Blue light flexible cystoscopy (D-Light C PDD Flexible Videoscope System) with intravesical hexaminolevulinate HCl (HAL [Cysview]) for surveillance in the office setting significantly improved the detection of recurrent bladder tumors compared with white light cystoscopy.
Boston-Blue light flexible cystoscopy (D-Light C PDD Flexible Videoscope System) with intravesical hexaminolevulinate HCl (HAL [Cysview]) for surveillance in the office setting significantly improved the detection of recurrent bladder tumors compared with white light cystoscopy.
In addition, repeat use of HAL was safe to use in the operating room (OR) and significantly improved the detection of carcinoma in situ (CIS) and of papillary tumors, according to the results of a prospective phase III clinical trial.
The research was presented by Siamak Daneshmand, MD, at the AUA annual meeting in Boston.
Siamak Daneshmand, MD“We know that the recurrence rate of nonmuscle-invasive bladder cancer is high following transurethral resection so that surveillance is required every 3 to 4 months with white light cystoscopy. We also know that blue light rigid cystoscopy with HAL is more sensitive than white light cystoscopy for detecting both papillary tumors and CIS,” said Dr. Daneshmand, associate professor of urology and director of urologic oncology, University of Southern California, Los Angeles.
“The results of this pivotal trial show that in the office setting, blue light flexible cystoscopy with Cysview (BLFCC) improves bladder cancer detection. This has the potential to improve care by earlier detection of cancer, and more cost-effective management, although further studies are needed to establish its impact.”
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The study was conducted at 17 academic centers across the United States. It enrolled 304 patients presenting for a first surveillance visit who had a high risk of recurrence defined by having a history of multiple tumors, recurrent tumors, and/or high-grade tumors. Patients were excluded if they had gross hematuria, inability to undergo cystoscopy, or received intravesical therapy during the previous 6 weeks. Baseline and demographic data showed the study patients’ characteristics were typical of the general nonmuscle-invasive bladder cancer population.
All patients received intravesical HAL 1 to 3 hours prior to cystoscopy (mean exposure time, 68 minutes), and in all patients, the bladder was first inspected for suspicious lesions with white light flexible cystoscopy. Patients were randomized as to whether or not they would subsequently be examined with blue light flexible cystoscopy.
“With this design, urologists would do their best job examining the bladder under white light because they did not know who would continue with blue light cystoscopy,” Dr. Daneshmand said.
The first four patients enrolled at each site were considered training patients and not included in the efficacy analysis. A total of 103 patients had a suspected recurrence and were referred for operating room examination.
The OR examination was performed within 6 weeks of the surveillance examination and included white light and blue light rigid cystoscopy with biopsy or resection of suspicious lesions. Sixty-five of the 103 patients had a histologically confirmed malignancy, of which 26 were CIS.
The findings of the primary endpoint analysis showed that in 14 (21.5%) of the 65 patients with a histologically confirmed malignancy, the lesion was detected in the surveillance exam only with BLFCC (p<.0001).
Of the 220 patients included in the analysis of the surveillance examination, 19 (8.6%) had a false-positive lesion seen only with BLFCC. The same number of patients had a false-positive finding with white light flexible cystoscopy, and there was some overlap of patients in those two groups.
A secondary outcome analysis of the OR data showed blue light rigid cystoscopy with HAL detected additional tumors compared with white light cystoscopy in 30 patients (46.2%). Of the 26 patients with confirmed CIS, nine (34.6%) had their lesion detected only with blue light cystoscopy (p<.0001).
The incidence of adverse events considered causally related to blue light and/or HAL was low both in the surveillance examination (2.0%) and in the OR examination (2.9%).
“There were no indications of increased adverse events with repeated blue light cystoscopy,” Dr. Daneshmand said.
Surgeons were also asked how findings of the surveillance cystoscopy under blue light might have influenced their management of a patient in clinical practice. They were given four response options, and the results showed that one-third of the time, the findings would have caused surgeons to change their management.
Patient-reported outcome data were collected as well. For both the blue light surveillance exam and OR exam, about 90% of patients felt the procedure was worthwhile, said they would undergo it again, and would recommend it to others.
Dr. Daneshmand is a paid consultant to Photocure. Several of his co-authors are scientific study/trial participants for Photocure and/or have a financial or other relationship with several pharmaceutical companies.
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