A phase I/II study of bortezomib and capecitabine in patients with metastatic breast cancer previously treated with taxanes and/or anthracyclines.
Ann Oncol
; 19(5): 871-6, 2008 May.
Article
em En
| MEDLINE
| ID: mdl-18209010
ABSTRACT
BACKGROUND:
Proteasome inhibitors are a novel class of compounds entering clinical trials as a method to increase tumour sensitivity to standard chemotherapy. This phase I/II trial was carried out to evaluate the combination of capecitabine and the proteasome inhibitor bortezomib in anthracycline and/or taxane-pretreated patients with metastatic breast cancer. PATIENTS ANDMETHODS:
A total of 35 patients were treated with bortezomib (1.0-1.3 mg/m(2) on days 1, 4, 8 and 11) and capecitabine (1500-2500 mg/m(2) on days 1-14) in 3-week intervals for up to eight cycles.RESULTS:
The maximum tolerated doses (MTDs) were bortezomib 1.3 mg/m(2) and capecitabine 2500 mg/m(2). The treatment was generally well tolerated and associated with toxic effects that were consistent with the known side-effects of the individual agents. The intent-to-treat overall response rate was 15% and an additional 27% of patients had stable disease (SD). In the 20 patients treated at the MTD, the response rate was 15% and 40% had SD. Median time to progression and overall survival were 3.5 months [95% confidence interval (CI) 1.9-4.4] and 7.5 months (95% CI 5.6-14.6), respectively. Median duration of response was 4.4 months.CONCLUSION:
The combination of bortezomib and capecitabine is well tolerated and has moderate antitumour activity in heavily pretreated patients.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Mama
/
Carcinoma
/
Protocolos de Quimioterapia Combinada Antineoplásica
/
Terapia de Salvação
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
Idioma:
En
Ano de publicação:
2008
Tipo de documento:
Article