Presentation Authors: Shane L. Barney*, San Antonio, TX, Cory M. Hugen, Irvine, CA, Yair Lotan, Dallas, TX, Edward M. Messing, Rochester, NY, Robert S. Svatek, San Antonio, TX
Introduction: Surveillance guidelines for patients with non-muscle invasive bladder cancer (NMIBC) are variable and are largely based on expert opinion. The primary objective was to determine the feasibility. Secondary objectives were to test the hypotheses that patients randomized to low frequency (LF) surveillance experience improvement in patient-reported quality-of-life (QOL) and decreased procedure-related pain and cost compared to patients randomized to high frequency (HF) surveillance.
Methods: Patients with low- or low-intermediate risk NMIBC were approached for study participation following a normal cystoscopy after 3 months from the incident tumor (clinicaltrials.gov identifier NCT02298998). Eligible patients were randomized 1:1 to HF vs. LF surveillance regimens. Patients in the HF group underwent cystoscopy every three months for 2 years, then every 6 months for 2 years, then annually following incident tumor removal. Patients in the LF group underwent cystoscopy at 9 months following the 3-month cystoscopy, then annually. QOL was assessed with the Functional Assessment of Bladder (FACT-BL) questionnaire.
Results: Of total patients approached, 35 (61.4%) patients agreed to participate, 18 (31.6%) patients denied enrollment due to preference for HF surveillance and 4 (7%) patients enrolled but subsequently withdrew. 17 were randomized to the HF and 18 to LF group. Patients were well matched for baseline demographic variables and risk of recurrence. The median follow-up for the entire cohort was 18.5 months (interquartile range, 8.7-22.5). Over the course of the study, a total of 9 biopsies were performed post-randomization, including 3 (17.6%) in the LF and 6 (33.3%) in the HF groups (P = 0.44). Out of those biopsies 2 (11.8%) and 4 (22.2%) were confirmed to be recurrences by pathology in the LF and HF groups, respectively (P = 0.5). No patients progressed. Groups reported similar procedure-related discomfort and FACT-BL summary scores at study termination and similar changes from baseline. Estimated total out of pocket costs per patient for the HF group was $70.96 more compared to the LF group.
Conclusions: Randomization of patients to variable frequency surveillance cystoscopy is possible but challenging because many patients prefer a more frequent regimen. Differences in patient-reported QOL and cost differences were minimal, calling into doubt the benefit of LF regimens. Further study is needed to determine if less frequent surveillance regimens are justified.