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

Mulligan, Stephen P.; Karlsson, Karin LU ; Stromberg, Mats; Jonsson, Viggo; Gill, Devinder; Hammerstrom, Jens; Hertzberg, Mark; McLennan, Roger; Uggla, Bertil and Norman, John, et al. (2014) In Leukemia & Lymphoma 55(12). p.2769-2777
Abstract
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)... (More)
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. (Less)
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publication status
published
subject
keywords
Lymphoid leukemia, chemotherapeutic approaches, pharmacotherapeutics, CLL
in
Leukemia & Lymphoma
volume
55
issue
12
pages
2769 - 2777
publisher
Taylor & Francis
external identifiers
  • wos:000346571100016
  • scopus:84919414874
ISSN
1042-8194
DOI
10.3109/10428194.2014.893306
language
English
LU publication?
yes
id
00a5bd0c-e10d-402a-95c5-fc843d118213 (old id 4944703)
date added to LUP
2015-02-03 07:06:38
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2017-01-01 05:53:47
@article{00a5bd0c-e10d-402a-95c5-fc843d118213,
  abstract     = {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.},
  author       = {Mulligan, Stephen P. and Karlsson, Karin and Stromberg, Mats and Jonsson, Viggo and Gill, Devinder and Hammerstrom, Jens and Hertzberg, Mark and McLennan, Roger and Uggla, Bertil and Norman, John and Wallvik, Jonas and Sundstrom, Gunnel and Johansson, Hemming and Brandberg, Yvonne and Liliemark, Jan and Juliusson, Gunnar},
  issn         = {1042-8194},
  keyword      = {Lymphoid leukemia,chemotherapeutic approaches,pharmacotherapeutics,CLL},
  language     = {eng},
  number       = {12},
  pages        = {2769--2777},
  publisher    = {Taylor & Francis},
  series       = {Leukemia & Lymphoma},
  title        = {Cladribine prolongs progression-free survival and time to second treatment compared to fludarabine and high-dose chlorambucil in chronic lymphocytic},
  url          = {http://dx.doi.org/10.3109/10428194.2014.893306},
  volume       = {55},
  year         = {2014},
}