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Randomized Controlled Trial
. 2021 May-Jun;35(3):1561-1568.
doi: 10.21873/invivo.12411.

Repeated 5-aminolevulinic Acid Instillations During Follow-up in Non-muscle-invasive Bladder Cancer: A Randomized Study

Eija Kelloniemi  1 , Riikka Järvinen  2 , Pekka Hellström  3 , Erkki Rintala  2 , Sirpa Aaltomaa  4 , Taina Isotalo  5 , Kalmer Innos  5 , Eero Kaasinen  6
Affiliations
Randomized Controlled Trial

Repeated 5-aminolevulinic Acid Instillations During Follow-up in Non-muscle-invasive Bladder Cancer: A Randomized Study

Eija Kelloniemi et al. In Vivo. 2021 May-Jun.

Abstract

Background/aim: Non-muscle invasive bladder carcinoma (NMIBC) is highly recurrent. We studied if 5-aminolevulinic acid (5-ALA) instillations before transurethral resection of bladder tumours (TURBT) and cystoscopy extend the time to recurrence during follow-up with NMIBC patients.

Patients and methods: A prospective multicenter study enrolled 328 NMIBC patients. All TURBTs and control cystoscopies during the one-year study period were done with or without 5-ALA instillations. The primary endpoint was time to recurrence. The secondary endpoints were time to recurrence after 7.5, 10.5, and 13.5 months and the number of patients with progressive disease.

Results: The overall median follow-up time was 80.4 and 87.0 months for the control and study groups, respectively. There was no statistical difference in time to first recurrence between the two groups.

Conclusion: We could not obtain significant differences between the control and 5-ALA groups in tumour recurrence among patients with NMIBC.

Keywords: 5-aminolevulinic acid; Non-muscle-invasive bladder cancer; fluorescence cystoscopy; photodynamic diagnosis; tumour detection.

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Conflict of interest statement

The Authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1. After randomization, treatments in the A group were done with a blue light and in the B group with a white light. During a one-year study period, control cystoscopies were realized every three months in both groups. WL: White light group; 5-ALA: 5-aminolevulinic acid group; TUR: transurethral resection of bladder tumour.
Figure 2
Figure 2. Kaplan-Meier curves showing time to first recurrence since randomization. WL: White light group; 5-ALA: 5-aminolevulinic acid group; HR: hazard ratio; CI: confidence interval.
Figure 3
Figure 3. Kaplan-Meier curves showing time to recurrence after 7.5 (A), 9.5 (B), and 13.5 months (C). WL: White light group; 5-ALA: 5-aminolevulinic acid group; HR: hazard ratio; CI: confidence interval.
See this image and copyright information in PMC

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