A European expert panel recommends the use of Hexvix®-cystoscopy in the diagnosis and follow up of non-muscle-invasive bladder cancer (NMIBC) (1)
(Thomson Reuters ONE) -
EAU, Barcelona, Spain - April 21, 2010
Despite considerable positive evidence, the use of Hexvix has historically
differed widely from country to country and between clinics. European
recommendations from a consensus group have now been published, which may make
the use of Hexvix-guided fluorescence cystoscopy more unison in Europe.
A group of European experts have reviewed and discussed the evidence for
fluorescence cystoscopy using hexaminolevulinate Hexvix. When the group met in
2009, the members noted the accumulation of a strong evidence base for
Hexvix-guided Transurethral Resection of Bladder (TURB) and that the technique
was in use, as an adjunct to white-light cystoscopy in bladder cancer diagnosis,
in many countries across Europe.
Various guidelines have been produced across the continent, acknowledging the
role of fluorescence cystoscopy in the diagnosis and follow up of bladder
cancer. However, there is no European consensus on its specific applications. In
their analysis, the panel members argue that appropriate use of the technique
brings benefits to patients, and to the healthcare economy, and they support the
use of Hexvix-guided fluorescence cystoscopy in a range of indications. "We hope
that our statement will lead to improved care and better outcomes for patients,
through more complete resection of tumors and improved follow up" said Professor
J A Witjes, chair of the panel.
The European expert panel's recommendations are available to support urologists
in the clinical practice of fluorescence cystoscopy in the diagnosis and follow
up of bladder cancer patients (Table 1).
Table 1. Recommendations from the European expert panel for the use of
Hexvix-guided TURB in the diagnosis and follow up of bladder cancer
+-------------------------+--------------------------+-------------------------+
|Indication |Role of Hexvix-guided TURB|Comments |
+-------------------------+--------------------------+-------------------------+
|Suspected bladder |· Tumour detection|Fluorescence cystoscopy |
|cancer*() |· Tumour staging |reduces the need for |
| |· Guidance of |random biopsy and |
| |resection |facilitates informed |
| | |follow up |
+-------------------------+--------------------------+-------------------------+
|Tumour recurrence |· Tumour staging, |Fluorescence cystoscopy |
| |if the patient was not |may detect previously |
| |previously staged using |missed tumours, |
| |fluorescence cystoscopy |particularly carcinoma in|
| | |situ |
+-------------------------+--------------------------+-------------------------+
|Positive urine cytology |· Tumour detection|Fluorescence cystoscopy |
|in the presence of | |offers enhanced detection|
|negative white-light | |rates compared with |
|cystoscopy | |white-light cystoscopy |
| | |alone |
+-------------------------+--------------------------+-------------------------+
|Specialist training |· Clear |Assists clinicians in the|
| |visualisation of tumours |development and |
| |and tumour margins |improvement of their TURB|
| | |technique |
+-------------------------+--------------------------+-------------------------+
(*)If a patient with newly suspected bladder cancer is to undergo cystectomy,
fluorescence cystoscopy is unlikely to provide additional information, and is
not recommended by the expert panel.
"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 eight most
common malignancies in women", says expert panel member and Professor Per Uno
Malmstrom, Department of Urology, University Hospital, Uppsala, Sweden. He adds,
"Bladder cancer patients have access to effective therapies for the treatment of
non-invasive tumours. However, up to 46% 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".
Mr. Elgstrom, a bladder cancer survivor, says, "After the first operation the
doctor told me the tumour was gone. Within the following year he discovered
another tumour 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".
The European expert panel recommendations reflect the acceptance of the benefits
which Hexvix provides to the bladder cancer patients and health-care providers.
Hexvix, has through several studies shown significant improvement in detection
of bladder cancer that relates to reduced recurrence of bladder cancer and
improved patient management.(2,3)
References
1. Witjes JA et al. Eur Urol 2010; 57: 607-614.
2. Stenzl AS et al. Hexvix® fluorescence cystoscopy improves detection and
resection of papillary bladder cancer and reduces early recurrence: a
multicentre, prospective, randomised study. Eur Urol 2009; 8 (4): Abstract
#1010
3. The Danish recurrence study. Data on file, Photocure. Presented at the
Nordic Urology Congress in Iceland, June 2009
About Photocure
Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock
Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical
devices for the photodynamic treatment and diagnosis of cancer and selected
dermatology indications.
Photocure's commercial activities includes own marketing and sales in selected
markets as well as out-licensing on a regional or global basis prior to phase
III.
Photocure has one proprietary pharmaceutical product on the market: Hexvix(®),
for the diagnosis of bladder cancer. Hexvix is approved in EU. In addition, the
company has developed a proprietary light source, which is used in combination
with the Visonac(TM) cream. Through worldwide studies, Photocure is continuously
testing its products for new indications, and the aim is to develop a pipeline
of follow-on products based on the Photocure Technology(TM) platform.
For more information about Photocure, visit our website at www.photocure.com.
Photocure(®), the Photocure logo and Hexvix(®) are registered trademarks of
Photocure ASA.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1406511]
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Datum: 21.04.2010 - 16:41 Uhr
Sprache: Deutsch
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