Hexvix guided fluorescence cystoscopy reduces recurrence in patients with non-muscle invasive bladder cancer

07-Oct-2010 - Norway

Photocure announces a publication in Journal of urology on Hexvix. This publication shows that Hexvix guided fluorescence cystoscopy (Hexvix®), as an adjunct to conventional white-light cystoscopy, improves the detection of bladder cancer and reduces the rate of early tumour recurrence, compared with white-light cystoscopy alone.

The publication is based on Photocure's prospective, randomised study conducted in 28 centres in Europe and North America. The study demonstrated that by using Hexvix®-guided fluorescence cystoscopy Ta/T1 tumours that had not been seen under conventional cystoscopy were detected in 47 (16%) of the patients with Ta or T1 tumours (p=0.001). Of these tumours that were only seen using Hexvix cystoscopy, 28 (59%) were medium-grade tumours (G2), and 19 were tumours of high risk of recurrence and progressions (high grade or T1). Furthermore, 32% of the patients with carcinoma in situ (CIS, a, high-grade aggressive cancer) were identified only by Hexvix®-guided fluorescence cystoscopy.

The study group, led by H. Barton Grossman, Professor of Urology at MD Anderson Cancer Center, Houston, USA, also reports a 16% relative reduction of bladder tumours recurrence in patients with Ta /T1 tumours assessed with Hexvix®-guided fluorescence cystoscopy, compared with white-light cystoscopy alone (p=0.026). At 9 months' follow up, there was a 9% absolute decrease in recurrence in the Hexvix® group, compared with white-light cystoscopy alone, which means that only 11 patients needed to undergo the procedure to avoid one recurrence.

The group also report reduced recurrence of aggressive/clinically significant lesions. They found more CIS, T1 and muscle-invasive disease recurrence in the patients who had undergone white-light cystoscopy compared to Hexvix guided cystoscopy (24% vs 16%, respectively, p=0.17).

As the paper points out, improved tumour detection is likely to result in more accurate tumour mapping and disease staging, and hence more complete cancer resection. A reduced recurrence rate is an objective marker for these benefits.

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