Is Kelami's Method Still Useful in the Smartphone Era? The Virtual 3-Dimensional Reconstruction of Penile Curvature in Patients With Peyronie's Disease: A Pilot Study.

BACKGROUND: Peyronie's disease is an idiopathic fibrotic disease affecting the penile tunica albuginea. Among other resulting deformities, the more common penile curvature should be assessed preferentially with in-office goniometric estimation after pharmacologically induced erection, although clearly invasive and uncomfortable. AIM: In the present pilot study, we investigated the usefulness for the patient and the surgeon of a 3-dimensional (3D) reconstruction of the penile curvature obtained through photogrammetry software in clinical evaluation and surgical planning. METHODS: Enrolled patients received alprostadil 10 µg by intracavernous injection. Then, the medical personnel took a sequence of up to 50 photographs in orthostatism via a smartphone and processed them to obtain a 3D model of the whole groin area with 3DF Zephyr free software (3Dflow SRL, Verona, Italy), to take measurements of the penile curvature with MeshLab software (National Research Council of Italy, Rome, Italy) and to simulate the results after corporoplasty with Blender software (Blender Foundation, Amsterdam, the Netherlands). Finally, we submitted a 1-5 Likert scale to patients and surgeons investigating their satisfaction with the use of the 3D model during preoperative counseling, surgical planning, and the esthetic results after surgery. OUTCOMES: We investigated the patient and surgeon satisfaction with the use of the 3D model in understanding/evaluating the pathology and the surgical planning during the preoperative visit and the satisfaction with the final esthetic results in relation to the preoperative model itself. RESULTS: 4 patients were included. The median photographs acquisition and computer processing time were 39 seconds and 347.5 minutes, respectively. All the patients and surgeons involved gave a score of ≥4 to all the items investigated. CLINICAL IMPLICATIONS: The 3D model of the penile curvature is very useful both to the patient and the surgeon to understand the severity of the disease and the possible surgical management. STRENGTH & LIMITATIONS: This is a pilot study including only 4 cases, but it is the first experience in which the patients with Peyronie's disease had the possibility to see a virtual 3D model of their penile curvature and final esthetic results after corporoplasty, based on 3 freely available computer applications. CONCLUSION: Our pilot study has shown that it is possible to quickly obtain a sequence of photographs to create an accurate virtual 3D model of the penis of patients with Peyronie's disease, helping the patients and the surgeon during preoperative counseling and surgical planning. Pavone C, Abrate A, Altomare S, et al. Is Kelami's Method Still Useful in the Smartphone Era? The Virtual 3-Dimensional Reconstruction of Penile Curvature in Patients With Peyronie's Disease: A Pilot Study. J Sex Med 2021;18:209-214.

Association of patients' sex with treatment outcomes after intravesical bacillus Calmette-Guérin immunotherapy for T1G3/HG bladder cancer.

PURPOSE: To investigate the association of patients' sex with recurrence and disease progression in patients treated with intravesical bacillus Calmette-Guérin (BCG) for T1G3/HG urinary bladder cancer (UBC). MATERIALS AND METHODS: We analyzed the data of 2635 patients treated with adjuvant intravesical BCG for T1 UBC between 1984 and 2019. We accounted for missing data using multiple imputations and adjusted for covariate imbalance between males and females using inverse probability weighting (IPW). Crude and IPW-adjusted Cox regression analyses were used to estimate the hazard ratios (HR) with their 95% confidence intervals (CI) for the association of patients' sex with HG-recurrence and disease progression. RESULTS: A total of 2170 (82%) males and 465 (18%) females were available for analysis. Overall, 1090 (50%) males and 244 (52%) females experienced recurrence, and 391 (18%) males and 104 (22%) females experienced disease progression. On IPW-adjusted Cox regression analyses, female sex was associated with disease progression (HR 1.25, 95%CI 1.01-1.56, p = 0.04) but not with recurrence (HR 1.06, 95%CI 0.92-1.22, p = 0.41). A total of 1056 patients were treated with adequate BCG. In these patients, on IPW-adjusted Cox regression analyses, patients' sex was not associated with recurrence (HR 0.99, 95%CI 0.80-1.24, p = 0.96), HG-recurrence (HR 1.00, 95%CI 0.78-1.29, p = 0.99) or disease progression (HR 1.12, 95%CI 0.78-1.60, p = 0.55). CONCLUSION: Our analysis generates the hypothesis of a differential response to BCG between males and females if not adequately treated. Further studies should focus on sex-based differences in innate and adaptive immune system and their association with BCG response.

NEPA as antiemetic prophylaxis after failure of 5HT3-RA plus dexamethasone in patients receiving carboplatin and gemcitabine chemotherapy: A monocentric real-life experience.

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) may affect adherence to planned chemotherapy treatments and compromise patients' quality of life during the therapy. NEPA is an oral fixed combination of netupitant, a highly-selective NK1-RA and palonosetron, a 5HT3-RA, approved for the prevention of acute and delayed CINV. The aim of this study was to evaluate the efficacy and safety of NEPA with dexamethasone for CINV prophylaxis in the challenging setting of carboplatin and gemcitabine combination chemotherapy, after failure of prophylaxis with 5HT3 receptor antagonist. METHODS: Eligible patients were undergoing carboplatin and gemcitabine combination chemotherapy for metastatic non-small cell lung cancer (NSCLC), ovarian cancer or urothelial cancer and experienced nausea and/or vomiting after the first cycle of chemotherapy, despite an antiemetic prophylaxis with a 5HT3-RA and dexamethasone. Primary efficacy endpoint was complete response (CR: no emesis, no rescue medication) obtained with NEPA, during the overall phase (0-120 h), after the start of chemotherapy. RESULTS: During the first cycle of chemotherapy, 15 out of 30 (50%) patients did not properly control CINV with a 5HT3-RA plus dexamethasone used as primary antiemetic prophylaxis and then were switched to NEPA from the subsequent cycle. During NEPA administration, 13 out of 15 patients (86.7%) achieved an overall CR (no emesis, no rescue medication). Antiemetic treatment with NEPA was very well tolerated with only two patients (13.3%) that experienced a grade 1 TEAE. CONCLUSIONS: Our experience showed that NEPA has proven to be very effective and well tolerated in the prophylaxis of CINV induced by carboplatin-based chemotherapy.

Does Smoking Cessation at Primary Diagnosis Reduce the Recurrence Risk of Nonmuscle-Invasive Bladder Cancer? Results of a Prospective Study.

INTRODUCTION: Evidence that smoking cessation at first diagnosis of nonmuscle-invasive bladder cancer (NMIBC) reduces the risk of recurrence is lacking. The aim of our prospective study was to analyze the association between patients' changes in smoking habits after diagnosis and recurrence-free survival (RFS). PATIENTS: After transurethral resection of primary NMIBC, patients were classified as "ex-smokers," i.e., those definitively stopping, and as "active smokers," i.e., those continuing or restarting to smoke. Smoking status was reassessed every 3 months during the first year and every 6 months thereafter. Data on patients' demographics, smoking status, tumor characteristics, treatments, and follow-up were collected. Statistical analysis was performed adopting SPSS 15.0.1 and R3.4.2 software. RESULTS: Out of 194 patients, 67 (34.5%) quit smoking after the diagnosis, while 127 (65.5%) did not. The clinical and pathological characteristics were homogeneously distributed. At a median follow-up of 38 months, 106 patients (54.6%) recurred, 33 (49.2%) ex- and 73 (60.3%) active smokers with a 3-year RFS of 42.3 and 50.7%, respectively (p = 0.55). No statistically significant association between recurrence, pathological features of the primary tumor, and patient smoking habits after diagnosis was detected. Results were not statistically influenced by the intensity (cigarette/day) and duration (years) of smoking. In multivariate analysis, cigarette smoking cessation at diagnosis did not significantly reduce tumor recurrence. CONCLUSION: In our prospective study, more than half of our patients recurred at 3 years. In multivariate analysis, smoking cessation did not significantly reduce tumor recurrence. However, the 8.4% reduction in favor of the ex-smokers suggests the need of larger studies with longer follow-ups. Surprisingly, only 35% of smokers definitively quit after diagnosis. The urologists should play a more active role to persuade the patients to stop smoking at first cancer diagnosis.

Sildenafil orodispersible film in the treatment of erectile dysfunction after radical prostatectomy: A single-centre open-label uncontrolled trial.

Phosphodiesterase-5 inhibitors are the first-line therapy for erectile dysfunction (ED) after radical prostatectomy (RP). This single-centre open-label uncontrolled study evaluated the efficacy and safety of the new sildenafil orodispersible film (ODF) in ED treatment after RP. Sildenafil 100 mg ODF was administered twice a week for 3 months to patients under 75 years of age, with a Framingham cardiovascular risk score < 20% and a pre-operative International Index of Erectile Function (IIEF)-5 score ≥ 17, who had undergone open RP between 2016 and 2018. Erectile function was assessed pre-operatively, post-operatively and after treatment through the IIEF-5 score, the Sexual Encounter Profile Question (SEP-Q) 2 and SEP-Q3; adverse events (AE) were also investigated after 3 months. A total of 65 patients with a median (25th-75th percentile) post-operative IIEF-5 score of 8 (7-9) were treated. Nine (13.8%) patients reported AE of mild/moderate grade and discontinued treatment. A significant IIEF-5 score median (25th-75th percentile) increase of 10 (0-12) was found after treatment in the other 56 patients (p < .001). Sildenafil 100 mg ODF was effective in ED after RP in terms of improved IIEF-5 score and improved SEP-Q2 and SEP-Q3 in 67.9% of patients. It could represent a valid alternative for those patients with low compliance to tablet intake.

Acute and late toxicity and preliminary outcomes report of moderately hypofractionated helical tomotherapy for localized prostate cancer: a mono-institutional analysis.

AIMS: To assess toxicity and clinical outcomes of moderately hypofractionated helical tomotherapy (HT) for the curative treatment of localized prostate cancer (PC). METHODS: From December 2012 to May 2018, 170 patients were treated with definitive intent for PC. Thirty-four percent were low risk, 30% intermediate risk (IR) and 36% high risk (HR). All patients received 70 Gy in 28 fractions to the prostate; 61.6 Gy were delivered to the seminal vesicles for IR; pelvic lymph nodes irradiation for a total dose of 50.4 Gy was added in the HR subgroup. Toxicity was assessed using CTCAE V4.0, and biochemical failure was defined following Phoenix criteria. Time-to-event data were analyzed using the Kaplan-Meier method and log-rank test. RESULTS: The median follow-up was 36 months (range 12-78); acute toxicity was as follows: G1 and G2 in 27.6% and 19.4% for GI; 53% and 24% for GU. No G ≥ 3 event was observed. For late toxicity, G ≥ 3 GI and GU rates were, respectively, 3% and 2.4% at 3 years and 3% and 4.8% at 4 years; no G4 occurred. A statistical correlation between acute or late G3 incidence and clinical or dosimetric parameters was not found. At the time of analysis, 2- and 3-year biochemical relapse-free survival rates were 90% and 87.5% and 2- and 3-year overall survival rates were 96.4% and 90%, respectively. The log-rank test revealed no difference between the risk groups in terms of biochemical control (p = 0.16). CONCLUSIONS: Moderately hypofractionated RT with HT for localized prostate cancer reported excellent outcomes with mild acute and late toxicity incidence, with promising biochemical control rates.

Segmental resection of distal ureter with termino-terminal ureteric anastomosis vs bladder cuff removal and ureteric re-implantation for upper tract urothelial carcinoma: results of a multicentre study.

OBJECTIVES: To compare overall (OS), cancer-specific (CSS), recurrence-free survival (RFS) and postoperative renal function amongst patients with upper tract urothelial carcinoma (UTUC) of the distal (lower lumbar and pelvic) ureter, electively treated with segmental resection and termino-terminal anastomosis (TT) vs bladder cuff removal and ureteric re-implantation (RR). PATIENTS AND METHODS: A multicentre retrospective study, including 84 patients diagnosed with UTUC of the distal ureter and treated with TT or RR, is presented. The primary endpoint was to compare TT and RR in terms of OS, CSS and RFS. As a secondary outcome, we compared the postoperative creatinine values as an index of renal function in the two groups. RESULTS: Of 521 patients with UTUC, 65 (77.4%) and 19 (22.6%) patients underwent RR and TT, respectively. Pre- and postoperative characteristics were not statistically different between the two groups. The median follow-up period was 22.7 months. Patients treated with TT and those treated with RR did not have significantly different 5-year OS, CSS or RFS (73.7% vs 92.3%, P = 0.052; 94.7% vs 95.4%, P = 0.970: and 63.2% vs 53.9%, P = 0.489, respectively). No difference in postoperative creatinine variation emerged in association with the surgical technique (P = 0.411). CONCLUSION: Patients treated with TT or RR for UTUC showed comparable OS, CSS, RFS and postoperative renal function. Our data suggest that bladder cuff removal is not imperative in the treatment of distal ureteric UTUC, and TT can be a safe solution in selected cases.

An increased body mass index is associated with a worse prognosis in patients administered BCG immunotherapy for T1 bladder cancer.

PURPOSE: The body mass index (BMI) may be associated with an increased incidence and aggressiveness of urological cancers. In this study, we aimed to evaluate the impact of the BMI on survival in patients with T1G3 non-muscle-invasive bladder cancer (NMIBC). METHODS: A total of 1155 T1G3 NMIBC patients from 13 academic institutions were retrospectively reviewed and patients administered adjuvant intravesical Bacillus Calmette-Guérin (BCG) immunotherapy with maintenance were included. Multivariable Cox regression analysis was performed to identify factors predictive of recurrence and progression. RESULTS: After re-TURBT, 288 patients (27.53%) showed residual high-grade NMIBC, while 867 (82.89%) were negative. During follow-up, 678 (64.82%) suffered recurrence, and 303 (30%) progression, 150 (14.34%) died of all causes, and 77 (7.36%) died of bladder cancer. At multivariate analysis, tumor size (hazard ratio [HR]:1.3; p = 0.001), and multifocality (HR:1.24; p = 0.004) were significantly associated with recurrence (c-index for the model:55.98). Overweight (HR: 4; p < 0.001) and obesity (HR:5.33 p < 0.001) were significantly associated with an increased risk of recurrence. Addition of the BMI to a model that included standard clinicopathological factors increased the C-index by 9.9. For progression, we found that tumor size (HR:1.63; p < 0.001), multifocality (HR:1.31; p = 0.01) and concomitant CIS (HR: 2.07; p < 0.001) were significant prognostic factors at multivariate analysis (C-index 63.8). Overweight (HR: 2.52; p < 0.001) and obesity (HR: 2.521 p < 0.001) were significantly associated with an increased risk of progression. Addition of the BMI to a model that included standard clinicopathological factors increased the C-index by 1.9. CONCLUSIONS: The BMI could have a relevant role in the clinical management of T1G3 NMIBC, if associated with bladder cancer recurrence and progression. In particular, this anthropometric factor should be taken into account at initial diagnosis and in therapeutic strategy decision making.

High-Grade T1 on Re-Transurethral Resection after Initial High-Grade T1 Confers Worse Oncological Outcomes: Results of a Multi-Institutional Study.

INTRODUCTION: The aim of this multicenter study was to investigate the prognostic impact of residual T1 high-grade (HG)/G3 tumors at re-transurethral resection (TUR of bladder tumor) in a large multi-institutional cohort of patients with primary T1 HG/G3 bladder cancer (BC). PATIENTS AND METHODS: The study period was from January 2002 to -December 2012. A total of 1,046 patients with primary T1 HG/G3 and who had non-muscle invasive BC (NMIBC) on re-TUR followed by adjuvant intravesical Bacillus Calmette-Guerin (BCG) therapy with maintenance were included. Endpoints were time to disease recurrence, progression, and overall and cancer-specific death. RESULTS: A total of 257 (24.6%) patients had residual T1 HG/G3 tumors. The presence of concomitant carcinoma in situ, multiple and large tumors (> 3 cm) at first TUR were associated with residual T1 HG/G3. Five-year recurrence-free survival (RFS), progression-free survival (PFS), overall survival (OS), and cancer-specific survival (CSS) were 17% (CI 11.8-23); 58.2% (CI 50.7-65); 73.7% (CI 66.3-79.7); and 84.5% (CI 77.8-89.3), respectively, in patients with residual T1 HG/G3, compared to 36.7% (CI 32.8-40.6); 71.4% (CI 67.3-75.2); 89.8% (CI 86.6-92.3); and 95.7% (CI 93.4-97.3), respectively, in patients with NMIBC other than T1 HG/G3 or T0 tumors. Residual T1 HG/G3 was independently associated with RFS, PFS, OS, and CSS in multivariable analyses. CONCLUSIONS: Residual T1 HG/G3 tumor at re-TUR confers worse prognosis in patients with primary T1 HG/G3 treated with maintenance BCG. Patients with residual T1 HG/G3 for primary T1 HG/G3 are very likely to fail BCG therapy alone.

Cabazitaxel in Metastatic Castration-Resistant Prostate Cancer Patients Progressing after Docetaxel: A Prospective Single-Center Study.

PURPOSE: The present study aims to evaluate the efficacy of cabazitaxel in combination with prednisone treatment in Italian patients affected by hormone-refractory metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel plus prednisone. METHODS: Thirty patients with mCRPC were enrolled between June 2013 and January 2016 (the last follow-up was in January 2016). Cabazitaxel was used according to the summary of product characteristics and administered at a dose of 25 mg/m2 every 3 weeks plus oral prednisone at a dose of 5-mg tablets twice a day continuously. The reduction in serum prostate-specific antigen (PSA) was the primary endpoint while reducing pain, safety, progression-free survival, response rate and overall survival (OS) were secondary endpoints. RESULTS: Cabazitaxel was well tolerated, showing a manageable toxicity profile, associated with a modest objective response rate and a good reduction in PSA levels. Only 12 patients (40%) had a partial response, 10 patients (33%) showed stabilization of disease and 8 (27%) experienced disease progression. The median OS was 14.8 months (95% CI: 11.6-19.8). The linear regression analysis revealed that PSA response was an important predictor of OS, showing a positive correlation with OS (ß = 0.377, p < 0.01). CONCLUSIONS: Three-week treatment with cabazitaxel was found to be valid and was a well-tolerated treatment option for patients with mCRPC after a first-line docetaxel treatment.

The impact of re-transurethral resection on clinical outcomes in a large multicentre cohort of patients with T1 high-grade/Grade 3 bladder cancer treated with bacille Calmette-Guérin.

OBJECTIVES: To determine if a re-transurethral resection (TUR), in the presence or absence of muscle at the first TUR in patients with T1-high grade (HG)/Grade 3 (G3) bladder cancer, makes a difference in recurrence, progression, cancer specific (CSS) and overall survival (OS). PATIENTS AND METHODS: In a large retrospective multicentre cohort of 2451 patients with T1-HG/G3 initially treated with bacille Calmette-Guérin, 935 (38%) had a re-TUR. According to the presence or absence of muscle in the specimen of the primary TUR, patients were divided in four groups: group 1 (no muscle, no re-TUR), group 2 (no muscle, re-TUR), group 3 (muscle, no re-TUR) and group 4 (muscle, re-TUR). Clinical outcomes were compared across the four groups. RESULTS: Re-TUR had a positive impact on recurrence, progression, CSS and OS only if muscle was not present in the primary TUR specimen. Adjusting for the most important prognostic factors, re-TUR in the absence of muscle had a borderline significant effect on time to recurrence [hazard ratio (HR) 0.67, P = 0.08], progression (HR 0.46, P = 0.06), CSS (HR 0.31, P = 0.07) and OS (HR 0.48, P = 0.05). Re-TUR in the presence of muscle in the primary TUR specimen did not improve the outcome for any of the endpoints. CONCLUSIONS: Our retrospective analysis suggests that re-TUR may not be necessary in patients with T1-HG/G3, if muscle is present in the specimen of the primary TUR.

Does the Compliance to Intravesical BCG Differ between Common Clinical Practice and International Multicentric Trials?

INTRODUCTION: The aim of this study was to analyze the reasons for intravesical BCG interruption in clinical practice. BCG for at least one year is advocated as the best regimen to treat high-risk non-muscle invasive bladder cancer (NMIBC). However, almost 50% of patients don't complete it. Toxicity accounts for 10% of dropouts in international trials. MATERIALS AND METHODS: Patients with T1HG NMIBC undergoing 1-year BCG were enrolled in this study. BCG was administered for one year. Toxicity and causes of treatment interruption were recorded. RESULTS: A total of 411 patients were enrolled in the study. Out of these total number of patients, 380 (92.5%) completed the induction cycle and 215 (52.3%) completed one year. Toxicity requiring interruption or postponement was recorded in 25 (6.1%) and 60 (14.6%) patients. Ninety-three patients (30.2%) stopped BCG, 9 (9.7%) for recurrence and 14 (15.1%) for grade-3 toxicity. Intriguingly, 55 (59.1%) patients refused BCG due to mild discomfort and deterioration in quality of social life. CONCLUSIONS: Grades 2-3 toxicity causes BCG interruption in a few cases. Almost 60% of interruptions are attributable to persistent grade-1 toxicity, which is inadequately treated.

BCG and bladder cancer. Forty-eight years after Morales report.

Although BCG use as an anticancer drug was nearly abandoned due to the poor results in most tumors, in 1976 Morales reported a relevant reduction in recurrence with intravesical BCG in few patients affected by NMIBC. Since then BCG was globally accepted as an empirical and effective therapy in treating Tis and preventing recurrence of intermediate and high risk NMIBC. Forty-eight years after Morales' report, although some open questions remain object of debate, we have been able to find answers to many doubts improving BCG activity and toxicity. We better select patients undergoing BCG and many trials have indicated the best dosage and schedule. Moreover, we are able to better identify the patient unresponsive to BCG who might benefit of a timely radical cystectomy. We are also aware of the difficulties and toxicities that can be encountered with BCG use in every-day clinical practice. Research is ongoing to obtain genetically modified BCG to increase its efficacy and reduce toxicity. Moreover, the combination of BCG with other immunotherapeutic drugs given intravesically or systemically, first immune checkpoint inhibitors, is under study to obtain a response in patients unresponsive or intolerant to BCG. Almost 50 years after Morales publication, intravesical BCG remains an inalienable tool against NMIBC.

Can COVID-19 pandemic surveillance reduce nosocomial urinary infections in urologic surgery?

INTRODUCTION: Since COVID-19 pandemic spread, strict preventive measures were adopted to reduce the risk of transmission. Antiseptic dispensers for hand hygiene were diffusely available for patients and hospital staff. To investigate the prophylactic role played by the strict antiseptic rules adopted during pandemic, the rates of nosocomial urinary infections in 2019 and 2020 were compared. MATERIALS AND METHODS: Patients' clinical pre-operative characteristics, symptoms, fever, and laboratory data were recorded pre- and post-operatively. Urological surgery was classified in five categories: 1. major surgery 2. upper urinary tract endoscopy, 3. lower urinary tract endoscopy, 4. minor surgery, and 5. Nephrostomy and ureteral stenting. Clavien-Dindo complication score was used. Statistical analysis was performed with R 3.4.2 software. RESULTS: Out of 495 patients, 383 (57.1%) underwent surgical intervention in pre-pandemic March-May 2019 period and 212 (42.9%) in the same pandemic 2020 interval. Preoperatively, 40 (14.1%) and 11 (5.2%) and 77 (27.3%) and 37 (17.5%) patients had fever (p < 0.003) and leukocytosis (p < 0.02), in 2019 and 2020 respectively. Urine culture was positive in 29 (10.2%) and 13 (6.2%) patients respectively (p = 0.22). Post-operatively, 54 (19.1%) and 22 (10.4%) patients and 17 (6.1%) and 2 (0.6%) patients showed fever (p < 0.003) and positive urineculture (p < 0.03), in 2019 and 2020 respectively. DISCUSSION AND CONCLUSION: Preoperative and post-operative clinical and laboratory signs of nosocomial urinary infection showed a statistically significant lower incidence during the pandemic period in 2020. This observation could be ascribed to the strong preventive measures, to the medical staff high adherence to hygiene and the diffuse availability of hand sanitizers.

A Prospective Observational Study on the Structuring Process and Implementation of a Large Regional, Inter-hospital, Virtual Multidisciplinary Tumor Board on Prostate Cancer.

BACKGROUND/AIM: At present, multidisciplinary tumor boards (MDTB) are considered best practice in oncology. However, web-based virtualization of MDTB may increase participation in meetings, the number of cases discussed, and adherence to guidelines, deliver better treatment, and eventually improve outcomes for patients with prostate cancer. PATIENTS AND METHODS: This is an observational study focused on exploring the structuring process and implementing a multi-institutional virtual MDTB in Sicily, Italy. Other endpoints included the analysis of cooperation between participants, adherence to guidelines, patient outcomes, and patient satisfaction. RESULTS: Overall, 126 patients were referred to the virtual MDTB for a total of 302 cases discussed in an 18-month period. Nearly 45% of cases were referred from general hospitals or tertiary centers, 38% from comprehensive cancer centers, and only 17% from academic ones. Most health professional participants (95%) reported eliminating geographical barriers and consequently reducing costs and saving time as key advantages of virtual meetings over face-to-face ones. Using a specifically designed platform for virtual MDTBs was another excellent point, especially to geolocate clinical trials and time-lapse data storage. The majority of referred patients had stage T 3-4 prostate cancer (79%). Overall, 71% of proposals discussed were approved unchanged, while 19% changed after the virtual MDTB discussion. Debated points were mostly radiologic, surgical, medical, or radiation treatment-related issues. In particular, the prescriptive appropriateness of positron emission tomography with 68Ga-prostatic specific membrane antigen, newer drugs, radiation versus surgical approach, stage T3-4 cases, and adjuvant therapy represented the most debated issues. The proposed diagnostic and/or therapeutic options were controlled for adherence to the guidelines and/or updated scientific evidence. Overall, 98% of approved proposals and changes were in line with the guidelines. Overall, most participants felt virtual MDTB was very useful and case discussions led to a major change of strategy in 19% of cases. CONCLUSION: Virtual MDTBs are a very useful way to achieve best management of prostate cancer while saving time and fostering cooperation.

Post-operative hypofractionated radiotherapy for prostate cancer: a mono-institutional analysis of toxicity and clinical outcomes.

BACKGROUND: As the use of hypofractionation has spread in the setting of curative prostate radiotherapy, few data are available in the post-operative scenario. This study reports a mono-institutional experience of moderate post-operative hypofractionated radiotherapy for prostate cancer. METHODS: In February 2021, we retrospectively assessed the outcomes of 129 patients who received between April 2013 and May 2020 hypofractionated post-operative radiotherapy using Helical Tomotherapy. Toxicity was assessed using CTCAE criteria v4.0. Survival endpoints were calculated with Kaplan-Meier method. RESULTS: Median age and follow-up were, respectively, 67 years and 43 months. Adjuvant and salvage treatment were delivered to 63.5% and 36.4% of patients to a median total dose of 63.8 Gy (61.6-65.25 Gy) in 29 fractions (2.12-2.25 Gy/fraction). Pelvic lymph-nodes irradiation was performed in 67.4% of cases. ADT was added in 50%. Acute toxicity was: G1 and G2 GU events in 36% and 9.3% of cases; G1 and G2 GI events in 29.4% and 13.9%. Late GU toxicity occurred in 12.4% of cases: 3.1% G1, 7.7% G2 and 1.5% G3 events; GI toxicity consisted of 1.5% G1 and 7.7% G2 events. Biochemical relapse occurred in 26.3% of cases, recording no significant differences between adjuvant and salvage (p = 0.67), with 4- and 5-years bRFS rates of 78.7% and 75.6%. Two patients died of progressive disease and eight for non-oncological causes resulting in 3-years overall survival and cancer-specific survival rates of 98% and 98.4%. CONCLUSIONS: Our experience supports the use of moderate hypofractionation for prostate bed radiotherapy, with minimal toxicity and promising results in terms of clinical outcomes.

A prospective observational study on oral administration of Ellagic Acid and Annona Muricata in patients affected by non-muscle invasive bladder cancer not undergoing maintenance after 6-week intravesical prophylaxis.

INTRODUCTION: BCG and MMC shortage and Covid-19 pandemic, more recently, limit accessibility to maintenance regimen in intravesical prophylaxis against recurrence of non-muscle invasive bladder cancer (NMIBC). Ellagic acid (EA) and Annona muricata (AM) exert antitumor activity against different human tumours. An observational prospective study on the prophylactic effect of oral administration of EA+AM in patients avoiding maintenance regimen is presented. MATERIALS AND METHODS: Patients affected by NMIBC and not undergoing maintenance after a 6-week course of intravesical prophylaxis with MMC or BCG were entered. Tis and very high-risk tumours were excluded. After informed consent, the patients were subdivided in relation to the oral assumption or not of EA (100 mg) plus AM (100 mg), daily for 6 months. All patients were submitted to 3-month cytology and cystoscopy. RESULTS: 162 (90%) of 180 entered patients are evaluable, 90 and 72 receiving or not EA+AM. No difference emerged in patients' characteristics between the two groups. BCG was given in 86 (54%) and chemotherapy in 74 (46%) patients. The recurrence free rate at 3, 6 and 12 months in patients assuming or not EA was 96.5% versus 84.6% (p = 0.003), 85.4% versus 64.8% (p = 0.005) and 74.2% versus 60.6% (p = 0.246), respectively. The recurrence free survival at 12 months in patients assuming or not EA was 63.0% versus 34.5% (p < 0.0001). DISCUSSION AND CONCLUSIONS: Our study suffers several limits: not randomized trial although prospective, limited number of patients and short follow-up, nevertheless it shows the prophylactic effect of oral EA+AM in absence of maintenance after intravesical chemotherapy or immunotherapy induction.

Are referral centers for non-muscle-invasive bladder cancer compliant to EAU guidelines? A report from the vesical antiblastic therapy Italian study.

INTRODUCTION: Adherence to international guidelines is viewed as a prerequisite for optimal medical care delivery. Previously reported surveys for non-muscle-invasive bladder cancer (NMIBC) employed mailed questionnaires to urologists or patients resulting in conflicting degrees of agreement with existing guidelines. In the current study, contemporary information on the management of NMIBC was generated from a sample of italian centers. PATIENTS AND METHODS: Eight Italian referral centers for the treatment of NMIBC were asked to collect information relative to all consecutive patients with a histology-proven NMIBC undergoing a transurethral resection from January 1 to March 31, 2009. The primary study objective was to verify the level of adherence of disease management with European guidelines. RESULTS: 344 patients resulted in being evaluable. 49.2% of high-risk patients underwent a repeat transurethral resection. Bacillus Calmette-Guérin was employed in 35% of cases, while chemotherapy was in 22%. An early single regimen was adopted in 136 patients and only in 1 out of 3 low-risk patients. High-risk NMIBC received bacillus Calmette-Guérin and chemotherapy as first-line therapy in 66 and 12.5% respectively. After 3 months, cystoscopy had been reported for 82.5% of patients with a recurrence rate of 13%. CONCLUSION: Adherence of Italian Institutions to EAU guidelines was optimal when reporting baseline variables. Significant degrees of discrepancy emerged in treatment choices.

Virtual Clinical and Precision Medicine Tumor Boards-Cloud-Based Platform-Mediated Implementation of Multidisciplinary Reviews Among Oncology Centers in the COVID-19 Era: Protocol for an Observational Study.

BACKGROUND: Multidisciplinary tumor boards play a pivotal role in the patient-centered clinical management and in the decision-making process to provide best evidence-based, diagnostic, and therapeutic care to patients with cancer. Among the barriers to achieve an efficient multidisciplinary tumor board, lack of time and geographical distance play a major role. Therefore, the elaboration of an efficient virtual multidisciplinary tumor board (VMTB) is a key point to successfully obtain an oncology team and implement a network among health professionals and institutions. This need is stronger than ever during the COVID-19 pandemic. OBJECTIVE: This paper presents a research protocol for an observational study focused on exploring the structuring process and the implementation of a multi-institutional VMTB in Sicily, Italy. Other endpoints include analysis of cooperation between participants, adherence to guidelines, patients' outcomes, and patient satisfaction. METHODS: This protocol encompasses a pragmatic, observational, multicenter, noninterventional, prospective trial. The study's programmed duration is 5 years, with a half-yearly analysis of the primary and secondary objectives' measurements. Oncology care health professionals from various oncology subspecialties at oncology departments in multiple hospitals (academic and general hospitals as well as tertiary centers and community hospitals) are involved in a nonhierarchic manner. VMTB employs an innovative, virtual, cloud-based platform to share anonymized medical data that are discussed via a videoconferencing system both satisfying security criteria and compliance with the Health Insurance Portability and Accountability Act. RESULTS: The protocol is part of a larger research project on communication and multidisciplinary collaboration in oncology units and departments spread in the Sicily region. The results of this study will particularly focus on the organization of VMTBs, involving oncology units present in different hospitals spread in the area, and creating a network to allow best patient care pathways and a hub-and-spoke relationship. The present results will also include data concerning organization skills and pitfalls, barriers, efficiency, number, and types with respect to clinical cases and customer satisfaction. CONCLUSIONS: VMTB represents a unique opportunity to optimize patient management through a patient-centered approach. An efficient virtualization and data-banking system is potentially time-saving, a source for outcome data, and a detector of possible holes in the hull of clinical pathways. The observations and results from this VMTB study may hopefully be useful to design nonclinical and organizational interventions that enhance multidisciplinary decision-making in oncology. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26220.

Sexual dysfunction in dialytic patients. A prospective cross-sectional observational study in two hemodialysis centers.

OBJECTIVES: Incidence and prevalence of patients in dialytic therapy increased considerably in recent years. The onset of new issues, once overshadowed, linked to a lower quality of life like sexual dysfunction became increasingly common. The first study in this area, dating back to the 1970s, shows the high prevalence of sexual dysfunction among patients in dialytic therapy of both sexes. Later studies proved an association of sexual dysfunction with psyche disorders, anxiety, depression and lack of self-confidence. The aim of this study is to describe the incidence of male and female sexual main dysfunctions, the latter not least in literature, in patients in hemodialytic therapy. With this aim two dialytic centers have been compared, one located in northern Italy and one in southern Italy, and the different prevalence has been compared to the general population. METHODS: We conducted a prospective cross-sectional observational study in patients undergoing dialytic therapy in two hemodialysis centers, one located in Palermo and one in Lecco. Male sexual dysfunction was investigated by the International Index of Erectile Function-15 (IIEF15) questionnaire and the Premature Ejaculation Diagnotic Tool (PEDT) questionnaire, and the female dysfunction by Female Sexual Function Index (FSFI) questionnaire. Criteria for inclusion in our study were: age < 75 years and dialytic age > 3 months; exclusion criteria were: advanced cancer diseases, life expectancy < 6 months, previous urological manipulation, anti-androgenic therapy, sexual dysfunction unrelated to kidney disease, psychiatric disorders. Data were compared with mean-standard deviation (SD) and with the variance analysis (ANOVA). A value of p < 0.05 is considered significant. Discrete data were analyzed with contingency analysis. A chi2 < 0.05 was considered significant. RESULTS: Data of 78 patients have been collected. Mean age and dialytic time were 54 ± 12 years and 42 ± 35 month; 33 patients were from Palermo and 24 from Lecco; 21 patients were excluded. Age and dialytic age of the two subgroups did not demonstrate statistically significant differences. Between the two centers there was a statistically significant difference (p < 0.005) in the distribution of basic nephropathy: an higher incidence of diabetic and obstructive nephropathy has been observed in the southern center compared to northern center, while glomerulonephritis and polycystic kidney disease had an higher incidence in the northern center compared to southern one. The main sexual dysfunctions in both sexes, erectile dysfunction (ED) and premature ejaculation (PE) in men and orgasm disorder and pelvic pain in women, have been investigated. ED was present in 70%  of hemodialyzed patients, which is an higher incidence compared to the general population. The severity of ED between patients of the two groups was significantly different (chi2 < 0.001) with higher incidence of moderate/severe forms in northern Italy. The score, in addition to discrete data (severe, moderate, mild, absence), of ED was significantly different (p < 0.001) between patients of the two centers (22 ± 7 Palermo vs. 9 ± 8, Lecco). The PE was absent in 20 patients (54%), present in 12 patients (32%) and probable in 5 patients (14%) (scores of 7.6 ± 4.0 and 8.9 ± 6.8, respectively in Palermo and Lecco patients). For women, orgasmic dysfunction was severe in 10 patients (50%), mild in 4 patients (20%), very mild in 5 patients (25%), while it was normal in 1 patient (5%), with a statistically significant difference (p< 0.05) between Palermo and Lecco patients (3.0 ± 1.4 vs 1.2 ± 2.0). Sexual pain in women was severe in 11 patients (55%), moderate in 4 patients (20%) and mild in 5 patients (25%). Sexual pain was present in all patients (p < 0.05). CONCLUSIONS: Regardless of sex, sexual dysfunction is one of the most common side effect in patients with end stage renal disease in dialytic therapy. Our study confirms literature data. The growing number of the dialytic population with sexual disorders needs specialist support to improve quality of life of these patients.