Investigation of the Effect of 70 Potential Interferents on Measurement Results of Two Blood Glucose Monitoring Systems.

BACKGROUND: Reliable blood glucose (BG) measurements are important for people with diabetes to manage their therapy as well as in point-of-care testing (POCT) performed by health care professionals to monitor BG of patients or even to diagnose diabetes. Among other factors, endogenous and exogenous substances present in blood samples can impact the measurement results. To ensure and prove that blood glucose monitoring systems (BGMSs) are robust in terms of potential interferents, manufacturers have to perform extensive evaluations. METHOD: An interference screening test was performed for three reagent system lots of a POCT system and of a BGMS for self-monitoring of BG. A paired-difference approach based on ISO 15197:2013 and CLSI guideline EP07 was used with venous whole blood samples at two different glucose concentrations. Seventy potential interferents expected to be common in people with diabetes were evaluated. RESULTS: The interference effects were determined as normalized biases between test samples and corresponding control samples. For 69 of the 70 investigated potential interferents, both systems met the predefined acceptance criteria, with the normalized biases falling within ±10 mg/dL or ±10% at glucose concentrations ≤100 mg/dL or >100 mg/dL, respectively, for each of the three evaluated reagent system lots. CONCLUSIONS: The BGMS investigated in this study were found to be robust with respect to the 70 evaluated potential interferents. Interference effects were observed only for N-Acetyl-L-cysteine. Extensive evaluations of potential interfering factors can make an important contribution to ensure reliability of BGMS.

Assessments of therapeutic effects according to timings for combined therapy with axitinib and immune check point inhibitor in a mouse renal cell carcinoma model.

Recently, several types of systemic therapy using tyrosine kinase inhibitor (TKI) and immune checkpoint inhibitor (ICI) have been performed for advanced renal cell carcinoma (aRCC) patients; however, the optimal strategy of sequential treatment with these agents has not been well established. The objective of this study was to determine the differences of therapeutic effects according to timing for the introduction of TKI and ICI using a mouse RCC, RenCa model. The effects of combined treatment of TKI and/or ICI with axitinib, anti-mouse programmed death (PD)-1, or PD-ligand 1 (PD-L1) antibody on tumor growth and survival after subcutaneous and intravenous injection of RenCa cells, respectively, were compared according to three different treatment schedules: simultaneous administration, initial axitinib administration, and initial ICI administration. Infiltrating patterns of lymphocytes into tumors after combined treatments were evaluated by immunohistochemical staining. In mice treated with anti-PD-1 and anti-PD-L1 antibodies, significantly marked inhibitory effects on subcutaneous growth of tumors were observed in the simultaneous and initial ICI treatment groups, but not the group with the initial axitinib administration, compared to controls without treatment. Survival intervals of mice after intravenous injection of RenCa cells were significantly longer in the simultaneous and initial ICI administration, but not the initial axitinib administration, compared to the control. Furthermore, both CD8+ to CD3+ and CD8+ to CD11b+ T-lymphocyte ratios in subcutaneous RenCa tumors were significantly higher in the simultaneous and initial ICI administration, but not the initial axitinib administration, compared to the control. Favorable control against aRCC progression may be achieved by administering TKI and ICI simultaneously or ICI followed by TKI.

Predictive factors of de novo overactive bladder in clinically localized prostate cancer patients after robot-assisted radical prostatectomy.

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.

Significance of second progression-free survival in patients with advanced urothelial cancer who received platinum-based combination chemotherapy followed by pembrolizumab.

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.

Effects of Changes in Erectile Function After Holmium Laser Enucleation of the Prostate on Postoperative Outcomes in Patients With Benign Prostatic Hyperplasia.

BACKGROUND/AIM: Sexual function in patients with benign prostatic hyperplasia (BPH) could be affected by surgical intervention, such as holmium laser enucleation of the prostate (HoLEP). The objective of the present study was to investigate whether changes in erectile function (EF) after HoLEP affect postoperative outcomes in patients with BPH. PATIENTS AND METHODS: We retrospectively reviewed 54 consecutive Japanese patients with BPH undergoing HoLEP at our institution between August 2017 and December 2020, and analyzed data obtained before and 6 months after HoLEP, including the Erection Hardness Score (EHS), International Prostate Symptom Score (IPSS), IPSS-Quality of Life (IPSS-QOL), Overactive Bladder Symptom Score (OABSS), and the Medical Outcomes Study 8-Item Short-Form Health Survey consisting of a mental health component summary (MCS) and physical health component summary (PCS). RESULTS: Although no significant differences were observed between preoperative and postoperative EHS, postoperative EHS deteriorated in 19 out of 54 patients. Total IPSS, IPSS-QOL, and OABSS significantly improved after HoLEP, irrespective of the deterioration of EHS; however, despite the lack of significant changes in MCS and PCS in 19 patients with deteriorated EHS, significant improvements in MCS, but not PCS, were postoperatively observed in the remaining 35. A multivariable analysis of several factors identified a preoperative estimated prostate volume >100 cm3 as an independent risk factor associated with the postoperative deterioration of EHS. CONCLUSION: HoLEP had limited impact on postoperative EF in BPH patients; however, favorable QOL may be expected in patients without the postoperative deterioration of EF. Accordingly, it may be important to consider the prostate volume and its effect on postoperative EF when selecting indications for HoLEP.

Summary of the Clinical Practice Guidelines for Penile Cancer 2021 by the Japanese Urological Association.

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.

Comparison of perioperative outcomes among patients with exophytic, mesophytic, and endophytic renal tumors undergoing robot-assisted partial nephrectomy.

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.

Robot-assisted radical nephrectomy and inferior vena cava tumor thrombectomy: Initial experience in Japan.

Introduction: Open surgical approach remains the standard treatment for renal cell carcinoma with an inferior vena cava tumor thrombus. In recent years, however, robot-assisted radical nephrectomy and inferior vena cava tumor thrombectomy have emerged as minimally invasive alternatives to conventional open surgery. Case presentation: Here, we describe a 76-year-old female patient with right renal cell carcinoma with a level I inferior vena cava thrombus undergoing robot-assisted radical nephrectomy and inferior vena cava tumor thrombectomy, which was successfully completed with a purely robotic procedure, resulting in the following outcomes: console time,167 min; total operative time, 211 min; and estimated blood loss, 150 mL. To our knowledge, this is the first case managed by robot-assisted radical nephrectomy and inferior vena cava tumor thrombectomy in Japan. Conclusion: Based on our experience, it might be worthwhile to consider purely robotic surgery for the treatment of renal cell carcinoma with an inferior vena cava thrombus.

Association between 25-hydroxyvitamin D levels and COVID-19 severity.

BACKGROUND AND AIMS: Despite reports on the impact of vitamin D status on coronavirus disease 2019 (COVID-19) severity, the association between low vitamin D status and severe COVID-19 remains unclear. Moreover, researchers have not determined the aforementioned association in Japanese patients. This study aimed to investigate the association between 25-hydroxyvitamin D [25(OH)D] levels and COVID-19 severity in Japanese patients. METHODS: This retrospective observational study included 117 consecutive patients with COVID-19 admitted to the Kobe City Medical Center General Hospital between October 01, 2020, and January 31, 2021. We measured the serum 25(OH)D levels using blood specimens collected within 5 days of hospital admission using liquid chromatography-tandem mass spectrometry. RESULTS: There were 21 (17.9%), 73 (62.4%), 19 (16.2%) and 4 (3.4%) patients with severe deficiency (<10 ng/mL), deficiency (10-<20 ng/mL), insufficiency (20-<30 ng/mL), and sufficiency (≥30 ng/mL) of vitamin D, respectively. In univariate logistic regression analyses, lower serum 25(OH)D levels [odds ratio (OR) 1.18 per 1 ng/mL decrease, 95% confidence interval (CI) 1.04-1.33, p = 0.007] were significantly associated with invasive mechanical ventilation (IMV) or death. In a multivariate logistic regression analysis, low serum 25(OH)D levels [OR 1.22 per 1 ng/mL decrease, 95% CI 1.06-1.40, p = 0.005] were significantly associated with IMV or death. The cut-off value of serum 25(OH)D levels was 10.4 ng/mL, calculated by the receiver operating characteristic curve to detect the requirement for IMV or death. CONCLUSIONS: To the best of our knowledge, this is the first study to assess the association between vitamin D status and COVID-19 severity in Japanese patients. Low serum 25(OH)D level was detected as an independent risk factor for severe COVID-19 among Japanese patients.

Significant impact of a history of prior or concomitant upper urinary tract cancer on the recurrence and progression of non-muscle invasive bladder cancer.

BACKGROUND: The objective of the present study was to evaluate the prognostic impact of the upper urinary tract cancer status on recurrence-free survival and progression-free survival, and to develop risk stratification systems that include the upper urinary tract cancer status for patients with non-muscle invasive bladder cancer. PATIENTS AND METHODS: The present study included 40 (upper urinary tract cancer-non-muscle invasive bladder cancer group) and 285 (non-muscle invasive bladder cancer alone group) patients with and without a history of prior or concomitant upper urinary tract cancer, respectively. Nine clinicopathological findings between the two groups were compared, and risk stratification systems for the recurrence and progression of non-muscle invasive bladder cancer were developed. RESULTS: Recurrence-free survival and progression-free survival in the upper urinary tract cancer-non-muscle invasive bladder cancer group were significantly inferior to those in the NMIBC alone group (P < 0.001 and P = 0.006, respectively). Multivariate analyses identified the following independent prognosticators: multiplicity and upper urinary tract cancer status for recurrence-free survival, and pT category and upper urinary tract cancer status for progression-free survival. Significant differences were noted by the risk stratification systems based on the positive number of independent predictors of recurrence-free survival and progression-free survival (P < 0.001 and P = 0.007, respectively). The concordance indices of recurrence-free survival were 0.627, 0.588 and 0.499 in this study stratification, EORTC risk table and CUETO model, respectively. Those of progression-free survival were 0.752, 0.740 and 0.714, respectively. CONCLUSION: The present results suggest the significant impact of a history of prior or concomitant UUTC on recurrence-free survival and progression-free survival in non-muscle invasive bladder cancer patients, and risk stratification systems that include the upper urinary tract cancer status for the recurrence and progression of non-muscle invasive bladder cancer are promising tools for predicting the outcomes of these patients.

Feasibility of interaortocaval clamping for renal artery during robot-assisted right partial nephrectomy: A propensity score-matching analysis.

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.

Limited impact of erectile function on health-related quality of life in Japanese men undergoing robot-assisted radical prostatectomy.

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.

Risk factors for recurrence after operation in patients with pT1a renal cell carcinoma: sub-analysis of the multi-institutional national database of the Japanese Urological Association.

BACKGROUND: More patients with renal cell carcinoma are now diagnosed with the disease in its early stages. Although patients with pT1a renal cell carcinoma have a good prognosis and low recurrence rate, a few patients still experience recurrence. Herein, we evaluated the clinicopathological risk factors for postoperative recurrence of pT1aN0M0 renal cell carcinoma. METHODS: An renal cell carcinoma survey was conducted by the Japanese Urological Association to register newly diagnosed cases of renal cell carcinoma. A total of 1418 patients diagnosed with pT1aN0M0 renal cell carcinoma who underwent surgery as the primary surgical treatment were included. We analyzed the recurrence-free survival using the Kaplan-Meier method and clinicopathological factors for recurrence using Cox proportional hazards models. RESULTS: Among 1418 patients, 58 (4.1%) had recurrences after a median follow-up of 62.8 months. The median time to recurrence was 31.0 months. Metastases to the lungs and the bone were observed in 20 and 10 cases, respectively. Significant differences in sex, tumor size, Eastern Cooperative Oncology Group performance status, and dialysis history, preoperative hemoglobin levels, C-reactive protein levels and creatinine levels were observed between the recurrence and non-recurrence groups. Multivariate analysis identified male sex, high C-reactive protein level and tumor size ≥3 cm as independent risk factors. The 5-year recurrence-free survival of patients with 0, 1, 2 and 3 risk factors was 99.0, 97.2, 93.1 and 80.7%, respectively. CONCLUSIONS: Male sex, tumor diameter and a high C-reactive protein level were independent recurrence risk factors for pT1a renal cell carcinoma; special attention should be paid to patients with these risk factors during postoperative follow-up.

Efficacy of combined androgen blockade therapy in patients with metastatic hormone-sensitive prostate cancer stratified by tumor burden.

OBJECTIVE: To determine the effect of combined androgen blockade with a first-generation anti-androgen on the prognoses of metastatic hormone-sensitive prostate cancer patients stratified by tumor burden. METHODS: We retrospectively analyzed the cases of metastatic hormone-sensitive prostate cancer patients who were treated with androgen deprivation therapy in 2008-2017 at 30 institutions in Japan. To compare the overall survival and progression-free survival rates of the patients treated with castration monotherapy and combined androgen blockade, we carried out a Cox proportional hazards regression analysis using both inverse probability of treatment weighting and instrumental variables methods. High-burden disease was defined as the presence of four or more bone metastases and/or visceral metastasis. RESULTS: Of 2048 patients, 702 (34.3%) and 1346 (65.7%) patients were classified as the low- and high-burden groups, respectively. In each group, >80% of the patients were treated with combined androgen blockade. Although there was no significant between-group difference in the overall survival according to the androgen deprivation therapy method, in the high-burden group the progression-free survival of the combined androgen blockade-treated patients was significantly better than that of patients treated with castration monotherapy: inverse probability of treatment weighting method, hazard ratio 0.49, 95% confidence interval 0.34-0.71; instrumental variables method, hazard ratio 0.80, 95% confidence interval 0.60-0.98. CONCLUSION: In the high-burden group, combined androgen blockade with a first-generation anti-androgen resulted in superior progression-free survival compared with castration monotherapy. For well-selected metastatic hormone-sensitive prostate cancer patients, the use of combined androgen blockade might still have some suitable scenarios.

Prognostic assessments in patients with upper tract urothelial carcinoma undergoing radical nephroureterectomy and systematic regional lymph node dissection.

OBJECTIVES: Systematic regional lymph node dissection (LND) combined with radical nephroureterectomy (RNU) has been reported to improve the outcomes of upper tract urothelial carcinoma (UTUC) patients. The objective of the present study was to assess the prognostic outcomes of UTUC patients undergoing systematic regional LND combined with RNU. PATIENTS AND METHODS: We conducted a retrospective evaluation of prognostic outcomes of 68 consecutive UTUC patients treated with RUN and systematic regional LND. RESULTS: The median durations of recurrence-free survival (RFS) and overall survival (OS) were 45 and 166 months, respectively. Univariate analyses of several parameters showed that despite the lack of a significant predictor for RFS, the presence of lymph node metastasis correlated with poor OS. CONCLUSION: These results suggest that comparatively favorable outcomes are achievable in UTUC patients by RNU and systematic regional LND; however, special attention is needed for patients with nodal involvement even after systematic regional LND due to the adverse impact of this factor on OS.

Initial experience of robot-assisted radical nephrectomy in Japan: Single institutional study of 12 cases.

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.

Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System.

BACKGROUND: Blood glucose monitoring (BGM) is essential for glycemic control in diabetic therapy. Followingly, accurate sensors are required for both daily personal and clinical use. The frequency of sensor use in patients with diabetes facilitates the use of disposable components. However, BGM systems are not exempt from green innovation sustainability initiatives. METHODS: Clinical study of a high-accuracy green design blood glucose monitor using an innovative optical transmission absorbance system was carried out. Venous blood samples were collected from 104 patients with type II diabetes. The heat resistance of sensor strips was evaluated by storing sensor strips at 25℃ and 60℃ for approximately 3 months. Accuracy of the BGM system was evaluated via the ISO 15197:2013 protocol. RESULTS: The BGM system achieved ±7.1% accuracy in glycemic level measurement, with 84% of all measurements within ±5% of the reference values. Furthermore, the sensor strip demonstrated heat resistance for more than 3 months when stored at 60℃. CONCLUSIONS: A new, highly accurate BGM system was developed based on the latest optical measurement system, introducing a rare metal-free "green-strip." The developed BGM system achieved the highest reported accuracy in clinical research, using venous blood from patients with diabetes. The sensor strip also exhibited high heat resistance, reducing limitations on storage conditions.

Prognostic significance of third-line treatment for patients with metastatic castration-resistant prostate cancer: comparative assessments between cabazitaxel and other agents.

BACKGROUND: Cabazitaxel has played an important role in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC); however, several types of sequential therapy against mCRPC have been performed in routine clinical practice. The objective of this study was to investigate the impact of third-line treatment on prognostic outcomes of mCRPC patients. METHODS: This study retrospectively analyzed the clinical outcomes of 166 patients who received 3 agents following the diagnosis of mCRPC, consisting of 81 sequentially treated with either abiraterone or enzalutamide and then docetaxel, followed by third-line cabazitaxel (group A) and 85 treated with 3 agents, including abiraterone, enzalutamide, and docetaxel (group B). RESULTS: There were no significant differences in major characteristics at the introduction of the third-line agent between these 2 groups. The proportion of patients with prostate-specific antigen (PSA) reduction > 50% by cabazitaxel in group A was significantly greater than that by either third-line agent in group B. Both PSA progression-free survival (PFS) and overall survival (OS) following third-line therapy in group A were significantly longer than those in group B. Furthermore, OS after the diagnosis of mCRPC in group A was significantly longer than that in group B. Multivariate analysis identified independent predictors of favorable prognostic outcomes after third-line therapy as follows: high-performance status (PS), low PSA level and third-line cabazitaxel for PSA PFS, and high PS, low lactate dehydrogenase level and third-line cabazitaxel for OS. CONCLUSIONS: The introduction of cabazitaxel as a third-line agent could markedly improve the prognostic outcomes of mCRPC patients.

Novel metastatic burden-stratified risk model in de novo metastatic hormone-sensitive prostate cancer.

The metastatic burden is a critical factor for decision-making in the treatment of metastatic hormone-sensitive prostate cancer (HSPC). This study aimed to develop and validate a novel risk model for survival in patients with de novo low- and high-burden metastatic HSPC. The retrospective observational study included men with de novo metastatic prostate cancer who were treated with primary androgen-deprivation therapy at 30 institutions across Japan between 2008 and 2017. We created a risk model for overall survival (OS) in the discovery cohort (n = 1449) stratified by the metastatic burden (low vs high) and validated its predictive ability in a separate cohort (n = 951). Based on multivariate analyses, lower hemoglobin levels, higher Gleason grades, and higher clinical T-stage were associated with poor OS in low-burden disease. Meanwhile, lower hemoglobin levels, higher Gleason grade group, liver metastasis, and higher extent of disease scores in bone were associated with poor OS in patients with high-burden disease. In the discovery and validation cohorts, the risk model using the aforementioned parameters exhibited excellent discriminatory ability for progression-free survival and OS. The predictive ability of this risk model was superior to that of previous risk models. Our novel metastatic burden-stratified risk model exhibited excellent predictive ability for OS, and it is expected to have several clinical uses, such as precise prognostic estimation.

Impact of Bladder Neck Angle Measured by Postoperative Magnetic Resonance Imaging on Midterm Recovery of Urinary Continence in Prostate Cancer Patients Undergoing Robot-Assisted Radical Prostatectomy.

Introduction: MRI has helped clarify the relationship between pelvic anatomical structures and functional outcomes after robot-assisted radical prostatectomy (RARP). The objective of this study was to assess the impact of the bladder neck angle (BNA) measured by postoperative MRI on midterm recovery of urinary continence (UC) in patients undergoing RARP. Patients and Methods: This study retrospectively included 200 consecutive patients with prostate cancer who were treated by RARP and received MRI 3 months after RARP. Based on postoperative MRI, the BNA was measured as the angle between the anterior and posterior bladder walls. The midterm recovery of UC was defined as the use of either no pad or an occasional security pad at 6 months after RARP. Results: One hundred forty-four of the 200 patients (72.0%) achieved midterm recovery of UC and the median BNA was 70°. There were no significant differences in several parameters, including age, body mass index, total prostate volume, preservation of the neurovascular bundle, and postoperative membranous urethral length (MUL), between patients with BNA ≥70° and <70°. Of these parameters, only the BNA and postoperative MUL were independently associated with the midterm recovery of UC. The optimal cutoff points of the BNA and MUL (65° and 9 mm, respectively) were calculated by the receiver operating characteristics curve, and a scoring model for the prediction of midterm recovery of UC was developed according to the logistic regression analysis. This scoring model was demonstrated to be satisfactorily calibrated (p for Hosmer-Lemeshow test = 0.49) and provide good discrimination (area under the curve: 0.723; p < 0.001). Conclusions: These findings suggest that midterm recovery of UC after RARP is favorably affected by the large BNA and long postoperative MUL, and our scoring model can be used as a reliable tool for predicting the midterm continence status after RARP.