CYSVIEW® with blue-light cystoscopy (BLC) significantly improves the detection of papillary non-muscle invasive bladder cancer (pNMIBC) compared to white-light cystoscopy (WLC) alone.1
Hexaminolevulinate Guided Fluorescence Cystoscopy Reduces Recurrence in Patients with Non-muscle Invasive Bladder Cancer1
Arnulf Stenzl, Maximilian Burger, Yves Fradet, Lance A. Mynderse,
Mark S. Soloway, J. Alfred Witjes, Martin Kriegmair, Alexander Karl, Yu Shen
and H. Barton Grossman
This study demonstrated that CYSVIEW® results in a statistically significant improvement in the detection of Ta/T1 tumors.1
Improved detection of tumours can result in more appropriate treatment due to better visualization of the tumours leading to more complete resection, benefitting the patient.1
Study 305/04 (North America and Europe - Randomized) Detection Results1
Study 305/04 was a pivotal trial for the approval of CYSVIEW® with BLC. This study demonstrated that:1
286 patients were confirmed to have Ta or T1 bladder cancer on biopsy:
- 47 patients (16.4%) had one or more Ta or T1 tumours (p=0.001) which were found with CYSVIEW® with BLC only
- In this study many of the additional tumours detected by BLC were clinically significant, including Grade 2 & 3 and T1 tumours that had been overlooked with WLC
- CYSVIEW® significantly reduced the rate of tumour recurrence. In the 9 month follow up, the relative reduction in recurrence rate in the BLC group was 16% (p=0.026)
- The investigators found that CYSVIEW® “induced fluorescence cystoscopy significantly improves the detection of Ta and T1 lesions”.1
- The study conclusions were that CYSVIEW® with BLC “significantly improves the detection of bladder cancer leading to a more complete resection and significantly better disease-free survival.”1
- “These results are in line with those of previous studies demonstrating improved detection of lesions with CYSVIEW®”.1
The results show that WLC can overlook some tumours and leave residual tumour following resection in the bladder. Compared to WLC, CYSVIEW® with BLC improves the detection of Ta/T1 tumours of the bladder resulting in a more complete detection and resection to reduce residual tumour and tumour appearance during 12 months of follow up.
CYSVIEW®. CONFIDENCE AT FIRST SIGHT.
For full details on the indications and administration of CYSVIEW® as well as contraindications, warnings & 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.
- Stenzl A, Burger M, Fradet Y, et al., Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with non-muscle invasive bladder cancer. J Urol. 2010;184(5):1907-1913.