OBJECTIVE: To evaluate the effect of hexaminolevulinate (HAL)-induced fluorescence during resection of noninvasive bladder cancer on tumor recurrence compared with resection under white light. METHODS:Between 2008 and 2010, 102 consecutive patients with suspected bladder cancer were randomized to undergo transurethral resection with either conventional white light or combination of white light and HAL-induced fluorescence. Difference in tumor recurrence rate and recurrence-free survival between the 2 groups was evaluated. Subgroup analysis on recurrence-free survival was performed for different tumor parameters. RESULTS: Cystoscopy at 3 months revealed tumor recurrence in 6 of 45 (13.3%) patients of the white light group compared with only 1 of 41 patients of the HAL group (2.4%) (P < .001). The recurrence-free rates in white light patients at 12 and 18 months were 56.3% and 50.6%, respectively, compared with 91% and 82.5% in HAL patients (P = .0006). In subgroup analyses, recurrence-free survival was similar between the 2 groups when solitary tumors were treated (P = .3525). However, the HAL group had a favorable recurrence-free survival compared with the white light group when multifocal tumors (P < .001), primary tumors (P = .0237), recurrent tumors (P = .0189), nonaggressive (papillary urothelial neoplasm of low malignant potential and low grade) tumors (P = .0204), or aggressive (high grade and carcinoma in situ) tumors (P = .0134) were treated. CONCLUSION:HAL significantly aids resection of non-muscle-invasive bladder cancer with the result of reduction in tumor recurrence rates.
RCT Entities:
OBJECTIVE: To evaluate the effect of hexaminolevulinate (HAL)-induced fluorescence during resection of noninvasive bladder cancer on tumor recurrence compared with resection under white light. METHODS: Between 2008 and 2010, 102 consecutive patients with suspected bladder cancer were randomized to undergo transurethral resection with either conventional white light or combination of white light and HAL-induced fluorescence. Difference in tumor recurrence rate and recurrence-free survival between the 2 groups was evaluated. Subgroup analysis on recurrence-free survival was performed for different tumor parameters. RESULTS: Cystoscopy at 3 months revealed tumor recurrence in 6 of 45 (13.3%) patients of the white light group compared with only 1 of 41 patients of the HAL group (2.4%) (P < .001). The recurrence-free rates in white light patients at 12 and 18 months were 56.3% and 50.6%, respectively, compared with 91% and 82.5% in HALpatients (P = .0006). In subgroup analyses, recurrence-free survival was similar between the 2 groups when solitary tumors were treated (P = .3525). However, the HAL group had a favorable recurrence-free survival compared with the white light group when multifocal tumors (P < .001), primary tumors (P = .0237), recurrent tumors (P = .0189), nonaggressive (papillary urothelial neoplasm of low malignant potential and low grade) tumors (P = .0204), or aggressive (high grade and carcinoma in situ) tumors (P = .0134) were treated. CONCLUSION:HAL significantly aids resection of non-muscle-invasive bladder cancer with the result of reduction in tumor recurrence rates.
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