Blue Light Cystoscopy with
Cysview®(hexaminolevulinate HCI)
for Bladder Cancer
About Bladder Cancer Detection
Bladder cancer is the sixth most commonly diagnosed cancer in the United
States and has the highest recurrence rate of any form of cancer.1 Doctors
who suspect patients may have bladder cancer can use a procedure called
cystoscopy to obtain images of tumors in the urinary bladder.2
Traditional cystoscopy involves a cystoscope with a lens and a white light for
visualizing suspicious lesions. Once lesions are identified, doctors can
surgically remove cancerous tissues through a procedure called a
transurethral resection of the bladder tumor (TURBT).2 However, an
estimated 10 to 20 percent of bladder tumors are overlooked or not visible
using this traditional form of white light cystoscopy, which may mean doctors
aren’t removing all of the cancer during a TURBT.3
About Cysview®
In patients that are suspected or known to have lesions based on prior
cystoscopy, Blue Light Cystoscopy with Cysview is approved by the FDA for
the detection of non-muscle invasive papillary cancer of the bladder. Cysview
is delivered into the bladder about an hour prior to the cystoscopy and is
absorbed by cancerous tissue, exploiting the fluorescent properties of
naturally occurring molecules in malignant tissues.4
Using Cysview with the KARL STORZ D-Light C Photodynamic Diagnostic
(PDD)™ device, doctors are able to view comparative white and blue images
that may make hard-to-see tumors more visible (see below), and thereby
easier for the doctor to identify and remove.5,6
WHITE LIGHT CYSTOSCOPY
BLUE LIGHT CYSTOSCOPY AS
AN ADJUNCT TO WHITE LIGHT
Clinical Data of Cysview
In a clinical study of 814 patients, one or more additional Ta or T1
bladder cancer lesions were detected by Cysview in 16.4% of the
patients compared to white light alone.5
Blue light cystoscopy supports a more complete resection and has
been reported as improving oncological patient outcomes, reducing
recurrence rates by approximately 20 percent, and prolonging
recurrence-free survival.7
Based on a combination of clinical data and economic analysis, a study
showed that the five years costs for patients who initially receive blue
light cystoscopy as part of their TURBT were lower than those patients
who initially receive white light TURBT.7
Blue light Cystoscopy with Cysview can easily be incorporated into
clinical practice. To date more than 200,000 patients has received this
innovation world wide
Important Safety Information
Cysview is not a replacement for random bladder biopsies or other
procedures used in the detection of bladder cancer and is not for repetitive
use.
Anaphylaxis reactions including anaphylactoid shock, hypersensitivity
reactions, bladder pain, cystitis, and abnormal urinalysis have been reported
after administration of Cysview. The most common adverse reactions seen in
clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.
Cysview should not be used in patients with porphyria, gross hematuria, or
with known hypersensitivity to hexaminolevulinate, or in patients receiving
intravesical chemotherapy or BCG treatment within 3 months of Cysview
photodynamic blue-light cystoscopy. There are no known drug interactions
with hexaminolevulinate; however, no specific drug interaction studies have
been performed. Using Cysview, fluorescence of non-malignant areas may
occur, and Cysview may fail to detect some malignant lesions.
Safety and effectiveness have not been established in pediatric patients.
Cysview should only be used during pregnancy if the potential benefit
justifies the potential risk to the fetus. It is not known whether
hexaminolevulinate is excreted in human milk. Because many drugs are
excreted in human milk, exercise caution when Cysview is administered to
nursing mothers. No clinically important differences in safety or efficacy have
been observed between older and younger patients.
Cysview is approved for use with the Karl Storz D-Light C Photodynamic
Diagnostic (PDD) system. For system set up and general information for the
safe use of the PDD system, please refer to the Karl Storz instruction
manuals for each of the components.
Prior to Cysview administration, read the Full Prescribing Information and
follow the preparation and reconstitution instructions.
Full Prescribing Information is available here.
(2013) General Information. Bcan.org Retrieved July 8, 2013 from
http://www.bcan.org/facing-bladder-cancer/frequently-askedquestions/general-information
Witjes, Alfred & van der Heijden, Antoine. (2009) 556–562.
Recurrence, Progression, and Follow-Up in Non–Muscle-Invasive
Bladder Cancer. European Association of Urology. Retrieved July 9,
2013 from http://euacme.org/europeanurology/upload_articles/van%20der%20Heijden%2
0Sept%20Supp.pdf.
Kausch I, Sommerauer M, Montorsi F, et al. Photodynamic diagnosis in
non–muscle-invasive bladder cancer: a systematic review and
cumulative analysis of prospective studies. Eur Urol. 2010;57(4):595606.
Cysview [prescribing information]. Princeton, NJ: Photocure ASA;
2011.
Stenzl A, Burger M, Fradet Y, et al. Hexaminolevulinate guided
fluorescence cystoscopy reduces recurrence in patients with nonmuscle
invasive bladder cancer. J Urol. 2010;184(5):1907-1913.
Fradet Y, Grossman HB, Gomella L, et al. A comparison of
hexaminolevulinate fluorescence cystoscopy and white light cystoscopy
for the detection of carcinoma in situ in patients with bladder cancer: a
phase III, multicenter study. J Urol. 2007;178(1):68-73.
Sievert, K.D et al. (6/27/2009). Economic aspects of bladder cancer:
what are the benefits and costs? World Journal of Urology. Retrieved
on July 9, 2013 from
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2694315/