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.
Written by:
Chevreau C1, Ravaud A2, Escudier B3, Amela E4, Delva R5, Rolland F6, Tosi D7, Oudard S8, Blanc E9, Ferlay C9, Négrier S10 Are you the author?
1Institut Claudius Regaud, Toulouse, France. Electronic address: . 2Centre Hospitalier Universitaire Saint André, Bordeaux, France. 3Institut Gustave Roussy, Villejuif, France. 4Centre Oscar Lambret, Lille, France. 5Institut de Cancérologie de l'Ouest, Angers, France. 6Institut de Cancérologie de l'Ouest, Saint Herblain, France. 7Institut regional de Cancérologie de Montpellier, Montpellier, France. 8Hôpital Européen Georges Pompidou, University Paris Descarte, Paris, France. 9Centre Leon Bérard, Lyon, France. 10Centre Leon Bérard, Lyon, France; Université Lyon, Lyon, France.
Reference: Clin Genitourin Cancer. 2014 Feb;12(1):50-4 (Epub 2013 Sep 28)
doi: 10.1016/j.clgc.2013.09.008
PubMed Abstract
PMID: 24268852
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