FLUORESCENCE CYSTOSCOPY IMPROVES DETECTION AND RESECTION OF PAPILLARY BLADDER CANCER LESIONS AND REDUCES EARLY RECURRENCES

 

EAU, Stockholm, Sweden - March 19, 2009 - A study presented at 2009 EAU (European Association of Urology Congress) shows that Hexvix® fluorescence cystoscopy can identify tumors not visible under white light cystoscopy, improving detection and resection of non-muscle invasive papillary bladder tumors and leading to a reduction in recurrence rates at nine months.

This large multicentre phase III study was performed in Europe and North America and involved 766 patients who underwent either Hexvix cystoscopy or standard white light cystoscopy and TURB (Transurethral Resection of the Bladder).  A within patient comparison of 278 patients with non-muscle invasive papillary bladder tumors (Ta/T1) randomized to Hexvix cystoscopy and TURB showed that in 16.9% of these patients at least one additional Ta or T1 tumor was detected compared to white light cystoscopy.

402 Patients with non-muscle invasive papillary bladder cancer randomized to either Hexvix or standard white light cystoscopy were followed for nine months with standard white light.

It was shown that 46% of the patients undergoing white light cystoscopy/TURB experienced recurrences compared to only 36% of patients undergoing fluorescence cystoscopy /TURB, a relative reduction of 22% in the recurrence rate.

41 of the patients included in the study had a carcinoma in situ (CIS). 32% of these patients (13) were diagnosed only under Hexvix fluorescence cystoscopy.

The Principal Investigator of the study, Barton Grossman, MD, Professor of Department of Urology at MD Anderson Cancer Center, Houston Texas says: "It is well known that 50-70% of patients with non-muscle invasive bladder cancer will experience recurrence of their cancer. This is the first study to prospectively document that Hexvix cystoscopy not only improves detection but also reduces recurrence of non-muscle invasive bladder cancer and therefore provides better patient care. The urology community has been waiting for the results from this study, and these excellent results will be pivotal for the implementation of Hexvix fluorescence cystoscopy".

"Each year there are approximately 120,000 new cases of urinary bladder cancer in Europe and it is the fourth most common malignancy in men and the eighth most common malignancy in women1" says Prof. Per-Uno Malmström, Department of Urology, University Hospital, Uppsala, Sweden. He adds: "Bladder cancer patients have access today to effective therapies for the treatment of non-invasive tumors. However, up to 45.8% of bladder cancer will recur at first follow up. Fluorescence cystoscopy responds to the need for better diagnosis and treatment in order to reduce those recurrences".

 "This study shows that fluorescence cystoscopy can therefore be cost effective in the longer term, despite its higher initial costs, because of this significant reduction in surgical re-interventions "said Professor A Stenzl, Department of Urology. Eberhard-Karls-University Tuebingen. Tuebingen, Germany.

Mr. Elgstrøm, a bladder cancer survivor, says: "After the first operation the doctor told me the tumor was gone. Within the following year he discovered another tumor and I had to undergo surgery again. In my own experience, fluorescence cystoscopy can enable an earlier diagnosis, saving time, stress and suffering to the patient by increasing confidence in the treatment".