Authors' objectives:

This report considers the effectiveness and cost-utility of fludarabine (iv and oral) used as first-line treatment of B-cell chronic lymphocytic leukaemia (CLL) as an alternative to oral chlorambucil.

Authors' results and conclusions: Five trials were identified comparing the use of fludarabine to other first line therapies. One trial provided a comparison between fludarabine and the currently licensed first-line therapy, chlorambucil which was the main comparator of interest. In this trial, fludarabine was found to elicit a higher response rate compared with chlorambucil (60% vs 35%, p<0.001), and induce a longer median duration of progression-free survival ( 20 months vs 14 months, p<0.001). Although there was a trend towards longer median overall survival with fludarabine (66 months vs 56 months) this difference was not statistically significant. Offsetting these benefits were finding of significantly higher incidences of adverse events with fludarabine treatment compared to chlorambucil, especially with the incidence of infections where 16% of fludarabine patients experienced major infections compared with 9% of the chlorambucil-treated patients.

Authors' recommendations: There is early evidence of effectiveness of fludarabine as a first line treatment for CLL based on a single relatively small RCT. Results regarding improved response rates, and longer durations of median time to progression appear promising. The evidence concerning cost utility is inconclusive. The major areas of continuing uncertainty are the extent to which the results of iv fludarabine apply to oral fludarabine use, the impact of fludarabine on overall survival, the incidence, severity and duration of adverse events as a result of oral fludarabine treatment (especially in patients given prophylaxis against adverse events), the impact of fludarabine treatment on overall quality of life, and the costs of fludarabine treatment.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.birmingham.ac.uk/Documents/college-mds/haps/projects/WMHTAC/REPreports/2002/Fludarabine.pdf

Year Published: 2002

URL for published report: http://www.birmingham.ac.uk/research/activity/mds/projects/HaPS/PHEB/WMHTAC/REP/reports-list.aspx

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England

Organisation Name: West Midlands Health Technology Assessment Collaboration

Contact Address: Elaena Donald-Lopez, West Midlands Health Technology Assessment Collaboration, Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham B15 2TT Tel: +44 121 414 7450; Fax: +44 121 414 7878

Contact Name: louise.a.taylor@bham.ac.uk

Contact Email: louise.a.taylor@bham.ac.uk

Copyright: University of Birmingham