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Updated European Association of Urology Guidelines Regarding Adjuvant Therapy for Renal Cell Carcinoma

Bex, Axel; Albiges, Laurence; Ljungberg, Börje; Bensalah, Karim; Dabestani, Saeed LU ; Giles, Rachel H.; Hofmann, Fabian; Hora, Milan; Kuczyk, Markus A. and Lam, Thomas B, et al. (2017) In European Urology 71(5). p.719-722
Abstract

The European Association of Urology Renal Cell Carcinoma (RCC) guidelines panel updated their recommendation on adjuvant therapy in unfavourable, clinically nonmetastatic RCC following the recently reported results of a second randomised controlled phase 3 trial comparing 1-yr sunitinib to placebo for high-risk RCC after nephrectomy (S-TRAC). On the basis of conflicting results from the two available studies, the panel rated the quality of the evidence, the harm-to-benefit ratio, patient preferences, and costs. Finally, the panel, including representatives from a patient advocate group (International Kidney Cancer Coalition) voted and reached a consensus to not recommend adjuvant therapy with sunitinib for patients with high-risk RCC... (More)

The European Association of Urology Renal Cell Carcinoma (RCC) guidelines panel updated their recommendation on adjuvant therapy in unfavourable, clinically nonmetastatic RCC following the recently reported results of a second randomised controlled phase 3 trial comparing 1-yr sunitinib to placebo for high-risk RCC after nephrectomy (S-TRAC). On the basis of conflicting results from the two available studies, the panel rated the quality of the evidence, the harm-to-benefit ratio, patient preferences, and costs. Finally, the panel, including representatives from a patient advocate group (International Kidney Cancer Coalition) voted and reached a consensus to not recommend adjuvant therapy with sunitinib for patients with high-risk RCC after nephrectomy. Patient summary: In two studies, sunitinib was given for 1 yr and compared to no active treatment (placebo) in patients who had their kidney tumour removed and who had a high risk of cancer coming back after surgery. Although one study demonstrated that 1 yr of sunitinib therapy resulted in a 1.2-yr longer time before the disease recurred, the other study did not show a benefit and it has not been shown that patients live longer. Despite having been diagnosed with high-risk disease, many patients remain without recurrence, and the side effects of sunitinib are high. Therefore, the panel members, including patient representatives, do not recommend sunitinib after tumour removal in these patients. Two studies (ASSURE and S-TRAC) recently reported findings on whether adjuvant VEGF-targeted therapy can improve outcomes for patients with renal cell cancer. The poor benefit-to-harm ratio and the still absent evidence of an overall survival benefit led the European Association of Urology Renal Cell Cancer Guidelines Panel to provide a (weak) recommendation against the use of adjuvant sunitinib in this setting. Kidney cancer patients-through the International Kidney Cancer Coalition-participated in a questionnaire on the implications for S-TRAC, and approximately one-third of patients favoured not taking sunitinib.

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type
Contribution to journal
publication status
published
subject
keywords
Adjuvant, Guidelines, Management, Renal cell cancer, Sorafenib, Sunitinib
in
European Urology
volume
71
issue
5
pages
719 - 722
publisher
Elsevier
external identifiers
  • scopus:85008208816
ISSN
0302-2838
DOI
10.1016/j.eururo.2016.11.034
language
English
LU publication?
no
id
cf4a7a54-0bd4-49a2-bae5-11594e8df8ed
date added to LUP
2017-02-01 07:11:02
date last changed
2018-08-05 04:37:47
@article{cf4a7a54-0bd4-49a2-bae5-11594e8df8ed,
  abstract     = {<p>The European Association of Urology Renal Cell Carcinoma (RCC) guidelines panel updated their recommendation on adjuvant therapy in unfavourable, clinically nonmetastatic RCC following the recently reported results of a second randomised controlled phase 3 trial comparing 1-yr sunitinib to placebo for high-risk RCC after nephrectomy (S-TRAC). On the basis of conflicting results from the two available studies, the panel rated the quality of the evidence, the harm-to-benefit ratio, patient preferences, and costs. Finally, the panel, including representatives from a patient advocate group (International Kidney Cancer Coalition) voted and reached a consensus to not recommend adjuvant therapy with sunitinib for patients with high-risk RCC after nephrectomy. Patient summary: In two studies, sunitinib was given for 1 yr and compared to no active treatment (placebo) in patients who had their kidney tumour removed and who had a high risk of cancer coming back after surgery. Although one study demonstrated that 1 yr of sunitinib therapy resulted in a 1.2-yr longer time before the disease recurred, the other study did not show a benefit and it has not been shown that patients live longer. Despite having been diagnosed with high-risk disease, many patients remain without recurrence, and the side effects of sunitinib are high. Therefore, the panel members, including patient representatives, do not recommend sunitinib after tumour removal in these patients. Two studies (ASSURE and S-TRAC) recently reported findings on whether adjuvant VEGF-targeted therapy can improve outcomes for patients with renal cell cancer. The poor benefit-to-harm ratio and the still absent evidence of an overall survival benefit led the European Association of Urology Renal Cell Cancer Guidelines Panel to provide a (weak) recommendation against the use of adjuvant sunitinib in this setting. Kidney cancer patients-through the International Kidney Cancer Coalition-participated in a questionnaire on the implications for S-TRAC, and approximately one-third of patients favoured not taking sunitinib.</p>},
  author       = {Bex, Axel and Albiges, Laurence and Ljungberg, Börje and Bensalah, Karim and Dabestani, Saeed and Giles, Rachel H. and Hofmann, Fabian and Hora, Milan and Kuczyk, Markus A. and Lam, Thomas B and Marconi, Lorenzo and Merseburger, Axel S and Staehler, Michael and Volpe, Alessandro and Powles, Thomas},
  issn         = {0302-2838},
  keyword      = {Adjuvant,Guidelines,Management,Renal cell cancer,Sorafenib,Sunitinib},
  language     = {eng},
  number       = {5},
  pages        = {719--722},
  publisher    = {Elsevier},
  series       = {European Urology},
  title        = {Updated European Association of Urology Guidelines Regarding Adjuvant Therapy for Renal Cell Carcinoma},
  url          = {http://dx.doi.org/10.1016/j.eururo.2016.11.034},
  volume       = {71},
  year         = {2017},
}