Management Of High-risk Bladder Cancer Research Articles

Efficacy of outpatient surveillance in post-intravesical BCG management of high-risk bladder cancer

Background: Intravesical Bacillus Calmette–Guérin (BCG) instillation is an established form of immunotherapy for intermediate and high-risk bladder cancers. Mandatory cystoscopic surveillance is commonly performed under general anaesthesia (GA) to facilitate biopsy or other procedures. However, it is resource-intensive with unclear clinical benefit. Methods and patients: We performed a two-cycle audit, before and after changing post-BCG surveillance policy, from GA cystoscopy to local anaesthetic flexible cystoscopy (LAFC) on trans urethral laser ablation (TULA) lists, where patients may undergo a tumour biopsy or laser ablation. In the first cycle, we audited 53 patients undergoing 114 post-BCG rigid cystoscopies from January 2018 to December 2019. In the second cycle, there were 56 patients undergoing 99 post-BCG LAFCs on TULA lists in 2020. Results: In the first audit cycle cohort, the mean patient age was 72.29 ± 8.98 years and 48 were men; malignant histology was identified only on five occasions (three grade progressions). Fourteen patients required overnight admission. In the second audit cycle cohort, the mean patient age was 70.44 ± 9.17 years and 47 were men. Four had a grade progression, while another a stage progression. Out of 99 LAFCs, 47 confirmed normal bladder appearance. A biopsy was taken during other 52 cystoscopies: 17 (33%) confirmed malignancy. Fifteen patients showed findings that were labelled as recurrence, but only two required a further GA procedure to deal with recurrence. One patient was admitted for post-procedure bleeding, which settled with irrigation. Conclusion: Local anaesthetic TULA procedure is a safe and effective alternative for a GA rigid cystoscopy to survey bladders of patients on intravesical BCG therapy. Level of evidence: 3

Prevention of topic toxicity of BCG with single-dose prulifloxacin. Preliminary results of a randomized pilot study

Toxicity is a major problem for patients undergoing intravesical therapy with Bacillus Calmette-Guérin (BCG) for the conservative management of intermediate or high-risk non-muscle invasive bladder cancer (NMI-BC). A prospective pilot trial was designed to evaluate the adoption of a single dose of prulifloxacin to prevent the toxicity of BCG. Treatment tolerability and its possible influence on BCG efficacy have been analyzed. The study was designed to evaluate the action of prulifloxacin in patients with intermediate or high-risk NMI-BC, undergoing 6-week induction cycle of BCG. Main exclusion criteria were previous intravesical therapy, urinary infection and any other factor that could influence tolerability to BCG intravesical immunotherapy. The patients were randomized to receive BCG alone versus BCG plus prulifloxacin. BCG toxicity and local tolerability were evaluated by self-administered EORTC QLQ-BLS24 questionnaire, and BCG adverse events (AEs) were classified according a four-class classification. The toxicity and tolerability evaluations were performed at baseline, one week after every instillation and one week and one month after the last instillation. Cystoscopy and cytology were performed 3-monthly. Recurrence and progression were recorded. The study included 43 patients receiving 258 instillations of BCG. The patients were randomized to receive BCG alone (Arm A: 132 instillations in 22 patients) versus BCG plus prulifloxacin given as a single oral dose (600 mg) 6 hours after the instillation. An advantage in favor of prulifloxacin prophylaxis emerged, according to EORTC QLQ-BLS24, in overall incidence of nocturnal micturitions (56% vs 28.6%; p=0.001), insomnia (40% vs 14.3%; p=0.002), urgency (70% vs 42.6%; p=0.05), incontinence (44% vs 12.7%; p=0.01) and bothersome events due to intravesical therapy (84% vs 63.5%; p=0.02). Systemic class IIB and III adverse events occurred in only 14.2% and 3.5% of the patients, respectively. No class IV AE was detected. Due to the low incidence no statistically significant difference was evident between the two arms (p=0.6). Three patients of Arm B and 1 patient of Arm A interrupted the treatment, after the 3rd - 4th instillation. Anti-tuberculosis therapy war required for 3 months in only one patient. Three and 2 instillations were postponed for one-(two) week(s) in Arm B and Arm A, respectively. Prulifloxacin, generally well tolerated, was withdrawn in one patient due to skin allergic reaction. Recurrence rate at a mean follow-up of 12 months did not significantly differ between the two arms. Prulifloxacin decreases the incidence of local symptoms and improves the compliance to BCG intravesical therapy. Due to the low number of events, no evidence emerges in our study about its capability of preventing severe systemic toxicity, although it has proved effective in reducing local symptoms.