A multicentre phase II study to evaluate sequential docetaxel followed by capecitabine treatment in anthracycline-pretreated HER-2-negative patients with metastatic breast cancer
Clin. transl. oncol. (Print)
; 10(12): 817-825, dic. 2008.
Artigo
em Inglês
| IBECS
| ID: ibc-123562
Biblioteca responsável:
ES1.1
Localização: BNCS
ABSTRACT
INTRODUCTION:
Treatment of HER-2-negative metastatic breast cancer (MBC) patients after anthracycline exposure is controversial. Docetaxel/capecitabine is a promising regimen, but the administration schedule is not well established. MATERIALS ANDMETHODS:
Treatment included 3 cycles of docetaxel 100 mg/m2 day 1 every 21 days followed by 3 cycles of capecitabine 1250 mg/m2/12 h days 1-14. Patients not progressing were maintained with capecitabine 900 mg/m2/12 h on days 1-14 every 21 days until progression or unacceptable toxicity.RESULTS:
Fifty-three anthracycline-pretreated patients were enrolled median age 54 years, ECOG grade 0-1 86.7%. Most of the women received adjuvant chemotherapy (81%) and 5 patients (9%) had had prior metastatic chemotherapy treatment. Median time from anthracycline exposure was 29 months. ORR (intent-to-treatment analysis) after the sequential therapy was 51% (CI 95% 37-65) with 15% (CI 95% 7-28) of patients reaching complete responses. Median time to progression was 8.2 (CI 95% 7.1-10.7) months, with 61.9% (CI 95% 45.6-76.4) of the patients free of disease after 6 months. Median overall survival was not reached after a median follow-up of 10.4 months, and 75% of the patients were alive after 14.3 months. Survival rate after 12 months was 81.1% (CI 95% 68.0-90.6). The most frequent NCI grade 3-4 toxicities were hair loss (28.3%), asthenia (15.1%), stomatitis (11.32%) and nausea (11.32%). Severe hand-foot syndrome rate was 7.5%.CONCLUSIONS:
Sequential docetaxel-capecitabine is feasible, effective and well tolerated in first-line MBC treatment. Evaluation of this schedule in randomised studies is warranted (AU)RESUMEN
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Coleções:
Bases de dados nacionais
/
Espanha
Base de dados:
IBECS
Assunto principal:
Neoplasias da Mama
/
Protocolos de Quimioterapia Combinada Antineoplásica
/
Antraciclinas
/
Taxoides
/
Desoxicitidina
/
Fluoruracila
Tipo de estudo:
Ensaio clínico controlado
Limite:
Adulto
/
Idoso
/
Feminino
/
Humanos
Idioma:
Inglês
Revista:
Clin. transl. oncol. (Print)
Ano de publicação:
2008
Tipo de documento:
Artigo
Instituição/País de afiliação:
Juan Ramón Jiménez Hospital/Spain