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Молекулярный мониторинг эффективности терапии больных хроническим миелолейкозом в России (по материалам Всероссийской научно-практической конференции, Иркутск, 3–4 сентября 2010 г.)
Молекулярный мониторинг эффективности терапии больных хроническим миелолейкозом в России (по материалам Всероссийской научно-практической конференции, Иркутск, 3–4 сентября 2010 г.)
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Аннотация
Достижение большого и полного молекулярного ответа на терапии ингибиторами тирозинкиназ у больных ХМЛ – залог длительной безрецидивной выживаемости. Для оценки этих ответов необходимо внедрить методы стандартизации в молекулярно-генетических лабораториях. В статье представлены планы Российской стандартизации (методология и этапы) и механизмы их реализации.
Article describes the plans of such standardization in Russia (methods and key steps) as well as the mechanisms of their execution.
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Article describes the plans of such standardization in Russia (methods and key steps) as well as the mechanisms of their execution.
Полный текст
Список литературы
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2. Branford S, Hughes TP, Rudzki Z. Monitoring chronic myeloid leukaemia therapy by real-time quantitative PCR in blood is a reliable alternative to bone marrow cytogenetics. Br J Haematol 1999; 107: 587–99.
3. 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 (11): 994–1004.
4. Kaeda SA, Chase A, Goldman JM. Cytogenetic and molecular monitoring of residual desease in chronic myeloid leukemia. Acta Hematol 2002; 107: 64–75.
5. Goldman JM. chronic myeloid leukemia-still a few questions. Exp Hematol 2004; 32: 2–10.
6. Marin D, Marktel S, Szydlo R et al. Survival of patients with chronic phase chronic myeloid leukemia after failed response to interferon-alfa. Lancet 2003; 362: 617–9.
7. 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. Blood 2009; 114 (22): Abstr. 1126.
8. R. Press RD, Love Z, Tronnes AA et al. BCR-ABL mRNA levels at and after the time of a complete cytogenetic response (CCR) predict the duration of CCR in imatinib mesylate-treated patients with CML. Blood 2006; 107 (11): 4250–6.
9. M. 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 (35): 6041–51.
10. Hughes T, Hochhaus A, Branford S et al. Reduction of BCR-ABL transcript level at 6,12 and 18 months correlates with long-term outcomes on imatinib at 72 months: an analysis from the International randomized study of interferon versus STI571 (IRIS) in patients with chronic phase chronic myeloid leukemia. Blood 2008; 112: 129–30.
11. Hughes T, Hochhaus A, Branford S et al. Long-term prognostic significance of early molecular response to imatinib in newly diagnosed chronic myeloid leukemia: an analysis from the International Randomized Study of Interferon and STI571 (IRIS). Blood 2010; 116: 3578–65.
12. Kantarjian H, O’Brien S, Shan J et al. Cytogenetic and molecular responses and outcome in chronic myelogenous leukemia: need for new response definitions? Cancer 2008; 112 (4): 837–45.
13. Branford S, Seymour JF, Grigg A et al. BCR-ABL messenger RNA levels continue to decline in patients with chronic phase chronic myeloid leukemia treated with imatinib for more than 5 years and approximately half of all first-line treated patients have stable undetectable BCR-ABL using strict sensitivity criteria. Clin Cancer Res 2007; 13 (23): 7080–5.
14. Hughes T, Branford S. Molecular monitoring of BCR-ABL as a guide to clinical management in chronic myeloid leukaemia. Blood Rev 2006; 20 (1): 29–41.
15. Branford S, Rudzki Z, Parkinson I et al. Real-time quantitative PCR analysis can be used as a primary screen to identify patients with CML treated with imatinib who have BCR-ABL kinase domain mutations. Blood. 2004; 104 (9): 2926–32.
16. Hughes T, Branford S. Molecular monitoring of BCR-ABL as a guide to clinical management in chronic myeloid leukaemia. Blood Rev 2006; 20 (1): 29–41.
17. Saglio G et al. Nilotinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 2010; 362 (24): 2251–9.
18. Cortes JE et al. Nilotinib as front-line treatment for patients with chronic myeloid leukemia in early chronic phase. J Clin Oncol 2010; 28 (3): 392–7.
19. Mahon FX, Réa D, Guilhot J at al. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol 2010; 11 (11): 1029–35.
20. Ross DM, Branford S, Moore S, Hughes TP. Limited clinical value of regular bone marrow cytogenetic analysis in imatinib-treated chronic phase CML patients monitored by RQ-PCR for BCR-ABL. Leukemia 2006; 20 (4): 664–70.
21. Müller MC, Saglio G, Lin F et al. An international study to standardize the detection and quantitation of BCR-ABL transcripts from stabilized peripheral blood preparations by quantitative RT-PCR. Haematologica 2007; 92 (7): 970–3.
22. Müller MC, Erben P, Saglio G et al. European LeukemiaNet. Harmonization of BCR-ABL mRNA quantification using a uniform multifunctional control plasmid in 37 international laboratories. Leukemia 2008; 22 (1): 96–102.
23. Cross N. Standartisation of molecular monitoring for chronic myeloid leukemia. Best Pract Res Clin Hematol 2009; 22: 355–65.
2. Branford S, Hughes TP, Rudzki Z. Monitoring chronic myeloid leukaemia therapy by real-time quantitative PCR in blood is a reliable alternative to bone marrow cytogenetics. Br J Haematol 1999; 107: 587–99.
3. 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 (11): 994–1004.
4. Kaeda SA, Chase A, Goldman JM. Cytogenetic and molecular monitoring of residual desease in chronic myeloid leukemia. Acta Hematol 2002; 107: 64–75.
5. Goldman JM. chronic myeloid leukemia-still a few questions. Exp Hematol 2004; 32: 2–10.
6. Marin D, Marktel S, Szydlo R et al. Survival of patients with chronic phase chronic myeloid leukemia after failed response to interferon-alfa. Lancet 2003; 362: 617–9.
7. 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. Blood 2009; 114 (22): Abstr. 1126.
8. R. Press RD, Love Z, Tronnes AA et al. BCR-ABL mRNA levels at and after the time of a complete cytogenetic response (CCR) predict the duration of CCR in imatinib mesylate-treated patients with CML. Blood 2006; 107 (11): 4250–6.
9. M. 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 (35): 6041–51.
10. Hughes T, Hochhaus A, Branford S et al. Reduction of BCR-ABL transcript level at 6,12 and 18 months correlates with long-term outcomes on imatinib at 72 months: an analysis from the International randomized study of interferon versus STI571 (IRIS) in patients with chronic phase chronic myeloid leukemia. Blood 2008; 112: 129–30.
11. Hughes T, Hochhaus A, Branford S et al. Long-term prognostic significance of early molecular response to imatinib in newly diagnosed chronic myeloid leukemia: an analysis from the International Randomized Study of Interferon and STI571 (IRIS). Blood 2010; 116: 3578–65.
12. Kantarjian H, O’Brien S, Shan J et al. Cytogenetic and molecular responses and outcome in chronic myelogenous leukemia: need for new response definitions? Cancer 2008; 112 (4): 837–45.
13. Branford S, Seymour JF, Grigg A et al. BCR-ABL messenger RNA levels continue to decline in patients with chronic phase chronic myeloid leukemia treated with imatinib for more than 5 years and approximately half of all first-line treated patients have stable undetectable BCR-ABL using strict sensitivity criteria. Clin Cancer Res 2007; 13 (23): 7080–5.
14. Hughes T, Branford S. Molecular monitoring of BCR-ABL as a guide to clinical management in chronic myeloid leukaemia. Blood Rev 2006; 20 (1): 29–41.
15. Branford S, Rudzki Z, Parkinson I et al. Real-time quantitative PCR analysis can be used as a primary screen to identify patients with CML treated with imatinib who have BCR-ABL kinase domain mutations. Blood. 2004; 104 (9): 2926–32.
16. Hughes T, Branford S. Molecular monitoring of BCR-ABL as a guide to clinical management in chronic myeloid leukaemia. Blood Rev 2006; 20 (1): 29–41.
17. Saglio G et al. Nilotinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 2010; 362 (24): 2251–9.
18. Cortes JE et al. Nilotinib as front-line treatment for patients with chronic myeloid leukemia in early chronic phase. J Clin Oncol 2010; 28 (3): 392–7.
19. Mahon FX, Réa D, Guilhot J at al. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol 2010; 11 (11): 1029–35.
20. Ross DM, Branford S, Moore S, Hughes TP. Limited clinical value of regular bone marrow cytogenetic analysis in imatinib-treated chronic phase CML patients monitored by RQ-PCR for BCR-ABL. Leukemia 2006; 20 (4): 664–70.
21. Müller MC, Saglio G, Lin F et al. An international study to standardize the detection and quantitation of BCR-ABL transcripts from stabilized peripheral blood preparations by quantitative RT-PCR. Haematologica 2007; 92 (7): 970–3.
22. Müller MC, Erben P, Saglio G et al. European LeukemiaNet. Harmonization of BCR-ABL mRNA quantification using a uniform multifunctional control plasmid in 37 international laboratories. Leukemia 2008; 22 (1): 96–102.
23. Cross N. Standartisation of molecular monitoring for chronic myeloid leukemia. Best Pract Res Clin Hematol 2009; 22: 355–65.
Авторы
М.В.Дубина1,6, Д.А.Куевда2, Т.Е.Хомякова7, Г.А.Цаур3, С.И.Куцев4, А.Ю.Зарицкий5, 6
1 Санкт-Петербургский Академический университет – Научно-образовательный центр нанотехнологий РАН, Санкт-Петербург;
2 ФГУН ЦНИИ эпидемиологии Роспотребнадзора, Москва;
3 Областная детская клиническая больница №1, Екатеринбург;
4 ГОУ ВПО «Ростовский государственный медицинский университет Росздрава», Ростов-на-Дону;
5 ФГУ «Федеральный центр сердца, крови и эндокринологии им. В.А.Алмазова» Минздравсоцразвития РФ, Санкт-Петербург;
6 Санкт-Петербургский государственный медицинский университет им. И.П.Павлова Минздравсоцразвития РФ;
7 ООО «Новартис Фарма», Департамент онкологических препаратов
1 St-Peterburg Academic University - Nanotechnology Research and Educatioanal Centre the RAS;
2 Federal State Institution of Science Central Research Institute for Epidemiology, Moscow;
3 Regional Pediatric Hospital №1, Ekaterinburg;
4 Rostov State Medical University, Rostov-on-Don;
5 Almazov Federal Heart, Blood and Endocrinology Centre, St-Petersburg;
6 St-Petersburg Pavlov Medical University, St-Petersburg;
7 Novartis Pharma LLC, Oncology Department, Moscow
1 Санкт-Петербургский Академический университет – Научно-образовательный центр нанотехнологий РАН, Санкт-Петербург;
2 ФГУН ЦНИИ эпидемиологии Роспотребнадзора, Москва;
3 Областная детская клиническая больница №1, Екатеринбург;
4 ГОУ ВПО «Ростовский государственный медицинский университет Росздрава», Ростов-на-Дону;
5 ФГУ «Федеральный центр сердца, крови и эндокринологии им. В.А.Алмазова» Минздравсоцразвития РФ, Санкт-Петербург;
6 Санкт-Петербургский государственный медицинский университет им. И.П.Павлова Минздравсоцразвития РФ;
7 ООО «Новартис Фарма», Департамент онкологических препаратов
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1 St-Peterburg Academic University - Nanotechnology Research and Educatioanal Centre the RAS;
2 Federal State Institution of Science Central Research Institute for Epidemiology, Moscow;
3 Regional Pediatric Hospital №1, Ekaterinburg;
4 Rostov State Medical University, Rostov-on-Don;
5 Almazov Federal Heart, Blood and Endocrinology Centre, St-Petersburg;
6 St-Petersburg Pavlov Medical University, St-Petersburg;
7 Novartis Pharma LLC, Oncology Department, Moscow
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