A COMPARISON OF HEXAMINOLAEVULINATE (HEXVIX®) FLU- ORESCENCE CYSTOSCOPY AND WHITE LIGHT CISTOSCOPY FOR THE DETECTION OF BLADDER CANCER: RESULTS OF THE HERO OBSERVATIONAL STUDY

Aim of the study To evaluate the diagnostic accuracy of hexylaminolaevulinate (HAL) hydrochloride (Hexvix®) PDD cystoscopy compared with standard white light cystoscopy in an observational, open-label, comparative, controlled (within patient), multicenter study that used this diagnos- tic tool on a regular basis in daily practice. Materials and methods Between January 2010 and January 2011, 96 consecutive patients with suspected or confirmed bladder cancer were recruited for the HeRo observational, open-label, comparative, controlled (within pa- tient) study done at 5 centers in Italy. All patients had standard white light (WLC) followed by blue light cystoscopy (BLC). The presence and the number of positive lesions/suspicious areas compared to surrounding urothelium detected using WLC and BLC were record- ed. Biopsies/resection of each positive lesion/suspicious areas were always taken after the bladder was inspected under WLC and BLC. Results Overall, 234 suspicious lesions were detected in 96 patients; 108 (46.2%) were histologically confirmed to be bladder tumors/CIS. The sensitivity of BLC biopsies was significantly higher than for WLC technique. Discussion We acknowledge several strengths but also some limitations to the present study. First, this study was multicentric and prospective, moreover to date no study has presented the results of PDD cys- toscopy compared to WLC used in daily practice. However, a rand- omized scheme between BLC and WLC was not adopted and BLC was always performed after WLC. Another potential bias of the study is related to the lack of a random biopsy protocol associated with the targeted biopsies of suspicious areas/bladder tumors. Conclusions HAL hydrochloride PDD cystoscopy used on a regular basis in daily practice enhances the diagnostic accuracy of standard cystoscopy with an elevate negative predictive value for BLC compared to WLC permitting an improvement in patient prognosis.