The first line therapy for intermediate/ high risk patients with advanced renal cell carcinoma according to therapeutic program B.10 Review article
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Published:
Aug 19, 2023
Keywords:
renal cell carcinoma, intermediate risk group, unfavourable risk group, tyrosine kinases inhibitor, immune check-point inhibitor
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Abstract
The purpose of this article is to discuss the use of therapeutic options for the first-line systemic treatment of patients with advanced renal cell carcinoma under the B.10 drug program effective in Poland as of May 2022 – with a focus on intermediate and high-risk patient populations according to the IMDC. The specific situation created by reimbursement conditions with the exclusion of regimens combined with a tyrosine kinase inhibitor and immune checkpoint inhibitors along with the marginalisation of the use of an mTOR inhibitor necessitates a choice between two-drug immunotherapy or an antiangiogenic drug in monotherapy. In this context, choosing the right treatment in the context of specific clinical situations is a challenge.
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1.
Żołnierek J. The first line therapy for intermediate/ high risk patients with advanced renal cell carcinoma according to therapeutic program B.10. OncoReview [Internet]. 2023Aug.19 [cited 2024Nov.21];13(2(50):48-7. Available from: https://journalsmededu.pl/index.php/OncoReview/article/view/2849
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PERSONALIZED ONCOLOGY
Copyright: © Medical Education sp. z o.o. This is an Open Access article distributed under the terms of the Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). License (https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
Address reprint requests to: Medical Education, Marcin Kuźma (marcin.kuzma@mededu.pl)
References
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18. Chouerir TK, Escudier B, Powles T et al. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015; 373: 1814-23. http://doi.org/10.1056/NEJMoa1510016.
19. Bergmann L, Maute L, Guschmann M. Temsirolimus for advanced renal cell carcinoma. Expert Rev Anticancer Ther. 2014; 14(1): 9-21. http://doi.org/10.1586/14737140.2014.864562.
20. Tannir NM, Signoretii S, Choueiri TK et al. Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma. Clin Cancer Res. 2021; 27(1): 78-86. http://doi.org/10.1158/1078-0432.CCR-20-2063.
21. Motzer RJ, Tannir NM, McDermott DF et al. Nivolumab + Ipilimumab (N+I) vs Sunitinib (S) for treatment-naїve advanced or metastatic renal cell carcinoma (aRCC): results from CheckMate 214, including overall survival by subgroups. J Immunother Cancer. 2017; 5(Suppl. 3): 89.
22. McDermott DF, Huseni MA, Atkins MB et al. Clinical activity and molecular correlates of response to atezolizumab alone or in combination with bevacizumab versus sunitinib in renal cell carcinoma. Nat Med. 2018; 24: 749-57. http://doi.org/10.1038/s41591-018-0053-3.
23. Cella D, Grünwald V, Escudier B et al. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial. Lancet Oncol. 2019; 20(2): 297-310. http://doi.org/10.1016/S1470-2045(18)30778-2.
24. Suárez C, Choueiri TK, Burotto M et al. Association between depth of response (DepOR) and clinical outcomes: exploratory analysis in patients with previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 9ER. J Clin Oncol. 2022; 40(16_suppl): 4501. http://doi.org/10.1200/JCO.2022.40.16_suppl.4501.
25. Tannir NM, McDermott DF, Escudier B et al. Overall survival and independent review of response in CheckMate 214 with 42-month follow-up: First-line nivolumab + ipilimumab (N+I) versus sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). J Clin Oncol. 2020; 38(6_suppl): 609-9.
2. Bukavina L, Bensalah K, Bray F et al. Epidemiology of Renal Cell Carcinoma: 2022 Update. Eur Urol. 2022; 82: 529.
3. 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. http://doi.org/10.1200/JCO.2009.23.9764.
4. Motzer RJ, Hutson TE, Tomczak P et al. Sunitinib versus Interferon Alfa in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2007; 356: 115-24. http://doi.org/10.1056/NEJMoa065044.
5 Mehta A, Sonpavde G, Escudier B. Tivozanib for the treatment of renal cell carcinoma: results and implications of the TIVO-1 trial. Future Oncol. 2014; 10(11): 1819-26. http://doi.org/10.2217/fon.14.120.
6. Choueiri TK, Halabi S, Sanford BL et al. Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the alliance A031203 CABOSUN trial. J Clin Oncol. 2016; 35(6): 591-7. http://doi.org/10.1200/JCO.2016.70.7398.
7. 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): 1277-8. http://doi.org/10.1056/NEJMoa1712126.
8. 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. http://doi.org/10.1016/ S1470-2045(20)30436-8.
9. Motzer RJ, Robbins PB, Powles T et al. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN renal 101 trial. Nat Med. 2020; 26: 1733-41. http://doi.org/10.1038/s41591-020-1044-8.
10. Motzer R, Alekseev B, Rha SY et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. N Engl J Med. 2021; 384(14): 1289-300. http://doi.org/10.1056/NEJMoa2035716.
11. Choueiri TK, Powles T, Burotto M et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2021; 384(9): 829-41. http://doi.org/10.1056/NEJMoa2026982.
12. Wysocki PJ, Chłosta P, Chrzan R et al. Zalecenia postępowania diagnostyczno-terapeutycznego w raku nerkowokomórkowym – aktualizacja. Onkol Prakt Klin Edu. 2022; 8(6): 424-57.
13. EAU Guidelines Office, Arnhem, The Netherlands.
14. Powles T, Albiges L, Bex A et al; ESMO Guidelines Committee. ESMO Clinical Practice Guideline update on the use of immunotherapy in early stage and advanced renal cell carcinoma. Ann Oncol. 2021; 32(12): 1511-9. http://doi.org/10.1016/j.annonc.2021.09.014.
15. Motzer RJ, Jonasch E, Agarwal N et al. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Kidney Cancer. Version 1.2024 – June 21,2023.
16. 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. http://doi.org/10.1136/esmoopen-2020-001079.
17. 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. http://doi.org/10.1002/cncr.34180.
18. Chouerir TK, Escudier B, Powles T et al. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015; 373: 1814-23. http://doi.org/10.1056/NEJMoa1510016.
19. Bergmann L, Maute L, Guschmann M. Temsirolimus for advanced renal cell carcinoma. Expert Rev Anticancer Ther. 2014; 14(1): 9-21. http://doi.org/10.1586/14737140.2014.864562.
20. Tannir NM, Signoretii S, Choueiri TK et al. Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma. Clin Cancer Res. 2021; 27(1): 78-86. http://doi.org/10.1158/1078-0432.CCR-20-2063.
21. Motzer RJ, Tannir NM, McDermott DF et al. Nivolumab + Ipilimumab (N+I) vs Sunitinib (S) for treatment-naїve advanced or metastatic renal cell carcinoma (aRCC): results from CheckMate 214, including overall survival by subgroups. J Immunother Cancer. 2017; 5(Suppl. 3): 89.
22. McDermott DF, Huseni MA, Atkins MB et al. Clinical activity and molecular correlates of response to atezolizumab alone or in combination with bevacizumab versus sunitinib in renal cell carcinoma. Nat Med. 2018; 24: 749-57. http://doi.org/10.1038/s41591-018-0053-3.
23. Cella D, Grünwald V, Escudier B et al. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial. Lancet Oncol. 2019; 20(2): 297-310. http://doi.org/10.1016/S1470-2045(18)30778-2.
24. Suárez C, Choueiri TK, Burotto M et al. Association between depth of response (DepOR) and clinical outcomes: exploratory analysis in patients with previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 9ER. J Clin Oncol. 2022; 40(16_suppl): 4501. http://doi.org/10.1200/JCO.2022.40.16_suppl.4501.
25. Tannir NM, McDermott DF, Escudier B et al. Overall survival and independent review of response in CheckMate 214 with 42-month follow-up: First-line nivolumab + ipilimumab (N+I) versus sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). J Clin Oncol. 2020; 38(6_suppl): 609-9.