0.36 to 1.04). |
| PFSEligible women (N = 299) | finalThigpen 1999 | median 2.5 months | median 3.2 months | — |
| OSEligible women (N = 299) | finalThigpen 1999 | median 7 months | median 11.1 months | — |
- MPA 200 mg/day (control)
- MPA 1000 mg/day (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | MPA 200 mg/day | MPA 1000 mg/day |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 2 | 64.8% | 57.4% |
| 4 | 42.0% | 33.0% |
| 6 | 27.3% | 18.9% |
| 8 | 17.7% | 10.9% |
- MPA 200 mg/day (control)
- MPA 1000 mg/day (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | MPA 200 mg/day | MPA 1000 mg/day |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 7 | 64.6% | 50.0% |
| 14 | 41.7% | 25.0% |
| 21 | 26.9% | 12.5% |
| 28 | 17.4% | 6.3% |