Dasatinib dosing strategies in Philadelphia chromosome-positive leukemia

Journal of Oncology Pharmacy Practice

Volumn 15, Issue 1, 2009, Pages 17-27

  Wong, Siu Fun ^a  

^a WESTERN UNIVERSITY OF HEALTH SCIENCES   (United States)

Author keywords

BCR ABL; Chronic myelogenous leukemia; Cytogenetic; Dasatinib; Dosing; Hematologic; Philadelphia chromosome

Indexed keywords

AMIODARONE; ANTACID AGENT; CARBAMAZEPINE; CIMETIDINE; CIPROFLOXACIN; CLARITHROMYCIN; DASATINIB; DELAVIRDINE; DEXAMETHASONE; DIAZEPAM; DILTIAZEM; EFAVIRENZ; ERYTHROMYCIN; FLUCONAZOLE; FLUVOXAMINE; HISTAMINE H2 RECEPTOR ANTAGONIST; IMATINIB; INDINAVIR; MODAFINIL; NEVIRAPINE; OMEPRAZOLE; PHENOBARBITAL; PHENYTOIN; PROTON PUMP INHIBITOR; QUINIDINE; RIFABUTIN; RIFAMPICIN; SAQUINAVIR; UNINDEXED DRUG;

ACUTE LYMPHOCYTIC LEUKEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLEEDING; CARDIOMYOPATHY; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; CONGESTIVE CARDIOMYOPATHY; CONGESTIVE HEART FAILURE; CYTOPENIA; DIARRHEA; DIASTOLIC DYSFUNCTION; DOSAGE SCHEDULE COMPARISON; DRUG ANTAGONISM; DRUG COST; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDICATION; DRUG INDUCED HEADACHE; DRUG MANUFACTURE; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; DRUG STORAGE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EVENING DOSAGE; FATIGUE; FEVER; FLUID RETENTION; HEART EJECTION FRACTION; HEART FAILURE; HEART LEFT VENTRICLE FAILURE; HUMAN; LUNG EDEMA; MORNING DOSAGE; MYALGIA; NAUSEA; NEUTROPENIA; PATIENT COUNSELING; PATIENT MONITORING; PERICARDIAL EFFUSION; PERIPHERAL EDEMA; PHILADELPHIA CHROMOSOME POSITIVE CELL; PLEURA EFFUSION; PRIORITY JOURNAL; PULMONARY HYPERTENSION; RASH; RECOMMENDED DRUG DOSE; SIDE EFFECT; THROMBOCYTOPENIA; VOMITING;

CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG INTERACTIONS; DRUG RESISTANCE, NEOPLASM; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; PHILADELPHIA CHROMOSOME; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PROTEIN KINASE INHIBITORS; PYRIMIDINES; THIAZOLES;

EID: 61749090534     PISSN: 10781552     EISSN: None     Source Type: Journal    
DOI: 10.1177/1078155208094455     Document Type: Article

References (55)

1. Sawyers CL Chronic myeloid leukemia. N Engl J Med 1999; 340: 1330-40.
2. Jemal A., Siegel R., Ward E. et al. Cancer statistics, 2006. CA Cancer J Clin 2006; 56: 106-30.
3. Faderl S., Talpaz M., Estrov Z. et al. The biology of chronic myeloid leukemia. N Engl J Med 1999; 341: 164-72.
4. Druker BJ, Tamura S., Buchdunger E. et al. Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells. Nat Med 1996; 2: 561-6.
5. Hahn EA, Glendenning GA, Sorensen MV et al. IRIS Investigators. Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: results from the IRIS Study. J Clin Oncol 2003; 21: 2138-46.
6. Druker BJ, Guilhot F., O'Brien SG et al. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med 2006; 355: 2408-17.
7. O'Brien SG, Guilhot F., Larson RA et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 2003; 348: 994-1004.
8. Sawyers CL, Hochhaus A., Feldman E. et al. Imatinib induces hematologic and cytogenetic responses in patients with chronic myelogenous leukemia in myeloid blast crisis: Results of a phase II study. Blood 2002; 99: 3530-9.
9. Talpaz M., Silver RT, Druker BJ et al. Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: Results of a phase 2 study. Blood 2002; 99: 1928-37.
10. Ault P., Kaled S., Rios MB Management of molecular-targeted therapy for chronic myelogenous leukemia. J Am Acad Nurse Pract 2003; 15: 292-6.
11. Deininger MW, O'Brien SG, Ford JM, Druker BJ Practical management of patients with chronic myeloid leukemia receiving imatinib. J Clin Oncol 2003; 21: 1637-47.
12. Imatinib mesylate (Gleevec) Package Insert. 2006. Novartis Pharmaceuticals Corporation. East Hanover, NJ.
13. Ault P. Overview of second-generation tyrosine kinase inhibitors for patients with imatinib-resistant chronic myelogenous leukemia. Clin J Oncol Nurs 2007; 11: 125-9.
14. Kantarjian H., Sawyers C., Hochhaus A. et al. Hematologic and cytogenetic responses to imatinib mesylate in chronic myelogenous leukemia. N Engl J Med 2002; 346: 645-52.
15. Kerkela R., Grazette L., Yacobi R. et al. Cardiotoxicity of the cancer therapeutic agent imatinib mesylate. Nat Med. 2006; 12: 908-16.
16. 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: 4500-5.
17. Shah NP, Tran C., Lee FY et al. Overriding imatinib resistance with a novel ABL kinase inhibitor. Science 2004; 305: 399-401.
18. Lee FY, Lombardo L., Camuso A. et al. BMS-354825 potently inhibits multiple selected oncogenic tyrosine kinases and possesses broad-spectrum antitumor activities in vitro and in vivo. Proc Amer Assoc Cancer Res 2005; 46: Abstract 675.
19. 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: 6658-61.
20. 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: 9185-9.
21. Schittenhelm MM, Shiraga S., Schroeder A. et al. Dasatinib (BMS-354825), a dual SRC/ABL kinase inhibitor, inhibits the kinase activity of wild-type, juxtamembrane, and activation loop mutant KIT isoforms associated with human malignancies. Cancer Res 2006; 66: 473-81.
22. Danhauser-Riedl S., Warmuth M., Druker BJ et al. Activation of Src kinases p53/56lyn and p59hck by p210bcr/abl in myeloid cells. Cancer Res 1996; 56: 3589-96.
23. Lionberger JM, Wilson MB, Smithgall TE Transformation of myeloid leukemia cells to cytokine independence by Bcr-Abl is suppressed by kinase-defective Hck. J Biol Chem 2000; 275: 18581-5.
24. Meyn III MA, Wilson MB, Abdi FA et al. Src family kinases phosphorylate the Bcr-Abl SH3-SH2 region and modulate Bcr-Abl transforming activity. J Biol Chem 2006; 281: 30907-16.
25. Warmuth M., Bergmann M., Priess A. et al. The Src family kinase Hck interacts with Bcr-Abl by a kinase-independent mechanism and phosphorylates the Grb2-binding site of Bcr. J Biol Chem 1997; 272: 33260-70.
26. Donato NJ, Wu JY, Stapley J. et al. BCR-ABL independence and LYN kinase overexpression in chronic myelogenous leukemia cells selected for resistance to STI571. Blood 2003; 101: 690-8.
27. Donato NJ, Wu JY, Stapley J. et al. Imatinib mesylate resistance through BCR-ABL independence in chronic myelogenous leukemia. Cancer Res 2004; 64: 672-7.
28. Donato NJ, Wu J., Kong LY, et al. Constitutive activation of SRC-family kinases in chronic myelogenous leukemia patients resistant to imatinib mesylate in the absence of BCR-ABL mutations: A rationale for use of SRC/ ABL dual kinase inhibitor-based therapy. Blood (ASH Annual Meeting Abstracts). 2005; 106: Abstract 1087.
29. Nagar B., Bornmann WG, Pellicena P. et al. Crystal structures of the kinase domain of c-Abl in complex with the small molecule inhibitors PD173955 and imatinib (STI-571). Cancer Res 2002; 62: 4236-43.
30. Schindler T., Bornmann W., Pellicena P. et al. Structural mechanism for STI-571 inhibition of abelson tyrosine kinase. Science 2000; 289: 1938-42.
31. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in OncologyTM: Chronic myelogenous leukemia, V.3. http://www.nccn.org/ professionals/physician_gls/PDF/cml.pdf. 2007. Accessed December 2007.
32. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology TM: Chronic myelogenous leukemia, V.1.2008. http://www.nccn.org/professionals/physician_gls/PDF/cml.pdf 2008. Accessed September 2007.
33. Talpaz M., Shah NP, Kantarjian H. et al. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med 2006; 354: 2531-41.
34. Aebersold R., Anderson L., Caprioli R. et al. Perspective: A program to improve protein biomarker discovery for cancer. J Proteome Res 2005; 4: 1104-9.
35. Druker BJ, Talpaz M., Resta DJ et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 2001; 344: 1031-7.
36. Nichols GL, Raines MA, Vera JC et al. IRIS Investigators. Identification of CRKL as the constitutively phosphorylated 39-kD tyrosine phosphoprotein in chronic myelogenous leukemia cells. Blood 1994; 84: 2912-8.
37. Oda T., Heaney C., Hagopian JR et al. Crkl is the major tyrosine-phosphorylated protein in neutrophils from patients with chronic myelogenous leukemia. J Biol Chem 1994; 269: 22925-8.
38. ten Hoeve J., Arlinghaus RB, Guo JQ et al. Tyrosine phosphorylation of CRKL in Philadelphia+ leukemia. Blood 1994; 84: 1731-6.
39. Cortes J., Rousselot P., Kim DW 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: 3207-13.
40. Stone RM, Kantarjian HM, Baccarani M., et al. Efficacy of dasatinib in patients with chronic-phase chronic myelogenous leukemia with resistance or intolerance to imatinib: 2-year follow-up data from START-C (CA180-013). Blood (ASH Annual Meeting Abstracts). 2007; 110: Abstract 734.
41. Guilhot F., Apperley J., Kim DW 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: 4143-50.
42. Kantarjian H., Pasquini R., Hamerschlak N. et al. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia after failure of first-line imatinib: A randomized phase 2 trial. Blood 2007; 109: 5143-50.
43. 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 II study. Blood 2007; 110: 2309-15.
44. Dasatinib Package Insert. 2007. Bristol-Myers Squibb Company, Princeton, NJ.
45. Guilhot F., Apperley JF, Kim DW, et al. Efficacy of dasatinib in patients with accelerated-phase chronic myelogenous leukemia with resistance or intolerance to imatinib: 2-year follow-up data from START-A (CA180-005). Blood (ASH Annual Meeting Abstracts). 2007; 110: Abstract 470.
46. Gambacorti C., Cortes J., Kim DW, et al. Efficacy and safety of dasatinib in patients with chronic myeloid leukemia in blast phase whose disease is resistant or intolerant to imatinib: 2-year follow-up data from the START program. Blood (ASH Annual Meeting Abstracts). 2007; 110: Abstract 472.
47. Quintas-Cardama A., Kantarjian H., O'Brien S. et al. Pleural effusion in patients with chronic myelogenous leukemia treated with dasatinib after imatinib failure. J Clin Oncol 2007; 25: 3908-14.
48. 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: 2303-9.
49. Shah NP, Kim DW, Kantarjian H., et al. Dasatinib 50 mg or 70 mg BID compared to 100 mg or 140 mg QD in patients with CML in chronic phase (CP) who are resistant or intolerant to imatinib: One-year results of CA180034. J Clin Oncol [ASCO Annual Meeting Proceedings Part I (June 20 Supplement)]. 2007; 25: Abstract 7004.
50. Dombret H., Ottmann O., Goh Y. et al. Dasatinib 140 mg QD vs 70 mg BID in advanced-phase CML or Ph+ ALL resistant or intolerant to imatinib: results from a randomized, phase-III trial (CA180035). Haematologica (EHA Annual Meeting Abstracts) 2007; 92 (suppl 1): 319. Abstract 0859.
51. Marin D., Milojkovic D., Bua M. et al. The use of dasatinib in chronic myeloid leukemia: Some practical considerations. Clin Leuk 2007; 1: 229-33.
52. Freebern WJ, Fang HS, Slade MD et al. In vitro cardiotoxicity potential comparative assessments of chronic myelogenous leukemia tyrosine kinase inhibitor therapies: Dasatinib, imatinib and nilotinib. Blood (ASB Annual Meeting Abstracts). 2007; 110: Abstract 4582.
53. Frame D. New strategies in controlling drug resistance. J Manag Care Pharm 2007; 13 (Suppl A): 13-7.
54. Darkow T., Henk HJ, Thomas SK et al. Treatment interruptions and non-adherence with imatinib and associated healthcare costs: A retrospective analysis among managed care patients with chronic myelogenous leukaemia. Pharmacoeconomics 2007; 25: 481-96.
55. Osterberg L., Blaschke T. Adherence to medication. N Engl J Med 2005; 353: 487-97.