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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Published in:European journal of haematology 2015-03, Vol.94 (3), p.243-250
Main Authors: 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
Format: Article
Language:English
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
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Summary: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 
ISSN:0902-4441
1600-0609
1600-0609
DOI:10.1111/ejh.12423