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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
1. Wang YL, Lee JW, Cesarman E et al. Molecular monitoring of chronic myelogenous leukemia: identification of the most suitable internal control gene for real-time quantification of BCR-ABL transcripts. J Mol Diagnost 2006; 8 (2): 231–9.
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
________________________________________________
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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