NICE Guideline on Bladder cancer: diagnosis and management 2015

Following are the major recommendations of the guidelines

Information and Support for People with Bladder Cancer

Offer clinical nurse specialist support to people with bladder cancer and give them the clinical nurse specialist's contact details.

Ensure that the clinical nurse specialist:

• Acts as the key worker to address the person's information and care needs


• Has experience and training in bladder cancer care

Use a holistic needs assessment to identify an individualised package of information and support for people with bladder cancer and, if they wish, their partners, families or carers, at key points in their care such as:

• When they are first diagnosed


• After they have had their first treatment


• If their bladder cancer recurs or progresses


• If their treatment is changed


• If palliative or end of life care is being discussed

When carrying out a holistic needs assessment, recognise that many of the symptoms, investigations and treatments for bladder cancer affect the urogenital organs and may be distressing and intrusive. Discuss with the person:

• The type, stage and grade of their cancer and likely prognosis


• Treatment and follow-up options


• The potential complications of intrusive procedures, including urinary retention, urinary infection, pain, bleeding or need for a catheter


• The impact of treatment on their sexual health and body image, including how to find support and information relevant to their gender


• Diet and lifestyle, including physical activity


• Smoking cessation for people who smoke


• How to find information about bladder cancer, for example through information prescriptions, sources of written information, websites or DVDs


• How to find support groups and survivorship programmes


• How to find information about returning to work after treatment for cancer


• How to find information about financial support (such as free prescriptions and industrial compensation schemes)

Offer smoking cessation support to all people with bladder cancer who smoke

Offer people with bladder cancer and, if they wish, their partners, families or carers, opportunities to have discussions at any stage during their treatment and care with:

• A range of specialist healthcare professionals, including those who can provide psychological support


• Other people with bladder cancer who have had similar treatments

Clinicians caring for people with bladder cancer should ensure that there is close liaison between secondary and primary care with respect to ongoing and community-based support.

Trusts should consider conducting annual bladder cancer patient satisfaction surveys developed by their urology multidisciplinary team and people with bladder cancer, and use the results to guide a programme of quality improvement.

Diagnosing and Staging Bladder Cancer

Diagnosis

Do not substitute urinary biomarkers for cystoscopy to investigate suspected bladder cancer or for follow-up after treatment for bladder cancer, except in the context of a clinical research study.

Consider computed tomography (CT) or magnetic resonance imaging (MRI) staging before transurethral resection of bladder tumour (TURBT) if muscle-invasive bladder cancer is suspected at cystoscopy.

Offer white-light-guided TURBT with one of photodynamic diagnosis, narrow-band imaging, cytology or a urinary biomarker test (such as UroVysion using fluorescence in situ hybridisation [FISH], ImmunoCyt or a nuclear matrix protein 22 [NMP22] test) to people with suspected bladder cancer. This should be carried out or supervised by a urologist experienced in TURBT.

Obtain detrusor muscle during TURBT.

Do not take random biopsies of normal-looking urothelium during TURBT unless there is a specific clinical indication (for example, investigation of positive cytology not otherwise explained).

Record the size and number of tumours during TURBT.

Offer people with suspected bladder cancer a single dose of intravesical mitomycin C given at the same time as the first TURBT.

Staging

Consider further TURBT within 6 weeks if the first specimen does not include detrusor muscle.

Offer CT or MRI staging to people diagnosed with muscle-invasive bladder cancer or high-risk non-muscle-invasive bladder cancer that is being assessed for radical treatment.

Consider CT urography, carried out with other planned CT imaging if possible, to detect upper tract involvement in people with new or recurrent high-risk non-muscle-invasive or muscle-invasive bladder cancer.

Consider CT of the thorax, carried out with other planned CT imaging if possible, to detect thoracic malignancy in people with muscle-invasive bladder cancer.

Consider fluorodeoxyglucose positron emission tomography (FDG PET)-CT for people with muscle-invasive bladder cancer or high-risk non-muscle-invasive bladder cancer before radical treatment if there are indeterminate findings on CT or MRI, or a high risk of metastatic disease (for example, T3b disease).

Treating Non-Muscle-Invasive Bladder Cancer

Risk Classification in Non-Muscle-Invasive Bladder Cancer

There is no widely accepted classification of risk in non-muscle-invasive bladder cancer. To make clear recommendations for management, the Guideline Development Group (GDG) developed the consensus classification in the table below, based on the evidence reviewed and clinical opinion.

Risk Categories in Non-Muscle-Invasive Bladder Cancer

Low Risk	Urothelial cancer with any of: Solitary pTaG1 with a diameter of less than 3 cm Solitary pTaG2 (low grade) with a diameter of less than 3 cm Any papillary urothelial neoplasm of low malignant potential
Intermediate Risk	Urothelial cancer that is not low risk or high risk, including: Solitary pTaG1 with a diameter of more than 3 cm Multifocal pTaG1 Solitary pTaG2 (low grade) with a diameter of more than 3 cm Multifocal pTaG2 (low grade) pTaG2 (high grade) Any pTaG2 (grade not further specified) Any low-risk non-muscle-invasive bladder cancer recurring within 12 months of last tumour occurrence
High Risk	Urothelial cancer with any of: pTaG3 pT1G2 pT1G3 pTis (Cis) Aggressive variants of urothelial carcinoma, for example micropapillary or nested variants

Prognostic Markers and Risk Classification

Ensure that for people with non-muscle-invasive bladder cancer all of the following are recorded and used to guide discussions, both within multidisciplinary team meetings and with the person, about prognosis and treatment options:

• Recurrence history


• Size and number of cancers


• Histological type, grade, stage and presence (or absence) of flat urothelium, detrusor muscle (muscularis propria), and carcinoma in situ


• The risk category of the person's cancer


• Predicted risk of recurrence and progression, estimated using a risk prediction tool

Low-Risk Non-Muscle-Invasive Bladder Cancer

For the treatment of low-risk non-muscle-invasive bladder cancer, see recommendations above under "Diagnosing and Staging Bladder Cancer."

Intermediate-Risk Non-Muscle-Invasive Bladder Cancer

Offer people with newly diagnosed intermediate-risk non-muscle-invasive bladder cancer a course of at least 6 doses of intravesical mitomycin C.

If intermediate-risk non-muscle-invasive bladder cancer recurs after a course of intravesical mitomycin C, refer the person's care to a specialist urology multidisciplinary team.

High-Risk Non-Muscle-Invasive Bladder Cancer

If the first TURBT shows high-risk non-muscle-invasive bladder cancer, offer another TURBT as soon as possible and no later than 6 weeks after the first resection.

Offer the choice of intravesical Bacille Calmette-Guérin (BCG) or radical cystectomy to people with high-risk non-muscle-invasive bladder cancer, and base the choice on a full discussion with the person, the clinical nurse specialist and a urologist who performs both intravesical BCG and radical cystectomy. Include in your discussion:

• The type, stage and grade of the cancer, the presence of carcinoma in situ, the presence of variant pathology, prostatic urethral or bladder neck status and the number of tumours


• Risk of progression to muscle invasion, metastases and death


• Risk of understaging


• Benefits of both treatments, including survival rates and the likelihood of further treatment


• Risks of both treatments


• Factors that affect outcomes (for example, comorbidities and life expectancy)


• Impact on quality of life, body image, and sexual and urinary function

Intravesical BCG

Offer induction and maintenance intravesical BCG to people having treatment with intravesical BCG.

If induction BCG fails (because it is not tolerated, or bladder cancer persists or recurs after treatment with BCG), refer the person's care to a specialist urology multidisciplinary team.

For people in whom induction BCG has failed, the specialist urology multidisciplinary team should assess the suitability of radical cystectomy, or further intravesical therapy if radical cystectomy is unsuitable or declined by the person, or if the bladder cancer that recurs is intermediate- or low-risk.

Radical Cystectomy

See recommendations below for people who have chosen radical cystectomy.

Recurrent Non-Muscle-Invasive Bladder Cancer

Consider fulguration without biopsy for people with recurrent non-muscle-invasive bladder cancer if they have all of the following:

• No previous bladder cancer that was intermediate- or high-risk


• A disease-free interval of at least 6 months


• Solitary papillary recurrence


• A tumour diameter of 3 mm or less

Managing Side Effects of Treatment

Do not offer primary prophylaxis to prevent BCG-related bladder toxicity except as part of a clinical trial.

Seek advice from a specialist urology multidisciplinary team if symptoms of bladder toxicity after BCG cannot be controlled with antispasmodics or non-opiate analgesia and other causes have been excluded by cystoscopy.

Follow-up after Treatment for Non-Muscle-Invasive Bladder Cancer

Refer people urgently to urological services if they have haematuria or other urinary symptoms and a history of non-muscle-invasive bladder cancer.

See recommendation above on the use of urinary biomarkers for follow-up after treatment for bladder cancer.

Low-Risk Non-Muscle-Invasive Bladder Cancer

Offer people with low-risk non-muscle-invasive bladder cancer cystoscopic follow-up 3 months and 12 months after diagnosis.

Do not use urinary biomarkers or cytology in addition to cystoscopy for follow-up after treatment for low-risk bladder cancer.

Discharge to primary care people who have had low-risk non-muscle-invasive bladder cancer and who have no recurrence of the bladder cancer within 12 months.

Do not offer routine urinary cytology or prolonged cystoscopic follow-up after 12 months for people with low-risk non-muscle-invasive bladder cancer.

Intermediate-Risk Non-Muscle-Invasive Bladder Cancer

Offer people with intermediate-risk non-muscle-invasive bladder cancer cystoscopic follow-up at 3, 9 and 18 months, and once a year thereafter.

Consider discharging people who have had intermediate-risk non-muscle-invasive bladder cancer to primary care after 5 years of disease-free follow-up.

High-Risk Non-Muscle-Invasive Bladder Cancer

Offer people with high-risk non-muscle-invasive bladder cancer cystoscopic follow-up:

• Every 3 months for the first 2 years then


• Every 6 months for the next 2 years then


• Once a year thereafter

For people who have had radical cystectomy for high-risk non-muscle-invasive bladder cancer, see recommendations below under "Follow-up Treatment for Muscle-Invasive Bladder Cancer."

Treating Muscle-Invasive Bladder Cancer

Ensure that a specialist urology multidisciplinary team reviews all cases of muscle-invasive bladder cancer, including adenocarcinoma, squamous cell carcinoma and neuroendocrine carcinoma, and that the review includes histopathology, imaging and discussion of treatment options.

Neoadjuvant Chemotherapy for Newly Diagnosed Muscle-Invasive Urothelial Bladder Cancer

Offer neoadjuvant chemotherapy using a cisplatin combination regimen before radical cystectomy or radical radiotherapy to people with newly diagnosed muscle-invasive urothelial bladder cancer for whom cisplatin-based chemotherapy is suitable. Ensure that they have an opportunity to discuss the risks and benefits with an oncologist who treats bladder cancer.

Radical Therapy for Muscle-Invasive Urothelial Bladder Cancer

Offer a choice of radical cystectomy or radiotherapy with a radiosensitiser to people with muscle-invasive urothelial bladder cancer for whom radical therapy is suitable. Ensure that the choice is based on a full discussion between the person and a urologist who performs radical cystectomy, a clinical oncologist and a clinical nurse specialist. Include in the discussion:

• The prognosis with or without treatment


• The limited evidence about whether surgery or radiotherapy with a radiosensitiser is the most effective cancer treatment


• The benefits and risks of surgery and radiotherapy with a radiosensitiser, including the impact on sexual and bowel function and the risk of death as a result of the treatment

Radical Cystectomy

Offer people who have chosen radical cystectomy a urinary stoma, or a continent urinary diversion (bladder substitution or a catheterisable reservoir) if there are no strong contraindications to continent urinary diversion such as cognitive impairment, impaired renal function or significant bowel disease.

Members of the specialist urology multidisciplinary team (including the bladder cancer specialist urological surgeon, stoma care nurse and clinical nurse specialist) should discuss with the person whether to have a urinary stoma or continent urinary diversion, and provide opportunities for the person to talk with people who have had these procedures.

Offer people with bladder cancer and, if they wish, their partners, families or carers, opportunities to have discussions with a stoma care nurse before and after radical cystectomy as needed.

Adjuvant Chemotherapy after Radical Cystectomy for Muscle-Invasive or Lymph-Node Positive Urothelial Bladder Cancer

Consider adjuvant cisplatin combination chemotherapy after radical cystectomy for people with a diagnosis of muscle-invasive or lymph-node-positive urothelial bladder cancer for whom neoadjuvant chemotherapy was not suitable (because muscle invasion was not shown on biopsies before cystectomy). Ensure that the person has an opportunity to discuss the risks and benefits with an oncologist who treats bladder cancer.

Radical Radiotherapy

Use a radiosensitiser (such as mitomycin in combination with fluorouracil [5-FU]* or carbogen in combination with nicotinamide†) when giving radical radiotherapy (for example, 64 Gy in 32 fractions over 6.5 weeks or 55 Gy in 20 fractions over 4 weeks) for muscle-invasive urothelial bladder cancer.

*At the time of publication (February 2015), mitomycin in combination with 5-FU did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented.

†Although this use is common in UK clinical practice, at the time of publication (February 2015), carbogen in combination with nicotinamide did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented.

Managing Side Effects of Treatment

Seek advice from a specialist urology multidisciplinary team if symptoms of bladder toxicity after radiotherapy cannot be controlled with antispasmodics or non-opiate analgesia and other causes have been excluded by cystoscopy.

Follow-up after Treatment for Muscle-Invasive Bladder Cancer

Offer follow-up after radical cystectomy or radical radiotherapy.

After radical cystectomy consider using a follow-up protocol that consists of:

• Monitoring of the upper tracts for hydronephrosis, stones and cancer using imaging and glomerular filtration rate (GFR) estimation at least annually and


• Monitoring for local and distant recurrence using CT of the abdomen, pelvis and chest, carried out together with other planned CT imaging if possible, 6, 12 and 24 months after radical cystectomy and


• Monitoring for metabolic acidosis and B12 and folate deficiency at least annually and


• For men with a defunctioned urethra, urethral washing for cytology and/or urethroscopy annually for 5 years to detect urethral recurrence

After radical radiotherapy consider using a follow-up protocol that includes all of the following:

• Rigid cystoscopy 3 months after radiotherapy has been completed, followed by either rigid or flexible cystoscopy:
  
  
  
  • Every 3 months for the first 2 years then
  
  
  • Every 6 months for the next 2 years then
  
  
  • Every year thereafter, according to clinical judgement and the person's preference
  
  
  
  


• Upper-tract imaging every year for 5 years


• Monitoring for local and distant recurrence using CT of the abdomen, pelvis and chest, carried out with other planned CT imaging if possible, 6, 12 and 24 months after radical radiotherapy has finished.

See recommendation above on the use of urinary biomarkers for follow-up after treatment for bladder cancer.

Managing Locally Advanced or Metastatic Muscle-Invasive Bladder Cancer

First-Line Chemotherapy

Discuss the role of first-line chemotherapy with people who have locally advanced or metastatic bladder cancer. Include in your discussion:

• Prognosis of their cancer and


• Advantages and disadvantages of the treatment options, including best supportive care

Offer a cisplatin-based chemotherapy regimen (such as cisplatin in combination with gemcitabine, or accelerated [high-dose] methotrexate, vinblastine, doxorubicin and cisplatin [MVAC] in combination with granulocyte-colony stimulating factor [G-CSF]) to people with locally advanced or metastatic urothelial bladder cancer who are otherwise physically fit (have an Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1) and have adequate renal function (typically defined as a GFR of 60 ml/min/1.73m² or more).

Offer carboplatin in combination with gemcitabine‡ to people with locally advanced or metastatic urothelial bladder cancer with an ECOG performance status of 0–2 if a cisplatin-based chemotherapy regimen is unsuitable, for example, because of ECOG performance status, inadequate renal function (typically defined as a GFR of less than 60 ml/min/1.73m²) or comorbidity. Assess and discuss the risks and benefits with the person.

For people having first-line chemotherapy for locally advanced or metastatic bladder cancer:

• Carry out regular clinical and radiological monitoring and


• Actively manage symptoms of disease and treatment-related toxicity and


• Stop first-line chemotherapy if there is excessive toxicity or disease progression

‡At the time of publication (February 2015), carboplatin in combination with gemcitabine did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented.

Second-Line Chemotherapy

Discuss second-line chemotherapy with people who have locally advanced or metastatic bladder cancer. Include in your discussion:

• The prognosis of their cancer


• Advantages and disadvantages of treatment options, including best supportive care

Consider second-line chemotherapy with gemcitabine in combination with cisplatin, or accelerated (high-dose) MVAC in combination with G-CSF for people with incurable locally advanced or metastatic urothelial bladder cancer whose condition has progressed after first-line chemotherapy if:

• Their renal function is adequate (typically defined as a GFR of 60 ml/min/1.73m² or more) and


• They are otherwise physically fit (have an ECOG performance status of 0 or 1)

Consider second-line chemotherapy with carboplatin in combination with paclitaxel or gemcitabine¶ in combination with paclitaxel for people with incurable locally advanced or metastatic urothelial bladder cancer for whom cisplatin-based chemotherapy is not suitable, or who choose not to have it.

For recommendations on vinflunine as second-line chemotherapy for people with incurable locally advanced or metastatic urothelial bladder cancer,

For people having second-line chemotherapy for locally advanced or metastatic bladder cancer:

• Carry out regular clinical and radiological monitoring and


• Actively manage symptoms of disease and treatment-related toxicity and


• Stop second-line chemotherapy if there is excessive toxicity or disease progression

¶Although this use is common in UK clinical practice, at the time of publication (February 2015), gemcitabine in combination with paclitaxel did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented.

Managing Symptoms of Locally Advanced or Metastatic Bladder Cancer

Bladder Symptoms

Offer palliative hypofractionated radiotherapy to people with symptoms of haematuria, dysuria, urinary frequency or nocturia caused by advanced bladder cancer that is unsuitable for potentially curative treatment.

Loin Pain and Symptoms of Renal Failure

Discuss treatment options with people who have locally advanced or metastatic bladder cancer with ureteric obstruction. Include in your discussion:

• Prognosis of their cancer and


• Advantages and disadvantages of the treatment options, including best supportive care.

Consider percutaneous nephrostomy or retrograde stenting (if technically feasible) for people with locally advanced or metastatic bladder cancer and ureteric obstruction who need treatment to relieve pain, treat acute kidney injury or improve renal function before further treatment.

If facilities for percutaneous nephrostomy or retrograde stenting are not available at the local hospital, or if these procedures are unsuccessful, discuss the options with a specialist urology multidisciplinary team for people with bladder cancer and ureteric obstruction.

Intractable Bleeding

Evaluate the cause of intractable bleeding with the local urology team.

Consider hypofractionated radiotherapy or embolisation for people with intractable bleeding caused by incurable bladder cancer.

If a person has intractable bleeding caused by bladder cancer and radiotherapy or embolisation are not suitable treatments, discuss further management with a specialist urology multidisciplinary team.

Pelvic Pain

Evaluate the cause of pelvic pain with the local urology team.

Consider, in addition to best supportive care, 1 or more of the following to treat pelvic pain caused by incurable bladder cancer:

• Hypofractionated radiotherapy if the person has not had pelvic radiotherapy


• Nerve block


• Palliative chemotherapy

Specialist Palliative Care for People with Incurable Bladder Cancer

A member of the treating team should offer people with incurable bladder cancer a sensitive explanation that their disease cannot be cured and refer them to the urology multidisciplinary team.

Tell the primary care team that the person has been given a diagnosis of incurable bladder cancer within 24 hours of telling the person.

A member of the urology multidisciplinary team should discuss the prognosis and management options with people with incurable bladder cancer.

Discuss palliative care services with people with incurable bladder cancer and, if needed and they agree, refer them to a specialist palliative care team.

Offer people with symptomatic incurable bladder cancer access to a urological team with the full range of options for managing symptoms.



For full guidelines click on the following link:

NICE Guideline on Bladder cancer

Article Source: National Collaborating Centre for Cancer. Bladder cancer: diagnosis and management. London (UK): National Institute for Health and Care Excellence (NICE); 2015 Feb 25. 55 p. (NICE guideline; no. 2).