Results at 48 Months of a Randomized Trial on Maintenance after Early Adjuvant

Abstract

Introduction and objectives

The role of maintenance regimen following early intravesical chemotherapy after TUR of intermediate risk non-muscle invasive bladder cancer (NMI-BC) is still debated. Only few studies have been published on this topic, rarely dealing with patients receiving an early treatment. The aim of the present study is to evaluate the efficacy of one-year maintenance after a 6-week cycle of early intravesical chemotherapy.

Methods

Between May 2002 and August 2003, 482 patients with intermediate risk NMI-BC after TUR and early intravesical chemotherapy (epirubicin, 80mg/50mL) were randomized between 6-week induction cycle and induction plus maintenance with 10 monthly instillations. A written informed consent was obtained. All patients underwent cytology and cystoscopy 3-monthly for 2 years and 6-monthly thereafter.

Results

Treatment interruption for toxicity was required in 39 patients. Median follow-up was 48 months. Ten patients (2.5%) progressed and 117 patients (29.6%) recurred. The tumor characteristics were equally distributed between the two arms. No statistically significant difference in recurrence free survival (RFS) was detected between the two arms (p=0.43). An advantage in terms of recurrence free rate (RFR) in favor of the maintenance arm was evident only until 18 months after TUR (p=0.03). A trend for a higher benefit from maintenance in primary and multiple tumors was detected.

Conclusions

The risk of tumor recurrence is significantly reduced by one-year maintenance only for 18 months after TUR in comparison with patients receiving a 6-week cycle of early intravesical chemotherapy. The disadvantages of prolonged intravesical chemotherapy should be taken into account.