- In patients with clear cell metastatic renal cell carcinoma (mRCC), sunitinib followed by cytoreductive nephrectomy (CN) yields progression-free rate (PFR) and survival similar to immediate CN.
- The deferred approach improved OS in the intent-to-treat (ITT) but not the per protocol (PP) population.
Why this matters
- Sunitinib treatment before planned surgery may identify patients with inherent resistance to systemic therapy.
- In the open-label SURTIME trial, 99 treatment-naive patients (vs 458 planned) with clear cell mRCC were randomly assigned to immediate CN followed by sunitinib (n=50) or sunitinib followed by CN (deferred group; n=49).
- Revised endpoint: 28-week PFR.
- Funding: Pfizer.
- Median follow-up, 3.3 years.
- 48 patients received presurgical sunitinib in the deferred group, whereas 40 received postoperative sunitinib in the immediate CN group.
- ITT population: in the deferred CN vs the immediate CN groups:
- 28-week PFR was 43% vs 42% (P=.61).
- PFS was not statistically different (HR, 0.88; P=.57).
- Median OS was significantly higher (32.4 vs 15.0 months; HR, 0.57; P=.03).
- Grade ≥3 adverse event rate was 58% vs 52%.
- In the PP population (n=73), OS was similar between both groups (HR, 0.71; P=.23).
- Early termination resulting from poor accrual.