Optimised photodynamic diagnosis for transurethral resection of the bladder (TURB) in German clinical practice: results of the noninterventional study OPTIC III

Abstract

PurposeWhite light cystoscopy (WLC) is the standard procedure for visualising non-muscle invasive bladder cancer (NMIBC). However, WLC can fail to detect all cancerous lesions, and outcomes with transurethral resection of the bladder differ between institutions, controlled trials, and possibly between trials and routine application. This noninterventional study assessed the benefit of hexaminolevulinate blue light cystoscopy (HALC; Hexvix®, Ipsen Pharma GmbH, Germany) plus WLC versus WLC alone in routine use.MethodsFrom May 2013 to April 2014, 403 patients with suspected NMIBC were screened from 30 German centres to perform an unprecedented detailed assessment of the additional detection of cancer lesions with HALC versus WLC alone.ResultsAmong the histological results for 929 biopsy samples, 94.3 % were obtained from suspected cancerous lesions under either WLC or HALC: 59.5 % were carcinoma tissue and 40.5 % were non-cancerous tissue. Of all cancer lesions, 62.2 % were staged as Ta, 20.1 % as T1, 9.3 % as T2, 7.3 % as carcinoma in situ (CIS), and 1.2 % were unknown. Additional cancer lesions (+6.8 %) and CIS lesions (+25 %, p < 0.0001) were detected by HALC plus WLC versus WLC alone. In 10.0 % of patients, ≥1 additional positive lesion was detected with HALC, and 2.2 % of NMIBC patients would have been missed with WLC alone. No adverse events were observed.ConclusionsThe results of this study demonstrate that HALC significantly improves the detection of NMIBC versus WLC alone in routine clinical practice in Germany. While this benefit is statistically significant across all types of NMIBC, it seems most relevant in CIS.

Hexaminolevulinate blue light cystoscopy (Hal) assisted transurethral resection of the bladder tumour vs white light transurethral resection of the bladder tumour in non-muscle invasive bladder cancer (NMIBC) : a retrospective analysis.

“…A German multicenter study has confirmed that in patients undergoing TURB the use of HAL has improved by 6.8% the detection of cancerous lesions in comparison to the standard WL-TURB (8). In addition to that, a recent meta-analysis has confirmed the effectiuveness of HAL-TURB in reducing recurrence rate, however further studies have been claimed to reach a change in the clinical management of the disease (9).…”

Observational Studies Requested by European Health Authorities: Governmental Interference or an Enhancement of Everyday Urological Practice? The Hexvix® Observational Patients Evaluation Study as an Example of What to Expect

“…The HOPE study, therefore, provides evidence that PDD use in everyday clinical routine replicates the positive results obtained in the research setting. An improvement in the detection of NMIBC with bluelight cystoscopy with hexaminolevulinate as an adjunct to white-light cystoscopy (versus this technique alone) has also been shown in routine clinical practice in, for example, Spain [19] and Germany [20] .…”

Shedding Light on Bladder Cancer Diagnosis in Urine

“…Illuminated with blue-violet light, malignant tissue display a distinctive red fluorescence [9]. HAL-assisted BLC enhances the visual contrast between benign and malignant tissue which in turn improves diagnostic accuracy, particularly for NMIBC (defined as tumour stage T1, Ta or Tis), and patient outcomes [10,11]. Its long-term benefit with respect to cancer recurrence and progression remains unclear to date; nonetheless, both the AUA and EAU guidelines now recommend its use when available, particularly in patients with positive cytology and normal WLC [3,12].…”