A comparative study between GE Healthcare's Hexvix® fluorescence cystoscopy and white light cystoscopy has shown that Hexvix® cystoscopy is more effective in the detection of Ta and T1 papillary lesions than white light1 cystoscopy alone in 29% patients. The study has been published in this month's Journal of Urology issue.

The study involved a total of 196 evaluable patients with known or suspected bladder cancer. Because other randomized studies had shown that Hexvix® cystoscopy is capable of detecting more tumours than white light2, the 2 cystoscopy procedures were performed sequentially; white light visualization then fluorescence cystoscopy with Hexvix® . The results showed that 29% of the patients had at least one more pTa lesion detected with Hexvix® cystoscopy than white light cystoscopy alone, the current standard for visual diagnosis of bladder cancer (p<0.05). The improvement in detection rate for pTa tumours was statistically significant, at rates of 95% for Hexvix cystoscopy compared to 83% for white light cystoscopy (p<0.0001). The authors stated that the early detection and excision of such papillary tumours could lead to improved patient outcomes by prolonging the time when they are free of the disease, although this has yet to be shown in a clinical trial.

Six of the patients involved in the study had no tumour detected by white light alone and the presence of bladder cancer was only visually identified using Hexvix® cystoscopy. 12 patients thought to have only one papillary lesion were found to have multiple tumours when examined under blue light.
These changes in diagnosis should lead to patients being managed differently. 3

In this study, Hexvix® cystoscopy was shown to be an effective and well tolerated procedure, with only 2.4% of adverse events considered to be product-related. The study, the largest involving Hexvix to date, confirms early findings of a significantly improved detection rate with Hexvix® cystoscopy compared to white light cystoscopy. Therefore, the use of this technique as a supplement to white light cystoscopy improves the detection of papillary tumours and could potentially lead to decreased recurrence rates and improved patient outcomes, compared to white light cystoscopy alone, although this has yet to be demonstrated.

"Each year there are approximately 120,000 new cases of urinary bladder cancer in Europe, and the numbers are rising", commented Tim O'Brien, consultant urologist at Guy's and St Thomas' Hospitals in London, UK. "Bladder cancer is the fourth most common malignancy in men and the eighth most common malignancy in women," he added. "The high recurrence rate of bladder cancer -up to 45.8% at first follow-up -is of some concern and may be due to poor detection at investigation. Standard diagnosis with white light cystoscopy is inadequate for detecting many bladder lesions".

Background Information

Diagnostic procedure in bladder cancer -considered to be the gold standard today -consists of combined use of urinary cytology and white light cystoscopy. Cytology is a non-invasive technique, based on detecting neoplastic cells in urinary samples. Cytology provides both specificity and sensitivity in detecting high-grade lesions. However, no information on the location and extent of the disease is obtained with this technique. Therefore, direct visual inspection of the urothelium and mucosa is performed with white-light cystoscopy to localize the tumours with a subsequent transurethral resection of suspicious areas of the bladder (TURB). Finally, the samples thus obtained are histologically verified with respect to malignancy.

Medical research has tried to address the difficulties in diagnosing bladder cancer and this research eventually led to the development of Hexvix® fluorescence cystoscopy. This technique, involves instilling a photosensitizing agent -Hexvix®-into the bladder via a catheter. Hexvix induces preferential intracellular accumulation of photoactive (fluorescent) endogenous porphyrins in malignant cells as opposed to non-malignant cells. When subsequently illuminated with blue light, the neoplastic lesions emit red fluorescence that stands out against the normal mucosa. Thus malignant areas can be visually detected by switching the cystoscope to a blue light source.

The use of Hexvix has been strongly supported by countries across Europe. Hexvix is reimbursed in Spain, Greece and France, receiving ASMR (2) -High Improvement of Medical Benefit-designation in France and InEK support in Germany (InEK is the institute which regulates healthcare reimbursement in hospitals in Germany), all highly positive endorsements. The EAU (European Association of Urology) Guidelines on Urothelial Carcinoma in Situ and Ta / T1 (non-muscle invasive) bladder cancer also support the use of Hexvix cystoscopy.

Please visit hexvixmedinfo@ge.com for more information on Hexvix.

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1. H. Barton Grossman, Michael J. Droller et al. A Phase III, Multicenter Comparison of Hexaminolevulinate Fluorescence Cystoscopy and White Light Cystoscopy for the Detection of Superficial Papillary Lesions in Patients With Bladder Cancer. J Urol. Vol. 178, 62-67, July 2007. Article in Press.

2. Jocham D, Witjes F, Wagner S, et al. Improved Detection and Treatment of Bladder Cancer Using Hexaminolevulinate Imaging: A Prospective, Phase III Multicenter Study. J Urol 2005;174:862-6.

3. Oosterlinck W, van der Meijden A, Sylvester R et al. TaT1 (Non-muscle invasive) bladder cancer (update 2006). Available here

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