Office-based management of Non-Muscle Invasive Bladder Cancer (NMIBC): A position paper on current state of the art and future perspectives.

To the Editor, Bladder cancer is one of the most common cancers in humans, representing the 7th and 17th type of neoplasm in both genders. Its incidence and mortality are quite heterogeneous in different countries and are due to different risk factors, quality and prevalence of healthcare and the possibility of early diagnosis and treatment of the tumor and its potential recurrences [...].

A matched-analysis on short-term and long-term (up to 5 years of follow-up) urinary incontinence outcomes after robot-assisted radical prostatectomy with and without anterior and posterior reconstruction: data on 1358 patients.

PURPOSE: We report a comparative monocentric study with a short and long-term follow-up with the aim to assess differences about urinary continence outcomes in patients treated with Robot-Assisted Radical Prostatectomy (RARP) with two different techniques: with anterior and posterior reconstruction and without any kind of reconstruction. MATERIALS AND METHODS: From January 2016 to September 2021, at the Department of Urology of the "F. Miulli" Hospital of Acquaviva delle Fonti, in Italy, 850 eligible patients underwent extraperitoneal RARP with anterior and posterior reconstruction and 508 without reconstructions. RESULTS: In patients undergoing RARP with reconstructions 1 month after surgery the urinary continence was preserved in 287/850 patients (33.8%), 3 months after surgery in 688/850 (81%), 6 months in 721/850 (84.8%), 12 months in 734/850 (86.3%), 18 months in 671/754 (89%), 24 months in 696/754 (92.3%), 36 months in 596/662 (90%), 48 months in 394/421 (93.6%), 60 months in 207/212 (97.6%). In patients undergoing RARP without reconstruction 1 month after surgery urinary continence was preserved in 99/508 (19.4%), after 3 months in 276/508 (54.3%), 6 months in 305/508 (60%), 12 months in 329/508 (64.7%), 18 months in 300/456 (65.7%), 24 months in 295/456 (64.7%), 36 months in 268/371 (72.3%), 48 months in 181/224 (81%), 60 months in 93/103 (90.3%). CONCLUSION: In our case study, the RARP with anterior and posterior reconstruction technique is associated with a statistically significant higher rate (up to 48 months of follow-up) and a faster recovery of urinary continence compared to the technique without reconstructions.

New minimally invasive solutions for Benign Prostatic Obstruction (BPO) management: A position paper from the UrOP (Urologi Ospedalità Gestione Privata).

To the Editor, In recent years, alternative solutions have been proposed to obtain effective results comparable to TURP, which is currently considered the gold standard, and laser vapo-enucleation techniques (1, 2), but with the possibility of maintaining sexual functions. In recent years there has been a growing trend towards ejaculation preservation. Although the results of TURP (3), and most laser enucleation techniques are undoubted in the Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptoms (LUTS) management, they often lack in the preservation of ejaculation. All the alternative recently proposed interventions (Rezum, AquaBeam, Urolift, TPLA, i-TIND, LEST) are procedures considered by some authors to be promising in both managing BPO and preserving sexual functions. However, all these methods are limited by a lack of long-term follow-up that would evaluate the efficacy over time, possible complications related to the method and the correct patient selection for a specific method. The aim of this letter is to summarize the available evidence and provide clinicians with practical recommendations on the use of the brand new minimally invasive techniques for the management of BPO. [...].

Robot-Assisted Extraperitoneal Radical Prostatectomy for Giant Multilocular Prostatic Cystadenoma: A Case Report and Literature Review.

A 48-year-old man with a medical history of hypertension and no family history of prostate cancer presented with abdominal distension, lower abdominal pain, and lower urinary symptoms. Physical examination revealed a palpable mass in the lower abdomen, and a digital rectal examination detected a firm mass on the anterior side of the rectum. Laboratory tests showed an elevated PSA level (7.9 ng/mL). Imaging studies indicated a solid mass connected to the prostate's posterior and rectum's anterior walls, along with bladder compression. Transperitoneal biopsy and histological analysis led to a diagnosis of a stromal tumor with uncertain potential malignancy. Considering the absence of apparent malignancy signs and the smooth outer wall of the tumor, the patient underwent, for the first time in the literature, a robot-assisted radical extraperitoneal prostatectomy for complete macroscopic resection. The surgery involved excision of the bulky pelvic mass, preservation of the urethra, and anatomical reconstruction. The postoperative course was uneventful, and we discharged the patient with no complications. The pathological examination documented the diagnosis of multilocular prostatic cystadenoma. Post-surgery follow-up examinations, including PSA levels and imaging scans, showed no signs of tumor recurrence. At the 3-, 6-, and 9-month follow-ups, the patient was asymptomatic and had fully recovered, with no urinary or sexual dysfunction reported.

Diagnosis of prostate cancer with magnetic resonance imaging in men treated with 5-alpha-reductase inhibitors.

PURPOSE: The primary aim of this study was to evaluate if exposure to 5-alpha-reductase inhibitors (5-ARIs) modifies the effect of MRI for the diagnosis of clinically significant Prostate Cancer (csPCa) (ISUP Gleason grade ≥ 2). METHODS: This study is a multicenter cohort study including patients undergoing prostate biopsy and MRI at 24 institutions between 2013 and 2022. Multivariable analysis predicting csPCa with an interaction term between 5-ARIs and PIRADS score was performed. Sensitivity, specificity, and negative (NPV) and positive (PPV) predictive values of MRI were compared in treated and untreated patients. RESULTS: 705 patients (9%) were treated with 5-ARIs [median age 69 years, Interquartile range (IQR): 65, 73; median PSA 6.3 ng/ml, IQR 4.0, 9.0; median prostate volume 53 ml, IQR 40, 72] and 6913 were 5-ARIs naïve (age 66 years, IQR 60, 71; PSA 6.5 ng/ml, IQR 4.8, 9.0; prostate volume 50 ml, IQR 37, 65). MRI showed PIRADS 1-2, 3, 4, and 5 lesions in 141 (20%), 158 (22%), 258 (37%), and 148 (21%) patients treated with 5-ARIs, and 878 (13%), 1764 (25%), 2948 (43%), and 1323 (19%) of untreated patients (p < 0.0001). No difference was found in csPCa detection rates, but diagnosis of high-grade PCa (ISUP GG ≥ 3) was higher in treated patients (23% vs 19%, p = 0.013). We did not find any evidence of interaction between PIRADS score and 5-ARIs exposure in predicting csPCa. Sensitivity, specificity, PPV, and NPV of PIRADS ≥ 3 were 94%, 29%, 46%, and 88% in treated patients and 96%, 18%, 43%, and 88% in untreated patients, respectively. CONCLUSIONS: Exposure to 5-ARIs does not affect the association of PIRADS score with csPCa. Higher rates of high-grade PCa were detected in treated patients, but most were clearly visible on MRI as PIRADS 4 and 5 lesions. TRIAL REGISTRATION: The present study was registered at ClinicalTrials.gov number: NCT05078359.

Extreme hypofractionated stereotactic radiotherapy for elderly prostate cancer patients: side effects preliminary analysis of a phase II trial.

PURPOSE: Aim of this study is to evaluate safety and efficacy of SBRT in elderly patients affected by localized prostate cancer (PC). MATERIAL AND METHODS: Men aged 70 years or older were enrolled and analyzed. The SBRT schedule was 35 Gy in 5 fractions administered in 1-2 weeks. According to risk group, androgen deprivation therapy (ADT) was prescribed. Urinary symptoms were evaluated at baseline using the International Prostate Symptom Score (IPSS). Genitourinary (GU) and gastrointestinal (GI) toxicities were assessed at the end of treatment, 2 weeks after SBRT and during follow-up using the Common Terminology Criteria for Adverse Events (CTCAE). PSA values were recorded before treatment and during follow-up as biochemical response criteria. RESULTS: Between 07/2019 and 09/2021, 111 patients were enrolled. Median age was 77 years. At the end of treatment, no acute GU/GI toxicities ≥ G2 were observed. At 2-3 weeks after treatment, 3 patients reported G2 GU toxicity, while 14 patients referred G2 GI toxicity. During the last follow up, 26 and 2 patients reported, respectively, G1 and G2 GU toxicity, while 22 and 1 cases described, respectively, G1 and G2 GI toxicity. No late toxicities ≥ G3 were recorded. GU toxicity is related to absence of urethra sparing, increasing PTV volume, Dmax PTV and IPSS; GI toxicity is related to RT schedule (each other day is better than consecutive day), Dmax rectum and IPSS, At a median follow-up of 24 months, excellent biochemical disease control was achieved in all cases with median PSA of 0.5 ng/ml. CONCLUSION: SBRT in elderly patients affected by PC is feasible and well tolerated with excellent biochemical disease control. Longer follow-up is needed to assess late toxicity profile and long-term clinical outcome.

Features of patients referring to the outpatient office due to benign prostatic hyperplasia: analysis of a national prospective cohort of 5815 cases.

BACKGROUND: Evidence on clinical presentation of benign prostatic hyperplasia (BPH) is scarce, and studies involving outpatients are lacking. We aimed to provide an insight into the contemporary Italian scenario of BPH-affected outpatients using symptom scores (International Prostate Symptom Score [IPSS], BPH Impact Index [BII]), and to compare characteristics of patients with known BPH and those first-diagnosed at the visit. METHODS: "IMPROVING THE PATH" project working group designed a questionary prospectively administered to BPH-affected outpatients by urologists. A cross-sectional study was performed. Data were adjusted for patient age as a potential confounding factor. RESULTS: Of 5815 patients enrolled, BPH was already diagnosed in 4144 (71.3%), and not in 1671 (28.7%). Patients with known BPH, compared to newly diagnosed, were older (median 68 versus [vs] 55), had more frequent smoking (smoker 27.2 vs 22.6%, and ex-smoker 16.4 vs 12.5%) and drinking habits (55.4 vs 45.1%), were more frequently affected by hypertension (60.0 vs 42.4%), obesity (15.3 vs 9.6%), diabetes (17.9 vs 12.5%), and cardiovascular diseases (14.2 vs 9.5%), p < 0.001. At IPSS, moderate and severe symptoms correlated with already known BPH (56.1 vs 47.3% and 24.8 vs 7.8%), whereas newly diagnosed patients showed milder symptoms (44.9 vs 19.1%), all p < 0.001. At BII, concern for one's health and time lost due to urinary problems were higher in patients with known BPH (p < 0.001). For these patients, the urologist changes at least one of the ongoing medications in 63.5%. For patients newly diagnosed, supplements/phytotherapeutics, alpha-blockers, and 5-alfa reductase inhibitors were prescribed in 54.6%, 21.6%, and 7.1%, respectively. CONCLUSIONS: Despite medical treatment, natural history of BPH leads to a progressive deterioration of symptoms. This may reflect the difference between newly diagnosed patients and those with known BPH in lifestyle and associated comorbidities. A healthy lifestyle and treatments including local anti-inflammatory agents may delay worsening of symptoms and improve quality of life.

Electromotive Drug Administration of Mitomycin C (EMDA/MMC) versus Intravesical Immunotherapy with Bacillus Calmette-Guérin (BCG) in Intermediate and High Risk Non Muscle Invasive Bladder Cancer.

BACKGROUND: Although TURB of tumor (TURBT) by itself can eradicate a non-muscle-invasive bladder cancer (NMIBC) completely, these tumors commonly recur and can progress to MIBC. It is, therefore, necessary to consider adjuvant therapy in most patients. The primary objective of the present study was to report our experience with EMDA/MMC and BCG, considering efficacy, progression, and recurrence, as adjuvant therapy in NMIBC patients; the secondary objective was to assess the efficacy of EMDA/MMC versus BCG as a comparative treatment. METHODS: Between April 2016 and February 2020, a series of 216 patients, with a diagnosis of intermediate- and high-risk NMIBC after TURBT, underwent adjuvant intravesical therapy. In 26 cases with a failure of the treatment, in patients unfit and unwilling for radical cystectomy, a repeated intravesical therapy was performed (2 had a twice repetition). Out of 244 adjuvant therapies, 140 EMDA/MMC and 104 BCG treatments were done. The following data were collected for each patient: baseline demographics and clinical data and perioperative and postoperative data. Overall patients' adjuvant intravesical therapies were included in a prospectively maintained institutional database, and a retrospective chart review was performed. We collected data on 2 main outcomes, recurrence-free survival (defined as a negative cystoscopy, cytology, and/or histology at the evaluation time point) and progression-free survival (defined as a negative cystoscopy or a nonprogressive tumor recurrence). RESULTS: The NMIBC progression rate was higher in BCG than EMDA/MMC but not statistically significant (respectively, 4.2% vs. 2.5%; p = 0.703). In the overall population, the risk of NMIBC recurrence was higher after BCG than EMDA/MMC (p = 0.025). In the subgroups of 59 paired patients with similar characteristics, no difference was observed between groups in NMIBC progression and recurrence. CONCLUSIONS: Our findings suggest that EMDA/MMC and BCG are safe and reproducible approaches as adjuvant treatment in NMIBC. EMDA/MMC permits to achieve a fine oncological management as adjuvant treatment in NMIBC, which is not less than that obtained with BCG.

Modified Glasgow Prognostic Score as a Predictor of Recurrence in Patients with High Grade Non-Muscle Invasive Bladder Cancer Undergoing Intravesical Bacillus Calmette-Guerin Immunotherapy.

BACKGROUND: A systemic inflammatory marker, the modified Glasgow prognostic score (mGPS), could predict outcomes in non-muscle-invasive bladder cancer (NIMBC). We aimed to investigate the predictive power of mGPS in oncological outcomes in HG/G3 T1 NMIBC patients undergoing Bacillus Calmette-Guérin (BCG) therapy. METHODS: We retrospectively reviewed patient's medical data from multicenter institutions. A total of 1382 patients with HG/G3 T1 NMIBC have been administered adjuvant intravesical BCG therapy, every week for 3 weeks given at 3, 6, 12, 18, 24, 30 and 36 months. The analysis of mGPS for recurrence and progression was performed using multivariable and univariable Cox regression models. RESULTS: During follow-up, 659 patients (47.68%) suffered recurrence, 441 (31.91%) suffered progression, 156 (11.28%) died of all causes, and 67 (4.84%) died of bladder cancer. At multivariable analysis, neutrophil to lymphocyte ratio [hazard ratio (HR): 7.471; p = 0.0001] and erythrocyte sedimentation rate (ESR) (HR: 0.706; p = 0.006 were significantly associated with recurrence. mGPS has no statistical significance for progression (p = 0.076). Kaplan-Meier survival analysis showed a significant difference in survival among patients from different mGPS subgroups. Five-year OS was 93% (CI 95% 92-94), in patients with mGPS 0, 82.2% (CI 95% 78.9-85.5) in patients with mGPS 1 and 78.1% (CI 95% 60.4-70) in mGPS 2 patients. Five-year CSS was 98% (CI 95% 97-99) in patients with mGPS 0, 90% (CI 95% 87-94) in patients with mGPS 1, and 100% in mGPS 2 patients. Limitations are applicable to a retrospective study. CONCLUSIONS: mGPS may have the potential to predict recurrence in HG/G3 T1 NMIBC patients, but more prospective, with large cohorts, studies are needed to study the influence of systemic inflammatory markers in prediction of outcomes in NMIBC for a definitive conclusion.

Multiparametric Magnetic Resonance Imaging-Ultrasound Fusion Transperineal Prostate Biopsy: Diagnostic Accuracy from a Single Center Retrospective Study.

The management of prostate biopsy in men with clinical suspicion of prostate cancer has changed in the last few years, especially with the introduction of imaging techniques, to overcome the low efficacy of risk stratification based on PSA levels. Here, we aimed to compare the diagnostic accuracy of multiparametric MRI with fusion ultrasound-guided prostate biopsy and standard biopsy, both performed through the transperineal route. To this end, we retrospectively analyzed 272 patients who underwent combined transperineal targeted and standard biopsy during the same session. The primary outcome was to compare the cancer detection rate between targeted and standard biopsy. The secondary outcome was to evaluate the added value of combined targeted and standard biopsy approach as compared to only targeted or standard biopsy. Results showed that a rate of 16.7% clinically significant tumors (International Society of Urological Pathology (ISUP) grade ≥ 2) would have been lost if only the standard biopsy had been used. The combined targeted and standard biopsy showed an added value of 10.3% and 9.9% in reducing the risk of prostate cancer missing after targeted or standard biopsy alone, respectively. The combined targeted and standard biopsy pathway is recommended to reduce the risk of missing clinically significant prostate cancer.

Nephron sparing surgery for the treatment of renal masses: A single center experience.

BACKGROUND: Nowadays, the partial nephrectomy (PN) not only is considered oncological equivalent to radical nephrectomy as renal tumor's treatment, but has also give benefits in quality of life and overall survival of patients. OBJECTIVES: The primary objective of the present study was to report our single center experience with NSS, predominantly performed by a robot assisted access, in a high-volume center with large experience with minimally invasive surgery. METHODS: Between June 2018 and January 2020, a consecutive series of 109 patients (pts) with a renal mass suspicious of renal cell carcinoma, feasible of NSS, detected by ultrasound and abdominal computed tomography (CT), underwent NSS and they were included in a prospectively maintained institutional database. Baseline demographics and clinical characteristics, perioperative and postoperative parameters, pathological data were recorded. RESULTS: The mean clinical maximum CT tumor diameter was 37.3 ± 19.6 mm (median 31.5 mm; interquartile range 25-45 mm). PADUA risk was low in 54 pts (49.5%), intermediate in 48 pts (44.0%), high in seven pts (6.4%). The clinical T stage was mostly pT1a (70.6%). NSS was performed by open surgery in nine pts (8.3%), laparoscopy in one pts (0.9%) and was robot assisted in 99 pts (90.8%). A simple enucleation was performed in 67 pts (61.5%), an enucleoresection was performed in 37 pts (33.9%) and a partial nephrectomy was performed in five pts (4.6%). Warm ischemia was performed in 41 pts (37.6%), with a mean warm ischemia time of 5.1 ± 7.1 min. The mean pathological maximum tumor diameter was 35.5 ± 21.7 mm (median 30 mm; interquartile range 22-40 mm). Overall PSM rate was 11.9% (13 pts). In 78% of cases no complication was recorded. No major complications (grade III-IV-V) were noted. CONCLUSION: Our findings suggest that NSS is a safe, reproducible and minimally invasive approach as treatment of small renal masses. NSS permits to achieve a fine oncological management without any worsening of renal function.

Athermal versus ultrasonic nerve-sparing laparoscopic radical prostatectomy: a comparison of functional and oncological outcomes.

PURPOSE: Many urologists emphasize the concept of heat-related damage suggesting the avoidance of any energy to perform nerve-sparing radical prostatectomy. At our institution, both athermal and ultrasonic dissection have been used over the last years to perform a nerve-sparing laparoscopic radical prostatectomy (NSLRP). In this study, we compare functional and oncological outcomes of the two procedures. METHODS: All charts from patients undergoing NSLRP between January 2009 and June 2015 were reviewed. The International Index of Erectile Function (IIEF-5) was recorded preoperatively and 3, 12 and 24 months after surgery; continence was recorded at 3 and 12 months; PSA was recorded at last follow-up. Uni- and multivariate analyses were performed to assess the association of variables with functional and oncological outcomes. RESULTS: Ultrasonic NSLRP was used for 120 patients, while athermal NSLRP on 111. The impact of the cutting technique on erection recovery was different at 3 months, favoring athermal dissection (p = 0.002); however, significance was lost at 12 (p = 0.09) and 24 (p = 0.14) months. Continence recovery was comparable at 3 (p = 0.1) and 12 (p = 0.2) months; the rate of positive surgical margins and PSA recurrence were also similar (p = 0.2 and p = 0.06, respectively). At univariate analysis, age, Gleason sum, nerve-sparing laterality, and extension (intra- vs interfascial) were associated with overall erection recovery; only age and nerve-sparing laterality were independent predictors. Age and preoperative TRUS prostate volume were associated with continence recovery, both at uni- and multivariate analysis. CONCLUSIONS: The use of an ultrasonic device compared to athermal dissection during NSLRP does not affect long-term potency, nor continence and early biochemical recurrence.

Enzalutamide in patients with castration-resistant prostate cancer: retrospective, multicenter, real life study.

BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) is the final stage of pCa history and represents a clinically relevant phenotype with an elevated burden of mortality. The aim of the present study was to evaluate the efficacy and safety of enzalutamide in a "real-life" setting in mCRPC patients. METHODS: Data about all mCRPC patients treated with enzalutamide from September 2017 to September 2018 were collected. Demographics, comorbidities, clinical parameters, outcomes, toxicity, overall survival and progression free survival were analyzed. RESULTS: Overall, 158 patients were enrolled. Mean age was 75.8 (±8.7) years with a baseline median PSA of 16.5 (IQR 7.4-47.8) ng/mL. The median follow-up lasted 7.7 (IQR 4-14.1) months. Of all the 10.1% of patients reported grade 3-4 adverse events. 43.7% of patients experienced a progression. Overall, the 6 and 12 months PFS rates were 69.5% (95% CI: 61.7-78.3%) and the 45.6% (95% CI: 36.5-57.1%); a median baseline PSA>16 ng/mL (HR:2.0, 95% CI: 1.2-3.3, P<0.005), the use of opioid (HR: 3.1, 95% CI: 1.9-5.0, P<0.001), a previous treatment (abiraterone, docetaxel or abiraterone + docetaxel) were significantly associated with higher rates of cancer progression. Conversely, a brief pain questionnaire of 0-1 (HR: 0.4, 95% CI: 0.2-0.7, P<0.001), a 12 weeks 50% PSA reduction (HR: 0.4, 95% CI: 0.2-0.8, P<0.006) and a longer time to mCRPC (HR: 0.4, 95% CI: 0.3-0.7, P<0.002) were related to lower cancer progression rates. CONCLUSIONS: Our data shows an effective and safe profile of enzalutamide in a "real world" perspective in patients with mcRPC.

Precision medicine in localized bladder cancer: Personalizing therapies to improve outcomes.

In the last decades, only few improvements have been made in the comprehension of bladder cancer tumor leading to few improvements in the development of new diagnostic and therapeutic approaches.However, in the last years several step forwards in the field of precision medicine have been made. In this review we focused on some of these elements such as the available biomarkers, the role of enhanced transurethral resection of the bladder and the role of the molecular classification in defining prognosis and therapeutic approaches in bladder cancer patients. Although several progresses have been made, at the time none of the existing biomarkers appear to be able to safely avoid the need of cystoscopy during the follow up of bladder cancer patients. However, these biomarkers representan important tool to follow up patients with a less invasive methods and in the near future might be able to substitute the need of cystoscopy. Enhanced transurethral resection technique can in some cases reduce the risk of recurrence during follow up, although its impact on survival outcomes is still under debate. Transurethral resection of the bladder represents a fundamental diagnostic and therapeutic step in the management of bladder cancer and these techniques can successfully improve its outcomes. Finally, the molecular classification of the bladder cancer represents one of the most exciting novelty in this field, improving consistently the knowledge of bladder cancer. Improvements regarding prognoses and therapeutics can be achieved although data stil need validation.

En las ultimas décadas, pocas mejoras se han hecho en la comprensión del cáncer de vejiga, llevándonos a tener muy poco desarrollo de nuevas técnicas diagnósticas y terapéuticas. En cambio, en los últimos años, varios pasos adelante se han realizado en este campo de la medicina de precisión. En este resumen nos centraremos en algunos elementos importantes como los biomarcadores, el papel de la resección transuretral de vejiga y el papel de las clasificaciones moleculares, en definir el pronóstico y nuevas terapias en pacientes con cáncer de vejiga. Algún progreso se ha conseguido, pero ninguno de los biomarcadore sexistentes parece ser capaz de evitar con seguridad la cistoscopia durante el seguimiento del cáncer de vejiga.A unque estos biomarcadores representan una herramienta importante en el seguimiento de pacientes con métodos menos invasivos y en un futuro no muy lejano podrán substituir a la cistoscopia. La técnica de resección transuretral mejorada en algunos casos reduce elriesgo de recurrencia durante el seguimiento, aunque el impacto en supervivencia aún está en debate. La resección transuretral de vejiga representa un paso fundamental para el diagnóstico y tratamiento en el manejo del cáncer de vejiga y estas técnicas pueden mejorar los resultados. Finalmente, la clasificación molecular del cáncer de vejiga representa una de las novedades mas interesantes en este campo, mejorando de forma consistente los conocimientos del cáncer de vejiga. Las mejoras en relación al pronóstico y tratamiento pueden ser conseguidas aunque los datos aún requieren validación.

Precision medicine in localized bladder cancer: Personalizing therapies to improve outcomes / Medicina de precisión en cáncer de vejiga localizado: terapias personalizadas para mejorar los resultados

In the last decades, only few improvements have been made in the comprehension of bladder cancer tumor leading to few improvements in the development of new diagnostic and therapeutic approaches. However, in the last years several step forwards in the field of precision medicine have been made. In this review we focused on some of these elements such as the available biomarkers, the role of enhanced transurethral resection of the bladder and the role of the molecular classification in defining prognosis and therapeutic approaches in bladder cancer patients. Although several progresses have been made, at the time none of the existing biomarkers appear to be able to safely avoid the need of cystoscopy during the follow up of bladder cancer patients. However, these biomarkers represent an important tool to follow up patients with a less invasive methods and in the near future might be able to substitute the need of cystoscopy. Enhanced transurethral resection technique can in some cases reduce the risk of recurrence during follow up, although its impact on survival outcomes is still under debate. Transurethral resection of the bladder represents a fundamental diagnostic and therapeutic step in the management of bladder cancer and these techniques can successfully improve its outcomes. Finally, the molecular classification of the bladder cancer represents one of the most exciting novelty in this field, improving consistently the knowledge of bladder cancer. Improvements regarding prognoses and therapeutics can be achieved although data still need validation

En las últimas décadas, pocas mejoras se han hecho en la comprensión del cáncer de vejiga, llevándonos a tener muy poco desarrollo de nuevas técnicas diagnósticas y terapéuticas. En cambio, en los últimos anos, varios pasos adelante se han realizado en este campo de la medicina de precisión. En este resumen nos centraremos en algunos elementos importantes como los biomarcadores, el papel de la resección transuretral de vejiga y el papel de las clasificaciones moleculares, en definir el pronóstico y nuevas terapias en pacientes con cáncer de vejiga. Algún progreso se ha conseguido, pero ninguno de los biomarcadores existentes parece ser capaz de evitar con seguridad la cistoscopia durante el seguimiento del cáncer de vejiga. Aunque estos biomarcadores representan una herramienta importante en el seguimiento de pacientes con métodos menos invasivos y en un futuro no muy lejano podrán substituir a la cistoscopia. La técnica de resección transuretral mejorada en algunos casos reduce el riesgo de recurrencia durante el seguimiento, aunque el impacto en supervivencia aún está en debate. La resección transuretral de vejiga representa un paso fundamental para el diagnóstico y tratamiento en el manejo del cáncer de vejiga y estas técnicas pueden mejorar los resultados. Finalmente, la clasificación molecular del cáncer de vejiga representa una de las novedades más interesantes en este campo, mejorando de forma consistente los conocimientos del cáncer de vejiga. Las mejoras en relación al pronóstico y tratamiento pueden ser conseguidas aunque los datos aun requieren validación

Effectiveness of abiraterone acetate plus prednisone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer in a large prospective real-world cohort: the ABItude study.

BACKGROUND: Real-world data on chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone plus prednisone are limited, largely deriving from small retrospective studies. METHODS: ABitude is an Italian, observational, prospective, multicenter study of mCRPC patients receiving abiraterone plus prednisone in clinical practice. Chemotherapy-naïve mCRPC patients were consecutively enrolled at abiraterone start (February 2016 to June 2017) and are being followed for 3 years, with evaluation approximately every 6 months. Several clinical and patients reported outcomes were examined. RESULTS: In this second interim analysis, among 481 enrolled patients, 453 were evaluable for analyses. At baseline, the median age was 77 years and ~69% of patients had comorbidities (mainly cardiovascular diseases). Metastases were located mainly at bones and lymph nodes; 8.4% of patients had visceral metastases. During a median follow-up of 18 months, 1- and 2-year probability of radiographic progression-free survival were 73.9% and 56.2%, respectively; the corresponding rates for overall survival were 87.3% and 70.4%. In multivariable analyses, the number of bone metastases significantly affected radiographic progression-free survival and overall survival. During abiraterone plus prednisone treatment, 65% of patients had a ⩾50% prostate-specific antigen decline, and quality of life remained appreciably high. Among symptomatic patients according to the Brief Pain Inventory) (32%), scores significantly declined after 6 months of treatment. Overall, eight patients (1.7%) had serious adverse reactions to abiraterone. CONCLUSIONS: Abiraterone plus prednisone is effective and safe for chemotherapy-naïve mCRPC patients in clinical practice.

Patients with cancer in the COVID-19 era: the clinical trial issue.

Coronavirus disease 2019 (COVID-19) hospital reorganization may result in reduced ability for the hospital to fully use its armamentarium for battling cancer. Thus different therapeutic modalities have been recommended. During the pandemic, despite regulatory agencies' recommendations, several considerations and doubts remain for oncologic clinical trials. Considering patients who had been enrolled before the pandemic, and who plan to take the study medication, the situation becomes complicated. These patients should undergo monitoring visits, blood sampling, questionnaire, physical examination, and drug and radiation administration. To avoid deviations from the protocol and trial discontinuation, follow-up should be performed regularly, in concordance with safety guidelines. Here we report several considerations.

Electro-mediated drug administration of mitomycin C in preventing non-muscle-invasive bladder cancer recurrence and progression after transurethral resection of the bladder tumour in intermediate- and high-risk patients.

OBJECTIVE: To evaluate the effectiveness of electro-mediated drug administration of mitomycin C (EMDA/MMC) after transurethral resection of the bladder tumour (TURBT) in preventing non-muscle-invasive bladder cancer (NMIBC) recurrence and progression and to explore clinical and demographic factors associated with treatment response. PATIENTS AND METHODS: Between April 2016 and August 2019, 112 patients diagnosed with intermediate- or high-risk NMIBC underwent a TURBT followed by an EMDA/MMC treatment. The percentage of treatment responders and progression-free survivors at 3 and 6 months were evaluated. RESULTS: Follow-up data were available for 101 patients (90%) at 3 months and 92 (82%) at 6 months. Response rates to EMDA/MMC treatment were 85% at 3 months and 75% at 6 months, and progression-free rates were 94% and 90%, respectively. No statistically significant differences were seen between intermediate- and high-risk patients. A higher risk of tumour recurrence and progression was associated with previous Bacillus Calmette-Guérin (BCG) failure. According to the Clavien-Dindo classification, only low-grade complications were observed. CONCLUSIONS: EMDA/MMC after TURBT was associated with high response and progression-free rates at 3 and 6 months, with only low-grade adverse events. These results confirm the efficacy and safety of EMDA/MMC as a therapeutic option for both intermediate- and high-risk patients. However, patients with BCG failure responded poorly to EMDA/MMC.Abbreviations: ACCI: age-adjusted Charlson Comorbidity Index; CHT: chemohyperthermia; CIS: carcinoma in situ; EMDA: electro-mediated drug administration; EORTC: European Organisation for Research and Treatment of Cancer; IQR: interquartile range; (N)MIBC: (non-)muscle-invasive bladder cancer; MMC: mitomycin C; OR, odds ratio; TURBT: transurethral resection of the bladder tumour.

Intravesical Treatment with Electro-Mediated Administration of Mytomicin C as Prophylaxis for Intermediate and High-Risk Nonmuscle-Invasive Bladder Cancer: A Retrospective Multicenter Study.

BACKGROUND: Topical therapy of nonmuscle-invasive bladder cancer (NMIBC) is based on immunotherapy with Bacillus Calmette-Guerin and chemotherapy administered by passive instillation, but an active drug administration achieves a better concentration of the drugs in the bladder. AIM: This study aimed to investigate the effectiveness of electromotive drug administration (EMDA) of mitomycin C (EMDA/MMC) in intermediate- and high-risk NMIBC patients 6 months after the end of induction treatment. MATERIALS AND METHODS: Sixty-five patients diagnosed with histologically confirmed NMIBC, with a complete transurethral resection of all visible tumors underwent EMDA/MMC. Primary endpoint was the proportion of responders at 3 or 6 months. RESULTS: Data on follow-up were available for 62 subjects at 3 months and 45 at 6 months. EMDA was effective in intermediate- and high-risk patients: because of the small number of cases no conclusions can be drawn on the efficacy in the low-risk group. No difference in the response to treatment between intermediate- (83.3%) and high-risk (84%) patients could be seen. CONCLUSIONS: EMDA/MMC is a useful technique for an effective and safe treatment of primary and recurrent NMIBC, and a valuable therapeutic option in intermediate- and high-risk NMIBC patients.