A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202.
Cancer Chemother Pharmacol
; 68(6): 1595-602, 2011 Dec.
Article
em En
| MEDLINE
| ID: mdl-21556747
ABSTRACT
PURPOSE:
Patients with gallbladder cancer or cholangiocarcinoma were treated with the combination of gemcitabine 1,000 mg/m(2) IV over 100 min on days 1 and 8 and capecitabine 650 mg/m(2) BID PO on days 1-14, administered every 21 days.METHODS:
The primary objective of this study was to assess the response rate (confirmed complete and partial responses) of gemcitabine and capecitabine used in advanced/metastatic biliary neoplasms. Secondary objectives included overall survival and toxicities.RESULTS:
The study accrued 57 patients from September 2003 to April 2005. Three patients were ineligible, and two others received no treatment. Characteristics of analyzable patients 35 (67%) cholangiocarcinoma, 17 (33%) gallbladder cancer; PS 0 (18 pts), 1 (26 pts), 2 (8 pts); 26 (50%) men; median age 58.8 years (29.5-85.6). Among 51 patients evaluated for toxicity, 6 experienced grade 4 toxicities. Among 52 patients, there were 7 confirmed partial responses for a confirmed response probability of 13% (95% CI 6-26%). Six patients had an unconfirmed partial response for an overall response probability of 25% (95% CI 14-39%). Twelve patients (23%) demonstrated stable disease. The 6-month overall survival was 55% (95% CI 41-69%), and median survival was 7 months (95% CI 5-8 months).CONCLUSIONS:
The combination of gemcitabine and capecitabine is a well-tolerated regimen with activity in patients with advanced gallbladder cancer and cholangiocarcinoma.
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Base de dados:
MEDLINE
Assunto principal:
Neoplasias dos Ductos Biliares
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Ductos Biliares Intra-Hepáticos
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Protocolos de Quimioterapia Combinada Antineoplásica
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Colangiocarcinoma
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Neoplasias da Vesícula Biliar
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article