Jacqmin D, et al. – Researchers carried out a Hexvix Observational Patients Evaluation (HOPE) study to determine the extent of distribution of the use of hexaminolevulinate in the diagnosis of non–muscle invasive bladder cancer (NMIBC) and evaluate patient and treatment characteristics associated with different endoscopic modalities and to address the French authorities' request for information on routine practices for non–muscle invasive bladder cancer (NMIBC) diagnosis and surveillance. In France, it was noted that hexaminolevulinate was in frequent use with specific patient and disease characteristics associated with its use. HOPE demonstrates the type of data that can be gained in post–authorisation studies to address requests from European health authorities.

Methods

• Researchers carried out a prospective, observational study in 30 centres in France.
• Thereafter, all candidates for endoscopy with transurethral resection who gave their consent were eligible.
• The preliminary outcome was the proportion of patients with an NMIBC diagnosis performed with hexaminolevulinate.

Results

• Researchers enrolled 506 patients: 252 (49.8%) diagnosed with hexaminolevulinate and 254 (50.2%) with white–light endoscopy alone.
• According to the data, there were more patients with tumour recurrence, multiple lesions, lesions with a diameter <3 cm, stage Ta disease, and grade 1 lesions in the hexaminolevulinate group.
• They observed that the first quartile median recurrence–free survival time was 310 days in the hexaminolevulinate group and 144 days in the standard–endoscopy group (p = 0.0015).