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Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006)

Hjorth-Hansen, Henrik; Stenke, Leif; Soderlund, Stina; Dreimane, Arta; Ehrencrona, Hans LU ; Gedde-Dahl, Tobias; Gjertsen, Bjorn Tore; Hoglund, Martin; Koskenvesa, Perttu and Lotfi, Kourosh, et al. (2015) In European Journal of Haematology 94(3). p.243-250
Abstract
We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100mg QD or imatinib 400mg QD and report outcome as an intention-to-treat analysis with 36months follow-up. Early cytogenetic and molecular responses were superior in the dasatinib group, with a tendency that imatinib patients caught up with time. For instance, MR3.0 was reached at 3months in 36% vs. 8% (P=0.02), at 12months in 81% vs. 46% (P=0.02) and at 18months in 73% vs. 65% (n.s.) of the patients in the two groups. In contrast, MR4.5 was consistently superior in the dasatinib group at all time points from 6months onwards, reaching 61% vs. 21% (P<0.05) at 36months. Sixty-four vs. 71% of the patients in the dasatinib and... (More)
We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100mg QD or imatinib 400mg QD and report outcome as an intention-to-treat analysis with 36months follow-up. Early cytogenetic and molecular responses were superior in the dasatinib group, with a tendency that imatinib patients caught up with time. For instance, MR3.0 was reached at 3months in 36% vs. 8% (P=0.02), at 12months in 81% vs. 46% (P=0.02) and at 18months in 73% vs. 65% (n.s.) of the patients in the two groups. In contrast, MR4.5 was consistently superior in the dasatinib group at all time points from 6months onwards, reaching 61% vs. 21% (P<0.05) at 36months. Sixty-four vs. 71% of the patients in the dasatinib and imatinib arms, respectively, remained on assigned drug. Dasatinib dose was frequently reduced, but with maintained excellent effect. One imatinib patient progressed to blastic phase, but no CML-related deaths occurred. In conclusion, our data compare favourably with those of the dasatinib registration study, DASISION. The fast and deep molecular responses induced by dasatinib compared with imatinib may be exploited to increase the proportion of patients who can achieve a treatment-free remission after treatment discontinuation. (Less)
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publication status
published
subject
keywords
dasatinib, imatinib, randomized controlled trial, deep response, toxicity
in
European Journal of Haematology
volume
94
issue
3
pages
243 - 250
publisher
Wiley-Blackwell
external identifiers
  • wos:000350357900008
  • scopus:84923445733
ISSN
1600-0609
DOI
10.1111/ejh.12423
language
English
LU publication?
yes
id
2eae8c78-7324-459c-9ff0-31ec9ace2e3e (old id 5297140)
date added to LUP
2015-05-04 08:32:15
date last changed
2017-10-01 03:16:08
@article{2eae8c78-7324-459c-9ff0-31ec9ace2e3e,
  abstract     = {We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100mg QD or imatinib 400mg QD and report outcome as an intention-to-treat analysis with 36months follow-up. Early cytogenetic and molecular responses were superior in the dasatinib group, with a tendency that imatinib patients caught up with time. For instance, MR3.0 was reached at 3months in 36% vs. 8% (P=0.02), at 12months in 81% vs. 46% (P=0.02) and at 18months in 73% vs. 65% (n.s.) of the patients in the two groups. In contrast, MR4.5 was consistently superior in the dasatinib group at all time points from 6months onwards, reaching 61% vs. 21% (P&lt;0.05) at 36months. Sixty-four vs. 71% of the patients in the dasatinib and imatinib arms, respectively, remained on assigned drug. Dasatinib dose was frequently reduced, but with maintained excellent effect. One imatinib patient progressed to blastic phase, but no CML-related deaths occurred. In conclusion, our data compare favourably with those of the dasatinib registration study, DASISION. The fast and deep molecular responses induced by dasatinib compared with imatinib may be exploited to increase the proportion of patients who can achieve a treatment-free remission after treatment discontinuation.},
  author       = {Hjorth-Hansen, Henrik and Stenke, Leif and Soderlund, Stina and Dreimane, Arta and Ehrencrona, Hans and Gedde-Dahl, Tobias and Gjertsen, Bjorn Tore and Hoglund, Martin and Koskenvesa, Perttu and Lotfi, Kourosh and Majeed, Waleed and Markevarn, Berit and Ohm, Lotta and Olsson-Stromberg, Ulla and Remes, Kari and Suominen, Merja and Simonsson, Bengt and Porkka, Kimmo and Mustjoki, Satu and Richter, Johan},
  issn         = {1600-0609},
  keyword      = {dasatinib,imatinib,randomized controlled trial,deep response,toxicity},
  language     = {eng},
  number       = {3},
  pages        = {243--250},
  publisher    = {Wiley-Blackwell},
  series       = {European Journal of Haematology},
  title        = {Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006)},
  url          = {http://dx.doi.org/10.1111/ejh.12423},
  volume       = {94},
  year         = {2015},
}