Added by | celine.gongora |
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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) |