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New relevant references have been identified through a structured assessment of the literature and
incorporated in the various chapters of the 2017 Non-muscle-invasive Bladder Cancer Guidelines.
Key changes in the 2017 print:
- Section 4.3 – T1 subclassification. This is a new section.
- Section 5.5 – Urinary Cytology. Diagnostic categories based on the Paris Working Group Classification have been added.
- Section 5.10.2 – Surgical and technical aspects of tumour resection. This section has been revised and enlarged, resulting in changes in the recommendations (Section 5.14).
- Section 5.12 – Second resection. Additional literature has been included, resulting in changes in the recommendations (Section 5.14).
- Section 6.4 – Subgroup of highest risk tumours. This is a new section.
- Section 220.127.116.11.2 – Device-assisted intravesical chemotherapy. This is a new section.
Changes in the recommendations
Section 5.9: A new recommendation has been added.
|Recommendations for the primary assessment of NMIBC||GR|
|Repeat urine cytology in patients with suspicious initial cytology results.||C|
Section 5.14: Additional information has been included.
|Recommendations for transurethral resection of the bladder (TURB) and/or biopsies and pathology report||GR|
|Perform en-block resection or resection in fractions (exophytic part of the tumour, the underlying bladder wall and the edges of the resection area). The presence of detrusor muscle in the specimen is required in all cases except for TaG1/LG tumours.||B|
|Perform a second TURB in the following situations:
|Register the results of a second TURB as it reflects the quality of the initial resection.||A|
Section 7.5: A new recommendation has been included.
|Recommendations for adjuvant therapy in TaT1 tumours and for therapy of CIS||GR|
|In patients with bacillus Calmette-Guérin failure, who are not candidates of radical cystectomy due to comorbidities, use preservation strategies (device-assisted instillations of chemotherapy, intravesical chemotherapy, intravesical immunotherapy).||C|
Section 8.1: A new recommendation has been added.
|In patients initially diagnosed with TaLG/G1-2 bladder cancer, use ultrasound of the bladder during surveillance in case cystoscopy is not possible, or refused by the patient.||C|
All chapters of the 2016 RCC Guidelines have been updated, based on the 2015 version of the guideline.
Conclusions and recommendations have been rephrased and added to, throughout the current document.
Key changes in the 2016 print:
Changes in recommendations
In Section 5.16 – a recommendation has been added:
|Recommendations for TURB and/or biopsies, tumour classification and pathology report||GR|
|In patients suspected of harbouring bladder cancer TURB followed by pathology investigation of the obtained specimen(s) is recommended as a diagnostic procedure and initial treatment step.||A|
TURB = transurethral resection of the bladder.
Section 18.104.22.168 – A single, immediate, post-operative intravesical instillation of chemotherapy – has been expanded to include the findings of systematic review and individual patient data meta-analysis of randomized trials comparing a single immediate instillation of chemotherapy after transurethral resection with transurethral resection alone in patients with stage pTa-pT1 urothelial carcinoma of the bladder: Which patients benefit from the instillation? .
- The recommendations as presented in Section 7.5 and Table 7.6 – Treatment recommendations in Ta, T1 tumours and CIS according to risk stratification – have been adapted. The recommendation grade did not change.
|Section 7.5 Recommendations for adjuvant therapy in Ta, T1 tumours and for therapy of CIS||GR|
|In patients with tumours presumed to be at low risk and in those presumed to be at intermediate risk with previous low recurrence rate (less than or equal to one recurrence per year) and expected EORTC recurrence score < 5, one immediate chemotherapy instillation is recommended.||A|
CIS = carcinoma in situ; EORTC = European Organization for Research and Treatment of Cancer.
Table 7.6 – Treatment recommendations in Ta, T1 tumours and CIS according to risk stratification
|Risk category||Definition||Treatment recommendation|
|Intermediate-risk tumours||All cases between categories of low and high risk||In patients with previous low recurrence rate (less than or equal to one recurrence per year) and expected EORTC recurrence score < 5, one immediate instillation of intravesical chemotherapy after TURB.In all patients either 1-year full-dose BCG treatment (induction plus 3-weekly instillations at 3,6 and 12 months), or instillations of chemotherapy (the optimal schedule is not known) for a maximum of 1 year.|
BCG = Bacillus Calmette-Guérin; EORTC = European Organization for Research and Treatment of Cancer;
TURB = transurethral resection of the bladder.
22.214.171.124 Summary of evidence
- Section 3.4 – A summary of evidence has been added to Chapter 3 – Epidemiology, aetiology and pathology.
- Section 4.7 – A summary of evidence has been added to Chapter 4 – Staging and classification systems.
- Section 5.15 – Summary of evidence has been added to Chapter 5 – Diagnosis.
- Section 6.4 – A summary of evidence has been added to Chapter 6 – Predicting disease recurrence and progression.
- Section 126.96.36.199 – A summary of evidence has been added to Section 7.2.1 Intravesical chemotherapy.
- Section 188.8.131.52 – A summary of evidence has been added to Section 7.2.2 Intravesical bacillus Calmette Guérin immunotherapy.
- Section 184.108.40.206 – A summary of evidence has been added to Section 7.2.4 Specific aspects of treatment of CIS.
- Section 7.3.4 – A Summary of evidence has been added to Section 7.3 Treatment failure of intravesical therapy.
The literature for the complete document has been assessed and updated, whenever relevant.
Key changes for the 2015 publication:
- A new section on resection techniques has been added, also expanding on the significance of biopsy for bladder cancer pathology.
- The sections on the role of imaging for initial diagnosis and follow-up have been updated (Section 5.4).
- The sections on stratification of patients into risk groups and high-risk disease have been enlarged.
- A new section on Bacillus Calmette-Guérin (BCG) is included and the section on intravesical BCG and immunotherapy schedule has been expanded.
Recommendations have been rephrased and added to throughout the current document, not resulting in a change in the grade of recommendation (GR). New recommendations have been included in sections:
5.14 Guidelines for TURB and/or biopsies, tumour classification and pathology report
|Avoid cauterization as much as possible during TURB to avoid tissue deterioration.||C|
|In patients with positive cytology, but negative cystoscopy, exclude a UTUC, CIS in the bladder (random biopsies or PDD targeted biopsies) and tumour in prostatic urethra (prostatic urethra biopsy).||C|
|If indicated, perform a second TURB within 2-6 weeks after initial resection. It should include the resection of the primary tumour site.||C|
|Classification and pathological report|
|Do not use the term “Superficial BC”.||A|
|In difficult cases, consider an additional review by an experienced genitourinary pathologist.||B|
CIS = carcinoma in situ; PDD = photodynamic diagnosis; TURB = transurethral resection of the bladder.
6.3.1 Recommendations for stratification of NMIBC
|In patients treated with BCG use CUETO risk tables for individual prediction of the risk of tumour recurrence and progression.||B|
BCG = Bacillus Calmette-Guérin; CUETO = Club Urológico Español de Tratamiento Oncológico.
7.5 Recommendations for adjuvant therapy in Ta, T1 tumours and for therapy of CIS
|In patients with intermediate-risk tumours, one immediate instillation of chemotherapy should be followed by 1-year full-dose BCG treatment, or by further instillations of chemotherapy for a maximum of 1 year. The final choice should reflect the individual patient’s risk of recurrence and progression as well as the efficacy and side effects of each treatment modality.||A|
|In patients with high-risk tumours, full-dose intravesical BCG for 1-3 years is indicated. The additional beneficial effect of the second and third years of maintenance should be weighed against its added costs and inconvenience.||A|
|Give clear instructions to the nursing staff to control the free flow of the bladder catheter at the end of the immediate instillation.||C|
BCG = Bacillus Calmette-Guérin.
8.1 Guidelines for follow-up in patients after TURB of NMIBC
|Consider R-biopsies or biopsies with PDD after intravesical treatment (at 3 or 6 months) in patients with CIS.||C|
TURB = transurethral resection of the bladder; R-biopsies = random biopsies.
For all chapters in these guidelines the literature has been assessed and has resulted in the inclusion of 23 new publications. Two new treatment algorithms have been provided: ‘Management of patients with a primary or recurrent BC without previous BCG’ and ‘Management of patients with recurrence after intravesical BCG for NMIBC’.
A short new section on smoking cessation was added (see Section 7).
For all chapters the literature has been assessed.
Classification: A clear definition of non-muscle-invasive bladder cancer is presented. Since appropriate classification and grading directly influences treatment decisions, additional information on pathological parameters has been added.
Diagnosis: An illustration on bladder diagram to facilitate the description of cystoscopy finding has been added. The new data on endoscopic diagnosis and pathological evaluation of the tissue included in this section resulted in a number of changes in the recommendations.
Predicting disease recurrence and progression: The new stratification of patients into 3 risk groups facilitating treatment recommendation is presented.
Adjuvant treatment: Updated information on intravesical chemo- and immunotherapy is provided. The definition and stratification of BCG toxicity and side-effects is provided in an overview table. The definition of BCG failures has been specified.
Radical cystectomy for NMIBC: The indication criteria were updated.