Use of Tyrosine Kinase inhibitors for Chronic Myeloid leukemia: Management of Patients and Practical Applications for Pharmacy Practitioners

Annals of Pharmacotherapy

Volumn 45, Issue 6, 2011, Pages 787-797

  Wong, Siu Fun ^a   Mirshahidi, Hamid ^b  

^a LOMA LINDA UNIVERSITY   (United States)

^b LOMA LINDA UNIVERSITY HEALTH   (United States)

Author keywords

Chronic myeloid leukemia; Dasatinib; Imatinib; Nilotinib

Indexed keywords

BCR ABL PROTEIN; CYTARABINE; DASATINIB; IMATINIB; INTERFERON; NILOTINIB; PROTEIN TYROSINE KINASE INHIBITOR;

CHRONIC DISEASE; CHRONIC LEUKEMIA; CHRONIC MYELOID LEUKEMIA; CLINICAL ASSESSMENT; CLINICAL TRIAL; COMORBIDITY; CONTROLLED STUDY; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG INTERACTION; DRUG SAFETY; FEMALE; HEMATOLOGY; HUMAN; MALE; MEDICAL PRACTICE; MEDLINE; MUTATION; PATIENT CARE; PATIENT MONITORING; PHILADELPHIA 1 CHROMOSOME; PRIORITY JOURNAL; REVIEW; STATISTICAL SIGNIFICANCE; UNITED STATES;

ANTINEOPLASTIC AGENTS; DRUG DELIVERY SYSTEMS; DRUG INTERACTIONS; DRUG MONITORING; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES;

EID: 79958795275     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1P784     Document Type: Review

References (62)

1. Altekruse S, Kosary C, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2007, National Cancer Institute 2010. http://seer.cancer.gov/ statfacts/html/cmyl.html (accessed 2010 Nov 9).
2. Perrotti D, Jamieson C, Goldman J, Skorski T. Chronic myeloid leukemia: mechanisms of blastic transformation. J Clin Invest 2010;120: 2254-64. DOI 10.1172/JCI4124641246
3. Kalidas M, Kantarjian H, Talpaz M. Chronic myelogenous leukemia. JAMA 2001;286:895-8.
4. CML Trialists' Collaborative Group. Interferon alfa versus chemotherapy for chronic myeloid leukemia: a meta-analysis of seven randomized trials: Chronic Myeloid Leukemia Trialists' Collaborative Group. J Natl Cancer Inst 1997;89:1616-20.
5. Deininger M. Resistance and relapse with imatinib in CML: causes and consequences. J Natl Compr Canc Netw 2008;6(suppl 2):S11-21.
6. Deininger M, O'Brien SG, Guilhot F, et al. International randomized study of interferon vs STI571 (IRIS) 8-year follow up: sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) treated with imatinib (abstract). Blood (ASH Annual Meeting Abstracts) 2009;114:1126.
7. O'Brien SG, Guilhot F, Goldman JM, et al. International randomized study of interferon versus STI571 (IRIS) 7-year follow-up: sustained survival, low rate of transformation and increased rate of major molecular response (MMR) in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CMLCP) treated with imatinib (IM) (abstract). Blood (ASH Annual Meeting Abstracts) 2008;112:186.
8. 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. DOI 10.1056/NEJMoa022457348/11/994
9. 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. DOI 10.1056/NEJMoa062867
10. Weisberg E, Manley P, Mestan J, Cowan-Jacob S, Ray A, Griffin JD. AMN107 (nilotinib): a novel and selective inhibitor of BCR-ABL. Br J Cancer 2006;94:1765-9. DOI 10.1038/sj.bjc.6603170
11. Osborn M, Hughes T. Managing imatinib resistance in chronic myeloid leukaemia. Curr Opin Hematol 2010;17:97-103. DOI 10.1097/MOH.0b013e3283366bcb
12. Lombardo LJ, Lee FY, Chen P, et al. Discovery of N-(2-chloro-6-methylphenyl)- 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.
13. Novartis Pharmaceuticals. Risk Evaluation and Mitigation Strategy (REMS): Tasigna (nilotinib). 2010:1-57. http://www.accessdata.fda.gov/ drugsatfda_docs/label/2010/022068s001REMS.pdf (accessed 2011 Feb 11).
14. Prescribing information. Tasigna (nilotinib). Hanover, NJ: Novartis Pharmaceuticals, 2010.
15. Prescribing information. Sprycel (dasatinib). Princeton, NJ: Bristol Myers Squibb Company, 2010.
16. Apperley J. Issues of imatinib and pregnancy outcome. J Natl Compr Canc Netw 2009;7:1050-8.
17. Cortes J, Kim DW, Raffoux E, et al. Efficacy and safety of dasatinib in imatinib-resistant or -intolerant patients with chronic myeloid leukemia in blast phase. Leukemia 2008;22:2176-83. DOI 10.1038/leu.2008.221
18. 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. DOI 10.1182/blood-2006-09-047266
19. Kantarjian H, Pasquini R, Levy V, et al. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia resistant to imatinib at a dose of 400 to 600 milligrams daily: two-year follow-up of a randomized phase 2 study (START-R). Cancer 2009;115:4136-47. DOI 10.1002/cncr.24504
20. Mauro MJ, Baccarani M, Cervantes F, et al. Dasatinib 2-year efficacy in patients with chronic-phase chronic myelogenous leukemia (CML-CP) with resistance or intolerance to imatinib (START-C) (abstract). J Clin Oncol (Meeting Abstracts) 2008;26:7009.
21. Kantarjian H, Cortes J, Kim DW, 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;113:6322-9. DOI 10.1182/blood-2008-11-186817
22. Shah NP, Kantarjian HM, Kim DW, 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;26:3204-12. DOI 10.1200/JCO.2007.14.9260
23. Kantarjian HM, Giles F, Gattermann N, et al. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood 2007;110:3540-6. DOI 10.1182/blood-2007-03-080689
24. Kantarjian HM, Giles FJ, Bhalla KN, et al. Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results. Blood 2011;117: 1141-5. DOI 10.1182/blood-2010-03-277152
25. Kantarjian H, Shah NP, Hochhaus A, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 2010;362:2260-70. DOI 10.1056/NEJMoa1002315
26. Shah N, Kantarjian H, Hochhaus A, et al. Dasatinib versus imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) in the DASISION trial: 18-month follow-up (abstract). Blood 2010;116:206.
27. Saglio G, Kim DW, Issaragrisil S, et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med 2010;362: 2251-9. DOI 10.1056/NEJMoa0912614
28. Hughes TP, Hochhaus A, Saglio G, et al. ENESTnd update: continued superiority of nilotinib versus imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) (abstract). Blood 2010;116:207.
29. Hughes TP, Hochhaus A, Saglio G, et al. ENESTnd update: continued superiority of nilotinib versus imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) (oral presentation). Presented at: American Society of Hematology, Orlando, FL, 2010.
30. NCCN. National Comprehensive Cancer Network: clinical practice guidelines in oncology. Chronic myelogenous leukemia. Version 2. 2011:1-63. http://www.nccn.org/professionals/physician_gls/PDF/cml. pdf (accessed 2011 Jan 24).a
31. Baccarani M, Cortes J, Pane F, et al. Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol 2009;27:6041-51. DOI 10.1200/JCO.2009.25.0779
32. Faderl S, Talpaz M, Estrov Z, Kantarjian HM. Chronic myelogenous leukemia: biology and therapy. Ann Intern Med 1999;131:207-19.
33. Clark RE. Facts and uncertainties in monitoring treatment response in chronic myeloid leukaemia. Leuk Res 2009;33:1151-5. DOI 10.1016/j.leukres.2009.04.001
34. Baccarani M, Saglio G, Goldman J, et al. Evolving concepts in the management of chronic myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet. Blood 2006;108:1809-20. DOI 10.1182/blood-2006-02-005686
35. Alvarado Y, Kantarjian H, O'Brien S, et al. Significance of suboptimal response to imatinib, as defined by the European LeukemiaNet, in the long-term outcome of patients with early chronic myeloid leukemia in chronic phase. Cancer 2009;115:3709-18. DOI 10.1002/cncr.24418
36. Muller MC, Hochhaus A, Lauseker M, et al. Molecular response <1% BCR-ABL IS at 12 months is associated with improved overall and progression- free survival: the randomized german CML-study IV (abstract). Blood 2010;116:669.
37. Marin D, Bazeos A, Mahon FX, et al. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol 2010;28:2381-8. DOI 10.1200/JCO.2009.26.3087
38. Noens L, van Lierde MA, De Bock R, et al. Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood 2009;113:5401-11. DOI 10.1182/blood-2008-12-196543
39. Wu EQ, Johnson S, Beaulieu N, et al. Healthcare resource utilization and costs associated with non-adherence to imatinib treatment in chronic myeloid leukemia patients. Curr Med Res Opin 2010;26:61-9. DOI 10.1185/03007990903396469
40. St. Charles M, Bollu VK, Hornyak E, Coombs J, Blanchette CM, DeAngelo DJ. Predictors of treatment non-adherence in patients treated with imatinib mesylate for chronic myeloid leukemia (abstract). Blood 2009;114: 2209.
41. Williams LA, Garcia-Gonzalez A, Ault PS, et al. Symptom burden in patients with chronic myeloid leukemia (CML) on kinase inhibitor (KI) therapy (abstract). Blood 2010;116:3838.
42. Atallah E, Durand JB, Kantarjian H, Cortes J. Congestive heart failure is a rare event in patients receiving imatinib therapy. Blood 2007;110:1233-7. DOI 10.1182/blood-2007-01-070144
43. Salie R, Silver RT. Uncommon or delayed adverse events associated with imatinib treatment for chronic myeloid leukemia. Clin Lymphoma Myeloma Leuk 2010;10:331-5. DOI 10.3816/CLML.2010.n.065
44. Kantarjian HM, Giles FJ, Bhalla KN, et al. Update on imatinib-resistant chronic myeloid leukemia patients in chronic phase (CML-CP) on nilotinib therapy at 24 months: clinical response, safety, and long-term outcomes (abstract). Blood 2009;114:1129.
45. Kantarjian HM, Giles FJ, Hochhaus A, et al. Nilotinib in patients with imatinib-resistant or -intolerant chronic myelogenous leukemia in chronic phase (CML-CP): updated phase II results (abstract). J Clin Oncol 2008;26:7010.
46. Masiello D, Gorospe G, Yang AS. The occurrence and management of fluid retention associated with TKI therapy in CML, with a focus on dasatinib. J Hematol Oncol 2009;2:46. DOI 10.1186/1756-8722-2-46
47. 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. DOI 10.1200/JCO.2003.11.143JCO.2003.11.143
48. van Erp NP, Gelderblom H, Guchelaar HJ. Clinical pharmacokinetics of tyrosine kinase inhibitors. Cancer Treat Rev 2009;35:692-706. DOI S0305-7372(09)00116-9 [pii]10.1016/j.ctrv.2009.08.004
49. Tinsley SM. Safety profiles of second-line tyrosine kinase inhibitors in patients with chronic myeloid leukaemia. J Clin Nurs 2010;19:1207-18. DOI 10.1111/j.1365-2702.2009.03167.x
50. Ault P, Kantarjian H, O'Brien S, et al. Pregnancy among patients with chronic myeloid leukemia treated with imatinib. J Clin Oncol 2006;24: 1204-8. DOI 10.1200/JCO.2005.04.6557
51. Golas JM, Arndt K, Etienne C, et al. SKI-606, a 4-anilino-3-quinolinecarbonitrile dual inhibitor of Src and Abl kinases, is a potent antiproliferative agent against chronic myelogenous leukemia cells in culture and causes regression of K562 xenografts in nude mice. Cancer Res 2003;63:375-81.
52. Kimura S, Naito H, Segawa H, et al. NS-187, a potent and selective dual Bcr-Abl/Lyn tyrosine kinase inhibitor, is a novel agent for imatinib-resistant leukemia. Blood 2005;106:3948-54. DOI 10.1182/blood-2005-06-2209
53. Gambacorti-Passerini C, Kim D-W, Kantarjian HM, et al. An ongoing phase 3 study of bosutinib (SKI-606) versus imatinib in patients with newly diagnosed chronic phase chronic myeloid leukemia (abstract). Blood 2010;116:208.
54. Yokota A, Kimura S, Masuda S, et al. INNO - 406, a novel BCRABL/ Lyn dual tyrosine kinase inhibitor, suppresses the growth of Ph+ leukemia cells in the central nervous system, and cyclosporine A augments its in vivo activity. Blood 2007;109:306-14. DOI 10.1182/blood-2006-03-013250
55. Giles FJ, Cortes J, Jones D, Bergstrom D, Kantarjian H, Freedman SJ. MK-0457, a novel kinase inhibitor, is active in patients with chronic myeloid leukemia or acute lymphocytic leukemia with the T315I BCRABL mutation. Blood 2007;109:500-2. DOI 10.1182/blood-2006-05-025049
56. Smith DC, Britten C, Clary DO, Nguyen LT, Woodward P, Hurwitz HI. A phase I study of XL228, a potent IGF1R/AURORA/SRC inhibitor, in patients with solid tumors or hematologic malignancies. J Clin Oncol 2009;27:3512.
57. Smith DC, Britten C, Garon EB, et al. A phase I study of XL228, a multitargeted protein kinase inhibitor, in patients (pts) with solid tumors or multiple myeloma (abstract). ASCO Meeting Abstracts 2010;28:3105.
58. Cortes J, Talpaz M, Bixby D, et al. A phase 1 trial of oral ponatinib (AP24534) in patients with refractory chronic myelogenous leukemia (CML) and other hematologic malignancies: emerging safety and clinical response findings (abstract). Blood 2010;116:210.
59. Legros L, Hayette S, Nicolini FE, et al. BCR-ABL(T315I) transcript disappearance in an imatinib-resistant CML patient treated with homoharringtonine: a new therapeutic challenge? Leukemia 2007;21:2204-6.
60. Cortes JE, Wetzler M, Lipton J, et al. Subcutaneous omacetaxine (OM) treatment of chronic phase (CP) chronic myeloid leukemia (CML) patients following multiple tyrosine kinase inhibitor (TKI) failure (abstract). Blood 2010;116:2290.
61. Weisberg E, Catley L, Wright RD, et al. Beneficial effects of combining nilotinib and imatinib in preclinical models of BCR-ABL+ leukemias. Blood 2007;109:2112-20. DOI 10.1182/blood-2006-06-026377
62. 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. DOI 10.1158/0008-5472.CAN-05-0259