Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials.
Br J Cancer
; 101(11): 1846-52, 2009 Dec 01.
Article
em En
| MEDLINE
| ID: mdl-19904267
ABSTRACT
BACKGROUND:
Gemcitabine, oxaliplatin and 5-fluorouracil (5-FU) are active in biliary tract cancer and have a potentially synergistic mode of action and non-overlapping toxicity. The objective of these trials was to determine response, survival and toxicity separately in patients with bile duct cancer (BDC) and gallbladder cancer (GBC) treated with gemcitabine/oxaliplatin/5-FU chemotherapy.METHODS:
Eligible patients with histologically proven, advanced or metastatic BDC (n=37) or GBC (n=35) were treated with gemcitabine (900 mg m(-2) over 30 min), oxaliplatin (65 mg m(-2)) and 5-FU (1500 mg m(-2) over 24 h) on days 1 and 8 of a 21-day cycle. Tumour response was the primary outcome measure.RESULTS:
Response rates were 19% (95% CI 6-32%) and 23% (95% CI 9-37%) for BDC and GBC, respectively. Median survivals were 10.0 months (95% CI 8.6-12.4) and 9.9 months (95% CI 7.5-12.2) for BDC and GBC, respectively, and 1- and 2-year survival rates were 40 and 23% in BDC and 34 and 6% in GBC (intention-to-treat analysis). Major grade III and IV adverse events were neutropenia, thrombocytopenia, elevated bilirubin and anorexia.CONCLUSION:
Triple-drug chemotherapy achieves comparable results for response and survival to previously reported regimens, but with more toxicity.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias dos Ductos Biliares
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Adenocarcinoma
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Neoplasias da Vesícula Biliar
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Antimetabólitos Antineoplásicos
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Br J Cancer
Ano de publicação:
2009
Tipo de documento:
Article
País de afiliação:
Alemanha