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Blood, 15 October 2009, Vol. 114, No. 16, pp. 3382-3391. Prepublished online as a Blood First Edition Paper on July 15, 2009; DOI 10.1182/blood-2009-02-206185. This Article Full Text Full Text (PDF) Supplemental Appendix and Figures All Versions of this Article: blood-2009-02-206185v1 114/16/3382    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Google Scholar Articles by Eichhorst, B. F. Articles by Hallek, M. PubMed PubMed Citation Articles by Eichhorst, B. F. Articles by Hallek, M. Related Collections Free Research Articles Lymphoid Neoplasia Clinical Trials and Observations Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia Barbara F. Eichhorst1, Raymonde Busch2, Stephan Stilgenbauer3, Martina Stauch4, Manuela A. Bergmann5, Matthias Ritgen6, Nicole Kranzhöfer7, Robert Rohrberg8, Ulrike Söling9, Oswald Burkhard10, Anne Westermann1, Valentin Goede1, Carmen D. Schweighofer1, Kirsten Fischer1, Anna-Maria Fink1, Clemens M. Wendtner1, Günter Brittinger11, Hartmut Döhner3, Bertold Emmerich12, Michael Hallek1, and the German CLL Study Group (GCLLSG) 1 Department I of Internal Medicine, Centre of Integrated Oncology Köln Bonn, University of Cologne, Cologne; 2 Institute of Medical Statistics and Epidemiology, Technical University, Munich; 3 Department of Internal Medicine III, University of Ulm, Ulm; 4 Private practice, Kronach; 5 Department of Internal Medicine III, University of Munich, Munich; 6 Department of Internal Medicine II, University of Schleswig-Holstein, Kiel; 7 Department of Internal Medicine, University of Saarland, Homburg; 8 Private practice, Halle; 9 Private practice, Kassel; 10 Private practice, Worms; 11 Department of Hematology, University of Duisburg-Essen, Essen; and 12 Department of Internal Medicine Innenstadt, Ludwig-Maximilians-University of Munich, Munich, Germany Although chronic lymphocytic leukemia (CLL) is a disease of elderly patients, subjects older than 65 years are heavily underrepresented in clinical trials. The German CLL study group (GCLLSG) initiated a multicenter phase III trial for CLL patients older than 65 years comparing first-line therapy with fludarabine with chlorambucil. A total of 193 patients with a median age of 70 years were randomized to receive fludarabine (25 mg/m2 for 5 days intravenously, every 28 days, for 6 courses) or chlorambucil (0.4 mg/kg body weight [BW] with an increase to 0.8 mg/kg, every 15 days, for 12 months). Fludarabine resulted in a significantly higher overall and complete remission rate (72% vs 51%, P = .003; 7% vs 0%, P = .011). Time to treatment failure was significantly shorter in the chlorambucil arm (11 vs 18 months; P = .004), but no difference in progression-free survival time was observed (19 months with fludarabine, 18 months with chlorambucil; P = .7). Moreover, fludarabine did not increase the overall survival time (46 months in the fludarabine vs 64 months in the chlorambucil arm; P = .15). Taken together, the results suggest that in elderly CLL patients the first-line therapy with fludarabine alone does not result in a major clinical benefit compared with chlorambucil. This trial is registered with www.isrctn.org under identifier ISRCTN 36294212. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: One step back but 2 steps forward John G. Gribben Blood 2009 114: 3359-3360. [Full Text] [PDF] This article has been cited by other articles: J. G. Gribben One step back but 2 steps forward Blood, October 15, 2009; 114(16): 3359 - 3360. [Full Text] [PDF]

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