Resection Of Bladder Cancer Research Articles

P222 A randomized phase II trial comparing single dose perioperative instillation of intravesical gemcitabine versus mitomycin-C following complete resection of nonmuscle invasive bladder cancer: Evaluation of efficacy and tolerance

P222 A randomized phase II trial comparing single dose perioperative instillation of intravesical gemcitabine versus mitomycin-C following complete resection of nonmuscle invasive bladder cancer: Evaluation of efficacy and tolerance

Effect of extending the period from oral administration of 5-aminolevulinic acid hydrochloride to photodynamic diagnosis during transurethral resection for non-muscle invasive bladder cancer on diagnostic accuracy and safety: a single-arm multicenter phase III trial.

In Japan, the authorized period (2-4 h) between oral administration of 5-aminolevulinic acid hydrochloride (5-ALA) and transurethral resection for non-muscle invasive bladder cancer (NMIBC) may restrict photodynamic diagnosis (PDD) usage. Therefore, this prospective, single-arm, phase III study aimed to evaluate the diagnostic accuracy and safety of PDD at an extended administration period (4-8h). From January 2022 to May 2023, 161 patients with NMIBC were enrolled from eight hospitals. The primary endpoint was the blue light (BL) sensitivity of pathologically positive biopsies. The secondary endpoints were a comparison of the specificity and positive and negative prediction rates under BL and white light (WL) conditions. A total of 1242 specimens comprising 337 histological NMIBC specimens were analyzed. BL-sensitivity was 95.3%. Its lower limit of 95% confidence interval (92.4-97.3%) exceeded the threshold (70%) of non-inferiority to authorized usage. Sensitivity and specificity were significantly higher and lower for BL than those for WL (95.3% vs. 61.1%, P < 0.001; 52.7% vs. 95.2%, P < 0.001), respectively. The positive and negative predictive rates were significantly lower and higher for BL than those for WL (42.9% vs. 82.7%, P < 0.001; 96.8% vs. 86.8%, P < 0.001), respectively. Of the 145 patients receiving 5-ALA, 136 (93.8%) and 75 (51.7%) experienced 377 adverse events and 95 adverse reactions, respectively, most of which were grade 1 or 2. For extended period, the efficacy of PDD for NMIBC was similar to that of authorized period, in terms of higher sensitivity and lower specificity compared with WL, and the safety was acceptable.

Alopecia as an uncommon side effect of single postoperative instillation of gemcitabine in patients with non-muscle-invasive urothelial carcinoma of the bladder.

274 Background: Single-dose administration of intravesical gemcitabine is a common part of clinical practice following transurethral resection (TURBT) of non-muscle invasive bladder cancer (NMIBC). Although the side effect profile for gemcitabine is well characterized in systemic and local therapy, rare side effects continue to be identified with ongoing use. Here we identify several cases of treatment-related alopecia with adjuvant single dose intravesical administration for NMIBC after TURBT. Methods: Using our single-institutional IRB-approved Cysview registry database, we identified patients who underwent TURBT for NMIBC and received a single dose of intravesical gemcitabine post-TURBT between January 2020 and June 2023 at Keck Hospital of USC. Patients with a history of low grade NMIBC or those undergoing their first TURBT received 2g of gemcitabine dissolved in 100 cc of saline 1h after tumor resection. We reviewed patient-reported adverse events and included patients who reported alopecia following gemcitabine instillation. Patients were questioned on the degree and length of hair loss and information was collected from patient charts. Results: Overall, 9 patients (2 male, 7 female) reported hair loss following single dose intravesical gemcitabine after the TURBT. One patient had an autoimmune disease. The hair loss started within a few days of gemcitabine instillation and resolved spontaneously. The table shows the clinicopathologic characteristics of this cohort in detail. Three patients experienced severe hair loss. The resection extent during TURBT was classified as small (&lt;2 cm), medium (2-5 cm), or large (&gt;5 cm). Three patients had a large resection, 2 patients a medium one and 3 patients a small resection. None of the patients had previous intravesical gemcitabine; however, 2 patients had a history of intravesical BCG and 1 had intravesical mitomycin before. Conclusions: This study demonstrates that hair loss is a rare but possible adverse effect of intravesical gemcitabine after TURBT. Prior to surgery, patients should be counseled regarding this potential side-effect. Additional research and multicenter studies are required to describe the occurrence and cause of this adverse event. Demographic, clinical, and pathologic characteristics of patients. Patient ID Age Sex History of other IVT Pathology of TURBT Number of prior TURBT Resection extent Severity of hair loss Prior UBC 1 73 M None LGTa 1 large moderate LGTa 2 88 M MMC LGTa multiple large severe LGTa 3 76 F BCG CIS multiple small moderate HGT1 in upper tract,HGTa &amp; LGTa in bladder 4 56 F BCG HGTa multiple large severe LG+HGTa 5 66 F None HGTa none small moderate None 6 84 F None LGTa none small severe None 7 62 F None LGTa 1 medium moderate LGTa 8 68 F None HGTa multiple medium mild LGTa 9 64 F None LGTa none medium severe None LG= Low Grade, HG = High Grade.

Do we need a re-TUR after en bloc resection of T1 stage bladder cancer?

BackgroundA second look trans-urethral resection of the bladder (re-TUR) is recommended after the diagnosis of T1 high grade (T1HG) bladder cancer. Few studies have evaluated the results of re-TUR after a first en bloc resection (EBR) and none of them have specifically reported the pathological results on the field of previous T1 disease.ObjectiveTo report the rate of upstaging and the rate of residual disease (RD) on the field of T1HG lesions resected with EBR.Materials and methodsBetween 01/2014 and 06/2022, patients from 2 centers who had a re-TUR after an EBR for T1HG urothelial carcinoma were retrospectively included. Primary endpoint was the rate of RD including the rate of upstaging to T2 disease on the scar of the primary resection. Secondary endpoints were the rate of any residual disease outside the field.ResultsSeventy-five patients were included. No muscle invasive bladder cancer lesions were found after re-TUR. Among the 16 patients who had a RD, 4 were on the resection scar. All of these lesions were papillary and high grade. RD outside the field of the first EBR was observed in 12 patients.ConclusionAfter EBR of T1HG disease, none of our patients had an upstaging to MIBC. However, the rate of RD either on and outside the field of the EBR remains quite significant. We suggested that predictive factors of residual papillary disease (number of tumors at the initial TUR and concomitant CIS) might be suitable to select patient who will benefit of the re-TUR.

Targeting tumour surface collage with hydrogel probe: a new strategy to enhance intraoperative imaging sensitivity and stability of bladder cancer.

The incomplete resection of non-muscle invasive bladder cancer (NMIBC) augments the risk of disease recurrence. Imaging-guided surgery by molecular probes represents a pivotal strategy for mitigating postoperative recurrence. Traditional optical molecular probes, primarily composed of antibodies/peptides targeting tumour cells and fluorescent groups, are challenged by the high heterogeneity of NMIBC cells, leading to inadequate probe sensitivity. We have developed a collagen-adhesive probe (CA-P) to target the collagen within the tumour microenvironment, aiming to address the issue of insufficient imaging sensitivity. The distribution characteristics of collagen in animal bladder cancer models and human bladder cancer tissues were explored. The synthesis and properties of CA-P were validated. In animal models, the imaging performance of CA-P was tested and compared with our previously reported near-infrared probe PLSWT7-DMI. The clinical translational potential of CA-P was assessed using human ex vivo bladder tissues. The distribution of collagen on the surface of tumour cells is distinct from its expression in normal urothelium. In vitro studies have demonstrated the ability of the CA-P to undergo a "sol-gel" transition upon interaction with collagen. In animal models and human ex vivo bladder specimens, CA-P exhibits superior imaging performance compared to PLSWT7-DMI. The sensitivity of this probe is 94.1%, with a specificity of 81%. CA-P demonstrates the capability to overcome tumour cell heterogeneity and enhance imaging sensitivity, exhibiting favorable imaging outcomes in preclinical models. These findings provide a theoretical basis for the application of CA-P in intraoperative navigation for NMIBC.

Fluorescence imaging‐guided pelvic lymph node localization and resection of bladder cancer after intracutaneous injection of indocyanine green into the lower limbs and perineum

AbstractBackgroundPelvic lymph node dissection (PLND) in radical cystectomy (RC) is of great significance, but the method and scope of PLND remain controversial. Based on the principle of indirect lymphadenography, we designed a method to localize the whole pelvic lymph nodes by intradermal injection of indocyanine green (ICG) through the lower limbs and perineum, and to evaluate the effectiveness of this method.MethodsIn a single center, 54 bladder cancer patients who underwent RC and PLND participated in a prospective clinical trial, which began on February 28, 2022 and ended on December 30, 2022. ICG solution was injected subcutaneously at the medial malleolus of both lower extremities and at both sides of the midline of the perineum. The fluorescent laparoscopy was used to trace, locate, and remove the targeted areas under the image fusion mode. The consistency of lymph node resection was determined by histopathological diagnosis. The impact of ICG guidance on the surgical time of PLND was compared with that of 11 bladder cancer patients who underwent RC and PLND without ICG injection, serving as the control group.ResultsPerineal lower limb combined injection can provide comprehensive visualization of pelvic lymph nodes. This technique reduces PLND surgical time and increases the accuracy of PLND.ConclusionIntracutaneous injection of ICG into the lower limbs and perineum can specifically mark pelvic lymph nodes. Intraoperative fluorescence imaging can accurately identify, locate, and resect lymph nodes in the pelvic region, reducing PLND surgical time and increasing the accuracy of PLND.

Comparison of thulium and holmium lasers with conventional transurethral bladder resection for non-muscle invasive bladder cancer

Introduction. The gold standard of treatment for intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) is transurethral resection of the bladder (TURB) in combination with intravesical therapy. However, this procedure may cause serious complications. At the same time, studies of various lasers for the treatment of NMIBC have demonstrated their safety and efficacy. Despite this, the topic has not yet been fully explored and is not widely practiced in clinical oncology, making further research necessary.Objective. To compare thulium and holmium lasers with conventional TURB for management of non-muscle-invasive bladder cancer (NMIBC).Materials &amp; methods. In our study, depending on the treatment approach, 84 NMIBC-patients were divided into three groups. Group 1 included 27 patients (34.14%), who underwent laser thulium bladder resection; group 2 included 25 patients (29.76%), who underwent laser holmium bladder resection, and group 3 included 32 patients (38.1%), who underwent standard TURB. Prior to surgery, all patients received a standard set of preoperative general clinical and instrumental examinations for bladder cancer, and the choice of surgical approach was based on informed patient consent, taking into account the benefits and risks of the three treatment options. All surgeries were performed in accordance with established protocols.Results. In the TURB group, the surgery time was the longest and totalled in 20.5 ± 7.4 min. Laser technologies reduce the surgery time to 16.3 ± 5.3 min for a holmium laser and to 14.7 ± 5.2 min for a thulium laser. Also, in groups 1 and 2, a shorter duration of postoperative bladder irrigation was noted (4.4 ± 1.8 and 4.7 ± 1.6 hours) and shorter periods of postoperative bladder catheterisation (1.5 ± 0.08 and 1.6 ± 0.08 days) compared to group 3, where these indicators were 16.4 ± 2.5 hours and 2.5 ± 0.13 days, respectively. Among patients undergoing either holmium or thulium surgery, a higher rate of disease-free survival has been noted. Independent prognostic factors that influence the prognosis of NMIBC in all groups include the type of surgery, history of bladder tumors, and pathological stage.Conclusion. The use of laser technology, such as thulium and holmium laser, in bladder wall resection for NMIBC shows promising results and provides a good clinical outcome that is comparable to (and in some cases, superior to) standard TURB.

Comparison of PDD-TURBT alone versus white light TURBT plus intravesical BCG therapy: A propensity-score matching study

BackgroundAlthough photodynamic-diagnosed transurethral resection of bladder cancer (PDD-TURBT) and Bacillus Calmette-Guérin (BCG) intravesical instillation are the two representative therapies for non-muscle invasive bladder cancer (NMIBC), no studies directly compare their efficacy. We evaluated the outcome of PDD-TURBT alone compared with white light TURBT with intravesical BCG therapy and analyzed the efficacy of both therapies depending on the characteristics of the tumors. MethodsWe retrospectively analyzed intermediate- and high-risk NMIBC patients treated with PDD-TURBT alone (the PDD group) or white light TURBT with BCG therapy (the white light group) using propensity score matched analysis. ResultsIn the propensity score matched cohort, the 1-, 2-, and 3-year recurrence-free survival rates for the PDD group were 77.6 %, 64.1 %, and 48.1 %, respectively, compared to 84.6 %, 75.1 %, and 75.1 % for the white light group (p = 0.44, 0.27, 0.17, respectively). The difference in recurrence rates between the two groups tended to become more pronounced over time, although there was no significant difference. In the univariate and multivariate analysis, recurrence, multiplicity, and tumor grade were the significant prognostic factors of recurrence in the PDD group (p = 0.010, 0.047, 0.048, respectively). Long-term RFS was similar in the PDD and white light groups when the population was limited to the primary and single tumors, suggesting that PDD-TURBT alone may be sufficient in this spectrum of patients. ConclusionsPDD-TURBT alone is insufficient to control the long-term recurrence of bladder cancer but can be effective in selected cases such as primary and single tumors.

Tumor fraction and copy number burden from urinary cell-free tumor DNA (utDNA) to predict minimal residual disease prior to repeat-transurethral resection in high-risk non-muscle invasive bladder cancer (HR-NMIBC).

Tumor fraction and copy number burden from urinary cell-free tumor DNA (utDNA) to predict minimal residual disease prior to repeat-transurethral resection in high-risk non-muscle invasive bladder cancer (HR-NMIBC).

Factors Influencing Bladder Perforation during Transurethral Resection of Bladder Cancer: A Comprehensive Analysis.

Bladder perforation (BP) is one of the important complications during transurethral resection of bladder tumour (TURBT). Additionally, multiple factors can contribute to BP. Here, we investigated the rates of BP, specifically in variant histology of bladder cancer (BC), and examined the clinical follow-up of relevant patients. Of the 797 patients who underwent TURBT between 2015 and 2023, they were divided into two groups according to BP during the operation. Group 1 (n = 744) consisted of patients without BP, whereas Group 2 (n = 53) consisted of patients with BP. Demographic, operative, postoperative and follow-up data were investigated and analysed. Groups were examined in terms of causes of BP. Significance was set at p < 0.05. A significantly higher rate of BP was found in patients operated with bipolar energy (p = 0.027) than in their counterparts. In multivariable analysis, the presence of the obturator reflex during TURBT was significantly associated with an increased risk of BP (p < 0.001). We observed a statistically significant increase in the rate of BP in patients with a history of previous intravesical Bacillus Calmette-Guérin (BCG) therapy (p = 0.023). Variant histology was reported in 32 patients (4%). However, we could not find any statistically significant relationship between the development of BP and the variant histology of BC (p = 0.641). Multiple factors can affect BP during TURBT. Understanding the factors associated with BP is crucial for improving patient safety and outcomes. According to the results of the present study, the energy source, the presence of obturator reflex during TURBT and intravesical BCG therapy may increase BP. Nevertheless, the presence of variant histology was not significantly associated with BP.

A surgical checklist for optimizing the quality and outcomes of transurethral resection of bladder tumors: A literature review.

To preserve the bladder without compromising survival, further treatments need to be optimized to prevent the recurrence and progression of non-muscle invasive bladder cancer. In clinical practice, transurethral resection of bladder tumors is essential for bladder cancer management. The primary goal of surgery is to achieve accurate pathological evaluation and complete resection of bladder cancer; high resection quality is required for the procedure. A representative surrogate indicator of the resection quality is the presence of the detrusor muscle in the resection specimen. Therefore, complete visual resection of bladder cancer with a muscle layer is crucial for decreasing the recurrence and progression rates of non-muscle-invasive bladder cancer. However, this procedure is complex and requires sufficient experience and knowledge to be performed thoroughly, safely, and efficiently. Surgical checklists represent an approach to filling the knowledge and experience gaps and improving the quality and safety of surgery. By checking items during transurethral resection, it is expected that the recording of risk factors related to recurrence and progression will improve, the rate of visually complete resection with muscles will increase, and the rate of intravesical recurrence will decrease. The simplicity of checklists is an additional benefit. In recent years, surgical checklists have received increasing attention in order to achieve high-quality resections and reduce disparities between surgeons and institutions. This literature review outlines the evolving treatment strategies for patients with non-muscle-invasive bladder cancer, focusing on surgical checklists for the transurethral resection of bladder tumors.

MDER-Net: A Multi-Scale Detail-Enhanced Reverse Attention Network for Semantic Segmentation of Bladder Tumors in Cystoscopy Images

White light cystoscopy is the gold standard for the diagnosis of bladder cancer. Automatic and accurate tumor detection is essential to improve the surgical resection of bladder cancer and reduce tumor recurrence. At present, Transformer-based medical image segmentation algorithms face challenges in restoring fine-grained detail information and local boundary information of features and have limited adaptability to multi-scale features of lesions. To address these issues, we propose a new multi-scale detail-enhanced reverse attention network, MDER-Net, for accurate and robust bladder tumor segmentation. Firstly, we propose a new multi-scale efficient channel attention module (MECA) to process four different levels of features extracted by the PVT v2 encoder to adapt to the multi-scale changes in bladder tumors; secondly, we use the dense aggregation module (DA) to aggregate multi-scale advanced semantic feature information; then, the similarity aggregation module (SAM) is used to fuse multi-scale high-level and low-level features, complementing each other in position and detail information; finally, we propose a new detail-enhanced reverse attention module (DERA) to capture non-salient boundary features and gradually explore supplementing tumor boundary feature information and fine-grained detail information; in addition, we propose a new efficient channel space attention module (ECSA) that enhances local context and improves segmentation performance by suppressing redundant information in low-level features. Extensive experiments on the bladder tumor dataset BtAMU, established in this article, and five publicly available polyp datasets show that MDER-Net outperforms eight state-of-the-art (SOTA) methods in terms of effectiveness, robustness, and generalization ability.

ASO Author Reflections: Changes in the Urinary Microbiome After Transurethral Resection of Nonmuscle-Invasive Bladder Cancer: Insights from a Prospective Observational Study.

ASO Author Reflections: Changes in the Urinary Microbiome After Transurethral Resection of Nonmuscle-Invasive Bladder Cancer: Insights from a Prospective Observational Study.

Ileal Artery to Sigmoid Fistula Following Cystectomy and Radiation: A Case Report

Abstract Arterial-enteric fistulas are a rare but devastating complication that can occur as a result of surgery or radiation exposure. Although this condition is most frequently seen following manipulation of the vasculature, especially in the presence of the vascular graft, other causes have been reported. Twenty-five cases have been reported in the literature, mostly related to previous vascular grafts. We present a case of ileal artery to sigmoid colon fistulas caused by previous resection of bladder cancer and radiation.

Cross-sectional and longitudinal analyses of urinary extracellular vesicle mRNA markers in urothelial bladder cancer patients

We designed this multi-center prospective study with the following objectives: (1) the cross-sectional validation of extracellular vesicles (EV) mRNA markers to detect urothelial bladder cancer (UBC) before transurethral resection of bladder cancer (TURBT), and (2) the longitudinal validation of EV mRNA markers to monitor non-muscle invasive bladder cancer (NMIBC) recurrence after TURBT. EV mRNA markers evaluated in this study were KRT17, GPRC5A, and SLC2A1 in addition to two additional markers from literatures, MDK and CXCR2, and measured by quantitative RT-PCR with normalization by a reference gene (ALDOB). Diagnostic performances of EV mRNA markers were compared to conventional markers. Regarding the first objective, we confirmed that EV mRNA biomarkers in urine were higher in UBC patients, particularly those with higher stage/grade tumors, than in those without UBC (n = 278 in total) and the diagnostic performance of EV mRNA MDK and KRT17 outperformed conventional biomarkers with AUC 0.760 and 0.730, respectively. Concerning the second objective, we prospectively analyzed the time courses of EV mRNA markers while NMIBC patients (n = 189) (median follow-up 19 months). The expression of EV mRNA KRT17 was significantly high in patients with recurrence, while it gradually decreased over time in those without recurrence (p < 0.01).

The impact of the COVID-19 pandemic on longitudinal trends of surgical mortality and inpatient quality of care in Ontario, Canada.

Previous studies have shown the COVID-19 pandemic was associated with reductions in volume across a spectrum of non-SARS-CoV-2 hospitalizations. In the present study, we examine the impact of the pandemic on patient safety and quality of care. This is a retrospective population-based study of discharge abstracts. We applied a set of nationally validated indicators for measuring the quality of inpatient care to hospitalizations in Ontario, Canada between January 2010 and December 2022. We measured 90-day mortality after selected types of higher risk admissions (such as cancer surgery and cardiovascular emergency) and the rate of patient harm events (such as delirium, pressure injuries and hospital-acquired infections) occurring during the hospital stay. A total 13,876,377 hospitalization episodes were captured. Compared with the pre-pandemic period, and independent of SARS-CoV-2 infection, the pandemic period was associated with higher rates of mortality after bladder cancer resection (adjusted risk ratio [aRR] 1.20 (1.07-1.34)) and open repair for abdominal aortic aneurysm (aRR 1.45 (1.06-1.99)). The pandemic was also associated with higher rates of delirium (adjusted odds ratio [aOR] 1.04 (1.02-1.06)), venous thromboembolism (aOR 1.10 (1.06-1.13)), pressure injuries (aOR 1.28 (1.24-1.33)), aspiration pneumonitis (aOR 1.15 (1.12-1.18)), urinary tract infections (aOR 1.02 (1.01-1.04)), Clostridiodes difficile infection (aOR 1.05 (1.02-1.09)), pneumothorax (aOR 1.08 (1.03-1.13)), and use of restraints (aOR 1.12 (1.10-1.14)), but was associated with lower rates of viral gastroenteritis (aOR 0.22 (0.18-0.28)). During the pandemic, SARS-CoV-2-positive admissions were associated with a higher likelihood of various harm events. The COVID-19 pandemic was associated with higher rates of patient harm for a wide range of non-SARS-CoV-2 inpatient populations. Understanding which quality measures are improving or deteriorating can help health systems prioritize quality improvement initiatives. No patient or public contribution.

Performance of a tumor-informed molecular residual disease (MRD) assay in resected bladder cancer with mixed or pure variant histology: Analysis of a real-world multicenter cohort.

649 Background: Circulating tumor DNA (ctDNA)-based MRD assays can detect clinically occult disease with high sensitivity and specificity in patients with solid tumors. Previous trials that evaluated MRD testing in bladder cancer, such as ABACUS and IMVigor010, enrolled patients with a predominant urothelial carcinoma component. Given the known histological and molecular heterogeneity in urothelial carcinoma, we examined the prognostic value of a tumor-informed MRD assay in bladder cancer patients with mixed or pure variant histologies (M/VH). Methods: This retrospective study analyzed the results of post-cystectomy longitudinal ctDNA testing from a multi-institutional database of patients with urothelial carcinoma (n=205). A personalized, tumor-informed assay (Signatera, Natera, Inc.) was used for the detection and quantification of ctDNA. Patients with M/VH and at least 3 months of postoperative follow-up data on relevant demographic, clinical, pathologic, and NGS variables were eligible for inclusion. Time-dependent Cox regression analyses were performed for disease-free survival (DFS) based on ctDNA during the MRD window (&lt;12 weeks from surgery, N=29) and surveillance window (&gt;12 weeks post-surgery or post-AT, N=29). Multivariable regression was performed to adjust hazards for clinicopathologic factors predicting DFS. Results: Of the 205 patients, 46 (74% male, median age: 69 years) met the inclusion criteria for analysis. Whole exome sequencing of tumor tissue revealed that TP53 (45.7%), ARID1A (32.6%), and KDM6A (30.4%) were the top three genes with somatic mutations. Twenty-seven (59%) patients received neoadjuvant therapy, 37% of whom (10/27) also received adjuvant therapy. ctDNA-positivity during the MRD window and during surveillance was strongly associated with poor DFS (MRD window: HR=4.93, 95%CI: 1.77-20.77, p=0.03; surveillance: HR=28.3, 95% CI: 3.52-3660, p&lt;0.001). None of the serially ctDNA-negative patients (N=25) recurred, whereas 58.9% (10/17) of patients who were ctDNA-positive anytime post-surgery recurred at a median follow-up of 9 months from the date of surgery, range: 3.1-36.4 months). When adjusted for all other risk factors, ctDNA-positivity anytime post-surgery was the only significant predictor of recurrence (HR=55.26, 95%CI: 5.3-7648, p&lt;0.00001). Conclusions: Personalized, tumor-informed ctDNA testing can identify patients with mixed or variant histology bladder cancer who are at high risk of recurrence. Further studies are warranted to evaluate the potential benefit of ctDNA-guided adjuvant therapy in this patient population.

Efficacy and safety of the combination of cisplatin plus nab-paclitaxel and nivolumab with radiotherapy after maximal tumor resection in non-metastatic muscle invasive bladder cancer (CNN-BC trial).

TPS723 Background: The therapeutic gold standard for muscle invasive bladder cancer (MIBC) is radical cystectomy (RC) preceded by neoadjuvant chemotherapy when appropriate. However, RC is a major surgery procedure with 13% rate of severe complication and a perioperative mortality rate of about 1.5 - 5 %. Trimodal therapy (TMT) is a “bladder sparing” option alternative to RC. TMT consists of complete transurethral bladder tumor resection (TURBT) followed by a combination of systemic chemotherapy and locoregional radiotherapy (RT), with the option of “salvage” cystectomy in case of local treatment failure. Immunotherapy with anti-PD1/PD-L1 monoclonal antibody significantly improves survival of metastatic BC patients, and it seems to potentiate the activity of RT without increased toxicity. Therefore, we investigate the role of a multimodal TMT strategy to increase the disease-free survival (DFS) and avoid or delay RC in non-metastatic MIBC pts. Methods: CNN-BC trial (NCT05203913) is a phase 2, open-label, mono-institutional study evaluating the activity and safety of TMT with cisplatin, nab-paclitaxel and nivolumab as systemic therapy in non-metastatic MIBC pts. Eligible pts should have undergone complete TURBT with diagnosis of T2-T3 N0M0 urothelial carcinoma, and no evidence of lymph nodes or metastatic disease at FDG-PET within 6 weeks from the start of treatments. TMT consists of nivolumab (480 mg IV every 4 weeks for a total of 13 doses), weekly nab-paclitaxel (60mg/m2) plus cisplatin (20mg/m2) administered concurrently with RT (60Gy in 25 fractions over 5 weeks on original bladder tumor, plus a concomitant boost of 50Gy in 25 fractions on whole bladder and pelvic nodes). The primary endpoint is the 1-year DFS rate, defined as the rate of survival free of recurrence in pelvic nodes or bladder, or appearance of distant metastases. Secondary endpoints include: the rate of pts who require salvage cystectomy, the rate of locoregional complete response (CR) and of locoregional DFS, median DFS, safety, and quality of life. Exploratory biomarkers analysis will be performed. The trial is actively recruiting. Clinical trial information: NCT05203913 .

Preoperative CT-based deep learning radiomics model to predict lymph node metastasis and patient prognosis in bladder cancer: a two-center study

ObjectiveTo establish a model for predicting lymph node metastasis in bladder cancer (BCa) patients.MethodsWe retroactively enrolled 239 patients who underwent three-phase CT and resection for BCa in two centers (training set, n = 185; external test set, n = 54). We reviewed the clinical characteristics and CT features to identify significant predictors to construct a clinical model. We extracted the hand-crafted radiomics features and deep learning features of the lesions. We used the Minimum Redundancy Maximum Relevance algorithm and the least absolute shrinkage and selection operator logistic regression algorithm to screen features. We used nine classifiers to establish the radiomics machine learning signatures. To compensate for the uneven distribution of the data, we used the synthetic minority over-sampling technique to retrain each machine-learning classifier. We constructed the combined model using the top-performing radiomics signature and clinical model, and finally presented as a nomogram. We evaluated the combined model’s performance using the area under the receiver operating characteristic, accuracy, calibration curves, and decision curve analysis. We used the Kaplan–Meier survival curve to analyze the prognosis of BCa patients.ResultsThe combined model incorporating radiomics signature and clinical model achieved an area under the receiver operating characteristic of 0.834 (95% CI: 0.659–1.000) for the external test set. The calibration curves and decision curve analysis demonstrated exceptional calibration and promising clinical use. The combined model showed good risk stratification performance for progression-free survival.ConclusionThe proposed CT-based combined model is effective and reliable for predicting lymph node status of BCa patients preoperatively.Critical relevance statementBladder cancer is a type of urogenital cancer that has a high morbidity and mortality rate. Lymph node metastasis is an independent risk factor for death in bladder cancer patients. This study aimed to investigate the performance of a deep learning radiomics model for preoperatively predicting lymph node metastasis in bladder cancer patients.Key points• Conventional imaging is not sufficiently accurate to determine lymph node status.• Deep learning radiomics model accurately predicted bladder cancer lymph node metastasis.• The proposed method showed satisfactory patient risk stratification for progression-free survival.Graphical

Clinical features and oncological outcomes of bladder cancer microsatellite instability.

Excellent anticancer effect for solid tumors with microsatellite instability (MSI)-high by anti-PD-1 antibody has been reported. In this study, we investigated the clinical impact of MSI status in bladder cancer. This study included 205 Japanese patients who underwent transurethral resection for bladder cancer between 2005 and 2021. The prevalence rates of microsatellite stable (MSS), MSI-low (MSI-L), and MSI-high (MSI-H) were determined using molecular testing. We examined the association of MSI status (MSS versus MSI-L/H) with clinicopathological characteristics and oncological outcomes. MSI-L/H tumors were associated with higher T-category in non-muscle invasive bladder cancer (NMIBC). Additionally, MSI-L/H tumors were associated with a higher risk of intravesical recurrence in NMIBC patients treated with intravesical bacillus Calmette-Guérin (BCG) but not with non-BCG therapy. This study suggested that the MSI status might serve as a predictive marker for intravesical recurrence after BCG intravesical therapy in NMIBC and highlighted an unmet need for an alternative treatment in patients with MSI-L/H tumors.