A phase II trial of sunitinib in patients with renal cell cancer and untreated brain metastases.
Clin Genitourin Cancer
; 12(1): 50-4, 2014 Feb.
Article
em En
| MEDLINE
| ID: mdl-24268852
ABSTRACT
BACKGROUND:
The expanded access program and anecdotal cases suggested sunitinib is safe in RCC patients with BM and might have worthwhile activity. PATIENTS ANDMETHODS:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pirróis
/
Neoplasias Encefálicas
/
Carcinoma de Células Renais
/
Indóis
/
Neoplasias Renais
/
Antineoplásicos
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Clin Genitourin Cancer
Assunto da revista:
NEOPLASIAS
/
UROLOGIA
Ano de publicação:
2014
Tipo de documento:
Article