“I think this study indicates that this is a procedure that not only improves detection, but also has a high rate of perceived value for patients, and therefore would be worthwhile to use in practice,” says researcher Angela B. Smith, MD.
In patients with bladder cancer at high risk of recurrence, blue light flexible cystoscopy with hexaminolevulinate (Cysview) was worthwhile and led to decreased anxiety, patient-reported outcomes from a recent phase III study suggest.
Patient-reported pain scores remained low following cystoscopies in newly reported results from this phase III study that, as previously reported, demonstrated improved detection of bladder cancer with blue light flexible cystoscopy during office surveillance.
Most patients said that the procedure was worthwhile, that they would recommend it to others, and that they were willing to pay out-of-pocket for it, according to this new report, published recently in BJU International (July 6, 2018 [epub ahead of print]) by researchers including Angela B. Smith, MD, of Lineberger Comprehensive Cancer Center, UNC-Chapel School of Medicine, Chapel Hill.
“I think this study indicates that this is a procedure that not only improves detection, but also has a high rate of perceived value for patients, and therefore would be worthwhile to use in practice,” Dr. Smith said in an interview with Urology Times.
To evaluate patient-reported outcomes, the PROMIS Anxiety, Pain, and “Was It Worthwhile” questionnaires were administered to patients at their screening visit, right after surveillance cystoscopy, and if referred to the operating room on suspicion of recurrence, once again after they received pathology findings and knew their diagnosis.
The mean anxiety score at baseline was 51.8, which decreased by 2.6 points following surveillance, with a trend toward significance (p=.051) in patients with a negative blue light flexible cystoscopy, investigators reported. For patients referred to the operating room, anxiety scores dropped by another 1.6 points, driven mainly by decreases in those with negative biopsies.
Pain was not impacted by blue light flexible cystoscopy at any time point, according to investigators, with mean pain scores of 0.6, 1.1, and 1.4 at baseline, post-surveillance, and post-operating room, respectively.
Next: More than 90% of patients say they find blue light flexible cystoscopy worthwhileMore than 90% of patients said they found blue light flexible cystoscopy worthwhile, they would do it again, and would recommend it to others, with no differences noted based on positive or negative blue light flexible cystoscopy results, investigators said. Moreover, 76% of patients said they were willing to pay out-of-pocket for the procedure.
Blue light cystoscopy should be offered at the time of transurethral resection of bladder tumor (TURBT) to increase detection and decrease recurrence, according to current guidelines from the AUA.
The role of blue light cystoscopy in regular follow-ups after TURBT or previous surveillance cystoscopy was evaluated in the present phase III trial, which included 304 patients with non-muscle invasive bladder cancer.
The trial evaluated white and blue light flexible cystoscopy in the office setting, and repeat white and blue light cystoscopy in the operating room in 17 U.S. centers. Of 103 patients referred to the operating room for suspicion of recurrence, 63 had confirmed recurrence. Thirteen of those 63 patients (20.6%) had recurrence seen only with blue light flexible cystoscopy, previously reported results show (J Urol 2018; 199:1158-65).
False positives in the surveillance setting occurred in 40 out of 220 patients, according to that report, including 20 (9.1%) with white light flexible cystoscopy and 20 (9.1%) with blue light flexible cystoscopy.
Based on those results, the FDA approved an extension to the indication for blue light cystoscopy to include flexible cystoscopies, Photocure ASA announced this past February.
Now, the patient-reported outcomes in the present study provide an important perspective on the potential impacts of blue light flexible cystoscopy on the patient, including the additional catheterization, added cost, and potential for false positive findings, according to Dr. Smith.
“While we do understand some of the benefits with regard to detection, we don't have evidence that this procedure improves progression or survival, as of yet, and therefore, we need to better understand how it's impacting the patient,” Dr. Smith said. “We have to make sure that this procedure is worthwhile in that regard.”
Dr. Smith is a consultant to Photocure ASA, which provided funding for the study.