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Эффективность таргетной терапии при лечении распространенных форм рака яичников
Эффективность таргетной терапии при лечении распространенных форм рака яичников
Саевец В.В., Важенин А.В., Чернова Л.Ф. и др. Эффективность таргетной терапии при лечении распространенных форм рака яичников. Современная Онкология. 2018; 20 (4): 16–19. DOI: 10.26442/18151434.2018.4.180176
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Аннотация
Цель исследования. Оценить эффективность таргетного препарата бевацизумаб (Авегра®) в комплексном лечении больных распространенными формами рака яичников после субоптимальных циторедуктивных хирургических вмешательств.
Материалы и методы. За период с января 2017 по ноябрь 2018 г. в клиническое исследование включены и пролечены пациентки (n=71) с диагнозом «рак яичников IIIC–IV стадии заболевания». Распространенность опухолевого процесса оценивалась согласно классификации FIGO и TNM (2009 г.). Больные были рандомизированы на 2 группы: в 1-ю включена 31 пациентка, лечение проводилось по схеме – паклитаксел 175 мг/м2, карбоплатин AUC 6, бевацизумаб 15 мг/кг с интервалом 21 день; во 2-ю (группу контроля) включены 40 пациенток, которым проводилась стандартная лекарственная терапия. Всем больным выполнена интервальная субоптимальная циторедуктивная операция – экстирпация матки с придатками, резекция сальника, перитонэктомия. Оценка эффективности непосредственных и отдаленных результатов осуществлялась методом статистической обработки при помощи программы Statistic 6.0.
Результаты. Согласно критериям RESIST 1.1 в 1-й группе зарегистрирован полный ответ в 25,8%, частичный – 51,6%, стабилизация заболевания – 12,9%, прогрессирование – 9,6% случаев. Во 2-й группе полный ответ составил 20% случаев, частичный – 45%, стабилизация – 22,5%, прогрессирование – 12,5%. Медиана общей выживаемости в 1-й группе – 16,5 мес против 10,1 мес во 2-й группе.
Ключевые слова: рак яичников, бевацизумаб, комплексное лечение.
Materials and methods. For the period from January 2017 to November 2018. A clinical study included and treated 71 patients with a diagnosis of ovarian cancer, stage IIIC–IV disease. The prevalence of the tumor process was estimated according to the classification of FIGO and TNM (2009). Patients were randomized into two groups. The first group included 31 patients, the treatment was carried out according to the scheme: paclitaxel 175 mg/m2, carboplatin AUC 6, bevacizumab 15 mg/kg with an interval of 21 days. The second group (control group) included 40 patients who received standard drug therapy. Interval suboptimal cytoreductive surgery was performed in all patients – hysterectomy with appendages, epiploic resection, peritonectomy. Evaluation of the effectiveness of immediate and remote The results were carried out by the method of statistical processing using the program Statistic 6.0.
Results. According to the criteria of RESIST 1.1 in the first group, a complete response was registered in 25.8%, a partial response in 51.6%, stabilization of the disease in 12.9%, progression of 9.6% of cases. In the second group, the complete response was in 20% of cases, a partial response was 45%, stabilization was 22.5%, progression was 12.5%. The median overall survival in the first group was 16.5 months аgainst 10.1 months in the second group.
Key words: ovarian cancer, bevacizumab, complex treatment.
Материалы и методы. За период с января 2017 по ноябрь 2018 г. в клиническое исследование включены и пролечены пациентки (n=71) с диагнозом «рак яичников IIIC–IV стадии заболевания». Распространенность опухолевого процесса оценивалась согласно классификации FIGO и TNM (2009 г.). Больные были рандомизированы на 2 группы: в 1-ю включена 31 пациентка, лечение проводилось по схеме – паклитаксел 175 мг/м2, карбоплатин AUC 6, бевацизумаб 15 мг/кг с интервалом 21 день; во 2-ю (группу контроля) включены 40 пациенток, которым проводилась стандартная лекарственная терапия. Всем больным выполнена интервальная субоптимальная циторедуктивная операция – экстирпация матки с придатками, резекция сальника, перитонэктомия. Оценка эффективности непосредственных и отдаленных результатов осуществлялась методом статистической обработки при помощи программы Statistic 6.0.
Результаты. Согласно критериям RESIST 1.1 в 1-й группе зарегистрирован полный ответ в 25,8%, частичный – 51,6%, стабилизация заболевания – 12,9%, прогрессирование – 9,6% случаев. Во 2-й группе полный ответ составил 20% случаев, частичный – 45%, стабилизация – 22,5%, прогрессирование – 12,5%. Медиана общей выживаемости в 1-й группе – 16,5 мес против 10,1 мес во 2-й группе.
Ключевые слова: рак яичников, бевацизумаб, комплексное лечение.
________________________________________________
Materials and methods. For the period from January 2017 to November 2018. A clinical study included and treated 71 patients with a diagnosis of ovarian cancer, stage IIIC–IV disease. The prevalence of the tumor process was estimated according to the classification of FIGO and TNM (2009). Patients were randomized into two groups. The first group included 31 patients, the treatment was carried out according to the scheme: paclitaxel 175 mg/m2, carboplatin AUC 6, bevacizumab 15 mg/kg with an interval of 21 days. The second group (control group) included 40 patients who received standard drug therapy. Interval suboptimal cytoreductive surgery was performed in all patients – hysterectomy with appendages, epiploic resection, peritonectomy. Evaluation of the effectiveness of immediate and remote The results were carried out by the method of statistical processing using the program Statistic 6.0.
Results. According to the criteria of RESIST 1.1 in the first group, a complete response was registered in 25.8%, a partial response in 51.6%, stabilization of the disease in 12.9%, progression of 9.6% of cases. In the second group, the complete response was in 20% of cases, a partial response was 45%, stabilization was 22.5%, progression was 12.5%. The median overall survival in the first group was 16.5 months аgainst 10.1 months in the second group.
Key words: ovarian cancer, bevacizumab, complex treatment.
Полный текст
Список литературы
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7. Du Bois A, Kristensen G, Roy-Coquard I et al. Standard first-line chemotherapy with or without nindetanib for advanced ovarian cancer (AGO-OVAR12): a randomised, double-blind, placebo controlled phase 3 trial. Lancet Oncol 2016; 17: 78–89.
8. Du Bois A, Floquet A, Kim J et al. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol 2014; 32: 3374–82.
9. Mazzoletti M, Broggini M. PI3K/AKT/mTOR inhibitors in ovarian cancer. Curr Med Chem 2010; 17 (36): 4433–47.
10. Tan DS, Iravani M, McCluggage WG et al. Genomic analysis reveals the molecular heterogeneity of ovarian clear cell carcinomas. Clin Cancer Res 2011; 17 (6): 1521–34.
11. Aghajanian C, Goff B, Nycum LR et al. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol 2015; 139 (1): 10–6.
12. Burger RA et al. Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): A Gynecologic Oncology Group study. J Clin Oncol 2010; 28 (Suppl. 18). Abstr. LBA1
13. Burger RA. Overview of anti-angiogenic agents in development for ovarian cancer. Gynecol Oncol 2011; 121 (1): 230–8.
14. Chan J, Brady JM, Penson R et al. Phase III trial of every-3-weeks paclitaxel vs. dose dense weekly paclitaxel with carboplatin ± bevacizumab in epithelial ovarian, peritoneal, fallopian tube cancer: GOG 262 (NCT01167712). Int J Gynecol Cancer 2013; 23 (Suppl. 8).
15. Crim A, Rowland M, Ruskin M et al. Evaluation of efficacy and toxicity profile associated with intraperitoneal chemotherapy use in older women. Gynecol Oncol 2017; 146 (2): 268–72.
16. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Ovarian Cancer 2013 (Suppl. 18).
17. Aghajanian C, Finkler NJ, Rutherford T et al. OCEANS: A randomized, double-blinded, placebo-controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC). J Clin Oncol 2011; 29 (Suppl. 18). Abstr. LBA5007.
18. Pujade-Lauraine E, Mahner S, Kaern J et al. A randomized, phase III study of carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in relapsed platinum-sensitive ovarian cancer (OC): CALYPSO study of the Gynecologic Cancer Intergroup (GCIG). J Clin Oncol 2009; 27 (18). Abst. LBA5509.
19. Moroni M. Predictive value of loci in VEGF pathway genes in bevacizumab treatment. Lancet Oncol 2012; 13: 659–60.
2. Davydov M.I. Zlokachestvennye novoobrazovaniia v Rossii i stranakh SNG v 2012 g. Pod red. M.I.Davydova, E.A.Aksel'. M.: Izdatel'skaia gruppa RONTs, 2014. [in Russian]
3. Jemal A, Siegel R, Ward E et al. Cancer statistics 2007. CA Cancer J Clin 2007; 57: 43–66.
4. Tiuliandin S.A., Den'gina N.V., Kolomiets L.A. i dr. Prakticheskie rekomendatsii po lecheniiu raka iaichnikov/pervichnogo raka briushiny/raka matochnykh trub. Zlokachestvennye opukholi. 2017; 7 (2): 135–45. [in Russian]
5. Rumiantsev A.A., Tiuliandina A.S., Pokataev I.A. i dr. Spornye voprosy optimal'noi taktiki khirurgicheskogo lecheniia bol'nykh rasprostranennym rakom iaichnikov. Zlokachestvennye opukholi. 2017; 7 (3): 13–22. [in Russian]
6. Du Bois A et al. AGO-OVAR 12: a randomized placebo-controlled gcig/engot-intergroup phase III trial of standard frontline chemotherapy ± nintedanib for advanced ovarian cancer. Int J Gynecol Cancer 2013; 23 (Suppl. 8).
7. Du Bois A, Kristensen G, Roy-Coquard I et al. Standard first-line chemotherapy with or without nindetanib for advanced ovarian cancer (AGO-OVAR12): a randomised, double-blind, placebo controlled phase 3 trial. Lancet Oncol 2016; 17: 78–89.
8. Du Bois A, Floquet A, Kim J et al. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol 2014; 32: 3374–82.
9. Mazzoletti M, Broggini M. PI3K/AKT/mTOR inhibitors in ovarian cancer. Curr Med Chem 2010; 17 (36): 4433–47.
10. Tan DS, Iravani M, McCluggage WG et al. Genomic analysis reveals the molecular heterogeneity of ovarian clear cell carcinomas. Clin Cancer Res 2011; 17 (6): 1521–34.
11. Aghajanian C, Goff B, Nycum LR et al. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol 2015; 139 (1): 10–6.
12. Burger RA et al. Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): A Gynecologic Oncology Group study. J Clin Oncol 2010; 28 (Suppl. 18). Abstr. LBA1
13. Burger RA. Overview of anti-angiogenic agents in development for ovarian cancer. Gynecol Oncol 2011; 121 (1): 230–8.
14. Chan J, Brady JM, Penson R et al. Phase III trial of every-3-weeks paclitaxel vs. dose dense weekly paclitaxel with carboplatin ± bevacizumab in epithelial ovarian, peritoneal, fallopian tube cancer: GOG 262 (NCT01167712). Int J Gynecol Cancer 2013; 23 (Suppl. 8).
15. Crim A, Rowland M, Ruskin M et al. Evaluation of efficacy and toxicity profile associated with intraperitoneal chemotherapy use in older women. Gynecol Oncol 2017; 146 (2): 268–72.
16. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Ovarian Cancer 2013 (Suppl. 18).
17. Aghajanian C, Finkler NJ, Rutherford T et al. OCEANS: A randomized, double-blinded, placebo-controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC). J Clin Oncol 2011; 29 (Suppl. 18). Abstr. LBA5007.
18. Pujade-Lauraine E, Mahner S, Kaern J et al. A randomized, phase III study of carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in relapsed platinum-sensitive ovarian cancer (OC): CALYPSO study of the Gynecologic Cancer Intergroup (GCIG). J Clin Oncol 2009; 27 (18). Abst. LBA5509.
19. Moroni M. Predictive value of loci in VEGF pathway genes in bevacizumab treatment. Lancet Oncol 2012; 13: 659–60.
2. Давыдов М.И. Злокачественные новообразования в России и странах СНГ в 2012 г. Под ред. М.И.Давыдова, Е.А.Аксель. М.: Издательская группа РОНЦ, 2014. / Davydov M.I. Zlokachestvennye novoobrazovaniia v Rossii i stranakh SNG v 2012 g. Pod red. M.I.Davydova, E.A.Aksel'. M.: Izdatel'skaia gruppa RONTs, 2014. [in Russian]
3. Jemal A, Siegel R, Ward E et al. Cancer statistics 2007. CA Cancer J Clin 2007; 57: 43–66.
4. Тюляндин С.А., Деньгина Н.В., Коломиец Л.А. и др. Практические рекомендации по лечению рака яичников/первичного рака брюшины/рака маточных труб. Злокачественные опухоли. 2017; 7 (2): 135–45. / Tiuliandin S.A., Den'gina N.V., Kolomiets L.A. i dr. Prakticheskie rekomendatsii po lecheniiu raka iaichnikov/pervichnogo raka briushiny/raka matochnykh trub. Zlokachestvennye opukholi. 2017; 7 (2): 135–45. [in Russian]
5. Румянцев А.А., Тюляндина А.С., Покатаев И.А. и др. Спорные вопросы оптимальной тактики хирургического лечения больных распространенным раком яичников. Злокачественные опухоли. 2017; 7 (3): 13–22. / Rumiantsev A.A., Tiuliandina A.S., Pokataev I.A. i dr. Spornye voprosy optimal'noi taktiki khirurgicheskogo lecheniia bol'nykh rasprostranennym rakom iaichnikov. Zlokachestvennye opukholi. 2017; 7 (3): 13–22. [in Russian]
6. Du Bois A et al. AGO-OVAR 12: a randomized placebo-controlled gcig/engot-intergroup phase III trial of standard frontline chemotherapy ± nintedanib for advanced ovarian cancer. Int J Gynecol Cancer 2013; 23 (Suppl. 8).
7. Du Bois A, Kristensen G, Roy-Coquard I et al. Standard first-line chemotherapy with or without nindetanib for advanced ovarian cancer (AGO-OVAR12): a randomised, double-blind, placebo controlled phase 3 trial. Lancet Oncol 2016; 17: 78–89.
8. Du Bois A, Floquet A, Kim J et al. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol 2014; 32: 3374–82.
9. Mazzoletti M, Broggini M. PI3K/AKT/mTOR inhibitors in ovarian cancer. Curr Med Chem 2010; 17 (36): 4433–47.
10. Tan DS, Iravani M, McCluggage WG et al. Genomic analysis reveals the molecular heterogeneity of ovarian clear cell carcinomas. Clin Cancer Res 2011; 17 (6): 1521–34.
11. Aghajanian C, Goff B, Nycum LR et al. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol 2015; 139 (1): 10–6.
12. Burger RA et al. Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): A Gynecologic Oncology Group study. J Clin Oncol 2010; 28 (Suppl. 18). Abstr. LBA1
13. Burger RA. Overview of anti-angiogenic agents in development for ovarian cancer. Gynecol Oncol 2011; 121 (1): 230–8.
14. Chan J, Brady JM, Penson R et al. Phase III trial of every-3-weeks paclitaxel vs. dose dense weekly paclitaxel with carboplatin ± bevacizumab in epithelial ovarian, peritoneal, fallopian tube cancer: GOG 262 (NCT01167712). Int J Gynecol Cancer 2013; 23 (Suppl. 8).
15. Crim A, Rowland M, Ruskin M et al. Evaluation of efficacy and toxicity profile associated with intraperitoneal chemotherapy use in older women. Gynecol Oncol 2017; 146 (2): 268–72.
16. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Ovarian Cancer 2013 (Suppl. 18).
17. Aghajanian C, Finkler NJ, Rutherford T et al. OCEANS: A randomized, double-blinded, placebo-controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC). J Clin Oncol 2011; 29 (Suppl. 18). Abstr. LBA5007.
18. Pujade-Lauraine E, Mahner S, Kaern J et al. A randomized, phase III study of carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in relapsed platinum-sensitive ovarian cancer (OC): CALYPSO study of the Gynecologic Cancer Intergroup (GCIG). J Clin Oncol 2009; 27 (18). Abst. LBA5509.
19. Moroni M. Predictive value of loci in VEGF pathway genes in bevacizumab treatment. Lancet Oncol 2012; 13: 659–60.
________________________________________________
2. Davydov M.I. Zlokachestvennye novoobrazovaniia v Rossii i stranakh SNG v 2012 g. Pod red. M.I.Davydova, E.A.Aksel'. M.: Izdatel'skaia gruppa RONTs, 2014. [in Russian]
3. Jemal A, Siegel R, Ward E et al. Cancer statistics 2007. CA Cancer J Clin 2007; 57: 43–66.
4. Tiuliandin S.A., Den'gina N.V., Kolomiets L.A. i dr. Prakticheskie rekomendatsii po lecheniiu raka iaichnikov/pervichnogo raka briushiny/raka matochnykh trub. Zlokachestvennye opukholi. 2017; 7 (2): 135–45. [in Russian]
5. Rumiantsev A.A., Tiuliandina A.S., Pokataev I.A. i dr. Spornye voprosy optimal'noi taktiki khirurgicheskogo lecheniia bol'nykh rasprostranennym rakom iaichnikov. Zlokachestvennye opukholi. 2017; 7 (3): 13–22. [in Russian]
6. Du Bois A et al. AGO-OVAR 12: a randomized placebo-controlled gcig/engot-intergroup phase III trial of standard frontline chemotherapy ± nintedanib for advanced ovarian cancer. Int J Gynecol Cancer 2013; 23 (Suppl. 8).
7. Du Bois A, Kristensen G, Roy-Coquard I et al. Standard first-line chemotherapy with or without nindetanib for advanced ovarian cancer (AGO-OVAR12): a randomised, double-blind, placebo controlled phase 3 trial. Lancet Oncol 2016; 17: 78–89.
8. Du Bois A, Floquet A, Kim J et al. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol 2014; 32: 3374–82.
9. Mazzoletti M, Broggini M. PI3K/AKT/mTOR inhibitors in ovarian cancer. Curr Med Chem 2010; 17 (36): 4433–47.
10. Tan DS, Iravani M, McCluggage WG et al. Genomic analysis reveals the molecular heterogeneity of ovarian clear cell carcinomas. Clin Cancer Res 2011; 17 (6): 1521–34.
11. Aghajanian C, Goff B, Nycum LR et al. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol 2015; 139 (1): 10–6.
12. Burger RA et al. Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): A Gynecologic Oncology Group study. J Clin Oncol 2010; 28 (Suppl. 18). Abstr. LBA1
13. Burger RA. Overview of anti-angiogenic agents in development for ovarian cancer. Gynecol Oncol 2011; 121 (1): 230–8.
14. Chan J, Brady JM, Penson R et al. Phase III trial of every-3-weeks paclitaxel vs. dose dense weekly paclitaxel with carboplatin ± bevacizumab in epithelial ovarian, peritoneal, fallopian tube cancer: GOG 262 (NCT01167712). Int J Gynecol Cancer 2013; 23 (Suppl. 8).
15. Crim A, Rowland M, Ruskin M et al. Evaluation of efficacy and toxicity profile associated with intraperitoneal chemotherapy use in older women. Gynecol Oncol 2017; 146 (2): 268–72.
16. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Ovarian Cancer 2013 (Suppl. 18).
17. Aghajanian C, Finkler NJ, Rutherford T et al. OCEANS: A randomized, double-blinded, placebo-controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC). J Clin Oncol 2011; 29 (Suppl. 18). Abstr. LBA5007.
18. Pujade-Lauraine E, Mahner S, Kaern J et al. A randomized, phase III study of carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in relapsed platinum-sensitive ovarian cancer (OC): CALYPSO study of the Gynecologic Cancer Intergroup (GCIG). J Clin Oncol 2009; 27 (18). Abst. LBA5509.
19. Moroni M. Predictive value of loci in VEGF pathway genes in bevacizumab treatment. Lancet Oncol 2012; 13: 659–60.
Авторы
В.В.Саевец*1, А.В.Важенин1,2, Л.Ф.Чернова1, И.Г.Шимоткина1, О.В.Курченкова1, А.А.Мухин1, А.В.Таратонов1
1 ГБУЗ «Челябинский областной клинический центр онкологии и ядерной медицины». 454087, Россия, Челябинск, ул. Блюхера, д. 42;
2 ФГБОУ ВО «Южно-Уральский государственный медицинский университет» Минздрава России. 454092, Россия, Челябинск, ул. Воровского, д. 64
*lalili2013@mail.ru
1 Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine. 454087, Russian Federation, Cheliabinsk, ul. Bliukhera, d. 42;
2 Medical University of South Ural State of the Ministry of Health of the Russian Federation. 454092, Russian Federation, Chelyabinsk, ul. Vorovskogo, d. 64
*lalili2013@mail.ru
1 ГБУЗ «Челябинский областной клинический центр онкологии и ядерной медицины». 454087, Россия, Челябинск, ул. Блюхера, д. 42;
2 ФГБОУ ВО «Южно-Уральский государственный медицинский университет» Минздрава России. 454092, Россия, Челябинск, ул. Воровского, д. 64
*lalili2013@mail.ru
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1 Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine. 454087, Russian Federation, Cheliabinsk, ul. Bliukhera, d. 42;
2 Medical University of South Ural State of the Ministry of Health of the Russian Federation. 454092, Russian Federation, Chelyabinsk, ul. Vorovskogo, d. 64
*lalili2013@mail.ru
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