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2021 Updated European Association of Urology Guidelines on the Use of Adjuvant Pembrolizumab for Renal Cell Carcinoma

Bedke, Jens ; Albiges, Laurence ; Capitanio, Umberto ; Giles, Rachel H. ; Hora, Milan ; Lam, Thomas B. ; Ljungberg, Börje ; Marconi, Lorenzo ; Klatte, Tobias and Volpe, Alessandro , et al. (2022) In European Urology 81(2). p.134-137
Abstract

Adjuvant treatment of nonmetastatic high-risk renal cell carcinoma is an unmet medical need. In the past, several tyrosine kinase inhibitor trials have failed to demonstrate an improvement of disease-free survival (DFS) in this setting. Only one trial (S-TRAC) provided evidence for improved DFS with sunitinib but without an overall survival (OS) signal. Keynote-564 is the first trial of an immune checkpoint inhibitor that significantly improved DFS with adjuvant pembrolizumab, a programmed death receptor-1 antibody, in clear cell renal cell carcinoma with a high risk of relapse. The intention-to-treat population, which included a group of patients after metastasectomy and no evidence of disease (M1 NED), had a significant DFS benefit.... (More)

Adjuvant treatment of nonmetastatic high-risk renal cell carcinoma is an unmet medical need. In the past, several tyrosine kinase inhibitor trials have failed to demonstrate an improvement of disease-free survival (DFS) in this setting. Only one trial (S-TRAC) provided evidence for improved DFS with sunitinib but without an overall survival (OS) signal. Keynote-564 is the first trial of an immune checkpoint inhibitor that significantly improved DFS with adjuvant pembrolizumab, a programmed death receptor-1 antibody, in clear cell renal cell carcinoma with a high risk of relapse. The intention-to-treat population, which included a group of patients after metastasectomy and no evidence of disease (M1 NED), had a significant DFS benefit. The OS data are not mature as yet. The Renal Cell Carcinoma Guideline Panel issues a weak recommendation for the adjuvant use of pembrolizumab for high-risk clear cell renal carcinoma, as defined by the trial until final OS data are available. However, the trial reilluminates the discussion on when and in whom metastasectomy should be performed. Here, caution is necessary not to perform metastasectomy in patients with poor prognostic features and rapid progressive disease, which must be excluded by a confirmatory scan of disease status prior to planned metastasectomy. Patient summary: New data from the adjuvant immune checkpoint inhibitor trial with pembrolizumab (a programmed death receptor-1 antibody) for the treatment of high-risk clear cell renal cell carcinoma (ccRCC) after surgery showed that the drug prolonged the period of being cancer free significantly, although whether it prolonged survival remained uncertain. Consequently, pembrolizumab is cautiously recommended as additional (ie, adjuvant) treatment in high-risk ccRCC after kidney cancer surgery.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Adjuvant, Clear cell, High risk, Metastasectomy, Pembrolizumab, Renal cell carcinoma, Tyrosine kinase inhibitor
in
European Urology
volume
81
issue
2
pages
4 pages
publisher
Elsevier
external identifiers
  • pmid:34920897
  • scopus:85121810191
ISSN
0302-2838
DOI
10.1016/j.eururo.2021.11.022
language
English
LU publication?
yes
id
29577be6-c194-4b0c-b476-e4e10ffe60c0
date added to LUP
2022-03-23 12:05:44
date last changed
2022-06-22 04:04:48
@article{29577be6-c194-4b0c-b476-e4e10ffe60c0,
  abstract     = {{<p>Adjuvant treatment of nonmetastatic high-risk renal cell carcinoma is an unmet medical need. In the past, several tyrosine kinase inhibitor trials have failed to demonstrate an improvement of disease-free survival (DFS) in this setting. Only one trial (S-TRAC) provided evidence for improved DFS with sunitinib but without an overall survival (OS) signal. Keynote-564 is the first trial of an immune checkpoint inhibitor that significantly improved DFS with adjuvant pembrolizumab, a programmed death receptor-1 antibody, in clear cell renal cell carcinoma with a high risk of relapse. The intention-to-treat population, which included a group of patients after metastasectomy and no evidence of disease (M1 NED), had a significant DFS benefit. The OS data are not mature as yet. The Renal Cell Carcinoma Guideline Panel issues a weak recommendation for the adjuvant use of pembrolizumab for high-risk clear cell renal carcinoma, as defined by the trial until final OS data are available. However, the trial reilluminates the discussion on when and in whom metastasectomy should be performed. Here, caution is necessary not to perform metastasectomy in patients with poor prognostic features and rapid progressive disease, which must be excluded by a confirmatory scan of disease status prior to planned metastasectomy. Patient summary: New data from the adjuvant immune checkpoint inhibitor trial with pembrolizumab (a programmed death receptor-1 antibody) for the treatment of high-risk clear cell renal cell carcinoma (ccRCC) after surgery showed that the drug prolonged the period of being cancer free significantly, although whether it prolonged survival remained uncertain. Consequently, pembrolizumab is cautiously recommended as additional (ie, adjuvant) treatment in high-risk ccRCC after kidney cancer surgery.</p>}},
  author       = {{Bedke, Jens and Albiges, Laurence and Capitanio, Umberto and Giles, Rachel H. and Hora, Milan and Lam, Thomas B. and Ljungberg, Börje and Marconi, Lorenzo and Klatte, Tobias and Volpe, Alessandro and Abu-Ghanem, Yasmin and Dabestani, Saeed and Fernández-Pello, Sergio and Hofmann, Fabian and Kuusk, Teele and Tahbaz, Rana and Powles, Thomas and Bex, Axel}},
  issn         = {{0302-2838}},
  keywords     = {{Adjuvant; Clear cell; High risk; Metastasectomy; Pembrolizumab; Renal cell carcinoma; Tyrosine kinase inhibitor}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{134--137}},
  publisher    = {{Elsevier}},
  series       = {{European Urology}},
  title        = {{2021 Updated European Association of Urology Guidelines on the Use of Adjuvant Pembrolizumab for Renal Cell Carcinoma}},
  url          = {{http://dx.doi.org/10.1016/j.eururo.2021.11.022}},
  doi          = {{10.1016/j.eururo.2021.11.022}},
  volume       = {{81}},
  year         = {{2022}},
}