Molecular tumor boards (MTBs) are essential for selecting therapies for patients with rare and advanced cancers. We hypothesized that integrating biomarkers beyond targeted DNA/RNA next-generation sequencing (NGS) could increase actionable findings. Human epidermal growth factor receptor 2 (HER2)-low status has emerged as a critical biomarker in breast cancer, with potential relevance across other tumor types. Homologous recombination deficiency (HRD) is pivotal for the application of Poly(ADP-Ribose)-Polymerase (PARP) inhibitors in ovarian and breast cancer, although its role in other malignancies remains unclear. Antibody–drug conjugates (ADCs) are expanding precision oncology, with promising biomarkers like Trop-2, Nectin-4, and folate receptor alpha (FRα) showing potential across multiple tumor entities. Tumors were analyzed using the TSO500® panel, enabling tumor mutational burden (TMB) readout. HER2 status was assessed via immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), alongside antibody–drug conjugate (ADC) IHC, microsatellite instability (MSI) polymerase chain reaction (PCR), mismatch repair (MMR) IHC, programmed death-ligand 1 (PD-L1) IHC, and HRD analysis. Cases were discussed weekly, and outcomes were systematically tracked. Data analysis evaluated the benefit of additional biomarker assessments. Among 658 patients, 329 received therapy recommendations, 182 based on supplementary biomarker analyses. One hundred recommendations were implemented, with 37

BACKGROUND AND OBJECTIVE:In metastatic hormone-sensitive prostate cancer (mHSPC), first-line treatment with either docetaxel + androgen deprivation therapy (ADT) or androgen receptor pathway inhibitors (ARPI) + ADT represented the standard of care. Triplet therapy (docetaxel + ARPI + ADT) has shown superiority over docetaxel + ADT, leading to regulatory approval. However, real-world data directly comparing ARPI + ADT and triplet therapy are lacking. This study evaluates real-world outcomes across 3 treatment regimens using inverse probability of treatment weighting (IPTW). METHODS:We retrospectively analyzed data from 13 centers of men with mHSPC treated with docetaxel + ADT, ARPI (apalutamide or enzalutamide) + ADT, or darolutamide + docetaxel + ADT. The primary endpoint was progression-free survival (PFS); secondary endpoints included adverse events. To address baseline imbalances, IPTW was employed. Time-to-event data were analyzed using weighted Cox proportional hazards regression with robust variance estimation. RESULTS:After excluding incomplete cases, 346 men were analyzed: 58 (16.8%) received docetaxel + ADT, 203 (58.7%) ARPI + ADT, and 85 (24.6%) triplet therapy. Before weighting, triplet patients demonstrated more adverse baseline features. After achieving covariate balance through IPTW adjustment, no significant differences in PFS were observed, with hazard ratios of 1.60 (95% CI: 0.78-3.28, P = 0.20) for docetaxel + ADT and 0.70 (95% CI: 0.36-1.35, P = 0.29) for ARPI + ADT compared to triplet therapy. Grade ≥3 adverse events occurred in 36.2%, 10.9%, and 31.8% of patients, respectively (P < 0.001). CONCLUSIONS:In this IPTW-adjusted real world cohort, triplet therapy was not significantly associated with improved PFS compared to ARPI + ADT or docetaxel + ADT. These findings should be interpreted in the context of limited sample size and follow-up, and further prospective studies are warranted.

BACKGROUND AND OBJECTIVE:Multidisciplinary tumor boards (MTBs) are the gold standard for oncological treatment planning, but their implementation is resource intensive. Large language models (LLMs) such as ChatGPT-4 and Claude 3.5 Sonnet have emerged as scalable tools for clinical decision support. As their comparative performance in urological oncology remains largely untested in prospective trials, this study aimed to prospectively evaluate them against real MTBs. METHODS:In this prospective, multicenter, noninferiority study (DRKS00034797), we evaluated whether therapeutic recommendations by ChatGPT-4 and Claude 3.5 Sonnet were noninferior to those of MTBs across 110 representative case scenarios involving locally advanced or metastatic genitourinary cancer. Standardized prompts elicited recommendations from both LLMs, which were rated independently by two blinded uro-oncologists using the validated modified System Causability Scale (mSCS). The predefined noninferiority margin was 0.15 mSCS points. KEY FINDINGS AND LIMITATIONS:The mean mSCS score of the MTBs was 0.849 (standard deviation [SD] = 0.157), setting the noninferiority margin at 0.699. Claude 3.5 Sonnet scored 0.731 (SD = 0.178; 95% confidence interval [CI]: 0.697-0.765), narrowly missing noninferiority. ChatGPT-4 scored 0.660 (SD = 0.193; 95% CI: 0.623-0.696), clearly below the margin. A subgroup analysis revealed better LLM performance in locally advanced versus metastatic cases (p < 0.05). Limitations include the use of synthetic cases and inherent LLM output variability. CONCLUSIONS AND CLINICAL IMPLICATIONS:Neither LLM matched the MTB standards. These findings highlight the current limitations of public LLMs, or of their use in our study, in supporting complex oncological decisions. This underscores the need for further validation and contextual refinement before integration into multidisciplinary care.

498 Background: IO-based combination therapies - either in combination with tyrosine kinase inhibitors (TKI) or as double checkpoint inhibition - have revolutionized first-line treatment of ccRCC patients. We compared tolerability and effectiveness of ipilimumab plus nivolumab (ipi/nivo), cabozantinib plus nivolumab (cabo/nivo), axitinib plus pembrolizumab (axi/pem), and lenvatinib plus pembrolizumab (len/pem) as first-line treatment in real-world cohorts. Methods: Data from retrospective, multicenter cohorts of advanced ccRCC patients were analyzed. Best response was evaluated by local investigators. Adverse events (AE) were assessed according to CTCAE v5.0. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. The log-rank test was used to calculate statistical differences between the cohorts. Results: A total of 543 patients were included in this analysis. Median age of all patients was 65 years (range 21-88), most patients were male (70%). Median number of affected organs were 2 and sites of metastases were comparable between treatment regimens. Key data on IMDC risk group distribution, median follow-up (FU), best response, disease control rate, median PFS, median PFS by IMDC risk group, 1-year OS-rate and occurrence of AEs by treatment regimens are depicted in the table. PFS was significantly superior for IO/TKI combinations compared to Ipi/Nivo (p=0.021). At a median FU of 21.2 months (95%CI 19.7-22.7) for all patients, 51% of patients had disease progression and 26% of patients died. Conclusions: IO/TKI combinations demonstrated significantly better PFS compared to IO/IO as first-line treatment for ccRCC patients. However, no specific IO/TKI regimen showed clear superiority over others, and 1-year OS rate was encouraging across all cohorts. Factors such as IMDC risk, comorbidities, AE profiles and individual treatment goals should be considered when tailoring therapy. Key limitations include the retrospective design, which introduces potential selection and recall biases, varying cohort sizes, the different and limited follow-up time between cohorts and limited OS events. Ipi/Nivo(n=251) Cabo/Nivo(n=47) Axi/Pem(n=118) Len/Pem(n=127) IMDC risk group- fav. risk- int./poor risk 8%92% 34%60% 24%72% 27%73% Median FU in mo. (95%CI) 32.1 (27.5-36.7) 14.0 (10.1-17.8) 22.5 (19.7-25.3) 14.7 (11.3-18.1) Best Response (CR rate) 40% (10%) 49% (2%) 64% (7%) 67% (7%) Disease control rate 64% 68% 86% 78% Median PFS (95%CI)- IMDC fav. risk- IMDC int./poor risk 9.0 (5.8-12.2)7.3 (6.9-7,7)9.7 (6.3-13.1) 16.1 (4.9-27.3)13.0 (6.8-19.2)10.7 (n.e.) 16.8 (10.4-23.2)25.4 (10.0-40.8)12.9 (9.4-16.4) 22.2 (11.7-23.7)22.2 (15.6-28.8)12.2 (0-24.6) 1 y OS rate (95%CI) 81.0 (75.8-86.2) 78.0 (63.8-92.2) 90.6 (84.8-96.4) 78.7 (70.5-86.9) AEs any grade 78% 79% 92% 95% AEs ≥ grade 3 40% 47% 47% 61%

e16548 Background: Patients with terminal renal failure (GFR <30 ml/min or dialysis), poor performance status (ECOG ≥2), and/or age ≥80 are often excluded or underrepresented in pivotal clinical trials evaluating enfortumab vedotin and pembrolizumab (EV/P) as first-line (1L) treatment in metastatic urothelial carcinoma (mUC). Consequently, data on safety and efficacy in these populations are limited. This study evaluates EV/P outcomes in this high-risk group. Methods: This multicenter, real-world, retrospective study included mUC patients receiving EV/P as 1L treatment who were underrepresented (age ≥ 80) or ineligible for the EV-302 trial due to GFR <30 ml/min, ECOG ≥2. Endpoints included overall and progression free survival (OS, PFS), objective response rate (ORR), and treatment-related adverse events (AE). Descriptive and survival analyses evaluated safety and efficacy in frail patients. Results: A total of 116 patients from 18 German tertiary care centers were treated between May 2022 and December 2024. The median age was 79 years (IQR 68–83), with 20.7% having a GFR <30 ml/min, 44.8% presenting with ECOG ≥2, and 49.1% aged ≥80. The median age-adjusted Charlson Comorbidity Index was 6 (IQR 4–8), highlighting the high burden of comorbidities in this population. The ORR was 54.1%, including an 8.1% complete response rate. The mPFS was 7.5 months (95% CI 5.9–NR), and the mOS was not reached. Any-grade AEs were reported in 72.2% of patients, with ≥grade 3 AEs in 31.3%. The most common treatment-related AEs were peripheral neuropathy (33.0%) and skin toxicity (23.3%). Among patients aged ≥80, 39% required dose reductions, compared to 31% in the overall cohort, occurring after a median of 68 days (IQR 42–137). Of all patients, 18.1% discontinued treatment due to progressive disease, with only 31.3% of them receiving subsequent anti-cancer therapy. In contrary a total of 26.7% of patients permanently discontinued EV/P due to toxicity or non-specified reasons, with a median treatment duration of 89 days (IQR 40–180). Conclusions: This retrospective real-world analysis suggests that EV/P demonstrates promising oncological efficacy, even in highly frail patients, including those with a GFR <30 ml/min, ECOG ≥2, or aged ≥80 years. However, frequent discontinuations in absence of disease progression underscore the need for prospective studies to evaluate more tolerable regimens and treatment interruptions strategies.

715 Background: The prospective phase 3 study EV-302 demonstrated superiority regarding efficacy of Enfortumab vedotin plus Pembrolizumab (EVP) compared to platinum-based chemotherapy in patients (pts) that received first-line (1L) therapy for metastatic urothelial carcinoma (mUC). Since presentation of the data in September 2023 EVP was considered a new standard of care (SOC) however only approved in Europe in August 2024. We analyzed efficacy and safety outcomes of pts treated with EVP outside of clinical trials. Methods: Retrospective data were collected from 19 German academic and community hospitals for pts with metastatic UC who received EVP as off-label therapy when reimbursed by their insurance company before European Medicines Agency (EMA) approval, or as SOC treatment after EMA approval. Imaging and therapy management were in accordance with local standards. Adverse events (AEs) were reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. Median progression-free survival (mPFS) and overall survival (mOS) were estimated using the Kaplan-Meier method by local investigators. Results: We identified 215 pts for the safety cohort (all pts who received EVP at least once) and 164 pts for the efficacy cohort (all pts who received at least one staging or died prior to first planned imaging).The median age for the eligible patients was 71 yr (range 25-89). The Eastern Cooperative Oncology Group performance status (ECOG PS) was 0/1/2/3-4/unknown for 46.0/31.6/17.2/4.7/0.5% of patients. The overall response rate was 60.7% (partial response 51.0%, complete response 9.7%). mOS was not reached and mPFS was 13 mo (95% confidence interval 4.5-21.5). Any-grade AEs were observed in 73.0% and CTCAE grade ≥3 AEs in 30.2%. Any-grade immune-related AEs were observed in 37.7% and CTCAE grade ≥3 AEs in 16.7%. The most common AEs were peripheral sensory neuropathy (all grade: 30.2%) and skin toxicity (all grade:24.2%). No treatment-related fatal event occurred. Limitations include the retrospective design and short follow-up. Conclusions: Administration of EVP in a real-world patient population showed promising effectiveness and an acceptable toxicity profile. No new safety signals were reported. Our results support the use of EVP in 1L in pts with mUC. Updated data with longer follow-up will be presented at the meeting.

PURPOSE:The higher detection efficacy of PSMA PET for oligometastatic recurrence of prostate cancer has promoted new loco-regional treatment options. PSMA-targeted radioguided surgery (PSMA-RGS) was introduced to facilitate salvage surgery of small tumor deposits. The objectives of this retrospective analysis are to describe an independent single-center consecutive cohort of patients undergoing PSMA-RGS and to evaluate its clinical and oncological outcomes. METHOD:Between 2018 and 2022, 53 patients were treated with PSMA-RGS and 50 patients were available for final analyses. All patients were initially treated with radical prostatectomy (RP) and presented with biochemical recurrence (BCR) with at least one positive lesion on PSMA-PET imaging. After preparation of 99mTc-PSMA-I&S and intravenous injection, surgery was performed by using a gamma-probe intraoperatively. RESULTS:Median age was 70 years (IQR 65-73) and the median PSA at salvage surgery was 1.2 ng/mL (IQR 0.6-3.0). In all patients pathologically positive lesions could be removed during PSMA-RGS. 29 (58%) patients had one pathologically positive lesion, 14 (28%) had two and 7 (14%) had three or more, respectively. The overall complication rate was 26% with 4 (8%), 1 (2%), and 8 (16%) having Clavien-Dindo (CD) type I, II, and IIIb complications, respectively. During the follow-up period 31 (62%) patients experienced BCR and 29 (58%) received further therapy. CONCLUSIONS:PSMA-RGS is a promising treatment option to enhance salvage surgery in early biochemical recurrence. However, only 42% of the patients treated with PSMA RGS remain without a biochemical recurrence. Further research is mandatory to identify patients, who profit from PSMA-RGS.

357 Background: Data for cabozantinib after IO-combinations in metastatic renal cell carcinoma (mRCC) remain scarce. We therefore evaluated safety and effectiveness of cabozantinib after failure of IO-based therapies. Methods: Data from patients (pts) with mRCC and cabozantinib treatment after IO-based therapy was retrospectively collected from medical records. Primary endpoint was the incidence of serious adverse events (SAEs). Response rate was assessed clinically (CRR) and/or according to RECIST 1.1. Overall Survival (OS) and Progression Free Survival (PFS) were assessed from start of therapy and data were compared for pts with starting dose of 60 mg (cohort A) vs < 60 mg (cohort B) in a post-hoc analysis. Descriptive statistics and KM-plots were utilized, where appropriate. Results: This final analysis (cut off 08-Oct-21) assessed 56 eligible pts (71.4% male) with median age of 66 yrs. 87.5% (n = 49) had previous nephrectomy. 66.1% (n = 37) had clear cell RCC. 89.3% (n = 50) had ≥2 previous lines. ECOG ≤1 was 33.9% (n = 19). IMDC factors were 0 in 2 (3.6%), ≥1 in 21 (37.5%), missing in 31 pts (55.4%). 62.5% (n = 35) started at reduced dose. 55.4% (n = 31) required dose reductions and 1.8% (n = 1) discontinuation. Median treatment duration was 6.1 months (m). PR was 10.7% (n = 6), SD 19.6% (n = 11), PD 12.5% (n = 7) and missing in 57.1% (n = 32). Median OS and PFS were 15.34 m (95% CI 8.94, 20.93) and 6.34 m (95% CI 5.29, 8.25) in the ITT, 10.48 m (95% CI 6.01, 34.14) and 6.51 m (95% CI 2.99, 10.87) in cohort A and 16.46 m (95% CI 9.56, 23.33) and 6.34 m (95% CI 4.86, 8.71) in cohort B, respectively. All grade AEs and grade 3-5 AEs were 87.5% (n = 49) and 44.6% (n = 25) in the ITT, 95.0% (n = 19) and 55.0% (n = 11) in cohort A and 85.7% (n = 30) and 40.0% (n = 14) in cohort B. SAEs were reported in 21.4% (n = 12) of pts, which were 30.0% (n = 6) of cohort A and 17.1% (n = 6) of cohort B. Treatment related SAEs were reported in 10.7% (n = 6) of pts, which were 15.0% (n = 3) in cohort A and 8.6% (n = 3) in cohort B. Conclusions: Cabozantinib directly after IO therapy was safe and feasible. No new safety signals were reported. A reduced starting dose was frequently utilized and was not associated with adverse outcomes. Our data supports the use of cabozantinib after IO-failure. Major limitation was the retrospective nature of our study.[Table: see text]

Introduction: The aim of this study was to prove if the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic resulted in a delay in diagnosis and treatment of prostate cancer (PC). Methods: A monocentric, retrospective analysis was conducted at a university cancer center. Included were all patients with untreated PC diagnosed between January 2019 and December 2021. The observation covered 22 months of the SARS-CoV-2 pandemic and 14 months preceding it. Results: Nine hundred sixty-nine men prior (T0) and 1,343 during the pandemic (T1) were included. Mean age was 68.0 (SD 8.2). Median initial prostate-specific antigen was 8.1 ng/mL (T0) and 7.9 ng/mL (T1, p = 0.288). Time from biopsy to tumor board (T0: 1.3 months vs. T1: 0.9 months, p = 0.001), to staging (T0: 1.1 months vs. T1: 0.75 months, p = 0.707), and to therapy (T0: 3.0 months vs. T1: 2.0 months, p < 0.001) was shortened during the pandemic. Classified by d'Amico, a significant shift toward higher risk groups was seen (p = 0.024). Local staging showed an insignificant increase in locally advanced PCs. Metastatic diseases decreased from 10.3% to 8.9% (p = 0.433). Pathological staging showed pT3+ in 44.4% versus 44.7% (p = 0.565) and pN+ in 9.9% versus 9.6% (p = 0.899). Conclusion: Regarding the diagnosis and treatment of PC, we could not demonstrate any delays due to the SARS-CoV-2 pandemic.

436 Background: The standard first-line treatment for metastatic renal cancer (mRCC) combines immune checkpoint- (ICI) and tyrosine kinase inhibitors (TKI). While TKI therapy continues until disease progression, ICI treatment is typically stopped after 24 months or 35 cycles, aligning with approval study criteria. However, in real-world practice, the decision to discontinue ICI therapy upon achieving a positive response can be distressing for both patients and healthcare providers; thus ICIs are not stopped. We conducted an initial analysis of prolonged pembrolizumab (Pem) use in axitinib-pembrolizumab (Axi-Pem) combination therapy to evaluate its effects and toxicity. Methods: We retrospectively analyzed data from mRCC patients treated with first-line Axi-Pem in 10 German tertiary care centers between 2019 and 2023. After completing 35 cycles or 24 months of Pem, patients were offered continued ICI therapy if positive response was assessed. We calculated objective response rate (ORR) and progression-free survival (PFS) from the treatment start to achievement of 36 therapy months. Adverse events (irAEs) were reported following CTCAE 5.0 criteria. Results: Out of 72 patients, 27 met strict eligibility criteria from the Keynote-426 study (NCT02853331), with a response at 24 months and continuous Pem therapy. Patients had a median age of 65.7 years (range: 34-84), and IMDC risk was favorable/intermediate/poor in 22.2%/55.5%/18.5%. Median follow-up was 33.2 months (range: 25.3-48.4). At the 36-mos landmark, median PFS was not reached (PFS 64.7%), ORR was 63.6%, with complete response, partial response, and stable disease observed in 9.1%(1)/54.5%(6)/9.1%(1) of cases, respectively. Permanent Pem discontinuation occurred due to progressive disease in two cases and complete response in one case. Another case led to Pem discontinuation due to immune-related toxicity. Conclusions: In our selected real-world patient cohort seeking prolonged ICI therapy, responders who received continuous Pem beyond 24 months achieve sustained efficacy in first-line treatment. Furthermore, the incidence of irAEs does not increase with prolonged exposure to ICI therapy. Additional results beyond the 36-month landmark are urgently needed to further support the clinical necessity and feasibility of ongoing ICI treatment in light of its impact on the overall financial burden of cancer care.

Recurrent cystitis in women represents an everyday challenge; however, little to no data regarding this population are available. This study aimed to evaluate this collective with respect to a rational calculated antibiotic therapy. Urine cultures and antibiograms from a urological office were retrospectively evaluated from patient data collected between January 2017 and June 2019. The evaluation was conducted using SPSS ©. In total, 84 female patients, who were aged between 18 and 87 years old (median 60 years), suffered from recurrent cystitis. Escherichia coli was found in 53.9% of cases, Staphylococcus aureus and enterococci were each found in 6.7%, and Proteus spp. and Streptococcus agalactiae were each found in 5.6%. The resistance levels to ciprofloxacin (CIP), trimethoprim–sulfamethoxazole (TRS), nitrofurantoin (NIT), and nitroxoline (NOX) were 18.2%, 30.7%, 16.1%, and 12.5% in the tested cases, respectively. Regarding E. coli, resistance to CIP, TRS, and NIT was found in 17.8%, 25%, and 4.2% of the tested cases, and no resistance to NOX was found. The resistance level to CIP was in a tolerable range of <20% in the overall cohort and the E. coli subgroup. More than a quarter of the bacteria were resistant to TRS. The low resistance rates for NIT and NOX are remarkable, promoting the use of these substances if they are not yet used.

The integration of artificial intelligence, particularly Large Language Models (LLMs), has the potential to significantly enhance therapeutic decision-making in clinical oncology. Initial studies across various disciplines have demonstrated that LLM-based treatment recommendations can rival those of multidisciplinary tumor boards (MTBs); however, such data are currently lacking for urological cancers. This preparatory study establishes a robust methodological foundation for the forthcoming CONCORDIA trial, including the validation of the System Causability Scale (SCS) and its modified version (mSCS), as well as the selection of LLMs for urological cancer treatment recommendations based on recommendations from ChatGPT-4 and an MTB for 40 urological cancer scenarios. Both scales demonstrated strong validity, reliability (all aggregated Cohen’s K > 0.74), and internal consistency (all Cronbach’s Alpha > 0.9), with the mSCS showing superior reliability, internal consistency, and clinical applicability (p < 0.01). Two Delphi processes were used to define the LLMs to be tested in the CONCORDIA study (ChatGPT-4 and Claude 3.5 Sonnet) and to establish the acceptable non-inferiority margin for LLM recommendations compared to MTB recommendations. The forthcoming ethics-approved and registered CONCORDIA non-inferiority trial will require 110 urological cancer scenarios, with an mSCS difference threshold of 0.15, a Bonferroni corrected alpha of 0.025, and a beta of 0.1. Blinded mSCS assessments of MTB recommendations will then be compared to those of the LLMs. In summary, this work establishes the necessary prerequisites prior to initiating the CONCORDIA study and validates a modified score with high applicability and reliability for this and future trials.

INTRODUCTION:The aim of this study was to assess the feasibility of sparing routine antibiotic prophylaxis in patients without preoperative urinary tract infection undergoing ureterorenoscopy (URS) for stone removal. METHODS:A retrospective, monocentric study was conducted to evaluate the outcome of a modified perioperative antibiotic management strategy according to the principles of antibiotic stewardship. Patients with preoperative unremarkable urine culture received no antibiotic prophylaxis for URS stone removal (NoPAP). The NoPAP group was compared to a historic URS cohort, when antibiotic prophylaxis (PAP) was standard of care. Analysis focused on postoperative complications. RESULTS:Postoperative fever occurred in 1% of the NoPAP and 2% of the PAP patients (p = 0.589). Clavien 1-3 complications did not differ between groups with 9% in the NoPAP and 6.2% in the PAP (p = 0.159). No Clavien 4-5 complications were seen. We identified a residual stone (p = 0.033) and an ASA score 3-4 (p = 0.004) as significant risk factors for postoperative fever. By sparing routine antibiotic prophylaxis, the overall antibiotic usage was reduced from 100% (PAP) to 8.3% (NoPAP). CONCLUSION:Sparing a routine antibiotic prophylaxis during URS for stone removal seems feasible in patients with unremarkable preoperative urine culture for most of the patients. A prospective validation is warranted.

Introduction: Combinations of immune-checkpoint inhibitors (ICIs) are the standard of care (SOC) for treatment-naive metastatic renal cell carcinoma (mRCC) patients. In this multicenter study, we evaluated the RW safety and efficacy of cabozantinib plus nivolumab in mRCC patients. Methods: Data were retrospectively collected from twelve cancer centers in Germany, Switzerland, and Austria. Patients with advanced or mRCC were eligible. The investigator-based objective response rate (ORR) and progression free survival (PFS) were calculated from the start of the treatment to progression or death. Descriptive statistics and Kaplan–Meier (KM) plots were utilized where appropriate. Results: In total, 96 eligible patients (66.6% male) with a median age of 66.0 years were included. The most common histology was clear-cell RCC (ccRCC) in 63.4% (n = 61). A prior nephrectomy was performed in 60.4% (n = 58). ECOG 0-1 was 68.8% (n = 66). A partial response was documented in 43.8% of patients (n = 42), a stable disease in 32.3% (n = 31), and a progressive disease in 8.3% (n = 8) as the best overall response. Response data were not evaluable in 13.5% (n = 13). The median follow-up time was 12.7 months (95% CI, 10.0–15.3). The PFS rate at 6 months was 89.8% in the overall population (86.8% for ccRCC; 90.0% for non-ccRCC). Adverse events (AEs) were reported in 82.3% (n = 79) for all grades and 41.7% (n = 40) for grades 3–5. Elevated liver enzymes (34.4%), diarrhea (31.3%), and hand–foot syndrome (29.2%) were the three most frequent AEs of any grade and causality. Discussion/Conclusions: In this real-world cohort of mRCC patients, the application of cabozantinib plus nivolumab was shown to be safe and feasible. Our data support the use of cabozantinib plus nivolumab as a first-line standard therapy in mRCC patients. Major limitations were the retrospective data capture and short follow-up time of our study.

Introduction Previous assumptions suggested that the technique of approximation without osteotomy in primary exstrophy repair (PER) could only be applied in newborns and anticipated poorer outcomes. Recent studies indicated that this technique can be successfully executed not only in immediate PER but also yields favorable long-term results. Therefore, we evaluated and compared the orthopaedic and radiological long-term outcomes after pubic symphysis approximation without osteotomy in immediate and delayed PER. Methods From March 2018 to December 2020, individuals with PER and approximation of the symphysis without osteotomy were recruited. Patients <12 years and with a history of orthopaedic surgery of the bony pelvis were excluded. Orthopaedic examinations and magnetic resonance imaging (MRI) of the bony pelvis including the hip joints were performed and pubic diastasis, the acetabulum angle (ACA), and the center-edge angle (CEA) were evaluated. Results Twenty-nine patients were included, 11 of them had an immediate and 18 had a delayed PER. Between the two groups, no significant differences could be observed concerning hip pain ( p = 0.419), mobility impairment ( p = 0.543), sports impairment ( p = 0.543), hip impingement ( p = 1.000), leg length discrepancy ( p = 0.505), and width of the pubic diastasis as measured by MRI ( p = 0.401). There were also no significant differences with regard to CEA right (median 30 degrees, p = 0.976), CEA left (median 31.5 degrees, p = 0.420), ACA right (median 19 degrees, p = 0.382), and ACA left (median 17 degrees, p = 0.880). Conclusion There were no significant differences in clinical orthopaedic or radiological long-term outcomes between bladder exstrophy patients after immediate and delayed bladder closure with symphysis approximation without osteotomy. Establishing core outcome sets is essential to get robust and comparable results, further advancing and substantiating our initial insights.

INTRODUCTION:According to guidelines, transrectal random biopsy of the prostate (TRBP) is performed under antibiotic prophylaxis (AP). Fosfomycin-trometamol (FOS) is not approved in Germany, but TRBP as indication was listed in the product information falsely. The aim was to investigate infectious complications of TRBP under FOS as a single dose. METHODS:All TRBPs under FOS 3,000 mg as a single dose between July 1, 2020, and June 30, 2021, at a university institution were recorded. 357 patients (41-85 years old, median 66) were included. 243 received first TRBP, 321 TRBP were MRI-fusionated. 10-22 cores were taken (median 14). Prostate-specific antigen (PSA) was 0.1-1224 ng/mL (median 7.7 ng/mL), prostate volume 5-263 mL (median 50 mL). Analysis was performed using Chi square test or Fisher's exact test, Mann-Whitney U test, and t test. RESULTS:Four patients suffered an infection (1.1%), without significant difference according to age (p = 0.849), PSA (p = 0.957), number of cores (p = 0.905), and increase in volume (p = 0.456). Limiting is the retrospective character. CONCLUSION:The complication rate was 1.1%, and FOS single dose therefore represents sufficient AP for TRBP in this collective. FOS as a single dose should be reevaluated in a prospective study to obtain approval in Germany for this indication.

Recently, the German Federal Institute for Medicines and Medical Products restricted the use of fosfomycin in transrectal biopsy of the prostate (TRBP). Accordingly, the need for other antibiotic agents for prophylaxis in TRBP is urgent since antibiotic prophylaxis is mandatory in accordance with these guidelines. After the restriction of the use of ciprofloxacin, and before the use of fosfomycin in Germany was falsely allowed, amoxicillin/clavulanic acid was evaluated as an alternative for antibiotic prophylaxis in TRBP. Regarding hospitalization for post-interventional infections, 359 patients at the Department of Urology of the University of Regensburg, at Caritas-St. Josef Medical Center as a single center, underwent TRBP between 2 July 2019 and 30 June 2020. Regarding antibiotic prophylaxis, the post-interventional hospitalization rate due to bacterial complications was relevant. Of the 359 patients, 10 (2.8%) had an infection requiring hospitalization post-TRBP. A total of 349 (97.2%) patients had no infection-related hospitalization. This corresponds to an incidence rate of only 2.8%. Referring to the previous infection rates under the now obsolete ciprofloxacin, amoxicillin/clavulanic acid can show a similar, if not tendentially even lower, risk of infection, and so this substance can be an alternative for antibiotic prophylaxis in TRBP. Another advantage is that, according to the WHO’s AWaRe classification, amoxicillin/clavulanic acid is one of the so-called Access antibiotics. This study is limited as rectal swabs and urine cultures were not performed on every patient before TRBP.