Clinical validity of non-contrast-enhanced VI-RADS: prospective study using 3-T MRI with high-gradient magnetic field.

OBJECTIVES: To develop a modified Vesical Imaging Reporting and Data System (VI-RADS) without dynamic contrast-enhanced imaging (DCEI), termed "non-contrast-enhanced VI-RADS (NCE-VI-RADS)", and to assess the additive impact of denoising deep learning reconstruction (dDLR) on NCE-VI-RADS. METHODS: From January 2019 through December 2020, 163 participants who underwent high-gradient 3-T MRI of the bladder were prospectively enrolled. In total, 108 participants with pathologically confirmed bladder cancer by transurethral resection were analyzed. Tumors were evaluated based on VI-RADS (scores 1-5) by two readers independently: an experienced radiologist (reader 1) and a senior radiology resident (reader 2). Conventional VI-RADS assessment included all three imaging types (T2-weighted imaging [T2WI], diffusion-weighted imaging [DWI], and dynamic contrast-enhanced imaging [DCEI]). Also evaluated were NCE-VI-RADS comprising only non-contrast-enhanced imaging types (T2WI and DWI), and "NCE-VI-RADS with dDLR" comprising T2WI processed with dDLR and DWI. All systems were assessed using receiver-operating characteristic curve analysis and simple and/or weighted κ statistics. RESULTS: Muscle invasion was identified in 23/108 participants (21%). Area under the curve (AUC) values for diagnosing muscle invasion were as follows: conventional VI-RADS, 0.94 and 0.91; NCE-VI-RADS, 0.93 and 0.91; and "NCE-VI-RADS with dDLR", 0.96 and 0.93, for readers 1 and 2, respectively. Simple κ statistics indicated substantial agreement for NCE-VI-RADS and almost perfect agreement for conventional VI-RADS and "NCE-VI-RADS with dDLR" between the two readers. CONCLUSION: NCE-VI-RADS achieved predictive accuracy for muscle invasion comparable to that of conventional VI-RADS. Additional use of dDLR improved the diagnostic accuracy of NCE-VI-RADS. KEY POINTS: • Non-contrast-enhanced Vesical Imaging Reporting and Data System (NCE-VI-RADS) was developed to avoid risk related to gadolinium-based contrast agent administration. • NCE-VI-RADS had predictive accuracy for muscle invasion comparable to that of conventional VI-RADS. • The additional use of denoising deep learning reconstruction (dDLR) might further improve the diagnostic accuracy of NCE-VI-RADS.

Prospective Validation of Vesical Imaging-Reporting and Data System Using a Next-Generation Magnetic Resonance Imaging Scanner-Is Denoising Deep Learning Reconstruction Useful?

PURPOSE: The Vesical Imaging Reporting and Data System (VI-RADS) was launched in 2018 to standardize reporting of magnetic resonance imaging for bladder cancer. This study aimed to prospectively validate VI-RADS using a next-generation magnetic resonance imaging scanner and to investigate the usefulness of denoising deep learning reconstruction. MATERIALS AND METHODS: We prospectively enrolled 98 patients who underwent bladder multiparametric magnetic resonance imaging using a next-generation magnetic resonance imaging scanner before transurethral resection of bladder tumor. Tumors were categorized according to VI-RADS, and we ultimately analyzed 68 patients with pathologically confirmed urothelial bladder cancer. We used receiving operating characteristic curve analyses to assess the predictive accuracy of VI-RADS for muscle invasion. Sensitivity, specificity, positive/negative predictive value, accuracy and area under the curve were calculated for different VI-RADS score cutoffs. RESULTS: Muscle invasion was detected in the transurethral resection of bladder tumor specimens of 18 patients (26%). The optimal cutoff value of the VI-RADS score was determined as ≥4 based on the receiver operating curve analyses. The accuracy of diagnosing muscle invasion using a cutoff of VI-RADS ≥4 was 94% (AUC 0.92). Additionally, we assessed the utility of denoising deep learning reconstruction. Combination with denoising deep learning reconstruction significantly improved the AUC of category by T2-weighted imaging, and of the 4 patients who were misdiagnosed by the final VI-RADS score 3 were correctly diagnosed by T2-weighted imaging+denoising deep learning reconstruction. CONCLUSIONS: In this prospective validation study with a next-generation magnetic resonance imaging scanner, VI-RADS showed high predictive accuracy for muscle invasion in patients with bladder cancer before transurethral resection of bladder tumor. Combining T2-weighted imaging with denoising deep learning reconstruction might further improve the diagnostic accuracy of VI-RADS.

Presepsin and procalcitonin as predictors of sepsis based on the new Sepsis-3 definitions in obstructive acute pyelonephritis.

BACKGROUND: Acute pyelonephritis (APN) with obstructive uropathy often causes sepsis. Recently, sepsis was redefined using the sequential organ failure assessment (SOFA) score, based on the new Sepsis-3 criteria. We investigated predictors for sepsis using this new definition in patients with obstructive APN associated with upper urinary tract calculi. METHODS: We retrospectively evaluated patients who were admitted to our hospital for treatment of obstructive APN associated with upper urinary tract calculi. Blood and urine samples were collected before treatment of obstructive APN. Treatment included adequate antimicrobial therapy and emergency drainage to decompress the renal collecting system. We diagnosed sepsis using the new Sepsis-3 definition. We assessed predictors for sepsis by multivariate logistic regression analysis. RESULTS: Sixty-one patients were included in this study. Overall, all patients underwent emergency drainage, and 11 (18.0%) patients showed sepsis. There were no significant differences in performance status or comorbidities between sepsis and non-sepsis groups. Platelet count and serum albumin level were significantly lower in the sepsis group than in the non-sepsis group (p = 0.001 and p = 0.016, respectively). Procalcitonin (PCT) and presepsin (PSEP) levels were significantly higher in the sepsis group than in the non-sepsis group (p < 0.001 and p < 0.001, respectively). Multivariate analysis showed that PCT elevation (OR = 13.12, p = 0.024) and PSEP elevation (OR = 13.13, p = 0.044) were independent predictors for sepsis. CONCLUSIONS: Elevation of PCT and PSEP levels before treatment might predict the development of sepsis in patients with obstructive APN.

Prognostic significance of the albumin-to-globulin ratio for upper tract urothelial carcinoma.

BACKGROUND: Although the albumin-to-globulin ratio (AGR) is a promising biomarker for various malignancies, few studies have investigated its prognostic significance for upper tract urothelial carcinoma (UTUC). METHODS: This retrospective study conformed to the REporting recommendations for tumour MARKer prognostic studies (REMARK) guideline. We reviewed 179 patients with UTUC who underwent radical nephroureterectomy at our institution between 2008 and 2018. Associations of preoperative clinicopathological factors, including the AGR, with cancer-specific survival (CSS) and overall survival (OS) were assessed. The Cox proportional hazards model was used for univariate and multivariable analyses. AGR was dichotomized as < 1.25 and ≥ 1.25, according to the most discriminatory cutoff determined from the receiver operating characteristic curve analysis. RESULTS: During a median follow-up of 34 months after surgery, 37 patients died from UTUC and 13 died of other causes. The preoperative AGR significantly correlated with pathological T stage, pathological N stage, and adjuvant chemotherapy. Multivariate analyses demonstrated that a decreased (< 1.25) preoperative AGR was an independent poor prognostic factor for both CSS (hazard ratio [HR] = 2.81, P <  0.01) and OS (HR = 2.09, P <  0.05). CONCLUSIONS: Preoperative AGR < 1.25 might serve as a useful prognostic marker for patients with UTUC undergoing radical nephroureterectomy.

Age- and height-adjusted total kidney volume growth rate in autosomal dominant polycystic kidney diseases.

BACKGROUND: The Mayo Clinic Image Classification (MIC) was proposed as a renal prognosis prediction model for autosomal dominant polycystic kidney disease (ADPKD). MIC is based on the assumption of exponential constant increase in height-adjusted total kidney volume (HtTKV). HtTKV growth rate is calculated by one-time measurement of HtTKV and age. We named it as an age-adjusted HtTKV growth rate (AHTKV-α). AHTKV-α was compared with HtTKV slope measured by at least two HtTKV values. METHODS: Comparison of repeatability between AHTKV-α and HtTKV slope, correlation of subgroups divided according to baseline AHTKV-α and HtTKV slope with disease manifestations, estimated glomerular filtration rate (eGFR) slope, and renal survival were analyzed in 296 patients with ADPKD. PKD genotype influences were compared between AHTKV-α and HtTKV slope in 88 patients with characterized PKD mutations. RESULTS: Absolute differences between baseline and follow-up measures were significantly larger for the HtTKV slope than for AHTKV-α (P < 0.0001). From baseline AHTKV-α-based subgroups A-E according to MIC, disease manifestations occurred earlier and future eGFR slopes became steeper (P < 0.0001). Multivariate hazard ratios of renal survival differed significantly among baseline AHTKV-α-based subgroups. Inter-subgroup differences in these predictors were less evident during baseline HtTKV slope-based classification. AHTKV-α values, but not HtTKV slopes, were significantly higher for PKD1 mutation carriers than for PKD2 mutation carriers (P < 0.0001). CONCLUSION: MIC is a good renal prediction model applicable to Japanese patients also. AHTKV-α can be a more sensitive and reliable indicator in TKV growth rate than HtTKV slope.

Effects of Mirabegron on Anxiety and Depression in Female Patients with Overactive Bladder.

BACKGROUND: Treatment of overactive bladder (OAB) with antimuscarinic agents has been shown to improve depression and/or anxiety symptoms. OBJECTIVES: The aim of this study was to evaluate the efficacy of mirabegron on OAB symptoms and its effects on depression and/or anxiety of treatment-naïve women with OAB. METHODS: Women treated with mirabegron were prospectively evaluated by the OAB symptom score and hospital anxiety and depression Scale before and at 4 and 8 weeks after treatment. Wilcoxon signed-rank and Spearman rank correlation coefficient were used for statistical analyses, and a p value of < 0.05 was considered as significant. RESULTS: Of the 112 patients who were enrolled, 25.0% had been previously diagnosed as having clinical anxiety and 22.3% as having clinical depression. The OAB, anxiety, and depression symptom scores were significantly improved at both 4 and 8 weeks (p < 0.05). Anxiety, but not depression, symptoms were significantly correlated with OAB symptoms. CONCLUSION: Improvement of OAB symptoms helps relieve anxiety, but not depression.

AR-V7 in circulating tumor cells cluster as a predictive biomarker of abiraterone acetate and enzalutamide treatment in castration-resistant prostate cancer patients.

OBJECTIVE: We examined whether androgen receptor splice variant 7 (AR-V7) in circulating tumor cell(CTC)clusters can be used to predict survival in patients with bone metastatic castration resistant-prostate cancer (mCRPC) treated with abiraterone or enzalutamide. METHODS: We retrospectively enrolled 98 patients with CRPC on abiraterone or enzalutamide, and investigated the prognostic value of CTC cluster detection (+ v -) and AR-V7 detection (+ v -) using a CTC cluster detection - based AR-V7 mRNA assay. We examined ≤50% prostate-specific antigen (PSA) responses, PSA progression-free survival (PSA-PFS), clinical and radiological progression-free survival (radiologic PSF), and overall survival (OS). We then assessed whether AR-V7 expression in CTC clusters identified after On-chip multi-imaging flow cytometry was related to disease progression and survival after first-line systemic therapy. RESULTS: All abiraterone-treated or enzalutamide-treated patients received prior docetaxel. The median follow-up was 20.7 (range: 3.0-37.0) months in the abiraterone and enzalutamide cohorts, respectively. Forty-nine of the 98 men (50.0%) were CTC cluster (-), 23 of the 98 men (23.5%) were CTC cluster(+)/AR-V7(-), and 26 of the 98 men (26.5%) were CTC cluster(+)/AR-V7(+). CTC cluster(+)/AR-V7(+) patients were more likely to have EOD ≥3 at diagnosis (P = 0.003), pain (P = 0.023), higher alkaline phosphatase levels (P < 0.001), and visceral metastases (P < 0.001). On multivariable analysis, pretherapy CTC cluster(+), CTC cluster(+)/AR-V7(-), and ALP >UNL were independently associated with a poor PSA-PFS, radiographic PFS, and OS in abiraterone-treated patients and enzalutamide-treated patients. CONCLUSION: The CTC clusters and AR-V7-positive CTC clusters detected were important for assessing the response to abiraterone or enzalutamide therapy and for predicting disease outcome.

Optimal equation for estimation of glomerular filtration rate in autosomal dominant polycystic kidney disease: influence of tolvaptan.

BACKGROUND: The reliability of various equations for estimating the GFR in ADPKD patients and the influence of tolvaptan on the resulting estimates have not been examined when GFR is calculated on the basis of inulin clearance. METHODS: We obtained baseline and on-tolvaptan measured GFRs (mGFRs), calculated on the basis of inulin clearance, in 114 ADPKD, and these mGFRs were compared with eGFRs calculated according to four basic equations: the MDRD, CKD-EPI, and JSN-CKDI equations and the Cockcroft-Gault formula, as well as the influence of tolvaptan and of inclusion of cystatin C on accuracy of the results. Accuracy of each of the seven total equations was evaluated on the basis of the percentage of eGFR values within mGFR ± 30% (P30). RESULTS: mGFRs were distributed throughout CKD stages 1-5. Regardless of the CKD stage, P30s of the MDRD, CKD-EPI, and JSN-CKDI equations did not differ significantly between baseline values and on-tolvaptan values. In CKD 1-2 patients, P30 of the CKD-EPI equation was 100.0%, whether or not the patient was on-tolvaptan. In CKD 3-5 patients, P30s of the MDRD, CKD-EPI, and JSN-CKDI equations were similar. For all four equations, regression coefficients and intercepts did not differ significantly between baseline and on-tolvaptan values, but accuracy of the Cockcroft-Gault formula was inferior to that of the other three equations. Incorporation of serum cystatin C reduced accuracy. CONCLUSIONS: The CKD-EPI equation is most reliable, regardless of the severity of CKD. Tolvaptain intake has minimal influence and cystatin C incorporation does not improve accuracy.

A potentially crucial role of the PKD1 C-terminal tail in renal prognosis.

BACKGROUND: Autosomal dominant polycystic disease (ADPKD) often results in renal failure. Recently, allelic influences of PKD1 mutation types on renal survival were extensively investigated. Here, we analyzed integrated influences of PKD1 mutation types and positions on renal survival. METHODS: We included 338 (82 pedigrees) and 72 (12 pedigrees) patients with PKD1 and PKD2 mutations, respectively, identified through comprehensive gene analysis of 101 probands with ADPKD. Genetic testing was performed using next-generation sequencing, long-range PCR, and multiplex ligation-dependent probe amplification. Pathogenic mutations were identified by a software package-integrated seven databases and provided access to five cloud-based computing systems. RESULTS: Mean renal survivals of carriers with PKD1 non-truncating-type mutations at positions upstream of G-protein-coupled receptor proteolytic site (GPS-upstream domain), transmembrane domain, or cytoplasmic C-terminal tail (CTT) domain were 70.2, 67.0, and 50.1 years, respectively (P < 0.0001); renal survival was shorter for mutation positions closer to CTT domain, suggesting its crucial role in renal prognosis. Furthermore, in truncating-type mutations, strong inactivation is anticipated on nucleotides downstream from the mutation site, implying CTT domain inactivation irrespective of mutation site. Shorter mean renal survival was found for PKD1 truncating-type than non-truncating-type mutation carriers (P = 0.0348); mean renal survival was not different between PKD1 3'- and 5'-region truncating-type mutation carriers (P = 0.4375), but was shorter in PKD1 3'-region than in 5'-region non-truncating-type mutation carriers (P = 0.0014). Variable strength of CTT domain inactivation might account for these results. CONCLUSIONS: Aforementioned findings indicate that CTT domain's crucial role in renal prognosis needs further investigation by larger studies (ClinicalTrials.gov; NCT02322385).

Sexual activity and quality of life in Japanese pelvic organ prolapse patients after transvaginal mesh surgery.

AIM: This study aimed to evaluate sexual activity and quality of life (QOL) after transvaginal mesh (TVM) surgery in Japanese patients with pelvic organ prolapse (POP). The objective cure rate and associated complications were also investigated. METHODS: The cases of patients who underwent TVM surgery were retrospectively analyzed. QOL was assessed using the Prolapse Quality of Life Questionnaire (P-QOL), and sexual function was evaluated using the Female Sexual Function Index (FSFI) before surgery and 12 months after surgery. RESULTS: A total of 237 patients completed the planned follow-up examinations. All P-QOL domains were significantly improved after surgery. In total, 6 (2.5%), 5 (2.1%), 13 (5.5%), 4 (1.7%) and 1 (0.4%) patients developed recurrent POP, mesh extrusion, de novo stress urinary incontinence, inguinal pain and de novo dyspareunia, respectively. Before surgery, 124 of the 237 patients (52.3%) refused to complete the FSFI because they had not engaged in any sexual activity. Among the 113 patients who completed the FSFI, 13 (11.5%) were sexually active. After surgery, 79 patients completed the FSFI, and 14 (17.7%) were sexually active. The overall scores for sexual function and arousal were significantly improved after surgery. CONCLUSION: Patients who underwent TVM surgery at our institution exhibited quite low sexual activity levels both before and after the operation. But TVM surgery achieved good QOL outcomes, a high success rate and a low complications rate at 12 months in Japanese POP patients. TVM implantation for POP is safe and effective in sexually inactive patients.

Urological laparoendoscopic single-site and reduced port surgery: A nationwide survey in Japan.

OBJECTIVES: To evaluate the current status of urological laparoendoscopic single-site and reduced port surgery in Japan. METHODS: Of the 152 institutions to which councilors of the Japanese Society of Endourology belong, 42 (28%) have carried out laparoendoscopic single-site and reduced port surgery. A total of 32 of these institutions agreed to participate in this survey. Patients who had undergone surgery between January 2008 and March 2014 were included in the present study. RESULTS: Overall, 1145 cases of laparoendoscopic single-site and reduced port surgery were recorded during the study period. The most frequent procedures were adrenalectomy and radical nephrectomy. Laparoendoscopic single-site and reduced port surgery represented 12% (872/7311) of all laparoscopic procedures carried out at participating institutions. The number of patients who underwent pyeloplasty, donor nephrectomy and simple nephrectomy tended to increase, whereas those who underwent adrenalectomy, radical nephrectomy and nephroureterectomy peaked in 2012, and then tended to decrease in 2013. The rates of conversion, perioperative and postoperative complications, were 2.7%, 2.2% and 4.5%, respectively. CONCLUSIONS: The number of laparoendoscopic single-site and reduced port urological surgeries in Japan has increased for benign indications, such as pyeloplasty, donor nephrectomy and simple nephrectomy. In contrast, procedures such as adrenalectomy and radical nephrectomy are trending down after reaching a peak in 2012. Overall, laparoendoscopic single-site and reduced port urological surgery in Japan is being safely carried out when compared with other reported series of laparoendoscopic single-site surgery and conventional laparoscopic surgery.

Effectiveness of platinum-based adjuvant chemotherapy for muscle-invasive bladder cancer: A weighted propensity score analysis.

OBJECTIVES: To evaluate the clinical benefit of adjuvant platinum-based chemotherapy after radical cystectomy for muscle-invasive bladder cancer in routine clinical practice. METHODS: The present observational study was carried out to compare the effectiveness of adjuvant chemotherapy versus observation post-radical cystectomy in patients with clinically muscle-invasive bladder cancer. Cancer-specific survival and overall survival between the adjuvant chemotherapy group and radical cystectomy alone group were compared using Kaplan-Meier method and log-rank test. After adjusting for background factors using propensity score weighting, differences in cancer-specific survival and overall survival between these two groups were compared. Subgroup analyses by the pathological characteristics were carried out. RESULTS: In total, 322 patients were included in the present study. Of these, 23% received adjuvant chemotherapy post-radical cystectomy. Clinicopathological characteristics showed that patients in the adjuvant chemotherapy group were pathologically more advanced and were at higher risk than the radical cystectomy alone group. In the unadjusted population, although it is not significant, the adjuvant chemotherapy group had lower overall survival (3-year overall survival; 61.5% vs 73.6%, HR 1.33, P = 0.243, log-rank test, adjuvant chemotherapy vs radical cystectomy alone). In the weighted propensity score analysis, although it is not significant, the adjuvant chemotherapy group were superior to radical cystectomy alone groups (overall survival: HR 0.65, 95% CI 0.39-1.09, P = 0.099, log-rank test, adjuvant chemotherapy vs radical cystectomy alone). Subgroup analyses showed that adjuvant chemotherapy significantly reduced the hazard ratio of overall survival and cancer-specific survival in the ≥pT3, pN+, ly+ and v+ subgroups. CONCLUSIONS: Platinum-based adjuvant chemotherapy might be associated with increased cancer-specific survival and overall survival in patients with high-risk invasive bladder cancer.

Laparoendoscopic single-site surgeries: A multicenter experience of 469 cases in Japan.

OBJECTIVE: To report on a multi-institutional series of non-robotic urological laparoendoscopic single-site surgery in Japan. METHODS: Consecutive cases of laparoendoscopic single-site surgery carried out between February 2009 and December 2012 at nine academic institutions were included. We examined the surgical outcomes, including conversion and complications rates. RESULTS: Four hundred and sixty-nine cases were included in the analysis. The most common procedure was adrenalectomy (n = 177) and the second most common procedure was radical nephrectomy (n = 143). The procedures also included nephroureterectomy (n = 40), living donor nephrectomy (n = 40), pyeloplasty (n = 30), urachal remnant excision (n = 9), simple nephrectomy (n = 7), radical prostatectomy (n = 6) and others (n = 17). The access sites included umbilicus (n = 248, 53%) and other sites (n = 221, 47%). A transperitoneal approach was used in 385 cases (82%), and retroperitoneal approach in 84 cases (18%). The median operation time of all procedures was 198 min. Conversion to reduced port surgery, conventional laparoscopy, or open surgery was noted in 27 cases (5.8%), 12 cases (2.6%), and two cases (0.4%), respectively, with an overall conversion rate of 8.7%. Intraoperative complications occurred in 10 cases (2.1%). Post-operative complications were noted in 29 cases (6.2%), including five major complications (1.1%). No mortality was recorded in this series. CONCLUSIONS: Non-robotic laparoendoscopic single-site surgery is technically feasible and safe for various urologic diseases in Japan. Furthermore, urological laparoendoscopic single-site surgery is a promising minimally invasive surgical option that is feasible for experienced urological surgeons in intermediate-volume centers as well as high-volume centers.

Epidermal Growth Factor Receptor Status in Circulating Tumor Cells as a Predictive Biomarker of Sensitivity in Castration-Resistant Prostate Cancer Patients Treated with Docetaxel Chemotherapy.

OBJECTIVE: We examined whether epidermal growth factor receptor (EGFR) expression in circulating tumor cells (CTCs) can be used to predict survival in a population of bone-metastatic castration-resistant prostate cancer (mCRPC) patients treated with docetaxel chemotherapy. METHODS: All patients with mCRPC who had experienced treatment failure with androgen-deprivation therapy and had received docetaxel chemotherapy were eligible. CTCs and EGFR expression in CTCs were enumerated with the CellSearch System in whole blood. This system is a semi-automated system that detects and enriches epithelial cells from whole blood using an EpCAM antibody-based immunomagnetic capture. In addition, the EGFR-positive CTCs were assessed using CellSearch® Tumor Phenotyping Reagent EGFR. RESULTS: The median CTC count at baseline before starting trial treatment was eight CTCs per 7.5 mL of blood (range 0-184). There were 37 patients (61.7%) who had ≥5 CTCs, with median overall survival of 11.5 months compared with 20.0 months for 23 patients (38.3%) with <5 CTCs (p < 0.001). A total of 15 patients (40.5%, 15/37) with five or more CTCs were subjected to automated immunofluorescence staining and cell sorting for EGFR protein. Patients with EGFR-positive CTCs had a shorter overall survival (OS) (5.5 months) than patients with EGFR-negative CTCs (20.0 months). CTCs, EGFR-positive CTCs, and alkaline phosphatase (ALP) were independent predictors of overall survival time (p = 0.002, p < 0.001, and p = 0.017, respectively). CONCLUSION: CTCs may be an independent predictor of OS in CRPC treated with docetaxel chemotherapy. The EGFR expression detected in CTCs was important for assessing the response to chemotherapy and predicting disease outcome.

[A Case of Atazanavir Urolithiasis Diagnosed by Stone Analysis].

A 70-year-old man was referred to our hospital for right back pain. His past history included human immunodeficiency virus infection, which had been treated with atazanavir for 7 years. Abdominal and pelvic computed tomographic scan showed right hydronephrosis due to a strongly suspected right ureteral radiolucent stone. He underwent indwelling of a right ureteral stent because of obstructive pyelonephritis due to the ureteral stone. After improvement of the pyelonephritis, he underwent transurethral ureterolithotripsy for the right ureteral stone. Stone analysis showed the atazanavir stone. He has been followed up for 8 months without evidence of recurrence. Herein, we report this rare case of an atazanavir stone in Japan, which was confirmed by calculus analysis, and present a review of the literature.

Clinical efficacy and prognostic factors of tumor progression in Japanese patients with advanced renal cell carcinoma treated with sorafenib.

OBJECTIVE: Result of clinical trial for registration purpose is often difficult to generalize because of its limited population in number and inclusion criteria. METHODS: To understand the efficacy of sorafenib under daily medical practice, we retrospectively investigated therapeutic outcomes of 175 Japanese patients with advanced renal cell carcinoma treated with sorafenib at 15 centers. RESULTS: The objective response rate and disease control rate were 15.4 and 77.1%, respectively, being similar to those in the Phase II study in Japanese patients (19.4 and 73.6 months). Any tumor shrinkage was observed with 53% of patients, while tumor control without growth was in 61%. Lung lesions were more sensitive to sorafenib than other lesions, in terms of any tumor shrinkage (54%) and the extent of maximal shrinkage, while tumor control was better in lymph node metastases (77%) than in lung (69%). Liver was worse in any tumor shrinkage (35%), tumor control (55%) and the extent of tumor growth. Slightly, shorter median overall survival of 21.1 months compared with Phase II clinical trial (25.3 months) is likely to be attributable to different patient population, because median overall survival was improved to 26.4 months when the population was matched to that in Phase II trial. Univariate and multivariate analyses identified prognostic factors for worse overall survival, including intermediate and poor Memorial Sloan-Kettering Cancer Center risk, Eastern Cooperative Oncology Group performance status ≥1, the presence of non-clear cell component and the presence of liver metastasis. CONCLUSIONS: In conclusion, the present study confirmed the efficacy of sorafenib in the real-world setting on advanced renal cell carcinoma.

Safety study of somatostatin analogue octreotide for autosomal dominant polycystic kidney disease in Japan.

BACKGROUND: The total kidney volume (TKV) and total liver volume (TLV) increase and renal function decreases progressively in patients with autosomal dominant polycystic kidney disease (ADPKD). Somatostatin analogues, such as octreotide, reduce these increases in TKV and TLV. The aim of this study was to examine the safety of the short-term administration of octreotide long-acting release (octreotide-LAR) in a small number of cases. METHODS: Four ADPKD patients with an estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m(2), TKV > 1,000 mL, and TLV > 3,000 mL were enrolled. Two 20-mg octreotide-LAR intramuscular injections were repeated every 4 weeks for 24 weeks. Laboratory and clinical assessments were repeated every 4 weeks, and TKV and TLV were measured by magnetic resonance imaging before and after the study. RESULTS: In the laboratory tests, there was no abnormal variable except for a significant decrease of alanine aminotransferase. The means of TKV and TLV decreased from 2,007 to 1,903 mL and from 9,197 to 8,866 mL, respectively, but the changes were not significant. eGFR did not change significantly. Adverse events involved loose stools in two patients, as well as injection site granuloma and abdominal pain in one patient each, which resolved spontaneously. CONCLUSION: Octreotide-LAR may be safe and effective for preventing TKV and TLV increases (UMIN000009214).