Dasatinib (Sprycel) for the first-line therapy of patients with newly diagnosed chronic phase philadelphia chromosome positive chronic myeloid leukemia.
Hintringer K
Record ID 32011000474
English
Authors' objectives:
In October 2010, the EMA granted a positive opinion for the approval of dasatinib for the 1st-line therapy of Philadelphia-chromosome positive CML in the chronic phase (Ph+CML-CP).
The pivotal DASISION trial investigates whether dasatinib 100mg orally once daily is more effective as 1st-line therapy in Ph+ CML-CP patients than the current standard of care – imatinib 400mg orally once daily.
Authors' recommendations:
The results of the trial indicate that dasatinib is clinically more effective than imatinib. The confirmed complete cytogenetic response, the primary endpoint, is 77% vs. 66% (p=0.007) in the dasatinib and imatinib groups, respectively. Progression to the accelerated phase or blast crisis occurred more frequent in the control group (3.5%) compared to the dasatinib group (1.9%). Whereas, haematological adverse events (AEs) occurred more frequent in the dasatinib group than in the imatinib group, the opposite is true for non-haematological AEs - except pleural effusions, these occurred only in dasatinib treated patients.
Despite these first encouraging interim results, further follow-up is essential to provide information on durability of the responses, quality-of- life and to further investigate the safety profile of dasatinib in the 1st-line therapy of CML.
Details
Project Status:
Completed
URL for project:
http://eprints.hta.lbg.ac.at/910/
Year Published:
2011
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
Austria
MeSH Terms
- Humans
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Pyrimidines
- Thiazoles
Contact
Organisation Name:
Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address:
Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99
Contact Name:
tarquin.mittermayr@aihta.at
Contact Email:
office@aihta.at
Copyright:
Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)
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