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Клинико-экономическое исследование применения акалабрутиниба у пациентов с хроническим лимфолейкозом
Клинико-экономическое исследование применения акалабрутиниба у пациентов с хроническим лимфолейкозом
Недогода С.В., Саласюк А.С., Барыкина И.Н., Лутова В.О., Попова Е.А. Клинико-экономическое исследование применения акалабрутиниба у пациентов с хроническим лимфолейкозом. Современная Онкология. 2021;23(4):612–620. DOI: 10.26442/18151434.2021.4.201339
DOI: 10.26442/18151434.2021.4.201339
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DOI: 10.26442/18151434.2021.4.201339
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Аннотация
Цель. Проведение оценки экономических последствий (клинико-экономический анализ и анализ влияния на бюджет – АВБ) при включении нового ингибитора тирозинкиназы Брутона акалабрутиниба в клиническую практику для терапии взрослых пациентов с хроническим лимфолейкозом (ХЛЛ) высокого риска в рамках льготного лекарственного обеспечения.
Материалы и методы. В ходе настоящего исследования построена аналитическая модель принятия решений в MS Excel, которая позволяет провести клинико-экономический анализ и АВБ при применении препарата акалабрутиниба в сравнении с ибрутинибом и комбинацией венетоклакса с обинутузумабом в 1-й линии терапии ХЛЛ высокого риска, а также акалабрутиниба, ибрутининба и комбинации венетоклакса с ритуксимабом в терапии рецидивов и рефрактерных форм ХЛЛ (рХЛЛ) высокого риска. В модели учтены только прямые медицинские затраты на 1 пациента (затраты на лекарственную терапию).
Результаты. Анализ минимизации затрат показал, что применение препарата акалабрутиниб в 1-й линии и при лечении рецидивов и рХЛЛ высокого риска относительно препаратов сравнения является предпочтительной опцией, обладая сопоставимой эффективностью и меньшей стоимостью. Снижение затрат в 1-й линии терапии ХЛЛ высокого риска и терапии рецидивов и рХЛЛ высокого риска по сравнению с ибрутинибом составило 0,8 млн руб., или 15,4%, в 1-й линии терапии ХЛЛ высокого риска по сравнению с комбинацией венетоклакс + обинутузумаб – 1,2 млн руб., или 21,4%, в терапии рецидивов и рХЛЛ высокого риска в сравнении с комбинацией венетоклакс + ритуксимаб – 0,9 млн руб., или 17,8%. АВБ показал, что в случае инициации акалабрутинибом 1-й линии и терапии рецидивов и рХЛЛ высокого риска нагрузку на бюджет системы здравоохранения удастся снизить на 0,813 млрд руб., или 16,0%, за 1 год терапии и на 1,219 млрд руб., или 9,1%, за 3 года терапии при учете только затрат на лекарственные препараты.
Ключевые слова: хронический лимфолейкоз, ингибитор тирозинкиназы Брутона, акалабрутиниб, ибрутиниб, обинутузумаб, венетоклакс, анализ минимизации затрат, анализ влияния на бюджет, фармакоэкономика
Materials and methods. In the course of this study, an analytical decision-making model was built in MS Excel, which allows to provide pharmacoeconomic analysis and analysis of the budget impact of acalabrutinib in comparison with the combination of venetoclax with obinutuzumab in the first line of therapy for high-risk CLL, as well as acalabrutinib and the combination of venetoclax with rituximab in the treatment of high-risk relapses and refractory forms of CLL. The model took into account only direct medical costs per patient (drug therapy costs).
Results. The “cost minimization” analysis showed that the use of the drug acalabrutinib in the 1st line and for the treatment of relapses and refractory forms of high-risk CLL is the preferred option compared to comparators, having comparable efficacy and lower cost. The cost reduction in the first-line therapy of high-risk CLL and the treatment of relapses and refractory forms of high-risk CLL compared with ibrutinib amounted to 0.8 million rubles or 15.4%, in the first-line therapy of high-risk CLL compared with the combination of venetoclax + obinutuzumab – 1.2 million rubles or 21.0%, in the treatment of relapses and refractory forms of high-risk CLL in comparison with the combination of venetoclax + rituximab – 0.9 million rubles or 17.6%. Budget impact showed that in the case of initiation of first-line acalabrutinib and treatment of relapses and refractory forms in high-risk CLL patients, the burden on the health care system budget can be reduced by 0.813 billion rubles or 16.0% for 1 year of therapy and by 1.219 billion rubles or 9.1% over 3 years of therapy, taking into account only the costs of drugs.
Keywords: chronic lymphocytic leukemia, Bruton's tyrosine kinase inhibitor, acalabrutinib, ibrutinib, obinutuzumab, venetoclax, cost minimization analysis, budget impact analysis, pharmacoeconomics
Материалы и методы. В ходе настоящего исследования построена аналитическая модель принятия решений в MS Excel, которая позволяет провести клинико-экономический анализ и АВБ при применении препарата акалабрутиниба в сравнении с ибрутинибом и комбинацией венетоклакса с обинутузумабом в 1-й линии терапии ХЛЛ высокого риска, а также акалабрутиниба, ибрутининба и комбинации венетоклакса с ритуксимабом в терапии рецидивов и рефрактерных форм ХЛЛ (рХЛЛ) высокого риска. В модели учтены только прямые медицинские затраты на 1 пациента (затраты на лекарственную терапию).
Результаты. Анализ минимизации затрат показал, что применение препарата акалабрутиниб в 1-й линии и при лечении рецидивов и рХЛЛ высокого риска относительно препаратов сравнения является предпочтительной опцией, обладая сопоставимой эффективностью и меньшей стоимостью. Снижение затрат в 1-й линии терапии ХЛЛ высокого риска и терапии рецидивов и рХЛЛ высокого риска по сравнению с ибрутинибом составило 0,8 млн руб., или 15,4%, в 1-й линии терапии ХЛЛ высокого риска по сравнению с комбинацией венетоклакс + обинутузумаб – 1,2 млн руб., или 21,4%, в терапии рецидивов и рХЛЛ высокого риска в сравнении с комбинацией венетоклакс + ритуксимаб – 0,9 млн руб., или 17,8%. АВБ показал, что в случае инициации акалабрутинибом 1-й линии и терапии рецидивов и рХЛЛ высокого риска нагрузку на бюджет системы здравоохранения удастся снизить на 0,813 млрд руб., или 16,0%, за 1 год терапии и на 1,219 млрд руб., или 9,1%, за 3 года терапии при учете только затрат на лекарственные препараты.
Ключевые слова: хронический лимфолейкоз, ингибитор тирозинкиназы Брутона, акалабрутиниб, ибрутиниб, обинутузумаб, венетоклакс, анализ минимизации затрат, анализ влияния на бюджет, фармакоэкономика
________________________________________________
Materials and methods. In the course of this study, an analytical decision-making model was built in MS Excel, which allows to provide pharmacoeconomic analysis and analysis of the budget impact of acalabrutinib in comparison with the combination of venetoclax with obinutuzumab in the first line of therapy for high-risk CLL, as well as acalabrutinib and the combination of venetoclax with rituximab in the treatment of high-risk relapses and refractory forms of CLL. The model took into account only direct medical costs per patient (drug therapy costs).
Results. The “cost minimization” analysis showed that the use of the drug acalabrutinib in the 1st line and for the treatment of relapses and refractory forms of high-risk CLL is the preferred option compared to comparators, having comparable efficacy and lower cost. The cost reduction in the first-line therapy of high-risk CLL and the treatment of relapses and refractory forms of high-risk CLL compared with ibrutinib amounted to 0.8 million rubles or 15.4%, in the first-line therapy of high-risk CLL compared with the combination of venetoclax + obinutuzumab – 1.2 million rubles or 21.0%, in the treatment of relapses and refractory forms of high-risk CLL in comparison with the combination of venetoclax + rituximab – 0.9 million rubles or 17.6%. Budget impact showed that in the case of initiation of first-line acalabrutinib and treatment of relapses and refractory forms in high-risk CLL patients, the burden on the health care system budget can be reduced by 0.813 billion rubles or 16.0% for 1 year of therapy and by 1.219 billion rubles or 9.1% over 3 years of therapy, taking into account only the costs of drugs.
Keywords: chronic lymphocytic leukemia, Bruton's tyrosine kinase inhibitor, acalabrutinib, ibrutinib, obinutuzumab, venetoclax, cost minimization analysis, budget impact analysis, pharmacoeconomics
Полный текст
Список литературы
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2. Khronicheskii limfotsitarnyi leikoz/limfoma iz malykh limfotsitov, 2020 g. Klinicheskie rekomendatsii 134/1. Available at: http://cr.rosminzdrav.ru/#!/recomend/111. Accessed: 02.11.2021 (in Russian).
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7. Patel V, Balakrishnan K, Bibikova E, et al. Comparison of Acalabrutinib, A Selective Bruton Tyrosine Kinase Inhibitor, with Ibrutinib in Chronic Lymphocytic Leukemia Cells. Clin Cancer Res. 2017;23(14):3734-43. DOI:10.1158/1078-0432.CCR-16-1446.
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DOI:10.1002/cmdc.200600221
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12. Sharman JP, Banerji V, Fogliatto LM, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Blood. 2019;134(Suppl. 1).
13. Ghia P, Pluta A, Wach M, et al. Acalabrutinib vs Rituximab plus Idelalisib or Bendamustine by Investigator Choice in Relapsed/Refractory Chronic Lymphocytic Leukemia: Phase 3 ASCEND Study. Journal of Oncology Navigation & Survivorship. 2019;10(11).
14. Wang M, Simon R, Zinzagi PL, et al. Long-term follow-up of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma. Blood. 2018;132(Suppl. 1):2876. DOI:10.1182/blood-2018-99-110327
15. Girard J, Reneau J, Devata S, et al. Evaluating Acalabrutinib In The Treatment Of Mantle Cell Lymphoma: Design, Development, And Place In Therapy. Onco Targets Therapy. 2019;12:8003-14. DOI:10.2147/OTT.S155778
16. Talha M, Gaitonde P, Waweru C. Cost-Effectiveness of Acalabrutinib Monotherapy Compared with Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia. Blood. 2020;136:13-4.
17. Tappenden P, Simpson E, Hamilton J, et al. Acalabrutinib for treating chronic lymphocytic leukaemia: A Single Technology Appraisal. School of Health and Related Research (ScHARR), University of Sheffield, 2020.
18. Chatterjee A, Shapouri S, Manzoor BS, et al. Cost-effectiveness of a 12-month fixed-duration venetoclax treatment in combination with obinutuzumab in first-line, unfit chronic lymphocytic leukemia in the United States. J Manag Care Spec Pharm. 2021;27(11):1532-44. DOI:10.18553/jmcp.2021.27.11.1532
19. Application No. 1607 – 17p deletion testing for access to acalabrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia. Available at: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/A6913F8408FC5649CA258522000CB855/$File/1.... Accessed: 02.11.2021.
20. CADTH DRUG Reimbursement Review. Acalabrutinib. Available at: https://www.cadth.ca/sites/default/files/pcodr/Reviews2020/10211AcalabrutinibCLL_fnEGR_REDACTABBREV_.... Accessed: 02.11.2021.
21. NICE Final appraisal document. Acalabrutinib for treating chronic lymphocytic leukaemia. Available at: https://www.nice.org.uk/guidance/ta689/documents/final-appraisal-determination-document. Accessed: 02.11.2021.
22. The Scottish Medicines Consortium. Available at: https://www.scottishmedicines.org.uk/media/6029/acalabrutinib-calquence-final-may-2021-for-website.p.... Accessed: 02.11.2021.
23. Public Summary Document – March 2020 PBAC Meeting. Available at: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2020-03/files/acalabrutinib-psd-m.... Accessed: 02.11.2021.
24. [A21-54] Acalabrutinib (pretreated chronic lymphocytic leukaemia). Available at: https://www.iqwig.de/en/projects/a21-54.html. Accessed: 02.11.2021.
25. [A21-52] Acalabrutinib (previously untreated chronic lymphocytic leukaemia). Available at: https://www.iqwig.de/en/projects/a21-52.html. Accessed: 02.11.2021.
26. Acalabrutinib (Calquence®) HTA ID: 20063. Available at: https://www.ncpe.ie/drugs/acalabrutinib-calquence-hta-id-20063/ Accessed: 02.11.2021.
27. Davids MS, Telford C, Abhyankar S, et al. Matching-adjusted indirect comparisons of safety and efficacy of acalabrutinib versus other targeted therapies in patients with treatment-naïve chronic lymphocytic leukemia. Leuk Lymphoma. 2021;62(10):2342-51. DOI:10.1080/10428194.2021.1913144
28. Matching-Adjusted Indirect Comparisons of Efficacy and Tolerability Outcomes with Acalabrutinib versus Selected Comparators for patients with Relapsed/Refractory Chronic Lymphocytic Leukemia. Study Report 4 October 2019.
29. Zlokachestvennye novoobrazovaniia v Rossii v 2019 godu (zabolevaemost' i smertnost'). Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. P.A. Gertsena − filial FGBU “NMITs radiologii” Minzdrava Rossii, 2020 (in Russian).
30. Rossi D, Cerri M, Deambrogi C, et al. The Prognostic Value of TP53 Mutations in Chronic Lymphocytic Leukemia Is Independent of Del17p13: Implications for Overall Survival and Chemorefractoriness. Clin Cancer Res. 2009;15(3):995-1004. DOI:10.1158/1078-0432.CCR-08-1630
31. Mikhailova NB, Kalashnikova OB, et al. Vedenie patsientov s khronicheskim limfoleikozom. Opyt PSPbGMU (poliklinika s KDTs i NII DOGiT im. R.M. Gorbachevoi) (in Russian).
32. Poddubnaya IV, Bialik T., Glonina NN, et al. The role of second generation Bruton tyrosine kinase inhibitors in the treatment of chronic lymphocytic leukemia. Resolution. Journal of Modern Oncology. 2019;21(4):45-7 (in Russian).
DOI:10.26442/18151434.2019.4.190725
33. Zenz T, Häbe S, Denzel T, et al. Detailed analysis of p53 pathway defects in fludarabine-refractory chronic lymphocytic leukemia (CLL): dissecting the contribution of 17p deletion, TP53 mutation, p53-p21 dysfunction, and miR34a in a prospective clinical trial. Blood. 2009;114(13):2589-97. DOI:10.1182/blood-2009-05-224071
34. Jansen JP. Network meta-analysis of survival data with fractional polynomials. BMC Medl Res Methodol. 2011;11:61. DOI:10.1186/1471-2288-11-61
35. Phillippo DM, Ades AE, Dias S, et al. Methods for population-adjusted indirect comparisons in health technology appraisal. Med Decis Making. 2018;38(2):200‑11. DOI:10.1177/0272989X17725740
36. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Eng J Med. 2019;380(23):2225-36. DOI:10.1056/NEJMoa1815281
37. Al-Sawaf O, Zhang C, Lu T, et al. Venetoclax‐Obinutuzumab for previously untreated chronic lymphocytic leukemia: 4‐year follow‐up analysis of the randomized CLL14 study. J Clin Oncol. 2021;39(36):4049-60. DOI:10.1200/JCO.21.01181
38. Kater AP, Seymour JF, Hillmen P, et al. Fixed duration of venetoclax-rituximab in relapsed/refractory chronic lymphocytic leukemia eradicates minimal residual disease and prolongs survival: post-treatment follow-up of the MURANO phase III study. J Clin Oncol. 2019;37(4):269-77. DOI:10.1200/JCO.18.01580
2. Хронический лимфоцитарный лейкоз/лимфома из малых лимфоцитов, 2020 г. Клинические рекомендации 134/1. Режим доступа: http://cr.rosminzdrav.ru/#!/recomend/111. Сылка активна на 02.11.2021 [Khronicheskii limfotsitarnyi leikoz/limfoma iz malykh limfotsitov, 2020 g. Klinicheskie rekomendatsii 134/1. Available at: http://cr.rosminzdrav.ru/#!/recomend/111. Accessed: 02.11.2021 (in Russian)].
3. ESMO Guidelines Committee. Chronic Lymphocytic Leukaemia Treatment Recommendations. Published: 27 June 2017. Available at: https://www.esmo.org/guidelines/haematological-malignancies/chronic-lymphocytic-leukaemia/eupdate-ch.... Accessed: 02.11.2021.
4. NCCN Guidelines for management of CLL Version.3 Feb 12th 2018. Available at: https://www.nccn.org/professionals/physician_gls/recently_updated.aspx. Accessed: 02.11.2021.
5. Росcийские клинические рекомендации по диагностике и лечению лимфопролиферативных заболеваний. Под ред. И.В. Поддубной, В.Г. Савченко. М., 2018 [Rosciiskie klinicheskie rekomendatsii po diagnostike i lecheniiu limfoproliferativnykh zabolevanii. Pod red. IV Poddubnoi, VG Savchenko. Moscow, 2018 (in Russian)].
6. Burki TK. Acalabrutinib for relapsed chronic lymphocytic leukaemia. Lancet Oncol. 2016;17(2):e48. DOI:10.1016/S1470-2045(15)00610-5
7. Patel V, Balakrishnan K, Bibikova E, et al. Comparison of Acalabrutinib, A Selective Bruton Tyrosine Kinase Inhibitor, with Ibrutinib in Chronic Lymphocytic Leukemia Cells. Clin Cancer Res. 2017;23(14):3734-43. DOI:10.1158/1078-0432.CCR-16-1446.
8. Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9:21.
9. Pan Z, Scheerens H, Li SJ, et al. Discovery of selective irreversible inhibitors for Bruton’s tyrosine kinase. ChemMedChem. 2007;2(1):58-61.
DOI:10.1002/cmdc.200600221
10. Byrd JC, Harrington B, O’Brien S, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374:323-32.
11. FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia. November 21, 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-takes-second-action-under-international-coll.... Assecced: 02.11.2021.
12. Sharman JP, Banerji V, Fogliatto LM, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Blood. 2019;134(Suppl. 1).
13. Ghia P, Pluta A, Wach M, et al. Acalabrutinib vs Rituximab plus Idelalisib or Bendamustine by Investigator Choice in Relapsed/Refractory Chronic Lymphocytic Leukemia: Phase 3 ASCEND Study. Journal of Oncology Navigation & Survivorship. 2019;10(11).
14. Wang M, Simon R, Zinzagi PL, et al. Long-term follow-up of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma. Blood. 2018;132(Suppl. 1):2876. DOI:10.1182/blood-2018-99-110327
15. Girard J, Reneau J, Devata S, et al. Evaluating Acalabrutinib In The Treatment Of Mantle Cell Lymphoma: Design, Development, And Place In Therapy. Onco Targets Therapy. 2019;12:8003-14. DOI:10.2147/OTT.S155778
16. Talha M, Gaitonde P, Waweru C. Cost-Effectiveness of Acalabrutinib Monotherapy Compared with Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia. Blood. 2020;136:13-4.
17. Tappenden P, Simpson E, Hamilton J, et al. Acalabrutinib for treating chronic lymphocytic leukaemia: A Single Technology Appraisal. School of Health and Related Research (ScHARR), University of Sheffield, 2020.
18. Chatterjee A, Shapouri S, Manzoor BS, et al. Cost-effectiveness of a 12-month fixed-duration venetoclax treatment in combination with obinutuzumab in first-line, unfit chronic lymphocytic leukemia in the United States. J Manag Care Spec Pharm. 2021;27(11):1532-44. DOI:10.18553/jmcp.2021.27.11.1532
19. Application No. 1607 – 17p deletion testing for access to acalabrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia. Available at: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/A6913F8408FC5649CA258522000CB855/$File/1.... Accessed: 02.11.2021.
20. CADTH DRUG Reimbursement Review. Acalabrutinib. Available at: https://www.cadth.ca/sites/default/files/pcodr/Reviews2020/10211AcalabrutinibCLL_fnEGR_REDACTABBREV_.... Accessed: 02.11.2021.
21. NICE Final appraisal document. Acalabrutinib for treating chronic lymphocytic leukaemia. Available at: https://www.nice.org.uk/guidance/ta689/documents/final-appraisal-determination-document. Accessed: 02.11.2021.
22. The Scottish Medicines Consortium. Available at: https://www.scottishmedicines.org.uk/media/6029/acalabrutinib-calquence-final-may-2021-for-website.p.... Accessed: 02.11.2021.
23. Public Summary Document – March 2020 PBAC Meeting. Available at: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2020-03/files/acalabrutinib-psd-m.... Accessed: 02.11.2021.
24. [A21-54] Acalabrutinib (pretreated chronic lymphocytic leukaemia). Available at: https://www.iqwig.de/en/projects/a21-54.html. Accessed: 02.11.2021.
25. [A21-52] Acalabrutinib (previously untreated chronic lymphocytic leukaemia). Available at: https://www.iqwig.de/en/projects/a21-52.html. Accessed: 02.11.2021.
26. Acalabrutinib (Calquence®) HTA ID: 20063. Available at: https://www.ncpe.ie/drugs/acalabrutinib-calquence-hta-id-20063/ Accessed: 02.11.2021.
27. Davids MS, Telford C, Abhyankar S, et al. Matching-adjusted indirect comparisons of safety and efficacy of acalabrutinib versus other targeted therapies in patients with treatment-naïve chronic lymphocytic leukemia. Leuk Lymphoma. 2021;62(10):2342-51. DOI:10.1080/10428194.2021.1913144
28. Matching-Adjusted Indirect Comparisons of Efficacy and Tolerability Outcomes with Acalabrutinib versus Selected Comparators for patients with Relapsed/Refractory Chronic Lymphocytic Leukemia. Study Report 4 October 2019.
29. Злокачественные новообразования в России в 2019 году (заболеваемость и смертность). Под ред. А.Д. Каприна, В.В. Старинского, А.О. Шахзадовой. М.: МНИОИ им. П.А. Герцена − филиал ФГБУ «НМИЦ радиологии» Минздрава России, 2020 [Zlokachestvennye novoobrazovaniia v Rossii v 2019 godu (zabolevaemost' i smertnost'). Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. P.A. Gertsena − filial FGBU “NMITs radiologii” Minzdrava Rossii, 2020 (in Russian)].
30. Rossi D, Cerri M, Deambrogi C, et al. The Prognostic Value of TP53 Mutations in Chronic Lymphocytic Leukemia Is Independent of Del17p13: Implications for Overall Survival and Chemorefractoriness. Clin Cancer Res. 2009;15(3):995-1004. DOI:10.1158/1078-0432.CCR-08-1630
31. Михайлова Н.Б., Калашникова О.Б., и др. Ведение пациентов с хроническим лимфолейкозом. Опыт ПСПбГМУ (поликлиника с КДЦ и НИИ ДОГиТ им. Р.М. Горбачевой) [Mikhailova NB, Kalashnikova OB, et al. Vedenie patsientov s khronicheskim limfoleikozom. Opyt PSPbGMU (poliklinika s KDTs i NII DOGiT im. R.M. Gorbachevoi) (in Russian)].
32. Поддубная И.В., Бялик Т.Е., Глонина Н.Н., и др. Экспертный совет. Роль ингибиторов тирозинкиназы Брутона II поколения в лечении хронического лимфолейкоза. Резолюция. Современная Онкология. 2019;21(4):45-7 [Poddubnaya IV, Bialik T., Glonina NN, et al. The role of second generation Bruton tyrosine kinase inhibitors in the treatment of chronic lymphocytic leukemia. Resolution. Journal of Modern Oncology. 2019;21(4):45-7 (in Russian)].
DOI:10.26442/18151434.2019.4.190725
33. Zenz T, Häbe S, Denzel T, et al. Detailed analysis of p53 pathway defects in fludarabine-refractory chronic lymphocytic leukemia (CLL): dissecting the contribution of 17p deletion, TP53 mutation, p53-p21 dysfunction, and miR34a in a prospective clinical trial. Blood. 2009;114(13):2589-97. DOI:10.1182/blood-2009-05-224071
34. Jansen JP. Network meta-analysis of survival data with fractional polynomials. BMC Medl Res Methodol. 2011;11:61. DOI:10.1186/1471-2288-11-61
35. Phillippo DM, Ades AE, Dias S, et al. Methods for population-adjusted indirect comparisons in health technology appraisal. Med Decis Making. 2018;38(2):200‑11. DOI:10.1177/0272989X17725740
36. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Eng J Med. 2019;380(23):2225-36. DOI:10.1056/NEJMoa1815281
37. Al-Sawaf O, Zhang C, Lu T, et al. Venetoclax‐Obinutuzumab for previously untreated chronic lymphocytic leukemia: 4‐year follow‐up analysis of the randomized CLL14 study. J Clin Oncol. 2021;39(36):4049-60. DOI:10.1200/JCO.21.01181
38. Kater AP, Seymour JF, Hillmen P, et al. Fixed duration of venetoclax-rituximab in relapsed/refractory chronic lymphocytic leukemia eradicates minimal residual disease and prolongs survival: post-treatment follow-up of the MURANO phase III study. J Clin Oncol. 2019;37(4):269-77. DOI:10.1200/JCO.18.01580
________________________________________________
2. Khronicheskii limfotsitarnyi leikoz/limfoma iz malykh limfotsitov, 2020 g. Klinicheskie rekomendatsii 134/1. Available at: http://cr.rosminzdrav.ru/#!/recomend/111. Accessed: 02.11.2021 (in Russian).
3. ESMO Guidelines Committee. Chronic Lymphocytic Leukaemia Treatment Recommendations. Published: 27 June 2017. Available at: https://www.esmo.org/guidelines/haematological-malignancies/chronic-lymphocytic-leukaemia/eupdate-ch.... Accessed: 02.11.2021.
4. NCCN Guidelines for management of CLL Version.3 Feb 12th 2018. Available at: https://www.nccn.org/professionals/physician_gls/recently_updated.aspx. Accessed: 02.11.2021.
5. Rosciiskie klinicheskie rekomendatsii po diagnostike i lecheniiu limfoproliferativnykh zabolevanii. Pod red. IV Poddubnoi, VG Savchenko. Moscow, 2018 (in Russian).
6. Burki TK. Acalabrutinib for relapsed chronic lymphocytic leukaemia. Lancet Oncol. 2016;17(2):e48. DOI:10.1016/S1470-2045(15)00610-5
7. Patel V, Balakrishnan K, Bibikova E, et al. Comparison of Acalabrutinib, A Selective Bruton Tyrosine Kinase Inhibitor, with Ibrutinib in Chronic Lymphocytic Leukemia Cells. Clin Cancer Res. 2017;23(14):3734-43. DOI:10.1158/1078-0432.CCR-16-1446.
8. Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9:21.
9. Pan Z, Scheerens H, Li SJ, et al. Discovery of selective irreversible inhibitors for Bruton’s tyrosine kinase. ChemMedChem. 2007;2(1):58-61.
DOI:10.1002/cmdc.200600221
10. Byrd JC, Harrington B, O’Brien S, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374:323-32.
11. FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia. November 21, 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-takes-second-action-under-international-coll.... Assecced: 02.11.2021.
12. Sharman JP, Banerji V, Fogliatto LM, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Blood. 2019;134(Suppl. 1).
13. Ghia P, Pluta A, Wach M, et al. Acalabrutinib vs Rituximab plus Idelalisib or Bendamustine by Investigator Choice in Relapsed/Refractory Chronic Lymphocytic Leukemia: Phase 3 ASCEND Study. Journal of Oncology Navigation & Survivorship. 2019;10(11).
14. Wang M, Simon R, Zinzagi PL, et al. Long-term follow-up of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma. Blood. 2018;132(Suppl. 1):2876. DOI:10.1182/blood-2018-99-110327
15. Girard J, Reneau J, Devata S, et al. Evaluating Acalabrutinib In The Treatment Of Mantle Cell Lymphoma: Design, Development, And Place In Therapy. Onco Targets Therapy. 2019;12:8003-14. DOI:10.2147/OTT.S155778
16. Talha M, Gaitonde P, Waweru C. Cost-Effectiveness of Acalabrutinib Monotherapy Compared with Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia. Blood. 2020;136:13-4.
17. Tappenden P, Simpson E, Hamilton J, et al. Acalabrutinib for treating chronic lymphocytic leukaemia: A Single Technology Appraisal. School of Health and Related Research (ScHARR), University of Sheffield, 2020.
18. Chatterjee A, Shapouri S, Manzoor BS, et al. Cost-effectiveness of a 12-month fixed-duration venetoclax treatment in combination with obinutuzumab in first-line, unfit chronic lymphocytic leukemia in the United States. J Manag Care Spec Pharm. 2021;27(11):1532-44. DOI:10.18553/jmcp.2021.27.11.1532
19. Application No. 1607 – 17p deletion testing for access to acalabrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia. Available at: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/A6913F8408FC5649CA258522000CB855/$File/1.... Accessed: 02.11.2021.
20. CADTH DRUG Reimbursement Review. Acalabrutinib. Available at: https://www.cadth.ca/sites/default/files/pcodr/Reviews2020/10211AcalabrutinibCLL_fnEGR_REDACTABBREV_.... Accessed: 02.11.2021.
21. NICE Final appraisal document. Acalabrutinib for treating chronic lymphocytic leukaemia. Available at: https://www.nice.org.uk/guidance/ta689/documents/final-appraisal-determination-document. Accessed: 02.11.2021.
22. The Scottish Medicines Consortium. Available at: https://www.scottishmedicines.org.uk/media/6029/acalabrutinib-calquence-final-may-2021-for-website.p.... Accessed: 02.11.2021.
23. Public Summary Document – March 2020 PBAC Meeting. Available at: https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2020-03/files/acalabrutinib-psd-m.... Accessed: 02.11.2021.
24. [A21-54] Acalabrutinib (pretreated chronic lymphocytic leukaemia). Available at: https://www.iqwig.de/en/projects/a21-54.html. Accessed: 02.11.2021.
25. [A21-52] Acalabrutinib (previously untreated chronic lymphocytic leukaemia). Available at: https://www.iqwig.de/en/projects/a21-52.html. Accessed: 02.11.2021.
26. Acalabrutinib (Calquence®) HTA ID: 20063. Available at: https://www.ncpe.ie/drugs/acalabrutinib-calquence-hta-id-20063/ Accessed: 02.11.2021.
27. Davids MS, Telford C, Abhyankar S, et al. Matching-adjusted indirect comparisons of safety and efficacy of acalabrutinib versus other targeted therapies in patients with treatment-naïve chronic lymphocytic leukemia. Leuk Lymphoma. 2021;62(10):2342-51. DOI:10.1080/10428194.2021.1913144
28. Matching-Adjusted Indirect Comparisons of Efficacy and Tolerability Outcomes with Acalabrutinib versus Selected Comparators for patients with Relapsed/Refractory Chronic Lymphocytic Leukemia. Study Report 4 October 2019.
29. Zlokachestvennye novoobrazovaniia v Rossii v 2019 godu (zabolevaemost' i smertnost'). Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. P.A. Gertsena − filial FGBU “NMITs radiologii” Minzdrava Rossii, 2020 (in Russian).
30. Rossi D, Cerri M, Deambrogi C, et al. The Prognostic Value of TP53 Mutations in Chronic Lymphocytic Leukemia Is Independent of Del17p13: Implications for Overall Survival and Chemorefractoriness. Clin Cancer Res. 2009;15(3):995-1004. DOI:10.1158/1078-0432.CCR-08-1630
31. Mikhailova NB, Kalashnikova OB, et al. Vedenie patsientov s khronicheskim limfoleikozom. Opyt PSPbGMU (poliklinika s KDTs i NII DOGiT im. R.M. Gorbachevoi) (in Russian).
32. Poddubnaya IV, Bialik T., Glonina NN, et al. The role of second generation Bruton tyrosine kinase inhibitors in the treatment of chronic lymphocytic leukemia. Resolution. Journal of Modern Oncology. 2019;21(4):45-7 (in Russian).
DOI:10.26442/18151434.2019.4.190725
33. Zenz T, Häbe S, Denzel T, et al. Detailed analysis of p53 pathway defects in fludarabine-refractory chronic lymphocytic leukemia (CLL): dissecting the contribution of 17p deletion, TP53 mutation, p53-p21 dysfunction, and miR34a in a prospective clinical trial. Blood. 2009;114(13):2589-97. DOI:10.1182/blood-2009-05-224071
34. Jansen JP. Network meta-analysis of survival data with fractional polynomials. BMC Medl Res Methodol. 2011;11:61. DOI:10.1186/1471-2288-11-61
35. Phillippo DM, Ades AE, Dias S, et al. Methods for population-adjusted indirect comparisons in health technology appraisal. Med Decis Making. 2018;38(2):200‑11. DOI:10.1177/0272989X17725740
36. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Eng J Med. 2019;380(23):2225-36. DOI:10.1056/NEJMoa1815281
37. Al-Sawaf O, Zhang C, Lu T, et al. Venetoclax‐Obinutuzumab for previously untreated chronic lymphocytic leukemia: 4‐year follow‐up analysis of the randomized CLL14 study. J Clin Oncol. 2021;39(36):4049-60. DOI:10.1200/JCO.21.01181
38. Kater AP, Seymour JF, Hillmen P, et al. Fixed duration of venetoclax-rituximab in relapsed/refractory chronic lymphocytic leukemia eradicates minimal residual disease and prolongs survival: post-treatment follow-up of the MURANO phase III study. J Clin Oncol. 2019;37(4):269-77. DOI:10.1200/JCO.18.01580
Авторы
С.В. Недогода, А.С. Саласюк*, И.Н. Барыкина, В.О. Лутова, Е.А. Попова
ФГБОУ ВО «Волгоградский государственный медицинский университет» Минздрава России, Волгоград, Россия
*salasyukas@outlook.com
Volgograd State Medical University, Volgograd, Russia
*salasyukas@outlook.com
ФГБОУ ВО «Волгоградский государственный медицинский университет» Минздрава России, Волгоград, Россия
*salasyukas@outlook.com
________________________________________________
Volgograd State Medical University, Volgograd, Russia
*salasyukas@outlook.com
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.