Fluorescent Ureterorenoscopy-Assisted Thulium:YAG and Holmium:YAG Dual-Laser Ablation for Upper Urinary Tract Urothelial Carcinoma: Results of the FLUAM Trial.
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.
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.
Authors
Miyake Miyake, Nishimura Nishimura, Oda Oda, Tomizawa Tomizawa, Shimizu Shimizu, Owari Owari, Gotoh Gotoh, Itami Itami, Nakahama Nakahama, Yoshikawa Yoshikawa, Fujimoto Fujimoto, Tomioka Tomioka, Anai Anai, Fujii Fujii, Fujimoto Fujimoto
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