ArticleClinical pharmacology : advances and applications2013
Differential effects of dosing regimen on the safety and efficacy of dasatinib: retrospective exposure-response analysis of a Phase III study.
Article in Clinical pharmacology : advances and applications, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
62 citing papers in PubMed.
- Incidence, outcomes, and risk factors of pleural effusion in patients receiving dasatinib therapy for Philadelphia chromosome-positive leukemia.Haematologica · 2019Trial
- Plasma concentrations of dasatinib have a clinical impact on the frequency of dasatinib dose reduction and interruption in chronic myeloid leukemia: an analysis of the DARIA 01 study.International journal of clinical oncology · 2018Trial
- Pretreatment evaluation of fluorescence resonance energy transfer-based drug sensitivity test for patients with chronic myelogenous leukemia treated with dasatinib.Cancer science · 2018Trial
- Association of Dasatinib With Progression-Free Survival Among Patients With Advanced Gastrointestinal Stromal Tumors Resistant to Imatinib.JAMA oncology · 2018Trial
- Pharmacokinetics and pharmacodynamics of dasatinib in the chronic phase of newly diagnosed chronic myeloid leukemia.European journal of clinical pharmacology · 2016Trial
- The use of betaine HCl to enhance dasatinib absorption in healthy volunteers with rabeprazole-induced hypochlorhydria.The AAPS journal · 2014Trial
- Efficacy and safety of dasatinib versus imatinib in the East Asian subpopulation of the DASISION trial of newly diagnosed chronic myeloid leukemia in chronic phase.Leukemia & lymphoma · 2014Trial
- Target Attainment and Clinical and Biochemical Parameters Associated with the Pharmacokinetics of 12 Tyrosine Kinase Inhibitors.Clinical pharmacokinetics · 2026Article
- The partner gene modulates response to asciminib in ABL1-rearranged Acute Lymphoblastic Leukemia.Neoplasia (New York, N.Y.) · 2026Article
- Suppression of the myofibroblastic cancer-associated fibroblast phenotype to enhance anti-PD-1 response.Journal of experimental & clinical cancer research : CR · 2026Article
- Characterizing P-glycoprotein and Breast Cancer Resistance Protein interactions of asciminib among other tyrosine kinase inhibitors used in chronic myeloid leukemia.Cancer chemotherapy and pharmacology · 2026Article
- Discovery of potent kinase inhibitors with improved pharmacokinetics and safety potentials through structural optimization of dasatinib.Communications medicine · 2026Article
- Ponatinib inhibits LCK and PI3K signaling and promotes CD8Nature communications · 2026Article
- Evaluation of dasatinib and ponatinib for the control of CD123 CAR-T cell functionalities.Molecular therapy. Oncology · 2025Article
- Severe Impact of Omeprazole Timing on pH-Sensitive Dasatinib Absorption: Unveiling Substantial Drug-Drug Interaction.Journal of clinical pharmacology · 2025Article
- Naringenin Mitigates Dasatinib-Induced Kidney Damage by Modulating Antioxidant Defense, Inflammation, and Apoptosis Pathways.International journal of medical sciences · 2025Article
- Dasatinib Dose Optimization Based on Therapeutic Drug Monitoring in Patients with Chronic-Phase Chronic Myeloid Leukemia.Drug design, development and therapy · 2025Article
- Biopharmaceutical and pharmacokinetic attributes to drive nanoformulations of small molecule tyrosine kinase inhibitors.Asian journal of pharmaceutical sciences · 2024Review
- Varying concentrations of tyrosine kinase inhibitors in chronic myeloid leukemia patients following bariatric surgery: a case series.Annals of hematology · 2024Article
- A physiologically-based pharmacokinetic precision dosing approach to manage dasatinib drug-drug interactions.CPT: pharmacometrics & systems pharmacology · 2024Article
2 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeDasatinib is a prototypic short half-life BCR-ABL1 tyrosine kinase inhibitor. The recommended dose of dasatinib for chronic myeloid leukemia in chronic phase was changed from 70 mg twice daily to 100 mg once daily following a Phase III dose-optimization study. To better understand the superior benefit-risk profile of dasatinib 100 mg once daily, exposure-response was characterized for efficacy (major cytogenetic response) and safety (pleural effusion). PATIENTS AND
methodsDasatinib exposure in patients with chronic myeloid leukemia in chronic phase was determined by population pharmacokinetic analysis of data from seven dasatinib clinical studies (N = 981), including the Phase III dose-optimization study (n = 567). Data from the Phase III study were then used to characterize exposure-response relationships for the four dasatinib treatment regimens investigated (100 mg once daily, 50 mg twice daily, 140 mg once daily, and 70 mg twice daily).
resultsMajor cytogenetic response was significantly (P < 0.01) associated with weighted average steady-state dasatinib plasma concentrations, and pleural effusion was significantly associated with trough concentration. Major cytogenetic response was also significantly associated with maintenance of uninterrupted dosing. The 100 mg once daily arm had the lowest steady-state trough concentration of the four dose arms investigated in the Phase III study, and although this arm also had the lowest weighted average steady-state dasatinib plasma concentration, it had the highest dose maintenance.
conclusionDasatinib dose optimization to 100 mg once daily from 70 mg twice daily significantly minimizes adverse events while maintaining efficacy by exploiting differences in the measures of exposure associated with efficacy and safety.
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