- 作者：Christine Chevreau ; Alain Ravaud ; Bernard Escudier ; Eric Amela ; Remy Delva ; Frederic Roll ; Diego Tosi ; Stephane Oudard ; Ellen Blanc ; Celine Ferlay ; Sylvie N茅grier ; French Group on Renal Cancer
- 关键词：Brain metastases ; Clinical trial ; Renal cell carcinoma ; Sunitinib
- 刊名：Clinical Genitourinary Cancer
- 出版年：February, 2014
- 年：2014
- 卷：12
- 期：1
- 页码：50-54
- 全文大小：221 K
Background
The expanded access program and anecdotal cases suggested sunitinib is safe in RCC patients with BM and might have worthwhile activity.Patients and Methods
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.
Results
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.
Conclusion
Although tolerability was acceptable in RCC patients with previously untreated BM, sunitinib has limited efficacy in this setting.