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Эффективность и безопасность иммунотерапии метастатического почечно-клеточного рака
Эффективность и безопасность иммунотерапии метастатического почечно-клеточного рака
Лядова М.А., Федоринов Д.С., Нерсесова Т.А., Гриднева Я.В., Волкова М.И., Лядов К.В., Кузьмина Е.С., Антонова Т.Г., Покатаев И.А., Галкин В.Н., Поддубная И.В. Эффективность и безопасность иммунотерапии метастатического почечно-клеточного рака. Современная Онкология. 2025;27(1):36–41. DOI: 10.26442/18151434.2025.1.203025
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
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Аннотация
Цель. Оценить эффективность и безопасность применения ингибиторов контрольных точек иммунитета у пациентов с метастатическим почечно-клеточным раком (ПКР) в российской популяции пациентов.
Материалы и методы. В данное ретроспективное исследование включен 231 пациент (157 мужчин и 74 женщины) в возрасте от 44 до 86 лет (медиана 64,56±8,09), которые проходили обследование и лечение в Онкологическом центре №1 ГБУЗ «ГКБ им. С.С. Юдина» и ООО МЦВЛ.
Результаты. Медиана наблюдения составила 16,6 мес (13,38–18,61). Оценка эффективности терапии проводилась у всех пациентов, включенных в исследование. Объективный ответ (полная регрессия + частичная регрессия) достигнут у 45 (19,5%) пациентов. Контроль над заболеванием (объективный ответ + стабилизация) зарегистрирован у 186 (80,5%) пациентов. Медиана общей выживаемости у пациентов с метастатическим ПКР составила 15,62 мес [95% доверительный интервал – ДИ 12,89–17,75], в группе 1-й линии – 13,18 мес [95% ДИ 11,21–17,75], в группе 2-й и более линий – 16,72 мес [95% ДИ 13,41–20,19]. Иммуноопосредованные нежелательные явления 1–2-й степени выявлены у 81,8% (n=189) пациентов, из которых 97 (78,9%) получали 1-ю линию иммунотерапии и 92 (85,2%) – 2-ю и более.
Заключение. Иммунотерапия ПКР в российской популяции пациентов позволяет достичь высоких показателей объективного ответа и контроля над заболеванием в 1-й линии лечения (19,5 и 80,5% соответственно). Для данного метода лечения характерно развитие незначительного количества иммуноопосредованных нежелательных явлений 3–4-й степени (3,03% по нашим данным), что свидетельствует о приемлемом профиле безопасности и сопоставимо с данными зарубежных исследований.
Ключевые слова: иммунотерапия, ингибиторы контрольных точек иммунитета, иммуноопосредованные нежелательные явления, рак почки
Materials and methods. This retrospective study included 231 patients (157 males and 74 females) aged 44 to 86 years (median 64.56±8.09) who underwent examination and treatment at Moscow City Hospital named after S.S. Yudin and Moscow Center for Rehabilitation Treatment.
Results. The median follow-up was 16.6 months (13.38-18.61). The effectiveness of therapy was evaluated in all patients included in the study. Objective response (complete regression + partial regression) was achieved in 45 (19.5%) patients. Disease control (objective response + stabilization) was reported in 186 (80.5%) subjects. Median of overall survival in patients with metastatic RCC was 15.62 months (95% confidence interval [CI] 12.89-17.75): in the 1st line group, 13.18 months (95% CI 11.21-17.75), and in the 2nd and subsequent lines group, 16.72 months (95% CI 13.41-20.19). Grade 1-2 immune-mediated adverse events were reported in 81.8% (n=189) of patients, of which 97 (78.9%) received 1st line immunotherapy and 92 (85.2%) received 2nd and subsequent lines.
Conclusion. RCC immunotherapy in the Russian population is associated with high rates of objective response and disease control in the first line of treatment (19.5 and 80.5%, respectively). This treatment method is typically associated with a small number of grade 3-4 immune-mediated adverse events (3.03% according to our data), which indicates an acceptable safety profile and is comparable with the data from foreign studies.
Keywords: immunotherapy, immune checkpoint inhibitors, immune-mediated adverse events, kidney cancer
Материалы и методы. В данное ретроспективное исследование включен 231 пациент (157 мужчин и 74 женщины) в возрасте от 44 до 86 лет (медиана 64,56±8,09), которые проходили обследование и лечение в Онкологическом центре №1 ГБУЗ «ГКБ им. С.С. Юдина» и ООО МЦВЛ.
Результаты. Медиана наблюдения составила 16,6 мес (13,38–18,61). Оценка эффективности терапии проводилась у всех пациентов, включенных в исследование. Объективный ответ (полная регрессия + частичная регрессия) достигнут у 45 (19,5%) пациентов. Контроль над заболеванием (объективный ответ + стабилизация) зарегистрирован у 186 (80,5%) пациентов. Медиана общей выживаемости у пациентов с метастатическим ПКР составила 15,62 мес [95% доверительный интервал – ДИ 12,89–17,75], в группе 1-й линии – 13,18 мес [95% ДИ 11,21–17,75], в группе 2-й и более линий – 16,72 мес [95% ДИ 13,41–20,19]. Иммуноопосредованные нежелательные явления 1–2-й степени выявлены у 81,8% (n=189) пациентов, из которых 97 (78,9%) получали 1-ю линию иммунотерапии и 92 (85,2%) – 2-ю и более.
Заключение. Иммунотерапия ПКР в российской популяции пациентов позволяет достичь высоких показателей объективного ответа и контроля над заболеванием в 1-й линии лечения (19,5 и 80,5% соответственно). Для данного метода лечения характерно развитие незначительного количества иммуноопосредованных нежелательных явлений 3–4-й степени (3,03% по нашим данным), что свидетельствует о приемлемом профиле безопасности и сопоставимо с данными зарубежных исследований.
Ключевые слова: иммунотерапия, ингибиторы контрольных точек иммунитета, иммуноопосредованные нежелательные явления, рак почки
________________________________________________
Materials and methods. This retrospective study included 231 patients (157 males and 74 females) aged 44 to 86 years (median 64.56±8.09) who underwent examination and treatment at Moscow City Hospital named after S.S. Yudin and Moscow Center for Rehabilitation Treatment.
Results. The median follow-up was 16.6 months (13.38-18.61). The effectiveness of therapy was evaluated in all patients included in the study. Objective response (complete regression + partial regression) was achieved in 45 (19.5%) patients. Disease control (objective response + stabilization) was reported in 186 (80.5%) subjects. Median of overall survival in patients with metastatic RCC was 15.62 months (95% confidence interval [CI] 12.89-17.75): in the 1st line group, 13.18 months (95% CI 11.21-17.75), and in the 2nd and subsequent lines group, 16.72 months (95% CI 13.41-20.19). Grade 1-2 immune-mediated adverse events were reported in 81.8% (n=189) of patients, of which 97 (78.9%) received 1st line immunotherapy and 92 (85.2%) received 2nd and subsequent lines.
Conclusion. RCC immunotherapy in the Russian population is associated with high rates of objective response and disease control in the first line of treatment (19.5 and 80.5%, respectively). This treatment method is typically associated with a small number of grade 3-4 immune-mediated adverse events (3.03% according to our data), which indicates an acceptable safety profile and is comparable with the data from foreign studies.
Keywords: immunotherapy, immune checkpoint inhibitors, immune-mediated adverse events, kidney cancer
Полный текст
Список литературы
1. Cancer Genome Atlas Research Network; Linehan WM, Spellman PT, Ricketts CJ, et al. Comprehensive Molecular Characterization of Papillary Renal-Cell Carcinoma. New Engl J Med. 2016;374(2):135-45. DOI:10.1056/NEJMoa1505917
2. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. DOI:10.3322/caac.21708
3. Fay AP, McKay RR, Lin X, et al. Impact of Geographic Regions on Overall Survival in Patients With Metastatic Renal Cell Carcinoma: Results From an International Clinical Trials Database. J Glob Oncol. 2018;4:1-14. DOI:10.1200/JGO.17.00119z
4. Zhuang TZ, Case K, Olsen TA, et al. Metastatic Clear-Cell Renal Cell Carcinoma in the Era of Immune Checkpoint Inhibitors: Therapies and Ongoing Trials. Cancers (Basel). 2022;14(12):2867. DOI:10.3390/cancers14122867
5. Padala SA, Barsouk A, Thandra KC, et al. Epidemiology of Renal Cell Carcinoma. World J Oncol. 2020;11(3):79-87. DOI:10.14740/wjon1279
6. Злокачественные новообразования в России в 2022 году (заболеваемость и смертность). Под ред. А.Д. Каприна, В.В. Старинского, А.О. Шахзадовой. М.: МНИОИ им. ПА. Герцена – филиал ФГБУ «НМИЦ радиологии» Минздрава России, 2023 [Zlokachestvennyie novoobrazovaniia v Rossii v 2022 godu (zabolevaiemost i smertnost). Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. PA. Gertsena – filial FGBU “NMITS radiologii” Minzdrava Rossii, 2023 (in Russian)].
7. Nakano O, Sato M, Naito Y, et al. Proliferative activity of intratumoral CD8(+) T-lymphocytes as a prognostic factor in human renal cell carcinoma: clinicopathologic demonstration of antitumor immunity. Cancer Res. 2001;61(13):5132-6.
8. Sharpe AH, Pauken KE. The diverse functions of the PD1 inhibitory pathway. Nature reviews. Immunology. 2018;18(3):153-67. DOI:10.1038/nri.2017.108
9. Postow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015;33(17):1974-82. DOI:10.1200/JCO.2014.59.4358
10. Topalian S, Hodi FS, Brahmer JR, et al. Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer Treated With Nivolumab. AMA Oncol. 2019;5(10):1411-20. DOI:10.1001/jamaoncol.2019.2187
11. McDermott DF, Motzer RJ, Atkins MB, et al. Longterm overall survival with nivolumab in previously treated patients with advanced renal cell carcinoma (aRCC) from phase I and II studies. Abstract (4507) presented at the Annual Meeting of the American Society of Clinical Oncology; June 3–7, 2016; Chicago, IL.
12. Motzer RJ, Escudier B, George S,et al. Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial. Cancer. 2020;126(18):4156-67. DOI:10.1002/cncr.33033
13. Motzer RJ, McDermott DF, Escudier B, et al. Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma. Cancer. 2022;128(11):2085-97. DOI:10.1002/cncr.34180
14. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-90. DOI:10.1056/NEJMoa1712126
15. Albiges L, Tannir NM, Burotto M, et al. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020;5(6):e001079. DOI:10.1136/esmoopen-2020-001079
16. Flippot R, Dalban C, Laguerre B, et al. Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. J Clin Oncol. 2019;37(23):2008-16. DOI:10.1200/JCO.18.02218
17. Emamekhoo H, Olsen MR, Carthon BC, et al. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced renal cell carcinoma with brain metastases: CheckMate 920. Cancer. 2022;128(5):966-74. DOI:10.1002/cncr.34016
18. Atkins MB, Plimack ER, Puzanov I, et al. Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial. Lancet Oncol. 2018;19(3):405-15. DOI:10.1016/S1470-2045(18)30081-0
19. Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019;380(12):1116-27. DOI:10.1056/NEJMoa1816714
20. Powles T, Plimack ER, Soulières D, et al. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol. 2020;21(12):1563-73. DOI:10.1016/S1470-2045(20)30436-8
21. 710P Phase II trial of lenvatinib (LEN) + pembrolizumab (PEMBRO) for progressive disease after PD-1/PD-L1 immune checkpoint inhibitor (ICI) in metastatic clear cell (mcc) renal cell carcinoma (RCC): Results by independent imaging review and subgroup analyses. Ann Oncol. 2020;31(4):S558-9. DOI:10.1016/j.annonc.2020.08.782
22. Postow MA, Sidlow R, Hellmann MD. Immune-Related Adverse Events Associated with Immune Checkpoint Blockade. N Engl J Med. 2018;378(2):158-68. DOI:10.1056/NEJMra1703481
23. Abou Alaiwi S, Xie W, Nassar AH, et al. Safety and efficacy of restarting immune checkpoint inhibitors after clinically significant immune-related adverse events in metastatic renal cell carcinoma. J Immunother Cancer. 2020;8(1):e000144. DOI:10.1136/jitc-2019-000144
24. Ornstein MC, Garcia JA. Toxicity of Checkpoint Inhibition in Advanced RCC: A Systematic Review. Kidney Cancer. 2017;1(2):133-41. DOI:10.3233/KCA-170017
25. Das S, Johnson DB. Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors. J Immunother Cancer. 2019;7(1):306. DOI:10.1186/s40425-019-0805-8
2. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. DOI:10.3322/caac.21708
3. Fay AP, McKay RR, Lin X, et al. Impact of Geographic Regions on Overall Survival in Patients With Metastatic Renal Cell Carcinoma: Results From an International Clinical Trials Database. J Glob Oncol. 2018;4:1-14. DOI:10.1200/JGO.17.00119z
4. Zhuang TZ, Case K, Olsen TA, et al. Metastatic Clear-Cell Renal Cell Carcinoma in the Era of Immune Checkpoint Inhibitors: Therapies and Ongoing Trials. Cancers (Basel). 2022;14(12):2867. DOI:10.3390/cancers14122867
5. Padala SA, Barsouk A, Thandra KC, et al. Epidemiology of Renal Cell Carcinoma. World J Oncol. 2020;11(3):79-87. DOI:10.14740/wjon1279
6. Zlokachestvennyie novoobrazovaniia v Rossii v 2022 godu (zabolevaiemost i smertnost). Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. PA. Gertsena – filial FGBU “NMITS radiologii” Minzdrava Rossii, 2023 (in Russian).
7. Nakano O, Sato M, Naito Y, et al. Proliferative activity of intratumoral CD8(+) T-lymphocytes as a prognostic factor in human renal cell carcinoma: clinicopathologic demonstration of antitumor immunity. Cancer Res. 2001;61(13):5132-6.
8. Sharpe AH, Pauken KE. The diverse functions of the PD1 inhibitory pathway. Nature reviews. Immunology. 2018;18(3):153-67. DOI:10.1038/nri.2017.108
9. Postow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015;33(17):1974-82. DOI:10.1200/JCO.2014.59.4358
10. Topalian S, Hodi FS, Brahmer JR, et al. Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer Treated With Nivolumab. AMA Oncol. 2019;5(10):1411-20. DOI:10.1001/jamaoncol.2019.2187
11. McDermott DF, Motzer RJ, Atkins MB, et al. Longterm overall survival with nivolumab in previously treated patients with advanced renal cell carcinoma (aRCC) from phase I and II studies. Abstract (4507) presented at the Annual Meeting of the American Society of Clinical Oncology; June 3–7, 2016; Chicago, IL.
12. Motzer RJ, Escudier B, George S,et al. Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial. Cancer. 2020;126(18):4156-67. DOI:10.1002/cncr.33033
13. Motzer RJ, McDermott DF, Escudier B, et al. Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma. Cancer. 2022;128(11):2085-97. DOI:10.1002/cncr.34180
14. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-90. DOI:10.1056/NEJMoa1712126
15. Albiges L, Tannir NM, Burotto M, et al. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020;5(6):e001079. DOI:10.1136/esmoopen-2020-001079
16. Flippot R, Dalban C, Laguerre B, et al. Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. J Clin Oncol. 2019;37(23):2008-16. DOI:10.1200/JCO.18.02218
17. Emamekhoo H, Olsen MR, Carthon BC, et al. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced renal cell carcinoma with brain metastases: CheckMate 920. Cancer. 2022;128(5):966-74. DOI:10.1002/cncr.34016
18. Atkins MB, Plimack ER, Puzanov I, et al. Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial. Lancet Oncol. 2018;19(3):405-15. DOI:10.1016/S1470-2045(18)30081-0
19. Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019;380(12):1116-27. DOI:10.1056/NEJMoa1816714
20. Powles T, Plimack ER, Soulières D, et al. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol. 2020;21(12):1563-73. DOI:10.1016/S1470-2045(20)30436-8
21. 710P Phase II trial of lenvatinib (LEN) + pembrolizumab (PEMBRO) for progressive disease after PD-1/PD-L1 immune checkpoint inhibitor (ICI) in metastatic clear cell (mcc) renal cell carcinoma (RCC): Results by independent imaging review and subgroup analyses. Ann Oncol. 2020;31(4):S558-9. DOI:10.1016/j.annonc.2020.08.782
22. Postow MA, Sidlow R, Hellmann MD. Immune-Related Adverse Events Associated with Immune Checkpoint Blockade. N Engl J Med. 2018;378(2):158-68. DOI:10.1056/NEJMra1703481
23. Abou Alaiwi S, Xie W, Nassar AH, et al. Safety and efficacy of restarting immune checkpoint inhibitors after clinically significant immune-related adverse events in metastatic renal cell carcinoma. J Immunother Cancer. 2020;8(1):e000144. DOI:10.1136/jitc-2019-000144
24. Ornstein MC, Garcia JA. Toxicity of Checkpoint Inhibition in Advanced RCC: A Systematic Review. Kidney Cancer. 2017;1(2):133-41. DOI:10.3233/KCA-170017
25. Das S, Johnson DB. Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors. J Immunother Cancer. 2019;7(1):306. DOI:10.1186/s40425-019-0805-8
2. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. DOI:10.3322/caac.21708
3. Fay AP, McKay RR, Lin X, et al. Impact of Geographic Regions on Overall Survival in Patients With Metastatic Renal Cell Carcinoma: Results From an International Clinical Trials Database. J Glob Oncol. 2018;4:1-14. DOI:10.1200/JGO.17.00119z
4. Zhuang TZ, Case K, Olsen TA, et al. Metastatic Clear-Cell Renal Cell Carcinoma in the Era of Immune Checkpoint Inhibitors: Therapies and Ongoing Trials. Cancers (Basel). 2022;14(12):2867. DOI:10.3390/cancers14122867
5. Padala SA, Barsouk A, Thandra KC, et al. Epidemiology of Renal Cell Carcinoma. World J Oncol. 2020;11(3):79-87. DOI:10.14740/wjon1279
6. Злокачественные новообразования в России в 2022 году (заболеваемость и смертность). Под ред. А.Д. Каприна, В.В. Старинского, А.О. Шахзадовой. М.: МНИОИ им. ПА. Герцена – филиал ФГБУ «НМИЦ радиологии» Минздрава России, 2023 [Zlokachestvennyie novoobrazovaniia v Rossii v 2022 godu (zabolevaiemost i smertnost). Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. PA. Gertsena – filial FGBU “NMITS radiologii” Minzdrava Rossii, 2023 (in Russian)].
7. Nakano O, Sato M, Naito Y, et al. Proliferative activity of intratumoral CD8(+) T-lymphocytes as a prognostic factor in human renal cell carcinoma: clinicopathologic demonstration of antitumor immunity. Cancer Res. 2001;61(13):5132-6.
8. Sharpe AH, Pauken KE. The diverse functions of the PD1 inhibitory pathway. Nature reviews. Immunology. 2018;18(3):153-67. DOI:10.1038/nri.2017.108
9. Postow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015;33(17):1974-82. DOI:10.1200/JCO.2014.59.4358
10. Topalian S, Hodi FS, Brahmer JR, et al. Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer Treated With Nivolumab. AMA Oncol. 2019;5(10):1411-20. DOI:10.1001/jamaoncol.2019.2187
11. McDermott DF, Motzer RJ, Atkins MB, et al. Longterm overall survival with nivolumab in previously treated patients with advanced renal cell carcinoma (aRCC) from phase I and II studies. Abstract (4507) presented at the Annual Meeting of the American Society of Clinical Oncology; June 3–7, 2016; Chicago, IL.
12. Motzer RJ, Escudier B, George S,et al. Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial. Cancer. 2020;126(18):4156-67. DOI:10.1002/cncr.33033
13. Motzer RJ, McDermott DF, Escudier B, et al. Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma. Cancer. 2022;128(11):2085-97. DOI:10.1002/cncr.34180
14. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-90. DOI:10.1056/NEJMoa1712126
15. Albiges L, Tannir NM, Burotto M, et al. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020;5(6):e001079. DOI:10.1136/esmoopen-2020-001079
16. Flippot R, Dalban C, Laguerre B, et al. Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. J Clin Oncol. 2019;37(23):2008-16. DOI:10.1200/JCO.18.02218
17. Emamekhoo H, Olsen MR, Carthon BC, et al. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced renal cell carcinoma with brain metastases: CheckMate 920. Cancer. 2022;128(5):966-74. DOI:10.1002/cncr.34016
18. Atkins MB, Plimack ER, Puzanov I, et al. Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial. Lancet Oncol. 2018;19(3):405-15. DOI:10.1016/S1470-2045(18)30081-0
19. Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019;380(12):1116-27. DOI:10.1056/NEJMoa1816714
20. Powles T, Plimack ER, Soulières D, et al. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol. 2020;21(12):1563-73. DOI:10.1016/S1470-2045(20)30436-8
21. 710P Phase II trial of lenvatinib (LEN) + pembrolizumab (PEMBRO) for progressive disease after PD-1/PD-L1 immune checkpoint inhibitor (ICI) in metastatic clear cell (mcc) renal cell carcinoma (RCC): Results by independent imaging review and subgroup analyses. Ann Oncol. 2020;31(4):S558-9. DOI:10.1016/j.annonc.2020.08.782
22. Postow MA, Sidlow R, Hellmann MD. Immune-Related Adverse Events Associated with Immune Checkpoint Blockade. N Engl J Med. 2018;378(2):158-68. DOI:10.1056/NEJMra1703481
23. Abou Alaiwi S, Xie W, Nassar AH, et al. Safety and efficacy of restarting immune checkpoint inhibitors after clinically significant immune-related adverse events in metastatic renal cell carcinoma. J Immunother Cancer. 2020;8(1):e000144. DOI:10.1136/jitc-2019-000144
24. Ornstein MC, Garcia JA. Toxicity of Checkpoint Inhibition in Advanced RCC: A Systematic Review. Kidney Cancer. 2017;1(2):133-41. DOI:10.3233/KCA-170017
25. Das S, Johnson DB. Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors. J Immunother Cancer. 2019;7(1):306. DOI:10.1186/s40425-019-0805-8
________________________________________________
2. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7-33. DOI:10.3322/caac.21708
3. Fay AP, McKay RR, Lin X, et al. Impact of Geographic Regions on Overall Survival in Patients With Metastatic Renal Cell Carcinoma: Results From an International Clinical Trials Database. J Glob Oncol. 2018;4:1-14. DOI:10.1200/JGO.17.00119z
4. Zhuang TZ, Case K, Olsen TA, et al. Metastatic Clear-Cell Renal Cell Carcinoma in the Era of Immune Checkpoint Inhibitors: Therapies and Ongoing Trials. Cancers (Basel). 2022;14(12):2867. DOI:10.3390/cancers14122867
5. Padala SA, Barsouk A, Thandra KC, et al. Epidemiology of Renal Cell Carcinoma. World J Oncol. 2020;11(3):79-87. DOI:10.14740/wjon1279
6. Zlokachestvennyie novoobrazovaniia v Rossii v 2022 godu (zabolevaiemost i smertnost). Pod red. AD Kaprina, VV Starinskogo, AO Shakhzadovoi. Moscow: MNIOI im. PA. Gertsena – filial FGBU “NMITS radiologii” Minzdrava Rossii, 2023 (in Russian).
7. Nakano O, Sato M, Naito Y, et al. Proliferative activity of intratumoral CD8(+) T-lymphocytes as a prognostic factor in human renal cell carcinoma: clinicopathologic demonstration of antitumor immunity. Cancer Res. 2001;61(13):5132-6.
8. Sharpe AH, Pauken KE. The diverse functions of the PD1 inhibitory pathway. Nature reviews. Immunology. 2018;18(3):153-67. DOI:10.1038/nri.2017.108
9. Postow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015;33(17):1974-82. DOI:10.1200/JCO.2014.59.4358
10. Topalian S, Hodi FS, Brahmer JR, et al. Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non-Small Cell Lung Cancer Treated With Nivolumab. AMA Oncol. 2019;5(10):1411-20. DOI:10.1001/jamaoncol.2019.2187
11. McDermott DF, Motzer RJ, Atkins MB, et al. Longterm overall survival with nivolumab in previously treated patients with advanced renal cell carcinoma (aRCC) from phase I and II studies. Abstract (4507) presented at the Annual Meeting of the American Society of Clinical Oncology; June 3–7, 2016; Chicago, IL.
12. Motzer RJ, Escudier B, George S,et al. Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long-term follow-up of the randomized, open-label, phase 3 CheckMate 025 trial. Cancer. 2020;126(18):4156-67. DOI:10.1002/cncr.33033
13. Motzer RJ, McDermott DF, Escudier B, et al. Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma. Cancer. 2022;128(11):2085-97. DOI:10.1002/cncr.34180
14. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018;378(14):1277-90. DOI:10.1056/NEJMoa1712126
15. Albiges L, Tannir NM, Burotto M, et al. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020;5(6):e001079. DOI:10.1136/esmoopen-2020-001079
16. Flippot R, Dalban C, Laguerre B, et al. Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. J Clin Oncol. 2019;37(23):2008-16. DOI:10.1200/JCO.18.02218
17. Emamekhoo H, Olsen MR, Carthon BC, et al. Safety and efficacy of nivolumab plus ipilimumab in patients with advanced renal cell carcinoma with brain metastases: CheckMate 920. Cancer. 2022;128(5):966-74. DOI:10.1002/cncr.34016
18. Atkins MB, Plimack ER, Puzanov I, et al. Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial. Lancet Oncol. 2018;19(3):405-15. DOI:10.1016/S1470-2045(18)30081-0
19. Rini BI, Plimack ER, Stus V, et al. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019;380(12):1116-27. DOI:10.1056/NEJMoa1816714
20. Powles T, Plimack ER, Soulières D, et al. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol. 2020;21(12):1563-73. DOI:10.1016/S1470-2045(20)30436-8
21. 710P Phase II trial of lenvatinib (LEN) + pembrolizumab (PEMBRO) for progressive disease after PD-1/PD-L1 immune checkpoint inhibitor (ICI) in metastatic clear cell (mcc) renal cell carcinoma (RCC): Results by independent imaging review and subgroup analyses. Ann Oncol. 2020;31(4):S558-9. DOI:10.1016/j.annonc.2020.08.782
22. Postow MA, Sidlow R, Hellmann MD. Immune-Related Adverse Events Associated with Immune Checkpoint Blockade. N Engl J Med. 2018;378(2):158-68. DOI:10.1056/NEJMra1703481
23. Abou Alaiwi S, Xie W, Nassar AH, et al. Safety and efficacy of restarting immune checkpoint inhibitors after clinically significant immune-related adverse events in metastatic renal cell carcinoma. J Immunother Cancer. 2020;8(1):e000144. DOI:10.1136/jitc-2019-000144
24. Ornstein MC, Garcia JA. Toxicity of Checkpoint Inhibition in Advanced RCC: A Systematic Review. Kidney Cancer. 2017;1(2):133-41. DOI:10.3233/KCA-170017
25. Das S, Johnson DB. Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors. J Immunother Cancer. 2019;7(1):306. DOI:10.1186/s40425-019-0805-8
Авторы
М.А. Лядова1,2, Д.С. Федоринов1,3, Т.А. Нерсесова*1, Я.В. Гриднева1,4, М.И. Волкова1,3, К.В. Лядов4,5, Е.С. Кузьмина1, Т.Г. Антонова1, И.А. Покатаев1, В.Н. Галкин1, И.В. Поддубная3
1ГБУЗ г. Москвы «Городская клиническая больница им. С.С. Юдина Департамента здравоохранения г. Москвы», Москва, Россия;
2Новокузнецкий государственный институт усовершенствования врачей – филиал ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Новокузнецк, Россия;
3ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
4ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
5ООО «Московский центр восстановительного лечения», Москва, Россия
*dr.nersesova@gmail.com
1Moscow State Budgetary Healthcare Institution "Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department", Moscow, Russia;
2Novokuznetsk State Institute for Postgraduate Medical Education – branch of the Russian Medical Academy of Continuous Professional Education, Novokuznetsk, Russia;
3Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
4Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
5Moscow Center for Rehabilitation Treatment, Moscow, Russia
*dr.nersesova@gmail.com
1ГБУЗ г. Москвы «Городская клиническая больница им. С.С. Юдина Департамента здравоохранения г. Москвы», Москва, Россия;
2Новокузнецкий государственный институт усовершенствования врачей – филиал ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Новокузнецк, Россия;
3ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
4ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
5ООО «Московский центр восстановительного лечения», Москва, Россия
*dr.nersesova@gmail.com
________________________________________________
1Moscow State Budgetary Healthcare Institution "Moscow City Hospital named after S.S. Yudin, Moscow Healthcare Department", Moscow, Russia;
2Novokuznetsk State Institute for Postgraduate Medical Education – branch of the Russian Medical Academy of Continuous Professional Education, Novokuznetsk, Russia;
3Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
4Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
5Moscow Center for Rehabilitation Treatment, Moscow, Russia
*dr.nersesova@gmail.com
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.
