AUA 2017: Phase III Study of Blue Light Cystoscopy With Optical Imaging Agent in Bladder Cancer

Key Points

  • Blue light flexible cystoscopy (BLFC) with Cysview detected bladder cancer recurrence in 21.5% of the patients undergoing surveillance cystoscopy that otherwise would have been missed with white light alone.
  • 9 out of 26 patients (34.6%) with flat, more aggressive high-grade lesions (carcinoma in situ) were diagnosed using confirmatory blue light cystoscopy with Cysview alone and not white light.
  • 92.7% of the patients said it was worthwhile to undergo BLFC, and 93.8% said that they would do it again.

New phase III study results of blue light flexible cystoscopy (BLFC) with an optical imaging agent (Hexvix/Cysview) were presented by Daneshmand et al during a late-breaking plenary session at the 2017 American Urological Association (AUA) Annual Meeting (Abstract PPTLBA-02).

Major Findings

The study showed that BLFC with Cysview detected bladder cancer recurrence in 21.5% of the patients undergoing surveillance cystoscopy that otherwise would have been missed with white light alone, which is highly significant (P < .0001). Of note, the study showed that 9 out of 26 patients (34.6%) with flat, more aggressive high-grade lesions (carcinoma in situ) were diagnosed using confirmatory blue light cystoscopy with Cysview alone and not white light (P < .0001). The study also showed that there was no increase in the rate of related adverse events after repeated administration of Cysview in patients with bladder cancer undergoing cystoscopy examination.

The study was a prospective, open, comparative, within-patient controlled study that included 304 patients with non–muscle invasive bladder cancer enrolled at 17 academic institutions in the United States. In the study, BLFC with Cysview was used with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System.

“This study shows that BLFC can provide a significant advantage for patients in terms of early detection of tumor recurrence, which may improve treatment and therefore lead to better outcomes,” said one of the lead investigators of the study, J. Stephen Jones, MD, President of Cleveland Clinic Regional Hospitals and Family Health Centers. “Overall, 92.7% of the patients said it was worthwhile to undergo BLFC, and 93.8% said that they would do it again. The results of the study show that BLFC will play a significant role in outpatient management of bladder cancer.”

“We are very pleased with the strong results of this phase III study and intend to submit the data to the U.S. Food and Drug Administration to seek approval of BLFC with Cysview in the surveillance setting in the United States and an expansion of the indication to include [carcinoma in situ],” said Ambaw Bellete, President of Photocure Inc.

Additional Study

Another study on blue light cystoscopy by Bazargani et al was also presented at the 2017 AUA Annual Meeting (Abstract MP15-02). The results from 9 centers included 1,325 lesions from 517 procedures in 426 patients. In this study, the investigators concluded that blue light cystoscopy significantly increased the detection of carcinoma in situ and papillary lesions over white light cystoscopy alone and can result in upstaging and upgrading in about 13% of patients, which can affect patient outcomes.

About Cysview/Hexvix

Cysview is a drug that is taken up selectively by cancer cells in the bladder, making them glow bright pink during blue light cystoscopy. Cysview is the trade name of the imaging agent in the United States and Canada, and the agent is known as Hexvix in Europe.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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