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Фармакоэкономический анализ применения фулвестранта в первой линии терапии метастатического рака молочной железы / Pharmacoeconomic analysis of fulvestrant use in the first line therapy of metastatic breast cancer

И.С. Крысанов1,3, М.М. Константинова2, В.Ю. Ермакова3,4, Л.Б. Васькова4, М.В. Тяпкина4

1 Институт медико-социальных технологий Московского государственного университета пищевых производств

2 Московский областной научно-исследовательский клинический институт им. М.Ф. Владимирского

3 Научно-исследовательский институт клинико-экономической экспертизы и фармакоэкономики, Мытищи

4 Первый Московский государственный медицинский университет им. И.М. Сеченова Минздрава России (Сеченовский университет)

Рак молочной железы (РМЖ) ассоциирован с высокой смертностью среди женщин во всем мире. Так, в Российской Федерации (РФ) в 2015 г. впервые диагноз рака молочной железы был поставлен 66 366 лицам женского пола, что составило 20,8% от всей опухолевой патологии у женщин. Выявляемость РМЖ на ранних стадиях В (I и II) за последние 10 лет выросла с 61,8 до 69,5%, в то же время смертность в течение первого года после установки диагноза за этот же период снизилась с 10,9 до 6,6% в 2015 г., тем не менее до сих пор в структуре смертности женского населения РМЖ остается на первом месте и составляет 17,0%. Основной задачей лечения больных метастатическим раком молочной железы (мРМЖ) является максимальное продление и сохранение качества жизни.

I.S. Krysanov1,3, M.M. Konstantinova2, V.Yu. Ermakova3,4, L.B. Vaskova4, M.V. Tyapkina4

1 Institute of Medical Social Technologies of the Moscow State University of Food Production

2 Vladimirsky Moscow Regional Research Clinical Institute

3 Research Institute of Clinical Economic Expertise and Pharmacoeconomics, Mytischi

4 Sechenov First Moscow State Medical University of the Ministry of Health of Russia (Sechenov University)

Breast cancer (BC) is associated with a high mortality rate among women all over the world. In the Russian Federation (RF) in 2015, 66,366 female patients were diagnosed with breast cancer for the first time, which accounted for 20.8% of the total tumour pathology in women. Early detection of breast cancer at B (I and II) stage has increased from 61.8% to 69.5% over the past 10 years, while mortality rate in the first year after diagnosis has decreased from 10.9 to 6% in 2015 over the same period, nevertheless, until now breast cancer remains ranked 1st in the mortality structure of the female population and is 17.0%. The main objective of treatment of patients with metastatic breast cancer (mBC) is the maximum extension and preservation of quality of life.

Список литературы

1. Клинические рекомендации РООМ по лечению рака молочной железы. Режим доступа: http://breastcancersociety.ru/rek/view/289.

2. Клинические рекомендации Российского профессионального общества онкологов-химиотерапевтов (RUSSCO). Рак молочной железы. Режим доступа: http://oncology-association.ru/klinicheskie-recomendatsii).

3. Кондратьев В.Б. IV Российская онкологическая конференция. Химиотерапия метастатических форм рака молочной железы: стандартные и перспективные препараты, их комбинации. Режим доступа: https://rosoncoweb.ru/library/congress/ru/04/36.php.

4. Постановление Правительства Москвы от 24 февраля 2010 г. №163-ПП «Об установлении торговых надбавок к ценам на лекарственные средства, включенные в перечень ЖНВЛП».

5. Постановление Правительства Российской Федерации от 08.12.2017 №1492 «О Программе государственных гарантий бесплатного оказания гражданам медицинской помощи на 2018 год и на плановый период 2019 и 2020 годов».

6. Приложение №6 к Тарифному соглашению на 2017 год от «29» декабря 2016 года. Тарифы на оплату медицинской помощи, оказываемой в амбулаторных условиях в рамках Территориальной программы ОМС, применяемые, в т. ч. для осуществления горизонтальных расчетов.

7. Biganzoli L, et al. Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: the European Organization for Research and Treatment of Cancer 10961 multicenter phase III trial. J Clin Oncol, 2002, 20: 3114–3121.

8. Bishop JF, et al. Paclitaxel as first-line treatment for metastatic breast cancer. The Taxol Investigational Trials Group, Australia and New Zealand. Oncology, 1997 Apr, 11(4 Suppl 3): 19-23.

9. Bonneterre J, et al. Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure. Br J Cancer, 2002, 87: 1210–1215.

10. Brain EG, et al. Life-threatening sepsis associated with adjuvant doxorubicin plus docetaxel for intermediate-risk breast cancer. J Am Med Assoc, 2005, 293: 2367–2371.

11. Chan S, et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol, 1999, 17: 2341–2354.

12. Dieras V, et al. Randomized parallel study of doxorubicin plus paclitaxel and doxorubicin plus cyclophosphamide as neoadjuvant treatment of patients with breast cancer. J Clin Oncol 2004; 22: 4958–4965.

13. Eiermann W, et al. Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol, 2011, 29: 3877–3884.

14. Evans TRJ, et al. Phase III randomized trial of doxorubicin and docetaxel versus doxorubicin and cyclophosphamide as primary medical therapy in women with breast cancer: an Anglo-Celtic Cooperative Oncology Group study. J Clin Oncol, 2005, 23: 2988–2995.

15. Harvey V, et al. Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol, 2006, 24: 4963–4970.

16. Joensuu H, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med, 2006; 354: 809–820.

17. Joensuu H, et al. Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial. Ann Oncol, 2010, 21: 968–973.

18. Jones S, et al. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of us oncology research trial 9735. J Clin Oncol, 2009, 27: 1177–1183.

19. Jones SE, et al. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol, 2005, 23: 5542–5551.

20. Jung SY and Rosenzweig M (2013) Sequential metastatic breast cancer chemotherapy: should the median be the message? Front. Public Health 1:49.

21. Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol, 2015 Feb 20, 33(6): 594-601.

22. Kelly CM, et al. Phase III trial evaluating weekly paclitaxel versus docetaxel in combination with capecitabine in operable breast cancer. J Clin Oncol, 2012, 30: 930–935.

23. Lobbezoo DJ, et al. In real life, one-quarter of patients with hormone receptor-positive metastatic breast cancer receive chemotherapy as initial palliative therapy: a study of the Southeast Netherlands Breast Cancer Consortium. Ann Oncol, 2016 Feb, 27(2): 256-62.

24. Muss HB, et al. Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med, 2009, 360: 2055–2065.

25. Pallis AG, et al. A multicenter randomized phase III trial of vinorelbine/gemcitabine doublet versus capecitabine monotherapy in anthracycline- and taxane-pretreated women with metastatic breast cancer. Ann Oncol, 2012, 23: 1164–1169.

26. Robertson JFR, et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Lancet, 2016 Dec 17, 388(10063): 2997-3005.

27. Sacco, Joseph J. et al. The Average Body Surface Area of Adult Cancer Patients in the UK: A Multicentre Retrospective Study. Ed. Beverley J. Shea. PLoS ONE, 5.1 (2010): e8933. PMC. Web. 24 Dec. 2017.

28. Seah DS, et al. Use and duration of chemotherapy in patients with metastatic breast cancer according to tumor subtype and line of therapy. J Natl Compr Canc Netw, 2014 Jan, 12(1): 71-80.

29. Slamon D, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med, 2011, 365: 1273–1283.

30. Sparano JA, et al. Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol, 2010, 28: 3256–3263.

31. Sparano JA, et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med, 2008, 358: 1663–1671.

32. Truong J et al. Interpreting febrile neutropenia rates from randomized, controlled trials for consideration of primary prophylaxis in the real world: a systematic review and meta-analysis. Annals of Oncology, 2016 April 1, 27(Issue 4): 608–618.

33. Vogel CL, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol, 2005, 23: 1178–1184.

34. Von Minckwitz G, et al. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol, 2005, 23: 2676–2685.

35. Von Minckwitz G, et al. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a German Breast Group 26/Breast International Group 03-05 study. J Clin Oncol, 2009, 27: 1999–2006.

36. Walker LG, et al. Effects on quality of life, anti-cancer responses, breast conserving surgery and survival with neoadjuvant docetaxel: a randomised study of sequential weekly versus three-weekly docetaxel following neoadjuvant doxorubicin and cyclophosphamide in women with primary breast cancer. BMC Cancer, 2011, 11: 179.

37. Belagali YR, et al. Therapeutic Place of Fulvestrant in the Management of Hormone-receptor Positive Breast Cancer. European Oncology & Haematology, 2016, 12(1): 44–50.

38. Zhang J, et al. Efficacy and safety of endocrine monotherapy as first-line treatment for hormone-sensitive advanced breast cancer: A network meta-analysis. Medicine (Baltimore), 2017 Aug, 96(33): e7846.

References

1. Clinical recommendations of the Russian Oncomammology Society on treatment of breast cancer. Available at http://breastcancersociety.ru/rek/view/289.

2. Clinical recommendations of the Russian professional society of oncologists-chemotherapeutists (RUSSCO). Breast cancer. Available at http://oncology-association.ru/klinicheskie-recomendatsii).

3. Kondratiev V.B. IV Russian Cancer Conference. Chemotherapy of metastatic breast cancer: standard and perspective drugs, drug combinations. Available at https://rosoncoweb.ru/library/congress/ru/04/36.php.

4. Decree of the Government of Moscow of February No 163-PP "On the establishment of trade mark-ups to prices for drugs included in the list of VED” of February 24, 2010.

5. Decree of the Government of the Russian Federation No. 1492 "On the program of the state guarantees of free medical care to citizens for 2018 and for planning period of 2019 and 2020” of December 08, 2017.

6. Appendix No 6 to the Tariff Agreement for 2017 of December 29, 2016. Tariffs for payment of medical care provided in outpatient conditions within the framework of the Territorial Program of CHI, applied among other things for the implementation of horizontal calculations.

7. Biganzoli L, et al. Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: the European Organization for Research and Treatment of Cancer 10961 multicenter phase III trial. J Clin Oncol, 2002, 20: 3114–3121.

8. Bishop JF, et al. Paclitaxel as first-line treatment for metastatic breast cancer. The Taxol Investigational Trials Group, Australia and New Zealand. Oncology, 1997 Apr, 11(4 Suppl 3): 19-23.

9. Bonneterre J, et al. Docetaxel vs 5-fluorouracil plus vinorelbine in metastatic breast cancer after anthracycline therapy failure. Br J Cancer, 2002, 87: 1210–1215.

10. Brain EG, et al. Life-threatening sepsis associated with adjuvant doxorubicin plus docetaxel for intermediate-risk breast cancer. J Am Med Assoc, 2005, 293: 2367–2371.

11. Chan S, et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol, 1999, 17: 2341–2354.

12. Dieras V, et al. Randomized parallel study of doxorubicin plus paclitaxel and doxorubicin plus cyclophosphamide as neoadjuvant treatment of patients with breast cancer. J Clin Oncol 2004; 22: 4958–4965.

13. Eiermann W, et al. Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol, 2011, 29: 3877–3884.

14. Evans TRJ, et al. Phase III randomized trial of doxorubicin and docetaxel versus doxorubicin and cyclophosphamide as primary medical therapy in women with breast cancer: an Anglo-Celtic Cooperative Oncology Group study. J Clin Oncol, 2005, 23: 2988–2995.

15. Harvey V, et al. Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol, 2006, 24: 4963–4970.

16. Joensuu H, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med, 2006; 354: 809–820.

17. Joensuu H, et al. Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial. Ann Oncol, 2010, 21: 968–973.

18. Jones S, et al. Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of us oncology research trial 9735. J Clin Oncol, 2009, 27: 1177–1183.

19. Jones SE, et al. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol, 2005, 23: 5542–5551.

20. Jung SY and Rosenzweig M (2013) Sequential metastatic breast cancer chemotherapy: should the median be the message? Front. Public Health 1:49.

21. Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol, 2015 Feb 20, 33(6): 594-601.

22. Kelly CM, et al. Phase III trial evaluating weekly paclitaxel versus docetaxel in combination with capecitabine in operable breast cancer. J Clin Oncol, 2012, 30: 930–935.

23. Lobbezoo DJ, et al. In real life, one-quarter of patients with hormone receptor-positive metastatic breast cancer receive chemotherapy as initial palliative therapy: a study of the Southeast Netherlands Breast Cancer Consortium. Ann Oncol, 2016 Feb, 27(2): 256-62.

24. Muss HB, et al. Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med, 2009, 360: 2055–2065.

25. Pallis AG, et al. A multicenter randomized phase III trial of vinorelbine/gemcitabine doublet versus capecitabine monotherapy in anthracycline- and taxane-pretreated women with metastatic breast cancer. Ann Oncol, 2012, 23: 1164–1169.

26. Robertson JFR, et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Lancet, 2016 Dec 17, 388(10063): 2997-3005.

27. Sacco, Joseph J. et al. The Average Body Surface Area of Adult Cancer Patients in the UK: A Multicentre Retrospective Study. Ed. Beverley J. Shea. PLoS ONE, 5.1 (2010): e8933. PMC. Web. 24 Dec. 2017.

28. Seah DS, et al. Use and duration of chemotherapy in patients with metastatic breast cancer according to tumor subtype and line of therapy. J Natl Compr Canc Netw, 2014 Jan, 12(1): 71-80.

29. Slamon D, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med, 2011, 365: 1273–1283.

30. Sparano JA, et al. Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol, 2010, 28: 3256–3263.

31. Sparano JA, et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med, 2008, 358: 1663–1671.

32. Truong J et al. Interpreting febrile neutropenia rates from randomized, controlled trials for consideration of primary prophylaxis in the real world: a systematic review and meta-analysis. Annals of Oncology, 2016 April 1, 27(Issue 4): 608–618.

33. Vogel CL, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol, 2005, 23: 1178–1184.

34. Von Minckwitz G, et al. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol, 2005, 23: 2676–2685.

35. Von Minckwitz G, et al. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a German Breast Group 26/Breast International Group 03-05 study. J Clin Oncol, 2009, 27: 1999–2006.

36. Walker LG, et al. Effects on quality of life, anti-cancer responses, breast conserving surgery and survival with neoadjuvant docetaxel: a randomised study of sequential weekly versus three-weekly docetaxel following neoadjuvant doxorubicin and cyclophosphamide in women with primary breast cancer. BMC Cancer, 2011, 11: 179.

37. Belagali YR, et al. Therapeutic Place of Fulvestrant in the Management of Hormone-receptor Positive Breast Cancer. European Oncology & Haematology, 2016, 12(1): 44–50.

38. Zhang J, et al. Efficacy and safety of endocrine monotherapy as first-line treatment for hormone-sensitive advanced breast cancer: A network meta-analysis. Medicine (Baltimore), 2017 Aug, 96(33): e7846.

Ключевые слова: РМЖ, фулвестрант, «затраты – эффективность», mBC, fulvestrant, "costs – efficacy"

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Издание зарегистрировано в Комитете по печати РФ
Рег. свидетельство ПИ №77-1138,
выдано 25.11.1999
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