Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer.

2.50
Hdl Handle:
http://hdl.handle.net/10541/76281
Title:
Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer.
Authors:
Rao, S; Cunningham, David; Hawkins, Robert E; Hill, M E; Smith, D; Daniel, F; Ross, P J; Oates, Jeremy E; Norman, A
Abstract:
The 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.
Affiliation:
Department of Medicine, Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT, UK.
Citation:
Phase 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. Cancer
Journal:
British Journal of Cancer
Issue Date:
9-May-2005
URI:
http://hdl.handle.net/10541/76281
DOI:
10.1038/sj.bjc.6602576
PubMed ID:
15856037
Type:
Article
Language:
en
ISSN:
0007-0920
Appears in Collections:
All Paterson Institute for Cancer Research

Full metadata record

DC FieldValue Language
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.en
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

Related articles on PubMed

All Items in Christie are protected by copyright, with all rights reserved, unless otherwise indicated.