Oral 5‐aminolevulinic acid‐mediated photodynamic diagnosis using fluorescence cystoscopy for non‐muscle‐invasive bladder cancer: A multicenter phase III study

Abstract

These findings confirm the diagnostic efficacy and safety of photodynamic diagnosis with 20 mg/kg of oral 5-aminolevulinic acid, and show that transurethral resection of bladder tumors with a fluorescent light source using oral 5-aminolevulinic acid is well tolerated.

A case in which bladder cancer invaded the ureteral orifice and was resected via photodynamic diagnosis‐assisted transurethral resection involving orally administered 5‐aminolevulinic acid

“…In Japan, oral‐PDD‐TUR‐BT was approved by the Ministry of Health, Labor, and Welfare in December 2017 based on several clinical trials, which demonstrated the safety and effectiveness of oral‐PDD‐TUR‐BT . It has been reported that PDD exhibits sensitivity and specificity of 79.6% and 80.6%, respectively, for detecting NMIBC . In addition, luminescence is frequently detected when PDD is used to examine tangential tissue walls and inflamed tissue at sites affected by bladder cancer .…”

“…In recent years, TUR‐BT has been widely used in combination with PDD (PDD‐TUR‐BT) to treat NMIBC . According to guidelines issued in 2018 by the European Association of Urology and the National Comprehensive Cancer Network, PDD‐TUR‐BT involving the intravesical injection of an aminolevulinic acid, that is either 5‐ALA or hexaminolevulinic acid, is recommended for NMIBC.…”

“…According to guidelines issued in 2018 by the European Association of Urology and the National Comprehensive Cancer Network, PDD‐TUR‐BT involving the intravesical injection of an aminolevulinic acid, that is either 5‐ALA or hexaminolevulinic acid, is recommended for NMIBC. The PDD‐TUR‐BT procedure performed in Japan involves the oral administration of 5‐ALA (20 mg/kg, oral‐PDD‐TUR‐BT) . It is unclear whether the oral or intravesical administration of 5‐ALA is better for NMIBC; however, the oral administration of 5‐ALA must be superior to the intravesical administration of 5‐ALA for tumors in the ureteral orifice because intravesically administered 5‐ALA would not reach such tumors without vesicoureteral reflux.…”

Transient liver toxicity as a result of the oral administration of 5‐aminolevulinic acid for photodynamic diagnosis in patients with bladder cancer

“…The clinical benefit of PDD‐assisted TURBT with 5‐ALA is evident from several studies . We carried out a phase III study of this new diagnostic technique in Japan using a preoperative oral administration of 20 mg/kg 5‐ALA .…”

“…The clinical benefit of PDD‐assisted TURBT with 5‐ALA is evident from several studies . We carried out a phase III study of this new diagnostic technique in Japan using a preoperative oral administration of 20 mg/kg 5‐ALA . On the basis of the reported high diagnostic accuracy and good safety profile, oral 5‐ALA has been approved as an intraoperative diagnostic drug in Japan since December 2017.…”