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Российский экспертный совет по применению нового высокоселективного ингибитора тирозинкиназы Брутона занубрутиниба в лечении пациентов с рецидивом/рефрактерным течением лимфомы из клеток мантии. Обзор мероприятия
Российский экспертный совет по применению нового высокоселективного ингибитора тирозинкиназы Брутона занубрутиниба в лечении пациентов с рецидивом/рефрактерным течением лимфомы из клеток мантии. Обзор мероприятия
Капланов К.Д. Российский экспертный совет по применению нового высокоселективного ингибитора тирозинкиназы Брутона занубрутиниба в лечении пациентов с рецидивом/рефрактерным течением лимфомы из клеток мантии. Обзор мероприятия. Современная Онкология. 2021; 23 (2): 253–255.
DOI: 10.26442/18151434.2021.2.200936
DOI: 10.26442/18151434.2021.2.200936
________________________________________________
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Аннотация
21 апреля 2021 г. в Москве состоялось заседание экспертного совета, посвященного применению нового высокоселективного ингибитора тирозинкиназы Брутона занубрутиниба в лечении пациентов с рецидивом/рефрактерным течением лимфомы из клеток мантии. В заседании приняли участие ведущие российские специалисты в области онкогематологии.
Ключевые слова: лимфома из клеток мантии, ингибитор тирозинкиназы Брутона, занубрутиниб
Keywords: mantle cell lymphoma, Bruton’s tyrosine kinase inhibitor, zanubrutinib
Ключевые слова: лимфома из клеток мантии, ингибитор тирозинкиназы Брутона, занубрутиниб
________________________________________________
Keywords: mantle cell lymphoma, Bruton’s tyrosine kinase inhibitor, zanubrutinib
Полный текст
Список литературы
1. Eskelund CW, Dahl C, Hansen JW, et al. TP53 mutations identify younger mantle cell lymphoma patients who do not benefit from intensive chemoimmunotherapy. Blood. 2017;130(17):1903-10. DOI:10.1182/blood-2017-04-779736; PMID: 28819011
2. Hill HA, Qi X, Jain P, et al. Genetic mutations and features of mantle cell lymphoma: a systematic review and meta-analysis. Blood Adv. 2020;4(13):2927-38. DOI:10.1182/bloodadvances.2019001350; PMID: 32598477; PMCID: PMC7362354
3. Jain P, Wang M. Mantle cell lymphoma: 2019 update on the diagnosis, pathogenesis, prognostication, and management. Am J Hematol. 2019;94(6):710-25. DOI:10.1002/ajh.25487; PMID: 30963600
4. Ferrero S, Rossi D, Rinaldi A, et al. KMT2D mutations and TP53 disruptions are poor prognostic biomarkers in mantle cell lymphoma receiving high-dose therapy: a FIL study. Haematologica. 2020;105(6):1604-12.
DOI:10.3324/haematol.2018.214056; PMID: 31537689; PMCID: PMC7271566
5. McCulloch R, Visco C, Eyre TA, et al. Efficacy of R-BAC in relapsed, refractory mantle cell lymphoma post BTK inhibitor therapy. Br J Haematol. 2020;189(4):684-8. DOI:10.1111/bjh.16416; PMID: 32011729
6. Rule S, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus: 3-year follow-up of patients with previously treated mantle cell lymphoma from the phase 3, international, randomized, open-label RAY study. Leukemia. 2018;32(8):1799-803. DOI:10.1038/s41375-018-0023-2; PMID: 29572505; PMCID: PMC6087720
7. Sharman J, Kabadi SM, Clark J, Andorsky D. Treatment patterns and outcomes among mantle cell lymphoma patients treated with ibrutinib in the United States: a retrospective electronic medical record database and chart review study. Br J Haematol. 2021;192(4):737-46. DOI:10.1111/bjh.16922; PMID: 33095453
8. Dimopoulos M, Sanz RG, Lee HP, et al. Zanubrutinib for the treatment of MYD88 wild-type Waldenström macroglobulinemia: a substudy of the phase 3 ASPEN trial. Blood Adv. 2020;4(23):6009-18.
DOI:10.1182/bloodadvances.2020003010; PMID: 33284944; PMCID: PMC7724905
9. Hillmen P, Brown JR, Eichhorst BF, et al. ALPINE: zanubrutinib versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Future Oncol. 2020;16(10):517-23. DOI:10.2217/fon-2019-0844; PMID: 32207333
10. Tam CS, Opat S, D'Sa S, Jurczak W, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. 2020;136(18):2038-50.
DOI:10.1182/blood.2020006844; PMID: 32731259; PMCID: PMC7596850
11. Tam CS, Trotman J, Opat S, et al. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134(11):851-9. DOI:10.1182/blood.2019001160; PMID: 31340982; PMCID: PMC6742923
12. Song Y, Zhou K, Zou D, et al. Treatment of Patients with Relapsed or Refractory Mantle-Cell Lymphoma with Zanubrutinib, a Selective Inhibitor of Bruton's Tyrosine Kinase. Clin Cancer Res. 2020;26(16):4216-24.
DOI:10.1158/1078-0432.CCR-19-3703; PMID: 32461234
13. Byrd JC, Wierda WG, Schuh A, et al. Acalabrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia: updated phase 2 results. Blood. 2020;135(15):1204-13. DOI:10.1182/blood.2018884940; PMID: 31876911; PMCID: PMC7146022
14. Rule S, Dreyling M, Goy A, et al. Ibrutinib for the treatment of relapsed/refractory mantle cell lymphoma: extended 3.5-year follow up from a pooled analysis. Haematologica. 2019;104(5):e211-4.
DOI:10.3324/haematol.2018.205229; PMID: 30442728; PMCID: PMC6518912
15. Owen C, Berinstein NL, Christofides A, Sehn LH. Review of Bruton tyrosine kinase inhibitors for the treatment of relapsed or refractory mantle cell lymphoma. Curr Oncol. 2019;26(2):e233-40. DOI:10.3747/co.26.4345; PMID: 31043832; PMCID: PMC6476444
16. Tang CPS, McMullen J, Tam C. Cardiac side effects of bruton tyrosine kinase (BTK) inhibitors. Leuk Lymphoma. 2018;59(7):1554-64. DOI:10.1080/10428194.2017.1375110; PMID: 28901789
17. Dickerson T, Wiczer T, Waller A, et al. Hypertension and incident cardiovascular events following ibrutinib initiation. Blood. 2019;134(22):1919-28. DOI:10.1182/blood.2019000840; PMID: 31582362; PMCID: PMC6887116
18. Ratain MJ, Moslehi JJ, Lichter AS. Ibrutinib's Cardiotoxicity-An Opportunity for Postmarketing Regulation. JAMA Oncol. 2021;7(2):177-8. DOI:10.1001/jamaoncol.2020.5742; PMID: 33237281
19. Shafaattalab S, Lin E, Christidi E, et al. Ibrutinib Displays Atrial-Specific Toxicity in Human Stem Cell-Derived Cardiomyocytes. Stem Cell Reports. 2019;12(5):996-1006. DOI:10.1016/j.stemcr.2019.03.011; PMID: 31031187; PMCID: PMC6524928
2. Hill HA, Qi X, Jain P, et al. Genetic mutations and features of mantle cell lymphoma: a systematic review and meta-analysis. Blood Adv. 2020;4(13):2927-38. DOI:10.1182/bloodadvances.2019001350; PMID: 32598477; PMCID: PMC7362354
3. Jain P, Wang M. Mantle cell lymphoma: 2019 update on the diagnosis, pathogenesis, prognostication, and management. Am J Hematol. 2019;94(6):710-25. DOI:10.1002/ajh.25487; PMID: 30963600
4. Ferrero S, Rossi D, Rinaldi A, et al. KMT2D mutations and TP53 disruptions are poor prognostic biomarkers in mantle cell lymphoma receiving high-dose therapy: a FIL study. Haematologica. 2020;105(6):1604-12.
DOI:10.3324/haematol.2018.214056; PMID: 31537689; PMCID: PMC7271566
5. McCulloch R, Visco C, Eyre TA, et al. Efficacy of R-BAC in relapsed, refractory mantle cell lymphoma post BTK inhibitor therapy. Br J Haematol. 2020;189(4):684-8. DOI:10.1111/bjh.16416; PMID: 32011729
6. Rule S, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus: 3-year follow-up of patients with previously treated mantle cell lymphoma from the phase 3, international, randomized, open-label RAY study. Leukemia. 2018;32(8):1799-803. DOI:10.1038/s41375-018-0023-2; PMID: 29572505; PMCID: PMC6087720
7. Sharman J, Kabadi SM, Clark J, Andorsky D. Treatment patterns and outcomes among mantle cell lymphoma patients treated with ibrutinib in the United States: a retrospective electronic medical record database and chart review study. Br J Haematol. 2021;192(4):737-46. DOI:10.1111/bjh.16922; PMID: 33095453
8. Dimopoulos M, Sanz RG, Lee HP, et al. Zanubrutinib for the treatment of MYD88 wild-type Waldenström macroglobulinemia: a substudy of the phase 3 ASPEN trial. Blood Adv. 2020;4(23):6009-18.
DOI:10.1182/bloodadvances.2020003010; PMID: 33284944; PMCID: PMC7724905
9. Hillmen P, Brown JR, Eichhorst BF, et al. ALPINE: zanubrutinib versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Future Oncol. 2020;16(10):517-23. DOI:10.2217/fon-2019-0844; PMID: 32207333
10. Tam CS, Opat S, D'Sa S, Jurczak W, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. 2020;136(18):2038-50.
DOI:10.1182/blood.2020006844; PMID: 32731259; PMCID: PMC7596850
11. Tam CS, Trotman J, Opat S, et al. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134(11):851-9. DOI:10.1182/blood.2019001160; PMID: 31340982; PMCID: PMC6742923
12. Song Y, Zhou K, Zou D, et al. Treatment of Patients with Relapsed or Refractory Mantle-Cell Lymphoma with Zanubrutinib, a Selective Inhibitor of Bruton's Tyrosine Kinase. Clin Cancer Res. 2020;26(16):4216-24.
DOI:10.1158/1078-0432.CCR-19-3703; PMID: 32461234
13. Byrd JC, Wierda WG, Schuh A, et al. Acalabrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia: updated phase 2 results. Blood. 2020;135(15):1204-13. DOI:10.1182/blood.2018884940; PMID: 31876911; PMCID: PMC7146022
14. Rule S, Dreyling M, Goy A, et al. Ibrutinib for the treatment of relapsed/refractory mantle cell lymphoma: extended 3.5-year follow up from a pooled analysis. Haematologica. 2019;104(5):e211-4.
DOI:10.3324/haematol.2018.205229; PMID: 30442728; PMCID: PMC6518912
15. Owen C, Berinstein NL, Christofides A, Sehn LH. Review of Bruton tyrosine kinase inhibitors for the treatment of relapsed or refractory mantle cell lymphoma. Curr Oncol. 2019;26(2):e233-40. DOI:10.3747/co.26.4345; PMID: 31043832; PMCID: PMC6476444
16. Tang CPS, McMullen J, Tam C. Cardiac side effects of bruton tyrosine kinase (BTK) inhibitors. Leuk Lymphoma. 2018;59(7):1554-64. DOI:10.1080/10428194.2017.1375110; PMID: 28901789
17. Dickerson T, Wiczer T, Waller A, et al. Hypertension and incident cardiovascular events following ibrutinib initiation. Blood. 2019;134(22):1919-28. DOI:10.1182/blood.2019000840; PMID: 31582362; PMCID: PMC6887116
18. Ratain MJ, Moslehi JJ, Lichter AS. Ibrutinib's Cardiotoxicity-An Opportunity for Postmarketing Regulation. JAMA Oncol. 2021;7(2):177-8. DOI:10.1001/jamaoncol.2020.5742; PMID: 33237281
19. Shafaattalab S, Lin E, Christidi E, et al. Ibrutinib Displays Atrial-Specific Toxicity in Human Stem Cell-Derived Cardiomyocytes. Stem Cell Reports. 2019;12(5):996-1006. DOI:10.1016/j.stemcr.2019.03.011; PMID: 31031187; PMCID: PMC6524928
2. Hill HA, Qi X, Jain P, et al. Genetic mutations and features of mantle cell lymphoma: a systematic review and meta-analysis. Blood Adv. 2020;4(13):2927-38. DOI:10.1182/bloodadvances.2019001350; PMID: 32598477; PMCID: PMC7362354
3. Jain P, Wang M. Mantle cell lymphoma: 2019 update on the diagnosis, pathogenesis, prognostication, and management. Am J Hematol. 2019;94(6):710-25. DOI:10.1002/ajh.25487; PMID: 30963600
4. Ferrero S, Rossi D, Rinaldi A, et al. KMT2D mutations and TP53 disruptions are poor prognostic biomarkers in mantle cell lymphoma receiving high-dose therapy: a FIL study. Haematologica. 2020;105(6):1604-12.
DOI:10.3324/haematol.2018.214056; PMID: 31537689; PMCID: PMC7271566
5. McCulloch R, Visco C, Eyre TA, et al. Efficacy of R-BAC in relapsed, refractory mantle cell lymphoma post BTK inhibitor therapy. Br J Haematol. 2020;189(4):684-8. DOI:10.1111/bjh.16416; PMID: 32011729
6. Rule S, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus: 3-year follow-up of patients with previously treated mantle cell lymphoma from the phase 3, international, randomized, open-label RAY study. Leukemia. 2018;32(8):1799-803. DOI:10.1038/s41375-018-0023-2; PMID: 29572505; PMCID: PMC6087720
7. Sharman J, Kabadi SM, Clark J, Andorsky D. Treatment patterns and outcomes among mantle cell lymphoma patients treated with ibrutinib in the United States: a retrospective electronic medical record database and chart review study. Br J Haematol. 2021;192(4):737-46. DOI:10.1111/bjh.16922; PMID: 33095453
8. Dimopoulos M, Sanz RG, Lee HP, et al. Zanubrutinib for the treatment of MYD88 wild-type Waldenström macroglobulinemia: a substudy of the phase 3 ASPEN trial. Blood Adv. 2020;4(23):6009-18.
DOI:10.1182/bloodadvances.2020003010; PMID: 33284944; PMCID: PMC7724905
9. Hillmen P, Brown JR, Eichhorst BF, et al. ALPINE: zanubrutinib versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Future Oncol. 2020;16(10):517-23. DOI:10.2217/fon-2019-0844; PMID: 32207333
10. Tam CS, Opat S, D'Sa S, Jurczak W, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. 2020;136(18):2038-50.
DOI:10.1182/blood.2020006844; PMID: 32731259; PMCID: PMC7596850
11. Tam CS, Trotman J, Opat S, et al. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134(11):851-9. DOI:10.1182/blood.2019001160; PMID: 31340982; PMCID: PMC6742923
12. Song Y, Zhou K, Zou D, et al. Treatment of Patients with Relapsed or Refractory Mantle-Cell Lymphoma with Zanubrutinib, a Selective Inhibitor of Bruton's Tyrosine Kinase. Clin Cancer Res. 2020;26(16):4216-24.
DOI:10.1158/1078-0432.CCR-19-3703; PMID: 32461234
13. Byrd JC, Wierda WG, Schuh A, et al. Acalabrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia: updated phase 2 results. Blood. 2020;135(15):1204-13. DOI:10.1182/blood.2018884940; PMID: 31876911; PMCID: PMC7146022
14. Rule S, Dreyling M, Goy A, et al. Ibrutinib for the treatment of relapsed/refractory mantle cell lymphoma: extended 3.5-year follow up from a pooled analysis. Haematologica. 2019;104(5):e211-4.
DOI:10.3324/haematol.2018.205229; PMID: 30442728; PMCID: PMC6518912
15. Owen C, Berinstein NL, Christofides A, Sehn LH. Review of Bruton tyrosine kinase inhibitors for the treatment of relapsed or refractory mantle cell lymphoma. Curr Oncol. 2019;26(2):e233-40. DOI:10.3747/co.26.4345; PMID: 31043832; PMCID: PMC6476444
16. Tang CPS, McMullen J, Tam C. Cardiac side effects of bruton tyrosine kinase (BTK) inhibitors. Leuk Lymphoma. 2018;59(7):1554-64. DOI:10.1080/10428194.2017.1375110; PMID: 28901789
17. Dickerson T, Wiczer T, Waller A, et al. Hypertension and incident cardiovascular events following ibrutinib initiation. Blood. 2019;134(22):1919-28. DOI:10.1182/blood.2019000840; PMID: 31582362; PMCID: PMC6887116
18. Ratain MJ, Moslehi JJ, Lichter AS. Ibrutinib's Cardiotoxicity-An Opportunity for Postmarketing Regulation. JAMA Oncol. 2021;7(2):177-8. DOI:10.1001/jamaoncol.2020.5742; PMID: 33237281
19. Shafaattalab S, Lin E, Christidi E, et al. Ibrutinib Displays Atrial-Specific Toxicity in Human Stem Cell-Derived Cardiomyocytes. Stem Cell Reports. 2019;12(5):996-1006. DOI:10.1016/j.stemcr.2019.03.011; PMID: 31031187; PMCID: PMC6524928
________________________________________________
2. Hill HA, Qi X, Jain P, et al. Genetic mutations and features of mantle cell lymphoma: a systematic review and meta-analysis. Blood Adv. 2020;4(13):2927-38. DOI:10.1182/bloodadvances.2019001350; PMID: 32598477; PMCID: PMC7362354
3. Jain P, Wang M. Mantle cell lymphoma: 2019 update on the diagnosis, pathogenesis, prognostication, and management. Am J Hematol. 2019;94(6):710-25. DOI:10.1002/ajh.25487; PMID: 30963600
4. Ferrero S, Rossi D, Rinaldi A, et al. KMT2D mutations and TP53 disruptions are poor prognostic biomarkers in mantle cell lymphoma receiving high-dose therapy: a FIL study. Haematologica. 2020;105(6):1604-12.
DOI:10.3324/haematol.2018.214056; PMID: 31537689; PMCID: PMC7271566
5. McCulloch R, Visco C, Eyre TA, et al. Efficacy of R-BAC in relapsed, refractory mantle cell lymphoma post BTK inhibitor therapy. Br J Haematol. 2020;189(4):684-8. DOI:10.1111/bjh.16416; PMID: 32011729
6. Rule S, Jurczak W, Jerkeman M, et al. Ibrutinib versus temsirolimus: 3-year follow-up of patients with previously treated mantle cell lymphoma from the phase 3, international, randomized, open-label RAY study. Leukemia. 2018;32(8):1799-803. DOI:10.1038/s41375-018-0023-2; PMID: 29572505; PMCID: PMC6087720
7. Sharman J, Kabadi SM, Clark J, Andorsky D. Treatment patterns and outcomes among mantle cell lymphoma patients treated with ibrutinib in the United States: a retrospective electronic medical record database and chart review study. Br J Haematol. 2021;192(4):737-46. DOI:10.1111/bjh.16922; PMID: 33095453
8. Dimopoulos M, Sanz RG, Lee HP, et al. Zanubrutinib for the treatment of MYD88 wild-type Waldenström macroglobulinemia: a substudy of the phase 3 ASPEN trial. Blood Adv. 2020;4(23):6009-18.
DOI:10.1182/bloodadvances.2020003010; PMID: 33284944; PMCID: PMC7724905
9. Hillmen P, Brown JR, Eichhorst BF, et al. ALPINE: zanubrutinib versus ibrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Future Oncol. 2020;16(10):517-23. DOI:10.2217/fon-2019-0844; PMID: 32207333
10. Tam CS, Opat S, D'Sa S, Jurczak W, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study. Blood. 2020;136(18):2038-50.
DOI:10.1182/blood.2020006844; PMID: 32731259; PMCID: PMC7596850
11. Tam CS, Trotman J, Opat S, et al. Phase 1 study of the selective BTK inhibitor zanubrutinib in B-cell malignancies and safety and efficacy evaluation in CLL. Blood. 2019;134(11):851-9. DOI:10.1182/blood.2019001160; PMID: 31340982; PMCID: PMC6742923
12. Song Y, Zhou K, Zou D, et al. Treatment of Patients with Relapsed or Refractory Mantle-Cell Lymphoma with Zanubrutinib, a Selective Inhibitor of Bruton's Tyrosine Kinase. Clin Cancer Res. 2020;26(16):4216-24.
DOI:10.1158/1078-0432.CCR-19-3703; PMID: 32461234
13. Byrd JC, Wierda WG, Schuh A, et al. Acalabrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia: updated phase 2 results. Blood. 2020;135(15):1204-13. DOI:10.1182/blood.2018884940; PMID: 31876911; PMCID: PMC7146022
14. Rule S, Dreyling M, Goy A, et al. Ibrutinib for the treatment of relapsed/refractory mantle cell lymphoma: extended 3.5-year follow up from a pooled analysis. Haematologica. 2019;104(5):e211-4.
DOI:10.3324/haematol.2018.205229; PMID: 30442728; PMCID: PMC6518912
15. Owen C, Berinstein NL, Christofides A, Sehn LH. Review of Bruton tyrosine kinase inhibitors for the treatment of relapsed or refractory mantle cell lymphoma. Curr Oncol. 2019;26(2):e233-40. DOI:10.3747/co.26.4345; PMID: 31043832; PMCID: PMC6476444
16. Tang CPS, McMullen J, Tam C. Cardiac side effects of bruton tyrosine kinase (BTK) inhibitors. Leuk Lymphoma. 2018;59(7):1554-64. DOI:10.1080/10428194.2017.1375110; PMID: 28901789
17. Dickerson T, Wiczer T, Waller A, et al. Hypertension and incident cardiovascular events following ibrutinib initiation. Blood. 2019;134(22):1919-28. DOI:10.1182/blood.2019000840; PMID: 31582362; PMCID: PMC6887116
18. Ratain MJ, Moslehi JJ, Lichter AS. Ibrutinib's Cardiotoxicity-An Opportunity for Postmarketing Regulation. JAMA Oncol. 2021;7(2):177-8. DOI:10.1001/jamaoncol.2020.5742; PMID: 33237281
19. Shafaattalab S, Lin E, Christidi E, et al. Ibrutinib Displays Atrial-Specific Toxicity in Human Stem Cell-Derived Cardiomyocytes. Stem Cell Reports. 2019;12(5):996-1006. DOI:10.1016/j.stemcr.2019.03.011; PMID: 31031187; PMCID: PMC6524928
Авторы
К.Д. Капланов*
ГБУЗ «Городская клиническая больница им. С.П. Боткина» Департамента здравоохранения г. Москвы, Москва, Россия
* kamilos@mail.ru
Botkin City Clinical Hospital, Moscow, Russia
*kamilos@mail.ru
ГБУЗ «Городская клиническая больница им. С.П. Боткина» Департамента здравоохранения г. Москвы, Москва, Россия
* kamilos@mail.ru
________________________________________________
Botkin City Clinical Hospital, Moscow, Russia
*kamilos@mail.ru
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