The progression-free rate (PFR) may not be affected in patients with metastatic renal cell carcinoma (mRCC) regardless of the treatment sequence of sunitinib and cytoreductive nephrectomy (CN), according to data presented at the European Society of Medical Oncology (ESMO) 2017 Congress in Spain.1
The standard of therapy for patients with mRCC is CN followed by targeted therapy. The authors of this study hypothesized that by reversing the order and administering targeted therapy prior to CN, tumor size would be reduced prior to surgery and lead to improved outcomes.
In the phase 3 EORTC 30073 SURTIME study (ClinicalTrials.gov Identifier: NCT01099423), 99 patients with mRCC were randomly assigned to undergo immediate CN followed by sunitinib or receive 3 cycles of sunitinib followed by CN and sunitinib. Due to slow accrual, instead of reporting progression-free survival, which required 380 patients for analysis, the PFR at week 28 was selected as the primary outcome, which required only 98 patients.
At the median follow-up of 3.3 years, the PFR was 42.0% (95% CI, 28.2-56.8) in the immediate CN arm compared with 42.9% (95% CI, 28.8-57.8) in the deferred CN arm (P > .99).
The median overall survival was 32.4 months (95% CI, 14.5-65.3) and 15.1 months (95% CI, 9.3-29.5) in the deferred and immediate CN arms, respectively (hazard ratio [HR], 0.57; 95 % CI, 0.34-0.95; P = .032).
Although patients in both study arms experienced benefit, there was no significant difference in PFR. The authors concluded that “the sample size precludes definitive conclusions from other endpoints, although an OS signal was seen for deferred CN. CN after sunitinib appears safe.”
- Bex A, Mulders P, Jewett MA, et al. Immediate versus deferred cytoreductive nephrectomy (CN) in patients with synchronous metastatic renal cell carcinoma (mRCC) receiving sunitinib (EORTC 30073 SURTIME). Presented at: 2017 ESMO Congress; Madrid, Spain: September 8-12, 2017. Abstract LBA35.