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,...
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| Veröffentlicht in: | European journal of haematology 2015-03, Vol.94 (3), p.243-250 |
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| creator | 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 |
| 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, MR3.0 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, MR4.5 was consistently superior in the dasatinib group at all time points from 6 months onwards, reaching 61% vs. 21% (P |
| doi_str_mv | 10.1111/ejh.12423 |
| format | Article |
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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 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, MR4.5 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.</description><identifier>ISSN: 0902-4441</identifier><identifier>ISSN: 1600-0609</identifier><identifier>EISSN: 1600-0609</identifier><identifier>DOI: 10.1111/ejh.12423</identifier><identifier>PMID: 25082346</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Antineoplastic Agents - therapeutic use ; Benzamides - therapeutic use ; Clinical Medicine ; Dasatinib ; deep response ; Drug Administration Schedule ; Female ; Follow-Up Studies ; Fusion Proteins, bcr-abl - antagonists & inhibitors ; Fusion Proteins, bcr-abl - genetics ; Fusion Proteins, bcr-abl - metabolism ; Gene Expression ; Hematologi ; Hematology ; Humans ; Hydroxyurea - therapeutic use ; imatinib ; Imatinib Mesylate ; Klinisk medicin ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - genetics ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - mortality ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - pathology ; Male ; Medical and Health Sciences ; Medicin och hälsovetenskap ; Middle Aged ; Original ; Piperazines - therapeutic use ; Protein Kinase Inhibitors - therapeutic use ; Pyrimidines - therapeutic use ; randomized controlled trial ; Remission Induction ; Risk ; Survival Analysis ; Thiazoles - therapeutic use ; toxicity</subject><ispartof>European journal of haematology, 2015-03, Vol.94 (3), p.243-250</ispartof><rights>2014 The Authors. Published by John Wiley & Sons Ltd.</rights><rights>2014 The Authors. European Journal of Haematology Published by John Wiley & Sons Ltd.</rights><rights>2014 The Authors. 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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 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, MR4.5 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.</description><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Benzamides - therapeutic use</subject><subject>Clinical Medicine</subject><subject>Dasatinib</subject><subject>deep response</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Fusion Proteins, bcr-abl - antagonists & inhibitors</subject><subject>Fusion Proteins, bcr-abl - genetics</subject><subject>Fusion Proteins, bcr-abl - metabolism</subject><subject>Gene Expression</subject><subject>Hematologi</subject><subject>Hematology</subject><subject>Humans</subject><subject>Hydroxyurea - therapeutic use</subject><subject>imatinib</subject><subject>Imatinib Mesylate</subject><subject>Klinisk medicin</subject><subject>Leukemia, Myelogenous, Chronic, BCR-ABL Positive - 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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 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, MR4.5 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.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>25082346</pmid><doi>10.1111/ejh.12423</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0902-4441 |
| ispartof | European journal of haematology, 2015-03, Vol.94 (3), p.243-250 |
| issn | 0902-4441 1600-0609 1600-0609 |
| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_519868 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; SWEPUB Freely available online |
| subjects | Adult Aged Antineoplastic Agents - therapeutic use Benzamides - therapeutic use Clinical Medicine Dasatinib deep response Drug Administration Schedule Female Follow-Up Studies Fusion Proteins, bcr-abl - antagonists & inhibitors Fusion Proteins, bcr-abl - genetics Fusion Proteins, bcr-abl - metabolism Gene Expression Hematologi Hematology Humans Hydroxyurea - therapeutic use imatinib Imatinib Mesylate Klinisk medicin Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy Leukemia, Myelogenous, Chronic, BCR-ABL Positive - genetics Leukemia, Myelogenous, Chronic, BCR-ABL Positive - mortality Leukemia, Myelogenous, Chronic, BCR-ABL Positive - pathology Male Medical and Health Sciences Medicin och hälsovetenskap Middle Aged Original Piperazines - therapeutic use Protein Kinase Inhibitors - therapeutic use Pyrimidines - therapeutic use randomized controlled trial Remission Induction Risk Survival Analysis Thiazoles - therapeutic use toxicity |
| 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 | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-09T05%3A11%3A08IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Dasatinib%20induces%20fast%20and%20deep%20responses%20in%20newly%20diagnosed%20chronic%20myeloid%20leukaemia%20patients%20in%20chronic%20phase:%20clinical%20results%20from%20a%20randomised%20phase-2%20study%20(NordCML006)&rft.jtitle=European%20journal%20of%20haematology&rft.au=Hjorth-Hansen,%20Henrik&rft.aucorp=Nordic%20CML%20Study%20Group&rft.date=2015-03&rft.volume=94&rft.issue=3&rft.spage=243&rft.epage=250&rft.pages=243-250&rft.issn=0902-4441&rft.eissn=1600-0609&rft_id=info:doi/10.1111/ejh.12423&rft_dat=%3Cproquest_swepu%3E1658706205%3C/proquest_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1658706205&rft_id=info:pmid/25082346&rfr_iscdi=true |