The 2021 Updated European Association of Urology Guidelines on Renal Cell Carcinoma: Immune Checkpoint Inhibitor–based Combination Therapies for Treatment-naive Metastatic Clear-cell Renal Cell Carcinoma Are Standard of Care

Jens Bedke; Laurence Albiges; Umberto Capitanio; Rachel H. Giles; Milan Hora; Thomas B. Lam; Börje Ljungberg; Lorenzo Marconi; Tobias Klatte; Alessandro Volpe; Yasmin Abu-Ghanem; Saeed Dabestani; Sergio Fernández Pello; Fabian Hofmann; Teele Kuusk; Rana Tahbaz; Thomas Powles; Axel Bex

doi:10.1016/j.eururo.2021.04.042

The 2021 Updated European Association of Urology Guidelines on Renal Cell Carcinoma: Immune Checkpoint Inhibitor–based Combination Therapies for Treatment-naive Metastatic Clear-cell Renal Cell Carcinoma Are Standard of Care

Jens Bedke, Laurence Albiges, Umberto Capitanio, Rachel H. Giles, Milan Hora, Thomas B. Lam, Börje Ljungberg, Lorenzo Marconi, Tobias Klatte, Alessandro Volpe, Yasmin Abu-Ghanem, Saeed Dabestani, Sergio Fernández Pello, Fabian Hofmann, Teele Kuusk, Rana Tahbaz, Thomas Powles, Axel Bex

Urological cancer, Malmö

Research output: Contribution to journal › Debate/Note/Editorial › peer-review

Abstract

The recent randomized controlled phase III CLEAR trial results are the last to complement immune checkpoint inhibitor (ICI)-based doublet combination therapies for treatment-naïve metastatic clear-cell renal cell carcinoma. The CLEAR trial demonstrated an improved progression-free survival (PFS), overall survival (OS), and an objective response rate (ORR) benefit for the combination of lenvatinib plus pembrolizumab over sunitinib. The CheckMate-9ER trial update demonstrated an ongoing PFS, OS, and quality-of-life benefit for cabozantinib plus nivolumab over sunitinib as did the update of Keynote-426 for axitinib plus pembrolizumab in the intention-to-treat population, with a PFS benefit seen across all International Metastatic Database Consortium (IMDC) subgroups. In the IMDC intermediate- and poor-risk groups, the CheckMate-214 trial of ipilimumab plus nivolumab confirmed the OS benefit with a PFS plateauing after 30 months. The RCC Guidelines Panel recommends three tyrosine kinase inhibitors + ICI combinations of axitinib plus pembrolizumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab across all IMDC risk groups in advanced first-line RCC, and dual immunotherapy of ipilimumab and nivolumab in IMDC intermediate- and poor-risk groups. Patient summary: New data from combination trials with immune checkpoint inhibitors for advanced kidney cancer confirm a survival benefit for lenvatinib plus pembrolizumab, cabozantinib plus nivolumab (with improved quality-of-life), axitinib plus pembrolizumab, and ipilimumab plus nivolumab. These combination therapies are recommended as first-line treatment for advanced kidney cancer.

Original language	English
Pages (from-to)	393-397
Number of pages	5
Journal	European Urology
Volume	80
Issue number	4
DOIs	https://doi.org/10.1016/j.eururo.2021.04.042
Publication status	Published - 2021 Oct

Subject classification (UKÄ)

Cancer and Oncology

Free keywords

Cabozantinib
Clear-cell
First-line
Lenvatinib, pembrolzumab, nivolumab
Renal cell carcinoma
Systemic therapy
Treatment-naive

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.eururo.2021.04.042

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Bedke, J., Albiges, L., Capitanio, U., Giles, R. H., Hora, M., Lam, T. B., Ljungberg, B., Marconi, L., Klatte, T., Volpe, A., Abu-Ghanem, Y., Dabestani, S., Pello, S. F., Hofmann, F., Kuusk, T., Tahbaz, R., Powles, T., & Bex, A. (2021). The 2021 Updated European Association of Urology Guidelines on Renal Cell Carcinoma: Immune Checkpoint Inhibitor–based Combination Therapies for Treatment-naive Metastatic Clear-cell Renal Cell Carcinoma Are Standard of Care. European Urology, 80(4), 393-397. https://doi.org/10.1016/j.eururo.2021.04.042

@article{a01343e49645481d8e722ed01de64640,

title = "The 2021 Updated European Association of Urology Guidelines on Renal Cell Carcinoma: Immune Checkpoint Inhibitor–based Combination Therapies for Treatment-naive Metastatic Clear-cell Renal Cell Carcinoma Are Standard of Care",

abstract = "The recent randomized controlled phase III CLEAR trial results are the last to complement immune checkpoint inhibitor (ICI)-based doublet combination therapies for treatment-na{\"i}ve metastatic clear-cell renal cell carcinoma. The CLEAR trial demonstrated an improved progression-free survival (PFS), overall survival (OS), and an objective response rate (ORR) benefit for the combination of lenvatinib plus pembrolizumab over sunitinib. The CheckMate-9ER trial update demonstrated an ongoing PFS, OS, and quality-of-life benefit for cabozantinib plus nivolumab over sunitinib as did the update of Keynote-426 for axitinib plus pembrolizumab in the intention-to-treat population, with a PFS benefit seen across all International Metastatic Database Consortium (IMDC) subgroups. In the IMDC intermediate- and poor-risk groups, the CheckMate-214 trial of ipilimumab plus nivolumab confirmed the OS benefit with a PFS plateauing after 30 months. The RCC Guidelines Panel recommends three tyrosine kinase inhibitors + ICI combinations of axitinib plus pembrolizumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab across all IMDC risk groups in advanced first-line RCC, and dual immunotherapy of ipilimumab and nivolumab in IMDC intermediate- and poor-risk groups. Patient summary: New data from combination trials with immune checkpoint inhibitors for advanced kidney cancer confirm a survival benefit for lenvatinib plus pembrolizumab, cabozantinib plus nivolumab (with improved quality-of-life), axitinib plus pembrolizumab, and ipilimumab plus nivolumab. These combination therapies are recommended as first-line treatment for advanced kidney cancer.",

keywords = "Cabozantinib, Clear-cell, First-line, Lenvatinib, pembrolzumab, nivolumab, Renal cell carcinoma, Systemic therapy, Treatment-naive",

author = "Jens Bedke and Laurence Albiges and Umberto Capitanio and Giles, {Rachel H.} and Milan Hora and Lam, {Thomas B.} and B{\"o}rje Ljungberg and Lorenzo Marconi and Tobias Klatte and Alessandro Volpe and Yasmin Abu-Ghanem and Saeed Dabestani and Pello, {Sergio Fern{\'a}ndez} and Fabian Hofmann and Teele Kuusk and Rana Tahbaz and Thomas Powles and Axel Bex",

year = "2021",

month = oct,

doi = "10.1016/j.eururo.2021.04.042",

language = "English",

volume = "80",

pages = "393--397",

journal = "European Urology",

issn = "0302-2838",

publisher = "Elsevier",

number = "4",

}

Bedke, J, Albiges, L, Capitanio, U, Giles, RH, Hora, M, Lam, TB, Ljungberg, B, Marconi, L, Klatte, T, Volpe, A, Abu-Ghanem, Y, Dabestani, S, Pello, SF, Hofmann, F, Kuusk, T, Tahbaz, R, Powles, T & Bex, A 2021, 'The 2021 Updated European Association of Urology Guidelines on Renal Cell Carcinoma: Immune Checkpoint Inhibitor–based Combination Therapies for Treatment-naive Metastatic Clear-cell Renal Cell Carcinoma Are Standard of Care', European Urology, vol. 80, no. 4, pp. 393-397. https://doi.org/10.1016/j.eururo.2021.04.042

The 2021 Updated European Association of Urology Guidelines on Renal Cell Carcinoma: Immune Checkpoint Inhibitor–based Combination Therapies for Treatment-naive Metastatic Clear-cell Renal Cell Carcinoma Are Standard of Care. / Bedke, Jens; Albiges, Laurence; Capitanio, Umberto et al.
In: European Urology, Vol. 80, No. 4, 10.2021, p. 393-397.

Research output: Contribution to journal › Debate/Note/Editorial › peer-review

TY - JOUR

T1 - The 2021 Updated European Association of Urology Guidelines on Renal Cell Carcinoma

T2 - Immune Checkpoint Inhibitor–based Combination Therapies for Treatment-naive Metastatic Clear-cell Renal Cell Carcinoma Are Standard of Care

AU - Bedke, Jens

AU - Albiges, Laurence

AU - Capitanio, Umberto

AU - Giles, Rachel H.

AU - Hora, Milan

AU - Lam, Thomas B.

AU - Ljungberg, Börje

AU - Marconi, Lorenzo

AU - Klatte, Tobias

AU - Volpe, Alessandro

AU - Abu-Ghanem, Yasmin

AU - Dabestani, Saeed

AU - Pello, Sergio Fernández

AU - Hofmann, Fabian

AU - Kuusk, Teele

AU - Tahbaz, Rana

AU - Powles, Thomas

AU - Bex, Axel

PY - 2021/10

Y1 - 2021/10

N2 - The recent randomized controlled phase III CLEAR trial results are the last to complement immune checkpoint inhibitor (ICI)-based doublet combination therapies for treatment-naïve metastatic clear-cell renal cell carcinoma. The CLEAR trial demonstrated an improved progression-free survival (PFS), overall survival (OS), and an objective response rate (ORR) benefit for the combination of lenvatinib plus pembrolizumab over sunitinib. The CheckMate-9ER trial update demonstrated an ongoing PFS, OS, and quality-of-life benefit for cabozantinib plus nivolumab over sunitinib as did the update of Keynote-426 for axitinib plus pembrolizumab in the intention-to-treat population, with a PFS benefit seen across all International Metastatic Database Consortium (IMDC) subgroups. In the IMDC intermediate- and poor-risk groups, the CheckMate-214 trial of ipilimumab plus nivolumab confirmed the OS benefit with a PFS plateauing after 30 months. The RCC Guidelines Panel recommends three tyrosine kinase inhibitors + ICI combinations of axitinib plus pembrolizumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab across all IMDC risk groups in advanced first-line RCC, and dual immunotherapy of ipilimumab and nivolumab in IMDC intermediate- and poor-risk groups. Patient summary: New data from combination trials with immune checkpoint inhibitors for advanced kidney cancer confirm a survival benefit for lenvatinib plus pembrolizumab, cabozantinib plus nivolumab (with improved quality-of-life), axitinib plus pembrolizumab, and ipilimumab plus nivolumab. These combination therapies are recommended as first-line treatment for advanced kidney cancer.

AB - The recent randomized controlled phase III CLEAR trial results are the last to complement immune checkpoint inhibitor (ICI)-based doublet combination therapies for treatment-naïve metastatic clear-cell renal cell carcinoma. The CLEAR trial demonstrated an improved progression-free survival (PFS), overall survival (OS), and an objective response rate (ORR) benefit for the combination of lenvatinib plus pembrolizumab over sunitinib. The CheckMate-9ER trial update demonstrated an ongoing PFS, OS, and quality-of-life benefit for cabozantinib plus nivolumab over sunitinib as did the update of Keynote-426 for axitinib plus pembrolizumab in the intention-to-treat population, with a PFS benefit seen across all International Metastatic Database Consortium (IMDC) subgroups. In the IMDC intermediate- and poor-risk groups, the CheckMate-214 trial of ipilimumab plus nivolumab confirmed the OS benefit with a PFS plateauing after 30 months. The RCC Guidelines Panel recommends three tyrosine kinase inhibitors + ICI combinations of axitinib plus pembrolizumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab across all IMDC risk groups in advanced first-line RCC, and dual immunotherapy of ipilimumab and nivolumab in IMDC intermediate- and poor-risk groups. Patient summary: New data from combination trials with immune checkpoint inhibitors for advanced kidney cancer confirm a survival benefit for lenvatinib plus pembrolizumab, cabozantinib plus nivolumab (with improved quality-of-life), axitinib plus pembrolizumab, and ipilimumab plus nivolumab. These combination therapies are recommended as first-line treatment for advanced kidney cancer.

KW - Cabozantinib

KW - Clear-cell

KW - First-line

KW - Lenvatinib, pembrolzumab, nivolumab

KW - Renal cell carcinoma

KW - Systemic therapy

KW - Treatment-naive

U2 - 10.1016/j.eururo.2021.04.042

DO - 10.1016/j.eururo.2021.04.042

M3 - Debate/Note/Editorial

C2 - 34074559

AN - SCOPUS:85107068841

SN - 0302-2838

VL - 80

SP - 393

EP - 397

JO - European Urology

JF - European Urology

IS - 4

ER -