• Babjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Bohle A, Palou J. Guidelines on TaT1 (non-muscle invasive) bladder cancer. Arnhem, The Netherlands: European Association of Urology (EAU); 2008 Mar. 22 p. [82 references]

This is the current release of the guideline.

Stage TaT1 (non-muscle invasive) bladder cancer

Diagnosis
Management
Risk Assessment
Treatment

Oncology
Surgery
Urology

Physicians

To help urologists with the clinical decisions regarding management of TaT1 (non-muscle invasive) bladder cancer

Patients with TaT1 (non-muscle invasive) bladder cancer

Diagnosis/Assessment

1. Tumor, node, metastasis (TNM) staging
2. Histologic grading (World Health Organization [WHO] system)
3. Assessment of risk of tumor progression or recurrence
4. Imaging studies: intravenous urography (IVU), computed tomography (CT), ultrasonography (US)
5. Cytology of voided urine or bladder washings
6. Determination of urinary molecular markers
7. Cystoscopy and fluorescence cystoscopy
8. Transurethral resection (TUR) or biopsy of bladder and prostatic urethra

Treatment/Management

1. TUR followed by immediate postoperative (same day) installation
2. Adjuvant intravesical chemotherapy (mitomycin C, epirubicin, or doxorubicin)
3. Adjuvant intravesical Bacillus Calmette-Guérin (BCG)
4. Cystectomy
5. Frequency of chemotherapy or BCG treatment
6. Frequency of follow-up

• Sensitivity and specificity of diagnostic tests
• Inter- and intra-operator variability assessing carcinoma in situ (CIS) and dysplasia, stage (Ta vs. T1) and grading of tumors
• Recurrence or progression rate
• Disease-free survival
• Morbidity and mortality

Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

A structured literature search was carried out aiming to identify the relevant meta-analyses of randomized trials. Whenever possible, recommendations are based on meta-analyses. In case meta-analyses could not be identified, data from randomized clinical trials formed the basis for the recommendations. Recommendations were based on consensus of expert opinions only when scientific data was ambiguous or conflicting, or in areas where scientific data was lacking.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Levels of Evidence

1a Evidence obtained from meta-analysis of randomized trials

1b Evidence obtained from at least one randomized trial

2a Evidence obtained from one well-designed controlled study without randomization

2b Evidence obtained from at least one other type of well-designed quasi-experimental study

3 Evidence obtained from well-designed non-experimental studies, such as comparative studies, correlation studies and case reports

4 Evidence obtained from expert committee reports or opinions or clinical experience of respected authorities

Review of Published Meta-Analyses
Systematic Review

Not stated

Expert Consensus

• The first step in the European Association of Urology (EAU) guidelines procedure is to define the main topic.
• The second step is to establish a working group. The working groups comprise about 4-8 members, from several countries. Most of the working group members are academic urologists with a special interest in the topic. Specialists from other medical fields (radiotherapy, oncology, gynaecology, anaesthesiology etc.) are included as full members of the working groups as needed. In general, general practitioners or patient representatives are not part of the working groups. Each member is appointed for a four-year period, renewable once. A chairman leads each group.
• The third step is to collect and evaluate the underlying evidence from the published literature.
• The fourth step is to structure and present the information. All main recommendations are summarized in boxes and the strength of the recommendation is clearly marked in three grades (A-C), depending on the evidence source upon which the recommendation is based.  Every possible effort is made to make the linkage between the level of evidence and grade of recommendation as transparent as possible.

Grades of Recommendation

1. Based on clinical studies of good quality and consistency addressing the specific recommendations and including at least one randomized trial
2. Based on well-conducted clinical studies, but without randomized clinical trials
3. Made despite the absence of directly applicable clinical studies of good quality

Since the costs of a transurethral resection, anaesthesia and hospitalization in most countries exceed the cost of 8.5 times one adjuvant chemotherapy instillation, one immediate instillation of chemotherapy is considered to be cost-effective.

Internal Peer Review

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Early and successful treatment of bladder cancer confined to the mucosa or submucosa

• Severe complications have been reported in patients receiving intravesical chemotherapy in whom extravasation of the drug occurred. Thus, an immediate chemotherapy instillation should be omitted in case of overt or suspected intra- or extra-peritoneal perforation, which is most likely to appear in extensive transurethral resection (TUR) procedures.
• Assuming that maintenance therapy is necessary for optimal efficacy, the issue of Bacillus Calmette-Guérin (BCG) toxicity becomes more relevant. Compared to intravesical chemotherapy, BCG has more pronounced side-effects. Deaths due to BCG sepsis and the high frequency of BCG-induced cystitis have been reported and compromised the use of BCG. However, with increased experience in applying BCG, the side-effects now appear to be less prominent. Serious side-effects are encountered in less than 5% of patients and can be effectively treated in virtually all cases. Major complications can appear after systemic absorption of the drug. Thus, BCG should not be administered during the first 2 weeks after transurethral resection, in patients with haematuria and after traumatic catheterization.

Severe complications have been reported in patients receiving intravesical chemotherapy in whom extravasation of the drug occurred. Thus, an immediate chemotherapy instillation should be omitted in case of overt or suspected intra- or extra-peritoneal perforation, which is most likely to appear in extensive transurethral resection (TUR) procedures.

• The purpose of this text is not to be proscriptive in the way a clinician should treat a patient but rather to provide access to the best contemporaneous consensus view on the most appropriate management currently available. European Association of Urology (EAU) guidelines are not meant to be legal documents but are produced with the ultimate aim to help urologists with their day-to-day practice.
• The EAU believe that producing validated best practice in the field of urology is a very powerful and efficient tool in improving patient care. It is, however, the expertise of the clinician which should determine the needs of their patients. Individual patients may require individualized approaches which take into account all circumstances and treatment decisions often have to be made on a case-by-case basis.

Getting Better
Living with Illness

Effectiveness

• Babjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Bohle A, Palou J. Guidelines on TaT1 (non-muscle invasive) bladder cancer. Arnhem, The Netherlands: European Association of Urology (EAU); 2008 Mar. 22 p. [82 references]

Not applicable: The guideline was not adapted from another source.

2008 Mar

European Association of Urology - Medical Specialty Society

European Association of Urology

Non-Muscle Invasive Bladder Cancer Guidelines Writing Panel

Panel Members: M. Babjuk; W. Oosterlinck; R. Sylvester; E. Kaasinen; A. Böhle; J. Palou

All members of the Non-Muscle Invasive Bladder Cancer guidelines writing panel have provided disclosure statements of all relationships which they have and which may be perceived as a potential source of conflict of interest. This information is kept on file in the European Association of Urology (EAU) Central Office database. This guidelines document was developed with the financial support of the European Association of Urology. No external sources of funding and support have been involved. The EAU is a non-profit organisation and funding is limited to administrative assistance and travel and meeting expenses. No honoraria or other reimbursements have been provided.

This is the current release of the guideline.

The following are available:

• EAU guidelines office template. Arnhem, The Netherlands: European Association of Urology (EAU); 2007. 4 p.
• The European Association of Urology (EAU) guidelines methodology: a critical evaluation. Arnhem, The Netherlands: European Association of Urology (EAU); 18 p.

The following is also available:

• Guidelines on non-muscle invasive bladder cancer. 2008, Ultra short pocket guidelines. Arnhem, The Netherlands: European Association of Urology (EAU); 2008 Mar. 11 p.
• Babjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Böhle A, Palou-Redorta J. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder. Eur Urol 2008 Aug;54(2):303-14.

Print copies: Available from the European Association of Urology, PO Box 30016, NL-6803, AA ARNHEM, The Netherlands.

None available

This NGC summary was completed by ECRI Institute on July 2, 2008. The information was verified by the guideline developer on August 29, 2008.

This summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Downloads are restricted to one download and print per user, no commercial usage or dissemination by third parties is allowed.