SURTIME Trial: Surgery May Not Be Most Appropriate Frontline Treatment in mRCC
The findings of the SURTIME trial help confirm the results of the CARMENA phase 3 trial, according to investigators.
Pretreating patients with metastatic renal cell carcinoma (mRCC) with sunitinib prior to cytoreductive nephrectomy (CN) led to 28-week progression-free rates (PFRs) that were similar to those seen in patients who underwent immediate CN followed by postsurgical sunitinib, according to the results of the phase 3 SURTIME trial, which were published in JAMA Oncology.1 Although the pretreatment group had longer intention-to-treat (ITT) median overall survival (OS) compared with individuals in the immediate CN group, these same patients were also more likely overall to receive sunitinib therapy.
The trial involved 99 patients in the Netherlands, Belgium, the United Kingdom, and Canada whom had untreated clear cell mRCC. Based on criteria from the Memorial Sloan Kettering Cancer Center (MSKCC), most of the enrollees had intermediate-risk disease. Patients were randomly assigned to receive 3 cycles of sunitinib therapy followed by CN (49 individuals) or immediate CN followed by sunitinib (50 individuals); patients in the deferred surgical group also got sunitinib after surgery if there was no evidence of disease progression.
The 28-week PFR for the ITT population was 43% among patients who were pretreated with sunitinib prior to surgery and 42% among those who received immediate CN. The ITT median OS was 32.4 months in the pretreatment arm compared with 15 months in the immediate CN arm, however in the per-protocol population, the difference in OS between the 2 arms was not statistically significant. Furthermore, 98% of patients in the pretreatment arm received sunitinib, whereas only 80% did in the immediate CN arm.
The findings suggest that pretreating with sunitinib may lead to better or at least similar outcomes for patients with primary mRCC, wrote lead author Axel Bex, MD, PhD, consultant clinical lead, Specialist Centre for Kidney Cancer, Royal Free London NHS Foundation Trust, and honorary senior lecturer, UCL Division of Surgery and Interventional Science, London, UK, in an email to Cancer Therapy Advisor. Nevertheless, the trial was small and underpowered, and it was only able to observe a benefit of deferring CN in terms of ITT median OS as a secondary end point, he added.
It is not clear why patients in the pretreatment arm had improvements in ITT median OS but not ITT PFR, but it may be because progression-free survival, especially beyond the first several months, does not necessarily correlate with extent of progression and death from the disease, Dr Bex said.