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The aim of this study is to compare the perioperative outcomes and learning curves between intracorporeal and extracorporeal urinary diversion at our medium-sized institution. Between January 2018 and September 2020, a single surgeon at our institution performed 46 consecutive robot-assisted radical cystectomies with ileal conduit. We compared the perioperative outcomes between patients who underwent intracorporeal versus extracorporeal urinary diversion. We also investigated learning curves for the first and last 10 patients in each group. The extracorporeal group had shorter overall operative time (P = 0.003) and urinary diversion time (P

BackgroundThe advantages of photodynamic diagnostic technology using 5-aminolevulinic acid (ALA-PDD) have been established. The aim of this prospective cohort study was to evaluate the usefulness of ALA-PDD to diagnose upper tract urothelial carcinoma (UT-UC) using the Olympus VISERA ELITE video system.MethodsWe carried out a prospective, interventional, non-randomized, non-contrast and open label cohort pilot study that involved patients who underwent ureterorenoscopy (URS) to detect UT-UC. 5-aminolevulinic acid hydrochloride was orally administered before URS. The observational results and pathological diagnosis with ALA-PDD and traditional white light methods were compared, and the proportion of positive subjects and specimens were calculated.ResultsA total of 20 patients were enrolled and one patient who had multiple bladder tumors did not undergo URS. Fifteen of 19 patients were pathologically diagnosed with UT-UC and of these 11 (73.3%) were ALA-PDD positive. Fourteen of 19 patients were ALA-PDD positive and of these 11 were pathologically diagnosed with UC. For the 92 biopsy specimens that were malignant or benign, the sensitivity for both traditional white light observation and ALA-PDD was the same at 62.5%, whereas the specificities were 73.1% and 67.3%, respectively. Of the 38 specimens that were randomly biopsied without any abnormality under examination by both white light and ALA-PDD, 11 specimens (28.9%) from 5 patients were diagnosed with high grade UC. In contrast, four specimens from 4 patients, which were negative in traditional white light observation but positive in ALA-PDD, were diagnosed with carcinoma in situ (CIS).ConclusionsOur results suggest that ALA-PDD using VISERA ELITE is not sufficiently applicable for UT-UC. Nevertheless, it might be better particularly for CIS than white light and superior results would be obtained using VISERA ELITE II video system.Trial registration: The present clinical study was approved by the Okayama University Institutional Review Board prior to study initiation (Application no.: RIN 1803–002) and was registered with the UMIN Clinical Trials Registry (UMIN-CTR), Japan (Accession no.: UMIN000031205).

Apalutamide-associated skin adverse events are more common in the Japanese than in the global population. However, limited clinical data have hampered further understanding. This real-world study investigated the clinical characteristics of skin adverse events in patients with advanced prostate cancer.We retrospectively reviewed 119 patient records from 16 institutions in Japan. Skin adverse events were graded according to the Common Terminology Criteria for Adverse Events (v5.0). The incidence and characteristics of skin adverse events (along with the clinical risk factors for their incidence, worsening, and recurrence) were evaluated.Fifty-five patients (46.2%) experienced skin adverse events. The median times to the incidence and remission of skin adverse events were 62 and 30 days, respectively. Grade 3 skin adverse events were observed in 15 patients (12.6%). The median time from the first incidence to apalutamide interruption was significantly longer in patients with progression to grade 3 skin adverse events than in those without such a progression (8 vs. 0 days, p = 0.005). Skin adverse events were observed in 45.2% of patients who resumed apalutamide treatment (median treatment interruption time: 31.5 days). Sixteen patients (13.4%) permanently discontinued apalutamide due to skin adverse events. No significant clinical risk factors for the incidence, worsening and recurrence of apalutamide-associated skin adverse events were observed.Nearly half of the Japanese patients in this study experienced skin adverse events following apalutamide administration. The time to apalutamide discontinuation after the incidence of skin adverse events was positively correlated with the worsening of these events.

669 Background: Tuberous sclerosis complex (TSC) is an autosomal dominant inherited disease. Approximately 60%–80% of patients with TSC have bilateral angiomyolipoma (AML). Cryotherapy is one treatment option for renal tumors, but the safety and efficacy of cryotherapy for TSC–AML is not clear. We planned this study to establish the safety and efficacy of cryotherapy for TSC–AML. Methods: This was an open-label, single-arm phase II study to evaluate the safety and efficacy of cryotherapy for TSC–AML of 4 cm or less in diameter in patients at least 16 years old. The exclusion criteria were an inability to withdraw from mTOR inhibitor and failure to maintain rest during cryotherapy. mTOR inhibitors were withdrawn at least 7 days prior to cryotherapy and discontinued during the study period. Cryotherapy was performed using Cryohit (Galil Medical LTD, USA). Safety was assessed at 1, 2, 6, and 9 months after cryotherapy, and efficacy was assessed at 3 and 9 months after cryotherapy. The efficacy of cryotherapy was evaluated according to the modified RECIST or RECIST criteria. The primary endpoint was the disease control rate, and secondary endpoints included the overall response rate, safety, renal function, quality of life, and need for additional treatment. Results: The disease control and overall response rates were 100% and 93.3%, respectively. After 9 months of follow-up, the median creatine level was slightly increased by 0.06 mg/dL. Quality of life was stable, and no additional treatment was needed. Three Grade 3 adverse events (hematuria, chronic kidney disease, and aspartate aminotransferase elevation) were observed in three patients. Conclusions: Cryoablation is a safe and effective treatment option for TSC–AML. Clinical trial information: jRCTs072200039 .

SummaryLocally advanced or metastatic urothelial cancer is an aggressive form of cancer with high recurrence rates and low survival. Nectin-4 is a cell adhesion molecule commonly expressed in several tumors, including high expression in urothelial cancer. Enfortumab vedotin is an antibody–drug conjugate composed of an anti-Nectin-4 humanized monoclonal antibody linked to the microtubule disrupting agent, monomethyl auristatin E. In this phase I study (NCT03070990), Japanese patients with locally advanced/metastatic urothelial cancer treated with prior chemotherapy, or ineligible for cisplatin, were randomized 1:1 to receive 1.0 mg/kg (Arm A) or 1.25 mg/kg (Arm B) enfortumab vedotin on Days 1, 8, and 15 of each 28-day cycle. Assessing the pharmacokinetic and safety/tolerability profiles of enfortumab vedotin were primary objectives; investigator-assessed antitumor activity (RECIST v1.1) was a secondary objective. Seventeen patients (n = 9, Arm A; n = 8, Arm B) received treatment. Pharmacokinetic data suggest a dose-dependent increase in enfortumab vedotin maximum concentration and area under the concentration–time curve at Day 7. Enfortumab vedotin was well tolerated across both doses. Dysgeusia and alopecia (n = 9 each) were the most common treatment-related adverse events. Regardless of attribution, grade ≥ 3 adverse events occurring in ≥2 patients were anemia and hypertension (n = 2 each). One patient achieved a confirmed complete response (Arm A) and five achieved confirmed partial responses (n = 3, Arm A; n = 2, Arm B). Objective response and disease control rates were 35.3% and 76.5%, respectively. In Japanese patients with locally advanced/metastatic urothelial cancer, enfortumab vedotin is well tolerated with preliminary antitumor activity and a pharmacokinetic profile consistent with prior reports.

This study aimed to compare the interobserver variabilities in magnetic resonance imaging (MRI)/computed tomography (CT) fusion image–based post-implant dosimetry of permanent prostate brachytherapy (PPB) between 1.5-T and 3.0-T MRI. The study included 60 patients. Of these patients, 30 underwent 1.5-T MRI and CT 30 days after seed implantation (1.5-T group), and 30 underwent 3.0-T MRI and CT 30 days after seed implantation (3.0-T group). All patients received PPB alone. Two radiation oncologists performed MRI/CT fusion image–based post-implant dosimetry, and the interobserver variabilities of dose–volume histogram (DVH) parameters [dose (Gy) received by 90% of the prostate volume (prostate D90)], percentage of the prostate volume receiving at least the full prescribed dose (prostate V100), percentage of the prostate volume receiving at least 150% of the prescribed dose (prostate V150), dose (Gy) received by 5% of the urethral volume (urethral D5) and the urethral volume receiving at least 150% of the prescribed dose (urethral V150)] were retrospectively estimated using the paired Student’s t test and Pearson’s correlation coefficient. The Pearson’s correlation coefficients of all DVH parameters were higher in the 3.0-T group than in the 1.5-T group (1.5-T vs 3.0-T: prostate D90, 0.65 vs 0.93; prostate V100, 0.62 vs 0.82; prostate V150, 0.97 vs 0.98; urethral D5, 0.92 vs 0.93; and urethral V150, 0.88 vs 0.93). In the paired Student’s t test, no significant differences were observed in any of the DVH parameters between the two radiation oncologists in the 3.0-T group (0.068 ≤ P ≤ 0.842); however, significant differences were observed in prostate D90 (P = 0.004), prostate V100 (P = 0.011) and prostate V150 (P = 0.002) between the oncologists in the 1.5-T group. The interobserver variability of DVH parameters in the MRI/CT fusion image–based post-implant dosimetry analysis of brachytherapy was lower with 3.0-T MRI than with 1.5-T MRI.

TPS397 Background: Tuberous sclerosis complex (TSC) is an autosomal dominant inherited disease that causes benign tumors called hamartoma all over the body as well as neuropsychiatric symptoms such as epilepsy. One-third of patients have a family history of the disease, but the remaining two-thirds are solitary cases and are caused by newly arising mutations. The TSC1 gene on chromosome 9 and TSC2 on chromosome 16 have been identified as the causative genes. Approximately 60%–80% of patients with TSC have renal lesions, and angiomyolipoma (AML) occurs bilaterally. The frequency of TSC-associated AML (TSC-AML) increases with age, reaching 60%–80% in adults, and the rate of death from renal disease increases with age in TSC patients. The current standard of care for AML is arterial embolization or surgery (partial nephrectomy or nephrectomy), but TSC is a hereditary disease and AMLs occur one after another with age. Repeated surgical procedures are technically difficult, and arterial embolization has a high recurrence rate. Under these circumstances, an mTOR inhibitor, everolimus, has shown a marked reduction of TSC-AML and is widely used. However, everolimus must be administered permanently because AML re-occurs after discontinuation of everolimus. Cryotherapy has been used as a treatment for renal tumors, and there have been some reports of cryotherapy for solitary AML, but the safety and efficacy of cryotherapy for TSC-AML have not been established. Therefore, we planned this study to establish the safety and efficacy of cryotherapy for TSC-AML. Methods: This is an open-label, single-arm, phase II study to evaluate the safety and efficacy of cryotherapy for TSC-AML of 4 cm or less in patients with 16 years of age or older. The exclusion criteria are an inability to withdraw from mTOR inhibitor and failure to maintain rest during cryotherapy. mTOR inhibitor medication should be withdrawn at least 7 days prior to cryotherapy and discontinued during the study period. Cryotherapy will be performed using Cryohit (GALIL MEDICAL LTD, Israel). Safety will be assessed at 1, 2, 6, and 9 months after cryotherapy, and efficacy will be assessed at 3 and 9 months after cryotherapy. The efficacy of cryotherapy will be evaluated according to modified RECIST or RECIST criteria. The primary endpoint will be the disease control rate of AML treated with cryotherapy, and secondary endpoints will be the overall response rate, safety, renal function, quality of life, and whether additional treatment is required. Clinical trial information: jRCTs072200039.

Sb-doped Mg2Si was prepared using waste silicon sludge via a liquid-solid phase reaction and pulse-current sintering. Two types of Si sludge were used as a silicon source. One is an unwashed Si sludge, and the other is Si sludge washed with a water-based agent. In the samples prepared from unwashed Si sludge, Mg2Si, Mg, and MgO phases existed. In the case of samples prepared from the washed Si sludge, the X-ray diffraction patterns showed almost a single phase, although a small MgO phase remained. The thermoelectric properties of Mg2Si prepared from the washed Si sludge were improved by control of weighed composition and carrier concentration. The obtained maximum figure of merit of this study was 0.66 in the samples prepared from the washed Si sludge, which is equivalent to materials prepared from reagent Si with identical carrier concentration.

Objectives To determine whether neoadjuvant hormonal therapy improves oncological outcomes of patients with localized prostate cancer treated with permanent brachytherapy. Methods Between January 2004 and November 2014, 564 patients underwent transperineal ultrasonography-guided permanent iodine-125 seed brachytherapy. We retrospectively analyzed low- or intermediate-risk prostate cancer based on the National Comprehensive Cancer Network guidelines. The clinical variables were evaluated for influence on biochemical recurrence-free survival, progression-free survival, cancer-specific survival and overall survival. Results A total of 484 patients with low-risk (259 patients) or intermediate-risk disease (225 patients) were evaluated. Of these, 188 received neoadjuvant hormonal therapy. With a median follow up of 71 months, the 5-year actuarial biochemical recurrence-free survival rates of patients who did and did not receive neoadjuvant hormonal therapy were 92.9% and 93.6%, respectively (P = 0.2843). When patients were stratified by risk group, neoadjuvant hormonal therapy did not improve biochemical recurrence-free survival outcomes in low- (P = 0.8949) or intermediate-risk (P = 0.1989) patients. The duration or type of hormonal therapy was not significant in predicting biochemical recurrence. In a multivariate analysis, Gleason score, pretreatment prostate-specific antigen, clinical T stage, and prostate dosimetry, primary Gleason score and positive core rate were significant predictive factors of biochemical recurrence-free survival, whereas neoadjuvant hormonal therapy was insignificant. Furthermore, neoadjuvant hormonal therapy did not significantly influence progression-free survival, cancer-specific survival or overall survival. Conclusions In patients with low- or intermediate-risk disease treated with permanent prostate brachytherapy, neoadjuvant hormonal therapy does not improve oncological outcomes. Its use should be restricted to patients who require prostate volume reduction.

Purpose This study aimed to clarify the efficacy and toxicity of first-line combination treatment with paclitaxel, cisplatin, and gemcitabine (PCG) for advanced/metastatic urothelial carcinoma (UC) in cisplatin-unfit patients compared with cisplatin-fit patients. Methods We conducted a retrospective study of patients who received first-line PCG. Using international consensus criteria, patients were classified into cisplatin-fit and -unfit groups. Cisplatin-unfit patients received PCG with adjustment of the cisplatin dose after assessing 24-hour urinary creatinine clearance, without modifying the administration interval. Results From 2008 to 2017, 50 patients received first-line PCG, of whom 30 and 20 were classified into the cisplatin-fit and -unfit groups. After a median follow-up of 15.0 months, the median overall survival (OS) and progression-free survival (PFS) were 15.0 and 9.8 months in all patients, 15.0 and 10.0 months in the cisplatin-fit group, and 13.2 and 9.3 months in the cisplatin-unfit group, respectively. There was no significant difference in OS (hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.69–2.54) or PFS (HR: 1.38, 95% CI: 0.74–2.55) between the groups. The overall response rate and complete response rate were 58% (95% CI: 43.2–71.8) and 32% (95% CI: 19.5–46.7) in all patients, and 55% (95% CI: 31.5–76.9) and 35% (95% CI: 15.4-59.2) in the cisplatin-unfit group, respectively. The common grade 3 of 4 adverse events experienced were neutropenia (78%), followed by thrombocytopenia (56%), anemia (46%), and febrile neutropenia (16%). The 24-hour urinary creatinine clearance did not differ significantly between the groups after one, two, or three courses of PCG. Conclusions We found no significant difference regarding OS and PFS between the cisplatin-fit patients with a full dose of cisplatin and -unfit patients with cisplatin-dose-adjusted chemotherapy. In select cisplatin-unfit patients, PCG with dose adjustment of cisplatin may be useful for treating advanced/metastatic UC without any significant adverse events or impaired renal function compared with cisplatin-fit patients with a full dose of cisplatin.

We report a patient with adrenal incidentaloma due to synchronous and isolated metastasis from lung cancer, which is a relatively rare condition. Close checkups for incidentaloma in oncologic patients are mandatory, leading to successful operation.

The indications for renal autotransplantation (RATx) include renal vascular trauma, thrombosis, stenosis, aneurysm, complex ureteral injuries, renal cell carcinoma, urolithiasis, retroperitoneal fibrosis, and loin pain-hematuria syndrome. Unfortunately, RATx is underutilized because of its invasiveness. The current gold standard approach to RATx is laparoscopic nephrectomy and open autotransplantation, which requires a large pelvic incision. Robotic-assisted renal autotransplantation (robotic RATx) is a new, minimally invasive approach that has been used since 2014. The first completely intracorporeal robotic RATx, used to repair a ureteral injury, was reported in 2014. Since then, only three cases have been reported, all from North America. After an initial porcine study, we conducted the fourth robotic RATx procedure. Robotic surgery has multiple advantages, such as providing a three-dimensional magnified view, navigating in narrow spaces, and fine suturing and dissection, which are particularly helpful in cases with desmoplastic changes. Most robotic RATx procedures have been used to repair ureteral injuries. These cases tend to have desmoplastic changes due to previous surgeries. Nephrectomy and RATx are technically challenging, hence robotic surgery may be the best option in patients with complex and severe desmoplastic changes. The disadvantages of robotic RATx include the length of surgery and cost. However, with continued use, both the operative time and the cost should decrease. In conclusion, robotic RATx is a new, minimally invasive approach to renal preservation.

(Introduction and objectives) Radical nephroureterectomy with complete distal ureterectomy is the standard therapy for upper tract urothelial malignancy. Segmental ureterectomy with ueteroneocytostomy is an alternative for distal ureteral carcinoma. We describe extravesical complete distal ureterectomy combined by transurethral bladder cuff excision with frozen-section analysis. (Patient and methods) Since December 2008, 11 patients (median age 77 year old, male 10, female 1, right 10, left 1) with solitary distal ureteral carcinoma who had mild hydronephrosis of ipsilateral kidney remaining renal function on enhanced CT. Under general anesthesia, the patient was placed in lithotomy position, rigid cystoscopy was inserted into the bladder. Cold punch biopsy of 4 sites of bladder mucosa 5 mm away from ureteral orifice (12, 3, 6, 9 o'clock) was carried out and sent to frozen-section analysis. Use resectoscopy with needle-type electrode, incise the bladder mucosa along the biopsy sites circumferentially and incise submucosa tissue around the ureteral orifice deeply enough to detach intramural ureter. Then lower abdominal midline incision was made. After entering the retroperitoneal space, the ureter was dissected and ureteral margin was sent to frozen-section analysis. The distal ureter was dissected until the margin of bladder mucosa incised by transurethrally. After ascertainment of no cancer cell in the frozen-section, close the defect in the bladder. Then the ureter was re-implanted into the bladder by extravesical approach. (Results) Median estimate blood loss was 150 ml (40-350 ml) and median operative time was 258 min (170-317 min.). No patients in our series required a blood transfusion. The mean tumor size was 20+/- 4.4 mm. Pathological T stage was Ta 3, T1 3, T2 2 and T3 3. No positive surgical margin was noted. Mean serum creatinine before and 1 month after surgery was 1.05+/- 0.21 mg/dl and 089+/- 0.13 mg/dl. Mean eGFR before and 1 month after surgery was 54.1+/- 11.4 and 63.4+/- 8.4. Median followup was 35 months (range 4 to 93). Although there were two patients who died from distant metastatic disease, no patients have encountered cancer recurrence in the remained ipsilateral upper urinary tract. (Conclusions) Segmental ureterectomy combined by transurethral bladder cuff excision with frozen-section analysis could perform complete resection of distal ureteral carcinoma and preserve ipsilateral renal function. This technique is feasible for patients with distal ureteral carcinoma as an optional treatment. Better preservation of renal function can lead to increased tolerance of cisplatin-based adjuvant or salvage chemotherapy.

Fluoroquinolone-non-susceptible Escherichia coli isolated from patients with acute uncomplicated cystitis are a matter of increasing concern. Cefditoren pivoxil is an oral, β-lactamase-stable, extended-spectrum cephalosporin that is effective against fluoroquinolone-non-susceptible bacteria. To evaluate the clinical and microbiological efficacies of cefditoren pivoxil against acute uncomplicated cystitis and to determine the optimal duration of cefditoren pivoxil treatment. We compared 3 and 7 day regimens of cefditoren pivoxil in a multicentre, randomized, open-label study. A total of 104 female patients with acute uncomplicated cystitis were enrolled and randomized into 3 day (n = 51) or 7 day (n = 53) treatment groups. At first visit, 94 bacterial strains were isolated from the 104 participants of which 81.7% (85/104) were E. coli. Clinical and microbiological efficacies were evaluated 5–9 days following administration of the final dose of cefditoren pivoxil. The clinical efficacies of the 3 and 7 day groups were 90.9% (40/44) and 93.2% (41/44), respectively (P = 1.000). The microbiological efficacies of the 3 and 7 day groups were 82.5% (33/40) and 90.2% (37/41), respectively (P = 0.349). There were no adverse events due to cefditoren pivoxil treatment, with the exception of a mild allergic reaction in one patient, after which the cefditoren pivoxil was exchanged for another antimicrobial. Cefditoren pivoxil is safe and effective for uncomplicated cystitis, with no significant differences in clinical and microbiological efficacies between 3 and 7 day regimens.

TPS3119Background: Although immune-checkpoint inhibitors (ICIs) have shown significant survival benefits in several cancers, optimal outcomes have been limited to subsets of patients. We obtained c...

PURPOSE The usefulness of the screening for prostate cancer with prostate specific antigen (PSA) in the medical checkup ("Human Dock") at Onomichi Municipal Hospital was evaluated. METHODS From April 1997 to December 2007, serum PSA of 1,234 male (median age: 59) was measured in the medical checkup and each parameter of screening was evaluated. In addition, for the cases with prostate cancer, results of treatment and clinical significance were assessed. RESULTS PSA was elevated in 82 cases (6.6%), aged 42-87 (median 64), in which PSA varied 3.1-66.5 ng/ml (median 5.4). Trans-rectal biopsy was performed in 35 cases and prostate cancer was detected in 15 (42.9% of biopsied cases and 1.2% of whole group), aged 58-81 (median 70), with PSA value 4.2-66.5 ng/ml (median 10.3). Clinical stage of these cases was cT1cN0M0 in 12 and cT2aN0M0 or more in 3, Gleason score was 3 + 3 in 4 and 3 + 4 or more in 11. Initial treatment was radical prostatectomy in 12, androgen-deprivation therapy in 2 and external beam irradiation in 1. During the follow-up for 8-107 months (median 60), 14 were alive with good control and 1 was alive with relapse. Only one case was "clinically insignificant" cancer (impalpable and localized and tumor volume less than 0.5 ml and Gleason score 3 + 3 or less). CONCLUSIONS Most of the prostate cancers detected in the medical checkup were clinically significant, therefore, PSA screening doesn't result in overtreatment and it is meaningful to perform PSA screening in the medical checkup.

We compared the implant quality of intraoperatively built custom-linked (IBCL) seeds with loose seeds in permanent prostate brachytherapy. Between June 2012 and January 2015, 64 consecutive prostate cancer patients underwent brachytherapy with IBCL seeds ( n = 32) or loose seeds ( n = 32). All the patients were treated with 144 Gy of brachytherapy alone. Brachytherapy was performed using a dynamic dose calculation technique. Computed tomography/magnetic resonance imaging fusion-based dosimetry was performed 1 month after brachytherapy. Post-implant dose–volume histogram (DVH) parameters, prostate sector dosimetry, operation time, seed migration, and toxicities were compared between the IBCL seed group and the loose seed group. A sector analysis tool was used to divide the prostate into six sectors (anterior and posterior sectors at the base, mid-gland, and apex). V100 (95.3% vs 89.7%; P = 0.014) and D90 (169.7 Gy vs 152.6 Gy; P = 0.013) in the anterior base sector were significantly higher in the IBCL seed group than in the loose seed group. The seed migration rate was significantly lower in the IBCL seed group than in the loose seed group (6% vs 66%; P < 0.001). Operation time per seed was significantly longer in the IBCL seed group than in the loose seed group (1.31 min vs 1.13 min; P = 0.003). Other post-implant DVH parameters and toxicities did not differ significantly between the two groups. Our study showed more dose coverage post-operatively in the anterior base prostate sector and less seed migration in IBCL seed implantation compared with loose seed implantation.