Study Type – Therapy (individual cohort)
Level of Evidence 2b
What's known on the subject? and What does the study add?
HAL fluorescence cystoscopy is known to improve tumour detection in NMIBC cases and to have a potentially favourable impact concerning the recurrence rates.
The present trial assessed the advantages of HAL cystoscopy with regard to postoperative treatment changes and 2 years' recurrence rates, subjects that are poorly evaluated in the literature.
- • To evaluate in a prospective, randomized study the impact of hexaminolevulinate blue-light cystoscopy (HAL-BLC) on the diagnostic accuracy and treatment changes in cases of non-muscle invasive bladder cancer (NMIBC) compared with standard white-light cystoscopy (WLC).
- • To compare the long-term recurrence rates in the two study arms.
PATIENTS AND METHODS
- • In all, 362 patients suspected of NMIBC were included in the trial based on positive urinary cytology and/or ultrasonographic suspicion of bladder tumours and underwent transurethral resection of bladder tumours.
- • A single postoperative mytomicin-C instillation was performed in all cases, intravesical chemotherapy for intermediate-risk patients and BCG instillations for high-risk cases.
- • The follow-up protocol consisted of urinary cytology and WLC every 3 months for 2 years.
- • Only first-time recurrences after the initial diagnosis were considered.
- • In the 142 patients with NMIBC in the HAL-BLC series, tumour detection rates significantly improved for carcinoma in situ, pTa andoverall cases.
- • In 35.2% of the cases, additional malignant lesions were found by HAL-BLC and consequently, the recurrence- and progression-risk categories of patients and subsequent treatment improved in 19% of the cases due to fluorescence cystoscopy.
- • In all, 125 patients in the HAL-BLC group and 114 of the WLC group completed the follow-up.
- • The recurrence rate at 3 months was lower in the HAL-BLC series (7.2% vs 15.8%) due to fewer ‘other site’ recurrences when compared with the WLC series (0.8% vs 6.1%).
- • The 1 and 2 years recurrence rates were significantly decreased in the HAL-BLC group compared with the WLC group (21.6% vs 32.5% and 31.2% vs 45.6%, respectively).
- • HAL-BLC was better than WLC for detecting NMIBC cases and improved tumour detection rates.
- • HAL-BLC significantly modified the postoperative treatment of cases.
- • The 3 months, 1 and 2 years recurrence rates were significantly improved in the HAL-BLC arm.