Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias
Open accessAbstract
BACKGROUND: The BCR-ABL tyrosine kinase inhibitor imatinib is effective in Philadelphia chromosome-positive (Ph-positive) leukemias, but relapse occurs, mainly as a result of the outgrowth of leukemic subclones with imatinib-resistant BCR-ABL mutations. We evaluated dasatinib, a BCR-ABL inhibitor that targets most imatinib-resistant BCR-ABL mutations, in patients with chronic myelogenous leukemia (CML) or Ph-positive acute lymphoblastic leukemia (ALL). METHODS: Patients with various phases of CML or with Ph-positive ALL who could not tolerate or were resistant to imatinib were enrolled in a phase 1 dose-escalation study. Dasatinib (15 to 240 mg per day) was administered orally in four-week treatment cycles, once or twice daily. RESULTS: A complete hematologic response was achieved in 37 of 40 patients with chronic-phase CML, and major hematologic responses were seen in 31 of 44 patients with accelerated-phase CML, CML with blast crisis, or Ph-positive ALL. In these two phases, the rates of major cytogenetic response were 45 percent and 25 percent, respectively. Responses were maintained in 95 percent of patients with chronic-phase disease and in 82 percent of patients with accelerated-phase disease, with a median follow-up more than 12 months and 5 months, respectively. Nearly all patients with lymphoid blast crisis and Ph-positive ALL had a relapse within six months. Responses occurred among all BCR-ABL genotypes, with the exception of the T315I mutation, which confers resistance to both dasatinib and imatinib in vitro. Myelosuppression was common but not dose-limiting. CONCLUSIONS: Dasatinib induces hematologic and cytogenetic responses in patients with CML or Ph-positive ALL who cannot tolerate or are resistant to imatinib. (ClinicalTrials.gov number, NCT00064233 [ClinicalTrials.gov].).
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Dasatinib is an inhibitor of multiple tyrosine kinases with a mechanism linked to broad targeting of Src kinases, and is indicated as a second-line chemotherapeutic for chronic myeloid leukemia resistant to imatinib.
“Dasatinib is an inhibitor of multiple tyrosine kinases with mechanism of action linked to a broad targeting of Src kinases, and is currently indicated for use as a second line chemotherapeutic agent for treatment of chronic myeloid leukemia resistant to another tyrosine kinase inhibitor, imatinib.15,16”
From Senolytics dasatinib and quercetin in idiopathic pulmonary fibrosis: results of a phase I, single-blind, single-center, randomized, placebo-controlled pilot trial on feasibility and tolerability (2023) · cites this paper as [16]
The introduction describes dasatinib as inhibiting a distinct spectrum of kinases, and the study reports responses in patients with imatinib-resistant CML (Abstract; page unavailable). The paper does not establish that broad Src targeting is its mechanism of action or state that dasatinib was indicated as an approved second-line treatment; it was a phase 1 study. (LLM, conf=0.86)
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- Authors
- Talpaz, M., Shah, N. P., Kantarjian, H., Donato, N., Nicoll, J., Paquette, R., Cortes, J., O'Brien, S., Nicaise, C., Bleickardt, E., Blackwood-Chirchir, M. A., Iyer, V., Chen, T.-T., Huang, F., Decillis, A. P., & Sawyers, C. L.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- University of California, Los Angeles (US)
- Bristol-Myers Squibb (United States) (US)
- Howard Hughes Medical Institute (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2006-06-15
- Volume
- 354
- Issue
- 24
- Pages
- 2531-2541
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1994309500
- Cited by
- 1,760
- References
- 32
- Citations by year
- 2026: 27 · 2025: 25 · 2024: 36 · 2023: 44 · 2022: 77 · 2021: 52 · 2020: 51 · 2019: 48 · 2018: 60 · 2017: 70 · 2016: 74 · 2015: 62 · 2014: 77 · 2013: 87 · 2012: 121
- FWCI
- 120.02
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Center for Research Resources ((M01 RR00865), M01RR000865)
- Topics
- Health Sciences › Medicine › Hematology › Chronic Myeloid Leukemia Treatments
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Keywords
- dasatinib, imatinib resistance, Philadelphia chromosome-positive leukemia, chronic myeloid leukemia, BCR-ABL tyrosine kinase inhibitors, T315I mutation, cytogenetic response, hematologic response, relapse, myelosuppression, dose escalation
- MeSH terms
- Imatinib Mesylate, Dasatinib, Adolescent, Adult, Aged, Antineoplastic Agents, Benzamides, Female, Genotype, Humans, Male, Middle Aged, Mutation, Neutropenia, Piperazines, Protein-Tyrosine Kinases, Pyrimidines, Thiazoles, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Fusion Proteins, bcr-abl, Drug Resistance, Neoplasm, Protein Kinase Inhibitors, Precursor Cell Lymphoblastic Leukemia-Lymphoma
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