Search

This fourth edition of the Japanese Clinical Practice Guidelines for Prostate Cancer 2023 is compiled. It was revised under the leadership of the Japanese Urological Association, with members selected from multiple academic societies and related organizations (Japan Radiological Society, Japanese Society for Radiation Oncology, the Department of EBM and guidelines, Japan Council for Quality Health Care (Minds), Japanese Society of Pathology, and the patient group (NPO Prostate Cancer Patients Association)), in accordance with the Minds Manual for Guideline Development (2020 ver. 3.0). The most important feature of this revision is the adoption of systematic reviews (SRs) in determining recommendations for 14 clinical questions (CQs). Qualitative SRs for these questions were conducted, and the final recommendations were made based on the results through the votes of 24 members of the guideline development group. Five algorithms based on these results were also created. Contents not covered by the SRs, which are considered textbook material, have been described in the general statement. In the general statement, a literature search for 14 areas was conducted; then, based on the general statement and CQs of the Japanese Clinical Practice Guidelines for Prostate Cancer 2016, the findings revealed after the 2016 guidelines were mainly described. This article provides an overview of these guidelines. [ABSTRACT FROM AUTHOR]

Renal cell carcinoma (RCC) was diagnosed in over 400 000 individuals globally in 2020, making it a significant global health concern. The incidence of RCC varies by region and overall mortality rates have been declining. This decline is attributed in part to advancements in early cancer detection through imaging and the development of more effective systemic therapies. Cytoreductive nephrectomy (CN) was adopted as a standard treatment for metastatic RCC (mRCC) based on clinical experience and early clinical trials. However, the treatment landscape has shifted with the introduction of tyrosine kinase inhibitors (TKI) in 2007 and, more recently, immune checkpoint inhibitors (ICIs). Dual ICI therapy and combinations of ICIs with TKIs are collectively referred to as immuno‐combination therapies and have become standard first‐line treatments. This review examines the evolving role of CN in the era of immuno‐combination therapies, with a focus on patient selection and the timing of surgery. The immunogenic nature of RCC, characterized by spontaneous tumor regression and immune cell infiltration, suggests a potential benefit from combining CN with ICI therapy to enhance treatment outcomes. This is supported by several clinical studies that reported improved outcomes; however, these were limited by their retrospective nature. Ongoing clinical trials, such as NORDIC‐SUN, PROBE, and SEVURO‐CN, are expected to provide critical insights into the role of CN in the ICI era. Their findings will ultimately guide future clinical decision‐making and further refine treatment strategies for mRCC. [ABSTRACT FROM AUTHOR]

Background: Surgical resection for pheochromocytoma (PCC) is still challenging. This study assessed the perioperative outcomes of adrenalectomy for PCC and investigated the risk factors for intraoperative hemodynamic instability (HI). Methods: This retrospective study included 571 patients with adrenal tumors who underwent adrenalectomy at Kobe University Hospital and other related hospitals between April 2008 and October 2023. The perioperative outcomes of laparoscopic adrenalectomy were compared between PCC (n = 92) and non‐PCC (n = 464) groups. In addition, we investigated several potential risk factors for intraoperative HI in patients with PCC (n = 107; open, n = 11; laparoscopic, n = 92; robot‐assisted, n = 4). Results: While patients with PCC had a significantly larger amount of blood loss in comparison to those with non‐PCC (mean, 70 and 30 mL, respectively; p = 0.004), no significant difference was observed in the rate of perioperative grade ≥III complications (1.1% vs. 0.6%; p = 0.516), and no perioperative mortality was observed in either group. A tumor size of ≥40 mm, with preoperative hypertension and urinary metanephrines at a level ≥3 times the upper limit of the normal value, were found to be significant predictors of HI, with odds ratios of 2.74 (p = 0.025), 3.91 (p = 0.005), and 3.83 (p = 0.004), respectively. Conclusions: Our data suggest that laparoscopic adrenalectomy for PCC may be as safe as that for other types of adrenal tumors and that large tumors and hormonally active disease may be risk factors for intraoperative HI. The optimal perioperative management for PCC with these risk factors should be established. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare the prognostic outcomes between metastatic castration‐sensitive prostate cancer (mCSPC) patients receiving conventional androgen deprivation therapy (ADT) and those receiving ADT plus a novel androgen‐receptor signaling inhibitor (ARSI) in routine clinical practice in Japan. Methods: This was conducted as a retrospective multicenter study including 581 mCSPC patients, consisting of 305 receiving ADT alone or in combination with bicalutamide (group 1) and 276 receiving ADT plus one of the following ARSIs: abiraterone acetate, apalutamide, or enzalutamide (group 2). Prognostic outcomes between these 2 groups were comprehensively compared. Results: In the entire cohort, prostate‐specific antigen—progression‐free survival (PSA‐PFS) in group 2 was significantly longer than that in group 1, while no significant difference was noted in overall survival (OS) between the two groups. In patients corresponding to the LATITUDE high‐risk group, however, both PSA‐PFS and OS in group 2 were significantly longer than those in group 1. Of several factors examined, the following were identified as independent predictors of poor PSA‐PFS in the entire cohort as well as the LATITUDE high‐risk group: high C‐reactive protein, high lactate dehydrogenase, high alkaline phosphatase, high Gleason score, and group 1. Furthermore, it was possible to precisely classify both the entire cohort and LATITUDE high‐risk group into 3 risk groups regarding PSA‐PFS according to the positive numbers of independent factors: positive for ≤1 factor, favorable; 2 factors, intermediate; and ≥3 factors, poor. Conclusion: Combined use of ARSIs with ADT could improve the prognostic outcomes of mCSPC patients, particularly those in the LATITUDE high‐risk group, in real‐world clinical practice in Japan. [ABSTRACT FROM AUTHOR]

Objectives: In a primary analysis of data from the BRIGHT study (UMIN000035712), photodynamic diagnosis‐assisted transurethral resection of bladder tumor (PDD‐TURBT) using oral 5‐aminolevulinic acid hydrochloride reduced residual tumors in high‐risk non‐muscle invasive bladder cancer (NMIBC). We aimed to evaluate the effectiveness of PDD‐TURBT for intravesical recurrence after a second transurethral resection for high‐risk NMIBC. Methods: High‐risk NMIBC patients initially treated with PDD‐TURBT (PDD group) were prospectively registered between 2018 and 2020. High‐risk patients with NMIBC who were initially treated with white‐light TURBT (WL group) were retrospectively registered. Intravesical recurrence‐free survival after the second transurethral resection was compared between the PDD and WL groups using propensity score matching analysis. Results: In total, 177 patients were enrolled in the PDD group, and 306 patients were registered in the WL group. After propensity score matching (146 cases in each group), intravesical recurrence within 1 year was significantly less frequent in the PDD group than in the WL group (p = 0.004; hazard ratio [HR] 0.44, 95% confidence interval [CI]: 0.25–0.77). In subgroup analysis, PDD‐TURBT showed a particularly high efficacy in reducing intravesical recurrence within 1 year, especially in cases of tumors measuring less than 3 cm (p = 0.003; HR 0.31, 95% CI: 0.14–0.67), absence of residual tumor at second transurethral resection (p = 0.020; HR 0.37, 95% CI: 0.16–0.86), and no postoperative intravesical Bacillus Calmette‐Guérin therapy (p < 0.001; HR 0.27, 95% CI: 0.13–0.58). Conclusions: PDD‐TURBT may reduce short‐term intravesical recurrence in patients with high‐risk NMIBC. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to compare clinical outcomes between patients receiving second TUR after initial white‐light transurethral resection of bladder tumor (WL‐TURBT) and initial photodynamic diagnosis (PDD)‐assisted TURBT. Methods: A total of 1007 patients were divided into four groups based on the treatment pattern: WL‐TURBT with second TUR (161 patients, WL‐second group) or without second TUR (540 patients, WL‐alone group) and PDD‐TURBT with second TUR (112 patients, PDD‐second group) or without second TUR (194 patients, PDD‐alone group). Oncologic outcomes (bladder cancer recurrence, progression, urothelial cancer‐specific mortality) and rates of residual tumor and risk stratification of non‐muscle‐invasive bladder cancer (NMIBC) after second TUR were evaluated. Results: After propensity score‐matching 121 patients were included each in the WL‐alone and WL‐second groups, and 63 patients each in the PDD‐alone and PDD‐second groups. In the WL group, the second TUR was significantly associated with improved progression‐free (p = 0.012) and urothelial cancer‐specific free survival (p = 0.011), but not with recurrence‐free survival (p = 0.93). Patients initially treated with PDD‐TURBT, and with a tumor diameter <30 mm and multifocality had a relatively high benefit from second TUR. The rates of residual tumor and risk stratification of NMIBC did not significantly differ between WL‐TURBT and PDD‐TURBT groups. Conclusions: Our findings suggested that a second TUR could be omitted after an initial PDD‐TURBT in selected patients with high‐risk NMIBC. [ABSTRACT FROM AUTHOR]

Objectives: The JAVELIN Bladder 100 phase 3 trial showed that avelumab first‐line maintenance + best supportive care significantly prolonged overall survival and progression‐free survival versus best supportive care alone in patients with advanced urothelial carcinoma who were progression‐free following first‐line platinum‐based chemotherapy. We report findings from J‐AVENUE (NCT05431777), a real‐world study of avelumab first‐line maintenance therapy in Japan. Methods: Medical charts of patients with advanced urothelial carcinoma without disease progression following first‐line platinum‐based chemotherapy, who received avelumab maintenance between February and November 2021, were reviewed. Patients were followed until June 2022. The primary endpoint was patient characteristics; secondary endpoints included time to treatment failure and progression‐free survival. Results: In 79 patients analyzed, median age was 72 years (range, 44–86). Primary tumor site was upper tract in 45.6% and bladder in 54.4%. The most common first‐line chemotherapy regimen was cisplatin + gemcitabine (63.3%). Median number of chemotherapy cycles received was four. Best response to chemotherapy was complete response in 10.1%, partial response in 58.2%, and stable disease in 31.6%. Median treatment‐free interval before avelumab was 4.9 weeks. With avelumab first‐line maintenance therapy, the disease control rate was 58.2%, median time to treatment failure was 4.6 months (95% CI, 3.3–6.4), and median progression‐free survival was 6.1 months (95% CI, 3.6–9.7). Conclusions: Findings from J‐AVENUE show the effectiveness of avelumab first‐line maintenance in patients with advanced urothelial carcinoma in Japan in clinical practice, with similar progression‐free survival to JAVELIN Bladder 100 and previous real‐world studies, supporting its use as a standard of care. [ABSTRACT FROM AUTHOR]

Objectives: We assessed preoperative factors predicting the poor therapeutic efficacy of holmium laser enucleation of the prostate (HoLEP) in benign prostatic hyperplasia (BPH) patients. Methods: The present study included 159 patients who underwent HoLEP between August 2015 and June 2021 at our institution. Overall therapeutic efficacy was divided into good and poor therapeutic efficacies according to changes in the international prostate symptom score (IPSS), IPSS quality of life (IPSS‐QOL), and the maximum urinary flow rate. Patients were divided into good and poor therapeutic efficacy groups based on findings obtained 3 months after HoLEP, and comparative assessments were performed between the two groups. Results: The therapeutic efficacy of HoLEP was poor in 53 (33.3%) out of 159 patients. Intravesical prostatic protrusion (IPP), IPSS, IPSS‐QOL, post‐void residual volume (PVR), and the presence of overactive bladder (OAB) were significantly higher in the poor therapeutic efficacy group than in the good therapeutic efficacy group. A multivariable analysis of several factors identified the preoperative presence of OAB and short IPP as independent risk factors for the poor therapeutic efficacy of HoLEP. When treatment efficacy was divided according to risk factors, poor therapeutic efficacy was observed in only 14% of patients with prolonged IPP and the absence of OAB. Conclusions: The therapeutic efficacy of HoLEP may be poor in patients with OAB and short IPP, resulting in the significant deterioration of lower urinary tract symptoms. Accordingly, it is important to consider the presence or absence of OAB and IPP measurements when selecting indications for HoLEP. [ABSTRACT FROM AUTHOR]

This article discusses recent advances in the treatment of metastatic and advanced urothelial cancer (UC). The adoption of maintenance avelumab following cisplatin therapy has expanded treatment options. The article highlights the effectiveness of enfortumab vedotin plus pembrolizumab (EVP) and nivolumab plus gemcitabine-cisplatin (NGC) based on results from phase III randomized trials. The article also introduces the "shiny method," an innovative analytical approach that uses artificial intelligence to reconstruct individual patient data from Kaplan-Meier curves for indirect clinical trial comparisons. The shiny method was used to compare the efficacy of novel systemic therapies for UC and investigate their application to clinical practice. The study found that EVP had a significantly improved prognosis compared to NGC and gemcitabine-cisplatin (GC), and NGC also showed a more favorable prognosis compared to GC. The article acknowledges the limitations of the study but concludes that the shiny method presents a promising avenue for indirect treatment comparisons and can contribute to clinical decision-making. [Extracted from the article]

Vascular endothelial growth factor receptor‐targeted tyrosine kinase inhibitors (VEGFR‐TKIs) are often used for treatment of several types of cancer; however, they are associated with an increased risk of proteinuria, sometimes leading to treatment discontinuation. We searched PubMed and Scopus to identify clinical studies examining the incidence and risk factors for proteinuria caused by VEGFR‐TKIs in patients with renal cell carcinoma, thyroid cancer, and hepatocellular carcinoma. The global incidence of proteinuria ranged from 6% to 34% for all grades of proteinuria, and from 1% to 10% for grade ≥3 proteinuria. The incidence of proteinuria did not differ significantly by cancer type, but in all three cancer types, there was a trend toward a higher incidence of proteinuria with lenvatinib than with other VEGFR‐TKIs. In terms of risk factors, the incidence of proteinuria was significantly higher among Asians (including Japanese) compared with non‐Asian populations. Other risk factors included diabetes mellitus, hypertension, and previous nephrectomy. When grade 3/4 proteinuria occurs, patients should be treated according to the criteria for dose reduction or withdrawal specified for each drug. For grade 2 proteinuria, treatment should be continued when the benefits outweigh the risks. Referral to a nephrologist should be considered for symptoms related to decreased renal function or when proteinuria has not improved after medication withdrawal. These management practices should be implemented universally, regardless of the cancer type. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to assess the prognostic outcomes in mRCC patients receiving second‐line TKI following first‐line IO combination therapy. Methods: This study retrospectively included 243 mRCC patients receiving second‐line TKI after first‐line IO combination therapy: nivolumab plus ipilimumab (n = 189, IO–IO group) and either pembrolizumab plus axitinib or avelumab plus axitinib (n = 54, IO–TKI group). Oncological outcomes between the two groups were compared, and prognostication systems were developed for these patients. Results: In the IO–IO and IO–TKI groups, the objective response rates to second‐line TKI were 34.4% and 25.9% (p = 0.26), the median PFS periods were 9.7 and 7.1 months (p = 0.79), and the median OS periods after the introduction of second‐line TKI were 23.1 and 33.5 months (p = 0.93), respectively. Among the several factors examined, non‐CCRCC, high CRP, and low albumin levels were identified as independent predictors of both poor PFS and OS by multivariate analyses. It was possible to precisely classify the patients into 3 risk groups regarding both PFS and OS according to the positive numbers of the independent prognostic factors. Furthermore, the c‐indices of this study were superior to those of previous systems as follows: 0.75, 0.64, and 0.61 for PFS prediction and 0.76, 0.70, and 0.65 for OS prediction by the present, IMDC, and MSKCC systems, respectively. Conclusions: There were no significant differences in the prognostic outcomes after introducing second‐line TKI between the IO–IO and IO–TKI groups, and the histopathology, CRP and albumin levels had independent impacts on the prognosis in mRCC patients receiving second‐line TKI, irrespective of first‐line IO combination therapies. [ABSTRACT FROM AUTHOR]

This article is an English translation of the Clinical Practice Guidelines for Upper Tract Urothelial Carcinoma (2nd edition) published in June 2023. The Japanese Urological Association's (JUA) Guidelines Committee on Upper Tract Urothelial Carcinoma (UTUC) created a 2023 update guideline to support clinicians' current evidence‐based management of UTUC and to incorporate its recommendations into clinical practice. The new guideline adhered as closely as possible to the Minds Manual for Guideline Development 2020 ver. 3.0. Findings related to epidemiological, pathological, diagnosis, treatment, and follow‐up were reviewed. In addition, seven clinical questions (CQs) were set to determine the grade of recommendation and level of evidence. Preconceptions and biases were removed from the preparation process, the overall evidence was evaluated appropriately, and recommendations were made after fully considering the balance between benefits and harms. Although the evidence is still insufficient to be taken up as a CQ, the latest important information is described in seven columns, and clinical issues that should be resolved in the future related to the CQ are described as recommendations for tomorrow. We hope that these guidelines will help medical professionals, patients, and their families involved in the treatment of UTUC in their decision‐making, and hope that a critical review of these guidelines will lead to further refinements in the next edition. [ABSTRACT FROM AUTHOR]

This article presents the findings of a retrospective multicenter study conducted in Japan on the use of enfortumab vedotin (EV) in patients with advanced urothelial carcinoma (UC). The study included 78 patients who had previously received platinum-containing chemotherapy and immune checkpoint inhibitors. The results showed that EV had a satisfactory response rate, although the progression-free survival (PFS) and overall survival (OS) were slightly shorter compared to clinical trials. High levels of C-reactive protein (CRP) and poor performance status (PS) were identified as key prognostic factors in these patients. The study acknowledges its limitations and suggests that further research is needed to confirm the findings. [Extracted from the article]

Objectives: The aims of the present study were to describe the perioperative findings of the first series of patients undergoing robot‐assisted radical nephrectomy (RARN) with a newly launched platform, the hinotori surgical robot system, and compare the findings with a similar set receiving RARN with the existing system, da Vinci. Methods: This study included 34 patients, consisting of 13 and 21 undergoing RARN using the hinotori and da Vinci robotic systems, respectively. As a rule, RARN was performed via an intraperitoneal approach employing 3 robotic arms, irrespective of the robotic systems. Results: In the hinotori group, the median age, body mass index and tumor diameter were 65 years, 23.3 kg/m2 and 50 mm, respectively. All surgical procedures with hinotori could be completed by a purely robotic approach. In the hinotori group, the median operative time, time using the robotic system, estimated blood loss and length of hospital stay were 157, 83 min, 11 mL and 6 days, respectively, and major perioperative complications did not occur. In this group, 3, 1 and 9 patients were pathologically diagnosed with pT1a, pT1b and pT3a tumors, respectively. No significant differences in baseline characteristics were noted between the hinotori and da Vinci groups, and there were also no significant differences in perioperative findings between them. Conclusions: Despite a case series with a small sample size, this is the first report evaluating RARN using the hinotori surgical robot system, which could be safely conducted and achieved perioperative outcomes similar to that using the da Vinci system. [ABSTRACT FROM AUTHOR]

Objectives: Bladder cancer, especially non‐muscle invasive bladder cancer (NMIBC), is one of the most costly cancers owing to its long‐term management. Photodynamic diagnosis‐assisted transurethral resection of bladder tumor (PDD‐TURBT) reduces the risk of intravesical recurrence. However, its impact on healthcare economics in Japan remains unclear. We evaluated the comprehensive medical costs of Japanese healthcare economics regarding PDD‐TURBT. Methods: This large‐scale, multicenter, retrospective study included a dataset of 1531 patients who were diagnosed with primary NMIBC who underwent initial TURBT between April 2006 and June 2021. A one‐to‐one propensity‐score matching analysis was used for an unbiased comparison based on postTURBT follow‐up periods. The total medical costs, including hospitalization, surgical procedures for TURBT and salvage radical cystectomy, adjuvant intravesical therapies, and follow‐up examinations, were compared between white light (WL)‐TURBT and PDD‐TURBT groups. Results: After propensity‐score matching, 468 patients each of WL‐ and PDD‐TURBT groups were matched. Total costs were 510 337 128 and 514 659 328 ¥ in WL‐ and PDD‐TURBT groups, respectively. The costs of adjuvant intravesical therapies, follow‐up examinations, and salvage radical cystectomy in PDD‐TURBT group were equivalent to or lower than those in WL‐TURBT group. Furthermore, total costs of high‐ and highest‐risk NMIBC in PDD‐TURBT group were either equivalent or lower compared to those in WL‐TURBT group. Conclusions: The total costs associated with PDD‐TURBT were higher compared to WL‐TURBT, while there is the potential of PDD‐TURBT to reduce the burden on healthcare economics in limited cases. [ABSTRACT FROM AUTHOR]

Background: This study is part of the SNPs in Nivolumab PD‐1 inhibitor for RCC (SNiP‐RCC). Here we aimed to reveal clinical factors for tumor response, progression, and survival in nivolumab for advanced clear cell renal cell carcinoma (RCC) in Japanese patients. Methods: We included patients from 23 institutions in Japan. We evaluated the objective response, radiographic progression‐free survival (PFS), overall survival (OS), and treatment‐related grade ≥ 3 (serious adverse events [SAEs]). Results: We included 222 patients. The median age was 69 years (interquartile range 62–74 years), and 71% of the patients were male. Pancreas metastasis, lung metastases, prior cytokine therapy, and SAEs, were associated with objective response. The median PFS was 18 months. Liver metastases (hazard ratio [HR], 1.61), age ≥ 75 (HR, 0.48), previous resection of primary sites (HR, 0.47), and SAEs (HR, 0.47) were independent prognostic factors for PFS. Karnofsky Performance Status <70 (HR, 2.90), high platelets (HR, 4.48), previous resection of primary sites (HR, 0.23), and pathological grade (HR, 0.19 for grade 2 and HR, 0.12 for grade 3) were independent prognostic factors for OS. SAEs were reported in 45 (20.3%) cases. In the group of patients with prior nephrectomy, SAEs were associated with objective response, PFS, and OS. Conclusion: The SNiP‐RCC study identified clinical parameters correlated with treatment outcomes in Japanese patients with priorly treated advanced clear cell RCC undergoing nivolumab monotherapy. [ABSTRACT FROM AUTHOR]

Objectives: To examine the long‐term effectiveness of nivolumab monotherapy and following subsequent therapies for metastatic renal cell carcinoma (mRCC) in Japanese real‐world settings. Methods: This was a multicenter, retrospective, observational study, with a 36‐month follow‐up, and conducted in Japanese patients with mRCC who initiated nivolumab monotherapy between 1 Feb 2017 and 31 Oct 2017. Endpoints included overall survival (OS), progression‐free survival (PFS), and objective response rate (ORR). Results: Of the 208 patients, 36.5% received nivolumab monotherapy as second‐line, 30.8% as third‐line, and 31.7% as fourth‐ or later‐line therapy. By 36 months, 12.0% of patients continued nivolumab monotherapy; 88.0% discontinued, mainly because of disease progression (66.7%). The median (m) OS was not reached irrespective of treatment line, with a 36‐month OS rate of 54.3% (second‐line, 57.4%; third‐line, 52.6%; fourth‐ or later‐line, 52.9%). The ORR was 24.2% and five patients achieved complete response. The OS from first‐line therapy was 8.9 years. In the 95 patients receiving therapy after nivolumab, 87.4% received vascular endothelial growth factor receptor‐tyrosine kinase inhibitors, with mOS and mPFS of 27.4 and 8.1 months, respectively. Irrespective of treatment line, the mOS was not reached in patients with International Metastatic RCC Database Consortium (IMDC) favorable or intermediate risk at mRCC diagnosis. Conclusions: This 36‐month real‐world follow‐up analysis showed a survival benefit of nivolumab monotherapy for patients with mRCC. The long‐term effectiveness of sequential therapy from first‐line therapy to therapy after nivolumab was also demonstrated. Additionally, nivolumab monotherapy was beneficial for patients with favorable IMDC risk at the time of mRCC diagnosis. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study was to assess the clinical outcomes following combined treatment with pembrolizumab and axitinib as first‐line therapy for patients with advanced RCC. Methods: This study retrospectively included 47 consecutive Japanese patients who were diagnosed with advanced RCC and subsequently received pembrolizumab and axitinib between February 2020 and January 2022. Efficacy and safety of this combined therapy in these patients were comprehensively investigated. Results: The 47 included patients were classified into the following 3 groups by the IMDC system: favorable, 7 (14.9%); intermediate, 24 (51.1%) and poor, 16 (34.0%). Responses to this combined therapy in the 47 patients were as follows: CR, 8 (17.0%); PR, 20 (42.6%); SD, 16 (34.0%) and PD, 3 (6.4%); thus, the ORR was 59.6%. During the observation period, disease progression and death occurred in 19 (40.4%) and 9 (19.1%) patients, respectively, and the median PFS and OS were 18 months and not reached, respectively. Univariate analyses identified the following significant predictors for poor prognostic outcomes: lack of nephrectomy, liver metastasis, bone metastasis, elevated CRP and IMDC poor risk for PFS; and lack of nephrectomy, non‐CCC and elevated CRP for OS. AEs and those corresponding to grade ≥ 3 occurred in all (100%) and 30 (63.8%) patients, respectively. Conclusions: To our knowledge, this is the first study focusing on real‐world outcomes following pembrolizumab and axitinib for treatment‐naïve advanced Japanese RCC patients, which showed the efficacy and safety of this combined therapy being similar or even superior to those in clinical trial. [ABSTRACT FROM AUTHOR]

Objectives: The present study comprehensively investigated the significance of several factors reflecting the therapeutic effects of anticancer treatment on overall survival (OS) in advanced urothelial cancer (UC) patients receiving sequential systemic therapy. Methods: This study included 101 consecutive advanced UC patients who received first‐line platinum‐based combination chemotherapy followed by second‐line pembrolizumab. The impacts of the following factors on OS in these patients were analyzed: responses to chemotherapy, responses to pembrolizumab, progression‐free survival (PFS) with chemotherapy, PFS with pembrolizumab, and second PFS (PFS2). Results: The median age of patients was 71 years, and 35 and 66 had UC in the upper urinary tract and bladder, respectively. objective response rate to first‐line chemotherapy and second‐line pembrolizumab were 37.6% and 19.8%, respectively. Median PFS with chemotherapy, pembrolizumab, and PFS2 were 5, 4, and 9 months, respectively. Uni‐ and multivariate analyses of the five factors examined identified PFS with pembrolizumab and PFS2 as independent surrogates for OS, with PFS2 (hazard ratio [HR] = 0.23) being more closely associated with OS than PFS with pembrolizumab (HR = 0.31). Furthermore, uni‐ and multivariate analyses of various prognostic parameters showed the independent impacts of baseline performance status (PS) and neutrophil‐to‐lymphocyte ratio (NLR) on PFS2. Conclusions: The present results suggest the potential of PFS2 as an optimal surrogate for OS in advanced UC patients receiving standard sequential systemic therapy and indicate that intensive treatment needs to be considered for those with poor PS and/or high NLR prior to the introduction of first‐line chemotherapy. [ABSTRACT FROM AUTHOR]

Aim: The hinotori surgical robot system, a newly launched platform, has already been utilized in several urological robotic surgeries; however, limited information is available in terms of its feasibility and safety in each type of surgery. The objectives of this study were to describe the perioperative outcomes of the first series of six patients who underwent robot‐assisted adrenalectomy (RAA) using hinotori, and compare the outcomes with a similar set of five patients undergoing RAA with the existing system, da Vinci. Methods: This study included a total of 11 consecutive patients with adrenal tumors undergoing RAA between July 2020 and November 2022 at our institution. Comprehensive perioperative outcomes in these patients were retrospectively analyzed. Results: Median age, body mass index (BMI), and tumor diameter in the hinotori group were 48 years, 27.5 kg/m2, and 36 mm, respectively, and four patients were diagnosed with a functioning tumor, consisting of three and one with hypersecretion of cortisol and catecholamine, respectively. All procedures using hinotori were performed via the transperitoneal approach, and could be completed without conversion to open surgery. Median operative time, time using robotic system, the estimated blood loss, and length of hospital stay in this group were 119 min, 58 min, 8 mL, and 7 days, respectively, and no patient experienced major perioperative complications. There were no significant differences in clinical characteristics between the hinotori and da Vinci groups, and no significant differences in the perioperative outcomes were noted between these two groups. Conclusion: Despite being a small case series, this is the first study focusing on RAA using the hinotori surgical robot system, which could be efficaciously performed, resulting in the achievement of perioperative findings comparable with those of the da Vinci system. [ABSTRACT FROM AUTHOR]

Objectives: To validate the risk stratification newly defined in the Japanese Urological Association guidelines 2019 for non‐muscle invasive bladder cancer and provide a more accurate stratification model for a heterogeneous intermediate‐risk group. Methods: A total of 1610 patients, who underwent transurethral resection, diagnosed with non‐muscle invasive bladder cancer in nine collaborating hospitals were retrospectively reviewed. They were classified into low‐risk, intermediate‐risk, high‐risk, and highest‐risk groups, and recurrence‐free survival, progression‐free survival, cancer‐specific survival, and overall survival were compared among the groups. The intermediate‐risk group was subdivided into two groups based on the multivariable Cox regression model of recurrence and progression risk factors, and a revised risk model was created. Results: The progression‐free survival, cancer‐specific survival, and overall survival were well stratified, while the recurrence‐free survival of the intermediate‐risk group was the shortest among the four groups (p < 0.001). The independent risk factors for recurrence and progression‐free survival in the intermediate‐risk group were as follows: age ≥ 70 years, sex, multiple tumors, tumor size ≥3 cm, and recurrent cases. The intermediate‐risk group was subdivided into two groups: favorable intermediate‐risk group and unfavorable intermediate‐risk group. The revised risk model showed significant differences. Conclusion: We validated the Japanese Urological Association guidelines 2019 stratification model. The revised risk model provided a more accurate treatment selection for this disease subset. [ABSTRACT FROM AUTHOR]

Objectives: To assess the postoperative status of clinically localized prostate cancer patients who underwent robot‐assisted radical prostatectomy (RARP) with a focus on de novo overactive bladder (OAB). Methods: The present study included 156 patients who did not have preoperative OAB and underwent RARP between December 2015 and April 2020 at our institution. Patients were divided into the de novo OAB group and non‐OAB group based on the findings of overactive bladder symptoms score (OABSS) 6 months after RARP, and comparative assessments were performed between the two groups. Results: Six months after RARP, de novo OAB was detected in 38 (24.4%) out of 156 patients. Body mass index (BMI) and the proportion of patients with hypertension were significantly higher in the de novo OAB group than in the non‐OAB group. No significant differences were observed in the other characteristics examined. Furthermore, the preoperative findings of uroflowmetry and a urodynamic study did not significantly differ between the two groups. Despite the lack of significant differences in preoperative OABSS, total international prostate symptom score, the voiding symptom score, storage symptom score, and quality of life score between the two groups, all of these findings 6 months after RARP were significantly worse in the de novo OAB group than in the non‐OAB group. Among the several factors examined, only BMI was independently associated with the development of de novo OAB 6 months after RARP. Conclusions: Patients with a high BMI may develop de novo OAB after RARP, resulting in the significant deterioration of lower urinary tract symptoms. [ABSTRACT FROM AUTHOR]

Objective: To investigate the impact of erectile function on health‐related quality of life in Japanese prostate cancer patients following robot‐assisted radical prostatectomy. Methods: Time‐dependent changes in erectile function and health‐related quality of life were assessed using the erection hardness score and Medical Outcomes Study 8‐Item Short Form Health Survey, respectively, in 229 consecutive Japanese patients undergoing robot‐assisted radical prostatectomy. In this series, patients with erection hardness score ≥2 were considered to those having a certain erectile function. Results: Among the 229 patients examined, erection hardness score ≥2 was observed in 134 (58.5%) and 34 (14.9%) before and 12 months after robot‐assisted radical prostatectomy, respectively. Prior to robot‐assisted radical prostatectomy, all eight scale scores of 8‐Item Short Form Health Survey were significantly superior in patients with erection hardness score ≥2 than in those with erection hardness score = 0 or 1. However, significant differences were observed in two scale scores between patients with erection hardness score ≥2 and those with erection hardness score = 0 or 1 at 12 months after robot‐assisted radical prostatectomy. Furthermore, among patients with erection hardness score ≥2 before robot‐assisted radical prostatectomy, no significant differences were noted in any of the eight scale scores between patients with erection hardness score ≥2 and erection hardness score = 0 or 1 at 12 months after robot‐assisted radical prostatectomy. Conclusion: These findings suggest the limited impact of erectile function on postoperative health‐related quality of life in Japanese patients undergoing robot‐assisted radical prostatectomy. [ABSTRACT FROM AUTHOR]

Objective: The prognosis of high‐risk metastatic hormone‐naïve prostate cancer is poor, and real‐world evidence of therapeutic options and sequences is lacking. The J‐ROCK study aimed to evaluate the outcomes in a real‐world setting in Japan. Methods: Patients with high‐risk metastatic hormone‐naïve prostate cancer diagnosed after May 2019 were eligible. Based on their treatment within 3 months after diagnosis, patients were allocated to either cohort 1 (androgen deprivation therapy alone or combined androgen blockade with bicalutamide) or cohort 2 (androgen deprivation therapy with abiraterone acetate+prednisolone, docetaxel, enzalutamide, or apalutamide). Results: In this first interim analysis (cut‐off January 2021), 410 patients were enrolled, including 163 patients in cohort 1 and 247 in cohort 2. The median follow‐up period was 7.6 (range 0.1–20.5) months. A higher proportion of patients in cohort 2 (42.5%) achieved nadir prostate‐specific antigen levels ≤0.2 ng/ml within a year, compared with cohort 1 (22.1%). Prostate‐specific antigen‐progression‐free survival was also more favorable in cohort 2 (adjusted hazard ratio 0.629 [95% confidence interval 0.345–1.147]). Conclusions: The higher proportion of cohort 2 suggest a paradigm shift has occurred in the real‐world treatment of high‐risk metastatic hormone‐naïve prostate cancer in Japan. Some factors including prostate‐specific antigen may affect treatment selection but need further observation. Most patients in cohort 2 received abiraterone acetate+prednisolone. The proportion of patients in cohort 1 receiving combined androgen blockade was lower than previously reported in Japan. This analysis suggest that more intensive therapy tends to prolong prostate‐specific antigen‐progression‐free survival in patients with high‐risk metastatic hormone‐naïve prostate cancer. [ABSTRACT FROM AUTHOR]

Objective: The utility of 11C‐choline positron emission tomography/computed tomography for determining treatment response as compared with prostate‐specific antigen response and prognosis prediction in castration‐resistant prostate cancer patients was investigated. Methods: Eighty‐four 11C‐choline‐positron emission tomography/computed tomography scans before/after treatments with abiraterone (n = 12 patients), enzalutamide (n = 3), docetaxel (n = 9), cabazitaxel (n = 5), radiation therapy alone (n = 3), radiation therapy, enzalutamide, and/or abiraterone (n = 5), radium‐223 (n = 4), and radiofrequency ablation (n = 1) in 42 castration‐resistant prostate cancer patients were retrospectively examined. Prostate‐specific antigen values were determined before and after treatment. Using the Kaplan–Meier method, the correlation of Positron Emission Tomography Response Criteria In Solid Tumors with prostate‐specific antigen response and prognostic impact was evaluated. Results: Pretreatment 11C‐choline‐positron emission tomography/computed tomography findings identified local, lymph node, bone, and visceral metastasis in 12, 12, 29, and five patients, respectively. Following treatments, complete metabolic response was noted in one, partial metabolic response in eight, stable metabolic disease in 13, and progressive metabolic disease in 20. Mean prostate‐specific antigen change for complete metabolic response, partial metabolic response, stable metabolic disease and progressive metabolic disease was −48.9%, −55.0% (range −92.4% to −19.1%), −4.2% (−33.2% to 35.1%), and 142.7% (30.7% to 373.8%), respectively, significantly greater in the progressive metabolic disease cases (P < 0.01). Positron Emission Tomography Response Criteria In Solid Tumors was well correlated with prostate‐specific antigen change. Patients with no progression (complete metabolic response/partial metabolic response/stable metabolic disease) showed significantly longer cancer‐specific survival than progressive metabolic disease (P < 0.005). Using pretreatment 11C‐choline‐positron emission tomography/computed tomography results to divide into three groups; (a) local and/or lymph node metastasis without bone metastasis (n = 10), (b) <6 bone metastasis sites (n = 16), (c) ≥6 bone metastasis sites and/or visceral metastasis (n = 16), cancer‐specific survival showed significant stratification (P < 0.001). Conclusions: 11C‐choline‐positron emission tomography/computed tomography may reflect castration‐resistant prostate cancer metastatic lesion activity for treatment response and prognosis evaluations. [ABSTRACT FROM AUTHOR]

Objectives: It has been well documented that partial nephrectomy for completely endophytic renal tumors is a highly challenging procedure accompanied by several technical difficulties even with the assistance of a robotic surgical system. This study aimed to compare perioperative variables among patients with exophytic, mesophytic, and endophytic renal tumors undergoing robot‐assisted partial nephrectomy. Methods: This study retrospectively included 265 consecutive patients with localized small renal masses undergoing robot‐assisted partial nephrectomy at our institution. In this study, completely endophytic tumor was defined as the mass totally covered by renal healthy parenchyma, and according to the points for the 'E' domain of RENAL nephrometry score based on preoperative computed tomography, subjects were classified into three groups as follows: exophytic, mesophytic, and endophytic tumor groups, and perioperative outcomes among these groups were compared. Results: Of 265 patients, 127, 112, and 26 were classified into the exophytic, mesophytic, and endophytic tumor groups, respectively. A significantly smaller tumor diameter was observed in the endophytic group than in the other groups (P < 0.001), whereas the RENAL nephrometry score was significantly higher (P < 0.001). In addition, the warm ischemia time in the endophytic tumor group was significantly longer than that in other groups (P = 0.009); however, no significant difference in the trifecta achievement was noted among the three groups. Conclusions: This study suggests that robot‐assisted partial nephrectomy for patients with completely endophytic tumors can be regarded as a feasible approach without marked impairment of perioperative outcomes; however, further investigation of the long‐term functional and oncological outcomes in these patients is required. [ABSTRACT FROM AUTHOR]

Over the last decade, there have been substantial progress in the field of systemic therapy for advanced renal cell carcinoma. Through the transition from treatment with cytokines to molecular‐targeted agents, and currently to immuno‐oncology drugs, the prognostic outcomes of patients with advanced renal cell carcinoma have been markedly improved. In particular, based on the promising outcomes of recently conducted pivotal randomized clinical trials, immuno‐oncology drug‐based combination therapy by either dual immune checkpoint inhibition or combined inhibition of an immune checkpoint and tyrosine kinase, is currently regarded as a standard of care for treatment‐naïve advanced renal cell carcinoma patients. However, insufficient data are available with respect to the selection of optimal systemic therapies for advanced renal cell carcinoma in the first‐line setting due to the lack of a head‐to‐head comparison between approved immuno‐oncology drug‐based combination therapies. In this review, therefore, we summarize interesting findings associated with first‐line combination therapies for advanced renal cell carcinoma obtained from both randomized clinical trials and real‐world clinical practices, in order to present useful guidance to help make treatment decisions for patients with treatment‐naïve advanced renal cell carcinoma. [ABSTRACT FROM AUTHOR]

Penile cancer is a rare cancer for which no medical guidelines have been established before in Japan. These guidelines aim to standardize, as much as possible, the therapeutic modality for penile cancer, for which empirical evidence is limited on a global scale, thereby bolstering therapeutic outcomes for patients with penile cancer. The new guidelines conform to the Minds Guide for Developing Clinical Practice Guidelines (2017) as much as possible. However, virtually no randomized comparative studies and meta‐analyses based on such randomized studies have been conducted. Therefore, only the findings available at present were listed after conducting an exhaustive literature review of items with extremely low evidence levels and for which bodies of evidence and grades of recommendation were not evaluated. Clinical questions were set for items with a relatively large number of studies, including retrospective studies. However, since it is virtually impracticable to summarize bodies of evidence by systematic reviews, recommendation grades and evidence levels were discussed and determined by the consensus panel of the Preparatory Committee. The following were outlined: epidemiological, pathological, diagnostic, therapeutic, follow‐up, and quality of life‐related findings. Additionally, seven clinical questions were established to determine recommendation grades and evidence levels. We hope that these guidelines will prove to be useful to medical professionals engaged in clinical practice related to penile cancer in Japan and anticipate that critical reviews of the guidelines will lead to further refinement of the next edition. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the impact of the interaortocaval clamping technique for the right renal artery on perioperative outcomes of patients who underwent robot‐assisted partial nephrectomy (RAPN). Methods: This study included 111 consecutive patients with right renal masses undergoing RAPN via the transperitoneal approach. In this series, standard and interaortocaval clamping techniques were defined as those for the right renal artery at the renal hilus and interaortocaval space, respectively. Based on the 3D images reconstructed from CT, interaortocaval clamping was preoperatively selected for patients in whom standard clamping of the main renal artery at the right hilum was judged to be technically difficult due to complicated vascular distribution, such as multiple branches of right renal arteries and veins and/or intertwining of these vessels. Results: Of 111 patients, 95 and 16 were classified into the standard and interaortocaval clamping groups, respectively, and interaortocaval clamping was uneventfully performed as planned in all 16. After adjusting patient variables by 1:3 propensity score‐matching, 33 and 11 patients were included in the respective groups, and there were no significant differences in major clinical characteristics between them, while the incidences of multiple branches of right renal vessels as well as their intertwining beside the right renal hilus were significantly higher in the interaortocaval clamping group. However, no significant difference was noted in any of the perioperative outcomes, including operative time or intraoperative blood loss, between the two groups. Conclusions: The interaortocaval clamping technique during RAPN is a feasible procedure with acceptable perioperative outcomes compared with standard hilar clamping, making it possible to more accurately resect renal tumors under clear visualization without unnecessary arterial bleeding from the tumor bed in patients with complex vascular distribution at the right renal hilus; however, special attention should be paid to the considerable individual variability of the interaortocaval anatomy. [ABSTRACT FROM AUTHOR]

Objectives: Transurethral resection of bladder tumor with photodynamic diagnosis has been reported to result in lower residual tumor and intravesical recurrence rates in non‐muscle invasive bladder cancer. We aimed to evaluate the usefulness of photodynamic diagnosis‐transurethral resection of bladder tumor combined with oral 5‐aminolevulinic acid hydrochloride for high‐risk non‐muscle invasive bladder cancer. Methods: High‐risk non‐muscle invasive bladder cancer patients with an initial photodynamic diagnosis‐transurethral resection of bladder tumor (photodynamic diagnosis group) were prospectively registered between 2018 to 2020. High‐risk non‐muscle invasive bladder cancer cases with a history of initial white‐light transurethral resection of bladder tumor (white‐light group) were retrospectively registered. Propensity score‐matching analysis was used to compare residual tumor rates, and factors that could predict residual tumors at the first transurethral resection of bladder tumor were evaluated. Results: Analyses were conducted with 177 and 306 cases in the photodynamic diagnosis and white‐light groups, respectively. The residual tumor rates in the photodynamic diagnosis and white‐light groups were 25.7% and 47.3%, respectively. Factor analysis for predicting residual tumors in the photodynamic diagnosis group showed that the residual tumor rate was significantly higher in cases with a current/past smoking history, multiple tumors, and pT1/pTis. When each factor was set as a risk level of 1, cases with a total risk score ≤1 showed a significantly lower residual tumor rate than cases with a total risk score ≥2 (8.3% vs 33.3%, odds ratio 5.46 [1.81–22.28]). Conclusions: In high‐risk non‐muscle invasive bladder cancer cases, the odds of a residual tumor after initial photodynamic diagnosis‐transurethral resection of bladder tumor were 0.39‐fold that of the odds of those after initial white‐light transurethral resection of bladder tumor. A risk stratification model could be used to omit the second transurethral resection of bladder tumor in 27% of the cases. [ABSTRACT FROM AUTHOR]

Objective: Recently, hormonal therapy using abiraterone acetate, a second‐generation androgen receptor axis‐targeted agent, was reported to improve overall survival and progression‐free survival in men with LATITUDE‐high‐risk metastatic castration‐sensitive prostate cancer. This observational multicenter study aimed to assess the efficacy of upfront abiraterone acetate in Japanese patients with LATITUDE‐high‐risk metastatic castration‐sensitive prostate cancer. Methods: The present study included 112 Japanese patients with LATITUDE‐high‐risk metastatic castration‐sensitive prostate cancer who received upfront abiraterone acetate at four institutions belonging to the Tokai Urologic Oncology Research Seminar group, between January 2018 and September 2020. Progression‐free survival and overall survival were assessed, and Cox regression analyses were carried out to evaluate the prognostic significance of upfront abiraterone acetate for progression‐free survival. Results: Within a median follow‐up period of 13 months, the progression‐free survival and overall survival rates were 76.8% and 89.3%, respectively. Both univariate and multivariable Cox regression analyses showed that the presence of Gleason pattern 5, performance status and hemoglobin were independent predictors of progression‐free survival. The patients were subsequently divided into three groups as follows: group 1, 17 patients negative for these three independent progression‐free survival predictors; group 2, 49 patients with one positive independent progression‐free survival predictor; and group 3, 45 patients with two or three independent progression‐free survival predictors. Progression‐free survival was significantly different among these three groups (P < 0.001). Conclusion: Upfront abiraterone acetate might provide satisfactory outcomes for Japanese patients with LATITUDE‐high‐risk metastatic castration‐sensitive prostate cancer. Gleason pattern 5, performance status and hemoglobin are potential predictors of progression‐free survival in Japanese patients with LATITUDE‐high‐risk metastatic castration‐sensitive prostate cancer who received upfront abiraterone acetate. [ABSTRACT FROM AUTHOR]

Introduction: To evaluate the initial experience of robot‐assisted radical nephrectomy (RARN) in a single institution in Japan. Methods: This study included a total of 12 patients with renal tumors who were not preoperatively regarded as optimal candidates for robot‐assisted partial nephrectomy (RAPN) and subsequently treated with RARN between April 2019 and June 2021 at our institution. Comprehensive perioperative outcomes in these patients were retrospectively analyzed. Results: Of the 12 included patients, 10 and two were male and female, respectively, and the median age was 66 years. The median tumor diameter was 44 mm, and four, four and four patients were classified into cT1a, cT1b and cT3a, respectively. There was no patient requiring open conversion, and the median operative and console times were 167 and 79 minutes, respectively. The median estimated blood loss was 42 cc, and no patient required blood transfusion. During the perioperative period, no major complication corresponding to Clavien‐Dindo grade ≥3 occurred. Nine, two and one patient were pathologically diagnosed with clear cell carcinoma (CCC), non‐CCC and benign cyst, respectively, and there was no patient who developed recurrent diseases. Conclusions: Considering complicated tumor characteristics not amenable to RAPN in this series, such as an intravenous tumor thrombus or previous history of open partial nephrectomy, perioperative outcomes of initial experience with RARN in Japan could be considered favorable. Collectively, these findings suggest that RARN may be a promising alternative to laparoscopic radical nephrectomy for patients with complicated renal tumors, contraindicated for RAPN. [ABSTRACT FROM AUTHOR]

Introduction: Diagnosis is the key to improving spinal surgery outcomes. Improvements in the diagnosis of radiculopathy have created new indications for full‐endoscopic spine surgery. We assessed the finite element method (FEM) to visualize and digitize lesions not detected by conventional diagnostic imaging. Methods: We used FEM in two patients: a lumbar patient and a cervical patient. The lumbar patient was a 67‐year‐old woman with a history of rheumatoid arthritis; she also had osteoporosis and pulmonary fibrosis. She had left L3 radiculopathy due to an L3 vertebral fracture. The cervical patient was a 61‐year‐old woman with left C6 radiculopathy due to C5‐C6 disc herniation. We performed full endoscopic foraminotomy per the patients's request. Based on preoperative and postoperative CT Digital Imaging and Communications in Medicine data of 0.5‐mm slices, 3‐D imaging data were reproduced, and kinetic simulation of FEM was performed. Results: Postoperatively, both patients' radiculopathy disappeared, improving their activities of daily living and enabling them to walk and work. Also, the total contact area and maximum contact pressure of the nerve tissue decreased from 30% to 80% and from 33% to 67%, respectively. Conclusions: A new method for perioperative evaluation and simulation, FEM can be to visualize and digitize the conditions of the lesion causing radiculopathy. FEM that can overcome both time and economic constraints in routine clinical practice is needed. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to investigate the effects of renal tumor complexity on perioperative outcomes in patients receiving robot‐assisted partial nephrectomy (RAPN). Methods: This study included 153 consecutive patients with cT1 renal masses undergoing RAPN and analyzed their perioperative outcomes, particularly tumor complexity. In this series, cT1b, completely endophytic, hilar, and cystic tumors were considered complex tumors. Patients with tumors that met at least one of the complex criterion were placed in the complex tumor group; patients with tumors that did not meet any of the complex criteria were placed in the non‐complex tumor group. Results: Of the 153 patients, 54 (35.3%) had complex tumors; specifically, 18 (11.8%) had cT1b tumors, 15 (9.8%) had completely endophytic tumors, 28 (18.3%) had hilar tumors, and 8 (5.2%) had cystic tumors. The non‐complex group included 99 patients (64.7%). The complex tumor group had significantly longer warm ischemia and console times than the non‐complex tumor group, but there was no significant difference between them in the achievement of the trifecta. Both warm ischemia and console times were significantly correlated with the number of complex factors. Multivariate analyses of complex factors demonstrated that completely endophytic and cT1b tumors were independently associated with warm ischemia time and console time, respectively. Conclusions: For patients with complex tumors, RAPN may be a feasible procedure with acceptable perioperative outcomes. However, special attention should be paid to long warm ischemia and console times, particularly in those with completely endophytic and/or cT1b tumors. [ABSTRACT FROM AUTHOR]

Background: We aimed to evaluate the effect of transvaginal mesh surgery on overactive bladder symptoms in women with pelvic organ prolapse and to identify predictive factors for persistence of a preoperative overactive bladder after surgery. Materials and Methods: We retrospectively evaluated 102 patients who underwent transvaginal mesh surgery. All patients had stage 2 or greater pelvic organ prolapse accompanied by cystocele. The Overactive Bladder Symptom Score, International Prostate Symptom Score, uroflowmetry, and postvoid residual urine volume were evaluated preoperatively and 6 months postoperatively. To identify predictive factors for the persistence of a preoperative overactive bladder after surgery, preoperative parameters were statistically compared between patients with and without the persistence of preoperative overactive bladder symptoms. Receiver operator characteristic curves were generated, and the area under the curve was calculated. Results: Preoperatively, 54 women (53%) had an overactive bladder. After surgery, the symptoms disappeared in 34 (63%) and persisted in 20 (37%) women. There were no significant differences in preoperative parameters including age, body mass index, parity, or severity of pelvic organ prolapse between patients with and without persistent preoperative overactive bladder. Preoperative Overactive Bladder Symptom Score and International Prostate Symptom Score were significantly higher in patients with persistent preoperative overactive bladder symptoms. The International Prostate Symptom Score storage subscore had the highest area under the curve, with a cutoff value of 9.5. Conclusion: Transvaginal mesh surgery eliminates overactive bladder symptoms in about two‐thirds of pelvic organ prolapse patients. The preoperative International Prostate Symptom Score storage subscore was the most useful predictive factor for the persistence of preoperative overactive bladder symptoms after surgery. [ABSTRACT FROM AUTHOR]

The phase 3 JAVELIN Renal 101 trial of avelumab + axitinib vs sunitinib in patients with treatment‐naive advanced renal cell carcinoma (RCC) demonstrated significantly improved progression‐free survival (PFS) and higher objective response rate (ORR) with the combination vs sunitinib. Japanese patients enrolled in the study (N = 67) were randomized to receive avelumab + axitinib (N = 33) or sunitinib (N = 34); 67% vs 59% had PD‐L1+ tumors (≥1% of immune cells) and 6%/64%/27% vs 6%/82%/12% had International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) favorable/intermediate/poor risk status. In patients who received avelumab + axitinib vs sunitinib, median PFS (95% confidence interval [CI]) was not estimable (8.1 months, not estimable) vs 11.2 months (1.6 months, not estimable) (hazard ratio [HR], 0.49; 95% CI, 0.152, 1.563) in patients with PD‐L1+ tumors and 16.6 months (8.1 months, not estimable) vs 11.2 months (4.2 months, not estimable) (HR, 0.66; 95% CI, 0.296, 1.464) in patients irrespective of PD‐L1 expression. Median overall survival (OS) has not been reached in either arm in patients with PD‐L1+ tumors and irrespective of PD‐L1 expression. ORR (95% CI) was 60.6% (42.1%, 77.1%) vs 17.6% (6.8%, 34.5%) in patients irrespective of PD‐L1 expression. Common treatment‐emergent adverse events (all grade; grade ≥3) in each arm were hand‐foot syndrome (64%; 9% vs 71%; 9%), hypertension (55%; 30% vs 44%; 18%), hypothyroidism (55%; 0% vs 24%; 0%), dysgeusia (21%; 0% vs 56%; 0%) and platelet count decreased (3%; 0% vs 65%; 32%). Avelumab + axitinib was efficacious and tolerable in treatment‐naive Japanese patients with advanced RCC, which is consistent with results in the overall population. [ABSTRACT FROM AUTHOR]

Introduction: The objective of this study was to evaluate the initial learning curve for robot‐assisted partial nephrectomy (RAPN) using the da Vinci Xi Surgical System (Intuitive Surgical, Sunnyvale, California). Methods: This study included the initial 65 consecutive patients with small renal tumors who had undergone RAPN at our institution. A single trained surgeon with extensive experience in robot‐assisted radical prostatectomy, but not in laparoscopic partial nephrectomy, performed RAPN for all patients using the da Vinci Xi. The learning curve was analyzed by examining the perioperative outcomes among five groups each consisting of 13 consecutive patients. Results: In this series, the median tumor size and R.E.N.A.L. nephrometry score were 23 mm and 7, respectively, and the median console time and warm ischemia time (WIT) were 116 and 15 minutes, respectively. Fifty‐eight patients (89.2%) achieved trifecta outcomes, meaning that the ischemic time was ≤25 minutes, there was a negative surgical margin, and no major postoperative complications occurred. Although there were no significant changes in R.E.N.A.L. nephrometry scores over time, increased surgeon experience was significantly associated with a shorter console time and WIT. Drawing logarithmic approximation curves enabled the achievement of a console time ≤150 minutes and WIT ≤20 minutes at the sixth and fourth procedures, respectively. Furthermore, multivariate analysis identified an independent correlation between surgeon experience with WIT, but not with console time. Conclusion: These findings suggest that regardless of a surgeon's prior experience in laparoscopic partial nephrectomy, an experienced robotic surgeon can perform RAPN using the da Vinci Xi with acceptable perioperative outcomes after a small number of procedures. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to investigate the clinical characteristics of nocturia in patients with interstitial cystitis (IC), and the effects of bladder hydrodistention (with fulguration of Hunner lesions) on nocturia. Methods: The records of 81 patients who were diagnosed with IC were reviewed. Clinical characteristics were evaluated using the Interstitial Cystitis Symptom Index (ICSI), a visual analogue scale (VAS), and bladder diary data. Differences in characteristics between Hunner‐ and non‐Hunner‐type IC were compared. Correlations between nocturia and other clinical variables were assessed. Stepwise multiple regression analysis was performed to identify factors associated with nocturia. Further, changes in nocturia before and after hydrodistention (with fulguration of Hunner lesions) were analyzed. Results: The mean (± SD) age of patients was 62.2 ± 15.3 years. Significant differences in nocturia were observed between Hunner‐ and non‐Hunner‐type IC. Nocturia was positively correlated with age, urgency score (ICSI and VAS), mean number of urgency episodes per 24 hours and the nocturnal polyuria (NP) index, and negatively correlated with average voided volume. Age, NP index, average voided volume, and the presence of Hunner lesions were independent factors associated with nocturia. Bladder hydrodistention significantly decreased nocturia in non‐Hunner type IC without NP. In addition, regardless of the presence or absence of NP, bladder hydrodistention with fulguration of Hunner lesions significantly decreased nocturia in Hunner‐type IC. Conclusions: The severity of nocturia is associated with age, NP, average voided volume, and the presence of Hunner lesions in IC patients. Bladder hydrodistention (with fulguration of Hunner lesions) has the potential to decrease nocturia. [ABSTRACT FROM AUTHOR]

Isosamidin is a pharmacologically active compound extracted from Peucedanum japonicum which is used as a health food in East Asia. Our preliminary animal data suggested that isosamidin may have sufficient potency to treat patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia or overactive bladder. However, the efficacy of isosamidin in humans is unknown. Here, we examined whether isosamidin inhibits agonist-stimulated contractions in isolated human bladder and prostate tissue strips in vitro. Human bladder and prostate strips obtained from 9 to 10 male patients, respectively, were suspended in organ baths. After administration of isosamidin (10, 30, and 100 μM), concentration-response curves to agonists (acetylcholine or phenylephrine) were constructed by cumulatively increasing agonist concentration. Isosamidin inhibited phenylephrine-stimulated contractions of isolated human prostate tissue strips in a concentration-dependent manner, with significant differences observed between control and 100 μM isosamidin. In contrast, isosamidin had no effect on acetylcholine-stimulated contractions of isolated human bladder tissue strips. Isosamidin may have pharmacological potency in the treatment of male patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Clinical studies are needed to confirm the efficacy and safety of isosamidin in humans. [ABSTRACT FROM AUTHOR]

Objectives To identify clinical features and predictive factors of febrile neutropenia in Japanese patients with metastatic germ cell tumors undergoing cytotoxic chemotherapy. Methods Between April 2007 and May 2016, 86 consecutive Japanese patients with metastatic germ cell tumors were treated with cisplatin-based combination chemotherapy, including bleomycin, etoposide and cisplatin, and paclitaxel, ifosfamide and cisplatin. A total of 378 chemotherapy cycles administered for these 86 patients were retrospectively analyzed. Results During the 378 cycles, consisting of 212 for bleomycin, etoposide and cisplatin, and 166 for paclitaxel, ifosfamide and cisplatin, 81 episodes of febrile neutropenia (21.4%) developed in 34 patients (39.5%). Multivariate logistic regression analysis showed that low estimated glomerular filtration rate and albumin levels were independent risk factors for the development of febrile neutropenia. Furthermore, a significant difference in the incidence of febrile neutropenia was noted according to positive numbers of these two independent risk factors; that is, febrile neutropenia occurred in 13 of 171 courses in patients negative for any risk factors (7.6%), 44 of 155 courses in those positive for a single risk factor (28.4%) and 24 of 52 courses in those positive for two risk factors (46.2%). Conclusions The incidence of febrile neutropenia in Japanese metastatic germ cell tumor patients receiving cisplatin-based combination chemotherapy appears to be higher than reported previously by studies in Western countries. When carrying out cytotoxic chemotherapy, special attention should be paid to patients with low estimated glomerular filtration rate and/or albumin levels considering the high probability of febrile neutropenia. [ABSTRACT FROM AUTHOR]