Click here for a link to the abstract.
The results demonstrate that bladder examinations and biopsies of lesions performed with Blue Light Flexible Cystoscopy in the outpatient setting are equivalent to those performed in the inpatient setting with rigid scopes in the operating room and the patient under general anaesthesia. Furthermore, there were significant Quality of Life (QoL) benefits to the patients in the outpatient setting versus the inpatient setting.
The study was a prospective open comparative non-inferiority study on 31 patients that had received standard therapy with the recommended immunotherapy BCG six weeks prior to the examination. Nine patients had primary CIS and 22 patients had recurrent disease. The median patient age was 72.
“CIS are flat aggressive tumors that are difficult to detect using standard white light alone, and many randomized controlled trials have demonstrated that rigid BLC™ with Hexvix® is superior in detecting these flat tumors. This new study shows that BLFC™ with Hexvix® does not compromise the ability to monitor patients with CIS following immunotherapy. By moving the monitoring of the patient to the outpatient setting there is the potential to reduce the burden on the patient and provide savings to the healthcare system,” says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.
“These results show that managing CIS with Blue Light Flexible Cystoscopy in the outpatient setting does not compromise the diagnosis of this rather aggressive form of bladder cancer, yet it provides considerable QoL benefits to the patients. With the flexible procedure patients experienced less pain, urinary symptoms and only 90 minutes of outpatient hospital stay as compared to 1-3 days of hospital inpatient admittance with the current standard of care in Denmark when using rigid cystoscopy in the operating theatre,” said Dr Gregers G. Hermann, Consultant Urologist, DM Sc. F.E.B.U. Herlev and Gentofte Hospital, University of Copenhagen and an investigator in the study.”
About Bladder Cancer
There are 167 000 new cases of bladder cancer in Europe and more than 59 000 deaths from the disease annually. Approx. 75% of all bladder cancer cases occur in men1. It has a high recurrence rate with an average of 61% in year one and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all3,4. Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 Billion Euro in 20122.
There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat5.
1. Globocan. Incidence/mortality by population. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
2. Leal et al, Eur Urol 2016; 69: 438-447
3. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al. EAU Guidelines on
non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016 Guidelines Edition:1-40.
4. Sievert KD et al. World J Urol 2009;27:295–300
5. Bladder Cancer. American Cancer Society.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLCTM with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US and the Nordic region, and has strategic partnerships for the commercialization of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.
About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company focusing on urology. Based on its unique proprietary Photocure Technology® platform, Photocure is committed to developing and commercializing highly selective and minimally invasive solutions to improve health outcomes for patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO). More information about Photocure is available at www.photocure.com, www.hexvix.com, www.cysview.com.
For more information, please contact:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000