Résumé
In this prospective trial, the efficacy and safety of sunitinib in patients with previously untreated brain metastases (BM) in metastatic renal cell cancer (RCC) were evaluated. Safety appears to be acceptable, however, its efficacy is limited, with no objective response and poor median overall survival.
The expanded access program and anecdotal cases suggested sunitinib is safe in RCC patients with BM and might have worthwhile activity.
In a phase II trial, patients with untreated BM received the standard regimen of sunitinib. The primary end point was objective response (OR) rate in BM after 2 cycles. An OR rate of 35% was prospectively defined as the minimum needed to warrant further investigation. According to Simon's optimal 2-stage design, at least 3 of the initial 15 patients had to have an OR for accrual to continue.
Among 16 evaluable patients, 1 had a complete response outside the central nervous system (CNS). CNS disease was stabilized in 5 (31%). However, no BM showed an OR. Therefore, no further accrual took place. Median time to progression was 2.3 months and overall survival was 6.3 months. There was 1 toxic death, from peritonitis with gastric perforation. Three patients experienced at least 1 treatment-related grade 3 or greater toxicity but no neurological adverse events were attributable to sunitinib.
Although tolerability was acceptable in RCC patients with previously untreated BM, sunitinib has limited efficacy in this setting.