Presentation Authors: David D'Andrea, Francesco Soria, Vienna, Austria, Paolo Gontero, Turin, Italy, André T. Machado, Ricardo Waksman, São Paulo, Brazil, Shahrokh F. Shariat, Vienna, Austria, Daher C. Chade*, São Paulo, Brazil
Introduction: Intravesical instillation with bacillus Calmette-GuÃ©rin (BCG) is the most effective intravesical therapy for the treatment of high-risk NMIBC after TURB.Several BCG trains are available all originating from the original vaccine for tuberculosis. Their efficacy has been compared or in prospective trials which are underpowered or patients did not receive maintenance instillations. A metanalysis by the EORTC-GUCG pooled the data from 24 randomized trials and showed no difference in progression to muscle-invasive disease (MIBC) between five strains. The limitation of this finding relies on the lack of maintenance cycles in the BCG-RIVM trials.To our knowledge, a direct comparison of the TICE vs Moreau strain has not been made.
Methods: We retrospective reviewed clinical data from patients treated with BCG for NMIBC at three academic centers. Patients were treated with the Moreau strain at the University of SÃ£o Paulo and with the TICE strain at the University of Turin and Vienna. Univariable and multivariable Cox regression models were built to assess the association of the strains with recurrence-free survival and progression-free survival.
Results: A total of 321 (48.6 %) patients were treated with the TICE strain and 339 (51,4 %) were treated with the Moreau strain.Within a median follow-up of 41 months (IQR 24 â€“ 60) a total of 177 (36.6%) patients had a high-grade recurrence; 92 (28.7%) of those treated with the TICE strain and 85 (25.1%) of those treated with the Moreau strain.Median time to recurrence was 124 months (91 â€“ not reached); 98 months (91 â€“ not reached) in the TICE cohort and 237 months (106 â€“ not reached) in the Moreau cohort (HR 0.53, 95%CI 0.39 â€“ 0.71, p < 0.001).Overall, 60 (10%) patients progressed to a muscle invasive disease; 29 (9%) of those treated with the TICE strain and 31 (9.1%) of those treated with the Moreau strain. There was no statistical difference between the two treatment groups (HR 0.69, 95%CI 0.41 â€“ 1.15, p = 0.15).On multivariable Cox regression analysis, which adjusted for pathological T stage, grade, number of tumors, tumor recurrence, tumor size, concomitant CIS and number of maintenance instillations, the strain used was no longer associated with disease recurrence (HR 0.96, 95%CI 0.57 - 1.63, p = 0.88). However, the number of maintenance instillations was significantly associated with longer recurrence-free survival (HR 0.86, 95%CI 0.82 â€“ 0.91, p < 0.001).On exploratory analyses we investigated the effect of the strains in the intermediate and high-risk population. There was no independent association of the used strain with RFS or PFS in either of the subgroups.
Conclusions: Our retrospective analysis did not show a difference in RFS and PFS between TICE and Moreau strains. However, we confirmed the importance of maintenance cycles for achieving a sustainable response.