Outcomes and Safety of Biweekly and Monthly Nivolumab in Patients with Metastatic Renal Cell Carcinoma and Dialysis: Three Case Reports and Literature Review.

Nivolumab is a fully human immunoglobulin G4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody that selectively blocks the interaction between PD-1, which is expressed on activated T cells, and its ligands PD-L1 and PD-L2, which are expressed on immune cells and tumour cells. Patients with severe renal dysfunction and haemodialysis are not enrolled in clinical trials. However, in daily clinical practice, we have patients with metastatic renal cell carcinoma (mRCC) and end-stage renal disease (ESRD). The scientific evidence about the efficacy and safety of nivolumab in these patients is scarce. We report three cases of mRCC patients with ESRD treated with second-line nivolumab therapy. They received both biweekly and monthly schemes. None of our patients showed grade 2-4 toxicities. Two patients achieved partial response and one progressive disease as best response. Our patients did not show increased toxicity by ESRD; also, two of the three patients had objectifiable clinical benefit. Nivolumab seems to be similarly safe for ESRD or dialysis patients as for patients without impaired kidney function (IKF). Dose adjustments might not be necessary. We suggest that patients on dialysis could be treated with nivolumab in the same way as populations without IKF.

Climacturia after robot-assisted laparoscopic radical prostatectomy.

INTRODUCTION: Adverse effects in the sexual sphere are common in patients who have undergone radical prostatectomy (RP). Climacturia, involuntary loss of urine during orgasm, occurs in 20-40% of cases after PR. We analyse its prevalence and associated risk factors after Robotic-assisted laparoscopic radical prostatectomy (RALRP). OBJECTIVES: We analyse the climacturia prevalence after robotic-assisted laparoscopic radical prostatectomy (RALRP) and the association with other related factors. MATERIALS AND METHODS: Retrospective study of 100 patients underwent PRLAR from May 2011 to July 2014. After excluding patients who received radiotherapy after surgery (17), those who did not have sexual activity (7) and those with whom it could not be possible contacted (14), a structured telephone interview was conducted in 62 patients, investigating: presence and intensity of climacturia, orgasmic quality, incontinence and erectile dysfunction (ED). Other factors analysed included neurovascular preservation and rehabilitative treatment for ED. The statistical analysis consisted of Chi2test and logistic regression to evaluate associated factors. RESULTS: The mean age was 56 vs 59 years and the mean follow-up time was 26.6 vs 20.3 months, in the group with climacturia and without climacturia, respectively. The prevalence of climacturia was 17.9% (slight leaks-82% and severe leaks-18%). In 37% of these patients occurred in all orgasms. The quality of orgasm after surgery was worse in 47%, better in 13% and equal in 40%. The quality of the orgasm worsened more frequently in the climacturia group (63% vs 37%). The urinary incontinence rate was 41%, always effort incontinence. It was more frequent in patients with climacturia (62% vs 38%). In all patients with climacturia, bilateral neurovascular bundles preservation was performed. 32% of the patients had undergone post-surgical erectile rehabilitation with oral drugs. No statistically significant differences were found between patients with or without climacturia respect to the parameters analysed. CONCLUSIONS: Climacturia rate after PRLAR in our series was 17.9%. Patients with climacturia presented worse quality orgasms and a higher incontinence rate (p> 0.05). None of the analysed parameters could be defined as predictors of climacturia.

How to obtain a 3D printed model of renal cell carcinoma (RCC) with venous tumor thrombus extension (VTE) for surgical simulation (phase I NCT03738488).

This is the phase 1 of a multicenter clinical trial (NCT03738488), which aims to assess the efficacy and efficiency of surgery planning with 3D models of renal cell carcinoma (RCC) with venous tumor thrombus extension (VTE) compared to the standard images (CT). The objective of this phase is to obtain a 3D printed model of RCC with VTE that is feasible, accurate, reproducible, suitable for surgical simulation, and affordable. A specific protocol was developed to obtain the computed tomography (CT) image: early arterial and nephrogenic phase. ITK-snap® and VirSSPA Software® were used to segment the areas of interest. The resulting 3D mesh was processed with MeshMixer® and Cura®. Ten models from seven different cases were segmented and printed using different 3D printers and materials. We evaluated the material, scale, wall thickness, anatomy printed, 3D conformation, accuracy compared to the CT, suitability to perform the surgery, material, cost, and time (segmentation + design + fabrication + finishing). The four selected models were printed with a BQ Witbox FDM printer in polyurethane filament with a 0.8 mm wall thickness and 100% scale. All the relevant anatomical structures could be correctly identified, the 3D conformation was maintained with good accuracy compared to the CT and the surgery could be performed on them. Mean design time, model cost and printing time were 8.3 h, 33.4 €, and 38.5 h respectively. Various feasible 3D models of RCC with VTE were obtained after a few attempts. The final models were proved to be reproducible, accurate compared to the CT, and suitable for surgery simulation. The printing process was standardized making it possible to manufacture affordable 3D printed models.