Single‐dose versus multiple instillations of epirubicin as prophylaxis for recurrence after transurethral resection of pTa and pT1 transitional‐cell bladder tumours: a prospective, randomized controlled study

Abstract

Objective To compare single-dose and multiple instilthe patients treated with epirubicin than in the control group (24, 25 and 52%, respectively; P<0.001). In lations of epirubicin in the chemoprophylaxis of superficial bladder tumours.those receiving epirubicin, the rates of recurrence were statistically comparable (P=0.9). Patients who had a Patients and methods In a prospective randomized and controlled study, 168 evaluable patients were large tumour burden showed slightly lower recurrence rates with single-dose epirubicin than with delayed assigned to three groups after transurethral resection of bladder tumour (TURBT) and histological confirmaintenance therapy but the diÂerence was statistically insignificant. Patients with a history of bladder mation of its superficial nature (pTa and pT1). The groups were comparable for tumour stage, grade and tumours before treatment had lower recurrence rates with maintenance treatment than with a single dose other tumour characteristics. In group 1, patients received a single dose of 50 mg epirubicin in 50 mL (34.6 and 22.6% in groups 1 and 2, respectively); again this diÂerence was statistically insignificant. normal saline immediately after TURBT; group 2 received 50 mg epirubicin in 50 mL normal saline Patients with grade 3 tumours showed a marginal diÂerence in favour of maintenance therapy. The rates 1-2 weeks after TURBT and the instillations were repeated for 8 weeks and thereafter monthly to of progression amongst the three groups were 5.5, 3.4 and 9.3%, respectively, with no significant diÂer-complete one year of treatment; group 3 (control group) received no adjuvant therapy after TURBT.ences. The overall toxicity rates were comparable in the two treated groups (22 and 25%). The patients were assessed by cysto-urethroscopy, urine cytology and DNA flow cytometry 8 weeks Conclusion With the possible exception of grade 3 tumours, single-dose immediate epirubicin is as eÂec-after resection and then every 3 months during the first 2 years and 6 monthly thereafter during the tive as delayed maintenance therapy, with the advantage of being more cost-eÂective. next 2 years. Intravenous urography was performed annually and when otherwise indicated.

The Schedule and Duration of Intravesical Chemotherapy in Patients with Non–Muscle-Invasive Bladder Cancer: A Systematic Review of the Published Results of Randomized Clinical Trials

“…No differences were found in trials comparing one immediate instillation to either 8 weekly instillations starting 1-2 wk after TUR followed by monthly instillations to 1 yr (18 instillations) [16] or to weekly instillations for 6-8 wk followed by monthly instillations to 1 yr (16-18 instillations) [17]. In another trial comparing one immediate instillation to 4 weekly instillations starting 2 wk after TUR followed by monthly instillations to 1 yr (15 instillations), fewer patients had recurrences in the delayed multiple instillation group, 24.8% versus 30.2% (p = 0.05) [12].…”

Randomized Study of Single Instillation of Epirubicin for Superficial Bladder Carcinoma: Long-Term Clinical Outcomes

“…Significant local toxicities often prevent patients to fulfill all schedules. Recently, some studies have revealed that a single instillation immediately after TUR-Bt prevents recurrences (7,(18)(19)(20)(21). Oostelinck et al (18) first demonstrated that a single instillation clearly prevented recurrence for patients with a single tumor.…”

“…The prophylactic effect of single 80 mg of epirubicin equals that of consecutive 40 mg of epirubicin or mitomycin C (18,20,21).…”

Clinical Significance of Heme Oxygenase-1 Expression in Non-Muscle-Invasive Bladder Cancer

“…Two large-scale randomized control trials confirmed that an immediate intravesical administration of epirubicin could decrease the recurrence rate [2,3] . However, some patients gained little clinical benefit from the intravesical therapy because of poor sensitivity of cancer cells to these chemicals.…”