CYSVIEW® WITH BLUE-LIGHT CYSTOSCOPY (BLC)
CYSVIEW® (hexaminolevulinate hydrochloride) is a photosensitizer used with blue-light cystoscopy (BLC) as an adjunct to standard white-light cystoscopy (WLC), which is approved and recommended for the detection and management of papillary non-muscle invasive bladder cancer (pNMIBC).1
By enhancing the visual contrast between normal and malignant cells, CYSVIEW®
significantly increases the detection of Ta/T1 tumours which were not detected
by standard WLC alone.1 It also improves resection of tumours compared to WLC alone.* 12, 14
CYSVIEW® leads to the accumulation of fluorescent compounds in cancer cells that emit highly visible red light against a dark blue background on normal tissue when under blue light. Visualization of the tumour cells is possible 1-3 hours after instillation.1
Indications and Clinical Use:1
CYSVIEW® (hexaminolevulinate hydrochloride) is indicated as:
- An adjunct to WLC in the detection of non-muscle invasive papillary bladder cancer in patients with known or suspicion of bladder cancer.
Only approved cystoscopic equipment should be used, equipped with necessary filters to allow both WLC and blue light (wavelength 360–450nm) fluorescence cystoscopy. Training in BLC with an approved Photodynamic Diagnosis (PDD) System is essential prior to the use of CYSVIEW®.
How Does it Work?
“This is a technique that enhances the visual contrast between the benign cell and the malignant cells by the interaction of a specific light on a photosensitizing agent which has a particular affinity for the tumour cells.” 2
CYSVIEW® mode of action:
- After instillation of the CYSVIEW® solution into the bladder, CYSVIEW® enters the cellular membrane of cancer cells.
- In these cells, CYSVIEW® is used in the formation of photoactive porphyrins (PAPs), particularly protoporphyrin IX (PpIX).
- PAPs selectively accumulate in rapidly dividing neoplastic cells.
- After 1 hour, sufficient PAPs have accumulated to start the cystoscopy under blue light illumination.
- At wavelengths between 360-450nm, the PAPs fluoresce emitting red light against a dark blue background of normal tissue.
- This bright red fluorescence emitted from the tumour cells allows more accurate visualization of the tumour and its borders with considerable contrast between normal and malignant urothelial cells.
CYSVIEW® is the only approved diagnostic agent for the detection and management of pNMIBC in the US and Canada. In the EU it is marketed under the brand name Hexvix®. It is recommended by the European Association of Urology (EAU),3 US guidelines on NMIBC,19 and a number of expert panels.3-6
“That we need something of therapeutic value for the diagnosis and treatment of non-muscle invasive bladder cancer (NMIBC) is obvious.” 7
Worldwide, bladder cancer is the ninth most common cancer.10 In Canada, bladder cancer is the fifth most common cancer18 and is estimated to be the fourth most common in men. Every year, there are 8,300 new cases of bladder cancer in Canada.11
It is one of the most expensive cancers to manage, from diagnosis to death, due to the costs relating to long-term surveillance, monitoring and treatment.8-10 TURBT is considered, by far, the largest bladder cancer expense in the UK and other countries. “The quality and result of the initial TURBT strongly determines the patient’s prognosis and overall bladder cancer treatment costs.”9
Compared to standard WLC alone:
CYSVIEW® with BLC improves
- Detection of pNMIBC because more lesions are visualized. 5,12,14
- Resection of tumours due to more complete visualization of the lesion. 5,12,14
…which results in
- Fewer residual tumours.12,14
- Fewer short and long-term recurrences. 12,14,15
- Improved patient management during and after TURBT.5,12
CYSVIEW® with BLC has demonstrated clear benefits over WLC alone in terms of clinical practice and patients’ experiences from diagnosis to management of cancer. CYSVIEW® with BLC improves the detection of papillary tumours, leading to improved treatment of pNMIBC, which results in better management of bladder cancer.5,12,14,17
Benefits in clinical practice:
Detect more lesions: CYSVIEW® significantly improves the detection of Ta/T1 non-muscle invasive bladder cancer compared to WLC alone. 5,12,13,14,17
Enhance tumour visualization: CYSVIEW® enables a more complete resection* which reduces residual tumours and the rate of tumour recurrence. 12,14,17
Improve long-term management: CYSVIEW® improves the identification of papillary bladder tumours leading to longer recurrence-free intervals, improved patient care and reduced costs.16,17
- CYSVIEW® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container
- CYSVIEW® is contraindicated in patients with porphyria
*Resection should be done under white light cystoscopy
For full details on the indications and administration of CYSVIEW® as well as contraindications, warnings and precautions, adverse reactions, and drug interactions, please refer to the product monograph.
Note: CYSVIEW® (hexaminolevulinate (HAL) hydrochloride) is used with blue-light cystoscopy (BLC) as an adjunct to white-light cystoscopy (WLC) and not separately. CYSVIEW® with BLC may be referred to in a number of ways, such as CYSVIEW®, CYSVIEW® with BLC, CYSVIEW® with Photodynamic Diagnosis (PDD) System, HAL with BLC and HAL with PDD.
- Cysview® Canadian Product Monograph, Oct 16, 2015
- Wallerand et al, Interest and practical modalities of fluorescence cystoscopy in 2011 for the treatment of urothelial carcinoma of the bladder: a review of the Cancer Committee of the French Association of Urology, Prog Urol, 2011, 21, 12, 823-828
- Babjuk M et al., European Association of Urology. Guidelines on Non-Muscle-Invasive Bladder Cancer (TaT1 and CIS). 2015. Replaced with 2015 instead of 2013
- Witjes JA et al., Hexaminolevulinate-Guided Fluorescence Cystoscopy in the Diagnosis and Follow-up of Patients with Non-Muscle-Invasive Bladder Cancer: Review of the Evidence and Recommendations; European Urology 2010;57:607-614.
- Daneshmand S et al,. Expert Consensus Document, Hexaminolevulinate blue-light cystoscopy in non-muscle-invasive bladder cancer: review of the clinical evidence and consensus statement on appropriate use in the USA, Nature Reviews Urology, Vol 11, Oct 2014, p 589-596
- Soloway M & Khoury S., Bladder Cancer 2nd International Consultation on Bladder Cancer – Vienna. 2nd ed. ICUD-EAU. 2012.
- Witjes JA., Is Fluorescent Cystoscopy of Cost/Benefit/Therapeutic Value for Carcinoma In Situ of the Bladder?; Journal of Urology 2013;190:19-21
- Botteman MF et al., The Health Economics of Bladder Cancer – A Comprehensive Review of the Published Literature; Pharmaeconomics 2003;21(18):1315-1330.
- Sievert KD et al., Economic Aspects of Bladder Cancer: What are the Benefits and Costs?; World Journal of Urology 2009;27(3):295-300.
- Witjes J.A et al., European Association of Urology. Guidelines on Bladder Cancer Muscle-invasive and Metastatic. 2015. http://uroweb.org/wp-content/uploads/07-Muscle-Invasive-BC_LR.pdf
- Canadian Cancer Statistics 2015 – The Canadian Cancer Society http://www.cancer.ca/en/cancer-information/cancer-type/bladder/statistics/?region=on
- Stenzl A et al., Hexaminolevulinate Guided Fluorescence Cystoscopy Reduces Recurrence in Patients with Nonmuscle Invasive Bladder Cancer; Journal of Urology 2010;184(5):1907-1913
- Jocham D et al., Improved Detection and Treatment of Bladder Cancer Using Hexaminolevulinate Imaging: A Prospective Phase III Multicenter Study; Journal of Urology 2005;174(3):862-866
- Hermann GG et al., Fluorescence-Guided Transurethral Resection of Bladder Tumours Reduces Bladder Tumour Recurrence Due to Less Residual Tumour Tissue in Ta/T1 Patients: a Randomized Two-Centre Study; BJU International 2011;108(8Pt2):E297-303
- Grossman HB et al., Long-Term Decrease in Bladder Cancer Recurrence with Hexaminolevulinate Enabled Fluorescence Cystoscopy; Journal of Urology 2012;188(1):58-62
- Witjes J.A et al, Clinical and Cost Effectiveness of Hexaminolevulinate-guided Blue-light Cystoscopy: Evidence Review and Updated Expert Recommendation, European Urology 66 (2014) 863-871
- Burger M et al., Photodynamic Diagnosis of Non-muscle-invasive Bladder Cancer with Hexaminolevulinate Cystoscopy: A Meta-Analysis of Detection and Recurrence Based on Raw Data. European Urology 2013, http://dx.doi.org/10.1016/j.eururo.2013.03.059A.
- Bladder Cancer Canada. Facing Bladder Cancer; Bladder Cancer Facts. Accessed November 5, 2015 at https://bladdercancercanada.org/en/facing-bladder-cancer/bladder-cancer-facts .
- 19. US Guidelines on Non-muscle-invasive bladder cancer (TaT1 and CIS, Guideline Summary NGC-9825. http://www.guideline.gov/summary_redirect.aspx?type=replaced&objectID=34059 .