DESKTOP III
Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer
N = 407NCT01166737
- Population
- Recurrent ovarian cancer, first relapse after a platinum-free interval of 6 months or more, with a positive AGO score
- Design
- Patients with recurrent ovarian cancer at first relapse after a platinum-free interval of 6 months or more were randomly assigned to secondary cytoreductive surgery followed by platinum-based chemotherapy, or platinum-based chemotherapy alone. Eligibility required a positive AGO score (ECOG performance status 0, ascites under 500 ml, complete resection at initial surgery). The primary end point was overall survival.
- Primary endpoint
- OS
- Arms
- Surgery plus chemotherapy (experimental, n = 206): Secondary cytoreductive surgery followed by platinum-based chemotherapy
- Chemotherapy alone (control, n = 201): Platinum-based chemotherapy alone
- People
- Harter P
OSHR 0.75 (95% CI 0.59–0.96)Δ median OS+7.7 months
Show the numbers
| Endpoint | Analysis | Surgery plus chemotherapy | Chemotherapy alone | Effect |
|---|---|---|---|---|
| OSAll randomised patients (407); analysis population not stated in the abstract | primaryHarter 2021 | median 53.7 months | median 46 months | HR 0.75 (95% CI 0.59–0.96)P=0.02Hazard ratio for death, surgery group compared with no-surgery group. |
| OSPatients in the surgery group with complete resection (denominator not stated in the abstract) | exploratoryHarter 2021 | median 61.9 months | — | Median overall survival in the subgroup of the surgery group with complete resection; a single-arm subgroup figure, not a randomised comparison. |
| Complete resection ratePatients in the surgery group who underwent the procedure | primaryHarter 2021 | 75.5% | — | — |
| Endpoint | Analysis | Surgery plus chemotherapy | Chemotherapy alone | Effect |
|---|---|---|---|---|
| OSAll randomised patients (407); analysis population not stated in the abstract | primaryHarter 2021 | median 53.7 months | median 46 months | HR 0.75 (95% CI 0.59–0.96)P=0.02Hazard ratio for death, surgery group compared with no-surgery group. |
| OSPatients in the surgery group with complete resection (denominator not stated in the abstract) | exploratoryHarter 2021 | median 61.9 months | — | Median overall survival in the subgroup of the surgery group with complete resection; a single-arm subgroup figure, not a randomised comparison. |
| Complete resection ratePatients in the surgery group who underwent the procedure | primaryHarter 2021 | 75.5% | — | — |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.75 | 0.59–0.96 |
- Surgery plus chemotherapy (experimental)
- Chemotherapy alone (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Surgery plus chemotherapy | Chemotherapy alone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 34 | 64.5% | 59.9% |
| 67 | 42.1% | 36.4% |
| 101 | 27.2% | 21.8% |
| 134 | 17.7% | 13.3% |
- Surgery plus chemotherapy (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Surgery plus chemotherapy |
|---|---|
| 0 | 100.0% |
| 39 | 64.6% |
| 77 | 42.2% |
| 116 | 27.3% |
| 155 | 17.6% |