Real-world experience with 5-aminolevulinic acid for the photodynamic diagnosis of bladder cancer: Diagnostic accuracy and safety.

BACKGROUND

5-Aminolevulinic acid (ALA)-mediated photodynamic diagnosis (PDD) has recently been approved in Japan for the management of non-muscle invasive bladder cancer. As such, the current study aimed to investigate the real-world diagnostic accuracy and safety of ALA-PDD-assisted transurethral resection of bladder tumor (TURBT).

METHODS

A total of 76 patients who underwent PDD-assisted TURBT were enrolled. ALA (20 mg/kg body weight) was orally administered before TURBT. Fluorescence observation and tissue collection were performed during surgery, after which diagnostic accuracy was determined. Potential side effects of ALA, including vomiting, hypotension, and liver toxicity, were carefully monitored.

RESULTS

The sensitivity, specificity, positive predictive value, and negative predictive value for detecting urothelial carcinoma were 90.1 %, 61.2 %, 55.1 %, and 92.2 % for fluorescence light (FL) and 65.4 %, 88.9 %, 75.7 %, and 83.9 %, for white light (WL) respectively. The mean number of tumors detected per patient was 1.92 and 1.39 for FL and WL (p < 0.05), respectively. No significant differences in the FL sensitivity and specificity were observe among the three patient groups classified according to ALA exposure time after oral administration (2-3, 3-4, and >4 h). ALA-related adverse effects included vomiting (seven cases), hypotension (seven cases, two of which were severe), and liver toxicity (four cases). All side effects disappeared shortly after standard treatment.

CONCLUSION

ALA-PDD showed sufficient diagnostic accuracy even after more than 4 h of ALA exposure prior to surgery, as well as acceptable safety profiles.