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dc.contributor.authorRao, S
dc.contributor.authorCunningham, David
dc.contributor.authorHawkins, Robert E
dc.contributor.authorHill, M E
dc.contributor.authorSmith, D
dc.contributor.authorDaniel, F
dc.contributor.authorRoss, P J
dc.contributor.authorOates, Jeremy E
dc.contributor.authorNorman, A
dc.date.accessioned2009-08-04T17:24:18Z
dc.date.available2009-08-04T17:24:18Z
dc.date.issued2005-05-09
dc.identifier.citationPhase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. 2005, 92 (9):1650-4 Br. J. Canceren
dc.identifier.issn0007-0920
dc.identifier.pmid15856037
dc.identifier.doi10.1038/sj.bjc.6602576
dc.identifier.urihttp://hdl.handle.net/10541/76281
dc.description.abstractThe purpose of this study was to determine whether epirubicin, cisplatin and infused 5FU (ECF) improves overall survival (OS) compared to 5FU, etoposide and leucovorin (FELV) in patients with previously untreated advanced biliary cancer in a prospective randomised study. Patients were randomly assigned to receive epirubicin, cisplatin and infused 5FU ECF or bolus 5FU etoposide and leucovorin (FELV). The primary end point was OS with secondary end points of objective response rate (ORR), failure-free survival (FFS), quality of life (QOL) and toxicity. In all, 54 patients were recruited with 27 randomly assigned to each arm. The median OS for ECF was 9.02 months (95% confidence interval (CI): 6.46-11.51) and FELV 12.03 months (95% CI: 9.3-14.7), P=0.2059. Objective response rates were similar for both arms: ECF 19.2% (95% CI: 6.55-39.3); FELV 15% (95% CI: 3.2-37.9), P=0.72. There was significantly increased grade 3/4 neutropenia with FELV vs ECF (53.8 vs 29.5%, respectively, P=0.020). Symptom resolution was impressive for both regimens. This is the largest reported randomised study to date in this setting. ECF did not improve OS compared to FELV, but was associated with less acute toxicity. These data suggest that chemotherapy can prolong OS and achieve good symptomatic relief in advanced biliary cancer.
dc.language.isoenen
dc.subjectBiliary Tract Canceren
dc.subjectAnticancer Combined Chemotherapy Protocolsen
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshBiliary Tract Neoplasms
dc.subject.meshEtoposide
dc.subject.meshFemale
dc.subject.meshFluorouracil
dc.subject.meshHumans
dc.subject.meshLeucovorin
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshSurvival Analysis
dc.subject.meshTime Factors
dc.titlePhase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer.en
dc.typeArticleen
dc.contributor.departmentDepartment of Medicine, Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT, UK.en
dc.identifier.journalBritish Journal of Canceren
html.description.abstractThe purpose of this study was to determine whether epirubicin, cisplatin and infused 5FU (ECF) improves overall survival (OS) compared to 5FU, etoposide and leucovorin (FELV) in patients with previously untreated advanced biliary cancer in a prospective randomised study. Patients were randomly assigned to receive epirubicin, cisplatin and infused 5FU ECF or bolus 5FU etoposide and leucovorin (FELV). The primary end point was OS with secondary end points of objective response rate (ORR), failure-free survival (FFS), quality of life (QOL) and toxicity. In all, 54 patients were recruited with 27 randomly assigned to each arm. The median OS for ECF was 9.02 months (95% confidence interval (CI): 6.46-11.51) and FELV 12.03 months (95% CI: 9.3-14.7), P=0.2059. Objective response rates were similar for both arms: ECF 19.2% (95% CI: 6.55-39.3); FELV 15% (95% CI: 3.2-37.9), P=0.72. There was significantly increased grade 3/4 neutropenia with FELV vs ECF (53.8 vs 29.5%, respectively, P=0.020). Symptom resolution was impressive for both regimens. This is the largest reported randomised study to date in this setting. ECF did not improve OS compared to FELV, but was associated with less acute toxicity. These data suggest that chemotherapy can prolong OS and achieve good symptomatic relief in advanced biliary cancer.


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