Initial Experience of Robot-Assisted Partial Nephrectomy Using Hinotori Surgical Robot System: Single Institutional Prospective Assessment of Perioperative Outcomes in 30 Cases.

Introduction: Innovation of robotic surgery is still actively growing, and various novel robotic systems are in the process of development. The objective of this study was to assess the perioperative outcomes of robot-assisted partial nephrectomy (RAPN) using the hinotori surgical robot system, a recently developed robot-assisted surgical platform, for patients with small renal tumors. Methods: This study prospectively included a total of 30 consecutive patients who were found to have small renal tumors and subsequently underwent RAPN using hinotori between April and November 2022. Major perioperative outcomes in these 30 patients were comprehensively analyzed. Results: The median tumor size and R.E.N.A.L. nephrometry score in the 30 patients were 28 and 8 mm, respectively. Of these 30, 25 and 5 received RAPN by intra- and retroperitoneal approaches, respectively. RAPN could be completed in all 30 patients without conversion to nephrectomy or open surgery. The median operative time, time using hinotori, and warm ischemia time were 179, 106, and 13 minutes, respectively. No patient was found to have a positive surgical margin or experienced major perioperative complications, corresponding to Clavien-Dindo 3≤. Achievements of trifecta and margin, ischemia, and complications (MIC) outcomes in this series were 100% and 96.7%, respectively, and median changes in the estimated glomerular filtration rate 1 day and 1 month after RAPN were -20.9% and -11.7%, respectively. Conclusions: This is the first study focusing on RAPN using hinotori, which showed favorable perioperative outcomes, considering the findings of trifecta and MIC. Although it will be necessary to investigate the long-term effects of RAPN using hinotori on oncologic and functional outcomes, the present findings strongly suggest that the hinotori surgical robot system could be safely applied to RAPN for patients with small renal tumors.

A multicenter survey of effects and challenges of an 8K ultra-high-definition endoscopy system compared to existing endoscopy systems for endoscopic surgery.

INTRODUCTION: 8K ultra-high-definition (UHD) images enabling clearer recognition of anatomical structures could contribute to further development of surgical techniques and advanced applications in endoscopic surgery fields. This study aimed to clarify effects and challenges of endoscopic surgery with 8K UHD endoscopy compared to existing endoscopy systems. METHODS: In this multicenter, cross-sectional, questionnaire survey, data were collected from surgical participants who newly used and observed 8K UHD endoscopy in patients undergoing surgery from February 2020 to February 2021. Survey items included sense of presence, reality, depth perception, visibility of tissue, eyestrain, and degree of satisfaction for operators and observers, and weight, operability, focus adjustment, physical fatigue, eyestrain, and satisfaction for camera assistants. Participants rated each 8K UHD endoscopic surgery on a one-to-five scale (definitively inferior, relatively inferior, equivalent, relatively superior, definitively superior) compared to the existing endoscopy system of each facility. RESULTS: Overall, questionnaire responses from 139 participants assessing 8K UHD endoscopic surgery were collected from surgeries performed in 46 patients. Respective ratings of operators and observers included sense of presence: "superior or relatively superior", 97.8% and 91.5%; reality: "superior or relatively superior", 76.1% and 72.3%; and visibility of tissue: "superior or relatively superior", 93.5% and 87.2%. Weight was rated as "inferior or relatively inferior" by 73.9% of camera assistants and focus adjustment as "inferior" by 60.9% of them. CONCLUSIONS: 8K UHD endoscopic surgery enabled identification of surgical anatomies more clearly, provided a sense of presence and reality, and might improve educational effect. Technological development is expected to reduce the burden of camera assistants.

Model-based assessment of pharmacokinetic changes of sunitinib, tacrolimus, and everolimus in a patient with metastatic renal cell carcinoma after renal transplantation.

The safety of the coadministration of sunitinib with tacrolimus and everolimus with regard to therapeutic drug monitoring has not been demonstrated. Here, we report a patient who showed high sunitinib concentrations, in addition to pharmacokinetic changes in tacrolimus and everolimus after sunitinib therapy. A living-donor renal transplant patient treated with tacrolimus and everolimus was diagnosed with pulmonary and pleural metastases of renal cell carcinoma. The patient received sunitinib therapy (37.5 mg/day, 2 weeks on and 1 week off). This patient exhibited a high total sunitinib concentration (sunitinib, 105.8 ng/mL; N-desethyl sunitinib, 27.9 ng/mL) on day 10 postinitiation and experienced grade 3 diarrhea. The observed sunitinib concentrations were a little higher than those reported in the 421C>A polymorphism of the ATP-binding cassette subfamily G member 2 gene carrier. The observed concentrations of both tacrolimus and everolimus gradually decreased compared with the Bayesian-predicted values after the onset of sunitinib therapy, and the doses of tacrolimus and everolimus were increased. Careful therapeutic drug monitoring of sunitinib, tacrolimus, and everolimus concentrations is necessary during combination therapy, especially after episodes of diarrhea.

[SIMULATION ANALYSIS ON COST-EFFECTIVENESS OF SANITARY AND MEDICAL MATERIAL USAGE AT URINARY TRACT INFECTION OUTBREAK CAUSED BY ANTIBIOTIC-RESISTANT BACTERIA IN UROLOGICAL WARD].

(Purpose) The purpose of this study is to compare the costs of active surveillance culture (ASC) and of an environmental cleaner and disinfectant, with the medical costs for inhibiting hospitalized urinary tract infection (UTI) outbreaks in a urology ward over a 3 year 8 months period by simulation calculation. (Methods) We previously reported a UTI outbreak via antibiotic resistant bacteria transmission in 9 hospitalized patients, for which we initiated ASC and introduced a potassium peroxymonosulfate-based product (RUBYSTA® (RST)) as a disinfectant environmental cleaner, then prevented recurrence for 3 years and 8 months. This study compared the actual costs of ASC and RST use to the calculated medical expense for an outbreak leading to urosepsis on the same scale caused by transmission of antibiotic resistant bacteria. (Results) Based on our simulation calculation, ASC and disinfectant costs were about 770,000 Japanese yen lower than the medical expense of resolving an outbreak without recurrence for a period of 3 years and 8 months, based on our direct clinical experience. (Conclusion) Even though it is needless to say that education for medical stuffs, patients and their families is the most important as to the measures for prevention of infections, our simulation study suggests that ASC and RST use may reduce medical costs for resolving such outbreaks and preventing their recurrence for an extended period of time.

Comparison of cost-effectiveness between the quantiFERON-TB Gold-In-Tube and T-Spot tests for screening health-care workers for latent tuberculosis infection.

OBJECTIVE/BACKGROUND: There are several methods used to screen for latent tuberculosis (TB) infection (LTBI) including the QuantiFERON-TB Gold-in-Tube (QFT-GIT) and T-SPOT-TB (T-SPOT) tests. Many studies have reported the equivalence of these two methods, but it is unclear which of them is more cost effective. We investigated the age and cost issues of these tests in screening for LTBI among health-care workers. MATERIALS AND METHODS: One hundred and forty new employees during 2008-2011 in our hospital were screened using the QFT-GIT test, and 140 new employees during 2011-2014 were screened with the T-SPOT test for LTBI. The results of both tests were classified as positive, undetermined (retesting required), or negative. RESULTS: There were six positive results (4.29%), eight undetermined results (5.71%), and 126 negative results (90.0%) with the QFT-GIT test. As for the T-SPOT test, there were eight positive results (5.71%), three undetermined results (2.14%), and 129 negative results (92.1%). Fourteen LTBI employees (6 in QFT-GIT and 8 in T-SPOT) were detected statistically equally using the two methods (P = 0.79). The total costs, including those incurred for retesting, were $7,711.86 (US dollar) and $6,525.42 for the QFT-GIT and T-SPOT tests (cost of one test is $55.08 for QFT-GIT and $46.61 for T-SPOT), respectively. CONCLUSION: T-SPOT is one of the options for screening for LTBI partly owing to the viewpoint of cost-effectiveness. Further prospective studies need to be considered for a definitive conclusion.

Comparative Assessment of Efficacies Between 2 Alternative Therapeutic Sequences With Novel Androgen Receptor-Axis-Targeted Agents in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

BACKGROUND: The objective of this study was to compare the efficacies of sequential therapies with novel androgen receptor-axis-targeted (ARAT) agents in patients with docetaxel-naïve metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: This study included 108 consecutive patients with mCRPC who sequentially received abiraterone acetate (AA) and enzalutamide (Enz), in either order, without prior treatment with docetaxel. The combined prostate-specific antigen (PSA) progression-free survival (PFS) was defined as the sum of PFS1 and PFS2, representing PSA PFSs on the first and second ARAT agents, respectively. RESULTS: Of these patients, 49 and 59 received ARAT therapy with the AA-to-Enz sequence (AA-to-Enz group) and with the reverse sequence (Enz-to-AA group), respectively. No significant differences in the baseline characteristics were noted between the 2 groups. In the overall patient population, the PSA response rate to the second-line ARAT agent (21.3%) was significantly lower than that of the first-line ARAT agent (58.3%). The combined PSA PFS in the AA-to-Enz group (median, 18.4 months) was significantly superior to that of the Enz-to-AA group (median, 12.8 months). Furthermore, multivariate analysis identified the treatment sequence (ie, AA-to-Enz vs. Enz-to-AA group) in addition to performance status as an independent predictor of combined PSA PFS in these patients. However, there was no significant difference in overall survival (OS) between the 2 groups. CONCLUSIONS: Although cross-resistance between ARAT agents is a common phenomenon in docetaxel-naïve patients with mCRPC, different efficacies were observed favoring the AA-to-Enz rather than Enz-to-AA sequence in this series with respect to combined PSA PFS but not OS.

Assessment of Efficacy, Safety, and Quality of Life of 124 Patients Treated With Axitinib as Second-Line Therapy for Metastatic Renal-Cell Carcinoma: Experience in Real-World Clinical Practice in Japan.

PURPOSE: To comprehensively analyze the efficacy of axitinib for metastatic renal-cell carcinoma (mRCC) patients. PATIENTS AND METHODS: This study included 124 consecutive Japanese patients treated with axitinib as second-line systemic therapy for mRCC in a routine clinical setting. RESULTS: In addition to 4 indeterminate patients (3.2%), 0 (0%), 21 (16.9%), 87 (70.2%), and 12 (9.7%) were judged to show complete response, partial response, stable disease, and progressive disease, respectively, as the best responses to axitinib. The median progression-free survival (PFS) and overall survival (OS) after initiating treatment with axitinib were 9.3 and 27.0 months, respectively. Multivariate analyses of several parameters identified the following independent predictors of PFS and OS: Memorial Sloan Kettering Cancer Center (MSKCC) classification and C-reactive protein level for PFS; and MSKCC classification, C-reactive protein level, bone metastasis, and liver metastasis for OS. Common grade 3 or higher adverse events associated with axitinib were hypertension in 41 (33.1%), proteinuria in 14 (11.3%), and hand-foot syndrome in 14 (11.3%). Quality-of-life analysis using the Medical Outcomes Study 36-Item Short Form showed that 2 scores were significantly improved 12 weeks after the administration of axitinib, while there were no significant differences in the remaining 6 scores between surveys administered before and 12 weeks after the treatment with axitinib. CONCLUSION: Favorable disease control could be achieved with acceptable tolerability by introducing axitinib as second-line systemic therapy, resulting in improvement of the prognosis and quality of life of Japanese patients with mRCC.

Comparative Assessment of Clinical Outcomes Between Abiraterone Acetate and Enzalutamide in Patients With Docetaxel-Naive Metastatic Castration-Resistant Prostate Cancer: Experience in Real-World Clinical Practice in Japan.

BACKGROUND: The objective of the present study was to comprehensively compare the clinical outcomes between abiraterone acetate (AA) and enzalutamide (Enz) in Japanese patients with docetaxel-naive metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: The present study retrospectively included 280 consecutive mCRPC patients, consisting of 113 and 167 who had received AA and Enz, respectively, without previous treatment with docetaxel. RESULTS: Of the several baseline characteristics examined, some parameters, including performance status (PS), prostate-specific antigen (PSA) value, and incidence of lymph node metastasis, significantly favored the Enz over the AA group. The PSA response rate in the Enz group was significantly greater than that in the AA group, and the PSA progression-free survival in the Enz group was significantly superior to that in the AA group. Multivariate analyses of several parameters identified the following independent predictors of PSA progression-free survival: duration of androgen deprivation therapy and PS for the AA group, age and PS for the Enz group, and PS but not the introduced agent (ie, AA vs. Enz) for the overall patients. The common adverse events observed in the present series were fatigue (19.4%) and liver toxicity (11.5%) in the AA group and fatigue (32.3%) and appetite loss (19.2%) in the Enz group. In addition, the proportion of patients with adverse events grade ≥ 3 in the Enz group (11.4%) was significantly greater than that in the AA group (4.4%). CONCLUSION: Both AA and Enz were effective and tolerable for patients with docetaxel-naive mCRPC in the routine clinical setting.

Prospective assessment of time-dependent changes in quality of life of Japanese patients with prostate cancer following robot-assisted radical prostatectomy.

The objective of this study was to characterize changes in the quality of life (QOL) of Japanese patients following robot-assisted radical prostatectomy (RARP). This study included 298 consecutive localized prostate cancer (PC) patients undergoing RARP. The health-related QOL and disease-specific QOL were assessed using The Medical Outcomes Study 8-Item Short Form (SF-8) and The Extended Prostate Cancer Index Composite (EPIC), respectively, before and 1, 3, 6, 12 and 24 months after RARP. At 1 month after RARP, four (physical function, role limitations because of physical health problems, social function and role limitations because of emotional problems) of the eight scores in SF-8 were significantly impaired compared with those of baseline scores. However, all eight scores on all postoperative assessments, except for at 1 month after RARP, showed no significant differences from baseline scores. Although there were no significant differences in the bowel function, bowel bother, sexual bother, hormonal function or hormonal bother between baseline and postoperative assessments of EPIC at all time points, the urinary function, urinary incontinence and sexual function scores at 1, 3 and 6 months after RARP were significantly inferior to those of baseline scores, and urinary bother and urinary irritation/obstruction scores at 1 month after RARP were significantly impaired compared with those of baseline scores. These findings suggest that the health-related QOL of Japanese PC patients undergoing RARP may not be markedly deteriorated following RARP; however, as for the disease-specific QOL, urinary and sexual functions, particularly those early after RARP, appeared to be significantly impaired.

Assessment of Time-dependent Changes in Semen Parameters in Infertile Men After Microsurgical Varicocelectomy.

OBJECTIVE: To characterize the changes in seminogram findings in infertile men after varicocelectomy. METHODS: This study included 71 consecutive infertile men who underwent microsurgical low ligation varicocelectomy and received 3 semen analyses, 1 before microsurgical varicocelectomy and again at 3 and 12 months after. Total motile sperm count (TMSC) was calculated using the following formula: [volume (mL) × concentration (millions/mL) × motility (%)]. RESULTS: Despite the lack of significant changes in the proportion of sperm with abnormal morphology, sperm concentration, motility, and TMSC in the 71 patients were significantly higher at 3 and 12 months after varicocelectomy than before surgery. However, no further improvement in these parameters at 12 months after varicocelectomy was noted compared with those at 3 months. Furthermore, when the included men were divided into 3 groups according to preoperative TMSC as <3 million, 3-9 million, and >9 million, TMSCs at 3 months after varicocelectomy in all 3 groups were significantly higher than those before varicocelectomy; however, TMSCs at 12 months after surgery in all groups were similar to those at 3 months. CONCLUSION: The level of improvement in semen parameters at 3 months after varicocelectomy may be stable at 12 months after surgery, irrespective of baseline values of TMSC. Therefore, varicocelectomy could be offered as a therapeutic option for infertile men, even for couples with an older woman, because its efficacy is evaluable at 3 months after surgery, and assisted reproductive technology could be immediately applied to ineffective cases.

Significant impact of R.E.N.A.L. nephrometry score on changes in postoperative renal function early after robot-assisted partial nephrectomy.

BACKGROUND: Our objective was to evaluate the significance of the R.E.N.A.L. nephrometry score (RNS)--developed to quantitatively evaluate the complexity of renal tumors in a reproducible manner--in perioperative and renal functional outcomes following robot-assisted partial nephrectomy (RAPN). METHODS: This study assessed 48 consecutive patients with renal tumors who underwent RAPN. Preoperative RNS for each patient was calculated, and its impact on several parameters associated with perioperative outcomes, including postoperative renal function, was investigated with Spearman's rank correlation test. RESULTS: Mean RNS in the 48 patients was 6.8; of these 48 patients, 21 (43.7%), 24 (50.0%), and three (6.3%) were classified into low-, moderate-, and high-complexity groups, respectively. The RNS was significantly correlated with resected tumor weight and postoperative changes in estimated glomerular filtration rate (eGFR) at both 1 and 4 weeks--but not age, body mass index (BMI), preoperative eGFR, operative time, warm ischemia time, estimated blood loss, postoperative complications, or eGFR-- after RAPN. No component of the RNS (R: radius; E: exophytic/endophytic properties; N: nearness of tumor to the collecting system or sinus; A: anterior/posterior; L: location relative to polar lines) alone had a significant impact on postoperative changes in eGFR at 1 and 4 weeks, whereas resected tumor weight was significantly associated with the R and E subcategories. CONCLUSIONS: Measurement of total RNS is useful for predicting renal functional outcomes early after RAPN.

Objective assessment of residual nerve tissues in radical prostatectomy specimens by immunohistochemical staining of neuronal nitric oxide synthase-positive nerves and its impact on postoperative erectile function.

OBJECTIVE: To compare the quality of surgical management of the neurovascular bundle (NVB) by assessment of neuronal nitric oxide synthase (nNOS)-positive nerves in surgical specimens between open retropubic radical prostatectomy (RP; ORRP) and robot-assisted RP (RARP). METHODS: This study included 65 (99 sides, NVB resection; 31 sides, NVB preservation) and 83 (106 sides, NVB resection; 60 sides, NVB preservation) patients undergoing ORRP and RARP, respectively. The posterior sectors from the apex, mid, and base areas on each side were immunohistochemically stained with an nNOS antibody. RESULTS: On the sides with NVB resection, there were no significant differences in the numbers of nNOS-positive nerves in any areas between the ORRP and RARP groups; however, on the sides with NVB preservation, the numbers of nNOS-positive nerves in the ORRP group were significantly higher than those in the RARP group at the apex (84.4 vs 59.2; P = .0028), mid (71.2 vs 52.4; P = .016), and base (148.0 vs 40.8; P <.001) areas. In 55 patients who were judged not to have severe erectile dysfunction before surgery and subsequently underwent nerve-sparing RP, there was a significantly inverse correlation between the total number of nNOS-positive nerves on both sides and the postoperative erectile function. CONCLUSION: These findings suggest that RARP might be suitable for performing precise nerve-sparing surgery compared with ORPP, particularly in the base area of the prostate and that the quantification of nNOS-positive nerves in surgical specimens could be a useful approach for predicting the postoperative erectile function.

Assessment of health-related quality of life in Japanese patients with metastatic renal cell carcinoma during treatment with tyrosine kinase inhibitors.

The objective of this study was to comprehensively analyze the health-related quality of life (HRQOL) in Japanese patients with metastatic renal cell carcinoma (mRCC) during treatment with tyrosine kinase inhibitors (TKIs). This study included 240 Japanese mRCC patients treated with TKIs. We conducted a total of 305 surveys assessing the HRQOL before and 3 months after the introduction of TKIs, including 150, 95 and 60 during treatment with sorafenib, sunitinib and axitinib, respectively, using the Medical Outcomes Study 36-Item Short Form, consisting of eight multi-item scales measuring the health status. There were no significant differences in any of the eight scale scores between these 305 surveys conducted before and 3 months after TKI treatment. Two scores in the surveys during axitinib treatment were significantly superior to those during sorafenib treatment; however, no significant differences were noted in any of the remaining scale scores among the surveys during treatment with the three TKIs. Multivariate analyses, which were performed to evaluate the contribution of several factors to each scale score, revealed that the therapeutic efficacy had independent impacts on two scale scores, despite the lack of an independent association between any scores and the remaining factors, including the age, gender, introduced TKI, timing of TKI introduction and degree of adverse events. Collectively, these findings suggest that treatment with TKIs did not result in a significant impairment of the HRQOL in Japanese patients with mRCC; however, patients with unfavorable disease control appeared to fail to achieve a satisfactory HRQOL during treatment with TKIs.

Assessment of efficacy, safety and quality of life of 110 patients treated with sunitinib as first-line therapy for metastatic renal cell carcinoma: experience in real-world clinical practice in Japan.

The objective of this study was to comprehensively evaluate the clinical outcomes of 110 consecutive Japanese patients who received at least two cycles of sunitinib as first-line therapy for metastatic renal cell carcinoma (mRCC) in a routine clinical setting. Initially, 50 mg of sunitinib was administered once daily on a 4 weeks on, followed by 2 weeks off dosing schedule; however, dose modification was required in 102 patients, and the relative dose intensity was 62.6 % throughout this series. As the best responses to sunitinib, 2, 28, 65 and 15 were judged to show a complete response, partial response, stable disease and progressive disease, respectively. The median progression-free survival (PFS) and overall survival (OS) following the treatment with sunitinib were 7.8 and 33.2 months, respectively. Multivariate analyses of several factors identified the following independent predictors of PFS and OS: Memorial Sloan Kettering Cancer Center (MSKCC) classification and C-reactive protein (CRP) level for PFS and liver metastasis, MSKCC classification and CRP level for OS. The common adverse events related to sunitinib corresponding to ≥grade 3 were thrombocytopenia in 59, leukopenia in 23, fatigue in 22, hand-foot syndrome in 15 and hypertension in 12. Quality of life (QOL) analysis using 36-Item Short Form revealed no significant differences in any scale scores between surveys performed before and 3 months after the treatment with sunitinib. Collectively, these findings suggest that the introduction of sunitinib as a first-line agent can lead to favorable disease control with acceptable tolerability, resulting in improvement in the prognosis and QOL of Japanese patients with mRCC.

Assessment of postoperative quality of life: comparative study between laparoscopic and minimum incision endoscopic radical prostatectomies.

BACKGROUND: To investigate the changes in postoperative quality of life (QOL) in patients with prostate cancer who underwent laparoscopic radical prostatectomy (LRP) or minimum incision endoscopic radical prostatectomy (MIE-RP). METHODS: This study included a total of 115 Japanese patients with clinically localized prostate cancer who underwent either LRP or MIE-RP and were subsequently followed for more than 12 months. Before and 12 months after surgery, health-related QOL and disease-specific QOL were assessed using the Medical Outcomes Study 8-item Short-Form Health Survey (SF-8) and the Expanded Prostate Index Composite (EPIC), respectively. RESULTS: LRP and MIE-RP were performed in 57 and 58 patients, respectively, and there were no significant differences in major clinicopathological parameters between these two groups. There were no significant differences in perioperative outcomes between the two groups except for the estimated blood loss, which was lower in the LRP group. There were no significant differences between the two groups in the preoperative and postoperative all-scale scores of the SF-8 survey. Of the fourteen scores evaluated by the EPIC survey, postoperative scores for urinary summary, sexual summary, urinary function, urinary incontinence and sexual function were significantly worse than these preoperative scores in both LRP and MIE-RP groups, while there were no significant differences between the two groups in the preoperative and postoperative all-scale scores of the EPIC survey. CONCLUSIONS: The postoperative QOL status in patients undergoing MIE-RP appeared to be equivalent to that in those undergoing LRP.

Assessment of efficacy, safety and quality of life of 55 patients with metastatic renal cell carcinoma treated with temsirolimus: a single-center experience in Japan.

BACKGROUND: To evaluate experience of the use of temsirolimus for metastatic renal cell carcinoma (mRCC) in a single center in Japan. METHODS: This study included 55 consecutive patients with mRCC who received temsirolimus in a routine clinical setting, and retrospectively reviewed the comprehensive outcomes of these patients. RESULTS: Of the 55 patients, 20 had a Karnofsky performance status of ≤80, and 5, 41 and 9 were classified into favorable, intermediate and poor risk groups, respectively, according to the Memorial Sloan-Kettering Cancer Center model. Initially, 25 mg of temsirolimus was applied weekly; however, dose modification was required in 19 patients, resulting in a relative dose intensity of 90.5 % throughout this series. As the best responses to temsirolimus, 4, 44 and 7 were judged to have a partial response, stable disease and progressive disease, respectively. The median progression-free survival (PFS) and overall survival (OS) of these patients following the introduction of temsirolimus was 7.0 and 25.0 months, respectively. Of several factors examined, only the pretreatment C-reactive protein level was shown to be independently associated with both PFS and OS. The common adverse events related to temsirolimus corresponding to ≥grade 3 were anemia in 4, thrombocytopenia in 3, stomatitis in 3 and hyperglycemia in 3. Quality of life analysis using 36-Item Short Form showed that there were no significant differences in any scale scores between surveys performed before and 3 months after the introduction of temsirolimus. CONCLUSIONS: Temsirolimus was well tolerated and facilitated comparatively favorable cancer control in Japanese patients with mRCC.

Assessment of antimicrobial prophylaxis to prevent perioperative infection in patients undergoing prostate brachytherapy: multicenter cohort study.

To propose an appropriate prophylactic antimicrobial therapy for patients undergoing brachytherapy, we evaluated the relationships between various antimicrobial prophylaxis (AMP) protocols and the incidence of postimplant infections in a multicenter cohort study conducted in Japan. The records of 826 patients with localized prostate cancer who underwent a transperineal (125)I brachytherapy procedure between January 2009 and December 2010 were retrospectively reviewed. Perioperative infections, including surgical site and remote infections, were recorded up to postoperative day 30. A total of 6 (0.73%) patients had a perioperative infection following seed implantation, of whom all received AMP for 1 or more days. None of the patients who received a single-dose protocol of AMP using fluoroquinolone p.o. or penicillin with a beta-lactamase inhibitor i.v. developed a perioperative infection. Statistical analysis showed that a single-dose protocol was more significantly related to a lower risk of perioperative infection as compared to the other AMP protocols examined (p = 0.045). Furthermore, our results indicated that bacteriuria and preoperative hair removal were risk factors of perioperative infection with statistical significance (p = 0.007, p = 0.004). Analysis of patient clinical parameters, including age, American Society of Anesthesiologists score, diabetes mellitus, prostate volume, numbers of implanted seeds and needle punctures, operation time, and indwelling duration time of the Foley catheter, did not reveal significant differences in terms of perioperative infection. Our results indicated that a single-dose AMP protocol is sufficient to prevent perioperative infections following seed implantation. On the other hand, AMP is only one of several measures to prevent perioperative infectious complications. It is necessary to know that the patient must have no bacteriuria and that preoperative hair removal should be avoided.

Orthotopic sigmoid vs. ileal neobladders in Japanese patients: a comparative assessment of complications, functional outcomes, and quality of life.

OBJECTIVES: To compare the clinical outcomes of sigmoid and ileal neobladders (NBs) created following radical cystectomy. MATERIALS AND METHODS: This study included 90 and 144 Japanese patients undergoing radical cystectomy and orthotopic NB reconstruction with a sigmoid and ileal segment, respectively. Postoperative clinical outcomes between the sigmoid and ileal NB groups (SNBG and INBG) were compared. RESULTS: In this series, 110 early and 51 late complications occurred in 71 and 41 patients, respectively; however, there was no significant difference in the incidence of complications between SNBG and INBG. At 1 year postoperatively, there were no significant differences in the proportion of spontaneous voiders and the continence status between these 2 groups; however, despite the lack of significant differences in the maximal flow rate and voided volume, the post-void residual in SNBG was significantly smaller than that in INBG. Voiding functional outcomes at 5 years postoperatively were also obtained from 28 and 49 in SNBG and INBG, respectively. Although there were no significant changes in the functional outcomes in SNBG, the proportion of spontaneous voiders and post-void residual in INBG at 5 years postoperatively were significantly poorer than those at 1 year postoperatively. Furthermore, the postoperative health-related quality of life assessed by a Short-Form 36 survey did not show any significant differences in all 8 scores between these 2 groups. CONCLUSIONS: Both types of NB reconstruction resulted in comparatively satisfactory outcomes; however, the voiding function, particularly that on long-term follow-up, in SNBG appeared to be more favorable than that in INBG.

Assessment of optimal target genes for detecting micrometastases in pelvic lymph nodes in patients with prostate cancer undergoing radical prostatectomy by real-time reverse transcriptase-polymerase chain reaction.

OBJECTIVES: To compare the accuracy to diagnose micrometastases to pelvic lymph nodes (LNs) in patients undergoing radical prostatectomy (RP) by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) targeting several genes specifically expressed in the prostate. MATERIALS AND METHODS: Expression of prostate-specific antigen (PSA), prostate-specific membrane antigen (PSMA), human kallikrein 2 (hK2), prostate stem cell antigen (PSCA), and differential display code 3 (DD3) in 2215 LNs isolated from 120 patients with localized prostate cancer were assessed by fully quantitative real-time RT-PCR. RESULTS: In addition to pathologically diagnosed LN metastases in 11 patients, real-time RT-PCR targeting PSA, PSMA, hK2, PSCA, and DD3 further identified micrometastases in 23, 29, 31, 15, and 11, respectively. In this series, biochemical recurrence (BR) occurred in 32 patients, of whom 25, 22, 28, 10, and 9 were diagnosed as having micrometastases by real-time RT-PCR targeting PSA, PSMA, hK2, PSCA, and DD3, respectively. Univariate analysis identified pathologic stage, pathologic LN metastases, Gleason score, surgical margin status, and micrometastases detected by real-time RT-PCR targeting PSA, PSMA, hK2, and their combinations as significant predictors for BR-free survival (BRFS), of which only surgical margin status and micrometastases detected by real-time RT-PCR targeting PSA and hK2 appeared to be independently associated with BRFS on multivariate analysis. CONCLUSIONS: Of PSA, PSMA, hK2, PSCA, DD3, and their combinations, combined analysis of PSA and/or hK2 expression in pelvic LNs by real-time RT-PCR could provide findings most precisely predicting BRFS following RP.