Presentation Authors: Emanuele Zaffuto*, Milan, Italy, Marco Moschini, Lucerne, Switzerland, Giusy Burgio, Simone Scuderi, Francesco Barletta, Luigi Nocera, Milan, Italy, Vincenzo Mirone, Naples, Italy, Andrea Salonia, Renzo Colombo, Francesco Montorsi, Alberto Briganti, Andrea Necchi, Andrea Gallina, Milan, Italy
Introduction: Neoadjuvant therapy is poorly adopted among patients submitted to radical cystectomy (RC) for urothelial carcinoma of the bladder. Recently, pembrolizumab has been tested in the neoadjuvant setting with promising oncological results in an open-label phase II study. However, there is a lack of data regarding the safety of such approach in terms of postoperative outcomes after RC. We tried to evaluate these outcomes in a population of patients treated with RC at a single tertiary care referral center
Methods: We evaluated 802 patients treated with RC between 2010 and 2018. Among those, we identified 61 patients who received neoadjuvant therapy according to the MVAC scheme vs. 52 patients treated with pembrolizumab vs. 689 patients who did not receive any neoadjuvant treatment. Descriptive statistics showed the differences in clinical features of patients across the three groups. Logistic regression analyses evaluated the effect of neoadjuvant regimen on the risk of post-op complications after RC
Results: Median patient age was higher in the no-adjuvant group compared to MVAC and pembrolizumab (70 vs. 63.9 vs. 68.1 yrs; p < 0.001). Similarly, comorbidities significantly differed among the three groups (CCI 1 vs. 0 vs. 0; p < 0.001). Orthotopic neobladder was more represented in the MVAC and in the pembrolizumab groups (24.1% vs. 37.7% vs. 46.2%). Median operative time did not significantly differ among the three groups (379 vs. 401 vs. 372 min, p=0.1). Overall post-op complications (45.4% vs. 45.9% vs. 63.5%; p=0.09) and postoperative high-grade complications (Clavienâ‰¥3) did not differ between the examined groups. However, when looking at the single complications, we observed a significant difference in the rates of post-op ileus (6.1% vs. 4.9% vs. 19.2%; p < 0.01) and urinary complications treated with percutaneous nephrostomy (3.6% vs. 6.6% vs. 15.4%; p < 0.01). In multivariable logistic regression analyses, patients who received pembrolizumab were 3-fold more likely to achieve pT0 after RC compared to no-adjuvant (p < 0.01), while MVAC failed to achieve independent predictor status (p=0.8). Multivariable logistic regression analyses failed to demonstrate the role of any type of neoadjuvant treatment on the risk of postoperative complications.
Conclusions: Neoadjuvant treatments available prior to RC can be safely administered. In particular, neoadjuvant pembrolizumab results in a higher rate of pT0 after RC, with no major toxicity added in terms of peri- and post-operative complications.