Renal Cell Carcinoma

Full Text Guidelines Summary of Changes Scientific Publications & Appendices Pocket Guidelines Archive Panel

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B. Ljungberg (Chair), L. Albiges, K. Bensalah, A. Bex (Vice-chair), R.H. Giles (Patient Advocate), M. Hora, M.A. Kuczyk, T. Lam, L. Marconi, A.S. Merseburger, T. Powles, M. Staehler, A. Volpe
Guidelines Associates: Y. Abu-Ghanem, S. Dabestani, S. Fernández-Pello Montes, F. Hofmann, R. Tahbaz

1.INTRODUCTION

1.1.Aims and scope

The European Association of Urology (EAU) Renal Cell Cancer (RCC) Guidelines Panel has compiled these clinical guidelines to provide urologists with evidence-based information and recommendations for the management of RCC.

It must be emphasised that clinical guidelines present the best evidence available to the experts but following guideline recommendations will not necessarily result in the best outcome. Guidelines can never replace clinical expertise and judgement when making treatment decisions for individual patients, but rather help to focus decisions whilst also taking personal values and preferences/individual circumstances of patients into account. Guidelines are not mandates and do not purport to be a legal standard of care.

1.2.Panel composition

The RCC Guidelines Panel is an international group of clinicians consisting of urological surgeons, oncologists, methodologists, a pathologist and a radiologist, with particular expertise in the field of renal cancer care. Since 2015, the Panel has incorporated a patient advocate to provide a consumer perspective for its guidelines.

All experts involved in the production of this document have submitted potential conflict of interest statements, which can be viewed on the EAU website Uroweb: http://uroweb.org/guideline/renal-cell-carcinoma/.

1.3.Acknowledgement

The RCC Guidelines Panel is most grateful for the methodological and scientific support provided by Prof.Dr. O. Hes (pathologist, Pilzen, Czech Republic) for two sections of this document: Histological diagnosis and Other renal tumours.

1.4.Available publications

A quick reference document (Pocket Guidelines) is available, both in print and as an app for iOS and Android devices, presenting the main findings of the RCC Guidelines. These are abridged versions which may require consultation together with the full text version. Several scientific publications are available, as are a number of translations of all versions of the EAU RCC Guidelines [1,2]. All documents can be accessed on the EAU website: http://uroweb.org/guideline/renal-cell-carcinoma/.

1.5.Publication history and summary of changes

1.5.1.Publication history

The EAU RCC Guidelines were first published in 2000. This 2018 RCC Guidelines document presents a limited update of the 2017 publication.

1.5.2.Summary of changes

All chapters of the 2018 RCC Guidelines have been updated, based on the 2017 version of the Guidelines. References have been added throughout the document.

Key changes in this 2018 print:

  • Section 3.3 – Other renal tumours has been expanded, to include:

    3.3.1 Renal medullary carcinoma;

    3.3.6 Renal oncocytoma;

    3.3.7 Cystic renal tumours.

New data have been included in the following sections, resulting in changed recommendations:

3.4 Summary of evidence and guidelines for the management of other renal tumours

Recommendations

Strength rating

Offer systemic therapy to patients at need for therapy with surgically unresectable angiomyolipomas not amendable to embolisation.

Weak

Prior to management, perform pre-operative renal mass biopsies in patients with unclear kidney lesions.

Weak

Perform radical nephrectomy in patients with renal medullary carcinoma.

Weak

Base systemic therapy for renal medullary carcinoma on chemotherapy regiments containing cisplatinum such as gemcitabine plus cisplatin.

Weak

5.4 Summary of evidence and recommendations for the diagnostic assessment of renal cell cancer

Recommendations

Strength rating

Use MRI to better evaluate venous involvement, reduce radiation or avoid intravenous CT contrast.

Weak

Use a core biopsy technique rather than fine needle aspiration for histological characterisation for solid renal tumours

Strong

7.1.2.2.4 Summary of evidence and recommendations for the treatment of localised renal cell cancer

Summary of evidence

LE

Retrospective studies suggest a clinical benefit associated with lymphadenectomy in high-risk patients.

2b

Recommendations

Strength rating

Offer embolisation in patients unfit for surgery presenting with massive haematuria or flank pain.

Weak

7.1.3.4 Summary of evidence and recommendations for radical and partial nephrectomy techniques

Recommendations

Strength rating

Do not perform minimally invasive surgery if this approach may compromise oncological, functional and peri-operative outcomes.

Strong

7.2.5.1 Summary of evidence and recommendations for adjuvant therapy

Recommendations

Strength rating

Do not offer adjuvant therapy with sorafenib or pazopanib.

Strong

Do not offer adjuvant sunitinib following surgically resected high-risk clear-cell renal cell cancer.

Weak

7.3.1.1.2 Summary of evidence and recommendation for local therapy of advanced/metastatic renal cell cancer

Summary of evidence

LE

Deferred cytoreductive nephrectomy with presurgical sunitinib in intermediate-risk patients with clear-cell metastatic RCC leads to a survival benefit in secondary endpoint analysis and selects out patients with inherent resistance to systemic therapy.

2b

Patients with IMDC poor risk (≥ 4 risk factors) do not benefit.

2b

Recommendations

Strength rating

Do not offer cytoreductive nephrectomy in IMDC poor-risk patients with ≥ 4 risk factors.

Weak

Perform immediate cytoreductive nephrectomy in patients with oligometastases when complete resection can be achieved.

Weak

Offer deferred cytoreductive nephrectomy to intermediate-risk patients with clear-cell metastatic RCC who require systemic therapy with sunitinib.

Weak

7.4.2.5 Summary of evidence and recommendations for immunotherapy in metastatic renal cell cancer

Summary of evidence

LE

The combination of nivolumab and ipilimumab in treatment-naïve patients with clear-cell metastatic RCC of IMDC intermediate and poor-risk leads to superior survival compared to sunitinib.

1b

The combination of nivolumab and ipilimumab in the ITT population of treatment-naïve unselected patients with clear-cell metastatic RCC leads to superior survival compared to sunitinib.

2b

Due to the exploratory nature of PD-L1 tumour expression, the small sample size, the lack of OS data and the premature results in this subpopulation, definitive conclusions cannot be drawn.

2b

Nivolumab plus ipilimumab was associated with 15% grade 3-5 toxicity and 1.5% treatment-related deaths.

1b

Recommendations

Strength rating

Use ipilimumab plus nivolumab in treatment-naïve patients with clear-cell metastatic RCC of IMDC intermediate and poor risk.

Strong

Do not use bevacizumab plus IFN-α in treatment-naïve clear-cell favourable- and intermediate-risk RCC patients.

Weak

Do not use PD-L1 tumour expression as a predictive biomarker.

Weak

Administer nivolumab plus ipilimumab in centres with experience of immune combination therapy and appropriate supportive care within the context of a multidisciplinary team.

Weak

Do not rechallenge patients who stop nivolumab plus ipilimumab because of toxicity with the same drugs in the future without expert guidance and support from a multidisciplinary team.

Strong

Figure 7.1: Updated EAU Guidelines recommendations for the treatment of first-line clear-cell metastatic renal cancer’ has been revised.

7.4.6.3 Summary of evidence and recommendations for targeted therapy in metastatic renal cell cancer

Summary of evidence

LE

Cabozantinib in intermediate- and poor-risk treatment-naïve clear-cell RCC leads to better RR and PFS but not OS when compared to sunitinib.

2a

Tivozanib has recently been approved but the evidence is still considered inferior over existing choices.

3

In treatment-naïve patients, bevacizumab in combination with IFN-α has not been tested against nivolumab plus ipilimumab and the evidence for subsequent therapies is unclear.

3

In treatment-naïve patients temsirolimus has not been tested against nivolumab plus ipilimumab and the evidence for subsequent therapies is unclear.

3

Both mTOR inhibitors (everolimus and temsirolimus) and VEGF-targeted therapies (sunitinib or sorafenib) have limited oncological efficacy in non-clear cell RCC. There is a non-significant trend for improved oncological outcomes for sunitinib, over everolimus.

2a

Lenvatinib in combination with everolimus modestly improved PFS over everolimus alone.

2a

Recommendations

Strength rating

Use cabozantinib in treatment-naïve patients with clear-cell metastatic RCC of IMDC intermediate and poor risk.

Weak

Do not use bevacizumab plus Interferon (IFN)-α in treatment-naïve clear-cell favourable- and intermediate-risk RCC patients.

Weak

Do not use tivozanib in treatment-naïve clear-cell metastatic RCC patients.

Weak

Do not use temsirolimus in treatment-naïve clear-cell poor-risk RCC patients.

Weak

Use VEGF-TKIs in second-line in patients refractory to nivolumab plus ipilimumab.

Weak

Do not offer sorafenib as first- or second-line treatment to patients with metastatic RCC.

Weak

7.5.2 Summary of evidence and recommendation for advanced/metastatic renal cell cancer

Recommendations

Strength rating

Offer surgical resection of local recurrent disease, when complete resection is achievable.

Weak

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