Age represents the main driver of surgical decision making in patients candidate to radical cystectomy.

BACKGROUND AND OBJECTIVES: Age might influence the choice of surgical approach, type of urinary diversion (UD) and lymph node dissection (LND) in patients candidate to radical cystectomy (RC) for urothelial bladder cancer (UBC). Similarly, age may enhance surgical morbidity and worsen perioperative outcomes. We tested the impact of age (octogenarian vs. younger patients) on surgical decision making and peri- and postoperative outcomes of RC. METHODS: Non-metastatic muscle-invasive UBC patients treated with RC at 18 high-volume European institutions between 2006 and 2021 were identified and stratified according to age (≥80 vs. <80 years). Intraoperative Complications Assessment and Reporting with Universal Standards and European Association of Urology guidelines recommendations were accomplished in collection and reporting of, respectively, intraoperative and postoperative complications. Multivariable logistic regression models (MVA) tested the impact of age on outcomes of interest. Sensitivity analyses after 1:3 propensity score matching were performed. RESULTS: Of 1955 overall patients, 251 (13%) were ≥80-year-old. Minimally invasive RC was performed in 18% and 40% of octogenarian and younger patients, respectively (p < 0.001). UD without bowel manipulation (ureterocutaneostomy, UCS) was performed in 31% and 7% of octogenarian and younger patients (p < 0.001). LND was delivered to 81% and 93% of octogenarian and younger patients (p < 0.001). At MVA, age ≥80 years independently predicted open approach (odds ratio [OR]: 1.55), UCS (OR: 3.70), and omission of LND (OR: 0.41; all p ≤ 0.02). Compared to their younger counterparts, octogenarian patients experienced higher rates of intraoperative (8% vs. 4%, p = 0.04) but not of postoperative complications (64% vs. 61%, p = 0.07). At MVA, age ≥80 years was not an independent predictor of length of stay, intraoperative or postoperative transfusions and complications, and readmissions (all p values >0.1). These results were replicated in sensitivity analyses. CONCLUSIONS: Age ≥80 years does not independently portend worse surgical outcomes for RC. However, octogenarians are unreasonably more likely to receive open approach and UCS diversion, and less likely to undergo LND.

Oncofid-P-B: a novel treatment for BCG unresponsive carcinoma in situ (CIS) of the bladder: Results of a prospective European Multicentre study at 15 months from treatment start.

PURPOSE: This study reports the safety and efficacy of Oncofid-P-B, a novel compound under development by Fidia Farmaceutici S.p.A. with specific binding to CD44 receptor, in patients with CIS unresponsive or intolerant to BCG. MATERIALS AND METHODS: This is a phase 1 open-label, single arm, multicenter European study to assess safety, tolerability and efficacy of Oncofid-P-B administered in 20 patients with CIS ± Ta-T1, unresponsive or intolerant to BCG, unwilling or unfit for cystectomy. Oncofid-P-B was administered by intravesical instillation for 12 consecutive weeks (intensive phase) followed, in CR patients, by 12 monthly instillations (maintenance phase). The primary objective was the overall safety profile. Secondary objectives included: i) any evidence of antitumor activity, ii) patient's compliance, iii) systemic absorption. The CR was defined as a negative cystoscopy, negative biopsy of the urothelium and negative cytology. RESULTS: At the end of the intensive phase, 15 of the 20 enrolled patients (75%), achieved the CR. Patients still in CR after 3, 6, 9 and 12 months of maintenance phase were 13 (65%), 12 (60%), 9 (45%) and 8 (40%), respectively. Only seven (5 mild and 2 moderate) drug-related AEs were reported in three patients. No drug related serious AEs and no drug related withdrawals have been reported. In all plasma samples, the drug concentratiosn was below the LLOQ (1ng/ml). CONCLUSIONS: Oncofid-P-B is very safe, well tolerated and highly effective (75% CR) when administered weekly for up to 12 consecutive weeks (75% CR), with 40% CR still after 15 months from treatment start.

Robot assisted radical prostatectomy in kidney transplant recipients: surgical, oncological and functional outcomes of two different robotic approaches

ABSTRACT Background: To date, few series on robot-assisted radical prostatectomy (RARP) in kidney transplant recipients (KTRs) have been published. Purpose: To report the experience of two referral centers adopting two different RARP approaches in KTRs. Surgical, oncological and functional results were primary outcomes evaluated in the study. Material and methods: We retrospectively analyzed data from 9 KTRs who underwent transperitoneal RARP or Retzius-sparing RARP for PCa from October 2012 to April 2016. Data were reported as median and interquartile range (IQR). Pre- and postoperative outcomes were compared by non-parametric Wilcoxon signed-rank test. Significant differences were accepted when p ≤ 0.05. Overall survival was assessed using Kaplan-Meier method. Results: Four KTRs underwent a T-RARP and 5 a RS-RARP. Patient median age was 60 (56-63) years. Charlson comorbidity index was 6 (5-6). Preoperative median PSA was 5.6 (5-15) ng / mL. Preoperative Gleason score (GS) was 6 in 5 patients, 7 (3 + 4) in 3, and 8 (4 + 4) in one. Pre- and postoperative creatinine were 1.17 (1.1; 1.4) and 1.3 (1.07; 1.57) mg / dL (p = 0.237), while eGFR was 66 (60-82) and 62 (54-81) mL / min / 1.73m2 (p = 0.553), respectively. One (11.1%) Clavien-Dindo grade II complication occurred. Two extended template lymphadenectomies were performed, both with nodal invasion. These two patients experienced a biochemical recurrence and were subjected to RT. Two patients (22.2%) had PSMs. Median follow-up was 42 months. Seven patients (77.8%) were continent, 5 (55.6%) were potent. Two (22.2%) patients died during follow-up for oncologic unrelated causes. Conclusions: Our series suggests that both RARP approaches are safe and feasible techniques in KTRs for PCa.