Introduction and objectives
The therapeutic management of intermediate risk NMI-BC recurring after intravesical therapy (IT) is not established. Cystectomy will be offered to patients at higher risk of progression but the majority will be retreated by IT. Although some Authors suggest BCG when intravesical chemotherapy (ICH) fails, some patients are retreated by ICH and some others repeat BCG adopted as first-line treatment. Not many studies have been published on this issue. The response to retreatment by intravesical therapy in terms of recurrence-free rate (RFR) and recurrence-free survival (RFS) is analyzed in 179 intermediate-risk patients.
Materials and methods
Only intermediate-risk tumours (EORTC Risk Tables recurrence-risk score 5-9) in absence of TIS were selected. The patients not receiving at least 6 instillations of BCG or ICH after the first diagnosis and again after the TUR of the first recurrence, were excluded. Only BCG, mitomycin c and epirubicin were accepted. All patients were submitted to cytology and cystoscopy 3-monthly for the first 2-years and then 6-monthly. A statistical analysis was performed for RFR and RFS and progression, considering first line IT (BCG versus ICH), previous recurrence free interval, T-category, G-grade, multiplicity, second line IT (BCG versus ICH) and maintenance regimen.
Results
The study included 179 patients. The first-line IT was ICH in 131 (73.2%) and BCG in 48 (26.8%) patients. The median recurrence free interval was 16 months. Intravesical therapy at recurrence was BCG in 83 (46.4%) and ICH in 96 (53.6%) patients. Maintenance of at least 12 months was given in 31.3% and 38.5% of patients respectively. Of the 48 patients previously treated by BCG, 40 (83.3%) repeated it, while of the 131 previously treated by ICH, 88 (67.2%) received ICH again and 43 (32.8%) BCG. Thus, only 8 patients received ICH after BCG. At a median follow-up of 29 months, 65 (36.3%) patients recurred, 25 (30.1%) and 40 (41.7%) after BCG and ICH respectively. No statistical difference emerged in terms of RFS between BCG and ICH (p=0.97). Thirteen patients showed progression at a median interval of 19 months. At multivariate analysis no statistically significant correlation was detected among the considered parameters. Surprisingly, no statistical difference emerged in terms of recurrence free interval between first and second line IT (16 versus 15 months, Mann Whitney U-Test p=0.38), and between patients receiving BCG or ICH as second line therapy after ICH (=0.28).
Conclusions
Intravesical re-treatment by chemotherapy or BCG did not show any reduction in terms of RFS when compared with the first line therapy. Moreover, in patients recurring after intravesical chemotherapy, chemotherapy and BCG resulted equally effective in terms of RFR and RFS