Publications by authors named "Kazunari Tanabe"

440 Publications

Validation of predictive model for new baseline renal function after robot-assisted partial nephrectomy or radical nephrectomy in Japanese patients.

J Endourol 2021 Nov 22. Epub 2021 Nov 22.

Tokyo Women's Medical University, Urology, 8-1, Kawacacho, Shinjyuku-ku, Tokyo, Japan, 162-8666;

Purpose: The study aim was to externally validate a new predictive model for new baseline glomerular filtration rate post-nephrectomy among Japanese patients.

Materials And Methods: Patients with renal tumors who underwent radical nephrectomy or robot-assisted partial nephrectomy at a single Japanese institution in 2000-2020 were retrospectively analyzed. New baseline glomerular filtration rate is defined as the final estimated glomerular filtration rate within postoperative 3-12 months. The correlation/bias/accuracy/precision of the equation was examined by comparing the calculated new baseline glomerular filtration rate with the observed rate.

Results: The study included 485 cases of radical nephrectomy, and 1030 cases of robot-assisted partial nephrectomy. The correlation/bias/accuracy/precision of the new equation predicting new baseline glomerular filtration rate were 0.86/-0.92/95.9/-5.65-3.62 in robot-assisted partial nephrectomy and 0.79/-1.02/87.8/-6.26-3.91 in radical nephrectomy, respectively. The fractional polynomial regression line approximated zero and its pointwise 95% confidence interval was considerably tight for the majority of both cohorts. The 95% confidence interval to discriminate new baseline glomerular filtration rates of ≥45 ml/min/1.73 m2 from receiver operating curves was 0.96 (0.95-0.97) and 0.89 (0.87-0.92) in robot-assisted partial nephrectomy and radical nephrectomy, respectively. Various preoperative factors including age, tumor size, complexity, body mass index, hypertension, and diabetes did not affect the predictive ability (correlation > 0.7) from the subgroup analysis.

Conclusion: The novel simple equation can accurately predict new baseline glomerular filtration rates after radical and robot-assisted partial nephrectomies in Japanese patients. This model will help physicians choose surgical treatments for renal tumors in daily clinical practice.
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http://dx.doi.org/10.1089/end.2021.0655DOI Listing
November 2021

Predictive Impact of Early Changes in Serum C-Reactive Protein Levels in Nivolumab Plus Ipilimumab Therapy for Metastatic Renal Cell Carcinoma.

Clin Genitourin Cancer 2021 Oct 13. Epub 2021 Oct 13.

Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.

Background: Serum C-reactive protein (CRP) is reportedly associated with metastatic renal cell carcinoma (mRCC) activity. However, in the era of immune checkpoint inhibitors, the predictive value of CRP is unclear. In this study, we investigated the predictive impact of pretreatment CRP levels and early changes in CRP levels for the treatment of mRCC with nivolumab plus ipilimumab (NIVO-IPI) therapy.

Methods: Forty-eight patients with mRCC treated with NIVO-IPI as a first-line therapy were retrospectively analyzed. First, patients were divided into 2 groups: initial CRP ≥ 1.0 mg/dL and < 1.0 mg/dL. Progression-free survival (PFS) was compared between the 2 groups. Second, based on the CRP change within the first 3 months of NIVO-IPI, patients were placed in the normal group (CRP remains < 1.0 mg/dL), normalized group (CRP decreased < 1.0 mg/dL), and non-normalized group (CRP remained or increased to ≥ 1.0 mg/dL). The predictive association between CRP change and PFS was evaluated.

Results: PFS was significantly lower in the high initial CRP group (n = 24, 50%) compared to the normal CRP group (n = 24, 50%) (median: 4.3 vs. 28.1 months, P = .03). As for the early CRP change, the normal (2.7 vs. 28.1, P = .0002) and normalized (2.7 vs. 11.0, P = .0094) groups showed significantly higher PFS, compared to the non-normalized group. Meanwhile, there was no significant difference between normal, and normalized groups (P = .51). The objective response rate was higher in the normal (57.1% vs. 18.7%, P = .015) and normalized (81.8 vs. 18.7%, P = .0008) groups, compared to the non-normalized group. Multivariate Cox regression analysis showed that normal [Hazard ratio (HR) = 0.15, 95% Confidence interval (CI) = 0.02-0.70, P = .026] and normalized (HR 0.21, 95% CI = 0.05-0.73, P = .015) CRP showed significant association with PFS.

Conclusion: In the NIVO-IPI therapy for mRCC, early changes in CRP could predict PFS. This data may be useful for the early detection of ineffective NIVO-IPI therapy and conversion to subsequent therapies.
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http://dx.doi.org/10.1016/j.clgc.2021.10.005DOI Listing
October 2021

Efficacy and safety of immune checkpoint inhibitors in elderly patients with metastatic renal cell carcinoma.

Int Urol Nephrol 2021 Oct 26. Epub 2021 Oct 26.

Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan.

Purpose: To clarify the efficacy and safety profile of immune checkpoint inhibitors (ICIs) for elderly patients with metastatic renal cell carcinoma (mRCC).

Methods: We retrospectively evaluated 149 mRCC patients treated with nivolumab monotherapy as subsequent therapy (n = 89) and nivolumab plus ipilimumab as first-line therapy (n = 60) at 5 affiliated institutions. The patients were divided according to age: > 70 (elderly) vs. ≤ 70 years (young). Efficacy was analyzed by comparing progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR) between elderly and young patients. Safety was assessed by comparing the incidence rates of immune-related adverse events (irAEs).

Results: In the nivolumab monotherapy group, 34/89 patients (38%) were classified as elderly. There was no significant difference in PFS (p = 0.607), OS (p = 0.383), ORR (p = 0.0699), or DCR (p = 0.881) between elderly and young patients. In the nivolumab plus ipilimumab group, 20/60 patients (33%) were classified as elderly. There was no significant difference in PFS (p = 0.995), OS (p = 0.714), ORR (p = 0.763), or DCR (p = 1.000) between the two groups. The incidence rate of irAEs was not significantly different in the nivolumab (any grade: p = 0.121; grade ≥ 3: p = 0.542) or in the nivolumab plus ipilimumab (any grade: p = 0.666; grade ≥ 3: p = 0.576) group; a higher rate of gastrointestinal irAEs was observed in elderly than in young patients (any grade 15% vs. 3%).

Conclusions: The efficacy and safety of nivolumab monotherapy and nivolumab plus ipilimumab were comparable between elderly and young patients. Thus, chronological age alone should not be a contraindication in the use of ICIs for mRCC.
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http://dx.doi.org/10.1007/s11255-021-03042-yDOI Listing
October 2021

Three Cases of Nivolumab Plus Ipilimumab Therapy in Haemodialysis Patients With Metastatic Renal Cell Carcinoma.

In Vivo 2021 Nov-Dec;35(6):3585-3589

Department of Urology, Tokyo Women's Medical University Hospital, Tokyo, Japan.

Background: Although the CheckMate 214 trial affirmed the effectiveness of nivolumab-ipilimumab combination therapy in advanced or metastatic renal cell carcinoma (mRCC), its safety and efficacy in patients with end-stage renal disease (ESRD) on haemodialysis remains unexplored.

Case Report: All patients were male and underwent mRCC treatment with partial nephrectomy or nephrectomy. They had ESRD and were undergoing haemodialysis. Cases 1 and 2 showed lymph node and lung metastases after initial surgery and received nivolumab-ipilimumab therapy. Case 1 had grade 3 adrenal insufficiency after four courses, which was controlled with steroids. Case 2 did not experience adverse events. Both were well controlled with complete (CR) or partial response (PR). Case 3 suffered local recurrence after nephrectomy and received combination therapy. Grade 3 adrenal insufficiency occurred following three courses, and tumour size did not change remarkably.

Conclusion: Nivolumab-ipilimumab combination therapy can effectively treat mRCC patients with ESRD undergoing haemodialysis.
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http://dx.doi.org/10.21873/invivo.12663DOI Listing
October 2021

Prognostic Impact of Trial-Eligibility Criteria in Patients with Metastatic Renal Cell Carcinoma.

Urol Int 2021 Aug 26:1-8. Epub 2021 Aug 26.

Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.

Objective: The aim of the study was to evaluate the prognostic impact of trial-eligibility criteria on outcome in real-world metastatic renal cell carcinoma (mRCC) patients treated with tyrosine kinase inhibitors (TKIs).

Patients And Methods: mRCC patients treated with TKIs as first-line systemic therapy were retrospectively evaluated. The patients were determined as trial-ineligible when they met at least 1 following trial-ineligible criteria; Karnofsky performance status score <70, hemoglobin <9.0 g/dL, creatinine >2.4 mg/dL (male) or >2.0 mg/dL (female), calcium >12.0 mg/dL, platelet <100,000 /μL, neutrophil <1,500 /μL, nonclear-cell histology, and brain metastasis.

Results: Of 238 patients, 101 patients (42%) were determined as trial-ineligible. Progression-free survival (PFS) and overall survival (OS) after the TKI initiation were significantly shorter in the trial-ineligible patients than in the trial-eligible patients (median PFS: 5.53 vs. 15.8 months, p < 0.0001; OS: 13.8 vs. 43.4 months, p < 0.0001). Objective response rate was also significantly lower in the trial-ineligible patients (15% vs. 37%, p = 0.0003). Multivariate analysis further showed that the trial-eligibility was an independent factor for PFS (hazard ratio [HR]: 2.46, p < 0.0001) and OS (HR: 2.39, p < 0.0001). In addition, the number of trial-ineligible factors were negatively correlated with PFS and OS.

Conclusions: In real-word, the substantial number of mRCC patients did not meet the trial-eligibility criteria, and their outcome was worse than that in the trial-eligible patients. Further studies focusing on the outcome in real-world trial-ineligible patients in the immune checkpoint inhibitor era are warranted.
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http://dx.doi.org/10.1159/000518162DOI Listing
August 2021

Desensitization Regimen Consisting of High-Dose Intravenous Immunoglobulin, Plasmapheresis, and Rituximab (an Anti-CD20 Antibody), Without Eculizumab and/or Bortezomib, in 41 Highly Sensitized Kidney Transplant Recipients.

Exp Clin Transplant 2021 Oct 8;19(10):1032-1040. Epub 2021 Sep 8.

From the Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.

Objectives: Antibody-mediated rejection in patients with positive crossmatches can be severe and result in sudden onset of oliguria, leading to graft loss. In an attempt to prevent posttransplant oliguria, we adopted a preoperative desensitization protocol involving the use of high-dose intravenous immunoglobulin/plasmapheresis and the anti-CD20 antibody, rituximab, in 41 transplant recipients with positive crossmatch test results.

Materials And Methods: We retrospectively examined the clinical courses of the 41 kidney transplant recipients, paying special attention to renal graft function, urine volume, and changes in the titers of donor-specific antibodies.

Results: Four grafts were lost during an average of 4.5-year follow-up. Average graft function was excellent, with a serum creatinine level of 1.3 ± 0.4 mg/dL. Sufficient urine output, with no oliguria or anuria, was achieved postoperatively in 40 of the 41 patients. However, among the 34 patients who underwent graft biopsies, the biopsies revealed acute antibody-mediated rejection in 21 patients (62%), and chronic antibodymediated rejection in 10 patients (30%).

Conclusions: The high-dose intravenous immunoglobulin treatment included in our desensitization protocol was shown to be safe and effective for achieving successful transplant outcomes and allowed the avoidance of more aggressive B-cell-targeted treatments, such as C5 inhibitors and/or proteosome inhibitors, for preventing posttransplant oliguria and anuria.
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http://dx.doi.org/10.6002/ect.2021.0234DOI Listing
October 2021

Association of tumor burden with outcome in first-line therapy with nivolumab plus ipilimumab for previously untreated metastatic renal cell carcinoma.

Jpn J Clin Oncol 2021 Sep 8. Epub 2021 Sep 8.

Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.

Objectives: To investigate the prognostic impact of tumor burden in patients receiving nivolumab plus ipilimumab as first-line therapy for previously untreated metastatic renal cell carcinoma (mRCC).

Methods: We retrospectively evaluated 62 patients with IMDC intermediate- or poor-risk mRCC, treated with nivolumab plus ipilimumab as first-line therapy at five affiliated institutions. Tumor burden was defined as the sum of diameters of baseline targeted lesions according to the RECIST version.1.1. We categorized the patients into two groups based on the median value of tumor burden (i.e., high vs. low). The association of tumor burden with progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) with nivolumab plus ipilimumab treatment was analyzed.

Results: The median tumor burden was 63.0 cm (interquartile range: 34.2-125.8). PFS was significantly shorter in patients with high tumor burden (n = 31) than in those with low tumor burden (n = 31) (median: 6.08 [95% CI: 2.73-9.70] vs. 12.5 [4.77-24.0] months, P = 0.0134). In addition, OS tended to be shorter in patients with high tumor burden; however, there was no statistically significant difference (1-year rate: 77.3 vs. 96.7%, P = 0.166). ORR was not significantly different between patients with high and low tumor burden (35 vs. 55%, P = 0.202). Multivariate analysis of PFS further showed that tumor burden was an independent factor (HR: 2.22 [95% CI: 1.11-4.45], P = 0.0242).

Conclusions: Tumor burden might be a useful factor for outcome prediction, at least for PFS prediction, in patients receiving nivolumab plus ipilimumab for mRCC. Further prospective studies are warranted to confirm our findings.
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http://dx.doi.org/10.1093/jjco/hyab142DOI Listing
September 2021

Hypopituitarism in patients with metastatic renal cell carcinoma treated with ipilimumab and nivolumab combination therapy.

Jpn J Clin Oncol 2021 Sep 6. Epub 2021 Sep 6.

Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.

Objective: We investigated the incidence of hypopituitarism in Japanese patients with metastatic renal cell carcinoma (mRCC) who received ipilimumab and nivolumab (I-P) therapy and compared patient characteristics and survival rates between patients with hypopituitarism and those without.

Methods: Twenty-two patients with mRCC who received I-P therapy as first-line treatment were the subjects of this retrospective study. The diagnosis of hypopituitarism was based on the hormone loading test.

Results: Hypopituitarism occurred in 41% (9/22) patients who received I-P therapy. Median time of diagnosis was 12 weeks (IQR: 9.5-20). Clinical symptoms, such as fatigue, weakness or fever, were observed in 7 patients, while 2 patients had no clinical presentation. The following deficiency patterns were observed: isolated ACTH in 4 patients, ACTH and GH in 2 patients, ACTH and TSH in 2 patients and triple deficiency (ACTH, GH and TSH) in 1 patient. All patients with hypopituitarism were in the IMDC intermediate group, while 46% of those without hypopituitarism were in the IMDC intermediate group. Other patient characteristics were not different between the two groups. Object response rate was 33% (3/9) in patients with hypopituitarism and 23% (3/13) in those without (P = 0.5954). Progression free survival (PFS) was significantly longer in those with hypopituitarism than those without (median: 24.7 vs. 4.5 months, P = 0.0008), while overall survival did not differ (P = 0.136).

Conclusions: Compared with the clinical trial, the incidence of hypopituitarism was higher than expected. Patients with hypopituitarism tended to have longer PFS, which may suggest that optimal management of hypopituitarism results in better prognosis.
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http://dx.doi.org/10.1093/jjco/hyab141DOI Listing
September 2021

COVID-19 pandemic and worldwide organ transplantation: a population-based study.

Lancet Public Health 2021 10 30;6(10):e709-e719. Epub 2021 Aug 30.

Université de Paris, INSERM, PARCC, Paris Translational Research Centre for Organ Transplantation, Paris, France; Department of Medicine, Renal-Electrolyte and Hypertension Division, University of Pennsylvania, Philadelphia, PA, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.

Background: Preliminary data suggest that COVID-19 has reduced access to solid organ transplantation. However, the global consequences of the COVID-19 pandemic on transplantation rates and the effect on waitlisted patients have not been reported. We aimed to assess the effect of the COVID-19 pandemic on transplantation and investigate if the pandemic was associated with heterogeneous adaptation in terms of organ transplantation, with ensuing consequences for waitlisted patients.

Methods: In this population-based, observational, before-and-after study, we collected and validated nationwide cohorts of consecutive kidney, liver, lung, and heart transplants from 22 countries. Data were collected from Jan 1 to Dec 31, 2020, along with data from the same period in 2019. The analysis was done from the onset of the 100th cumulative COVID-19 case through to Dec 31, 2020. We assessed the effect of the pandemic on the worldwide organ transplantation rate and the disparity in transplant numbers within each country. We estimated the number of waitlisted patient life-years lost due to the negative effects of the pandemic. The study is registered with ClinicalTrials.gov, NCT04416256.

Findings: Transplant activity in all countries studied showed an overall decrease during the pandemic. Kidney transplantation was the most affected, followed by lung, liver, and heart. We identified three organ transplant rate patterns, as follows: countries with a sharp decrease in transplantation rate with a low COVID-19-related death rate; countries with a moderate decrease in transplantation rate with a moderate COVID-19-related death rate; and countries with a slight decrease in transplantation rate despite a high COVID-19-related death rate. Temporal trends revealed a marked worldwide reduction in transplant activity during the first 3 months of the pandemic, with losses stabilising after June, 2020, but decreasing again from October to December, 2020. The overall reduction in transplants during the observation time period translated to 48 239 waitlisted patient life-years lost.

Interpretation: We quantified the impact of the COVID-19 pandemic on worldwide organ transplantation activity and revealed heterogeneous adaptation in terms of organ transplantation, both at national levels and within countries, with detrimental consequences for waitlisted patients. Understanding how different countries and health-care systems responded to COVID-19-related challenges could facilitate improved pandemic preparedness, notably, how to safely maintain transplant programmes, both with immediate and non-immediate life-saving potential, to prevent loss of patient life-years.

Funding: French national research agency (INSERM) ATIP Avenir and Fondation Bettencourt Schueller.
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http://dx.doi.org/10.1016/S2468-2667(21)00200-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8460176PMC
October 2021

Limited impact of warm ischemic threshold for partial nephrectomy in the robotic surgery era: A propensity score matching study.

Int J Urol 2021 Sep 1. Epub 2021 Sep 1.

Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.

Objectives: To evaluate the association between extended (≥30 min) warm ischemic time and renal function in patients undergoing robot-assisted partial nephrectomy.

Methods: This multi-institutional study retrospectively recruited 1131 patients who underwent robot-assisted partial nephrectomy. Patients were classified into shorter (<30 min; n = 1038) and longer (≥30 min; n = 92) groups based on the ischemic time required, and 1:2 propensity score matching was used to minimize selection bias. The perioperative outcomes, including acute kidney injury and trifecta attainment, and mid/long-term renal function were assessed before and after matching.

Results: Patients in the longer group had tumors with a significantly larger diameter and RENAL nephrometry score. The decline in the nadir of the estimated glomerular filtration rate was significantly greater in the longer than the shorter group in the unmatched and matched cohorts (-16.2 vs -5.5%, P < 0.001; 15.5 vs -9.5%, P = 0.003, respectively). A higher incidence of acute kidney injury (9.8 vs 2.6%, P = 0.002) was observed in the longer group before matching, whereas the difference was comparable after matching. Before matching, the decline in estimated glomerular filtration rate at 6 months postoperatively was greater (-8.2 vs -5.1%, P = 0.005) and trifecta attainment was lower (50.0 vs 63.5%, P < 0.001) in the longer group. However, the differences were comparable for both the parameters between the groups in the matched cohort.

Conclusions: While extended warm ischemia during robot-assisted partial nephrectomy can be demanded in case of large and complex tumors, its impact on postoperative renal function is limited.
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http://dx.doi.org/10.1111/iju.14674DOI Listing
September 2021

Albumin-to-Alkaline Phosphatase Ratio as a Novel Prognostic Marker of Nivolumab Monotherapy for Previously Treated Metastatic Renal Cell Carcinoma.

In Vivo 2021 Sep-Oct;35(5):2855-2862

Department of Urology, Tokyo Women's Medical University, Shinjuku, Japan.

Background/aim: The relationship between albumin-to-alkaline phosphatase ratio (AAPR) and the outcome of patients with metastatic renal cell carcinoma (mRCC) treated with immune checkpoint inhibitors remains unresolved. We aimed to clarify the prognostic role of AAPR in nivolumab monotherapy for previously treated mRCC.

Patients And Methods: We retrospectively evaluated 60 patients with mRCC treated with nivolumab after failure of at least one molecular targeted therapy. The patients were stratified into two groups based on the baseline AAPR. The threshold of AAPR was determined using receiver-operating characteristics and Youden index analyses. Overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) of nivolumab therapy were compared between the high and low AAPR groups.

Results: The threshold of AAPR was set at 0.3, and 20 patients (33%) were assigned to the low AAPR group. The median OS and PFS were significantly lower in the low AAPR group than those in the high group (OS: 8.3 months vs. not reached, p<0.0001; PFS: 2.9 vs. 10.4 months, p=0.0006). Moreover, ORR was significantly lower in the low AAPR group than in the high group (16% vs. 45%, p=0.0397). Multivariate analyses further showed that AAPR was an independent factor for OS [HR=0.27 (95% CI=0.09-0.77), p=0.0151] but not for PFS (p=0.174).

Conclusion: Baseline AAPR was significantly associated with outcome in patients with mRCC receiving nivolumab monotherapy and may, therefore, constitute an effective prognostic factor for nivolumab treatment.
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http://dx.doi.org/10.21873/invivo.12573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408722PMC
August 2021

Surgical outcomes of robot-assisted laparoscopic partial nephrectomy for cystic renal cell carcinoma.

J Robot Surg 2021 Aug 3. Epub 2021 Aug 3.

Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.

To compare the surgical outcomes of robot-assisted partial nephrectomy (RAPN) between patients with cystic renal cell carcinoma (cRCC) and those with solid RCC (sRCC). We retrospectively analyzed 1065 patients who underwent RAPN between 2013 and 2020 for a pathological diagnosis of RCC. Patients were divided into two groups: cRCC and sRCC. cRCC was diagnosed according to the Bosniak classification system. To minimize selection bias between the two groups, patient variables (patient characteristics) and tumor factors (such as size and complexity) were adjusted using 1:1 propensity score matching. Of the 1065 patients, 94 (9%) were diagnosed with cRCC. Bosniak categories of IIF, III, and IV were noted in 4 (4.2%), 31 (33%), and 59 (63%) patients, respectively. After matching, 83 patients each were assigned to the cRCC and sRCC groups. The operation time in cRCC tended to be longer than in sRCC but not significantly different (164 vs. 150 min, P = 0.0767). Other surgical outcomes, such as change in estimated glomerular filtration rate ( - 5.2 vs.  - 7.2%, P = 0.1577), perioperative complications (14.5 vs. 15.7%, P = 0.9225), estimated blood loss (62 vs. 58 mL, P = 0.5613), or negative surgical margin status (100 vs 99%, P = 0.236), were not significantly different between the two groups. During the follow-up period of about 2 years, one and two patients showed recurrence in the cRCC and sRCC groups, respectively. The surgical outcomes of RAPN were similar between cRCC and sRCC, demonstrating the feasibility of RAPN for cRCC.
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http://dx.doi.org/10.1007/s11701-021-01292-7DOI Listing
August 2021

Antibiotic use and survival of patients receiving pembrolizumab for chemotherapy-resistant metastatic urothelial carcinoma.

Urol Oncol 2021 Dec 18;39(12):834.e21-834.e28. Epub 2021 Jul 18.

Department of Urology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan.

Objectives: The use of antibiotics alters gut microbiota and has been reported to impact outcomes in immune checkpoint inhibitor (ICI) treatment in various types of cancer. We investigated the impact of antibiotics on patients with metastatic urothelial carcinoma (mUC) treated with pembrolizumab.

Materials And Methods: The data of 67 patients with chemotherapy-resistant mUC who were treated with pembrolizumab were retrospectively evaluated. The patients were classified into groups according to antibiotic status (with-antibiotic and without-antibiotic), and the progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR) were compared between the 2 groups.

Results: PFS (median: 1.1 vs. 8.9 months; P < 0.001) and OS (median: 2.3 vs. 19.5 months; P < 0.001) were significantly shorter in the with-antibiotic group (n = 15, 22%) than in the without-antibiotic group (n = 52, 78%). Patients in the with-antibiotic group had significantly higher Eastern Cooperative Oncology Group performance status scores (P = 0.042). Multivariable analyses revealed antibiotic use as an independent predictor of PFS (P < 0.001) and OS (P = 0.002). No patients in the with-antibiotic group achieved a complete response to pembrolizumab. The ORR (complete response (CR) + partial response (PR)) was higher among patients not treated with antibiotics than among patients treated with antibiotics, though the difference was not significant (34.6% vs. 13.3%, P = 0.093). The DCR (CR + PR + stable disease) was also higher among patients in the with-antibiotic group than in the without-antibiotic group (57.7% vs. 20.0%, P = 0.008).

Conclusion: The use of antibiotics was negatively associated with outcomes in patients with mUC who are administered pembrolizumab. Baseline performance status was worse for these patients. Further analyses are required to identify associations between antibiotic use, bacterial infection for which it was indicated or its influence on performance status, on treatment outcomes.
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http://dx.doi.org/10.1016/j.urolonc.2021.05.033DOI Listing
December 2021

Comparison of surgical outcomes between enucleation and standard resection in robot-assisted partial nephrectomy for completely endophytic renal tumors through a 1:1 propensity score-matched analysis.

J Endourol 2021 Jul 8. Epub 2021 Jul 8.

Tokyo Women's Medical University, 13131, Urology, Shinjuku-ku, Tokyo, Japan;

Objective: Robot-assisted laparoscopic partial nephrectomy (RAPN) for completely endophytic renal tumors is challenging because of the tumor complexity. The enucleation technique is an ideal resection method to maximally preserve the renal parenchyma. In the present study, we investigated the surgical outcomes of RAPN for completely endophytic renal tumors and compared them between the enucleation and standard resection techniques.

Methods: One-hundred-and-forty-four patients who underwent RAPN for completely endophytic tumors were the subjects of this study. The subjects were divided into two groups according to the surface-intermediate-margin (SIB) score: enucleation group (SIB score 0-2) and standard resection group (SIB score 3-5). To minimize selection bias between the two surgical methods, patient variables such as age, sex, body mass index, American Society of Anesthesiologists score, tumor size, RENAL NS, and preoperative renal function were adjusted using 1:1 propensity score matching.

Results: Of the 144 patients, 72 were assigned to the enucleation group and 72 to the standard resection group. After matching, 45 patients were included in each group. The mean tumor size was 26-27 mm and the mean RENAL NS score was 9.0-9.1, after matching. The enucleation group showed significantly better preservation of the estimated glomerular filtration rate (eGFR) in the early postoperative period (-4.9% vs. -16%, p = 0.0005) and at 6-12 months after surgery (-4.9% vs. -9.2%, p = 0.0327) than the standard resection group. In addition, a shorter operation time (140 vs. 167 min, p = 0.0028) was observed in the enucleation group. Other outcomes including estimated blood loss, positive surgical margin rate, incidence rate of complications, and length of hospital stay were not significantly different between the two groups.

Conclusion: The enucleation technique showed better surgical outcomes for completely endophytic renal tumors in terms of preservation of renal function and operation time than the standard resection technique.
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http://dx.doi.org/10.1089/end.2021.0213DOI Listing
July 2021

Prognostic Impact of Early Treatment Interruption of Nivolumab Plus Ipilimumab Due to Immune-Related Adverse Events as First-Line Therapy for Metastatic Renal Cell Carcinoma: A Multi-Institution Retrospective Study.

Target Oncol 2021 07 26;16(4):493-502. Epub 2021 Jun 26.

Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan.

Background: It remains unclear how early treatment interruption of nivolumab plus ipilimumab due to immune-related adverse events affects the outcome of previously untreated metastatic renal cell carcinoma (mRCC).

Objective: To investigate the prognostic impact of the early interruption of nivolumab plus ipilimumab, used as first-line therapy for mRCC.

Patients And Methods: We retrospectively evaluated 59 intermediate- or poor-risk mRCC patients who received nivolumab plus ipilimumab as first-line therapy. Based on whether early treatment interruption was implemented within the initial four treatment cycles (i.e., 3 months) or not, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were compared. The prognostic association was further compared with that of 186 patients treated with tyrosine kinase inhibitors (TKIs) as first-line therapy.

Results: Twenty-three of the 59 patients (39%) experienced interruption of nivolumab plus ipilimumab therapy. The patients with interruption had longer PFS (p = 0.0055), similar OS (p = 0.366), and likely higher ORR (p = 0.0660) than those without interruption. Of the patients treated with TKIs, 60 of 186 (32%) experienced interruption, with shorter PFS (p = 0.0121), similar OS (p = 0.378), and similar ORR (p = 0.738) than those without interruption. In the 23 patients with nivolumab plus ipilimumab interruption, high-dose corticosteroids were administered in seven patients (30%). PFS (p = 0.638), OS (p = 0.968), or ORR (p = 0.760) did not differ based on corticosteroid administration.

Conclusions: Early treatment interruption, which exerted a negative effect for TKIs, was a preferable event for nivolumab plus ipilimumab when considering PFS. Furthermore, early administration of high-dose corticosteroids did not diminish the anti-tumor effect of nivolumab plus ipilimumab.
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http://dx.doi.org/10.1007/s11523-021-00825-2DOI Listing
July 2021

Prognostic impact of immune-related adverse events in metastatic renal cell carcinoma treated with nivolumab plus ipilimumab.

Urol Oncol 2021 10 22;39(10):735.e9-735.e16. Epub 2021 Jun 22.

Department of Urology, Kidney Center, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan.

Objectives: Evidence regarding the prognostic impact of immune-related adverse events (irAEs) remains limited in patients with metastatic renal cell carcinoma (mRCC) treated with nivolumab plus ipilimumab as a first-line systemic therapy. Thus, we investigated the association between irAE development and oncological outcomes during nivolumab plus ipilimumab therapy.

Methods: We retrospectively evaluated 46 patients with mRCC who were treated with nivolumab plus ipilimumab at our hospital and its affiliated institutions. The associations between irAE development and progression-free survival (PFS), overall survival (OS), and objective response rates (ORRs) were assessed after treatment initiation.

Results: A total of 60 irAEs occurred in 33 patients (72%), with 24 grade ≥ 3 irAEs developed in 20 patients (43%). PFS was significantly longer in patients with irAEs than that in patients without irAEs (P < 0.0001); however, OS was not different (P = 0.571). Multivariable analysis further revealed that the development of irAEs was an independent predictor of a longer PFS (hazard ratio: 0.18, P = 0.0005). A landmark analysis for the initial four cycles of nivolumab plus ipilimumab administration also showed that PFS was significantly longer in patients with irAEs than that in patients without irAEs (P = 0.0386). The ORRs were also higher in patients with irAEs (P = 0.0064). Furthermore, in 22 patients (48%) who discontinued nivolumab plus ipilimumab treatment, the 6-month PFS rate was 87%.

Conclusion: This multi-institutional study showed that irAE development was significantly associated with PFS but not with OS in patients treated with nivolumab plus ipilimumab as a first-line therapy. The development of irAEs may be used as a surrogate prognostic marker for PFS in this treatment regimen.
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http://dx.doi.org/10.1016/j.urolonc.2021.05.012DOI Listing
October 2021

Surgery for renal cell carcinoma extending to the right atrium in Japanese institutions: Focusing on cardiopulmonary bypass with or without deep hypothermic circulatory arrest.

Int J Urol 2021 Oct 22;28(10):1001-1007. Epub 2021 Jun 22.

Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.

Objectives: To evaluate the outcomes of Japanese patients with renal cell carcinoma undergoing surgery for tumor thrombus invading the right atrium.

Methods: We retrospectively evaluated 23 patients who underwent extracorporeal circulation-assisted surgery at two institutions. Perioperative outcomes and survival rates were evaluated and compared between two groups of patients, which were set according to the use or not of deep hypothermic circulatory arrest. Data on systemic treatments were assessed.

Results: The median age was 64 years; the majority of patients were fit according to the Charlson Comorbidity Index. Five (21.7%) patients had at least one distant metastasis, and 17 (73.9%) received systemic therapy. A total of 16 (69.6%) patients underwent deep hypothermic circulatory arrest. Baseline characteristics were comparable between groups. Patients who underwent deep hypothermic circulatory arrest had a non-significant reduction in blood loss compared with those who did not undergo this procedure (1866.0 vs 3513.0 mL, P = 0.102). The complication rate, both of any grade (43.8% vs 71.4%, P = 0.215) and grade ≥3 (6.3% vs 28.6%, P = 0.162), tended to be lower in patients who underwent deep hypothermic circulatory arrest. The mean 90-day mortality rate was 8.7%, with no difference among groups (6.3% vs 14.3%, respectively; P = 0.545). The overall median cancer-specific and overall survival were both 64.4 months, and did not differ between groups.

Conclusions: Renal cell carcinoma patients undergoing extracorporeal circulation-assisted surgery and systemic therapy for right atrial tumor thrombus have acceptable long-term survival rates. Outcomes are comparable regardless of the use of deep hypothermic circulatory arrest.
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http://dx.doi.org/10.1111/iju.14627DOI Listing
October 2021

Preoperative autologous blood donation for kidney transplant and end-stage renal disease patients: A single-center study.

Transfus Apher Sci 2021 Aug 24;60(4):103149. Epub 2021 Apr 24.

Department of Transfusion Medicine and Cell Processing, Tokyo Women's Medical University Hospital, Tokyo, Japan.

Although preoperative autologous blood donation (PABD) has many advantages, there has been a decrease in the performance due to a decrease in the residual risk of allogeneic blood transfusion. In allogeneic blood transfusion, anti HLA antibodies and donor-specific antibodies mediate antibody-mediated rejection, which results in graft failure. PABD for anemic patients such as those with end-stage renal disease (ESRD) and a kidney transplant is relatively contraindicated. In this study, we aimed to investigate the characteristics of patients who underwent PABD and elucidate the safety and feasibility of PABD. We performed PABD safely in ten ESRD patients and nine kidney transplant patients and retrospectively analyzed medical records of the hospital. All kidney transplant patients avoided allogeneic blood transfusion, but 4 out of 10 ESRD patients had allogeneic blood transfusion, even if their blood donation volume was larger than those of the kidney transplant patients. It depends on the type of operation; cardiovascular surgery was more common in ESRD patients, and orthopedic surgery was more common in kidney transplant patients. There was profuse bleeding in cardiovascular surgery compared to orthopedic surgery because of longer operation time of the former. Completely avoiding allogeneic blood transfusion in major surgery was rather difficult even if PABD was performed. To prevent the formation of anti- HLA antibodies, PABD would be considered for ESRD patients undergoing kidney transplantation and kidney transplant patients that are potential candidates for secondary kidney transplantation.
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http://dx.doi.org/10.1016/j.transci.2021.103149DOI Listing
August 2021

Recipient myeloperoxidase-producing cells regulate antibody-mediated acute versus chronic kidney allograft rejection.

JCI Insight 2021 07 8;6(13). Epub 2021 Jul 8.

Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Antibody-mediated rejection (ABMR) continues to be a major problem undermining the success of kidney transplantation. Acute ABMR of kidney grafts is characterized by neutrophil and monocyte margination in the tubular capillaries and by graft transcripts indicating NK cell activation, but the myeloid cell mechanisms required for acute ABMR have remained unclear. Dysregulated donor-specific antibody (DSA) responses with high antibody titers are induced in B6.CCR5-/- mice transplanted with complete MHC-mismatched A/J kidneys and are required for rejection of the grafts. This study tested the role of recipient myeloid cell production of myeloperoxidase (MPO) in the cellular and molecular components of acute ABMR. Despite induction of equivalent DSA titers, B6.CCR5-/- recipients rejected A/J kidneys between days 18 and 25, with acute ABMR, whereas B6.CCR5-/-MPO-/- recipients rejected the grafts between days 46 and 54, with histopathological features of chronic graft injury. On day 15, myeloid cells infiltrating grafts from B6.CCR5-/- and B6.CCR5-/-MPO-/- recipients expressed marked phenotypic and functional transcript differences that correlated with the development of acute versus chronic allograft injury, respectively. Near the time of peak DSA titers, activation of NK cells to proliferate and express CD107a was decreased within allografts in B6.CCR5-/-MPO-/- recipients. Despite high titers of DSA, depletion of neutrophils reproduced the inhibition of NK cell activation and decreased macrophage infiltration but increased monocytes producing MPO. Overall, recipient myeloid cells producing MPO regulate graft-infiltrating monocyte/macrophage function and NK cell activation that are required for DSA-mediated acute kidney allograft injury, and their absence switches DSA-mediated acute pathology and graft outcomes to chronic ABMR.
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http://dx.doi.org/10.1172/jci.insight.148747DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8410093PMC
July 2021

Robot-Assisted Laparoscopic Partial Nephrectomy for Allograft Renal Cell Carcinoma: A Case Report.

Transplant Proc 2021 Jun 4;53(5):1445-1449. Epub 2021 May 4.

Department of Urology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan.

Background: Nephron-sparing surgery is required for patients with kidney transplant with organ-confined renal cell carcinoma (RCC) in the allograft kidney to preserve renal function. Robot-assisted laparoscopic partial nephrectomy (RAPN) is expected to be the optimal surgical approach for these patients, as in the general population. However, RAPN for RCC arising in the allograft kidney is rarely reported. Here, we report 2 cases of patients who underwent RAPN for allograft RCC.

Case Presentation: Two patients were diagnosed with RCC in the renal allograft based on enhanced computed tomography findings. Case 1 was a 69-year-old man with a 32-mm mass in the middle portion of the right iliac fossa renal allograft, and case 2 was a 55-year-old man with a 24-mm mass in the lower pole of the right iliac fossa renal allograft. In each patient, RAPN was performed for the renal mass through a transperitoneal approach, with clamping of the renal artery. No major perioperative complications occurred in either patient, negative surgical margins were achieved, and no significant changes in kidney function were observed during either surgery. Pathologic findings showed clear cell RCC in case 1 and papillary RCC in case 2.

Conclusion: RAPN can be a feasible and effective treatment option for allograft RCC.
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http://dx.doi.org/10.1016/j.transproceed.2021.03.033DOI Listing
June 2021

Comparable survival outcome between acquired cystic disease associated renal cell carcinoma and clear cell carcinoma in patients with end-stage renal disease: a multi-institutional central pathology study.

Pathology 2021 Oct 2;53(6):720-727. Epub 2021 May 2.

Department of Surgical Pathology, Aichi Medical University Hospital, Nagakute, Japan.

Acquired cystic disease (ACD) associated renal cell carcinoma (RCC) is designated as a new subtype unique to patients with end-stage renal disease (ESRD) according to the 2016 World Health Organization (WHO) classification. However, the oncological outcomes of the prognostic factors for patients with this subtype are not fully understood. In the present study, we compared the survival of ACD associated RCC patients who underwent nephrectomy with that of patients with other histological subtypes who developed ESRD. Over 378 patients who underwent nephrectomy at three Japanese institutes between 1987 and 2016 were included in this study. A central pathologist reviewed the sections from all patients according to the 2016 WHO classification. The central pathological review showed a clear cell subtype in 165 patients (43.6%), ACD associated RCC in 112 (29.6%), papillary in 61 (16.1%), and others in 40 (10.7%). The proportion of patients with pathological stage 1 was extremely high in both clear cell and ACD associated RCC cohorts (86.6%, 85.7%). The cancer specific survival (CSS) and recurrence free survival rates of patients with ACD associated RCC were comparable with those with clear cell carcinoma and significantly better than those with the papillary subtype. The factors predictive of unfavourable outcomes were long dialysis duration, tumour size, pathological stage, grade 4 tumour, and the presence of lymphovascular invasion or a sarcomatoid component. Patients with a pre-operative dialysis duration of 20 years or longer showed a significantly worse CSS than other patients, probably owing to sarcomatoid differentiation and stage migration during the advanced stages. In conclusion, this study included the largest number of patients with ACD associated RCC, showing a survival similar to that of clear cell histology patients with ESRD, except for the rarity of late recurrence. ACD associated RCC was not as indolent as initially recognised when patients were on long term dialysis.
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http://dx.doi.org/10.1016/j.pathol.2021.01.014DOI Listing
October 2021

Greater Renal Function Benefit from Enucleation Technique for More Complex Renal Tumors in Robot-Assisted Partial Nephrectomy.

J Endourol 2021 Oct 11;35(10):1512-1519. Epub 2021 May 11.

Department of Urology, Tokyo Women's Medical University, Shinjuku-ku, Japan.

Tumor enucleation technique in robot-assisted partial nephrectomy (RAPN) reportedly contributes to renal function preservation. Which tumors and which part to utilize this technique have not been determined. This multi-institutional retrospective study included patients who underwent RAPN at tertiary surgery centers. Patients were first stratified into High, Intermediate, and Low categories based on renal nephrometry score. Patients were further classified into I/B-enucleation (I/B-E, I + B ≤ 1) and I/B-resection (I/B-R, I + B ≥ 2) groups based on surface-intermediate-base margin score. Perioperative outcomes, including percentile change in estimated glomerular filtration rate (eGFR), new-onset chronic kidney disease, complication rate, surgical margin, and trifecta achievement, were compared between the I/B-E and I/B-R groups in each category. Odds ratios (ORs) and β-coefficients were also compared. Overall, 704 patients were included in this study. Relative decrease in eGFR was significantly lower for the I/B-E group in all three categories, with medians of 8.1%, 4.4%, and 3.2% in the High, Intermediate, and Low, respectively. In multivariate analyses, excision technique was independently associated with eGFR change in all three. β-coefficient was higher in the High (5.06) category than in the Low (3.17) or Intermediate (3.33). Across all three categories, significantly more patients attained trifecta with a difference of 34.0%, 18.3%, and 15.1% in the High, Intermediate, and Low categories, respectively (all,  < 0.05), with a higher OR in the High (5.91) category than in the Low (3.20) or Intermediate (2.48). No significant differences were found in operation time, amount of estimated blood loss, rate of positive surgical margin, or complications. Warm ischemic time was significantly longer for the I/B-E group in the Intermediate (18.0 minutes 16.0 minutes,  = 0.002) and Low categories (13.0 11.0,  = 0.006), but not significant in High ( = 0.344). I/B-enucleation in RAPN contributes to renal function preservation, and the impact was more emphasized in complex tumors.
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http://dx.doi.org/10.1089/end.2020.1210DOI Listing
October 2021

Predictive Impact of Prognostic Nutritional Index on Pembrolizumab for Metastatic Urothelial Carcinoma Resistant to Platinum-based Chemotherapy.

Anticancer Res 2021 Mar;41(3):1607-1614

Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.

Background/aim: We investigated the prognostic nutritional index (PNI), comprised of lymphocytes and albumin, as a potential prognosticator of metastatic urothelial carcinoma (mUC) patients receiving pembrolizumab.

Patients And Methods: Sixty-five patients were retrospectively enrolled and classified as low (<40) and high (≥40) based on pretreatment PNI. Progression-free survival (PFS), overall survival (OS) and response rates were evaluated.

Results: In the low PNI group, significantly shorter PFS and OS were observed. PNI was shown to be an independent predictor of PFS and OS in the multivariate analysis. C-index for both PFS and OS improved with the addition of PNI to the model described in the KEYNOTE-045 study. Significantly more patients experienced initial disease progression in the low PNI group.

Conclusion: PNI is a useful predictor of prognosis and disease progression in mUC patients receiving pembrolizumab.
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http://dx.doi.org/10.21873/anticanres.14922DOI Listing
March 2021

Monoclonal and polyclonal immunoglobulin G deposits on tubular basement membranes of native and pretransplant kidneys: A retrospective study.

Pathol Int 2021 Jun 30;71(6):406-414. Epub 2021 Mar 30.

Department of Analytic Human Pathology, Nippon Medical School, Tokyo, Japan.

Monoclonal tubular basement membrane immune deposits (TBMID) are associated with progression of interstitial injury in renal allograft. However, the significance of monoclonal and polyclonal TBMID in the native kidney remains unclear. We retrospectively analyzed 1894 native kidney biopsies and 1724 zero-hour biopsies performed between 2008 and 2018 in our institution. The rate of immunoglobulin G (IgG) TBMID was found to be 8.4% among native kidney biopsies and 0.4% among zero-hour biopsies. Polyclonal TBMID is common in IgG4-related tubulointerstitial nephritis (37.5%), diabetic nephropathy (31.3%) and lupus nephritis (25.5%). Monoclonal IgG TBMID was identified in seven cases, including three zero-hour biopsies. The combination of IgG1κ was observed in two cases, IgG1λ in three, and IgG2κ in two. Electron microscopy revealed powdery electron-dense deposits in all cases. Monoclonal gammopathy of undetermined significance was diagnosed in one case. Although one patient with focal segmental glomerulosclerosis developed renal failure, all others exhibited stable renal function. Monoclonal IgG TBMID in the native kidney is not associated with renal prognosis. However, this may be an interesting immunopathological finding that would help clarify the pathogenesis of TBM immune deposits. Further study for both monoclonal and polyclonal TBMID is required in the future.
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http://dx.doi.org/10.1111/pin.13092DOI Listing
June 2021

Living-Donor Kidney Transplantation Performed in a Low-Volume Center by Visiting Surgeons From a High-Volume Center and Managed Clinically Solely by Nephrologists: 1-Year Outcomes.

Transplant Proc 2021 Apr 17;53(3):872-880. Epub 2021 Mar 17.

Department of Urology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan.

Background: Little is known about the outcome of living-donor kidney transplantation (LDKT) performed in low-volume centers lacking the services of full-time transplant surgeons. This retrospective cohort study assessed the outcome of LDKT performed in a low-volume center by visiting transplant surgeons from a high-volume center and managed perioperatively by transplant nephrologists.

Methods: We compared Japanese adult patients who had no donor-specific antibodies and underwent LDKT between 2006 and 2015 either in a low-volume (n = 31) or high-volume (n = 481) center. In the low-volume center, visiting transplant surgeons from the high-volume center conducted LDKT and transplant nephrologists managed the recipients peri- and postoperatively. The primary outcome was the composite of infection, cardiovascular disease, or cancer during 1-year follow-up. The outcomes of the low- and high-volume centers were compared using 1:2 propensity score matching.

Results: After matching, 9 of 29 patients in the low-volume center (31.0%) and 16 of 58 patients in the high-volume center (27.6%) experienced the primary composite outcome (risk ratio = 1.13; 95% confidence interval, 0.57-2.23). There were no significant differences between the 2 groups in graft function at 1 year, all-cause graft loss, biopsy-proven rejection, and urological complications. However, the median duration of post-LDKT hospitalization was significantly longer in the low-volume center than in the high-volume center (23 and 16 days, respectively).

Conclusions: Among Japanese patients without preformed donor-specific antibodies, LDKT conducted at a low-volume center by visiting transplant surgeons from a high-volume center and managed clinically by transplant nephrologists was not associated with significantly higher risk of postoperative complications.
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http://dx.doi.org/10.1016/j.transproceed.2021.02.011DOI Listing
April 2021

Outcome of advanced renal cell carcinoma arising in end-stage renal disease: comparison with sporadic renal cell carcinoma.

Clin Exp Nephrol 2021 Jun 27;25(6):674-682. Epub 2021 Feb 27.

Department of Urology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.

Background: The data regarding oncological outcome in advanced renal cell carcinoma (RCC) arising in end-stage renal disease (ESRD) are limited.

Methods: Patients diagnosed with advanced RCC on maintenance dialysis therapy (ESRD-RCC) and treated with tyrosine kinase inhibitors (TKIs) were retrospectively evaluated. Progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) after initiation of first-line TKI therapy in ESRD-RCC patients were compared to those in RCC arising in the general population (sporadic RCC).

Results: A total of 36 and 240 patients were diagnosed with advanced ESRD-RCC and sporadic RCC, respectively. PFS and OS were significantly shorter in patients with ESRD-RCC than in those with sporadic RCC (p = 0.0004 and p = 0.0045). After adjusting for histopathological type, MSKCC risk and liver metastasis status, ESRD status (ESRD-RCC vs. sporadic RCC) was not an independent risk factor for PFS or OS (both, p > 0.05). The ORR tended to be lower in patients with ESRD-RCC than in those with sporadic RCC (11% vs. 28%, p = 0.0833). In 34 patients with ESRD-RCC treated with sorafenib, longer duration of dialysis was an independent prognostic factor for shorter OS (hazard ratio 3.21, p = 0.0370).

Conclusions: Outcome of advanced ESRD-RCC was poorer than that of sporadic RCC, but this finding was affected by other prognostic factors. Nevertheless, the study suggested that advanced ESRD-RCC was not an indolent disease. Additionally, patients with a longer duration of dialysis therapy might require careful monitoring.
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http://dx.doi.org/10.1007/s10157-021-02038-3DOI Listing
June 2021

The Controlling Nutritional Status CONUT Score in Patients With Advanced Bladder Cancer After Radical Cystectomy.

In Vivo 2021 Mar-Apr;35(2):999-1006

Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.

Background/aim: The impact of the controlling nutritional status (CONUT) score on oncological outcomes after radical cystectomy (RC) for advanced bladder cancer (BC) is unknown.

Patients And Methods: We retrospectively evaluated 115 patients who underwent RC for advanced BC at our department between November 2003 and February 2019. The CONUT score was calculated from serum albumin levels, total lymphocyte counts, and total cholesterol levels. Relapse-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS) after RC were analyzed.

Results: For the CONUT score, the area under curve was 0.651 and the optimal cut-off value determined using the Youden index was 3. The high CONUT group had significantly shorter RFS, CSS, and OS than the low CONUT group. Multivariate analyses showed that the CONUT score was an independent prognostic factor of RFS, CSS, and OS.

Conclusion: The CONUT score could be an effective predictor for survival and tolerability following RC for advanced BC.
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http://dx.doi.org/10.21873/invivo.12343DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8045070PMC
June 2021

Effect of improved systemic therapy on patient survival in metastatic non-clear-cell renal cell carcinoma.

Int J Urol 2021 05 22;28(5):605-607. Epub 2021 Feb 22.

Department of Urology, Tokyo Women's Medical University, Tokyo, Japan.

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http://dx.doi.org/10.1111/iju.14523DOI Listing
May 2021

Polymerase-chain reaction testing to prevent hospital-acquired severe acute respiratory syndrome coronavirus 2 infection in Shinjuku, an epicenter in Tokyo: The Tokyo Women's Medical University model.

Respir Investig 2021 May 26;59(3):356-359. Epub 2021 Jan 26.

Department of General Medicine, Tokyo Women's Medical University, Tokyo, Japan.

Hospital-acquired severe acute respiratory virus coronavirus 2 (SARS-CoV-2) infection is a healthcare challenge. We hypothesized that polymerase chain reaction testing of symptomatic triaged outpatients and all inpatients before hospitalization in Shinjuku, a coronavirus disease 2019 (COVID-19) epicenter in Tokyo, using the Tokyo Women's Medical University (TMWU) model would be feasible and efficient at preventing COVID-19. This retrospective study enrolled 2981 patients from March to May 2020. The prevalence of SARS-CoV-2 infection was 1.81% (95% credible interval [CI]: 0.95-3.47%) in triaged symptomatic outpatients, 0.04% (95% CI: 0.0002-0.2%) in scheduled asymptomatic inpatients, 3.78% (95% CI: 1.82-7.26%) in emergency inpatients, and 2.4% (95% CI: 1.49-3.82%) in symptomatic patients. There were no cases of hospital-acquired SARS-CoV-2 infection. This shows that the TWMU model could prevent hospital-acquired SARS-CoV-2 infection and is feasible and effective in reducing the impact of SARS-CoV-2 infection in the hospitals.
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http://dx.doi.org/10.1016/j.resinv.2020.12.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835075PMC
May 2021
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