Muscle-invasive and Metastatic Bladder Cancer

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

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J.A. Witjes (Chair), M. Bruins, R. Cathomas, E. Compérat, N.C. Cowan, G. Gakis, V. Hernández, A. Lorch, M.J. Ribal (Vice-chair), G.N Thalmann, A.G. van der Heijden, E. Veskimäe
Guidelines Associates: E. Linares Espinós, M. Rouanne, Y. Neuzillet

1.INTRODUCTION

1.1.Aims and scope

The European Association of Urology (EAU) Guidelines Panel for Muscle-invasive and Metastatic Bladder Cancer (MIBC) have prepared these guidelines to help urologists assess the evidence-based management of MIBC and to incorporate guideline recommendations into their clinical practice.

Separate EAU guidelines documents are available addressing upper urinary tract (UUT) tumours [1], non-muscle-invasive bladder cancer (TaT1 and carcinoma in situ) (NMIBC) [2], and primary urethral carcinomas [3].

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 when making treatment decisions for individual patients, but rather help to focus decisions - 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 EAU Guidelines Panel consists of an international multidisciplinary group of clinicians, including urologists, oncologists, a pathologist and a radiologist.

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/bladder-cancer-muscle-invasive-and-metastatic/?type=panel.

1.3.Available publications

A quick reference document (Pocket Guidelines) is available, both in print and as an app for iOS and Android devices. These are abridged versions which may require consultation together with the full text version.

Several scientific publications are available (the most recent paper dating back to 2017 [4]), as are a number of translations of all versions of the EAU MIBC Guidelines. All documents are accessible through the EAU website: http://uroweb.org/guideline/bladder-cancer-muscle-invasive-and-metastatic/.

1.4.Publication history and summary of changes

1.4.1.Publication history

The EAU published its first guidelines on BC in 2000. This document covered both NMIBC and MIBC. Since these conditions require different treatment strategies, it was decided to give each condition its own guidelines, resulting in the first publication of the MIBC Guidelines in 2004. This 2019 document presents a limited update of the 2018 version.

1.4.2.Summary of changes

New relevant references have been identified through a structured assessment of the literature and incorporated in the various chapters of the 2019 EAU MIBC Guidelines.

Key changes in the 2019 print are:

  • Section 6.3 Prognostic markers – this section was revised, to include new data. Based on the current data, no recommendation can be provided.
  • Figures 7.1: Flow chart for the management of T2-T4a N0M0 urothelial BC was adapted.
  • Section 7.2 Neoadjuvant therapy – this section was revised and restructured. A new recommendation was added.

7.2.4 Summary of evidence and guidelines for neoadjuvant therapy

Summary of evidence

LE

Currently immunotherapy with checkpoint inhibitors is tested in phase II and III trials. First results are promising.

Recommendation

Strength rating

Only offer neoadjuvant immunotherapy to patients within a clinical trial setting.

Strong


  • New Section 7.4.7 – Impact of hospital and surgeon volume on treatment outcomes, has been included. This section is based on the findings of a systematic review (SR) on ‘The impact of the annual hospital and surgeon radical cystectomy volume for BC on peri-operative outcomes and long-term oncological outcomes’ [5];
  • Section 7.6.2 External beam radiotherapy (EBRT) - this section was revised, to include new data. The recommendations did not change.
  • Section 7.6.4 Multimodality bladder-preserving treatment - this section was revised, to include new data. The recommendations did not change.
  • Section 7.7 Adjuvant therapy - this section was revised, to include new data. A new recommendation was included.

7.7.3 Guideline for adjuvant therapy

Recommendation

Strength rating

Offer immunotherapy with a checkpoint inhibitor only in a clinical trial setting.

Strong


  • Section 7.8 Metastatic disease – this section was revised, to include new data, resulting in changes to both the Summary of evidence and the recommendations.

7.8.11 Summary of evidence and guidelines for metastatic disease

Summary of evidence

LE

Post-chemotherapy surgery after partial or complete response may contribute to long-term disease-free survival in selected patients.

3

PD-1 inhibitor pembrolizumab has been approved for patients with advanced or metastatic urothelial cancer ineligible for cisplatin-based first-line chemotherapy based on the results of a phase II trial but use of pembrolizumab is restricted to PD-L1 positive patients.

2a

PD-L1 inhibitor atezolizumab has been approved for patients with advanced or metastatic urothelial cancer ineligible for cisplatin-based first-line chemotherapy based on the results of a phase II trial but use of atezolizumab is restricted to PD-L1 positive patients.

2a

Recommendations

Strength rating

First-line treatment for cisplatin-eligible patients

Use cisplatin-containing combination chemotherapy with GC, MVAC, preferably with G-CSF, HD-MVAC with G-CSF or PCG.

Strong

Do not offer carboplatin and non-platinum combination chemotherapy.

Strong

First-line treatment in patients ineligible (unfit) for cisplatin

Offer checkpoint inhibitors pembrolizumab or atezolizumab depending on PDL-1 status.

Strong

Offer carboplatin combination chemotherapy if PD-L1 is negative.

Weak

Second-line treatment

Offer checkpoint inhibitor (pembrolizumab) to patients progressing during or after platinum-based combination chemotherapy for metastatic disease. Alternatively, offer treatment within a clinical trial setting.

Strong

Offer zoledronic acid or denosumab for supportive treatment in case of bone metastases.

Weak

Only offer vinflunine to patients for metastatic disease as second-line treatment if immunotherapy or combination chemotherapy is not feasible. Alternatively, offer vinflunine as third- or subsequent treatment line.

Weak

GC = gemcitabine plus cisplatin; G-CSF = granulocyte colony-stimulating factor; HD-MVAC = high-dose methotrexate, vinblastine, adriamycin plus cisplatin; PCG = paclitaxel, cisplatin, gemcitabine.


  • Figure 7.2: Flow chart for the management of metastatic urothelial cancer was adapted.
  • Section 7.9 Quality of life - this section was revised to include new data. However, the recommendations did not change.

Summary of evidence

LE

Compared to non-cancer controls, the diagnosis and treatment of bladder cancer has a negative impact on health-related quality of life (HRQoL).

2a

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