gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Fludarabine (Fludara®) ist highly effective and safe treatment of advanced CLL also in elderly and comorbid patients: Interim analysis of a quality assurance documentation in the oncological practice

Meeting Abstract

  • corresponding author presenting/speaker Barbara Tschechne - Gemeinschaftspraxis für Hämatologie und Internistische Onkologie, Lehrte, Deutschland
  • Stefanie Luft - Gemeinschaftspraxis für Hämatologie und Internistische Onkologie, Lehrte
  • Dirk Meyer - Gemeinschaftspraxis für Hämatologie und Internistische Onkologie, Göttingen
  • Klaus Blumenstengel - Gemeinschaftspraxis für Hämatologie und Internistische Onkologie, Eisenach
  • Klaus Ulrich Däßler - Internistische Praxis, Freital
  • Sven Detken - Gemeinschaftspraxis für Hämatologie und Internistische Onkologie, Northeim
  • Felix Marquard - Onkologische Schwerpunktpraxis, Celle
  • Hans F. Hinrichs - Onkolog GmbH, Oldenburg
  • Burkhard Otremba - Gemeinschaftspraxis für Hämatologie und Internistische Onkologie, Oldenburg
  • Hans Werner Tessen - Praxis für Hämatologie und Internistische Onkologie, Goslar
  • Andreas Ammon - Gemeinschaftspraxis für Hämatologie und Internistische Onkologie, Göttingen
  • Peter von Wussow - Praxis für Hämatologie und Internistische Onkologie, Hannover

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO111

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dkk2006/06dkk221.shtml

Veröffentlicht: 20. März 2006

© 2006 Tschechne et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Purpose: The indroduction of purine analogues like Fludarabine (F) into the treatment of newly diagnosed and relapsed CLL has changed the outcome of CLL patients (pts) as compared with alkylating agents. Fludarabine is associated with high response rates and prolonged time to progression. In the present data documentation initiative the efficacy and safety of F in the treatment of advanced CLL under conditions of routine use in oncological practice were investigated. The structured collection and evaluation of treatment data should also lead to a quality assurance and improvement of tumor therapy of CLL pts.

Methods: F could be given as monotherapy in the standard schedule (25 mg/m² days 1-5; q4w, max.6 cycles) or in elderly comorbid pts, pts with reduced creatinine clearance or impaired bone marrow reserve in a reduced schedule (30 mg/m², days 1,3,5; q4-6w, max. 6 cycles).

Results: Until July 2005 36 of 50 planned CLL pts with stage Binet B or C and need for treatment have been enrolled and are evaluable for interim analysis. Median age was 72,5 years (range 43-88 years). 12 pts were male, 24 pts female. 9 pts were untreated, 27 pts had more than one therapy before (median number of prior therapies: 4). 138 cycles of F treatment were applied (mean 4 cycles per patient). 28 pts were treated with the standard dose, 7 pts with a reduced dose and one patient with 5 cycles of standard and 3 cycles of reduced F therapy. 27 pts (75%) responded to F therapy, 6 (17%) with a CR. CR rates were higher in 28 pts treated with the standard dose (21%) compared to pts treated with the reduced dose, but ORR were comparable (71% vs.77%). Hematological WHO grade 1-4 adverse reactions were reported in 40 cycles. Severe myelosuppression consisted of 2,5% anemia grade 3, 18% leucopenia grade 3 and 18% thrombopenia grade 3/4. Two patients developed a hemolysis grade 4 that was likely triggered by the treatment.

Conclusions: F proved to be a highly effective and safe therapy of CLL pts in all pts leading to an improved quality of life. There was also a good effectiveness in comorbid or renally/hematologically impaired pts that were treated less intensively. The tolerability was very good with side effects consisting mainly of mild and reversible myelosuppression. Therefore F represents the treatment of choice for CLL also for elderly or comorbid pts for whom a dose reduced regimen (30 mg/m², days 1,3,5) is a good option.