A comparison of hexaminolevulinate (Hexvix) fluorescence cystoscopy and white-light cystoscopy for detection of bladder cancer: results of the HeRo observational study

Background To date, no study has presented results of
photodynamic diagnosis (PDD) cystoscopy compared with
white-light cystoscopy (WLC) in daily practice. The aim of
the present study is to evaluate the diagnostic accuracy of
hexylaminolevulinate hydrochloride (Hexvix) PDD cystoscopy
compared with standardWLCused in daily practice.
Methods An observational, open-label, comparative,
controlled (within patient), multicenter study was carried
out on 96 consecutive patients with suspected or confirmed
bladder cancer. All patients had standard WLC followed by
blue-light cystoscopy (BLC). Positive lesions detected using
WLC and BLC were recorded. Biopsies/resection of each
positive lesion were taken after the bladder was inspected.
Sensitivity, specificity, positive predictive value, and negative
predictive value with each method were calculated.
Results Overall, 234 suspicious lesions were detected;
108 (46.2 %) were histologically confirmed to be bladder
tumors/carcinoma in situ (CIS). The sensitivity of BLC
biopsies was significantly higher than for WLC technique
(99.1 vs 76.8 %; p\0.00001). The relative sensitivity of
BLC versus WLC was 1.289, showing superiority of BLC
of 28.9 %. The specificity of BLC biopsies was not significantly
different compared with WLC (36.5 vs 30.2 %).
Positive predictive value for BLC- and WLC-guided
biopsies was 54.9 and 50.9 %, respectively. Negative
predictive value per biopsy for BLC- and WLC-guided
biopsies was 97.4 and 64.8 %, respectively. BLC and WLC
reached the correct diagnosis in 97.9 and 88.5 % of
patients, respectively. This difference was statistically
significant (p = 0.0265). The lack of a random biopsy
protocol was the major limitation of the study.
Conclusions Hexvix PDD cystoscopy used in daily
practice enhances the diagnostic accuracy of standard
cystoscopy with higher negative predictive value, potentially
permitting an improvement in patient prognosis.