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Erschienen in: Drugs 1/2017

01.01.2017 | Adis Drug Evaluation

Dasatinib: A Review in Chronic Myeloid Leukaemia and Ph+ Acute Lymphoblastic Leukaemia

verfasst von: Gillian M. Keating

Erschienen in: Drugs | Ausgabe 1/2017

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Abstract

Dasatinib (Sprycel®) is an orally administered, small molecule inhibitor of multiple tyrosine kinases. In the phase 3 DASISION trial, dasatinib 100 mg once daily resulted in deeper and faster cytogenetic and molecular responses than imatinib 400 mg once daily in patients with newly diagnosed, chronic-phase chronic myeloid leukaemia (CML), although there was no significant between-group difference in progression-free survival (PFS) or overall survival (OS) in the longer term. In the phase 3 CA180-034 trial, a regimen of dasatinib 100 mg once daily provided the most favourable benefit-risk profile in patients with imatinib-resistant or -intolerant chronic-phase CML. In the phase 3 CA180-035 trial, a regimen of dasatinib 140 mg once daily demonstrated efficacy in patients with accelerated- or blast-phase CML or Ph+ acute lymphoblastic leukaemia (ALL) resistant or intolerant to imatinib. Dasatinib had an acceptable tolerability profile. In conclusion, dasatinib is an important option for the treatment of patients with newly diagnosed chronic-phase CML and for imatinib-resistant or -intolerant patients with chronic- or advanced-phase CML or Ph+ ALL.
Literatur
1.
Zurück zum Zitat National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines): chronic myelogenous leukemia (version 1.2017). 2016. https://www.nccn.org/. Accessed 1 Dec 2016. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines): chronic myelogenous leukemia (version 1.2017). 2016. https://​www.​nccn.​org/​. Accessed 1 Dec 2016.
2.
Zurück zum Zitat National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines): acute lymphoblastic leukemia (version 2.2016). 2016. http://www.nccn.org/. Accessed 1 Dec 2016. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN guidelines): acute lymphoblastic leukemia (version 2.2016). 2016. http://​www.​nccn.​org/​. Accessed 1 Dec 2016.
3.
Zurück zum Zitat Baccarani M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013;122(6):872–84.CrossRefPubMedPubMedCentral Baccarani M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013;122(6):872–84.CrossRefPubMedPubMedCentral
4.
Zurück zum Zitat Lombardo LJ, Lee FY, Chen P, et al. Discovery of N-(2-chloro-6-methyl-phenyl)-2-(6-(4-(2-hydroxyethyl)-piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thiazole-5-carboxamide (BMS-354825), a dual Src/Abl kinase inhibitor with potent antitumor activity in preclinical assays. J Med Chem. 2004;47(27):6658–61.CrossRefPubMed Lombardo LJ, Lee FY, Chen P, et al. Discovery of N-(2-chloro-6-methyl-phenyl)-2-(6-(4-(2-hydroxyethyl)-piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thiazole-5-carboxamide (BMS-354825), a dual Src/Abl kinase inhibitor with potent antitumor activity in preclinical assays. J Med Chem. 2004;47(27):6658–61.CrossRefPubMed
5.
Zurück zum Zitat Rix U, Hantschel O, Dürnberger G, et al. Chemical proteomic profiles of the BCR-ABL inhibitors imatinib, nilotinib, and dasatinib reveal novel kinase and nonkinase targets. Blood. 2007;110(12):4055–63.CrossRefPubMed Rix U, Hantschel O, Dürnberger G, et al. Chemical proteomic profiles of the BCR-ABL inhibitors imatinib, nilotinib, and dasatinib reveal novel kinase and nonkinase targets. Blood. 2007;110(12):4055–63.CrossRefPubMed
6.
Zurück zum Zitat Huang F, Reeves K, Han X, et al. Identification of candidate molecular markers predicting sensitivity in solid tumors to dasatinib: rationale for patient selection. Cancer Res. 2007;67(5):2226–38.CrossRefPubMed Huang F, Reeves K, Han X, et al. Identification of candidate molecular markers predicting sensitivity in solid tumors to dasatinib: rationale for patient selection. Cancer Res. 2007;67(5):2226–38.CrossRefPubMed
7.
Zurück zum Zitat O’Hare T, Walters DK, Stoffregen EP, et al. In vitro activity of Bcr-Abl inhibitors AMN107 and BMS-354825 against clinically relevant imatinib-resistant Abl kinase domain mutants. Cancer Res. 2005;65(11):4500–5.CrossRefPubMed O’Hare T, Walters DK, Stoffregen EP, et al. In vitro activity of Bcr-Abl inhibitors AMN107 and BMS-354825 against clinically relevant imatinib-resistant Abl kinase domain mutants. Cancer Res. 2005;65(11):4500–5.CrossRefPubMed
8.
Zurück zum Zitat Tokarski JS, Newitt JA, Chang CY, et al. The structure of dasatinib (BMS-354825) bound to activated ABL kinase domain elucidates its inhibitory activity against imatinib-resistant ABL mutants. Cancer Res. 2006;66(11):5790–7.CrossRefPubMed Tokarski JS, Newitt JA, Chang CY, et al. The structure of dasatinib (BMS-354825) bound to activated ABL kinase domain elucidates its inhibitory activity against imatinib-resistant ABL mutants. Cancer Res. 2006;66(11):5790–7.CrossRefPubMed
9.
Zurück zum Zitat Shah NP, Skaggs BJ, Branford S, et al. Sequential ABL kinase inhibitor therapy selects for compound drug-resistant BCR-ABL mutations with altered oncogenic potency. J Clin Invest. 2007;117(9):2562–9.CrossRefPubMedPubMedCentral Shah NP, Skaggs BJ, Branford S, et al. Sequential ABL kinase inhibitor therapy selects for compound drug-resistant BCR-ABL mutations with altered oncogenic potency. J Clin Invest. 2007;117(9):2562–9.CrossRefPubMedPubMedCentral
10.
Zurück zum Zitat Shah NP, Tran C, Lee FY, et al. Overriding imatinib resistance with a novel ABL kinase inhibitor. Science. 2004;305(5682):399–401.CrossRefPubMed Shah NP, Tran C, Lee FY, et al. Overriding imatinib resistance with a novel ABL kinase inhibitor. Science. 2004;305(5682):399–401.CrossRefPubMed
11.
Zurück zum Zitat Redaelli S, Piazza R, Rostagno R, et al. Activity of bosutinib, dasatinib, and nilotinib against 18 imatinib-resistant BCR/ABL mutants. J Clin Oncol. 2009;27(3):469–71.CrossRefPubMed Redaelli S, Piazza R, Rostagno R, et al. Activity of bosutinib, dasatinib, and nilotinib against 18 imatinib-resistant BCR/ABL mutants. J Clin Oncol. 2009;27(3):469–71.CrossRefPubMed
12.
Zurück zum Zitat Shah NP, Kasap C, Weier C, et al. Transient potent BCR-ABL inhibition is sufficient to commit chronic myeloid leukemia cells irreversibly to apoptosis. Cancer Cell. 2008;14(6):485–93.CrossRefPubMed Shah NP, Kasap C, Weier C, et al. Transient potent BCR-ABL inhibition is sufficient to commit chronic myeloid leukemia cells irreversibly to apoptosis. Cancer Cell. 2008;14(6):485–93.CrossRefPubMed
13.
Zurück zum Zitat Luo FR, Yang Z, Camuso A, et al. Dasatinib (BMS-354825) pharmacokinetics and pharmacodynamic biomarkers in animal models predict optimal clinical exposure. Clin Cancer Res. 2006;12(23):7180–6.CrossRefPubMed Luo FR, Yang Z, Camuso A, et al. Dasatinib (BMS-354825) pharmacokinetics and pharmacodynamic biomarkers in animal models predict optimal clinical exposure. Clin Cancer Res. 2006;12(23):7180–6.CrossRefPubMed
14.
Zurück zum Zitat Li S. Src-family kinases in the development and therapy of Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia. Leuk Lymphoma. 2008;49(1):19–26.CrossRefPubMedPubMedCentral Li S. Src-family kinases in the development and therapy of Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia. Leuk Lymphoma. 2008;49(1):19–26.CrossRefPubMedPubMedCentral
15.
Zurück zum Zitat Nam S, Kim D, Cheng JQ, et al. Action of the Src family kinase inhibitor, dasatinib (BMS-354825), on human prostate cancer cells. Cancer Res. 2005;65(20):9185–9.CrossRefPubMed Nam S, Kim D, Cheng JQ, et al. Action of the Src family kinase inhibitor, dasatinib (BMS-354825), on human prostate cancer cells. Cancer Res. 2005;65(20):9185–9.CrossRefPubMed
16.
Zurück zum Zitat Mustjoki S, Auvinen K, Kreutzman A, et al. Rapid mobilization of cytotoxic lymphocytes induced by dasatinib therapy. Leukemia. 2013;27(4):914–24.CrossRefPubMed Mustjoki S, Auvinen K, Kreutzman A, et al. Rapid mobilization of cytotoxic lymphocytes induced by dasatinib therapy. Leukemia. 2013;27(4):914–24.CrossRefPubMed
17.
Zurück zum Zitat Kim DH, Kamel-Reid S, Chang H, et al. Natural killer or natural killer/T cell lineage large granular lymphocytosis associated with dasatinib therapy for Philadelphia chromosome positive leukemia. Haematologica. 2009;94(1):135–9.CrossRefPubMed Kim DH, Kamel-Reid S, Chang H, et al. Natural killer or natural killer/T cell lineage large granular lymphocytosis associated with dasatinib therapy for Philadelphia chromosome positive leukemia. Haematologica. 2009;94(1):135–9.CrossRefPubMed
18.
Zurück zum Zitat Qiu ZY, Xu W, Li JY. Large granular lymphocytosis during dasatinib therapy. Cancer Biol Ther. 2014;15(3):247–55.CrossRefPubMed Qiu ZY, Xu W, Li JY. Large granular lymphocytosis during dasatinib therapy. Cancer Biol Ther. 2014;15(3):247–55.CrossRefPubMed
19.
Zurück zum Zitat Schiffer CA, Cortes JE, Hochhaus A, et al. Lymphocytosis after treatment with dasatinib in chronic myeloid leukemia: effects on response and toxicity. Cancer. 2016;122(9):1398–407.CrossRefPubMedPubMedCentral Schiffer CA, Cortes JE, Hochhaus A, et al. Lymphocytosis after treatment with dasatinib in chronic myeloid leukemia: effects on response and toxicity. Cancer. 2016;122(9):1398–407.CrossRefPubMedPubMedCentral
22.
Zurück zum Zitat Quintás-Cardama A, Han X, Kantarjian H, et al. Tyrosine kinase inhibitor-induced platelet dysfunction in patients with chronic myeloid leukemia. Blood. 2009;114(2):261–3.CrossRefPubMedPubMedCentral Quintás-Cardama A, Han X, Kantarjian H, et al. Tyrosine kinase inhibitor-induced platelet dysfunction in patients with chronic myeloid leukemia. Blood. 2009;114(2):261–3.CrossRefPubMedPubMedCentral
23.
Zurück zum Zitat Christopher LJ, Cui D, Wu C, et al. Metabolism and disposition of dasatinib after oral administration to humans. Drug Metab Dispos. 2008;36(7):1357–64.CrossRefPubMed Christopher LJ, Cui D, Wu C, et al. Metabolism and disposition of dasatinib after oral administration to humans. Drug Metab Dispos. 2008;36(7):1357–64.CrossRefPubMed
24.
Zurück zum Zitat Yoshitsugu H, Imai Y, Seriu T, et al. Markov chain Monte Carlo Bayesian analysis for population pharmacokinetics of dasatinib in Japanese adult subjects with chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. Jpn J Clin Pharmacol Ther. 2012;43(1):29–41.CrossRef Yoshitsugu H, Imai Y, Seriu T, et al. Markov chain Monte Carlo Bayesian analysis for population pharmacokinetics of dasatinib in Japanese adult subjects with chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. Jpn J Clin Pharmacol Ther. 2012;43(1):29–41.CrossRef
25.
Zurück zum Zitat Chuah CT, Nakamae H, Shen ZX, et al. 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. Leuk Lymphoma. 2014;55(9):2093–100.CrossRefPubMed Chuah CT, Nakamae H, Shen ZX, et al. 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. Leuk Lymphoma. 2014;55(9):2093–100.CrossRefPubMed
26.
Zurück zum Zitat Cortes JE, Jones D, O’Brien S, et al. Results of dasatinib therapy in patients with early chronic-phase chronic myeloid leukemia. J Clin Oncol. 2010;28(3):398–404.CrossRefPubMed Cortes JE, Jones D, O’Brien S, et al. Results of dasatinib therapy in patients with early chronic-phase chronic myeloid leukemia. J Clin Oncol. 2010;28(3):398–404.CrossRefPubMed
27.
Zurück zum Zitat Radich JP, Kopecky KJ, Appelbaum FR, et al. A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Blood. 2012;120(19):3898–905.CrossRefPubMedPubMedCentral Radich JP, Kopecky KJ, Appelbaum FR, et al. A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Blood. 2012;120(19):3898–905.CrossRefPubMedPubMedCentral
28.
Zurück zum Zitat Kantarjian H, Shah NP, Hochhaus A, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010;362(24):2260–70.CrossRefPubMed Kantarjian H, Shah NP, Hochhaus A, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010;362(24):2260–70.CrossRefPubMed
29.
Zurück zum Zitat Kantarjian HM, Shah NP, Cortes JE, et al. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012;119(5):1123–9.CrossRefPubMedPubMedCentral Kantarjian HM, Shah NP, Cortes JE, et al. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012;119(5):1123–9.CrossRefPubMedPubMedCentral
30.
Zurück zum Zitat Jabbour E, Kantarjian HM, Saglio G, et al. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014;123(4):494–500.CrossRefPubMedPubMedCentral Jabbour E, Kantarjian HM, Saglio G, et al. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014;123(4):494–500.CrossRefPubMedPubMedCentral
31.
Zurück zum Zitat Cortes JE, Saglio G, Kantarjian HM, et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naïve chronic myeloid leukemia patients trial. J Clin Oncol. 2016;34(20):2333–40.CrossRefPubMed Cortes JE, Saglio G, Kantarjian HM, et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naïve chronic myeloid leukemia patients trial. J Clin Oncol. 2016;34(20):2333–40.CrossRefPubMed
32.
Zurück zum Zitat Hughes TP, Saglio G, Quintás-Cardama A, et al. BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase. Leukemia. 2015;29(9):1832–8.CrossRefPubMedPubMedCentral Hughes TP, Saglio G, Quintás-Cardama A, et al. BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase. Leukemia. 2015;29(9):1832–8.CrossRefPubMedPubMedCentral
33.
Zurück zum Zitat Fujisawa S, Nakamae H, Ogura M, et al. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014;99(2):141–53.CrossRefPubMed Fujisawa S, Nakamae H, Ogura M, et al. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014;99(2):141–53.CrossRefPubMed
34.
Zurück zum Zitat Hochhaus A, Kantarjian HM, Baccarani M, et al. Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy. Blood. 2007;109(6):2303–9.CrossRefPubMed Hochhaus A, Kantarjian HM, Baccarani M, et al. Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy. Blood. 2007;109(6):2303–9.CrossRefPubMed
35.
Zurück zum Zitat Guilhot F, Apperley J, Kim D-W, et al. Dasatinib induces significant hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in accelerated phase. Blood. 2007;109(10):4143–50.CrossRefPubMed Guilhot F, Apperley J, Kim D-W, et al. Dasatinib induces significant hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in accelerated phase. Blood. 2007;109(10):4143–50.CrossRefPubMed
36.
Zurück zum Zitat Cortes J, Rousselot P, Kim D-W, et al. Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in blast crisis. Blood. 2007;109(8):3207–13.CrossRefPubMed Cortes J, Rousselot P, Kim D-W, et al. Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in blast crisis. Blood. 2007;109(8):3207–13.CrossRefPubMed
37.
Zurück zum Zitat Ottmann O, Dombret H, Martinelli G, et al. Dasatinib induces rapid hematologic and cytogenetic responses in adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia with resistance or intolerance to imatinib: interim results of a phase 2 study. Blood. 2007;110(7):2309–15.CrossRefPubMed Ottmann O, Dombret H, Martinelli G, et al. Dasatinib induces rapid hematologic and cytogenetic responses in adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia with resistance or intolerance to imatinib: interim results of a phase 2 study. Blood. 2007;110(7):2309–15.CrossRefPubMed
38.
Zurück zum Zitat Talpaz M, Shah NP, Kantarjian H, et al. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med. 2006;354(24):2531–41.CrossRefPubMed Talpaz M, Shah NP, Kantarjian H, et al. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med. 2006;354(24):2531–41.CrossRefPubMed
39.
Zurück zum Zitat Shah NP, Kantarjian HM, Kim D-W, et al. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008;26(19):3204–12.CrossRefPubMed Shah NP, Kantarjian HM, Kim D-W, et al. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008;26(19):3204–12.CrossRefPubMed
40.
Zurück zum Zitat Kantarjian H, Cortes J, Kim D-W, et al. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. Blood. 2009;113(25):6322–9.CrossRefPubMedPubMedCentral Kantarjian H, Cortes J, Kim D-W, et al. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. Blood. 2009;113(25):6322–9.CrossRefPubMedPubMedCentral
41.
Zurück zum Zitat Saglio G, Hochhaus A, Goh YT, et al. Dasatinib in imatinib-resistant or imatinib-intolerant chronic myeloid leukemia in blast phase after 2 years of follow-up in a phase 3 study: efficacy and tolerability of 140 milligrams once daily and 70 milligrams twice daily. Cancer. 2010;116(16):3852–61.CrossRefPubMedPubMedCentral Saglio G, Hochhaus A, Goh YT, et al. Dasatinib in imatinib-resistant or imatinib-intolerant chronic myeloid leukemia in blast phase after 2 years of follow-up in a phase 3 study: efficacy and tolerability of 140 milligrams once daily and 70 milligrams twice daily. Cancer. 2010;116(16):3852–61.CrossRefPubMedPubMedCentral
42.
Zurück zum Zitat Lilly MB, Ottmann OG, Shah NP, et al. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: results from a phase 3 study. Am J Hematol. 2010;85(3):164–70.PubMed Lilly MB, Ottmann OG, Shah NP, et al. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: results from a phase 3 study. Am J Hematol. 2010;85(3):164–70.PubMed
43.
Zurück zum Zitat Shah NP, Rousselot P, Schiffer C, et al. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034. Am J Hematol. 2016;91(9):869–74.CrossRefPubMedPubMedCentral Shah NP, Rousselot P, Schiffer C, et al. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034. Am J Hematol. 2016;91(9):869–74.CrossRefPubMedPubMedCentral
44.
Zurück zum Zitat Shah NP, Kim D-W, Kantarjian H, et al. Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib. Haematologica. 2010;95(2):232–40.CrossRefPubMedPubMedCentral Shah NP, Kim D-W, Kantarjian H, et al. Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib. Haematologica. 2010;95(2):232–40.CrossRefPubMedPubMedCentral
45.
Zurück zum Zitat Shah NP, Guilhot F, Cortes JE, et al. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014;123(15):2317–24.CrossRefPubMedPubMedCentral Shah NP, Guilhot F, Cortes JE, et al. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014;123(15):2317–24.CrossRefPubMedPubMedCentral
46.
Zurück zum Zitat Steegmann JL, Baccarani M, Breccia M, et al. European LeukemiaNet recommendations for the management and avoidance of adverse events of treatment in chronic myeloid leukaemia. Leukemia. 2016;30(8):1648–71.CrossRefPubMedPubMedCentral Steegmann JL, Baccarani M, Breccia M, et al. European LeukemiaNet recommendations for the management and avoidance of adverse events of treatment in chronic myeloid leukaemia. Leukemia. 2016;30(8):1648–71.CrossRefPubMedPubMedCentral
47.
Zurück zum Zitat Shah NP, Wallis N, Farber HW, et al. Clinical features of pulmonary arterial hypertension in patients receiving dasatinib. Am J Hematol. 2015;90(11):1060–4.CrossRefPubMed Shah NP, Wallis N, Farber HW, et al. Clinical features of pulmonary arterial hypertension in patients receiving dasatinib. Am J Hematol. 2015;90(11):1060–4.CrossRefPubMed
48.
Zurück zum Zitat Morishita S, Hagihara M, Itabashi M, et al. Development of pulmonary arterial hypertension during oral dasatinib therapy for chronic myelogenous leukemia. Rinsho Ketsueki. 2016;57(8):999–1003.PubMed Morishita S, Hagihara M, Itabashi M, et al. Development of pulmonary arterial hypertension during oral dasatinib therapy for chronic myelogenous leukemia. Rinsho Ketsueki. 2016;57(8):999–1003.PubMed
49.
Zurück zum Zitat Ando T, Kojima K, Isoda H, et al. Reactivation of resolved infection with the hepatitis B virus immune escape mutant G145R during dasatinib treatment for chronic myeloid leukemia. Int J Hematol. 2015;102(3):379–82.CrossRefPubMed Ando T, Kojima K, Isoda H, et al. Reactivation of resolved infection with the hepatitis B virus immune escape mutant G145R during dasatinib treatment for chronic myeloid leukemia. Int J Hematol. 2015;102(3):379–82.CrossRefPubMed
50.
Zurück zum Zitat Soverini S, Hochhaus A, Nicolini FE, et al. BCR-ABL kinase domain mutation analysis in chronic myeloid leukemia patients treated with tyrosine kinase inhibitors: recommendations from an expert panel on behalf of European LeukemiaNet. Blood. 2011;118(5):1208–15.CrossRefPubMed Soverini S, Hochhaus A, Nicolini FE, et al. BCR-ABL kinase domain mutation analysis in chronic myeloid leukemia patients treated with tyrosine kinase inhibitors: recommendations from an expert panel on behalf of European LeukemiaNet. Blood. 2011;118(5):1208–15.CrossRefPubMed
51.
Zurück zum Zitat Miura M. Therapeutic drug monitoring of imatinib, nilotinib, and dasatinib for patients with chronic myeloid leukemia. Biol Pharm Bull. 2015;38(5):645–54.CrossRefPubMed Miura M. Therapeutic drug monitoring of imatinib, nilotinib, and dasatinib for patients with chronic myeloid leukemia. Biol Pharm Bull. 2015;38(5):645–54.CrossRefPubMed
52.
Zurück zum Zitat Wang X, Roy A, Hochhaus A, et al. Differential effects of dosing regimen on the safety and efficacy of dasatinib: retrospective exposure-response analysis of a phase III study. Clin Pharmacol Adv Appl. 2013;5:85–97. Wang X, Roy A, Hochhaus A, et al. Differential effects of dosing regimen on the safety and efficacy of dasatinib: retrospective exposure-response analysis of a phase III study. Clin Pharmacol Adv Appl. 2013;5:85–97.
53.
Zurück zum Zitat Porkka K, Khoury HJ, Paquette RL, et al. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer. 2010;116(2):377–86.CrossRefPubMedPubMedCentral Porkka K, Khoury HJ, Paquette RL, et al. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer. 2010;116(2):377–86.CrossRefPubMedPubMedCentral
54.
Zurück zum Zitat Rousselot P, Mollica L, Guerci-Bresler A, et al. Dasatinib daily dose optimization based on residual drug levels resulted in reduced risk of pleural effusions and high molecular response rates: final results of the randomized OPTIM dasatinib trial [abstract no. S678]. Haematologica. 2014;99(Suppl 1):237–8. Rousselot P, Mollica L, Guerci-Bresler A, et al. Dasatinib daily dose optimization based on residual drug levels resulted in reduced risk of pleural effusions and high molecular response rates: final results of the randomized OPTIM dasatinib trial [abstract no. S678]. Haematologica. 2014;99(Suppl 1):237–8.
55.
Zurück zum Zitat Imagawa J, Tanaka H, Okada M, et al. Discontinuation of dasatinib in patients with chronic myeloid leukaemia who have maintained deep molecular response for longer than 1 year (DADI trial): a multicentre phase 2 trial. Lancet Haematol. 2015;2(12):e528–35.CrossRefPubMed Imagawa J, Tanaka H, Okada M, et al. Discontinuation of dasatinib in patients with chronic myeloid leukaemia who have maintained deep molecular response for longer than 1 year (DADI trial): a multicentre phase 2 trial. Lancet Haematol. 2015;2(12):e528–35.CrossRefPubMed
56.
Zurück zum Zitat Shah NP, Paquette R, Müller MC, et al. Treatment-free remission (TFR) in patients with chronic phase chronic myeloid leukemia (CML-CP) and in stable deep molecular response (DMR) to dasatinib: the DASFREE study [abstract no. 1895]. In: ASH 58th annual meeting and exposition. 2016. Shah NP, Paquette R, Müller MC, et al. Treatment-free remission (TFR) in patients with chronic phase chronic myeloid leukemia (CML-CP) and in stable deep molecular response (DMR) to dasatinib: the DASFREE study [abstract no. 1895]. In: ASH 58th annual meeting and exposition. 2016.
57.
Zurück zum Zitat Kumagai T, Nakaseko C, Nishiwaki K, et al. Discontinuation of dasatinib after deep molecular response for over 2 years in patients with chronic myelogenous leukemia and the unique profiles of lymphocyte subsets for successful discontinuation: a prospective, multicenter Japanese trial (D-STOP trial) [abstract no. 791]. In: ASH 58th annual meeting and exposition. 2016. Kumagai T, Nakaseko C, Nishiwaki K, et al. Discontinuation of dasatinib after deep molecular response for over 2 years in patients with chronic myelogenous leukemia and the unique profiles of lymphocyte subsets for successful discontinuation: a prospective, multicenter Japanese trial (D-STOP trial) [abstract no. 791]. In: ASH 58th annual meeting and exposition. 2016.
58.
Zurück zum Zitat Rousselot P, Etienne G, Coiteux V, et al. Attempt to early discontinue dasatinib first line in chronic phase CML patients in early molecular response and included in the prospective OPTIM-dasatinib trial [abstract no. P599]. Haematologica. 2015;100(Suppl 1):230. Rousselot P, Etienne G, Coiteux V, et al. Attempt to early discontinue dasatinib first line in chronic phase CML patients in early molecular response and included in the prospective OPTIM-dasatinib trial [abstract no. P599]. Haematologica. 2015;100(Suppl 1):230.
59.
Zurück zum Zitat Santos FPS, Kantarjian H, Fava C, et al. Clinical impact of dose reductions and interruptions of second-generation tyrosine kinase inhibitors in patients with chronic myeloid leukaemia. Br J Haematol. 2010;150(3):303–12.CrossRefPubMedPubMedCentral Santos FPS, Kantarjian H, Fava C, et al. Clinical impact of dose reductions and interruptions of second-generation tyrosine kinase inhibitors in patients with chronic myeloid leukaemia. Br J Haematol. 2010;150(3):303–12.CrossRefPubMedPubMedCentral
Metadaten
Titel
Dasatinib: A Review in Chronic Myeloid Leukaemia and Ph+ Acute Lymphoblastic Leukaemia
verfasst von
Gillian M. Keating
Publikationsdatum
01.01.2017
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 1/2017
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-016-0677-x

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