Real-World Evidence of Triplet Therapy in Metastatic Hormone-Sensitive Prostate Cancer: An Austrian Multicenter Study.

INTRODUCTION: Two randomized trials demonstrated a survival benefit of triplet therapy (androgen deprivation therapy [ADT]) plus androgen receptor pathway inhibitor [ARPI] plus docetaxel) over doublet therapy (ADT plus docetaxel), thus changing treatment strategies in metastatic hormonesensitive prostate cancer (mHSPC). PATIENTS AND METHODS: We conducted the first real-world analysis comprising 97 mHSPC patients from 16 Austrian medical centers, among them 79.4% of patients received abiraterone and 17.5% darolutamide treatment. Baseline characteristics and clinical parameters during triplet therapy were documented. Mann-Whitney U test for continuous or X²-test for categorical variables was used. Variables on progression were tested using logistic regression analysis and tabulated as hazard ratios (HR), 95% confidence interval (CI). RESULTS: Of 83.5% patients with synchronous and 16.5% with metachronous disease were included. 83.5% had high-volume disease diagnosed by conventional imaging (48.9%) or PSMA PET-CT (51.1%). While docetaxel and ARPI were administered consistent with pivotal trials, prednisolone, prophylactic gCSF and osteoprotective agents were not applied guideline conform in 32.5%, 37%, and 24.3% of patients, respectively. Importantly, a nonsimultaneous onset of chemotherapy and ARPI, performed in 44.3% of patients, was associated with significantly worse treatment response (P = .015, HR 0.245). Starting ARPI before chemotherapy was associated with significantly higher probability for progression (P = .023, HR 15.781) than vice versa. Strikingly, 15.6% (abiraterone) and 25.5% (darolutamide) low-volume patients as well as 14.4% (abiraterone) and 17.6% (darolutamide) metachronous patients received triplet therapy. Adverse events (AE) occurred in 61.9% with grade 3 to 5 in 15% of patient without age-related differences. All patients achieved a PSA decline of 99% and imaging response was confirmed in 88% of abiraterone and 75% of darolutamide patients. CONCLUSIONS: Triplet therapy arrived in clinical practice primarily for synchronous high-volume mHSPC. Regardless of selected therapy regimen, treatment is highly effective and tolerable. Preferably therapy should be administered simultaneously, however if not possible, chemotherapy should be started first.

Impact of Surgical Experience Before Robot-assisted Partial Nephrectomy on Surgical Outcomes: A Multicenter Analysis of 2500 Patients.

Background: Robot-assisted partial nephrectomy (RAPN) is a challenging procedure that is influenced by a multitude of factors. Objective: To assess the impact of prior surgical experience on perioperative outcomes in RAPN. Design setting and participants: In this retrospective multicenter study, results for 2548 RAPNs performed by 25 surgeons at eight robotic referral centers were analyzed. Perioperative data for all consecutive RAPNs from the start of each individual surgeon's experience were collected, as well as the number of prior open or laparoscopic kidney surgeries, pelvic surgeries (open, laparoscopic, robotic), and other robotic interventions. Intervention: Transperitoneal or retroperitoneal RAPN. Outcome measurements and statistical analysis: The impact of prior surgical experience on operative time, warm ischemia time (WIT), major complications, and margin, ischemia, complication (MIC) score (negative surgical margins, WIT ≤20 min, no major complications) was assessed via univariate and multivariable regression analyses accounting for age, gender, body mass index (BMI), American Society of Anesthesiologists score, PADUA score, and RAPN experience. Results and limitations: BMI, PADUA score, and surgical experience in RAPN had a strong impact on perioperative outcomes. A plateau effect for the learning curve was not observed. Prior laparoscopic kidney surgery significantly reduced the operative time (p < 0.001) and WIT (p < 0.001) and improved the MIC rate (p = 0.022). A greater number of prior robotic pelvic interventions decreased WIT (p = 0.011) and the rate of major complications (p < 0.001) and increased the MIC rate (p = 0.011), while prior experience in open kidney surgery did not. One limitation is the short-term follow-up. Conclusions: Mastering of RAPN is an ongoing learning process. However, prior experience in laparoscopic kidney and robot-assisted pelvic surgery seems to improve perioperative outcomes for surgeons when starting with RAPN, while experience in open surgery might not be crucial. Patient summary: In this multicenter analysis, we found that a high degree of experience in keyhole kidney surgery and robot-assisted pelvic surgery helps surgeons in achieving good initial outcomes when starting robot-assisted kidney surgery.

Comparative Analysis of Guideline Adherence between Germany and Austria by Using the Example of Uncomplicated Urinary Tract Infections.

BACKGROUND: Medical guidelines represent the evidence-based state of the art of their scientific field. They aim to guide decisions for physicians and patients about appropriate health care for specific clinical circumstances. However, guideline recommendations are often not adhered to in clinical practice. In particular, a large discrepancy exists regarding the treatment of uncomplicated urinary tract infections. To date, just a few studies addressed the potential reasons for these guideline violations. OBJECTIVES: This investigation aimed to identify and complement reasons for the nonadherence to guideline recommendations. METHODS: A survey amongst a total of 563 German and Austrian urologists identified physician- and patient-related factors contributing to this current state. RESULTS: The physician's personal experience, the lack of applicability to individual patients, and shortage of time were identified as crucial barriers for the physician. Patient-related barriers were poor experience with the antibiotic, fear of collateral damage, and inadequate information about the disease and its therapy. CONCLUSIONS: We suggest modifying guideline designs by including abstracts and flowcharts appropriate for daily use and separate patient instructions to improve guideline compliance. Furthermore, guideline authors should communicate updates in a timely and accessible manner. Presentations at scientific congresses increase visibility and enhance the dialogue with colleagues.

Potential for optimizing the perioperative care in robotic prostatectomy patients by adoption of enhanced recovery after surgery principles.

Several benefits have been reported after applying the principles of enhanced recovery after surgery (ERAS) into the perioperative care of patients undergoing robot-assisted radical prostatectomy (RARP). Nevertheless, there are still barriers. We aimed to identify the key areas by systematically surveying urology departments in Germany and Austria. A 27-question survey on the adoption of ERAS principles for the perioperative care of RARP patients was designed, in compliance with the guidelines on good practice in conducting and reporting of survey research. After positive testing for face and content validity, the survey was distributed via postal mail to 82 departments performing RARP. In total, 39 departments responded to our survey (response rate 48%). The ERAS adoption rates ranged from 21 to 97%, with nine ERAS principles being widely adopted (72-92% of the departments). The lowest adoption rates and, subsequently, the largest potential for optimization were detected for the preoperative nutrition counselling (21%), preoperative pelvic floor physiotherapy (54%), postoperative early initiation of nutrition (44%) and postoperative patient audit for further quality improvement (36%). High-volume centers performed more frequently a perioperative nutrition counselling (8/27; 30%) than low-volume centers (0/12; 0%; p = 0.036). The implementation of the ERAS principles into the perioperative care algorithm were medium-to-high, yet not optimal. Our real-world data assessment revealed four key areas showing low adoption rates (nutrition counselling, preoperative pelvic floor physiotherapy, early initiation of nutrition and patient audit), implying a great potential for further optimization.

Cerebral oxygenation in 45-degree trendelenburg position for robot-assisted radical prostatectomy: a single-center, open, controlled pilot study.

BACKGROUND: Within the last decade, robotically-assisted laparoscopic prostatectomy (RALP) has become the standard for treating localized prostate cancer, causing a revival of the 45° Trendelenburg position. In this pilot study we investigated effects of Trendelenburg position on hemodynamics and cerebral oxygenation in patients undergoing RALP. METHODS: We enrolled 58 patients undergoing RALP and 22 patients undergoing robot-assisted partial nephrectomy (RAPN) (control group) in our study. Demographic patient data and intraoperative parameters including cerebral oxygenation and cerebral hemodynamics were recorded for all patients. Cerebral function was also assessed pre- and postoperatively via the Mini Mental Status (MMS) exam. Changes in parameters during surgery were modelled by a mixed effects model; changes in the MMS result were evaluated using the Wilcoxon signed rank test. RESULTS: Preoperative assessment of patient characteristics, standard blood values and vital parameters revealed no difference between the two groups. CONCLUSIONS: Applying a 45° Trendelenburg position causes no difference in postoperative brain function, and does not alter cerebral oxygenation during a surgical procedure lasting up to 5 h. Further studies in larger patient cohorts will have to confirm these findings. TRIAL REGISTRATION: German Clinical Trial Registry; DRKS00005094; Registered 12th December 2013-Retrospectively registered; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005094 .

Real-World Evidence Data on Metastatic Renal-Cell Carcinoma Treatment in Austria: The RELACS Study.

BACKGROUND: Treatment decisions in routine clinical practice are based on reports of clinical trials, which represent highly selected populations. Limited studies reported real-world evidences representing routine clinical practices in patients with renal-cell carcinoma (RCC) in Europe. The aim of this retrospective, noninterventional chart review was to collect data on the treatment landscape for patients with advanced/metastatic RCC in routine clinical practice in a broader patient population in Austria. PATIENTS AND METHODS: Patients with advanced/metastatic RCC receiving systemic treatment between June 2010 and June 2016 across 12 centers in Austria were included. Parameters were entered into an electronic case report form from the participating sites via the application Hermesoft electronic data capture system. Progression-free survival (PFS) and overall survival (OS) were the 2 primary end points. RESULTS: The median PFS and OS were 12 months and 44 months, respectively (first-line PFS was 14 months for pazopanib and 13 months for sunitinib; first-line OS was 44 months for pazopanib and 48 months for sunitinib). Factors influencing the OS were sex, with female patients at a significantly higher risk than male patients (hazard ratio = 1.719), Eastern Cooperative Oncology Group performance status > 0 increased the risk twice (hazard ratio = 2.048), and number of metastases > 3 before the first line doubled the risk compared to metastases (hazard ratio = 2.064). CONCLUSION: OS in this retrospective chart review was considerably longer than the previous reports in real-world patients, underlining the benefit of current RCC treatment options in routine clinical practice.

Future developments in ureteral stents.

PURPOSE OF REVIEW: We present a review of recent literature to summarize the most recent evidence on the use of ureteral stents, including the use of different materials and treatment of stent-related symptoms. RECENT FINDINGS: Metal stents are able to resist lumen occlusion from extrinsic compression allowing longer indwelling time and making them an option for long-term use. Biodegradable stents have the advantage not to require secondary procedures; however, they have not proven their safety in the clinical setting yet. Coated and drug-eluting stents seem to be promising concepts to prevent stent-related symptoms, but still have to be considered as experimental approaches. The most commonly used stent type is the standard double J stent, named for its J-shaped curled ends and manufactured from polyurethane, silicone or various polymers. SUMMARY: After more than 5 decades of using stents there are promising advancements in their designs and materials aiming to maintain their patency and control stent-related symptoms. Long-term metallic stents and coated stents are good options that should be considered in selected patients. Biodegradable stents are promising developments but not sophisticated yet. Pain medication, alpha-blocker and antimuscarinic medications are still frequently used and necessary. Treatment combinations can result in better outcomes than monotherapy.