Treatment changes and long‐term recurrence rates after hexaminolevulinate (HAL) fluorescence cystoscopy: does it really make a difference in patients with non‐muscle‐invasive bladder cancer (NMIBC)?

Abstract

4 9What ' s known on the subject? and What does the study add? HAL fl uorescence 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. OBJECTIVES• 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 whitelight 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 fi rst-time recurrences after the initial diagnosis were considered. RESULTS• In the 142 patients with NMIBC in the HAL-BLC series, tumour detection rates signifi cantly 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 fl uorescence 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 signifi cantly decreased in the HAL-BLC group compared with the WLC group (21.6% vs 32.5% and 31.2% vs 45.6%, respectively). CONCLUSIONS• HAL-BLC was better than WLC for detecting NMIBC cases and improved tumour detection rates .• HAL-BLC signifi cantly modifi ed the postoperative treatment of cases.• The 3 months, 1 and 2 years recurrence rates were signifi cantly improved in the HAL-BLC arm. KEYWORDShexaminolevulinate blue-light cystoscopy , non-muscle invasive bladder cancer , diagnostic accuracy , treatment changes , recurrence rates Study Type -Therapy (individual cohort) Level of Evidence 2b

Blue-light cystoscopy in the evaluation of non-muscle-invasive bladder cancer

“…At 2 years of follow up the rates were 4% versus 7% (p = 0.123) [Geavlete et al 2012]. Similarly, Grossmann and colleagues found a trend towards improvement of tumor-free survival and bladder preservation.…”

“…No phototoxicity is observed and most adverse events are mild and seem to be related to the tumor and the resection rather than to the photosensitizing drug [Hermann et al 2011;Geavlete et al 2012;Lapini et al 2012]. Frequently mentioned adverse events are bladder pain, bladder spasm, dysuria and hematuria.…”

“…Geavlete and colleagues found significantly lower recurrence rates at 24 months for BLC [21.6% (27/125) versus 32.5% (37/114); p = 0.005] [Geavlete et al 2012]. More recently, Grossmann and colleagues reported on a study extension protocol for their prior multicenter, prospective, randomized trial ] which led to long-term follow up of 255 patients in the PDD group (median follow up 55.1 months) and 261 from the WLC group (median follow up 53.0 months) [Grossman et al 2012].…”

Feasibility of Photodynamic Diagnosis for Challenging TUR-Bt Cases Including Muscle Invasive Bladder Cancer, BCG Failure or 2nd-TUR

“…Sensitivity and specificity of WLC and PDD are 46%-80% and 76-97%, and 43%-98% and 35-66%, respectively. (Zaak and Hofstetter, 2002;Grimbergen et al, 2003;Jichlinski et al, 2003;Schmidbauer et al, 2004;Fradet et al, 2007;Grossman et al, 2007;Jocham et al, 2008;Stenzl et al, 2008;Geavlete et al, 2012) Now PDD is emerging to diagnose NMIBC or carcinoma in situ. However no studies specifically used PDD for muscle invasive bladder cancer, cystoscopic observation for BCG failure cases or 2nd-TUR cases.…”

Hexaminolevulinate hydrochloride in the detection of nonmuscle invasive cancer of the bladder

“…Six studies reported additional Ta tumor detection rates with BLC, ranging from 9% to 42% of the total Ta tumors detected [Jocham et al 2005;Schmidbauer et al 2004;Grossman et al 2007;Burguèsa et al 2011;Geavlete et al 2011;Lapini et al 2012], with a proportion difference of 5.9% (95% CI 0.014-0.103) of additional lesion detection rates with BLC. The same studies reported additional T1 tumor detection rates ranging from 4.9% to 9% of the total T1 tumors detected [Schmidbauer et al 2004;Fradet et al 2007;Burguèsa et al 2011;Geavlete et al 2011;Lapini et al 2012], only Jocham and colleagues showed no differences in T1 tumors detection rates [Jocham et al 2005].…”