Успешный опыт длительного наблюдения больных хроническим миелоидным лейкозом с глубоким молекулярным ответом на сниженных дозах ингибиторов тирозинкиназ II поколения: описание клинических случаев и обзор литературы - Журнал Терапевтический архив №7 Вопросы гематологии 2020
Успешный опыт длительного наблюдения больных хроническим миелоидным лейкозом с глубоким молекулярным ответом на сниженных дозах ингибиторов тирозинкиназ II поколения: описание клинических случаев и обзор литературы
Гурьянова М.А., Челышева Е.Ю., Шухов О.А., Туркина А.Г. Успешный опыт длительного наблюдения больных хроническим миелоидным лейкозом с глубоким молекулярным ответом на сниженных дозах ингибиторов тирозинкиназ II поколения: описание клинических случаев и обзор литературы. Терапевтический архив. 2020; 92 (7): 90–94. DOI: 10.26442/00403660.2020.07.000789
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Аннотация
Современные подходы лечения хронического миелолейкоза (ХМЛ) ингибиторами тирозинкиназ (ИТК) позволяют вывести в состояние стабильного глубокого молекулярного ответа порядка 60–70% больных. В соответствии с существующими клиническими рекомендациями больным ХМЛ проводится длительная терапия ИТК в стандартных дозах, что зачастую сопровождается проявлениями токсического дозозависимого действия препаратов. Внедрение подхода терапии, заключающегося в долгосрочном наблюдении больных на терапии редуцированными дозами ИТК, является актуальным вопросом у данной категории пациентов. Нами представлено 2 клинических случая снижения дозы ИТК II поколения с целью уменьшения проявлений лекарственной токсичности и профилактики нежелательных явлений терапии ИТК.
Ключевые слова: хронический миелоидный лейкоз, ингибиторы тирозинкиназ, большой молекулярный ответ, глубокий молекулярный ответ, нежелательные явления, редукция доз, иматиниб, нилотиниб, дазатиниб.
Keywords: chronic myeloid leukemia, tyrosine kinase inhibitors, major molecular response, deep molecular response, adverse effects, doses reduction, imatinib, nilotinib, dasatinib.
Ключевые слова: хронический миелоидный лейкоз, ингибиторы тирозинкиназ, большой молекулярный ответ, глубокий молекулярный ответ, нежелательные явления, редукция доз, иматиниб, нилотиниб, дазатиниб.
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Keywords: chronic myeloid leukemia, tyrosine kinase inhibitors, major molecular response, deep molecular response, adverse effects, doses reduction, imatinib, nilotinib, dasatinib.
Список литературы
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6. Etienne G, Guilhot J, Rea D, et al. Long-term follow-up of the French Stop Imatinib (STIM1) study in patients with chronic myeloid leukemia. J Clin Oncol. 2017;35(3):298-305. doi: 10.1200/jco.2016.68.2914
7. Rea D, Nicolini FE, Tulliez M, et al. Discontinuation of dasatinib or nilotinib in chronic myeloid leukemia: interim analysis of the STOP 2G-TKI study. Blood. 2017;129(7):846-54. doi: 10.1182/blood-2016-09-742205
8. Chelysheva E, Petrova A, Shukhov O, et al. First interim analysis of the russian multicenter prospective study ru-ski: discontinuation of tyrosine kinase inhibitors in patients with chronic myeloid leukemia and deep molecular response. 23rd Congress of European Hematology Association. Hematologica. 2018;2(S1):PF374.
9. Туркина А.Г., Челышева Е.Ю., Шуваев В.А. и др. Результаты наблюдения больных хроническим миелолейкозом с глубоким молекулярным ответом без терапии ингибиторами тирозинкиназ. Терапевтический архив. 2017;89(12):86-96 [Turkina AG, Chelysheva EYu, Shuvaev VA, et al. Results of following up patients with chronic myeloid leukemia and a deep molecular response without tyrosine kinase inhibitor therapy. Therapeutic Archive. 2017;89(12):86-96 (In Russ.)]. doi: 10.17116/terarkh2017891286-96
10. Зейфман А.А., Челышева Е.Ю., Туркина А.Г., Чилов Г.Г. Роль селективности ингибиторов тирозинкиназ в развитии побочных эффектов при терапии хронического миелолейкоза. Клиническая онкогематология. 2014;7(1):16 [Zejfman AA, Chelysheva EYu, Turkina AG, Chilov GG. Role of tyrosine-kinase inhibitor selectivity in development of adverse effects during treatment of chronic myeloid leukemia. Klinicheskaya onkogematologiya. 2014;7(1):16 (In Russ.)].
11. 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;2:22-33 [Lomaia EG, Romanova EG, Sbityakova EI, Zarickij AY. Efficacy and safety of tyrosine kinase inhibitors (dasatinib, nilotinib) in the treatment of chronic phase chronic myeloid leukemia. Onkogematologiya. 2013;2:22-33 (In Russ.)].
12. Лазорко Н.С., Ломаиа Е.Г., Романова Е.Г. и др. Ингибиторы тирозинкиназ второго поколения и их токсичность у больных в хронической фазе хронического миелолейкоза. Клиническая онкогематология. 2015;8(3):302-8 [Lazorko NS, Lomaia EG, Romanova EG, et al. Second generation tyrosine kinase inhibitors and their toxicity in treatment of patients in chronic phase of chronic myeloid leukemia. Klinicheskaya onkogematologiya. 2015;8(3):302-8 (In Russ.)].
13. Kantarjian H, Pasquini R, Lévy 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
14. Quinta´s-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;1;25(25):3908-14. doi: 10.1200/JCO.2007.12.032
15. De Lavallade H, Punnialingam S, Milojkovic D, et al. Pleural effusions in patients with chronic myeloid leukaemia treated with dasatinib may have an immune-mediated pathogenesis. Br J Haematol. 2008;141(5):745-7. doi: 10.1111/j.1365-2141.2008.07108
16. Троицкая Е.А., Вельмакин С.В., Кобалава Ж.Д. Концепция сосудистого возраста: новый инструмент оценки сердечно-сосудистого риска. Артериальная гипертензия. 2017;23(2):160-71 [Troickaya EA, Vel'makin SV, Kobalava ZhD. Concept of vascular age: new tool in cardiovascular risk assessment. Arterial'naya gipertenziya. 2017;23 (2):160-71 (In Russ.)]. doi: 10.18705/1607-419X-2017-23-2-160-171
17. Hochhaus A, Saglio G, Hughes TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016;30(5):1044-54. doi: 10.1038/leu.2016.5
18. Cortes JE, Saglio G, Kantarjian H, et al. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients Trial. J Clin Oncol. 2016;10,34(20):2333-40. doi: 10.1200/jco.2015.64.8899
19. Шухов О.А., Туркина А.Г., Челышева Е.Ю. и др. Терапия хронического миелолейкоза согласно современным рекомендациям: результаты пилотного проспективного исследования «Ранняя индукционная терапия и мониторинг» (РИТМ). Клиническая онкогематология. 2019;12(2):194-201 [Shukhov OA, Turkina AG, Chelysheva EYu, et al. Treatment of chronic myeloid leukemia according to current guidelines: the results of the pilot prospective study “early induction therapy and monitoring” (РИТМ). Klinicheskaya onkogematologiya. 2019;12(2):194-201 (In Russ.)]. doi: 10.21320/2500-2139-2019-12-2-194-201
20. Clark RE, Polydoros F, Apperley JF, et al. De-escalation of tyrosine kinase inhibitor dose in patients with chronic myeloid leukaemia with stable major molecular response (DESTINY): an interim analysis of a non-randomised, phase 2 trial. Lancet Haematol. 2017;4:e310-16. doi: 10.1016/s2352-3026(17)30066-2
21. Rea D, Cayuela J, Dulucq S, Etienne G. Molecular responses after switching from a standard-dose twice-daily nilotinib regimen to a reduced-dose once-daily schedule in patients with chronic myeloid leukemia: a real life observational study (NILO-RED). Blood. 2017;130(1):318. 590th ASH, Atlanta.
22. Clark RE, Polydoros F, Apperley JF, et al. De-escalation of tyrosine kinase inhibitor therapy before complete treatment discontinuation in patients with chronic myeloid leukaemia (DESTINY): a non-randomised, phase 2 trial. Lancet Haematol. 2019;6(7):e375-e383. doi: 10.1016/S2352-3026(19)30094-8
23. Naqvi K, Jabbour E, Skinner J, et al. Long-Term Follow-Up of Lower Dose Dasatinib (50 mg Daily) as Frontline Therapy in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia. Cancer. 2020;126(1):67-75. doi: 10.1002/cncr.32504
2. Sasaki K, Strom SS, O'Brien S, et al. Relative survival in patients with chronic-phase chronic myeloid leukaemia in the tyrosine-kinase inhibitor era: analysis of patient data from six prospective clinical trials. Lancet Haematol. 2015;5:e186-93. doi: 10.1016/S2352-3026(15)00048-4. PMID: 26688093.
3. Hehlmann R, Lauseker M, Saußele S, et al. Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants. Leukemia. 2017;31:2398-406. doi: 10.1038/leu.2017.253
4. Shukhov OA, Turkina AG, Chelysheva EYu, et al. Long-term results of tyrosine kinase inhibitors treatment in chronic myeloid leukemia patients in early and late chronic phase. Klinicheskaya onkogematologiya. 2016;9:368 (In Russ.)
5. Saussele S, Richter J, Guilhot J, et al.; EURO-SKI investigators. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018;19(6):747-57. doi: 10.1016/S1470-2045(18)30192-X
6. Etienne G, Guilhot J, Rea D, et al. Long-term follow-up of the French Stop Imatinib (STIM1) study in patients with chronic myeloid leukemia. J Clin Oncol. 2017;35(3):298-305. doi: 10.1200/jco.2016.68.2914
7. Rea D, Nicolini FE, Tulliez M, et al. Discontinuation of dasatinib or nilotinib in chronic myeloid leukemia: interim analysis of the STOP 2G-TKI study. Blood. 2017;129(7):846-54. doi: 10.1182/blood-2016-09-742205
8. Chelysheva E, Petrova A, Shukhov O, et al. First interim analysis of the russian multicenter prospective study ru-ski: discontinuation of tyrosine kinase inhibitors in patients with chronic myeloid leukemia and deep molecular response. 23rd Congress of European Hematology Association. Hematologica. 2018;2(S1):PF374.
9. Turkina AG, Chelysheva EYu, Shuvaev VA, et al. Results of following up patients with chronic myeloid leukemia and a deep molecular response without tyrosine kinase inhibitor therapy. Therapeutic Archive. 2017;89(12):86-96 (In Russ.)
doi:10.17116/terarkh2017891286-96
10. Zejfman AA, Chelysheva EYu, Turkina AG, Chilov GG. Role of tyrosine-kinase inhibitor selectivity in development of adverse effects during treatment of chronic myeloid leukemia. Klinicheskaya onkogematologiya. 2014;7(1):16 (In Russ.)
11. Lomaia EG, Romanova EG, Sbityakova EI, Zarickij AY. Efficacy and safety of tyrosine kinase inhibitors (dasatinib, nilotinib) in the treatment of chronic phase chronic myeloid leukemia. Onkogematologiya. 2013;2:22-33 (In Russ.)
12. Lazorko NS, Lomaia EG, Romanova EG, et al. Second generation tyrosine kinase inhibitors and their toxicity in treatment of patients in chronic phase of chronic myeloid leukemia. Klinicheskaya onkogematologiya. 2015;8(3):302-8 (In Russ.)
13. Kantarjian H, Pasquini R, Lévy 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
14. Quinta´s-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;1;25(25):3908-14. doi: 10.1200/JCO.2007.12.032
15. De Lavallade H, Punnialingam S, Milojkovic D, et al. Pleural effusions in patients with chronic myeloid leukaemia treated with dasatinib may have an immune-mediated pathogenesis. Br J Haematol. 2008;141(5):745-7. doi: 10.1111/j.1365-2141.2008.07108
16. Troickaya EA, Vel'makin SV, Kobalava ZhD. Concept of vascular age: new tool in cardiovascular risk assessment. Arterial'naya gipertenziya. 2017;23 (2):160-71 (In Russ.) doi: 10.18705/1607-419X-2017-23-2-160-171
17. Hochhaus A, Saglio G, Hughes TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016;30(5):1044-54. doi: 10.1038/leu.2016.5
18. Cortes JE, Saglio G, Kantarjian H, et al. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients Trial. J Clin Oncol. 2016;10,34(20):2333-40. doi: 10.1200/jco.2015.64.8899
19. Shukhov OA, Turkina AG, Chelysheva EYu, et al. Treatment of chronic myeloid leukemia according to current guidelines: the results of the pilot prospective study “early induction therapy and monitoring” (РИТМ). Klinicheskaya onkogematologiya. 2019;12(2):194-201 (In Russ.) doi: 10.21320/2500-2139-2019-12-2-194-201
20. Clark RE, Polydoros F, Apperley JF, et al. De-escalation of tyrosine kinase inhibitor dose in patients with chronic myeloid leukaemia with stable major molecular response (DESTINY): an interim analysis of a non-randomised, phase 2 trial. Lancet Haematol. 2017;4:e310-16. doi: 10.1016/s2352-3026(17)30066-2
21. Rea D, Cayuela J, Dulucq S, Etienne G. Molecular responses after switching from a standard-dose twice-daily nilotinib regimen to a reduced-dose once-daily schedule in patients with chronic myeloid leukemia: a real life observational study (NILO-RED). Blood. 2017;130(1):318. 590th ASH, Atlanta.
22. Clark RE, Polydoros F, Apperley JF, et al. De-escalation of tyrosine kinase inhibitor therapy before complete treatment discontinuation in patients with chronic myeloid leukaemia (DESTINY): a non-randomised, phase 2 trial. Lancet Haematol. 2019;6(7):e375-e383. doi: 10.1016/S2352-3026(19)30094-8
23. Naqvi K, Jabbour E, Skinner J, et al. Long-Term Follow-Up of Lower Dose Dasatinib (50 mg Daily) as Frontline Therapy in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia. Cancer. 2020;126(1):67-75. doi: 10.1002/cncr.32504
2. Sasaki K, Strom SS, O'Brien S, et al. Relative survival in patients with chronic-phase chronic myeloid leukaemia in the tyrosine-kinase inhibitor era: analysis of patient data from six prospective clinical trials. Lancet Haematol. 2015;5:e186-93. doi: 10.1016/S2352-3026(15)00048-4. PMID: 26688093.
3. Hehlmann R, Lauseker M, Saußele S, et al. Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants. Leukemia. 2017;31:2398-406. doi: 10.1038/leu.2017.253
4. Шухов О.А., Туркина А.Г., Челышева Е.Ю. и др. Отдаленные результаты терапии ингибиторами тирозинкиназ у больных хроническим миелолейкозом в ранней и поздней хронической фазе. Клиническая онкогематология. 2016;9:368 [Shukhov OA, Turkina AG, Chelysheva EYu, et al. Long-term results of tyrosine kinase inhibitors treatment in chronic myeloid leukemia patients in early and late chronic phase. Klinicheskaya onkogematologiya. 2016;9:368 (In Russ.)].
5. Saussele S, Richter J, Guilhot J, et al.; EURO-SKI investigators. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018;19(6):747-57. doi: 10.1016/S1470-2045(18)30192-X
6. Etienne G, Guilhot J, Rea D, et al. Long-term follow-up of the French Stop Imatinib (STIM1) study in patients with chronic myeloid leukemia. J Clin Oncol. 2017;35(3):298-305. doi: 10.1200/jco.2016.68.2914
7. Rea D, Nicolini FE, Tulliez M, et al. Discontinuation of dasatinib or nilotinib in chronic myeloid leukemia: interim analysis of the STOP 2G-TKI study. Blood. 2017;129(7):846-54. doi: 10.1182/blood-2016-09-742205
8. Chelysheva E, Petrova A, Shukhov O, et al. First interim analysis of the russian multicenter prospective study ru-ski: discontinuation of tyrosine kinase inhibitors in patients with chronic myeloid leukemia and deep molecular response. 23rd Congress of European Hematology Association. Hematologica. 2018;2(S1):PF374.
9. Туркина А.Г., Челышева Е.Ю., Шуваев В.А. и др. Результаты наблюдения больных хроническим миелолейкозом с глубоким молекулярным ответом без терапии ингибиторами тирозинкиназ. Терапевтический архив. 2017;89(12):86-96 [Turkina AG, Chelysheva EYu, Shuvaev VA, et al. Results of following up patients with chronic myeloid leukemia and a deep molecular response without tyrosine kinase inhibitor therapy. Therapeutic Archive. 2017;89(12):86-96 (In Russ.)]. doi: 10.17116/terarkh2017891286-96
10. Зейфман А.А., Челышева Е.Ю., Туркина А.Г., Чилов Г.Г. Роль селективности ингибиторов тирозинкиназ в развитии побочных эффектов при терапии хронического миелолейкоза. Клиническая онкогематология. 2014;7(1):16 [Zejfman AA, Chelysheva EYu, Turkina AG, Chilov GG. Role of tyrosine-kinase inhibitor selectivity in development of adverse effects during treatment of chronic myeloid leukemia. Klinicheskaya onkogematologiya. 2014;7(1):16 (In Russ.)].
11. 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;2:22-33 [Lomaia EG, Romanova EG, Sbityakova EI, Zarickij AY. Efficacy and safety of tyrosine kinase inhibitors (dasatinib, nilotinib) in the treatment of chronic phase chronic myeloid leukemia. Onkogematologiya. 2013;2:22-33 (In Russ.)].
12. Лазорко Н.С., Ломаиа Е.Г., Романова Е.Г. и др. Ингибиторы тирозинкиназ второго поколения и их токсичность у больных в хронической фазе хронического миелолейкоза. Клиническая онкогематология. 2015;8(3):302-8 [Lazorko NS, Lomaia EG, Romanova EG, et al. Second generation tyrosine kinase inhibitors and their toxicity in treatment of patients in chronic phase of chronic myeloid leukemia. Klinicheskaya onkogematologiya. 2015;8(3):302-8 (In Russ.)].
13. Kantarjian H, Pasquini R, Lévy 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
14. Quinta´s-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;1;25(25):3908-14. doi: 10.1200/JCO.2007.12.032
15. De Lavallade H, Punnialingam S, Milojkovic D, et al. Pleural effusions in patients with chronic myeloid leukaemia treated with dasatinib may have an immune-mediated pathogenesis. Br J Haematol. 2008;141(5):745-7. doi: 10.1111/j.1365-2141.2008.07108
16. Троицкая Е.А., Вельмакин С.В., Кобалава Ж.Д. Концепция сосудистого возраста: новый инструмент оценки сердечно-сосудистого риска. Артериальная гипертензия. 2017;23(2):160-71 [Troickaya EA, Vel'makin SV, Kobalava ZhD. Concept of vascular age: new tool in cardiovascular risk assessment. Arterial'naya gipertenziya. 2017;23 (2):160-71 (In Russ.)]. doi: 10.18705/1607-419X-2017-23-2-160-171
17. Hochhaus A, Saglio G, Hughes TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016;30(5):1044-54. doi: 10.1038/leu.2016.5
18. Cortes JE, Saglio G, Kantarjian H, et al. Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients Trial. J Clin Oncol. 2016;10,34(20):2333-40. doi: 10.1200/jco.2015.64.8899
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20. Clark RE, Polydoros F, Apperley JF, et al. De-escalation of tyrosine kinase inhibitor dose in patients with chronic myeloid leukaemia with stable major molecular response (DESTINY): an interim analysis of a non-randomised, phase 2 trial. Lancet Haematol. 2017;4:e310-16. doi: 10.1016/s2352-3026(17)30066-2
21. Rea D, Cayuela J, Dulucq S, Etienne G. Molecular responses after switching from a standard-dose twice-daily nilotinib regimen to a reduced-dose once-daily schedule in patients with chronic myeloid leukemia: a real life observational study (NILO-RED). Blood. 2017;130(1):318. 590th ASH, Atlanta.
22. Clark RE, Polydoros F, Apperley JF, et al. De-escalation of tyrosine kinase inhibitor therapy before complete treatment discontinuation in patients with chronic myeloid leukaemia (DESTINY): a non-randomised, phase 2 trial. Lancet Haematol. 2019;6(7):e375-e383. doi: 10.1016/S2352-3026(19)30094-8
23. Naqvi K, Jabbour E, Skinner J, et al. Long-Term Follow-Up of Lower Dose Dasatinib (50 mg Daily) as Frontline Therapy in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia. Cancer. 2020;126(1):67-75. doi: 10.1002/cncr.32504
Авторы
М.А. Гурьянова, Е.Ю. Челышева, О.А. Шухов, А.Г. Туркина
ФГБУ «Национальный медицинский исследовательский центр гематологии» Минздрава России, Москва, Россия
National Research Center for Hematology, Moscow, Russia
ФГБУ «Национальный медицинский исследовательский центр гематологии» Минздрава России, Москва, Россия
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National Research Center for Hematology, Moscow, Russia
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