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Clinically relevant improvement of recurrence-free survival with 5-aminolevulinic acid induced fluorescence diagnosis in patients with superficial bladder tumors . PURPOSES Fluorescence diagnosis induced by 5-aminolevulinic acid enables more thorough transurethral resection of superficial bladder carcinoma compared with conventional white light . We performed a prospective , single institution , randomized trial to investigate whether the residual tumor rate and long-term tumor recurrence can be decreased by fluorescence diagnosis . MATERIALS AND METHODS A total of 301 patients underwent transurethral resection of bladder tumors with white light or fluorescence diagnosis . Transurethral resection was repeated 5 to 6 weeks later to evaluate the residual tumor rate . To determine recurrence-free survival patient followup was performed every 3 months by white light cystoscopy and urine cytology . Recurrence-free survival was analyzed via Kaplan-Meier methods and multivariable Cox regression analysis . RESULTS A total of 191 patients with superficial bladder carcinoma were available for efficacy analysis . The residual tumor rate was 25.2 % in the white light arm versus 4.5 % in the fluorescence diagnosis arm ( p < 0.0001 ) . Median followup in the white light arm in 103 cases was 21.2 months ( range 4 to 40 ) compared with 20.5 ( range 3 to 40 ) in the 88 in the fluorescence diagnosis arm . Recurrence-free survival in the fluorescence diagnosis group was 89.6 % after 12 and 24 months compared with 73.8 % and 65.9 % , respectively , in the white light group ( p = 0.004 ) . This superiority proved to be independent of risk group . The adjusted hazard ratio of fluorescence diagnosis versus white light transurethral resection was 0.33 ( 95 % confidence interval 0.16 to 0.67 ) . CONCLUSIONS Fluorescence diagnosis is significantly superior to conventional white light transurethral resection with respect to the residual tumor rate and recurrence-free survival . The differences in recurrence-free survival imply that fluorescence diagnosis is a clinically relevant procedure for decreasing the number of tumor recurrences .
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Intervention_Pharmacological
5-aminolevulinic acid
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Intervention_Pharmacological
5-aminolevulinic acid
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Intervention_Physical
transurethral resection
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Intervention_Educational
white light
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Intervention_Educational
fluorescence diagnosis
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Intervention_Physical
Transurethral resection
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Intervention_Educational
white light cystoscopy
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Intervention_Physical
urine cytology
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Outcome_Mortality
recurrence-free survival
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Outcome_Mortality
recurrence-free survival
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Outcome_Mortality
Recurrence-free survival
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Outcome_Physical
residual tumor rate
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Outcome_Mortality
Recurrence-free survival
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Outcome_Mortality
residual tumor rate
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Outcome_Mortality
recurrence-free survival
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Outcome_Mortality
recurrence-free survival
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Outcome_Physical
number of tumor recurrences .
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Participant_Condition
superficial bladder tumors
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Participant_Condition
superficial bladder carcinoma
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Participant_Sample-size
301
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Participant_Condition
transurethral resection of bladder tumors
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Participant_Sample-size
191
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Participant_Condition
superficial bladder carcinoma