title: A phase II trial of sunitinib in patients with renal cell cancer and untreated brain metastases.
abstract: BACKGROUND
  The expanded access program and anecdotal cases suggested sunitinib is safe in RCC patients with BM and might have worthwhile activity.
  
  
  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.
  
  
  CONCLUSIONS
  Although tolerability was acceptable in RCC patients with previously untreated BM, sunitinib has limited efficacy in this setting.
authors.affiliation: Institut Claudius Regaud, Toulouse, France. Electronic address: chevreau.christine@claudiusregaud.fr.
authors.forename: Christine
authors.initials: C
authors.lastname: Chevreau
authors.affiliation: Centre Hospitalier Universitaire Saint André, Bordeaux, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Ravaud
authors.affiliation: Institut Gustave Roussy, Villejuif, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Escudier
authors.affiliation: Centre Oscar Lambret, Lille, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Amela
authors.affiliation: Institut de Cancérologie de l'Ouest, Angers, France.
authors.forename: Remy
authors.initials: R
authors.lastname: Delva
authors.affiliation: Institut de Cancérologie de l'Ouest, Saint Herblain, France.
authors.forename: Frederic
authors.initials: F
authors.lastname: Rolland
authors.affiliation: Institut regional de Cancérologie de Montpellier, Montpellier, France.
authors.forename: Diego
authors.initials: D
authors.lastname: Tosi
authors.affiliation: Hôpital Européen Georges Pompidou, University Paris Descarte, Paris, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Oudard
authors.affiliation: Centre Leon Bérard, Lyon, France.
authors.forename: Ellen
authors.initials: E
authors.lastname: Blanc
authors.affiliation: Centre Leon Bérard, Lyon, France.
authors.forename: Celine
authors.initials: C
authors.lastname: Ferlay
authors.affiliation: Centre Leon Bérard, Lyon, France; Université Lyon, Lyon, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Négrier
mesh_terms: D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001921:Brain / Q000473:pathology; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002292:Carcinoma, Renal Cell / Q000188:drug therapy / Q000401:mortality / Q000473:pathology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D000077210:Sunitinib; D013534:Survival; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
keywords: Brain metastases; Clinical trial; Renal cell carcinoma; Sunitinib