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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)
We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100 mg QD or imatinib 400 mg QD and report outcome as an intention-to-treat analysis with 36 months follow-up. Early cytogenetic and molecular responses were superior in the dasatinib group,...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BlackWell Publishing Ltd
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365700/ https://www.ncbi.nlm.nih.gov/pubmed/25082346 http://dx.doi.org/10.1111/ejh.12423 |
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author | Hjorth-Hansen, Henrik Stenke, Leif Söderlund, Stina Dreimane, Arta Ehrencrona, Hans Gedde-Dahl, Tobias Gjertsen, Bjørn Tore Höglund, Martin Koskenvesa, Perttu Lotfi, Kourosh Majeed, Waleed Markevärn, Berit Ohm, Lotta Olsson-Strömberg, Ulla Remes, Kari Suominen, Merja Simonsson, Bengt Porkka, Kimmo Mustjoki, Satu Richter, Johan |
author_facet | Hjorth-Hansen, Henrik Stenke, Leif Söderlund, Stina Dreimane, Arta Ehrencrona, Hans Gedde-Dahl, Tobias Gjertsen, Bjørn Tore Höglund, Martin Koskenvesa, Perttu Lotfi, Kourosh Majeed, Waleed Markevärn, Berit Ohm, Lotta Olsson-Strömberg, Ulla Remes, Kari Suominen, Merja Simonsson, Bengt Porkka, Kimmo Mustjoki, Satu Richter, Johan |
author_sort | Hjorth-Hansen, Henrik |
collection | PubMed |
description | We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100 mg QD or imatinib 400 mg QD and report outcome as an intention-to-treat analysis with 36 months 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, MR(3.0) was reached at 3 months in 36% vs. 8% (P = 0.02), at 12 months in 81% vs. 46% (P = 0.02) and at 18 months in 73% vs. 65% (n.s.) of the patients in the two groups. In contrast, MR(4.5) was consistently superior in the dasatinib group at all time points from 6 months onwards, reaching 61% vs. 21% (P < 0.05) at 36 months. 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. |
format | Online Article Text |
id | pubmed-4365700 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BlackWell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-43657002015-03-23 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 Söderlund, Stina Dreimane, Arta Ehrencrona, Hans Gedde-Dahl, Tobias Gjertsen, Bjørn Tore Höglund, Martin Koskenvesa, Perttu Lotfi, Kourosh Majeed, Waleed Markevärn, Berit Ohm, Lotta Olsson-Strömberg, Ulla Remes, Kari Suominen, Merja Simonsson, Bengt Porkka, Kimmo Mustjoki, Satu Richter, Johan Eur J Haematol Original Articles We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100 mg QD or imatinib 400 mg QD and report outcome as an intention-to-treat analysis with 36 months 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, MR(3.0) was reached at 3 months in 36% vs. 8% (P = 0.02), at 12 months in 81% vs. 46% (P = 0.02) and at 18 months in 73% vs. 65% (n.s.) of the patients in the two groups. In contrast, MR(4.5) was consistently superior in the dasatinib group at all time points from 6 months onwards, reaching 61% vs. 21% (P < 0.05) at 36 months. 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. BlackWell Publishing Ltd 2015-03 2014-09-13 /pmc/articles/PMC4365700/ /pubmed/25082346 http://dx.doi.org/10.1111/ejh.12423 Text en © 2014 The Authors. European Journal of Haematology Published by John Wiley & Sons Ltd. http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Hjorth-Hansen, Henrik Stenke, Leif Söderlund, Stina Dreimane, Arta Ehrencrona, Hans Gedde-Dahl, Tobias Gjertsen, Bjørn Tore Höglund, Martin Koskenvesa, Perttu Lotfi, Kourosh Majeed, Waleed Markevärn, Berit Ohm, Lotta Olsson-Strömberg, Ulla Remes, Kari Suominen, Merja Simonsson, Bengt Porkka, Kimmo Mustjoki, Satu Richter, Johan 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) |
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) |
title_full | 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) |
title_fullStr | 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) |
title_full_unstemmed | 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) |
title_short | 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) |
title_sort | 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) |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365700/ https://www.ncbi.nlm.nih.gov/pubmed/25082346 http://dx.doi.org/10.1111/ejh.12423 |
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