A phase II study of sorafenib in patients with chemo-naive castration-resistant prostate cancer.
Ann Oncol
; 19(4): 746-51, 2008 Apr.
Article
em En
| MEDLINE
| ID: mdl-18056648
ABSTRACT
BACKGROUND:
The purpose of this trial was to evaluate the antitumor activity of sorafenib, a multikinase inhibitor of cell proliferation and angiogenesis, in patients with castration-resistant prostate cancer. PATIENTS ANDMETHODS:
This was a multicenter, two-stage, phase II study. Sorafenib 400 mg was administered orally twice daily continuously. Primary end point was prostate-specific antigen (PSA) 'response' defined as a > or =50% decrease for > or =4 weeks.RESULTS:
In all, 28 patients were enrolled. Eastern Cooperative Oncology Group performance status was zero or one in 19 and 9 patients. Two patients had no metastases, and 26 had bone and/or lymph node disease. A median of two cycles (range 1-8) was delivered. Adverse events were typical for sorafenib. The PSA response rate was 3.6% [95% confidence interval (CI) 0.1% to 18.3%] with response occurring in one patient (baseline = 10 000 and nadir = 1643 microg/l). No measurable disease responses occurred in eight patients. Time to PSA progression was 2.3 months (95% CI 1.8-6.4). Of 16 patients who discontinued sorafenib and then did not receive any immediate therapy, 10 had postdiscontinuation PSA declines of 7%-52%.CONCLUSIONS:
Sorafenib has limited activity using current PSA criteria. The declines in PSA observed on treatment discontinuation indicate an effect on PSA production/secretion. Further study may be warranted but needs to consider the limitations of PSA as an indicator of progression and response.
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Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Próstata
/
Piridinas
/
Benzenossulfonatos
/
Antineoplásicos Hormonais
/
Inibidores da Angiogênese
/
Inibidores de Proteínas Quinases
/
Neoplasias Hormônio-Dependentes
/
Antineoplásicos
Tipo de estudo:
Clinical_trials
Limite:
Aged80
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Ann Oncol
Assunto da revista:
NEOPLASIAS
Ano de publicação:
2008
Tipo de documento:
Article