Кабозантиниб в лечении пациентов с распространенным почечно-клеточным раком

Волкова М.И., Турупаев К.А., Калинин С.А. Кабозантиниб в лечении пациентов с распространенным почечно-клеточным раком. Современная Онкология. 2022;24(2):184–190.
DOI: 10.26442/18151434.2022.2.201704

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Volkova MI, Turupaev KA, Kalinin SA. Cabozantinib in the treatment of patients with advanced renal cell carcinoma. Journal of Modern Oncology. 2022;24(2):184–190. DOI: 10.26442/18151434.2022.2.201704

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Аннотация

В течение последних лет стандарты лекарственной терапии распространенного рака почки претерпели существенные изменения, связанные с появлением эффективных ингибиторов контрольных точек противоопухолевого иммунного ответа, а также высокоаффинных мультикиназных ингибиторов II поколения. Одним из новых тирозинкиназных ингибиторов, имеющих доказанную противоопухолевую активность и безопасность у пациентов с распространенными формами почечно-клеточного рака (ПКР), является кабозантиниб. В 1-й линии терапии распространенного рака почки комбинация кабозантиниба с ниволумабом стала режимом предпочтения у пациентов всех групп прогноза International Metastatic RCC Database Consortium (IMDC) независимо от наличия саркоматоидного компонента в опухоли на основании результатов рандомизированного клинического исследования (РКИ) III фазы CheckMate 9ER (n=651), продемонстрировавшего значимое преимущество иммунотаргетной терапии по сравнению с сунитинибом в отношении общей выживаемости – ОВ (медиана 37,7 и 34,3 мес соответственно), выживаемости без прогрессирования – ВБП (медиана 16,6 и 8,3 мес соответственно) и частоты объективных ответов (55,7 и 28,4% соответственно). Монотерапия кабозантинибом в 1-й линии лечения распространенного рака почки у больных групп промежуточного и плохого прогноза является альтернативным режимом, зарезервированным для пациентов с противопоказаниями к ингибиторам контрольных точек противоопухолевого иммунного ответа. Основанием для данной рекомендации служат результаты открытого РКИ II фазы CABOSUN (n=157), показавшего значимое увеличение ВБП в группе кабозантиниба по сравнению с сунитинибом (8,6 мес vs 5,3 мес соответственно). Также кабозантиниб является препаратом выбора при папиллярном ПКР в связи с доказанным преимуществом БПВ по сравнению с сунитинибом (9,0 и 5,6 мес соответственно), продемонстрированным в РКИ II фазы SWOG 1500 (n=152). Кабозантиниб остается режимом предпочтения для 2-й линии терапии ПКР, резистентного к антиангиогенной терапии, на основании результатов РКИ III фазы METEOR, в котором препарат показал убедительное преимущество по сравнению с эверолимусом в отношении БПВ (7,4 и 3,8 мес соответственно) и ОВ (21,4 и 16,5 мес соответственно). В статье представлен подробный анализ данных исследований.

Ключевые слова: почечно-клеточный рак, папиллярный почечно-клеточный рак, кабозантиниб, ниволумаб, иммунотаргетная терапия, 1-я и последующие линии терапии

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In recent years, the standards of drug therapy for advanced kidney cancer have undergone significant changes associated with the appearance of the effective immune checkpoint inhibitors, as well as the high affinity second-generation multi-kinase inhibitors. One of the new tyrosine kinase inhibitors associated with the proven antitumor activity and safety in patients with advanced forms of renal cell carcinoma (RCC) is cabozantinib. The standards of drug therapy for advanced renal cancer have significantly changed in recent years with the emergence of effective anti-tumor immune response checkpoint inhibitors and high-affinity second-generation multikinase inhibitors. One of the novel tyrosine kinase inhibitors with proven antitumor activity and safety in patients with advanced renal cell cancer (RCC) is cabozantinib. In the first-line therapy for advanced renal cancer, the combination of cabozantinib with nivolumab became the regimen of choice in patients of all risk groups, according to International Metastatic RCC Database Consortium (IMDC), regardless of the presence of a sarcomatoid component in the tumor based on the results of the randomized phase III CheckMate 9ER clinical trial (n=651), which demonstrated a significant benefit of immune targeted therapy compared to sunitinib in terms of overall survival (OS; median 37.7 and 34.3 months, respectively), progression-free survival (PFS; median 16.6 and 8.3 months, respectively) and objective response rate (ORR; 55.7 and 28.4%, respectively). Cabozantinib monotherapy in the first-line therapy of advanced renal cancer in patients in the intermediate-risk and poor-risk groups is an alternative regimen reserved for patients with contraindications to anti-tumor immune response checkpoint inhibitors. This recommendation is based on the results of the open-label phase II RCT, CABOSUN (n=157), which showed a significant increase in PFS in the cabozantinib group compared to sunitinib (8.6 month vs 5.3 months, respectively). Also, cabozantinib is the drug of choice in papillary RCC due to the proven advantage in terms of PFS over sunitinib (9.0 and 5.6 months, respectively) demonstrated in the SWOG 1500 phase II RCT (n=152). Cabozantinib remains the drug of choice for second-line therapy of RCC resistant to anti-angiogenic therapy, based on the results of the phase III METEOR RCT, in which the drug showed a compelling advantage over everolimus for PFS (7.4 and 3.8 months, respectively) and OS (21.4 and 16.5 months, respectively). The article presents a detailed analysis of these studies.

Keywords: renal cell cancer, papillary renal cell cancer, cabozantinib, nivolumab, immune targeted therapy, first and subsequent lines of therapy

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1. Ed. AD Kaprin, VV Starinskii, AO Shakhzadova. Sostoianie onkologicheskoi pomoshchi naseleniiu Rossii v 2020 godu. Moscow: P. Hertsen Moscow Oncology Research Institute – the branch of National Medical Research Radiological Centre, 2020 (in Russian).
2. Shen C, Kaelin WG. The VHL/HIF axis in clear cell renal carcinoma. Semin Cancer Biol. 2013;23(1):18-25. DOI:10.1016/j.semcancer.2012.06.001
3. Brugarolas J. Molecular genetics of clear-cell renal cell carcinoma. J Clin Oncol. 2014;32(18):1968-76. doi:10.1200/JCO.2012.45.2003
4. Linehan WM, Schmidt LS, Crooks DR, et al. The Metabolic Basis of Kidney Cancer. Cancer Discov. 2019;9(8):1006-21. DOI:10.1158/2159-8290.CD-18-1354
5. Bukur J, Jasinski S, Seliger B. The role of classical and non-classical HLA class I antigens in human tumors. Semin Cancer Biol. 2012;22:350-8. DOI:10.1016/j.semcancer.2012.03.003
6. Jian Y, Yang K, Sun X, et al. Current Advance of Immune Evasion Mechanisms and Emerging Immunotherapies in Renal Cell Carcinoma. Front Immunol. 2021;12:639636. DOI:10.3389/fimmu.2021.639636
7. Rahma OE, Hodi FS. The Intersection between Tumor Angiogenesis and Immune Suppression. Clin Cancer Res. 2019;25(18):5449-57.
DOI:10.1158/1078-0432.CCR-18-1543
8. Rini BI, Plimack ER, Stus V, et al. KEYNOTE-426 Investigators. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019;380(12):1116-27. DOI:10.1056/NEJMoa1816714
9. Motzer R, Alekseev B, Rha SY, et al. CLEAR Trial Investigators. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021;384(14):1289-300. DOI:10.1056/NEJMoa2035716
10. Choueiri TK, Motzer RJ, Rini BI, et al. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020;31:1030-9. DOI:10.1016/j.annonc.2020.04.010
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12. Motzer R. ESMO 2012 oral presentation; abstract LBA8_PR.
13. Choueiri Т. ESMO Virtual Congress 2020 #ESMO20, 18 Sept – 21 Sept 2020. CheckMate-9ER Study of Nivolumab Combined With Cabozantinib Vs. Sunitinib in Participants With Previously Untreated mRCC.
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17. Manola J, Royston P, Elson P, et al. Prognostic model for survival in patients with metastatic renal cell carcinoma: results from the international kidney cancer working group. Clin Cancer Res. 2011 Aug 15;17(16):5443-50. DOI:10.1158/1078-0432.CCR-11-0553
18. Volkova MI, Alekseev BI, Gladkov OA, et al. Prakticheskie rekomendatsii po lekarstvennomu lecheniiu pochechno-kletochnogo raka. Zlokachestvennye opukholi. Prakticheskie rekomendatsii RUSSCO #3s2. 2022;12 (in Russian).
19. Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007;370(9605):2103-11. DOI:10.1016/S0140-6736(07)61904-7
20. Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356(22):2271-81.
DOI:10.1056/NEJMoa066838
21. Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010;28(6):1061-8. DOI:10.1200/JCO.2009.23.9764
22. Motzer RJ, Escudier B, McDermott DF, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373(19):1803-13.
DOI:10.1056/NEJMoa1510665
23. Rini BI, Halabi S, Rosenberg JE, et al. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol. 2010;28(13):2137‑43. DOI:10.1200/JCO.2009.26.5561
24. Figlin RA, Hutson TE, Tomczak P, et al. Overall survival with sunitinib versus interferon (IFN)-alfa as first-line treatment of metastatic renal cell carcinoma (mRCC). J Clin Oncol. 2008;26(15):5024. DOI:10.1200/jco.2008.26.15_suppl.5024
25. Motzer RJ, Hutson TE, Cella D, et al. Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2013;369(8):722-31. DOI:10.1056/NEJMoa1303989
26. Escudier B, Eisen T, Stadler WM, et al. Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009;27(20):3312‑8. DOI:10.1200/JCO.2008.19.5511
27. Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008;372(9637):449-56. DOI:10.1016/S0140-6736(08)61039-9
28. Rini BI, Escudier BJ, Michaelson MD, et al. Phase III AXIS trial for second-line metastatic renal cell carcinoma (mRCC): Effect of prior first-line treatment duration and axitinib dose titration on axitinib efficacy. J Clin Oncol. 2012;30(5):354. DOI:10.1200/jco.2012.30.5_suppl.354
29. Powles T, Choueiri TK, Burotto M, et al. Final overall survival analysis and organ-specific target lesion assessments with two-year follow-up in CheckMate 9ER: Nivolumab plus cabozantinib versus sunitinib for patients with advanced renal cell carcinoma. J Clin Oncol. 2022;40(6):350. DOI:10.1200/JCO.2022.40.6_suppl.350
30. Choueiri T.K, Tomczak P, Park SH, et al. 6530 – Pembrolizumab (pembro) vs placebo as adjuvant therapy for patients (pts) with renal cell carcinoma (RCC): Patient-reported outcomes (PRO) in KEYNOTE-564. Annals of Oncology. 2021;32(5):S678-724. DOI:10.1016/annonc/annonc675
31. Apolo AB, Powles T, Burotto M, et al. Nivolumab plus cabozantinib (N+C) versus sunitinib (S) for advanced renal cell carcinoma (aRCC): Outcomes by baseline disease characteristics in the phase 3 CheckMate 9ER trial. J Clin Oncol. 2021;39(15):4553. DOI:10.1200/JCO.2021.39.15_suppl.4553
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Авторы

М.И. Волкова*1,2, К.А. Турупаев1, С.А. Калинин1,3

1 ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина» Минздрава России, Москва, Россия;
2 ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
3 ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия
*mivolkova6@gmail.com

________________________________________________

Maria I. Volkova*1,2, Kirill A. Turupaev1, Sergey A. Kalinin1,3

1 Blokhin National Medical Research Center of Oncology, Moscow, Russia;
2 Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
3 Pirogov Russian National Research Medical University, Moscow, Russia
*mivolkova6@gmail.com

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