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    Muscle-invasive and Metastatic Bladder Cancer (beta)

    Based on guidelines from the European Association of Urology, also endorsed by ASCO.

    Strength
    Strong recommendation
    Moderate recommendation
    Weak recommendation
    N/A
    Evidence
    High quality evidence
    Intermediate quality evidence
    Low quality evidence
    Insufficient evidence
    N/A

    Diagnostic Evaluation

    Primary Assessment of Presumably Invasive Bladder Tumors
    1. Cystoscopy should describe all macroscopic features of the tumor (site, size, number, and appearance) and mucosal abnormalities. A bladder diagram is recommended when feasible.
    2. Biopsy of the prostatic urethra is recommended when there is positive cytology without evidence of tumor in the bladder, or when abnormalities of the prostatic urethra are visible. Additionally, prostatic urethral biopsy should be considered for cases of bladder neck tumor or when bladder carcinoma in situ is present or suspected.
    3. If biopsy is not performed during the initial procedure, it should be completed at the time of the second resection.
    4. In women undergoing subsequent orthotopic neobladder construction, procedural information is required (including histological evaluation) of the bladder neck and urethral margin, either before or at the time of cystectomy.
    5. The pathological report should specify the grade, histology, depth of tumor invasion, and whether the lamina propria and muscle tissue are present in the specimen.

    Prognosis

    Comorbidity Scales
    1. Any decision regarding bladder-sparing or radical cystectomy in elderly/geriatric patients with invasive bladder cancer should be based on tumor stage, bladder function, and the ability to tolerate major surgery, radiotherapy and/or chemotherapy.
    2. The American Society of Anesthesiologists (ASA) score does not address comorbidity and should not be used in this setting.

    Management

    Treatment Failure of Non-muscle Invasive Bladder Cancer
    1. In all T1 tumors at high risk of progression (i.e., high grade, multifocality, carcinoma in situ, and tumor size, as outlined in the European Association of Urology (EAU) guidelines for non-muscle invasive bladder cancer), immediate radical treatment is an option.
    2. In all T1 patients failing intravesical therapy, radical treatment should be offered.
    Neoadjuvant Chemotherapy
    1. Neoadjuvant chemotherapy is recommended for T2-T4a, cN0M0 bladder cancer and should always be cisplatin-based combination therapy.
    2. Neoadjuvant chemotherapy is not recommended in patients who are ineligible for cisplatin-based combination chemotherapy, unless the goal is downstaging surgically unresectable tumors.
    Preoperative Radiotherapy
    1. Preoperative radiotherapy is not recommended to improve survival.
    Radical Cystectomy and Urinary Diversion
    1. For patients who are not receiving neoadjuvant chemotherapy, cystectomy for muscle-invasive bladder cancer should be performed within 3 months of diagnosis to lower the risk of progression and cancer-specific mortality.
    2. Before cystectomy, the patient should be fully informed about the benefits and potential risks of all possible alternatives, and the final decision should be based on a balanced discussion between patient and surgeon.
    3. In addition to ileal conduit diversion, an orthotopic bladder substitute should be offered to male and female patients lacking any contraindications and who have no tumor in the urethra or at the level of urethral dissection.
    4. Preoperative radiotherapy is not recommended for patients undergoing cystectomy with urinary diversion.
    5. Preoperative bowel preparation is not mandatory. “Fast track” measurements may reduce the time of bowel recovery.
    6. Radical cystectomy is recommended in T2-T4a, N0 M0, and high-risk non-muscle invasive bladder cancer. Chemoradiation-based organ preservation treatment may be offered to select patients with muscle-invasive bladder cancer.
    7. Lymph node dissection should be an integral part of cystectomy.
    8. The urethra can be preserved if margins are negative. If no bladder substitution is attached, the urethra must be surveyed regularly in males.
    9. Laparoscopic cystectomy and robot-assisted laparoscopic cystectomy are both management options. However, current data have not sufficiently proven the advantages or disadvantages for oncological and functional outcomes.
    Nonresectable Tumors
    1. In patients with inoperable locally advanced tumors (T4b), primary radical cystectomy is a palliative option.
    2. In patients with symptoms palliative cystectomy may be offered.
    Bladder-sparing Treatments for Localized Disease
    1. Transurethral resection of bladder tumor alone is not a curative treatment option in most patients.
    2. Radiotherapy alone is not recommended as primary therapy for localized bladder cancer.
    3. Chemotherapy alone is not recommended as primary therapy for localized bladder cancer.
    4. Neoadjuvant chemotherapy followed by radical cystectomy or bladder-preserving chemoradiotherapy treatments are the preferred curative therapeutic approaches as they are more effective than radiotherapy alone.
    5. Bladder-preserving multimodality treatment could be offered as an alternative to cystectomy in appropriately selected patients, and may be appropriate in some patients for whom cystectomy is not an option.
    Adjuvant Chemotherapy
    1. Adjuvant cisplatin based combination chemotherapy may be offered to patients with pT3/4 and/or pN+ disease if no neoadjuvant chemotherapy has been given.
    2. While neoadjuvant chemotherapy is recommended, adjuvant chemotherapy may be offered to high-risk patients who did not receive neoadjuvant treatment.
    Metastatic Disease
    1. First-line treatment for cisplatin-eligible patients: (1) Use cisplatin-containing combination chemotherapy with gemcitabine plus cisplatin, methotrexate, or high-dose methotrexate with granulocyte colony-stimulating factor; (2) Carboplatin and nonplatinum combination chemotherapy is not recommended.
    2. First-line treatment in patients ineligible for cisplatin: (1) Use carboplatin combination chemotherapy or single agents; (2) For cisplatin-ineligible patients, with performance status 2 (WHO) or impaired renal function, as well as those with 0 or 1 poor Bajorin prognostic factors and impaired renal function, treatment with carboplatin-containing combination chemotherapy, preferably with gemcitabine/carboplatin is indicated.
    3. Second-line treatment: (1) In patients progressing after platinum-based combination chemotherapy for metastatic disease, entry into a clinical trial is preferred. Alternatively, single agent therapy may be offered (e.g. paclitaxel, docetaxel, or vinflunine where available); (2) Zoledronic acid or denosumab may be offered for treatment of bone metastases.
    Biomarkers
    1. Currently, no biomarkers can be recommended in daily clinical practice because they have no impact on predicting outcome, treatment decisions, or monitoring therapy in muscle-invasive bladder cancer.
    Health-related Quality of Life
    1. The use of validated questionnaires is recommended to assess health-related quality of life in patients with muscle-invasive bladder cancer.
    2. Unless a patient’s comorbidities, tumor variables, and coping abilities present clear contraindications, a continent urinary diversion should be offered to patients undergoing cystectomy.
    3. Preoperative patient information, patient selection, surgical techniques, and careful postoperative follow-up are the cornerstones for achieving good long-term results.
    4. Patients should be encouraged to take active part in the decision-making process. Clear and exhaustive information on all potential benefits and side-effects should be provided, allowing them to make informed decisions.

    Follow-up

    Local Recurrence, Poor Prognosis
    1. Treatment should be individualized depending on the local extent of tumor.
    2. Radiotherapy, chemotherapy, and possibly surgery are options for treatment, either alone or in combination.
    Distant Recurrence, Poor Prognosis
    1. Chemotherapy is the first option, and consider individualized cases for metastatectomy when oligometastatic disease is present.
    Secondary Urethral Tumor
    1. Staging and treatment should be done as for primary urethral tumor.
    2. Local conservative treatment is possible for noninvasive tumor.
    3. In isolated invasive disease, urethrectomy should be performed.
    4. Urethral washes and cytology should be considered in high-risk patients.
    What do the icons mean?  
    Research PaperMilowsky MI, Rumble RB, Booth CM, et al. Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol. 2016;34(16):1945-52.