SURTIME
Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer
Phase 3N = 99NCT01099423
- Population
- Metastatic clear cell renal cell carcinoma with a resectable primary tumour and 3 or fewer surgical risk factors
- Design
- Randomised trial that began as a phase 3 trial: immediate cytoreductive nephrectomy followed by sunitinib versus 3 cycles of sunitinib followed by nephrectomy in the absence of progression, then sunitinib. The planned primary end point was progression-free survival (458 patients needed); because of poor accrual the independent data monitoring committee endorsed reporting the intention-to-treat 28-week progression-free rate instead. Overall survival, adverse events and postoperative progression were secondary end points. The study closed after 5.7 years.
- Primary endpoint
- 28-week progression-free rate
- Arms
- Immediate nephrectomy (control, n = 50): Cytoreductive nephrectomy followed by sunitinib
- Deferred nephrectomy (experimental, n = 49): Three cycles of sunitinib, then nephrectomy if no progression, then sunitinib
- People
- Bex A, senior author Haanen J
Δ 28-week progression-free rate+1 pointsOSHR 0.57 (95% CI 0.34–0.95)Δ median OS+17.4 months
Show the numbers
| Endpoint | Analysis | Deferred nephrectomy | Immediate nephrectomy | Effect |
|---|---|---|---|---|
| 28-week progression-free rate | primaryBex 2019 | 43% | 42% | P=0.61Reported in place of progression-free survival because of poor accrual. |
| OS | exploratoryBex 2019 | median 32.4 months (14.5–65.3) | median 15 months (9.3–29.5) | HR 0.57 (95% CI 0.34–0.95)P=0.03Secondary end point in an underpowered trial, so it is labelled exploratory; hazard ratio is deferred versus immediate nephrectomy. |
| Endpoint | Analysis | Deferred nephrectomy | Immediate nephrectomy | Effect |
|---|---|---|---|---|
| 28-week progression-free rate | primaryBex 2019 | 43% | 42% | P=0.61Reported in place of progression-free survival because of poor accrual. |
| OS | exploratoryBex 2019 | median 32.4 months (14.5–65.3) | median 15 months (9.3–29.5) | HR 0.57 (95% CI 0.34–0.95)P=0.03Secondary end point in an underpowered trial, so it is labelled exploratory; hazard ratio is deferred versus immediate nephrectomy. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.57 | 0.34–0.95 |
- Deferred nephrectomy (experimental)
- Immediate nephrectomy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Deferred nephrectomy | Immediate nephrectomy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 20 | 65.2% | 39.7% |
| 41 | 41.6% | 15.0% |
| 61 | 27.1% | 6.0% |
| 81 | 17.7% | 2.4% |