2018-04-03
PHO: Blue Light Flexible Cystoscopy followed by tumor treatment with Laser results in less patient burden, improved satisfaction and cost reduction.

Oslo, Norway, April 3rd, 2018, Photocure ASA (OSE: PHO), is pleased to announce
that a new study on Blue Light Cystoscopy (BLCTM) with Hexvix® using the KARL
STORZ flexible videoscope system in the outpatient setting for the laser
treatment of Low-Grade bladder tumors was published in Scandinavian Journal of
Urology, link to publication: https://bit.ly/2IlpylQ. This study, by Drs
Hermann, Mogensen and Susanne Rosthoj, MSc, established that the method of
removing lesions with the laser diode in an outpatient setting provides a well
tolerated treatment of low-grade non-invasive tumor recurrences, and allows for
the patients to leave immediately after treatment.
The study involved 21 patients who had histology verified, low-grade bladder
tumors smaller than 1.5 cm in the bladder identified during outpatient
surveillance flexible cystoscopy. Patients underwent the BLC with Hexvix
assisted laser procedure and had a 1-month follow-up cystoscopy and biopsy
guided by Blue Light Cystoscopy (BLCTM) and the KARL STORZ flexible videoscope.
Follow up of patients was for 12-16 months. The measurement of pain was with a
validated visual analog method from the European Organization for the Research
and treatment of Cancer Quality of Life Questionnaire for the Non-Muscle
Invasive Bladder Cancer.
"Use of BLCTM with Hexvix® to identify the tumors when they are small makes it
possible to treat more patients in the office setting. The laser treatment of
lesions caused limited pain and patients were able to return to their daily
activities immediately after the procedure. We found that this method is
effective for the treatment of Ta low-grade tumors. Treating more patients on an
outpatient basis results in considerable quality of life benefits to the
patients and economic benefits to the health care system. Following the results
of this methods validation study we are now evaluating the method in a
randomized controlled trial," said Dr Gregers G. Hermann, Consultant Urologist,
DM Sc. F.E.B.U. Herlev and Gentofte Hospital, University of Copenhagen and main
investigator of the study.
"In this proof of principle study of BLCTM with Hexvix® to detect and control,
and the laser technique to remove Ta low-grade lesions in the outpatient
setting, it was estimated that 25% of the TURBT procedures could be performed in
the outpatient (office) basis without general anesthesia. This resulted in an
estimated direct cost savings of EUR140,976 per million inhabitants. Using Blue
Light Flexible cystoscopy during this procedure makes the urologists confident
that all tumors are detected and removed and patients can avoid an operating
room surgery while receiving effective treatment for this recurrent and
progressive disease. It is exciting to see the emerging developments in bladder
cancer and the new role that Hexvix can play to offer patients improved
management of their disease," said Kjetil Hestdal, M.D., Ph.D., President and
CEO, Photocure ASA.
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 all. Bladder cancer is a costly, potentially progressive
disease for which patients have to undergo multiple cystoscopies due to the high
risk of recurrence3,4. 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. Bladder cancer is a costly, potentially progressive disease for
which patients have to undergo multiple cystoscopies due to the high risk of
recurrence. 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 treat.