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Эффективность и безопасность ингибиторов тирозинкиназ 2-го поколения (дазатиниб, нилотиниб) в терапии хронической фазы хронического миелолейкоза

https://doi.org/10.17650/1818-8346-2013-8-2-22-33

Аннотация

Современные возможности терапии хронического миелолейкоза (ХМЛ) иматинибом (ИМ) позволили достигнуть длительной беспрогрессивной и общей выживаемости, а также высокого качества жизни пациентов. В случаях развития резистентности к ИМ или его непереносимости в настоящее время возможно также проведение терапии ингибиторами тирозинкиназ 2-го поколения – дазатинибом и нилотинибом. В статье представлен обзор литературы с оценкой эффективности и возможного профиля токсичности обоих препаратов, с освещением наиболее актуальных практических вопросов лечения ХМЛ при неудаче терапии первой линии.

Об авторах

Е. Г. Ломаиа
ФГБУ «Федеральный центр сердца, крови и эндокринологии им. В.А. Алмазова» Минздрава России
Россия


Е. Г. Романова
ФГБУ «Федеральный центр сердца, крови и эндокринологии им. В.А. Алмазова» Минздрава России
Россия


Е. И. Сбитякова
ФГБУ «Федеральный центр сердца, крови и эндокринологии им. В.А. Алмазова» Минздрава России ФГБУ «Санкт-Петербургский государственный медицинский университет им. И.П. Павлова» Минздрава России
Россия


А. Ю. Зарицкий
ФГБУ «Федеральный центр сердца, крови и эндокринологии им. В.А. Алмазова» Минздрава России ФГБУ «Санкт-Петербургский государственный медицинский университет им. И.П. Павлова» Минздрава России
Россия


Список литературы

1. O’Brien S., Guilhot F., Larson R.A. 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.

2. Зарицкий А.Ю., Ломаиа Е.Г., Виноградова О.Ю. Факторы прогноза при терапии иматиниба мезилатом у больных в хронической фазе Рh-позитивного хронического миелолейкоза: данные многоцентрового нерандомизированного исследованияв России. Тер архив 2007;79(8):17–22.

3. Deininger M., O’Brien S., Guilhot F. et al. International randomized study of interferon vs. STI571 (IRIS) 8-year follow up: sustained survival and low risk for progression of events in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP)treated with imatinib. Blood 2009;114:abstr. 1126.

4. Mauro M., Baccarani F., Cervantes J. et al. Dasatinib 2-year efficacy in patients with chronic-phase chronic myelogenous leukemia (CML-CP) with resistance or intolerance to imatinib (START-C). J ClinOncol 2009;26:54–8.

5. 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.

6. Porkka K., Khoury H., Paquette R. 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;116:377–86.

7. Stone R., Kim D., Kantarjian H. et al. Dasatinib dose-optimization study in chronic phase chronic myeloidleukemia CML-CP): Three-year follow-up withdasatinib 100 mg once daily and landmark analysis of cytogenetic response and progression-free survival (PFS) [abstract]. J Clin Oncol 2009;27(15s).

8. Shah N., Kim D., 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.

9. Shah N., Kantarjian H., Kim D. et al. Six-year follow-up of patients with imatinibresistant or intolerant chronic-phase chronic myeloid leukemia receiving dasatinib. JCO 2012; ASCO annual meeting; abstr. 6506.

10. Jabbour E., Cortes J., Kantarjian H. Chronic myeloid leukemia. Emerging Cancer Therapies (ECAT). Leukemia 2011;2:239–58.

11. Kantarjian H., Giles F., Bhalla K. 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.

12. Huges T., Saglio G., Branford S. et al. Impact of baseline BCR-ABL mutations on response to nilotinib in patients with chronic myeloid leukemia in chronic phase.JCO 2009;27(25):4204–10.

13. Горюнова Е.Н., Ломаиа Е.Г., Алексеева Ю.А., Зарицкий А.Ю. Течение хронического миелолейкоза у пациентов с панрезистентной мутацией Т315I в фазе акселерации. Всегда ли необходима аллогенная трансплантация костного мозга при мутации Т315I. Клин онкогематол.Фунд иссл и клин практ 2009;2(1):11–3.

14. Milojkovic D., Nicholson E., Apperlay J. et al. Early prediction of success or failure of treatment with second-generation tyrosine kinase inhibitors in patients with chronic myeloid leukemia.Haematologica 2010;95(2):224–31.

15. Breccia M., Stagno F. Hammersmith score application identifies chronic myeloid leukemia patients with poor prognosis before treatment with second-generation tyrosine kinase inhibitors. Am J Hematol 2011;86(6):523–5.

16. Marin D., Morra E., Michallet M. et al. Effect of time to dasatinib initiation on outcome of imatinib-intolerant patients with chronic-phase chronic myelogenous leukemia: results from a European o bservational study (FORTE; CA180-211). Blood 2011;ASH; abstr. 1689.

17. Quintás-Cardama A., Cortes J., O’Brien S. et al. Dasatinib early intervention after cytogenetic or hematologic resistance to imatinib in patients with chronic myeloid leukemia. Cancer 2009;114(13):2912–21.

18. Pane F. The management of CML: current treatment paradigms and future perspectives. Updated ELN recommendation for the management of CML. Presented Naples, Italy 18 May 2009 CEINGE and faculty of medicine, Universiry Federico II.

19. Hochhaus A., Hagop M., Kantarjian H. 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.

20. Rosti G., Castagnetti F., Gugliotta G. et al. Dasatinib and nilotinib in imatinib resistant Philadelphia-positive chronic myelogenous leukemia: a ‘head-tohead’ comparison. Leuk Lymphoma 2010;51:583–91.

21. Jabbour E., Cortes J., Kantarjian H. Long-term outcomes in the second-line treatment of chronic myeloid leukemia. Cancer 2011;117(5):897–906.

22. Jabbour E., Cortes J., Kantarjian H. et al. Treatment selection after imatinib resistance in chronic myeloid leukemia. Target Oncol 2009;4:3–10.

23. Porkka K., Koskenvesa P., Lundán T. et al. Dasatinib crosses the blood-brain barrier and is an efficient therapy for central nervous system Philadelphia chromosomepositive leukemia. Blood 2008;112(4):1005–12.

24. Wang S., Lange T., Niederwieser D. et al. Nilotinib induced remission of central nervous system relapse of imatinib-resistant PH+ CML after allogeneic hematopoietic cell transplantation. Presented at the 36th Annual Meeting of the European Group for Blood and Marrow Тransplantation Vienna, Austria; 22 March 2010.

25. Wu E., Guerin A., Yu A. et al. Retrospective real-world comparison of medical visits, costs, and adherence between nilotinib and dasatinib in chronic myeloid leukemia. Curr Med Res Opin 2010;26(12):2861–9.

26. Mitra D., Trask P., Iyer S. et al. Patient characteristics and treatment patterns in chronic myeloid leukemia: evidence from a multi-country retrospective medical record chart review study. Int J Hematol 2012;95:263–73.

27. Baccarani M., Cortes J., Pane F. et al. Chronic myeloid leukemia: an update of concepts and management recommendations of European Leukemia Net.J Clin Oncol 2009;27:6041–51.

28. Giles F., Abruzzese E., Rosti G. et al. Nilotinib is active in chronic and accelerated phase chronic myeloid leukemia following failure of imatinib and dasatinib therapy. Leukemia 2010;24:1299–301.

29. Quintás-Cardama A., Kantarjian H., Jones D. et al. Dasatinib (BMS-354825) is active in Philadelphia chromosome positive chronic myelogenous leukemia after imatinib and nilotinib (AMN107) therapy

30. failure.Blood 2007;109:497–9.

31. Cannella L., Breccia M., Stefanizzi C. et al. Dasatinib overcomes imatinib and nilotinib failure in Philadelphia chromosome positive chronic myeloid leukemia with different mechanisms of resistance. Leuk Lymphoma 2009;50:848–50.

32. Fabian M.A. A small molecule-kinase interaction map for clinical kinase inhibitors.Nat Biotechnol 2005:23(3):329–36.

33. Khoury J., Guilhot F., Hughes T. et al. Dasatinib treatment for Philadelphia chromosome-positive leukemias practical considerations.Cancer 2009;115:1381–4.

34. Quintás-Cardama A., Pires De Souza Santos F., Kantarjian H. et al. Dynamics and management of cytopenias associated with dasatinib therapy in patients with chronic myeloid leukemia in chronic phase after imatinib failure cancer.Cancer 2009;115(7):3935–43.

35. Jabbour E., Deininger M., Hochhaus A. Management of adverse events associated with tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia. Leukemia 2011;25:201–10.

36. Wong S.F. New dosing schedules of dasatinib for CML and adverse event management. J Hematol Oncol 2009;2:10. doi: 10.1186/1756-8722-2-10.

37. Krauth M., Herndlhofer S., Schmook M. et al. Extensive pleural and pericardial effusion in chronic myeloid leukemia during treatment with dasatinib at 100 mg or 50 mg daily. Haematologica 2011;96(1):163–6.

38. Quintás-Cardama A., Kantarjian H., O’Brien S. et al. Effusion in patients with chronic myelogenous leukemia treated with dasatinib after imatinib failure. J Clin Oncol 2007;25:136–40.

39. Masiello D., Gorospe G.S., Yang A.S. The occurrence and management of fluid retention associated with TKI therapy in CML, with a focus on dasatinib.J Hematol Oncol 2009 Nov 12;2:46. doi: 10.1186/1756- 8722-2-46.

40. Nagata Y., Ohashi K., Fukuda S. et al. Clinical features of dasatinib-induced large granular lymphocytosis and pleural effusion. Int J Hematol 2010;91:799–807.

41. Mustjoki S., Ekblom M., Arstila T. et al. Clonal expansion of T/NK-cells during tyrosine kinase inhibitor dasatinib therapy. Leukemia 2009;23:1398–405.

42. Breccia M., Latagliata R., Stagno F. et al. Charlson comorbidity index and adult comorbidity evaluation-27 scores might predict treatment compliance and development of pleural effusions in elderly patients with chronic myeloid leukemia treated with second-line dasatinib. Haematologica 2011;96(10):1457–61.

43. Bergeron A., Réa D., Levy V. et al. Lung abnormalities after dasatinib treatment for chronic myeloid leukemia: a case series. Am J Respir Crit Care Med 2007;176:814–8.

44. Barber N.A., Ganti A.K. Pulmonary toxicities from targeted therapies: a review. Targ Oncol 2011;6:235–43.

45. Hennigs J., Keller G., Jörg Baumann H. t al. Multi tyrosine kinase inhibitor dasatinib as novel cause of severe pre-capillary pulmonary hypertension? BMC Pulm Med 2011;11:30.

46. Quintás-Cardama A., Kantarjian H., Ravandi B. et al. Bleeding diathesis in patients with chronic myelogenous leukemia receiving dasatinib therapy. Cancer 2009;115(11):2482–90.

47. Sprycel Scientific Discussion. Available at: http://209.85.165.104/search?qјcache:KW1gSD1bwJQJ:www.emea.eu.int/humandocs/PDFs/EPAR/sprycel/ H-709-en6.pdfdasatinib. and.bleeding&hlјen&glјus&ctјclnk &cdј1.Accessed on November 17, 2007.

48. Quintás-Cardama A., Han X., Kantarjian H. et al. Tyrosine kinase inhibitor – induced platelet ysfunction in patients with chronic myeloid leukemia. Blood 2009;114:261–3.

49. Mauro M.J., Deininger M.W. Management of drug toxicities in chronic myeloid leukaemia. Best practice & research clinical haematology 2009;22:409–29.

50. Beiveller P., Andreoli A., Mir O. et al. A dramatic fetal outcome following transplacental transfer of dasatinib. Anticancer Drugs 2012;23(7):754–7.

51. He K., Lago M., Iyer R.A. et al. Lacteal secretion, fetal and maternal tissue distribution of dasatinib in rats. Drug Metab Dispos2008;36(12):2564–70.

52. Oweini H., Zaher K., Mahfouz R.A., Bazarbachi A. Successful pregnancy involving a man with chronic myeloid leukemia on dasatinib. Arch Gynecol Obstet 2011 Jan;283(1):133–4.

53. Pemmaraju N., Kantarjian H.M., Tanaka M.F. et al. Memory impairment in chronic phase chronic myeloid leukemia patients treated with dasatinib tyrosine kinase inhibitor therapy.ASH 2011; abstr. 3771.

54. Shah N.P., Kantarjian H.M., Kim D.W. et al. Intermittent target inhibition with dasatinib 100 mg once daily preserves fficacy and improves tolerability in imatinib-resistant and -intolerant chronicphase chronic myeloid leukemia. J Clin Oncol 2008;26(19):3204–12.

55. Khoury H.J., Goldberg S.L., Mauro M.J. et al. Dasatinib lack of cross intolerance to imatinib in patients (pts) with chronic myelogenous leukemia chronic phase (CML-CP) intolerant to imatinib: a retrospective analysis of safety. J Clin Oncol 2008;26(15S):abstr. 7015.

56. Novitzky-Basso I., Craddock C. Crossintolerance to imatinib, dasatinib and nilotinib therapy in a patient with chronic myeloid leukaemia. Euro J Haematol 2011;86:548–9.

57. Saglio G., Kim W., Issaragrisil S. et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. Blood 2010;116:abstr. 3430. NEJM 2010;362:abstr. 2251–9.

58. Saglio G., Pinilla-Ibarz J., Cortes J. et al. Intolerance to tyrosine kinase inhibitors in chronic myeloid leukemia. Blood 2011;117(4):abstr. 3746.

59. Kantarjian H., Giles F., Wunderle L. et al. Nilotinib in imatinib-resistant CML and Philadelphia chromosome-positive ALL.N Engl J Med 2006;354:2542–51.

60. TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; June 2011.

61. Lipton J.H., le Coutre Ph.D., Wang J. et al. Nilotinib in elderly chronic myeloid leukemia patients in chronic phase ( CML-CP) with imatinib resistance or intolerance: efficacy and safety analysis. Blood 2008;112(11):abstr. 3233.

62. Tefferiand A., Wiley-Liss L. Nilotinib treatment-associated peripheral artery disease and sudden death: yet another reason to stick to imatinib as front-line therapy for chronic myelogenous leukemia. Am J Hematol 2011;86(7):610–1.

63. Gambacorti-Passerini C., Piazza R., Wiley-Liss L. Choosing the right TKI for chronic myeloid leukemia: when the truth lies in ‘‘long-term’’ safety and efficacy. Am J Hematol 2011;86(7):531–2.

64. Cortes J., Hochhaus A., Le Coutre P. et al. Minimal cross-intolerance with nilotinib in patients with chronic myeloid leukemia in chronic or accelerated phase who are intolerant to imatinib. Blood 2011;117(21):5600–6.

65. Atallah E., Durand B., Kantarjian H. et al. Congestive heart failure is a rare event in patients receiving imatinib therapy. Blood 2007;110(4):1233–7.


Рецензия

Для цитирования:


Ломаиа Е.Г., Романова Е.Г., Сбитякова Е.И., Зарицкий А.Ю. Эффективность и безопасность ингибиторов тирозинкиназ 2-го поколения (дазатиниб, нилотиниб) в терапии хронической фазы хронического миелолейкоза. Онкогематология. 2013;8(2):22-33. https://doi.org/10.17650/1818-8346-2013-8-2-22-33

For citation:


Lomaia E.G., Romanova E.G., Sbityakova E.I., Zaritskiy A.Yu. Efficacy and safety of tyrosine kinase inhibitors (dasatinib, nilotinib) in the treatment of chronic phase chronic myeloid leukemia. Oncohematology. 2013;8(2):22-33. (In Russ.) https://doi.org/10.17650/1818-8346-2013-8-2-22-33

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ISSN 1818-8346 (Print)
ISSN 2413-4023 (Online)