2.1

Study design

We reviewed a prospective database (IRB #05148) of 562 consecutive patients who underwent RARC and extracorporeal urinary diversion (ECUD) at a single tertiary referral center between February 2004 and December 2020. Procedures converted to open surgery (n=3) and patients with a preoperative diagnosis of pure adenocarcinoma, squamous, sarcomatoid, or neuroendocrine carcinoma (n=49) were excluded. Primary endpoints were recurrence free survival (RFS) and overall survival (OS). The secondary endpoints included the overall and major complication rates.

2.2

Perioperative management

RARC and extended pelvic lymph node dissection (ePLND) were performed by nine fellowship-trained urologic oncologists using a 6-port transperitoneal approach [ ]. Clinical staging was based on cystoscopic findings, transurethral pathology, and preoperative imaging. Patients with ≥cT2 disease were offered cisplatin-based neoadjuvant chemotherapy (NAC) prior to RARC and were considered to have received NAC if ≥1-cycle of cisplatin- or noncisplatin-based therapy was completed. Nerve sparing was performed if intraoperative evidence suggested that cancer control would not be compromised. Ureteral margin(s) and a urethral margin, if neobladder diversion was planned, were sent for frozen section analysis. A single surgeon (KGC) performed more than 95% of ECUDs with the assistance of intravenous indocyanine green to assess ureteral perfusion prior to ureteroenteric anastomosis after 2016. An institutional enhanced recovery after surgery protocol was introduced in 2014 [ ].

2.3

Follow-up

Disease surveillance was guided by the National Comprehensive Cancer Network guidelines. Specifically, follow-up was conducted every 3- to 6-months for the first 2 years, then biannually thereafter. Surveillance imaging occurred every 6-months for the first 2 years, then for years 3, 4, and 5, a renal ultrasound at the half-year mark and cross-sectional imaging annually. Local and distant recurrences were defined as evidence of radiographic or histologic recurrent disease within the confines of the pelvis or otherwise, respectively. The date of death was recorded using the patient’s death certificate.

2.4

Complications

Complications were identified according to the Clavien-Dindo classification system. Major complications were defined as ≥ grade III. Complications were assigned categorically ( Supplementary table 1 ) and stratified based on occurring >90-days or ≤90-days. Genitourinary, renal, infectious, stomal, and gastrointestinal complications that occurred >90-days were further substratified based on time for the duration of follow-up.

2.5

Statistical analysis

Descriptive statistics were used to summarize all variables. For continuous variables, median and interquartile ranges were reported. OS and RFS estimates were calculated using the Kaplan–Meier method. OS was measured from the date of surgery to date of death from any cause. Patients lost to follow-up or still alive as of their last visit/contact date were censored. RFS was measured from the date of surgery until the date of recurrence. Patients who died without documented recurrence, who were lost to follow-up, or were still alive without documented recurrence as of their last visit/contact date were censored. Death unrelated to bladder cancer was considered a competing risk for cancer-specific death and was estimated using the cumulative incidence function.

Cox proportional hazards regression was used to identify factors associated with OS and RFS. The following variables were included in the univariable analyses based on clinical relevance: age-adjusted Charlson Comorbidity Index (CCI), surgical margin, lymph node status, pathologic stage, pathologic downstaging, use of NAC, and grade of complications. Multicollinearity between covariates was examined using variance inflation factor and correlation analyses. Variables significantly associated with survival in univariable analyses were entered into a multivariable model. Estimates were presented as hazard ratios (HR) with 95% confidence intervals (CI) for univariable and multivariable regression models. Statistical significance was set at P < 0.05. Data management and statistical analyses were conducted using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA) and R version 4.3.0 (R Foundation for Statistical Computing).

3.1

Clinicopathologic data

A total of 510 patients, 340 (67%) of whom were ≥cT2, were included in the analysis ( Table 1 ). Median follow-up for the entire cohort was 57.1 (IQR 21.8–103.6) months and 88.7 (IQR 54.2–131.1) months for those that remained alive. Of the 259 (51%) patients with continent ECUDs, 82 (32%) and 177 (68%) underwent Indiana pouch and neobladder creations, respectively. Correlation between CCI score and ECUD are shown in Supplementary table 2 . Pathological upstaging occurred in 180 (35%) patients, 158 (31%) had ≥pT3 disease, and 104 (20%) were pN+ ( Table 1 ). The positive surgical margin (PSM) and local recurrence rates were 3.5% and 7.4%, respectively.

3.2

Neoadjuvant chemotherapy

Of the 340 ≥cT2 patients, 164 (48%) received NAC. Cisplatin-based NAC was administered to 153/164 (93%) patients. Postoperatively, 87 (53%) of the NAC recipients were downstaged (ypT0-T1). Following NAC + RARC, 9/164 (5.5%) and 46/164 (28%) patients had local or distant recurrences, respectively. In the univariable analysis, NAC reduced the risk of death from any cause (HR 0.61 95%CI: 0.46–0.82, P < 0.001), but did not affect the risk of recurrence ( P = 0.40) ( Supplementary table 3 ). Patients who received NAC and were downstaged had a further reduction in the risk of death (HR 0.40 95%CI: 0.25–0.64, P < 0.001) and recurrence (HR 0.35 95%CI: 0.20–0.61, P < 0.001).

3.3

Recurrence

Disease recurrence was observed in 157 (31%) patients. The 5-, and 10-year RFS estimates were 69% and 64%, respectively ( Fig. 1 A). In the multivariable analysis, lymph node positivity (HR 4.59 95%CI: 3.15–6.71, P < 0.001) and ≥pT3 (HR 1.79 95%CI: 1.18–2.69, P = 0.006) remained significant predictors of worse RFS ( Table 2 ).

Only gold members can continue reading. Log In or Register to continue

Related posts:

Tumor involvement of the trigone and urethra at the time of robot-assisted radical cystectomy is associated with adverse oncological outcomes Diet and the microbiome as mediators of prostate cancer risk, progression, and therapy response Understanding the microbiome as a mediator of bladder cancer progression and therapeutic response 5α-reductase inhibitors with or without alpha-blockers and risk of incident upper tract urothelial carcinoma in men with benign prostatic hyperplasia: Analysis of US insurance claims data Quantification of micropapillary component on transurethral resection is associated with likelihood of occult lymph node metastasis at radical cystectomy Causal relationship between bladder cancer and gut microbiota contributes to the gut-bladder axis: A two-sample Mendelian randomization study

Stay updated, free articles. Join our Telegram channel

Join