Neal D. Shore, MD
Although cystoscopy is a mainstay in diagnosing bladder cancer and monitoring its recurrence, researchers have been seeking to improve upon its ability to detect early evidence of cancer, particularly flat lesions and small papillary tumors.
Last year, the FDA approved the optical imaging agent Cysview™ for use with photodynamic blue light cystoscopy in conjunction with the standard white light cystoscopy.
The agent, which contains hexaminolevulinate hydrochloride, is injected into the bladder through a catheter. It enters the bladder mucosa, where it accumulates preferentially in malignant cells. When illuminated with blue light from the cystoscope, the diseased cells emit red fluorescence, improving the clinician’s ability to see potentially troublesome growths.
The approval was based on pivotal study data that demonstrated blue light cystoscopy improved detection by 16% in patients with Tα and/or T1 lesions when compared with white light cystoscopy. The most common adverse event was bladder spasms, which were reported by less than 3% of participants.
The data showed that Cysview “significantly improves detection of papillary bladder cancer, leading to a more complete resection of bladder cancer” in patients with initial and recurrent disease, H. Barton Grossman, MD, a professor in the Department of Urology at the MD Anderson Cancer Center in Houston, Texas, and lead investigator of the trial, said in a press release when the agent was approved.
Cysview is designed for use with the Karl Storz D-Light C Photodynamic Diagnosis (PDD)™ system. GE Healthcare, a unit of General Electric Company, licensed Cysview from Photocure ASA, a Norwegian pharmaceutical and medical device company. The agent is approved in Europe and marketed as Hexvix.
Last fall, Neal D. Shore, MD, became the first urologic oncologist in the United States to begin using Cysview.
Dr Shore, center, explains use of Cysview during cystoscopy.
He recently demonstrated its use in a live cystoscopy accessible through a virtual presentation from the Parkway Surgery Center, an outpatient facility in Myrtle Beach, South Carolina, that is part of Atlantic Urology Clinics. The patient was a 76-year-old woman who had several tumors resected and showed evidence of recurrence 6 months later. Using the Cysview technology, Shore confirmed 4 tumors, including 2 that he resected immediately and 2 smaller, nonmuscularly invasive tumors that he cauterized.
Shore, who is managing partner at Atlantic Urology and director of its research arm, has participated in more than 100 clinical trials involving urinary tract cancers. After performing up to 75 cystoscopies using Cysview, he is enthusiastic about the technology.
“If I can do a better job of performing a complete resection, I theoretically can reduce my short-term recurrence rates and then hopefully that will impact long-term recurrence rates,” Shore said in an interview with OncLive
. “And if I can do that, I’m also reducing the number of times patients will require tumor resection with its associated morbidity and risks.”
The Cysview kit contains 2 vials and a catheter adapter.
Onc: Please explain why you feel Cysview represents an advance over white light cystoscopy.
It allows the treating urologist to identify more potential malignant tissue with greater certainty than without using it. And because of that, it also allows you to resect the tissue that is potentially malignant. It allows you to identify and resect the malignant tissue in a way that may have been missed previously. The end result is it allows any urologist who has been resecting bladder tumors for a long period of time to improve his outcomes.
The bigger tumors you’ll see obviously with the white light. It is the smaller lesions, such as the 1- to 3-millimeter ones or those that are almost fl at that you will only see with the blue light and the fl uorescence uptake. The very obvious tumors on blue light will be obvious on white light as well.