E.1.1.1. Short title

Bladder cancer

E.1.3.1. Epidemiology

• Bladder cancer is the 7th most common cancer in the UK. However, because it is more common in men than in women it is the 4th most common cancer in men and the 11th in women.
• In 2008, 9583 people were diagnosed with bladder cancer in England, Wales and Northern Ireland, and there were 2997 deaths from bladder cancer.
• About 80% of bladder cancers do not involve the muscle wall of the bladder (non-muscle invasive) at presentation and are confined to the urothelium and lamina propria of the bladder (stages pTa, pTis and pT1 respectively). Progression to more advanced disease from the pTa stage is uncommon and most pTa tumours are not life-threatening. However, recurrences are common and other areas of the urinary tract may be affected (renal pelvis, ureters and urethra). Progression from pT1 disease is more common, and occurs in up to 50% of cases.
• When bladder cancer invades bladder muscle it can spread rapidly beyond the bladder and is life-threatening. Even with optimal treatment, 5-year survival is only 50%.

E.1.3.2. Current practice

• Non-muscle invasive bladder cancers can recur and progress. Non-muscle invasive bladder cancer is divided into low-risk tumours (pTaG1 and most pTaG2) and high-risk tumours (some pTaG2, pTis, pTaG3 and pT1), based on the risk of progression. Recurrence is not life-threatening but progression is. Non-muscle invasive bladder cancer is usually treated with intravesical therapy after initial telescopic surgery. In low-risk tumours this is usually intravesical chemotherapy, and it reduces the risk of recurrence. In high-risk tumours this is usually intravesical immunotherapy (with Bacillus Calmette-Guérin, BCG), which reduces the risk of recurrence and may also reduce the risk of progression. Frequent hospital-based observation is also needed, often over many years.
• Muscle invasive bladder cancer needs intensive treatment that may include radical cystectomy, chemotherapy and radiotherapy. This can result in significant morbidity.
• The intensive treatment needed for muscle invasive bladder cancer and the prolonged hospital-based surveillance needed for non-muscle invasive bladder cancer mean that bladder cancer is one of the most expensive cancers to treat.
• The significant disease and treatment-related morbidity, the substantial use of NHS resources and the wide variation in practice make a guideline on the diagnosis and management of bladder cancer a high priority. There is likely to be variation in current practice at every stage and with every intervention.

E.1.5.1. Groups that will be covered

• Adults (18 years and older) referred from primary care with suspected bladder cancer.
• Adults (18 years and older) with newly diagnosed bladder cancer (urothelial carcinoma, squamous carcinoma, adenocarcinoma and small-cell carcinoma).
• Adults (18 years and older) with newly diagnosed cancer of the urethra.
• Adults (18 years and older) with recurrent bladder or urethral cancer.
• Subgroups identified as needing specific consideration will be considered during development of the guideline.

E.1.5.2. Groups that will not be covered

• Adults with bladder sarcoma.
• Children (younger than 18 years).
• Adults with urothelial carcinoma of the ureter and renal pelvis.
• Adults with secondary cancers of the bladder or urethra (for example, colorectal cancer or cervical cancer invading the bladder).

E.1.7.1. Key clinical issues that will be covered

• What are the information and support needs of patients with bladder cancer, for instance for people at the point of diagnosis, those considering options for treatment, and those considering palliative care?
• What is the most effective technology involving a urine test for identifying new and recurrent bladder cancer?
• What are the optimal endoscopic techniques for diagnosing new and recurrent bladder cancer (for example, the extent, depth and location of biopsies; white light, blue light, narrow-band cystoscopy)?
• What is the most effective imaging for staging newly diagnosed and recurrent bladder cancer (for example, ultrasound, CT, MRI)?
• Which factors determine risk of relapse and progression in newly diagnosed non-muscle invasive bladder cancer (for example, histological grading of bladder cancer)?
• What are the comparative patient outcomes for treating low-risk non-muscle invasive bladder cancer with:
  • transurethral resection
  • intravesical chemotherapy
  • intravesical BCG?
• What are the comparative patient outcomes for treating high-risk non-muscle invasive bladder cancer with:
  • transurethral resection
  • intravesical chemotherapy
  • radiotherapy
  • intravesical BCG
  • radical cystectomy with urinary stoma or bladder reconstruction?
• What are the comparative patient outcomes for treating muscle invasive bladder cancer with:
  • radical cystectomy with urinary stoma or bladder reconstruction
  • radical radiotherapy (including a comparison of different radiotherapy schedules and chemoradiotherapy)
  • neo-adjuvant and adjuvant chemotherapy?
• What is the effect of smoking cessation on bladder cancer recurrence?
• What are the comparative patient outcomes for treating metastatic bladder cancer with:
  • first-line chemotherapy
  • second-line chemotherapy
  • radiotherapy
  • management of urinary tract obstruction?
• What is the optimum follow-up for patients with bladder cancer?
• What specific interventions are most effective for patients with intractable bleeding or bladder pain who are nearing the end of their lives (for example, nerve block, opioids, palliative radiotherapy, urinary diversion)?
• What specific interventions are most effective for patients with bladder toxicity following radiation or BCG therapy?

E.1.7.2. Clinical issues that will not be covered

• Referral from primary care with suspected bladder cancer, including haematuria [this will be covered by ‘Suspected cancer’, the update of ‘Referral guidelines for suspected cancer’ (NICE clinical guideline 27)].
• Vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract (this is the subject of an ongoing NICE technology appraisal).

E.1.11.1. Scope

This is the final scope.

E.1.11.2. Timing

The development of the guideline recommendations will begin in October 2012.

E.1.12.1. Published guidance

E.1.12.2. Guidance under development

NICE is currently developing the following related guidance (details available from the NICE website):

• Referral guidelines for suspected cancer (update). NICE clinical guideline. Publication date to be confirmed.
• Denosumab for the treatment of bone metastases from solid tumours and multiple myeloma. NICE technology appraisal guidance. Publication date to be confirmed.
• Vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract. NICE technology appraisal guidance. Publication date to be confirmed.