Fluorescent Ureterorenoscopy-Assisted Thulium:YAG and Holmium:YAG Dual-Laser Ablation for Upper Urinary Tract Urothelial Carcinoma: Results of the FLUAM Trial.

Abstract

The guidelines recommend kidney-sparing surgery as the primary treatment for selected patients with low-risk upper urinary tract urothelial carcinoma (UTUC). An important issue with ureteroscopic laser ablation (ULA) is the high rate of surgical-site recurrence, largely attributable to residual lesions at the initial ULA. This trial aimed to investigate the efficacy and safety of oral 5-aminolevulinic acid hydrochloride-mediated photodynamic diagnosis (ALA-PDD)-assisted ULA for UTUC. The study evaluated 20 patients with cTa-1N0M0 UTUC who underwent ALA-PDD-assisted ULA using thulium-holmium:YAG dual lasers. The primary endpoint was the 2-year progression-free survival rate. Treatment-related adverse events (AEs), usefulness of the UroVysion test combined with conventional urinary cytology for detecting recurrent tumors, and longitudinal changes in patient-reported health-related quality of life (HRQoL) after ULA were evaluated. Of the 20 patients, 3 (15 %) experienced disease progression, and the 2-year progression-free survival rate was 82 % (95 % confidence interval [CI], 54-93 %). The lower limit of the 95 % CI for the 2-year PFS rate was less than the prespecified threshold survival rate of 58 %. The most common AEs were transient urinary-related symptoms. No grade ≥3 AEs were observed throughout the trial. Due to the low positivity rate of pretreatment UroVysion testing, the study could not evaluate its usefulness for monitoring post-ULA recurrence. Most domains and scales of HRQoL showed acceptable changes during treatment and follow-up evaluation. In particular, the intervention positively affected mental and emotional conditions. This study provided evidence for the potential benefits and efficacy of this treatment option for selected patients with UTUC.