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Background <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Conclusions <p>This study provided evidence for the potential benefits and efficacy of this treatment option for selected patients with UTUC.</p>

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

  • 期刊论文

  • 发表日期：

    2026年3月5日

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  • Makito Miyake,
  • Nobutaka Nishimura,
  • Yuki Oda,
  • Mitsuru Tomizawa,
  • Takuto Shimizu,
  • Takuya Owari,
  • Daisuke Gotoh,
  • Yoshitaka Itami,
  • Tomonori Nakahama,
  • Motokiyo Yoshikawa,
  • Ken Fujimoto,
  • Atsushi Tomioka,
  • Satoshi Anai,
  • Tomomi Fujii,
  • Kiyohide Fujimoto

摘要

Background

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.

Methods

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.

Results

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.

Conclusions

This study provided evidence for the potential benefits and efficacy of this treatment option for selected patients with UTUC.