Oncological outcomes of patients with node positive disease following neoadjuvant chemotherapy and radical cystectomy for muscle-invasive bladder cancer: A multicenter observational study of the EAU Young Academic Urologists (YAU) urothelial carcinoma working group

Introduction: Until recently there was no recommended adjuvant therapy for patients with lymph nodes metastasis (ypN+) following neoadjuvant chemotherapy (NAC) and radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC). The aim of the study was to describe the oncological outcomes of ypN+ patients following NAC and RC for MIBC. Methods: This collaborative retrospective study included 195 patients with ypN+ disease after NAC followed by RC and bilateral pelvic lymph node dissection for MIBC between 2000 and 2019 in seven centers. Patients' demographics, clinical and pathological features were collected. Survival analyses were carried out with Kaplan-Meier estimates and a Cox model was generated. Results: A total of 120 patients (62%) were pN1, 51 pN2 (26%) and 24 pN3 (12%). Adjuvant radiation therapy was performed in 18 (9%), adjuvant chemotherapy in 40 (21%) and the remaining 137 (70%) patients were observed. The median follow-up time was 51 months (95%CI 44-62). Median times for recurrence-free survival, cancer-specific survival and overall survival (OS) were 18 months (95%CI 16-21), 47 months (95%CI 31-70) and 28 months (95%CI 22-34) respectively. On multivariable analysis, female gender (HR = 1.5, 95%CI 1.002-2.21, p = 0.049) and positive surgical margins (HR = 1.6, 95%CI 1.06-2.38, p = 0.026) were the only independent predictor of OS. The type of adjuvant therapy did not impact OS (adjuvant chemotherapy, p = 0.44; adjuvant radiotherapy p = 0.40). Conclusion: MIBC patients with residual node positive disease following NAC and RC have poor survival outcomes. Females and patients with positive margin status at RC carry a poorer prognosis. These results may be beneficial for clinical trial design.