SUO 2017: Assessment of Blue Light Flexible Cystoscopy with Cysview on Patient Reported Outcomes
Many studies across many different malignancies have began to examine the impact of long-term surveillance on patient reported outcomes. In this abstract, the authors of a multi-national Phase III study examine the effect of BLFC surveillance on patient report anxiety. Specifically, it was a prospective, multicenter, within-patient controlled study in patients with NMIBC at high risk of recurrence. BLFC was completed with a special photodynamic diagnosis cystoscope using HAL as the intravesicle agent. If suspicious lesions were noted on BLFC, they were taken to the operating room for BLC and TURBT. Patients were given the PROMIS Anxiety, “Was It Worthwhile” questionnaires, and asked about their “willingness to pay” at baseline, after surveillance, and after OR resection (if performed). Comparisons of scores were performed between groups at different time points. However, this was not a long-term study, so it only followed patients through the first surveillance cystoscopy.
The trial enrolled 304 patients, of whom 103 patients had suspicious BLFC requiring biopsy in the operating room. 56 of these patients had histologically confirmed malignancy in the OR.
Comparing anxiety levels from baseline to post-procedure, overall anxiety decreased after BLFCC (-2.6) with greater decrease among those with negative BLFCC compared to positive (p=0.051). For those who went to the OR, overall anxiety decreased marginally from post-surveillance (-2.6) but this was due exclusively to less anxiety among those with negative biopsies (“false positive”) as compared with true positives (p=0.054).
When patients were asked about their experience with BLFCC, most found it worthwhile with no differences noted between those with false or true positive (86% vs 88%; p=1.0), whether they would undergo the procedure again (91% vs 92%; p=1.0) or recommend to others (93% vs 88%; p=0.49). Similarly, no differences were noted among those with positive or negative BLFCC regarding whether they felt the procedure was worthwhile (91% vs 97%; p=0.07), would do it again (92% vs 96%; p=0.23) or would recommend to others (90% vs 92%; p=0.63).
The majority of patients were willing to pay out of pocket for the expense. However, it is unclear how the patients were counseled prior to the procedure regarding the benefit of BLFC and outcome results.
Limitations / Discussion Points:
1. Major limitation is the lack of a comparison arm. No patients received white light flexible cystoscopy alone. Anecdotally, patients do pretty well with routine flexible cystoscopy. It therefore makes it hard to compare surveillance regimens.
2. The questionnaires, while used in other malignancies, has not been validated
While the authors conclude that anxiety decreased following BLFCC, with a more pronounced decrease among those with negative BLFCC or false positive results, and that the majority of patients undergoing BLFCC found it worthwhile to undergo the procedure and would recommend it to others, irrespective of whether they had a positive BLFCC or false positive in the operating room, the study is severely limited as it only has one arm. No comparison to patients undergoing standard WLC flexible cystoscopy for surveillance was included nor was there long-term follow-up.
Presented by: Angela B. Smith, MD, MS
Co-Authors: Siamak Daneshmand MD², Kamal Pohar MD³, Michael Cookson MD⁴, Michael Woods MD¹, Eduard Trabulsi MD⁵, William Huang MD⁶, Jeffrey Jones MD⁷, Jennifer Taylor MD⁷, Trinity Bivalacqua MD⁸, Tracy Downs MD⁹, Michael O'Donnell MD¹⁰, Gary Steinberg MD¹¹, Joel DeCastro MD⁶, Ashish Kamat MD⁷, Badrinath Konety MD¹², Matthew Resnick MD¹³, Mark Schoenberg MD¹⁴, J. Stephen Jones MD¹⁵ and Yair Lotan MD¹⁶
Affiliation: ¹Chapel Hill, NC; ²Los Angeles, CA; ³Columbus, OH; ⁴Oklahoma City, OK; ⁵Philadelphia, PA; ⁶New York, NY; ⁷Houston, TX; ⁸Baltimore, MD; ⁹Madison, WI; ¹⁰Iowa City, IA; ¹¹Chicago, IL; ¹²Rochester, MN; ¹³Nashville, TN; ¹⁴Bronx, NY; ¹⁵Cleveland, OH; ¹⁶Dallas, TX
Written by: Thenappan Chandrasekar, MD, Clinical Fellow, University of Toronto, twitter: @tchandra_uromd at the 18th Annual Meeting of the Society of Urologic Oncology, November 20-December 1, 2017 – Washington, DC