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Five-year molecular response and overall survival with first- and second-generation tyrosine kinase inhibitors in patients with chronic myeloid leukemia in the chronic phase: a prospective, observational study : SIMPLICITY

SIMPLICITY (NCT01244750) was an observational study evaluating first-line (1 L) tyrosine kinase inhibitors (TKIs; dasatinib, nilotinib, imatinib) in patients with chronic myeloid leukemia in the chronic phase in routine clinical practice. At data cutoff (January 28, 2020), 810 prospective US patient...

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Main Authors: Mauro, Michael J. (Author) , Hehlmann, Rüdiger (Author) , Williams, Loretta A. (Author) , Goldberg, Stuart L. (Author) , Michallet, Mauricette (Author) , Gambacorti-Passerini, Carlo (Author) , Tang, Derek (Author) , DeGutis, Irene S. (Author) , McBride, Ali (Author) , Parsons, Lori (Author) , Montelongo, Monica (Author) , Cortes, Jorge E. (Author)
Format: Article (Journal)
Language:English
Published: 22 Jun 2025
In: Leukemia and lymphoma
Year: 2025, Volume: 66, Issue: 9, Pages: 1615-1624
ISSN:1029-2403
DOI:10.1080/10428194.2025.2495369
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1080/10428194.2025.2495369
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Author Notes:Michael J. Mauro, Rüdiger Hehlmann, Loretta A. Williams, Stuart L. Goldberg, Mauricette Michallet, Carlo Gambacorti-Passerini, Derek Tang, Irene S. DeGutis, Ali McBride, Lori Parsons, Monica Montelongo and Jorge E. Cortes
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Summary:SIMPLICITY (NCT01244750) was an observational study evaluating first-line (1 L) tyrosine kinase inhibitors (TKIs; dasatinib, nilotinib, imatinib) in patients with chronic myeloid leukemia in the chronic phase in routine clinical practice. At data cutoff (January 28, 2020), 810 prospective US patients were included/analyzed (dasatinib, 302; nilotinib, 264; imatinib, 244). Within 5 years, 95.4% of patients (dasatinib, 96.5%; nilotinib, 93.5%; imatinib, 95.9%) had major molecular response (BCR::ABL1 ≤ 0.1%), and 79.2% (dasatinib, 79.8%; nilotinib, 81.7%; imatinib, 75.9%) deep molecular response (MR4.5; BCR::ABL1 < 0.0032%) demonstrating major improvement during the study period. Of 734 patients followed for 5 years, 5-year overall survival rate was 89.8% (dasatinib, 92.9%; nilotinib, 88.6%; imatinib, 87.0%); similar to that in randomized studies. Patients who switched treatment had a poorer outcome regardless of TKI, indicating that non-kinase domain mutations may play a role. Despite missing data on outcomes in routine care, these results demonstrate excellent response and survival rates.
Item Description:Gesehen am 02.10.2025
Physical Description:Online Resource
ISSN:1029-2403
DOI:10.1080/10428194.2025.2495369

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