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Cladribine prolongs progression-free survival and time to second treatment compared to fludarabine and high-dose chlorambucil in chronic lymphocytic

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Author

  • Stephen P. Mulligan
  • Karin Karlsson
  • Mats Stromberg
  • Viggo Jonsson
  • Devinder Gill
  • Jens Hammerstrom
  • Mark Hertzberg
  • Roger McLennan
  • Bertil Uggla
  • John Norman
  • Jonas Wallvik
  • Gunnel Sundstrom
  • Hemming Johansson
  • Yvonne Brandberg
  • Jan Liliemark
  • Gunnar Juliusson
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Summary, in English

We conducted a randomized phase III trial to compare the efficacy and safety of two purine analogs, cladribine and fludarabine, with high-dose chlorambucil, in patients with previously untreated chronic lymphocytic leukemia (CLL). Between 1997 and 2004, 223 patients with CLL were randomly assigned to cladribine, fludarabine or chlorambucil, for six cycles of therapy with frequent health-related quality of life assessments. There was no statistical difference for the primary endpoint of overall response with cladribine (70%), fludarabine (67%) and chlorambucil (59%), or complete remission (12%, 7% and 8%), respectively. However, the median progression-free survival (25, 10, 9 months) and median time to second treatment (40, 22, 21 months) were superior with cladribine. There was no significant difference in overall survival (96, 82 and 91 months), nor in toxicity or HRQoL assessments. Monotherapy with cladribine gives superior PFS and longer response duration than fludarabine and chlorambucil as first-line treatment of CLL.

Department/s

  • Stem Cell Center
  • BioCARE: Biomarkers in Cancer Medicine improving Health Care, Education and Innovation

Publishing year

2014

Language

English

Pages

2769-2777

Publication/Series

Leukemia & Lymphoma

Volume

55

Issue

12

Document type

Journal article

Publisher

Taylor & Francis

Topic

  • Cancer and Oncology

Keywords

  • Lymphoid leukemia
  • chemotherapeutic approaches
  • pharmacotherapeutics
  • CLL

Status

Published

ISBN/ISSN/Other

  • ISSN: 1042-8194