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Added by celine.gongora
Group name EquipeCG
Item Type Journal Article
Title A phase II trial of sunitinib in patients with renal cell cancer and untreated brain metastases
Creator Chevreau et al.
Author Christine Chevreau
Author Alain Ravaud
Author Bernard Escudier
Author Eric Amela
Author Remy Delva
Author Frederic Rolland
Author Diego Tosi
Author Ellen Blanc
Author Celine Ferlay
Author Sylvie Négrier
Abstract 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.
Publication Clinical Genitourinary Cancer
Volume 12
Issue 1
Pages 50-54
Date Feb 2014
Journal Abbr Clin Genitourin Cancer
Language eng
DOI 10.1016/j.clgc.2013.09.008
ISSN 1938-0682
Library Catalog PubMed
Extra PMID: 24268852
Tags Angiogenesis Inhibitors, Antineoplastic Agents, Brain, Brain metastases, Brain Neoplasms, Carcinoma, Renal Cell, clinic, Clinical trial, Disease-Free Survival, Female, Humans, Indoles, Kidney Neoplasms, Male, Middle Aged, pfizer, Prospective Studies, Pyrroles, Renal cell carcinoma, Sunitinib, Survival, Treatment Outcome
Date Added 2019/05/14 - 12:27:52
Date Modified 2019/10/24 - 15:33:30
Notes and Attachments PubMed entry (Attachment)
Texte intégral (Attachment)


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