459 results on '"Renzo, Colombo"'
Search Results
2. Office-based management of non-muscle invasive bladder cancer (NMIBC): a position paper on current state of the art and future perspectives
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Rosario Leonardi, Francesca Ambrosini, Angelo Cafarelli, Alessandro Calarco, Renzo Colombo, Domenico Tuzzolo, Ferdinando De Marco, Giovanni Ferrari, Giuseppe Ludovico, Stefano Pecoraro, Ottavio De Cobelli, Carlo Terrone, and Guglielmo Mantica
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Bladder cancer ,office fulguration ,office laser ,local bladder treatment ,NMIBC ,Diseases of the genitourinary system. Urology ,RC870-923 - Abstract
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. [...]
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- 2024
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3. New minimally invasive solutions for Benign Prostatic Obstruction (BPO) management: A position paper from the UrOP (Urologi Ospedalità Gestione Privata)
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Rosario Leonardi, Francesca Ambrosini, Rafaela Malinaric, Angelo Cafarelli, Alessandro Calarco, Renzo Colombo, Ottavio de Cobelli, Ferdinando De Marco, Giovanni Ferrari, Giuseppe Ludovico, Stefano Pecoraro, Domenico Tuzzolo, Carlo Terrone, and Guglielmo Mantica
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Prostatic hyperplasia ,Minimally invasive surgical procedures ,Lower urinary tract symptoms ,Sexual dysfunction ,Urologic surgical procedures ,Diseases of the genitourinary system. Urology ,RC870-923 - Abstract
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. [...]
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- 2023
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4. Predicting global QoL after orthotopic neobladder or ileal conduit diversion: nomogram development
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Salvatore Siracusano, Agustina Zaka, Emanuele Zaffuto, Antonio Benito Porcaro, Renzo Colombo, Renato Talamini, Federico Romantini, Francesco Montorsi, and Cristina Lonardi
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bladder cancer ,orthotopic neobladder ,ileal conduit ,nomogram ,quality of life (QoL) ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
IntroductionQuality of life (QoL) outcomes in patients undergoing radical cystectomy (RC) with orthotopic neobladder (ONB) or ileal conduit (IC) have been extensively investigated. However, a general lack of consensus on QoL’s predictive factors exists. The aim of the study was to develop a nomogram using preoperative parameters to predict global QoL outcome in patients with localized muscle-invasive bladder cancer (MIBC) undergoing RC with ONB or IC urinary diversion (UD).MethodsA cohort of 319 patients who underwent RC and ONB or IC were retrospectively enrolled. Multivariable linear regression analyses were used to predict the global QoL score of the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), according to the patient characteristics and UD. A nomogram was developed and internally validated.ResultsPatients’ data in the two study groups significantly differed with regard to comorbidity profiles (chronic cardiac failure, p < 0.001; chronic kidney disease, p < 0.01; hypertension, p < 0.03; diabetic disease, p = 0.02; chronic arthritis, p = 0.02). A multivariable model that included patient age at surgery, UD, chronic cardiac disease, and peripheral vascular disease represented the basis for the nomogram. The calibration plot of the prediction model showed a systematic overestimation of the predicted global QoL score over the observed scores, with a slight underestimation for observed global QoL scores between 57 and 72. After performing leave-one-out cross-validation, the root mean square error (RMSE) emerged as 24.0.Discussion/conclusionA novel nomogram based completely on known preoperative factors was developed for patients with MIBC undergoing RC to predict a mid-term QoL outcome.
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- 2023
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5. Multicentre International Study for the Prevention with iAluRil of Radio-induced Cystitis (MISTIC): A Randomised Controlled Study
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Juan Palou Redorta, Francesco Sanguedolce, Gemma Sancho Pardo, Martin Romancik, Gianni Vittori, Andrea Minervini, Fabrizio Di Maida, Richard Lunik, Renzo Colombo, Vincenzo Serretta, Bülent Çetinel, Vittorio Bini, Davide Corradengo, and Massimo Lazzeri
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Prostate cancer ,Radiotherapy ,Cystitis ,Hyaluronic acid ,Chondroitin sulfate ,Questionnaries ,Diseases of the genitourinary system. Urology ,RC870-923 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background: Radiation-induced cystitis is a common side effect of radiotherapy (RT) to the pelvic area. Hyaluronic acid (HA) and chondroitin sulfate (CS) are components of the urothelial mucosa and positive results have been obtained for intravesical HA/CS instillations for the treatment of urinary tract infections and bladder pain syndrome. HA/CS may also have a protective effect against RT bladder toxicity. Objective: To investigate whether HA and CS protect the urothelium during RT, alleviate lower urinary tract symptoms, and improve quality of life. Design, setting, and participants: This multicentre randomised controlled trial was conducted across seven centres in four countries. Male patients aged ≥18 yr scheduled to undergo primary intensity-modulated radiotherapy for localised prostate cancer were enrolled. Intervention: Patients were randomised to intravesical HA/CS plus an oral formulation of curcumin, quercetin, HA, and CS (group A) or no treatment (group B). Outcome measurements and statistical analysis: The primary endpoint was absolute changes from baseline to follow-up in urinary domain scores for the Expanded Prostate Cancer Index Composite (EPIC), the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), and the EuroQol Group EQ-5D-5L questionnaire. Data analysis for efficacy and safety outcomes was performed using an intention-to-treat (ITT) approach; the ITT population was defined as all randomised patients. Results and limitations: Of 57 patients screened, 49 were enrolled and randomly assigned to either active treatment (group A, n = 25) or the control (group B, n = 24). Three patients in the control group withdrew after randomisation. Changes from baseline to 12 mo were worse in the control group for subtotal scores for urinary symptoms and impact of symptoms on quality of life and for the total score (p = 0.05, p = 0.003, and p = 0.008, respectively). There was a significant time × group interaction in favour of active treatment for the incontinence symptom score (p = 0.011) and bother score (p = 0.017). The absence of a sham procedure and/or placebo is the main limitation. Conclusions: Our results suggest that intravesical HA/CS in combination with an oral formulation may reduce urinary symptoms and improve QoL at short-term (1 yr) follow-up. Patient summary: We investigated whether hyaluronic acid (HA) and chondroitin sulfate (CS) have a protective effect against the bladder toxicity of radiotherapy for prostate cancer. HA/CS used for weekly bladder irrigation for 6 wk and given orally with curcumin and quercetin for 12 wk reduced urinary incontinence symptoms and bother measured at 1-year follow-up. This may hold promise as a preventive treatment if the results are confirmed in further trials.
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- 2021
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6. Protocol of the Italian Radical Cystectomy Registry (RIC): a non-randomized, 24-month, multicenter study comparing robotic-assisted, laparoscopic, and open surgery for radical cystectomy in bladder cancer
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Angelo Porreca, Katie Palmer, Walter Artibani, Alessandro Antonelli, Lorenzo Bianchi, Eugenio Brunocilla, Aldo Massimo Bocciardi, Maurizio Brausi, Gian Maria Busetto, Marco Carini, Giuseppe Carrieri, Antonio Celia, Luca Cindolo, Giovanni Cochetti, Renzo Colombo, Ettore De Berardinis, Ottavio De Cobelli, Fabrizio Di Maida, Amelio Ercolino, Franco Gaboardi, Antonio Galfano, Andrea Gallina, Michele Gallucci, Carlo Introini, Ettore Mearini, Andrea Minervini, Francesco Montorsi, Gennaro Musi, Giovannalberto Pini, Riccardo Schiavina, Silvia Secco, Sergio Serni, Claudio Simeone, Giovanni Tasso, and Daniele D’Agostino
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Cancer ,Neoplasm ,bladder ,Urinary ,Robotic ,Surgery ,Bladder reconstruction ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Bladder cancer is the ninth most common type of cancer worldwide. In the past, radical cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence. Methods We describe a protocol for an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing radical cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with the recruitment phase between 1st January 2017-31st October 2020. Information is collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerve sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading, and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc). Discussion The current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique. Trial registration ClinicalTrials.gov , NCT04228198 . Registered 14th January 2020- Retrospectively registered.
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- 2021
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7. Quality-of-Life Outcomes in Female Patients With Ileal Conduit or Orthotopic Neobladder Urinary Diversion: 6-Month Results of a Multicenter Prospective Study
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Salvatore Siracusano, Agustina Zaka, Pierfrancesco Bassi, Paolo Gontero, Ettore Mearini, Ciro Imbimbo, Alchiede Simonato, Fabrizio Dal Moro, Gianluca Giannarini, Claudio Valotto, Francesco Montorsi, Renzo Colombo, Francesco Porpiglia, Riccardo Bartoletti, Marco Vella, Andrea Minervini, Antonio Benito Porcaro, Federico Romantini, Carlo Vicentini, Renato Talamini, Vincenzo Ficarra, and Cristina Lonardi
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bladder cancer ,female ,radical cystectomy ,HRQOL ,urinary diversion ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Radical cystectomy (RC) often affects patients’ life as this surgery is a traumatic and invasive event for the patients, with drawbacks on their daily, social, working, and sex life. Such changes in the quality of life (QoL) of patients are commonly studied through retrospective clinical evaluations and rarely with longitudinal studies. To date, studies focusing on functional outcomes, sexual function, and health-related QoL for female patients are lacking. We evaluated 37 patients using EORTC QLQ-C30 (QLQ-30) and Short-Form 36 (SF-36) questionnaires, before and after surgery, at 3 and 6 months of follow-up. The mean values for the emotional functioning in QLQ-C30 as well as the mental health in SF-36 were significantly higher in the ONB group compared to the IC group at 3 months of follow-up. These differences were not significant at 6 months of follow-up. At 6 months of follow-up, the ONB group showed a higher mean score in the physical and role functioning than the IC group. Although there was a statistically significant age difference at baseline of the two groups, none of the results are correlated with age, as demonstrated by Spearman’s analysis. The ONB seems to represent the most advantageous solution compared to the IC in terms of QOL at the 6-month follow-up.
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- 2022
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8. Hospital care in Departments defined as COVID-free: A proposal for a safe hospitalization protecting healthcare professionals and patients not affected by COVID-19
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Rosario Leonardi, Piera Bellinzoni, Luigi Broglia, Renzo Colombo, Davide De Marchi, Lorenzo Falcone, Guido Giusti, Vincenzo Grasso, Guglielmo Mantica, Giovanni Passaretti, Silvia Proietti, Antonio Russo, Giuseppe Saitta, Salvatore Smelzo, Nazareno Suardi, and Franco Gaboardi
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Covid 19 ,Pandemy ,Surgery ,Endoscopy ,Filtration ,Diseases of the genitourinary system. Urology ,RC870-923 - Abstract
The COVID-19 pandemic influenced the normal course of clinical practice leading to significant delays in the delivery of healthcare services for patients non affected by COVID-19. In the near future, it will be crucial to identify facilities capable of providing health care in compliance with the safety of healthcare professionals, administrative staff and patients. All the staff involved in the project of a COVID-free hospital should be subjected to a diagnostic swab for COVID-19 before the beginning of healthcare activity and then periodically in order to avoid the risk of contamination of patients during the process of care. The modifications of various activities involved in the process of care are described: outpatient care, reception of inpatients, inpatient ward and operating room. For outpatient care, modality of appointment procedure, characteristics of waiting room and personal protective equipment (PPE) for healthcare professionals and administrative staff are presented. Reception of inpatients shall be conditional on a negative swab for COVID-19 obtained with a drive-in procedure. The management of the operating room represents the most crucial step of the patient's care process. The surgical team should be restricted and monitored with periodic swabs; surgical procedures should be performed by experienced surgeons according to standard procedures; surgical training experimental treatments and research protocols should be suspended. Adequate personal protective equipment and measures to reduce aerosolization in the operating room (closed circuits, continuous cycle insufflators, fume extraction) should be adopted. Prevention of possible transmission of the virus during procedures in open, laparoscopic and endoscopic surgery is to use a multi-tactic approach, which includes correct filtration and ventilation of the operating room, the use of appropriate PPE (FFP3 plus surgical mask and protective visor for all the staff working in the operating room) and smoke evacuation devices with a suction and filter system. *for the UrOP Executive Committee Giuseppe Ludovico, Angelo Cafarelli, Ottavio De Cobelli, Ferdinando De Marco, Giovanni Ferrari, Stefano Pecoraro, Angelo Porreca, Domenico Tuzzolo
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- 2020
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9. Neoadjuvant Pembrolizumab and Radical Cystectomy in Patients with Muscle-Invasive Urothelial Bladder Cancer: 3-Year Median Follow-Up Update of PURE-01 Trial
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Giuseppe Basile, Marco Bandini, Ewan A. Gibb, Jeffrey S. Ross, Daniele Raggi, Laura Marandino, Tiago Costa de Padua, Emanuele Crupi, Renzo Colombo, Maurizio Colecchia, Roberta Lucianò, Luigi Nocera, Marco Moschini, Alberto Briganti, Francesco Montorsi, and Andrea Necchi
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Carcinoma, Transitional Cell ,Cancer Research ,Urinary Bladder Neoplasms ,Oncology ,Muscles ,Urinary Bladder ,Humans ,Cystectomy ,B7-H1 Antigen ,Neoadjuvant Therapy ,Follow-Up Studies - Abstract
Purpose: The PURE-01 study (NCT02736266) pioneered the neoadjuvant immune-checkpoint inhibitor (ICI) therapy before radical cystectomy (RC) in patients with muscle-invasive urothelial bladder carcinoma (MIBC). We herein present the survival outcomes after a median follow-up of three years. Patients and Methods: The intention-to-treat (ITT) population included 155 patients. Event-free survival (EFS) was defined as the time from pembrolizumab initiation until radiographic disease progression precluding RC, initiation of neoadjuvant chemotherapy, recurrence after RC, or death. Further outcomes were recurrence-free survival (RFS) post-RC and overall survival (OS). Multivariable Cox regression analyses for EFS were performed. Kaplan–Meier analyses compared EFS outcomes according with baseline programmed cell-death-ligand-1 (PD-L1) combined positive score (CPS) and according to the molecular subtypes. Results: After a median (interquartile range, IQR) follow-up of 39 (30–47) months, 36-month EFS and OS were 74.4% [95% confidence interval (CI), 67.8–81.7] and 83.8% (95% CI, 77.8–90.2) in the ITT population, respectively. Overall, 143 (92.3%) patients underwent RC. Within the cohort of patients who did not receive additional chemotherapy (N = 125), 36-month RFS was 96.3% (95% CI, 91.6–100) for patients achieving a ypT0N0, 96.1% (95% CI, 89–100) for ypT1/a/isN0, 74.9% (95% CI, 60.2–93) for ypT2–4N0, and 58.3% (95% CI, 36.2–94.1) for ypTanyN1–3 response. EFS was significantly stratified among PD-L1 tertiles (lower tertile: 59.7% vs. medium tertile: 76.7% vs. higher tertile: 89.8%, P = 0.0013). The claudin-low and basal/squamous subtypes displayed the lowest rates of events. Conclusions: At a median follow-up of three years, PURE-01 results further confirm the sustained efficacy of neoadjuvant pembrolizumab before RC. PD-L1 expression was the strongest predictor of sustained response post-RC.
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- 2022
10. Data from Neoadjuvant Pembrolizumab and Radical Cystectomy in Patients with Muscle-Invasive Urothelial Bladder Cancer: 3-Year Median Follow-Up Update of PURE-01 Trial
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Andrea Necchi, Francesco Montorsi, Alberto Briganti, Marco Moschini, Luigi Nocera, Roberta Lucianò, Maurizio Colecchia, Renzo Colombo, Emanuele Crupi, Tiago Costa de Padua, Laura Marandino, Daniele Raggi, Jeffrey S. Ross, Ewan A. Gibb, Marco Bandini, and Giuseppe Basile
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Purpose:The PURE-01 study (NCT02736266) pioneered the neoadjuvant immune-checkpoint inhibitor (ICI) therapy before radical cystectomy (RC) in patients with muscle-invasive urothelial bladder carcinoma (MIBC). We herein present the survival outcomes after a median follow-up of three years.Patients and Methods:The intention-to-treat (ITT) population included 155 patients. Event-free survival (EFS) was defined as the time from pembrolizumab initiation until radiographic disease progression precluding RC, initiation of neoadjuvant chemotherapy, recurrence after RC, or death. Further outcomes were recurrence-free survival (RFS) post-RC and overall survival (OS). Multivariable Cox regression analyses for EFS were performed. Kaplan–Meier analyses compared EFS outcomes according with baseline programmed cell-death-ligand-1 (PD-L1) combined positive score (CPS) and according to the molecular subtypes.Results:After a median (interquartile range, IQR) follow-up of 39 (30–47) months, 36-month EFS and OS were 74.4% [95% confidence interval (CI), 67.8–81.7] and 83.8% (95% CI, 77.8–90.2) in the ITT population, respectively. Overall, 143 (92.3%) patients underwent RC. Within the cohort of patients who did not receive additional chemotherapy (N = 125), 36-month RFS was 96.3% (95% CI, 91.6–100) for patients achieving a ypT0N0, 96.1% (95% CI, 89–100) for ypT1/a/isN0, 74.9% (95% CI, 60.2–93) for ypT2–4N0, and 58.3% (95% CI, 36.2–94.1) for ypTanyN1–3 response. EFS was significantly stratified among PD-L1 tertiles (lower tertile: 59.7% vs. medium tertile: 76.7% vs. higher tertile: 89.8%, P = 0.0013). The claudin-low and basal/squamous subtypes displayed the lowest rates of events.Conclusions:At a median follow-up of three years, PURE-01 results further confirm the sustained efficacy of neoadjuvant pembrolizumab before RC. PD-L1 expression was the strongest predictor of sustained response post-RC.
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- 2023
11. Supplementary Table S2 from Neoadjuvant Pembrolizumab and Radical Cystectomy in Patients with Muscle-Invasive Urothelial Bladder Cancer: 3-Year Median Follow-Up Update of PURE-01 Trial
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Andrea Necchi, Francesco Montorsi, Alberto Briganti, Marco Moschini, Luigi Nocera, Roberta Lucianò, Maurizio Colecchia, Renzo Colombo, Emanuele Crupi, Tiago Costa de Padua, Laura Marandino, Daniele Raggi, Jeffrey S. Ross, Ewan A. Gibb, Marco Bandini, and Giuseppe Basile
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Surgical safety outcomes in PURE-01 trial
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- 2023
12. PD36-04 UTILITY OF PRE- AND POST-PEMBROLIZUMAB VESICAL IMAGING – REPORTING AND DATA SYSTEM (VIRADS) TO PREDICT THE PATHOLOGICAL RESPONSE IN MUSCLE-INVASIVE UROTHELIAL BLADDER CANCER (MIBC): AN ANALYSIS OF THE PURE-01 COHORT
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Giuseppe Basile, Giorgio Brambilla, Marco Bandini, Daniele Raggi, Laura Marandino, Tiago Costa De Padua, Emanuele Crupi, Renzo Colombo, Maurizio Colecchia, Roberta Lucianò, Marco Moschini, Jeffrey S Ross, Alberto Briganti, Francesco Montorsi, Francesco De Cobelli, and Andrea Necchi
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Urology - Published
- 2023
13. MP58-13 FUNCTIONAL OUTCOMES AFTER SURGERY IN PATIENTS WITH RENAL CANCER AND TUMOR THROMBUS
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Giuseppe Rosiello, Francesco Cei, Nazario Tenace, Giuseppe Basile, Giacomo Musso, Chiara Re, Giuseppe Fallara, Rayan Matloob, Federico Belladelli, Daniele Cignoli, Daniela Canibus, Isaline Rowe, Francesco De Cobelli, Giorgio Brembilla, Roberta Lucianò, Roberto Bertini, Alberto Briganti, Renzo Colombo, Francesco Montorsi, Andrea Salonia, Alessandro Larcher, and Umberto Capitanio
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Urology - Published
- 2023
14. Supplementary Figures S1-S4 from Neoadjuvant Pembrolizumab and Radical Cystectomy in Patients with Muscle-Invasive Urothelial Bladder Cancer: 3-Year Median Follow-Up Update of PURE-01 Trial
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Andrea Necchi, Francesco Montorsi, Alberto Briganti, Marco Moschini, Luigi Nocera, Roberta Lucianò, Maurizio Colecchia, Renzo Colombo, Emanuele Crupi, Tiago Costa de Padua, Laura Marandino, Daniele Raggi, Jeffrey S. Ross, Ewan A. Gibb, Marco Bandini, and Giuseppe Basile
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Supplementary Figure 1: Study flow-chart. Supplementary Figure 2: Kaplan-Meier curves of event-free survival according to tertile-split tumor mutational burden. Supplementary Figure 3. Kaplan-Meier curves of recurrence-free survival according to the molecular subtype. Supplementary Figure 4: PD-L1 staining values (CPS percentages) according to molecular subtypes, split by the three subtyping classifiers GSC/Decipher, Consensus classification, and TCGA.
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- 2023
15. Oncologic Surveillance for Variant Histology Bladder Cancer after Radical Cystectomy
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Giuseppe Simone, Evanguelos Xylinas, Luca Afferi, Alberto Briganti, Stefania Zamboni, Shahrokh F. Shariat, Agostino Mattei, Andrea Gallina, Claudio Simeone, Ottavio De Cobelli, Armando Stabile, Julianne G. Schultz, Mario Alvarez-Maestro, Ettore Di Trapani, Francesco Montorsi, Renzo Colombo, Giorgio Gandaglia, Chiara Lonati, Marco Moschini, Matteo Soligo, R. Jeffrey Karnes, Alberto Martini, Martini, Alberto, Afferi, Luca, Zamboni, Stefania, Schultz, Julianne G, Lonati, Chiara, Mattei, Agostino, Karnes, R Jeffrey, Soligo, Matteo, Stabile, Armando, Di Trapani, Ettore, De Cobelli, Ottavio, Simone, Giuseppe, Simeone, Claudio, Alvarez-Maestro, Mario, Gandaglia, Giorgio, Gallina, Andrea, Colombo, Renzo, Briganti, Alberto, Montorsi, Francesco, Xylinas, Evanguelo, Shariat, Shahrokh F, and Moschini, Marco
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Male ,medicine.medical_specialty ,Time Factors ,recurrence ,Urology ,medicine.medical_treatment ,Urinary Bladder ,Cystectomy ,Risk Assessment ,Disease-Free Survival ,cystectomy ,Risk Factors ,Humans ,Medicine ,Registries ,Watchful Waiting ,skin and connective tissue diseases ,Aged ,Neoplasm Staging ,Retrospective Studies ,Carcinoma, Transitional Cell ,Bladder cancer ,business.industry ,Age Factors ,Follow up studies ,Middle Aged ,medicine.disease ,follow-up studies ,Urinary Bladder Neoplasms ,Female ,Neoplasm Recurrence, Local ,urinary bladder neoplasms ,business ,Variant histology ,Follow-Up Studies - Abstract
Presently, major guidelines do not provide specific recommendations on oncologic surveillance for patients who harbor variant histology (VH) bladder cancer (BCa) at radical cystectomy. We aimed to create a personalized followup scheme that dynamically weighs other cause mortality (OCM) vs the risk of recurrence for VH BCa, and to compare it with a similar one for pure urothelial carcinoma (pUC).Within a multi-institutional registry, 528 and 1,894 patients with VH BCa and pUC, respectively, were identified. The Weibull regression was used to detect the time points after which the risk of OCM exceeded the risk of recurrence during followup. The risk of OCM over time was stratified based on age and comorbidities, and the risk of recurrence on pathological stage and recurrence site.Individuals with VH had a higher risk of recurrence (recurrence-free survival 30% vs 51% at 10 years, p0.001) and shorter median time to recurrence (88 vs 123 months, p0.01) relative to pUC. Among VH, micropapillary variant conferred the greatest risk of recurrence on the abdomen and lungs, and mixed variants carried the greatest risk of metastasizing to bones and other sites compared to pUC. Overall, surveillance should be continued for a longer time for individuals with VH BCa. Notably, patients younger than 60 years with VH and pT0/Ta/T1/N0 at radical cystectomy should continue oncologic surveillance after 10 years vs 6.5 years for pUC individuals.VH BCa is associated with greater recurrence risk than pUC. A followup scheme that is valid for pUC should not be applied to individuals with VH. Herein, we present a personalized approach for surveillance that may allow an improved shared decision.
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- 2021
16. Bladder perforation during transurethral resection of the bladder: a comprehensive algorithm for diagnosis, management and follow-up
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Renzo Colombo, Chiara Lonati, Francesco Esperto, Jeremy Yuen-Chun Teoh, Juan Gómez Rivas, Alberto Briganti, Francesco Montorsi, Ekaterina Laukhtina, Roberto M Scarpa, Rocco Papalia, Stefania Zamboni, Mario Alvarez-Maestro, Roberto Carando, Agostino Mattei, Marco Moschini, Christian D. Fankhauser, Luca Afferi, Claudio Simeone, and Wojciech Krajewski
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medicine.medical_specialty ,Bladder cancer ,medicine.diagnostic_test ,business.industry ,Urology ,Incidence (epidemiology) ,Urinary Bladder ,Urinary Bladder Diseases ,Bladder Perforation ,Abdominal Injuries ,medicine.disease ,Surgery ,Sepsis ,Cystography ,Systematic review ,Nephrology ,medicine ,Humans ,Neoplasm Recurrence, Local ,Antibiotic prophylaxis ,Complication ,business ,Algorithms ,Follow-Up Studies ,Systematic Reviews as Topic - Abstract
Despite bladder perforation (BP) is a frequent complication during transurethral resection of bladder (TURB) for bladder cancer (BCa), literature lacks systematic reviews focusing on this issue. We aimed to investigate incidence, diagnosis, therapy, and prognosis after BP during TURB for BCa; therapy was distinguished between conservative (without the need for bladder repair) and surgical management (requiring bladder wall closure).A systematic search was conducted up to April 2021 using PubMed, Scopus, Cochrane Database of Systematic Reviews, and Web of Science to identify articles focusing on incidence, detection, management, or survival outcomes after iatrogenic BP. The selection of articles followed the preferred reporting items for systematic review and meta-analyses process.We included 41 studies, involving 21,174 patients. Overall, 521 patients experienced BP during TURB for BCa, with a mean incidence of 2.4%, up to 58.3% when postoperative cystography is routinely performed after all TURB procedures. Risk factors were low body mass index (BMI) (P=0.01), resection depth (P=0.006 and P=0.03), and low surgical experience (P=0.006). Extraperitoneal BP (68.5%) were treated conservatively in 97.5% of patients; intraperitoneal BP were managed with surgical bladder closure in 56% of cases. Overall, three immediate BP-related deaths were recorded due to septic complications. Extravesical tumor seeding was observed after 6 intraperitoneal and 1 extraperitoneal BP (median time: 6.2 months). Intraperitoneal BP (P=0.0003) and bladder closure (P0.001) were found as independent predictors of extravesical tumor recurrence.BP is more frequent than expected when proper diagnosis is routinely performed after all TURB procedures. Risk factors include low BMI, resection depth, and unexperienced surgeon. The risk of sepsis after BP suggests empirical antibiotic prophylaxis after BP.
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- 2022
17. Utility of pre- and post-pembrolizumab (Pembro) Vesical Imaging–Reporting and Data System (VIRADS) to predict the pathological response in muscle-invasive urothelial bladder cancer (MIBC): An analysis of the PURE-01 cohort
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Giorgio Brembilla, Giuseppe Basile, Marco Bandini, Daniele Raggi, Laura Marandino, Tiago Costa de Padua, Damiano Alfio Patanè, Emanuele Crupi, Andrea Del Prete, Renzo Colombo, Maurizio Colecchia, Roberta Lucianò, Marco Moschini, Jeffrey S. Ross, Alberto Briganti, Francesco Montorsi, Francesco De Cobelli, and Andrea Necchi
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Cancer Research ,Oncology - Abstract
552 Background: The possibility to predict the pathologic complete response (pT0) or downstaging (pT≤1) after neoadjuvant therapy may have profound impact on the management of MIBC and orient next-generation bladder-sparing trials. The VIRADS is a standardized reporting system that uses mpMRI parameters to predict the probability of MIBC. No studies have analyzed the ability of VIRADS to predict the pT0 or pT≤1 response post-immunotherapy (IO). Methods: In PURE-01 patients (pts) were staged with bladder multiparametric magnetic resonance imaging (mpMRI: T2-weighted imaging, diffusion-weighted imaging, dynamic contrast enhancement) before and after treatment (3 cycles of pembro) prior to radical cystectomy (RC). All mpMRI scans were centrally reviewed. Logistic regression models analyzed pre- and post-pembro VIRADS against pT≤1 (primary endpoint) and pT0 (secondary endpoint). VIRADS scores were dichotomized between 0-3 and 4-5. Covariates included cT-stage, age, gender, PD-L1 combined positive score (CPS) and tumor mutational burden (TMB). Results: In total, 58 pts were had centrally-reviewed MRI scans (N=116 mpMRI), treated between 02/17 and 08/18. Demographic characteristics and outcomes were generally similar between the all-treated and VIRADS-evaluable populations of PURE-01. Median age was 65 years, 52 (89%) had pure/predominant urothelial carcinoma (UC) histology, 25 (43.1%) had cT3-4N0 MIBC. Pre-pembro: 8 pts (13.8%) had no measurable disease (VIRADS=0), 20 (34.5%) a VIRADS 1-3 score, and 30 (51.7%) had a VIRADS 4-5 score. Six pts (10.3%) had a downstage from VIRADS 4-5 to VIRADS 0-3 post-pembro. Both pre-pembro and post-pembro VIRADS 0-3 scores were significantly associated with pT≤1 endpoint on multivariable analyses (MVA): the strongest effect was seen with post-pembro VIRADS 0-3 against pT≤1 response (OR: 30.2, 95%CI: 6.2-223.2, p
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- 2023
18. A pharmacoeconomic analysis of the use of single MMC instillation in low risk NMIBC in Italy
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Renzo Colombo, Federico Pellucchi, Lorenzo Rocchini, Carmen Maccagnano, Pablo Katz, and Valeria Pegoraro
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low risk nmibc ,turb ,mitomycin c ,cost-benefit analysis ,single dose instillation ,Medicine (General) ,R5-920 - Abstract
BACKGROUND: Bladder cancer accounts for 5-10% of all cancers in Europe and up to 85% patients presents a noninvasive tumor, whose treatment of choice is the transurethral bladder resection (TURB) paired with adjuvant intravesical chemotherapy or immunotherapy. Despite several clinical trials showed that this treatment is safe and decreases recurrences by 17% to 44% this practice is limited for many reasons. The study objective is to analyze the economical advantages of the single immediate post operative Mitomycin C instillation in Non Muscle-invasive Bladder Cancer (NMIBC) low-risk patients. METHODS: A cost-benefit analysis was performed evaluating the economical gain that would raised from a scenario with a single immediate post operative mitomycin C instillation in each low-risk NMIBC patient who underwent to TURB. Net present value and cost-benefit ratio were calculated and sensitivity analyses were performed. Base case analysis was performed considering tumor recurrence rate reduction of 11.7% and a TURB costs of 2,167.0 €, while sensitivity analyses were performed using a recurrence rate reduction of 19.2% and 15.0% and a TURB cost of 2,472.93 €. The discount rate was 2%. RESULTS: The single immediate post operative instillation of mitomycin C resulted to be cost-beneficial with a cost-benefit ratio that goes from 0.48 to 0.79 when compared to TURB alone raising a Net Present Value that goes from 660,284.39 € to 2,650,530.79 €. CONCLUSION: This study demonstrates that even assuming conservative parameters for recurrence rates reduction, a single immediate post operative mitomycin C instillation in low risk NMIBC patients would lower not only the recurrence rate but also the caring cost for bladder cancer.
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- 2013
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19. Bacteraemia and bacteria spread into the irrigation fluid during percutaneous nephrolithotomy: A prospective study
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Carolina Bebi, Fabrizio Longo, F. Ripa, Renzo Colombo, Andrea Gallioli, A. Teri, C. Silvani, M. Turetti, Antonella Dodaro, C. Matinato, Chiara Vignati, Gianpaolo Lucignani, Lorenzo Rocchini, E. Lievore, E. De Lorenzis, Emanuele Montanari, and Luca Boeri
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medicine.medical_specialty ,Irrigation ,business.industry ,Urology ,medicine.medical_treatment ,medicine ,Percutaneous nephrolithotomy ,Prospective cohort study ,business ,Surgery - Published
- 2021
20. Predicting the Pathologic Complete Response After Neoadjuvant Pembrolizumab in Muscle-Invasive Bladder Cancer
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Giorgio Gandaglia, Marco Bianchi, Jeffrey S. Ross, Siraj M. Ali, Alberto Briganti, Filippo Pederzoli, Nicola Fossati, Patrizia Giannatempo, Marco Bandini, Umberto Capitanio, Maurizio Colecchia, Federico Dehò, Daniele Raggi, Andrea Salonia, Renzo Colombo, Elena Farè, Andrea Gallina, Jon Chung, Laura Marandino, Russell Madison, Roberta Lucianò, Andrea Necchi, Francesco Montorsi, Bandini, Marco, Ross, Jeffrey S, Raggi, Daniele, Gallina, Andrea, Colecchia, Maurizio, Lucianò, Roberta, Giannatempo, Patrizia, Farè, Elena, Pederzoli, Filippo, Bianchi, Marco, Colombo, Renzo, Gandaglia, Giorgio, Fossati, Nicola, Marandino, Laura, Capitanio, Umberto, Deho', Federico, Ali, Siraj M, Madison, Russell, Chung, Jon H, Salonia, Andrea, Briganti, Alberto, Montorsi, Francesco, and Necchi, Andrea
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Male ,Oncology ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Phases of clinical research ,Pembrolizumab ,Antibodies, Monoclonal, Humanized ,Cystectomy ,Logistic regression ,B7-H1 Antigen ,03 medical and health sciences ,0302 clinical medicine ,Text mining ,Internal medicine ,Biomarkers, Tumor ,medicine ,Humans ,Neoplasm Invasiveness ,Neoadjuvant therapy ,Aged ,Neoplasm Staging ,030304 developmental biology ,0303 health sciences ,neoadjuvant immunotherapy ,Bladder cancer ,business.industry ,Muscles ,biomarkers ,Middle Aged ,medicine.disease ,Neoadjuvant Therapy ,Tumor Burden ,Italy ,Urinary Bladder Neoplasms ,muscle-invasive bladder cancer ,030220 oncology & carcinogenesis ,Mutation ,Biomarker (medicine) ,Female ,risk calculator ,business - Abstract
BackgroundIn the PURE-01 study (NCT02736266), we aimed to evaluate the ability to predict the pathologic complete response (pT0N0) after pembrolizumab by using clinical and tumor biomarkers.MethodsIn an open-label, single-arm, phase 2 study, 3 courses of 200 mg pembrolizumab preceding radical cystectomy were administered in patients with T2-4aN0M0 muscle-invasive bladder cancer. The analyses included a comprehensive genomic profiling and programmed cell-death-ligand-1 (PD-L1)–combined positive score assessment (CPS; Dako 22C3 antibody) of pre- and posttherapy samples. Multivariable logistic regression analyses evaluated baseline clinical T stage and tumor biomarkers in association with pT0N0 response. Corresponding coefficients were used to develop a calculator of pT0N0 response based on the tumor mutational burden (TMB), CPS, and the clinical T stage. Decision-curve analysis was also performed. All statistical tests were 2-sided.ResultsFrom February 2017 to June 2019, 112 patients with biomarker data were enrolled (105 with complete TMB and CPS data). Increasing TMB and CPS values featured a linear association with logistic pT0N0 probabilities (P = .02 and P = .004, respectively). For low TMB values (≤11 mut/Mb, median value, n = 53), pT0N0 probability was not associated with increasing CPS. Conversely, for high TMB values (>11 mut/Mb, n = 52), pT0N0 was statistically significantly associated with higher CPS (P = .004). The C index of the pT0N0 probability calculator was 0.77. On decision-curve analysis, the net benefit of the model was higher than the “treat-all” option within the clinically meaningful threshold probabilities of 40%-50%.ConclusionsThe study presents a composite biomarker-based pT0N0 probability calculator that reveals the complex interplay between TMB and CPS, added to the clinical T stage.
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- 2020
21. Multiparametric Magnetic Resonance Imaging as a Noninvasive Assessment of Tumor Response to Neoadjuvant Pembrolizumab in Muscle-invasive Bladder Cancer: Preliminary Findings from the PURE-01 Study
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Renzo Colombo, Jeffrey S. Ross, Giuseppina Calareso, Filippo Pederzoli, Elena Farè, Daniele Raggi, Marco Bandini, Umberto Capitanio, Marco Bianchi, Alberto Briganti, Antonella Messina, Siraj M. Ali, Maurizio Colecchia, Nicola Fossati, Patrizia Giannatempo, Andrea Gallina, Laura Marandino, Jon Chung, Russell Madison, Giorgio Gandaglia, Francesco De Cobelli, Roberta Lucianò, Andrea Necchi, Francesco Montorsi, Andrea Salonia, Federico Dehò, Necchi, A., Bandini, M., Calareso, G., Raggi, D., Pederzoli, F., Farè, E., Colecchia, M, Marandino, L., Bianchi, M., Gallina, A., Colombo, R., Fossati, N., Gandaglia, G., Capitanio, U., Dehò, F., Giannatempo, P., Lucianò, R., Salonia, A., Madison, R., Ali, S. M., Chung, J. H., Ross, J. S., Briganti, A., Montorsi, F., De Cobelli, F., and Messina, A.
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medicine.medical_specialty ,Urology ,medicine.medical_treatment ,030232 urology & nephrology ,Pembrolizumab ,Antibodies, Monoclonal, Humanized ,Cystectomy ,03 medical and health sciences ,Antineoplastic Agents, Immunological ,0302 clinical medicine ,Cohen's kappa ,Multiparametric magnetic resonance imaging ,medicine ,Humans ,Multiparametric Magnetic Resonance Imaging ,Neoadjuvant therapy ,Aged ,Bladder cancer ,business.industry ,Muscle invasive ,Perioperative ,Middle Aged ,medicine.disease ,Neoadjuvant Therapy ,Treatment Outcome ,Urinary Bladder Neoplasms ,030220 oncology & carcinogenesis ,Bladder magnetic resonance imaging ,Radiology ,business ,Muscle-invasive bladder cancer - Abstract
Background: In the PURE-01 study, pembrolizumab was given preoperatively before radical cystectomy in clinical T2-4aN0M0 patients. An accurate clinical response assessment may be useful for developing new perioperative strategies in these patients. Objective: To evaluate the association between bladder multiparametric magnetic resonance imaging (mpMRI) findings after pembrolizumab and the pathological complete response (CR; pT0). Design, setting, and participants: Patients were staged using bladder mpMRI whereby radiologists were asked to characterize the following parameters: residual disease at T1- and T2-weighted images (step 1: yes/no), presence of hyperintense spots within the bladder wall on diffusion-weighted imaging (step 2: yes/no), and presence of pathological contrast enhancement (step 3: yes/no), before and after three cycles of pembrolizumab. Examinations were internally assessed by two senior radiologists and externally evaluated by a third senior radiologist. Intervention: To evaluate bladder tumor response after neoadjuvant pembrolizumab, mpMRI was used. Outcome measurements and statistical analysis: The primary objective was to predict the pT0 after neoadjuvant pembrolizumab by relying on the mpMRI findings. Cohen's kappa statistics was used to assess interobserver variability. Univariable analyses for pT0 were performed including internal and external post-therapy mpMRI steps. Results and limitations: From February 2017 to October 2018, 82 patients (164 total mpMRI assessments) were analyzed. The agreement between the internal and external mpMRI assessments after therapy was acceptable (κ values ranging from 0.5 to 0.76). Each mpMRI step was significantly associated with pT0 in both internal and external assessments. In patients with CR/no evidence of residual disease (NED) in all internally evaluated mpMRI steps (N = 37), the pT0 was seen in 23 (62%), compared with 19 of 26 externally evaluated NED patients (73%). Conclusions: In post-pembrolizumab muscle-invasive bladder cancer, mpMRI sequence assessment had acceptable interobserver variability and represented the basis for the proposal of a radiological CR/NED status definition predicting the pT0 response to pembrolizumab. After validation of these findings with external datasets, we propose this tool for developing bladder-sparing immunotherapy maintenance therapies. Patient summary: Assessment of the extent of disease in patients with muscle-invasive bladder cancer using conventional imaging yields serious limitations. In the PURE-01 study, we evaluated the potential of bladder multiparametric magnetic resonance imaging (MRI) to predict the pathological complete response to neoadjuvant pembrolizumab. After validation with larger datasets, the proposed stepwise assessment incorporating multiparametric MRI sequences will be used at our center to develop bladder-sparing approaches in future studies. • In the PURE-01 study, multiparametric magnetic resonance imaging (mpMRI) of the bladder was used to stage and evaluate the response to pembrolizumab, before radical cystectomy. • Assessments of mpMRI sequence were externally reviewed, showing preliminary but promising reproducibility. • We proposed an mpMRI-based definition of complete response predicting the pathological complete response to pembrolizumab that was externally replicated.
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- 2020
22. Updated Results of PURE-01 with Preliminary Activity of Neoadjuvant Pembrolizumab in Patients with Muscle-invasive Bladder Carcinoma with Variant Histologies
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Jeffrey S. Ross, Filippo Pederzoli, Andrea Necchi, Maurizio Colecchia, Francesco Montorsi, Rodolfo Montironi, Andrea Salonia, Marco Bianchi, Renzo Colombo, Nicola Fossati, Giorgio Gandaglia, Alberto Briganti, Daniele Raggi, Umberto Capitanio, Patrizia Giannatempo, Federico Dehò, Roberta Lucianò, Andrea Gallina, Jon Chung, Laura Marandino, Russell Madison, Elena Farè, Siraj M. Ali, Marco Bandini, Necchi, A., Raggi, D., Gallina, A., Madison, R., Colecchia, M, Lucianò, R., Montironi, R., Giannatempo, P., Farè, E., Pederzoli, F., Bandini, M., Bianchi, M., Colombo, R., Gandaglia, G., Fossati, N., Marandino, L., Capitanio, U., Dehò, F., Ali, S. M., Chung, J. H., Ross, J. S., Salonia, A., Briganti, A., and Montorsi, F.
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Oncology ,medicine.medical_specialty ,Urology ,medicine.medical_treatment ,Population ,030232 urology & nephrology ,Pembrolizumab ,Cystectomy ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Carcinoma ,Clinical endpoint ,education ,Pathological ,education.field_of_study ,Bladder cancer ,business.industry ,Variant histologies ,medicine.disease ,Neoadjuvant immunotherapy ,030220 oncology & carcinogenesis ,Biomarkers ,Muscle-invasive bladder cancer ,Biomarker (medicine) ,business - Abstract
Background Patients with predominant variant histology (VH) of bladder tumors, defined as involving >50 % of the tumor specimens, are typically excluded from clinical trials, and for these patients, the efficacy of standard chemotherapy is limited. Objective To evaluate the activity of preoperative pembrolizumab in patients with muscle-invasive bladder carcinoma (MIBC) and VH, enrolled in PURE-01 study (NCT02736266). Design, setting, and participants In the open-label, single-arm, phase 2 PURE-01 study, three courses of 200 mg pembrolizumab preceding radical cystectomy (RC) were administered in T2-4aN0M0 MIBC patients. The amended study design included patients with predominant VH. Intervention Neoadjuvant pembrolizumab and RC. Outcome measurements and statistical analysis Pathological complete response (pT0) in intention-to-treat population was the primary endpoint. Biomarker analyses included programmed cell-death ligand-1 (PD-L1) expression using the combined positive score (CPS; Dako 22C3 antibody) and comprehensive genomic profiling (FoundationOne assay). Multivariable logistic regression analyses (MVAs) evaluated the histological category (predominant VH vs nonpredominant VH vs pure urothelial carcinoma), tumor mutational burden (TMB) and CPS in association with the pathological response. Results and limitations From February 2017 to June 2019, 114 patients were enrolled; 34 (30%) of them presented with VH, including 19 (17%) with predominant VH. In total, the pT0 rate was 37% (95% confidence interval [CI]: 28–46) and the pT ≤ 1 rate was 55% (95% CI: 46–65). The majority of predominant VH patients presented with squamous-cell carcinoma (SCC; N = 7), and six of seven (86%) had downstaging to pT ≤ 1, with one pT0; two of three lymphoepithelioma-like (LEL) variants had a pT0 response. None of the remaining nine predominant VHs had a response. On MVA, TMB and CPS were associated with both the pT0 and the pT ≤ 1 response, regardless of tumor histology. Conclusions The updated PURE-01 results confirm the activity of neoadjuvant pembrolizumab in MIBC. Patients with SCC and LEL features may be suitable for neoadjuvant immunotherapy trials. CPS and TMB are the key response predictors irrespective of the histological subtypes. Patient summary In the PURE-01 study, we have preliminarily evaluated the activity of neoadjuvant pembrolizumab in patients with predominant variant histology (VH). Of these patients, those harboring squamous-cell carcinoma or a lymphoepithelioma-like variant feature had major, although preliminary, pathological responses compared with those with other predominant VHs. Expression of programmed cell-death ligand-1 and tumor mutational burden may predict the pathological response to pembrolizumab, and provide a rationale for selecting patients according to these features instead of the histological bladder cancer subtypes.
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- 2020
23. Impact of Molecular Subtyping and Immune Infiltration on Pathological Response and Outcome Following Neoadjuvant Pembrolizumab in Muscle -invasive Bladder Cancer
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Marco Bianchi, Alberto Briganti, Ewan A. Gibb, Joep J. de Jong, Maurizio Colecchia, Ryan Dittamore, Elena Farè, Andrea Gallina, Andrea Salonia, Joost L. Boormans, Andrea Necchi, Jeffrey S. Ross, Francesco Montorsi, Peter C. Black, Filippo Pederzoli, Yang Liu, Renzo Colombo, Laura Marandino, Umberto Capitanio, Nicola Fossati, Roberta Lucianò, Patrizia Giannatempo, Elai Davicioni, Giorgio Gandaglia, Marco Bandini, Daniele Raggi, Urology, Necchi, A., Raggi, D., Gallina, A., Ross, J. S., Fare, E., Giannatempo, P., Marandino, L., Colecchia, M., Luciano, R., Bianchi, M., Colombo, R., Salonia, A., Gandaglia, G., Fossati, N., Bandini, M., Pederzoli, F., Capitanio, U., Montorsi, F., de Jong, J. J., Dittamore, R., Liu, Y., Davicioni, E., Boormans, J. L., Briganti, A., Black, P. C., and Gibb, E. A.
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Male ,Oncology ,medicine.medical_specialty ,Urology ,medicine.medical_treatment ,030232 urology & nephrology ,Pembrolizumab ,Antibodies, Monoclonal, Humanized ,Cystectomy ,03 medical and health sciences ,Antineoplastic Agents, Immunological ,0302 clinical medicine ,SDG 3 - Good Health and Well-being ,Internal medicine ,Gene signature ,medicine ,Humans ,Neoplasm Invasiveness ,Neoadjuvant therapy ,Aged ,Retrospective Studies ,Chemotherapy ,Bladder cancer ,business.industry ,Gene Expression Profiling ,Biomarker ,Immunotherapy ,Middle Aged ,medicine.disease ,Neoadjuvant Therapy ,Progression-Free Survival ,Treatment Outcome ,Urinary Bladder Neoplasms ,Neoadjuvant immunotherapy ,030220 oncology & carcinogenesis ,T-stage ,Female ,business ,Muscle-invasive bladder cancer - Abstract
Background: The PURE-01 study (NCT02736266) evaluated the use of pembrolizumab before radical cystectomy (RC) in muscle-invasive bladder cancer (MIBC). Objective: To evaluate the ability of molecular signatures to predict the pathological complete response (CR: ypT0N0) and progression-free survival (PFS) after pembrolizumab and RC. Design, setting, and participants: We analyzed the expression data from patients with T2–4aN0M0 MIBC enrolled in the PURE-01 study (N = 84) and from patients of a retrospective multicenter cohort treated with cisplatin-based neoadjuvant chemotherapy (NAC; N = 140). Intervention: Neoadjuvant pembrolizumab or NAC and RC. Outcome measurements and statistical analysis: Immune signatures and molecular subtyping (The Cancer Genome Atlas, consensus model, and genomic subtyping classifier [GSC]) were evaluated in relation to CR and PFS. Multivariable logistic regression analyses for CR were used, adjusting for gender and clinical T stage. Results and limitations: The Immune190 signature was significant for CR on multivariable logistic regression analyses (p = 0.02) in PURE-01, but not in the NAC cohort (p = 0.7). Hallmark signatures for interferon gamma (IFNγ; p = 0.004) and IFNα response (p = 0.006) were also associated with CR for PURE-01, but not for NAC (IFNγ: p = 0.9 and IFNα: p = 0.8). In PURE-01, 93% of patients with the highest Immune190 scores (>1st quartile) had 2-yr PFS versus 79% of those with lower scores; no difference was observed in NAC patients, as well as for the other hallmarks in both groups. The neuroendocrine-like subtype had the worst 2-yr PFS in all three subtyping models (33%) and the GSC claudin-low subtype had the best, with no recurrences in 2 yr. Basal subtypes (across classifications) with higher Immune190 scores showed 100% 2-yr PFS after pembrolizumab therapy (p = 0.04, compared with basal-Immune190 low). Statistical analyses are limited by the small number of events and short follow-up. Conclusions: Higher RNA-based immune signature scores were significantly associated with CR and numerically improved PFS outcomes after pembrolizumab, but not after NAC. These data emphasize that RNA profiling is a potential tool for personalizing neoadjuvant therapy selection. Patient summary: We used gene expression profiling to evaluate the association between immune gene expression and response to neoadjuvant immunotherapy, compared with standard chemotherapy, in patients with muscle-invasive bladder cancer (MIBC). We found a significant association between immune gene expression and response to pembrolizumab, but not chemotherapy. We conclude that gene expression profiling has the potential to guide personalized neoadjuvant therapy in MIBC. By using gene expression profiling of transurethral bladder tumor resection samples from patients with muscle-invasive bladder cancer (MIBC), we reported a significant association between pre-existing immune gene expression and response to neoadjuvant pembrolizumab, but not to neoadjuvant chemotherapy. Different outcomes were also obtained according to the molecular subtype. Gene expression profiling has the potential to guide personalized neoadjuvant therapy in MIBC.
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- 2020
24. ABSTRACTS OF THE 31st ANNUAL MEETING OF THE ITALIAN SOCIETY OF URO-ONCOLOGY (SIUrO): 30 September - 2 October 2021, Virtual Meeting
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Orazio Caffo, Renzo Colombo, and Vittorio Vavassori
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Cancer Research ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Urinary system ,Incidence (epidemiology) ,Surgical wound ,General Medicine ,Disease ,Oncology ,Internal medicine ,Statistical significance ,Nephrostomy ,medicine ,business ,Abdominal surgery ,Upper urinary tract - Abstract
Background/Aim: Covid-19 pandemic has led to profound changes in healthcare system in Italy as well as in other countries showing a rapid spread of the disease (1). Italian hospitals modified their usual practice to ensure adequate number of beds for COVID-19 patients. The common management of admitted patients changed to reduce the risk of transmission and parent's visits were strongly limited. Moreover, fear and anxiety caused patients to delay appropriate treatment, resulting in poor outcomes. Urinary tract infection (UTI) is one of the major nosocomial infections. In more than 80% of cases it is related to urological diseases, especially linked to infective stone disease and use of urinary drainages. Pre-operative and post-operative infections are a main challenge in everyday urologic activity. The aim of the present study was to compare the incidence of nosocomial urinary infection during the pandemic period of 2020 with the non-pandemic period of 2019 to investigate the prophylactic role of the strict antiseptic rules adopted during pandemic. Materials and Methods: According with the aims of the study the files of the patients submitted to urological interventions in a 3-month period (March-May) 2019 and (March-May) 2020 were reviewed. A dedicated database was generated. Patients' clinical pre-operative characteristics, including smoking status and BMI were recorded. Charlson comorbidity index and main comorbidities with particular attention to cardiovascular, pulmonary and neurological diseases, diabetes and hypertension were included. Symptoms, fever, laboratory data and urine culture were recorded pre-intra- and postoperatively when available. Urological surgery was classified in five categories: i) major abdominal surgery, (both open and laparoscopic), ii) endoscopic intervention upper urinary tract, iii). endoscopic intervention lower urinary tract, iv) minor open surgery, v) nephrostomy and ureteral stenting. Post-operative complications were classified according to Clavien-Dindo score. The data obtained were submitted to statistical analysis to compare the two different 3-month periods, pre-pandemic in 2019 and pandemic in 2020. The association of the treatment period with categorical variables was assessed using χ2 test. All p-values were two-sided and statistical significance was defined as p
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- 2021
25. Immediate radical cystectomy versus BCG immunotherapy for T1 high-grade non-muscle-invasive squamous bladder cancer: an international multi-centre collaboration
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Chiara, Lonati, Luca, Afferi, Andrea, Mari, Andrea, Minervini, Wojciech, Krajewski, Marco, Borghesi, Gerald B, Schulz, Michael, Rink, Francesco, Montorsi, Alberto, Briganti, Renzo, Colombo, Alberto, Martini, Andrea, Necchi, Roberto, Contieri, Rodolfo, Hurle, Paolo, Umari, Stefania, Zamboni, Claudio, Simeone, Francesco, Soria, Giancarlo, Marra, Paolo, Gontero, Jeremy Yuen-Chun, Teoh, Tobias, Klatte, Anne-Sophie, Bajeot, Mathieu, Roumiguié, Morgan, Rouprêt, Alexandra, Masson-Lecomte, Ekaterina, Laukhtina, Anne Sophie, Valiquette, M Carmen, Mir, Alessandro, Antonelli, Sarah M H, Einerhand, Kees, Hendricksen, Roberto, Carando, Christian D, Fankhauser, Philipp, Baumeister, Agostino, Mattei, Shahrokh F, Shariat, and Marco, Moschini
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Male ,Urinary Bladder Neoplasms ,Urinary Bladder ,BCG Vaccine ,Carcinoma, Squamous Cell ,Humans ,Female ,Neoplasm Invasiveness ,Immunotherapy ,Neoplasm Recurrence, Local ,Cystectomy ,Neoplasm Staging ,Retrospective Studies - Abstract
To compare cancer-specific mortality (CSM) and overall mortality (OM) between immediate radical cystectomy (RC) and Bacillus Calmette-Guérin (BCG) immunotherapy for T1 squamous bladder cancer (BCa).We retrospectively analysed 188 T1 high-grade squamous BCa patients treated between 1998 and 2019 at fifteen tertiary referral centres. Median follow-up time was 36 months (interquartile range: 19-76). The cumulative incidence and Kaplan-Meier curves were applied for CSM and OM, respectively, and compared with the Pepe-Mori and log-rank tests. Multivariable Cox models, adjusted for pathological findings at initial transurethral resection of bladder (TURB) specimen, were adopted to predict tumour recurrence and tumour progression after BCG immunotherapy.Immediate RC and conservative management were performed in 20% and 80% of patients, respectively. 5-year CSM and OM did not significantly differ between the two therapeutic strategies (Pepe-Mori test p = 0.052 and log-rank test p = 0.2, respectively). At multivariable Cox analyses, pure squamous cell carcinoma (SqCC) was an independent predictor of tumour progression (p = 0.04), while concomitant lympho-vascular invasion (LVI) was an independent predictor of both tumour recurrence and progression (p = 0.04) after BCG. Patients with neither pure SqCC nor LVI showed a significant benefit in 3-year recurrence-free survival and progression-free survival compared to individuals with pure SqCC or LVI (60% vs. 44%, p = 0.04 and 80% vs. 68%, p = 0.004, respectively).BCG could represent an effective treatment for T1 squamous BCa patients with neither pure SqCC nor LVI, while immediate RC should be preferred among T1 squamous BCa patients with pure SqCC or LVI at initial TURB specimen.
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- 2021
26. Upper Tract Urothelial Carcinoma in the Lynch Syndrome Tumour Spectrum: A Comprehensive Overview from the European Association of Urology - Young Academic Urologists and the Global Society of Rare Genitourinary Tumors
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Chiara Lonati, Andrea Necchi, Juan Gómez Rivas, Luca Afferi, Ekaterina Laukhtina, Alberto Martini, Eugenio Ventimiglia, Renzo Colombo, Giorgio Gandaglia, Andrea Salonia, Alberto Briganti, Francesco Montorsi, Agostino Mattei, Claudio Simeone, Maria I. Carlo, Shahrokh F. Shariat, Philippe E. Spiess, Marco Moschini, Lonati, Chiara, Necchi, Andrea, Gómez Rivas, Juan, Afferi, Luca, Laukhtina, Ekaterina, Martini, Alberto, Ventimiglia, Eugenio, Colombo, Renzo, Gandaglia, Giorgio, Salonia, Andrea, Briganti, Alberto, Montorsi, Francesco, Mattei, Agostino, Simeone, Claudio, Carlo, Maria I, Shariat, Shahrokh F, Spiess, Philippe E, and Moschini, Marco
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Male ,Carcinoma, Transitional Cell ,Urologists ,Urology ,Global Society of Rare Genitourinary Tumors ,Colorectal Neoplasms, Hereditary Nonpolyposis ,Mismatch repair ,Lynch syndrome ,Oncology ,Urinary Bladder Neoplasms ,Upper tract urothelial carcinoma ,Humans ,Radiology, Nuclear Medicine and imaging ,Surgery ,EAU Young Academic Urologists ,Female ,Hereditary nonpolyposis colorectal cancer - Abstract
Context: Upper tract urothelial carcinoma (UTUC) represents the third most frequent malignancy in Lynch syndrome (LS). Objective: To systematically review the available literature focused on incidence, diagnosis, clinicopathological features, oncological outcomes, and screening protocols for UTUC among LS patients. Evidence acquisition: Medline, Scopus, Google Scholar, and Cochrane Database of Systematic Reviews were searched up to May 2021. Risk of bias was determined using the modified Cochrane tool. A narrative synthesis was undertaken. Evidence synthesis: Overall, 43 studies between 1996 and 2020 were included. LS patients exhibited a 14-fold increased risk of UTUC compared with the general population, which further increased to 75-fold among hMSH2 mutation carriers. Patients younger than 65 yr and patients with personal or family history of LS-related cancers should be referred to molecular testing on tumour specimen and subsequent genetic testing to confirm LS. Newly diagnosed LS patients may benefit from a multidisciplinary management team including gastroenterologist and gynaecologist specialists, while genetic counselling should be recommended to first-degree relatives (FDRs). Compared with sporadic UTUC individuals, LS patients were significantly younger (p = 0.005) and exhibited a prevalent ureteral location (p = 0.01). Radical nephroureterectomy was performed in 75% of patients (5-yr cancer-specific survival: 91%). No consensus on screening protocols for UTUC was achieved: starting age varied between 25-35 and 50 yr, while urinary cytology showed sensitivity of 29% and was not recommended for screening. Conclusions: Urologists should recognise patients at high risk for LS and address them to a comprehensive diagnostic pathway, including molecular and genetic testing. Newly diagnosed LS patients should be referred to a multidisciplinary team, while genetic counselling should be recommended to FDRs. Patient summary: In this systematic review, we analysed the existing literature focused on upper tract urothelial carcinoma (UTUC) among patients with Lynch syndrome (LS). Our purpose is to provide a comprehensive overview of LS-related UTUC to reduce misdiagnosis and improve patient prognosis.
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- 2021
27. Adjuvant chemotherapy is ineffective in patients with bladder cancer and variant histology treated with radical cystectomy with curative intent
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Atiqullah Aziz, Ettore Di Trapani, Michael Rink, Claudio Simeone, Giuseppe Simone, Alberto Briganti, Evanguelous Xylinas, Mariaconsiglia Ferriero, Cédric Poyet, Andrea Gallina, Renzo Colombo, Marco Moschini, Livio Mordasini, Charlotte S. Voskuilen, Stefania Zamboni, Mohammad Abufaraj, Francesco Soria, Giorgio Gandaglia, Alessandro Antonelli, David D'Andrea, Luca Afferi, Andrea Necchi, Francesco Montorsi, Shahrokh F. Shariat, Kees Hendricksen, Agostino Mattei, Philipp Baumeister, University of Zurich, Zamboni, Stefania, Zamboni, S., Afferi, L., Soria, F., Aziz, A., Abufaraj, M., Poyet, C., Necchi, A., D'Andrea, D., Simone, G., Ferriero, M., Di Trapani, E., Simeone, C., Antonelli, A., Gallina, A., Montorsi, F., Briganti, A., Colombo, R., Gandaglia, G., Mattei, A., Baumeister, P., Mordasini, L., Hendricksen, K., Voskuilen, C. S., Rink, M., Shariat, S. F., Xylinas, E., and Moschini, M.
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Nephrology ,Male ,2748 Urology ,medicine.medical_specialty ,Urology ,medicine.medical_treatment ,030232 urology & nephrology ,610 Medicine & health ,Cystectomy ,Neuroendocrine differentiation ,Variant histology ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Treatment Failure ,Lymph node ,Aged ,Retrospective Studies ,Bladder cancer ,business.industry ,Middle Aged ,medicine.disease ,ACT ,Confidence interval ,Adjuvant chemotherapy ,Radical cystectomy ,Survival Rate ,Dissection ,10062 Urological Clinic ,medicine.anatomical_structure ,Urinary Bladder Neoplasms ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Cohort ,Female ,business - Abstract
Objectives: Adjuvant chemotherapy (ACT) is recommended for non-organ-confined bladder cancer (BCa) after radical cystectomy (RC) and pelvic lymph node dissection (PLND), but there are sparse data regarding its specific efficacy in patients with histological variants. The aim of our study was to evaluate the role of ACT on survival outcomes in patients with variant histology in a large multicenter cohort. Materials and methods: We retrospectively evaluated data of 3963 patients with BCa treated with RC and bilateral PLND with curative intent at several institutions between 1999 and 2018. The histological type was classified into six groups: pure urothelial carcinoma (PUC) or squamous, sarcomatoid, micropapillary, glandular and neuroendocrine differentiation. Multivariable competing risk analysis was applied to assess the role of ACT on recurrence and cancer-specific mortality (CSM) in each histological subtype. Results: Of the 3963 patients included in the study, 23% had variant histology at RC specimen and 723 (18%) patients received ACT. ACT was found to be significantly associated with reduced risk of recurrence (sub-hazard ratio [SHR]: 0.55, confidence interval [CI] 0.42–0.71, p < 0.001) and CSM (SHR: 0.58, CI 0.44–0.78, p < 0.001) in the PUC only, while no histological subtype received a significant benefit on survival outcomes (all p > 0.05) from administration of ACT. The limitation of the study includes the retrospective design, the lack of a central pathology review and the number of ACT cycles. Conclusion: In our study, the administration of ACT was associated with improved survival outcomes in PUC only. No histological subtype found a benefit in overall recurrence and CSM from ACT.
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- 2021
28. The Role of Prior Bladder Cancer on Recurrence in Patients Treated with Radical Nephroureterectomy
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Alberto Martini, Chiara Lonati, Francesco Montorsi, Alberto Briganti, Renzo Colombo, Andrea Necchi, Claudio Simeone, Stefania Zamboni, Luca Afferi, Agostino Mattei, Roberto Carando, Guillaume Ploussard, Francesco Soria, Giancarlo Marra, Morgan Rouprêt, Evanguelos Xylinas, Benjamin Pradere, Mohammad Abufaraj, David D'Andrea, Shahrokh F. Shariat, and Marco Moschini
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Carcinoma, Transitional Cell ,Oncology ,Urinary Bladder Neoplasms ,Urology ,Humans ,Neoplasm Recurrence, Local ,Nephroureterectomy ,Retrospective Studies - Abstract
The prognostic role of prior history of bladder cancer (BCa) among patients treated with radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC) is poorly addressed. We aimed to investigate the role of prior BCa on any recurrence, distant metastases, and bladder recurrence following RNU among low-grade (LG) and high-grade (HG) UTUC patients.We retrospectively analyzed 1,580 UTUC patients treated with RNU at 8 tertiary referral centers between 1992 and 2016. Any recurrence was defined as recurrence in the urinary tract, in the resection bed, or distant metastases (defined as disease outside the urinary tract and regional lymph nodes). Time to recurrence was computed from RNU. Multivariable Cox models were generated to predict risk of any recurrence, distant metastases, and bladder recurrence according to prior BCa history, coded as no prior BCa, non-muscle-invasive (NMIBC), and muscle-invasive BCa (MIBC).Median follow-up for survivors was 4 years. Overall, 71%, 25%, and 4% of patients had no prior BCa, NMIBC and MIBC. 5-year any recurrence-free survival was 61%, 41%, and 19% in LG (P.001) and 42%, 34%, and 30% in HG patients (P = .1) with no prior BCa, NMIBC, and MIBC. On multivariable models, LG patients with NMIBC and MIBC showed a significantly higher risk of any recurrence compared to no prior BCa (both p≤0.005); previous NMIBC was associated with any recurrence among HG patients (P = 0.04). 5-year distant metastases-free survival was 92%, 90%, and 87% in LG (P.05) and 68%, 75%, and 45% in HG patients (P = .01) with no prior BCa, NMIBC, and MIBC. Previous NMIBC increased the risk of bladder recurrence among LG (P.001) and HG (P = .003) patients.UTUC patients with prior history of BCa exhibit a higher risk of any recurrence after RNU. Our study provides important information which could address patient's counseling and decision-making process.
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- 2021
29. Survival Outcomes After Immediate Radical Cystectomy Versus Conservative Management with Bacillus Calmette-Guérin Among T1 High-grade Micropapillary Bladder Cancer Patients: Results from a Multicentre Collaboration
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Andrea Necchi, Andrea Mari, Francesco Soria, Marco Moschini, Livio Mordasini, Soichiro Yoshida, Luca Afferi, Morgan Rouprêt, Shahrokh F. Shariat, Yasuhisa Fujii, Kees Hendricksen, Alessandro Antonelli, Paolo Gontero, Philipp Baumeister, Rodolfo Hurle, Renzo Colombo, David D'Andrea, Wojciech Krajewski, Agostino Mattei, Gerald Schulz, Chiara Lonati, Jeremy Yuen-Chun Teoh, Alberto Briganti, Ekaterina Laukhtina, Tobias Klatte, M. Carmen Mir, Claudio Simeone, Alberto Martini, Alexandra Masson-Lecomte, Stefania Zamboni, Andrea Minervini, Anne Sophie Valiquette, Maria Angela Cerruto, Sosan Azizi, Roberto Carando, Alessandro Tafuri, Roberto Contieri, Giancarlo Marra, Francesco Montorsi, Lonati, Chiara, Baumeister, Philipp, Afferi, Luca, Mari, Andrea, Minervini, Andrea, Krajewski, Wojciech, Azizi, Sosan, Hendricksen, Kee, Martini, Alberto, Necchi, Andrea, Montorsi, Francesco, Briganti, Alberto, Colombo, Renzo, Tafuri, Alessandro, Antonelli, Alessandro, Cerruto, Maria Angela, Rouprêt, Morgan, Masson-Lecomte, Alexandra, Laukhtina, Ekaterina, D'Andrea, David, Shariat, Shahrokh F, Soria, Francesco, Marra, Giancarlo, Gontero, Paolo, Contieri, Roberto, Hurle, Rodolfo, Valiquette, Anne Sophie, Mir, M Carmen, Zamboni, Stefania, Simeone, Claudio, Klatte, Tobia, Teoh, Jeremy Yuen-Chun, Yoshida, Soichiro, Fujii, Yasuhisa, Carando, Roberto, Schulz, Gerald B, Mordasini, Livio, Mattei, Agostino, and Moschini, Marco
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medicine.medical_specialty ,Lymphovascular invasion ,Urology ,medicine.medical_treatment ,Disease ,Cystectomy ,Conservative Treatment ,Variant histology ,Interquartile range ,Bacillus Calmette-Guérin ,Bladder cancer ,Conservative management ,Immediate radical cystectomy ,Micropapillary ,Internal medicine ,Medicine ,Humans ,Cumulative incidence ,Retrospective Studies ,Neoplasm Staging ,business.industry ,Carcinoma in situ ,medicine.disease ,Carcinoma, Papillary ,Urinary Bladder Neoplasms ,Concomitant ,BCG Vaccine ,Disease Progression ,Neoplasm Recurrence, Local ,business - Abstract
Background Literature lacks clear evidence regarding the optimal treatment for non–muscle-invasive micropapillary bladder cancer (MPBC) due to its rarity and the presence of only small sample size and single-centre studies. Objective To assess cancer-specific mortality (CSM) and overall mortality (OM) between immediate radical cystectomy (RC) and conservative management among T1 high-grade (HG) MPBC. Design, setting, and participants We retrospectively analysed a multicentre dataset including 119 T1 HG MPBC patients treated between 2005 and 2019 at 15 tertiary referral centres. The median follow-up time was 35 mo (interquartile range: 19–64). Intervention Patients underwent immediate RC versus conservative management with bacillus Calmette-Guerin. Outcomes measurements and statistical analysis Cumulative incidence functions and Kaplan-Meier methods were applied to estimate survival outcomes. Multivariable Cox analyses were performed to assess independent predictors of disease recurrence and disease progression after conservative management; covariates consisted of pure MPBC, concomitant lymphovascular invasion (LVI), and carcinoma in situ at initial diagnosis. Results and limitations Immediate RC and conservative management were performed in 27% and 73% of patients, respectively. CSM and OM did not differ significantly among patient treated with immediate RC versus conservative management (Pepe-Mori test p = 0.5 and log-rank test p = 0.9, respectively). Overall, 66.7% and 34.5% of patients experienced disease recurrence and disease progression after conservative management, respectively. At multivariable Cox analyses, concomitant LVI was an independent predictor of disease recurrence (p = 0.01) and progression (p = 0.03), while pure MPBC was independently associated with disease progression (p = 0.03). The absence of a centralised re-review and the retrospective design represent the main limitations of our study. Conclusions Conservative management could achieve satisfactory results among T1 HG MPBC patients with neither pure MPBC nor LVI at initial diagnosis. Patient summary Bacillus Calmette-Guerin seems to be an effective therapy for T1 micropapillary bladder cancer patients with neither pure micropapillary disease nor lymphovascular invasion at initial diagnosis.
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- 2021
30. Adjuvant recMAGE-A3 Immunotherapy After Cystectomy for Muscle-invasive Bladder Cancer: Lessons Learned from the Phase 2 MAGNOLIA Clinical Trial
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Cristian Surcel, Raymond Schipper, Igor Korneyev, Marc Colombel, Pavel Yakovlev, Renzo Colombo, Luis Martínez-Piñeiro, Wim P.J. Witjes, Piotr Radziszewski, Axel Heidenreich, Christien Caris, J. Alfred Witjes, Peter F.A. Mulders, and Marko Babjuk
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Oncology ,medicine.medical_specialty ,Urology ,medicine.medical_treatment ,education ,030232 urology & nephrology ,Cystectomy ,03 medical and health sciences ,All institutes and research themes of the Radboud University Medical Center ,Clinical Trials, Phase II as Topic ,0302 clinical medicine ,Double-Blind Method ,Antigens, Neoplasm ,Internal medicine ,Urological cancers Radboud Institute for Molecular Life Sciences [Radboudumc 15] ,Humans ,Medicine ,Neoplasm Invasiveness ,Randomized Controlled Trials as Topic ,Chemotherapy ,Bladder cancer ,business.industry ,Muscle invasive ,Perioperative ,Immunotherapy ,medicine.disease ,Recombinant Proteins ,Neoplasm Proteins ,Clinical trial ,Urinary Bladder Neoplasms ,Chemotherapy, Adjuvant ,Urological cancers Radboud Institute for Health Sciences [Radboudumc 15] ,030220 oncology & carcinogenesis ,Early Termination of Clinical Trials ,business ,Adjuvant - Abstract
The MAGNOLIA study, investigating the concept of perioperative immunotherapy in muscle- invasive bladder cancer, was prematurely terminated. The lessons learned that should be considered before initiating and conducting future clinical trials in this field are highlighted.
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- 2019
31. Diagnostic accuracy of preoperative lymph node staging of bladder cancer according to different lymph node locations: A multicenter cohort from the European Association of Urology - Young Academic Urologists
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Chiara Lonati, Livio Mordasini, Luca Afferi, Ottavio De Cobelli, Ettore Di Trapani, Andrea Necchi, Renzo Colombo, Alberto Briganti, Francesco Montorsi, Claudio Simeone, Stefania Zamboni, Giuseppe Simone, Robert Jeffrey Karnes, Giancarlo Marra, Francesco Soria, Paolo Gontero, Shahrokh F. Shariat, Benjamin Pradere, Kees Hendricksen, Maida Ammiwala, Michael Rink, Cédric Poyet, Wojciech Krajewski, Philipp Baumeister, Agostino Mattei, Marco Moschini, and Roberto Carando
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Male ,Oncology ,Urinary Bladder Neoplasms ,Urologists ,Urology ,Humans ,Lymph Node Excision ,Female ,Lymph Nodes ,Cystectomy ,Neoplasm Staging ,Retrospective Studies - Abstract
The preoperative lymph node (LN) staging of bladder cancer (BCa) addresses the subsequent therapeutic strategy and influences patient's prognosis. However, sparce evidence exists regarding the accuracy of conventional cross-sectional imaging, such as computed tomography or magnetic resonance imaging, in correctly detect LN status. We aimed to assess the diagnostic accuracy of conventional cross-sectional imaging in detecting preoperative LN involvement among BCa patients treated with radical cystectomy and pelvic lymph node dissection.We retrospectively analyzed data of 1,104 patients who underwent preoperative LN staging with computed tomography or magnetic resonance imaging and subsequent radical cystectomy with pelvic lymph node dissection for BCa between 1997 and 2017 at three tertiary referral centers. Patients receiving neoadjuvant chemotherapy were excluded. We assessed the concordance between clinical (cN) and pathological LN (pN) status, defined as the accuracy of imaging in detecting LN involvement using pathological specimen as reference; concordance was expressed according to Cohen's kappa coefficient. Location-based sub-analyses were performed, distinguishing among external iliac, intern iliac, obturator, common iliac, presacral and paraaortic LNs.Among 870 cN0 patients, 68.9% were confirmed pN0 at pathological report; while among 234 cN+ patients, 50.5% were found with LN metastases at pathological specimen. Overall, conventional imaging showed slight concordance (64.9%) between cN and pN stages (sensitivity: 30%; specificity: 84%). At sub-analysis, no agreement between cN and pN status was found in each LN location, with the only exception of common iliac LNs with slight concordance (37.5%). Common iliac LNs achieved the highest sensitivity and positive likelihood ratio (15% and 2.4, respectively) compared to other LN locations.Overall, preoperative cross-sectional imaging exhibited a slight concordance between cN and pN status. Our location-based sub-analyses showed unsatisfactory results in each LN location- Thus, nomograms combining morphological patterns with serological and clinicopathological features are urgently required.
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- 2021
32. Association of patients' sex with treatment outcomes after intravesical bacillus Calmette-Guerin immunotherapy for T1G3/HG bladder cancer
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Per-Uno Malmström, Núria Malats, Vincenzo Serretta, Renzo Colombo, Richard Sylvester, Savino M. Di Stasi, Bas W.G. van Rhijn, Shahrokh F. Shariat, Paolo Gontero, Anne J. Grotenhuis, Marek Babjuk, Riccardo Bartoletti, Steven Joniau, Jack Baniel, T. Tony Cai, Jeffrey Karnes, Martin Spahn, Joan Palou, J. Varkarakis, Francesco Soria, J. Irani, Peter U. Ardelt, David D'Andrea, Guido Dalbagni, Eugene K. Cha, and Stéphane Larré
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Nephrology ,Male ,medicine.medical_treatment ,Treatment outcome ,030232 urology & nephrology ,Gastroenterology ,0302 clinical medicine ,Immunologic ,Recurrence ,Urologi och njurmedicin ,BCG ,Progression ,Intravesical ,Hazard ratio ,Bladder cancer ,Response ,Urology & Nephrology ,Middle Aged ,Administration, Intravesical ,Treatment Outcome ,030220 oncology & carcinogenesis ,Administration ,BCG Vaccine ,Female ,Original Article ,Immunotherapy ,Adjuvant ,Life Sciences & Biomedicine ,Age ,medicine.medical_specialty ,Urology ,03 medical and health sciences ,Sex Factors ,Adjuvants, Immunologic ,Internal medicine ,medicine ,Humans ,Urology and Nephrology ,Adjuvants ,Aged ,Retrospective Studies ,Neoplasm Grading ,Urinary Bladder Neoplasms ,Science & Technology ,Proportional hazards model ,business.industry ,medicine.disease ,Confidence interval ,Settore MED/24 ,business - Abstract
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.
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- 2021
33. Risk factors for residual disease at re-TUR in a large cohort of T1G3 patients
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Richard Sylvester, Evanguelos Xylinas, Riccardo Bartoletti, S.F. Shariat, Juan Palou, Steven Joniau, P. Gontero, Alberto Briganti, Roy Mano, T. Tony Cai, Jack Baniel, S. Larrè, N. Malats, S. M. Di Stasi, Alfred Witjes, J. Irani, Anne J. Grotenhuis, Eugene K. Cha, B.W.G. Van Rhijn, Viktor Soukup, J. Varkarakis, Guido Dalbagni, Vincenzo Serretta, Renzo Colombo, Francesca Pisano, P. Ardelt, Robert Jeffrey Karnes, P.-U. Malmström, and Marek Babjuk
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Detrusor muscle ,medicine.medical_specialty ,030232 urology & nephrology ,Urology ,Disease ,Logistic regression ,03 medical and health sciences ,Tumor Status ,0302 clinical medicine ,Re-transurethral resection of the bladder ,Recurrence ,Risk Factors ,Urological cancers Radboud Institute for Molecular Life Sciences [Radboudumc 15] ,Medicine ,Humans ,Stage (cooking) ,Non-muscle invasive bladder cancer ,Residual disease ,Progression ,Neoplasm Staging ,Retrospective Studies ,Univariate analysis ,Carcinoma, Transitional Cell ,business.industry ,Retrospective cohort study ,General Medicine ,Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10] ,Settore MED/24 ,medicine.anatomical_structure ,Urinary Bladder Neoplasms ,Concomitant ,business - Abstract
Item does not contain fulltext Introduction and objectives: The goals of transurethral resection of a bladder tumor (TUR) are to completely resect the lesions and to make a correct diagnosis in order to adequately stage the patient. It is well known that the presence of detrusor muscle in the specimen is a prerequisite to minimize the risk of under staging. Persistent disease after resection of bladder tumors is not uncommon and is the reason why the European Guidelines recommended a re-TUR for all T1 tumors. It was recently published that when there is muscle in the specimen, re-TUR does not influence progression or cancer specific survival. We present here the patient and tumor factors that may influence the presence of residual disease at re-TUR. Material and methods: In our retrospective cohort of 2451 primary T1G3 patients initially treated with BCG, pathology results for 934 patients (38.1%) who underwent re-TUR are available. 74% had multifocal tumors, 20% of tumors were more than 3 cm in diameter and 26% had concomitant CIS. In this subgroup of patients who underwent re-TUR, there was no residual disease in 267 patients (29%) and residual disease in 667 patients (71%): Ta in 378 (40%) and T1 in 289 (31%) patients. Age, gender, tumor status (primary/recurrent), previous intravesical therapy, tumor size, tumor multi-focality, presence of concomitant CIS, and muscle in the specimen were analyzed in order to evaluate risk factors of residual disease at re-TUR, both in univariate analyses and multivariate logistic regressions. Results: The following were not risk factors for residual disease: age, gender, tumor status and previous intravesical chemotherapy. The following were univariate risk factors for presence of residual disease: no muscle in TUR, multiple tumors, tumors >= 3 cm, and presence of concomitant CIS. Due to the correlation between tumor multi-focality and tumor size, the multivariate model retained either the number of tumors or the tumor diameter (but not both), p < 0.001. The presence of muscle in the specimen was no longer significant, while the presence of CIS only remained significant in the model with tumor size, p < 0.001. Conclusions: The most significant factors for a higher risk of residual disease at re-TUR in T1G3 patients are multifocal tumors and tumors more than 3 cm. Patients with concomitant CIS and those without muscle in the specimen also have a higher risk of residual disease. (C) 2021 AEU. Published by Elsevier Espana, S.L.U. All rights reserved.
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- 2021
34. Is There a Detrimental Effect of Antibiotic Therapy in Patients with Muscle-invasive Bladder Cancer Treated with Neoadjuvant Pembrolizumab?
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Andrea Necchi, Alberto Briganti, Renzo Colombo, Massimo Alfano, Laura Marandino, Filippo Pederzoli, Francesco Montorsi, Marco Bandini, Giuseppe Basile, Andrea Salonia, Andrea Gallina, Daniele Raggi, Pederzoli, F., Bandini, M., Raggi, D., Marandino, L., Basile, G., Alfano, M., Colombo, R., Salonia, A., Briganti, A., Gallina, A., Montorsi, F., and Necchi, A.
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Oncology ,medicine.medical_specialty ,medicine.drug_class ,Urology ,medicine.medical_treatment ,Antibiotics ,030232 urology & nephrology ,Pembrolizumab ,Antibodies, Monoclonal, Humanized ,Cystectomy ,03 medical and health sciences ,0302 clinical medicine ,Antineoplastic Agents, Immunological ,Internal medicine ,medicine ,Humans ,Drug Interactions ,Neoplasm Invasiveness ,Immune Checkpoint Inhibitors ,Bladder cancer ,business.industry ,Microbiota ,Muscle invasive ,Antibiotic ,Cancer ,Immunotherapy ,medicine.disease ,Neoadjuvant Therapy ,Anti-Bacterial Agents ,Urinary Bladder Neoplasms ,030220 oncology & carcinogenesis ,Concomitant ,Cohort ,business ,Muscle-invasive bladder cancer - Abstract
In locally advanced and metastatic malignancies, antibiotic (ATB) therapy has a negative effect on immunotherapy efficacy. Therefore, we aimed to evaluate whether ATB therapy and use of specific ATB classes with concomitant neoadjuvant pembrolizumab affected pathologic complete response (ypT0N0) and relapse-free survival (RFS) for patients with clinical T2–4N0M0 bladder cancer enrolled in the PURE-01 study. Of the 149 patients evaluated, 48 (32%) received any concomitant ATB therapy. The ATB class most commonly administered was fluoroquinolones (16 patients; 33%). In the ATB cohort, seven patients (15%) achieved ypT0N0 status, compared to 50 (50%; p < 0.001) in the untreated group. Moreover, ATB use was negatively associated with ypT0N0 status (odds ratio 0.18, 95% confidence interval [CI] 0.05–0.48; p = 0.001). The 24-mo RFS rate was 63% (95% CI 48-83%) in the ATB group versus 90% (95% CI 83–97) in the untreated group. We found that ATB use was associated with a higher recurrence rate (hazard ratio [HR] 2.64, 95% CI 1.08–6.50; p = 0.03). Exploratory analyses showed that fluoroquinolone use was associated with a higher recurrence rate (HR 3.28, 95% CI 1.12–9.60; p = 0.03). Our study revealed an association between ATB use and neoadjuvant immunotherapy efficacy in an intention-to-cure population, highlighting the need for future studies to better investigate this relationship. Patient summary: The efficacy of immunotherapy for cancer is influenced by several patient and tumor factors, including the use of antibiotics. We found that antibiotics taken at the same time as immunotherapy drugs were associated with lower rates of complete response and of recurrence-free survival among patients with muscle-invasive bladder cancer. These findings need to be confirmed in future studies.
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- 2020
35. Perioperative and oncologic outcomes of open radical nephrectomy and inferior vena cava thrombectomy with liver mobilization and Pringle maneuver for Mayo III level tumor thrombus: single institution experience
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Umberto Capitanio, Roberto Nicoletti, Renzo Colombo, Alberto Briganti, Alessandro Nini, Walter Cazzaniga, Massimo Freschi, Michele Paganelli, Francesco De Cobelli, Alberto Zangrillo, Cristina Carenzi, Filippo Pederzoli, Alessandro Larcher, Patrizio Rigatti, Rayan Matloob, Luca Aldrighetti, Guglielmo Cornero, Marco Salvioni, Francesco Cianflone, Marco Catena, Claudio Doglioni, Francesco Montorsi, Fabio Muttin, Roberta Lucianò, Roberto Bertini, Andrea Salonia, Nini, Alessandro, Muttin, Fabio, Cianflone, Francesco, Carenzi, Cristina, Lucianó, Roberta, Catena, Marco, Larcher, Alessandro, Salvioni, Marco, Cazzaniga, Walter, Pederzoli, Filippo, Matloob, Rayan, Colombo, Renzo, Paganelli, Michele, Salonia, Andrea, Briganti, Alberto, Doglioni, Claudio, Zangrillo, Alberto, De Cobelli, Francesco, Rigatti, Patrizio, Freschi, Massimo, Cornero, Guglielmo, Nicoletti, Roberto, Aldrighetti, Luca, Montorsi, Francesco, Capitanio, Umberto, and Bertini, Roberto
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medicine.medical_specialty ,Urology ,medicine.medical_treatment ,Vena Cava, Inferior ,Inferior vena cava ,Nephrectomy ,law.invention ,law ,Medicine ,Humans ,Carcinoma, Renal Cell ,Retrospective Studies ,Thrombectomy ,Mobilization ,Performance status ,business.industry ,Carcinoma ,Thrombosis ,Perioperative ,Pringle manoeuvre ,Intensive care unit ,Kidney Neoplasms ,renal cell ,Surgery ,medicine.vein ,Liver ,Nephrology ,Cohort ,business - Abstract
Background Scarce data are available regarding the technique and outcomes for patients with RCC and Mayo III caval thrombi. To report surgical and oncological outcomes of RCC patients with Mayo III thrombi treated with radical nephrectomy and thrombectomy after liver mobilization (LM) and Pringle Manoeuvre (PM). Methods Retrospective analysis of surgical technique, outcomes and cancer control in 19 patients undergoing LM and PM in a single tertiary care institution. Results Overall, 78% of the patients had performance status ECOG 1 and 58% had a comorbidity index >2. Median surgical time was 305 minutes (IQR 264-440). Intraoperative complications were reported for 39% of patients and postoperative ones for 58% (only Grade 1 and 2). Intensive Care Unit support was necessary in 16% of the cases. Median length of hospital stay was 9 days (IQR 7-11). Thirty- and 90-day mortality were 5% and 15%. Twoyear overall survival and cancer-specific survival were 60% and 62%, respectively. Conclusions We reported surgical techniques, intra and perioperative complications and follow-up in the largest cohort of RCC patients requiring LM and PM.
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- 2020
36. Effect of wearing a FFP2 mask on tear film and ocular surface temperature during soft contact lens wear and non-contact lens wear
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Giancarlo Montani, Renzo Colombo, and Francesca Treso
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Ophthalmology ,General Medicine ,Optometry - Published
- 2022
37. P0249ESSFSFDSVXVXCVXVVVVDVDDDCVVV
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Francesco Montorsi, Alberto Briganti, Andrea Salonia, Renzo Colombo, Andrea Gallina, Umberto Capitanio, Riccardo Vago, Arianna Bettiga, Daniele Raggi, Andrea Necchi, FEDERICO DI MARCO, and Francesco Trevisani
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Transplantation ,Nephrology - Abstract
Background and Aims The use of Pembrolizumab, a selective humanized IgG4 kappa monoclonal antibody that inhibits the programmed death-1 receptor, has been largely accepted, especially in a series of trials in patients with advanced melanoma and in other cancers such as renal cell carcinoma (RCC), lymphoma and others. However, few recent studies demonstrated that Pembrolizumab promotes several renal dysfuncion such as acute tubular injury, acute interstitial nephritis and minimal change disease. To better elucidate this topic, we analyzed the renal function’s aspects from the PURE-01 protocol’s data, a phase 2, open label study of neoadjuvant Pembrolizumab before radical cystectomy (RC) for muscle invasive urothelial bladder cancer (MIUB). Method PURE-01 study (NCT02736266) enrolled preliminary 143 patients (pts). Eligibility criteria included: T2-T4N0 stage and residual disease after transurethral reduction of bladder. Pts received 3 cycles of Pembrolizumab 200 mg 3 weekly before RC. Computed tomography scan, FDG-PET/CT scan, and bladder multipara metric magnetic resonance imaging were performed during screening and before RC. Radiologically non-responders to pembro (per investigator decision) are given 3 additional courses of dose-dense MVAC chemotherapy. The collected data consisted in: the serum creatinine at baseline, after the first, second and last cycle in order to obtain the renal function by using eGFR formula (CKD-EPI-2009) for each time step; urine test analysis data after each cycle; the T stage from cTNM (AJCC TNM system-2019) before the treatment; clinical data such as presence of Diabetes, Hypertension, Hydronephrosis, BMI. The main outcome of the study was to correlate the renal function variation (from the pre-treatment to each treatment cycle) with the other clinical variables. Data analysis were performed using linear model, Kruskal-Wallis test and Wilcoxon test with holm’s correction. Results The median age of the patients was 68 years (62-73), with the 13% of the pts as female. We observed the presence of Hypertension, Hydronephrosis, Diabetes, Overweight (BMI≥25 and BMI Conclusion We observed that the treatment with neoadjuvant pembrolizumab, in patients with bladder cancer, does not correlate with a decay of eGFR, but on the contrary, from our data, is associated with a small improvement of renal function, especially for those patients who presented higher stage of T and hydronephrosis before the treatment suggesting the Permbrolizumab’s safety in neoadjuvant therapy before RC for MIUBC from the nephrological point of view. This results needs more in-depths studies to be confirmed.
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- 2020
38. Does the administration of preoperative pembrolizumab lead to sustained remission post-cystectomy? First survival outcomes from the PURE-01 study
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Renzo Colombo, Daniele Raggi, Andrea Salonia, Giorgio Gandaglia, Ewan A. Gibb, Roberta Lucianò, Marco Bandini, J.S. Ross, Maurizio Colecchia, F. Montorsi, Marco Bianchi, Alberto Briganti, Andrea Gallina, Andrea Necchi, Nicola Fossati, Filippo Pederzoli, Laura Marandino, Bandini, M., Gibb, E. A., Gallina, A., Raggi, D., Marandino, L., Bianchi, M., Ross, J. S., Colecchia, M., Gandaglia, G., Fossati, N., Pederzoli, F., Luciano, R., Colombo, R., Salonia, A., Briganti, A., Montorsi, F., and Necchi, A.
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0301 basic medicine ,Oncology ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,event-free survival ,Pembrolizumab ,Antibodies, Monoclonal, Humanized ,Cystectomy ,Disease-Free Survival ,03 medical and health sciences ,0302 clinical medicine ,Interquartile range ,Internal medicine ,medicine ,Humans ,education ,radical cystectomy ,Retrospective Studies ,Chemotherapy ,education.field_of_study ,business.industry ,Proportional hazards model ,Hematology ,Confidence interval ,Neoadjuvant Therapy ,030104 developmental biology ,Treatment Outcome ,Urinary Bladder Neoplasms ,muscle-invasive bladder cancer ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Biomarker (medicine) ,pembrolizumab ,Neoplasm Recurrence, Local ,business ,pathological response - Abstract
Background Initial studies of preoperative checkpoint inhibition before radical cystectomy (RC) have shown promising pathologic complete responses. We aimed to analyze the survival outcomes of patients enrolled in the PURE-01 study ( NCT02736266 ). Patients and methods We report the results of the secondary end points of PURE-01 in the final population of 143 patients. In particular, we report the event-free survival (EFS) outcomes, defined as the time from the first cycle of pembrolizumab to radiographic disease progression precluding RC, initiation of neoadjuvant chemotherapy (NAC), recurrence after RC, or death from any cause. Other end points were recurrence-free survival (RFS) and overall survival (OS). Subgroup analyses were carried out, including pathological response category, clinical complete responses (CR) assessed via multiparametric magnetic resonance imaging (mpMRI), and molecular subtyping. Cox regression analyses for EFS were also carried out. Results After a median [interquartile range (IQR)] follow-up of 23 (15-29) months, 12- and 24-month EFS were 84.5% [95% confidence interval (CI): 78.5-90.9] and 71.7% (62.7-82). The prognosis was favorable across all the different pathological response subgroups, with the exception of ypN+ (N = 21), showing a 24-month RFS (95% CI) of 39.3% (19.2% to 80.5%). A statistically significant EFS benefit was observed in patients with a clinical CR (P = 0.002). Programmed cell-death-ligand-1 combined positive score was significantly associated with longer EFS in multivariable analyses. Four patients refused RC after clinical evidence of CR, and none of them have recurred after a median follow-up of 10 months (IQR: 11-15). The claudin-low subtype displayed a numerically longer EFS after pembrolizumab and RC compared with the other subtypes. Conclusions The EFS results from PURE-01 revealed that the immunotherapy effect was maintained post-RC in most patients. Pembrolizumab compared favorably with neoadjuvant chemotherapy, irrespective of the biomarker status. Molecular subtyping may be a useful tool to select the patients who are predicted to benefit the most from neoadjuvant pembrolizumab.
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- 2020
39. MP55-20 INCONGRUENCE BETWEEN TURB AND RADICAL CYSTECTOMY FINDINGS IN TERMS OF HISTOLOGICAL VARIANT IDENTIFICATION: ANALYSIS OF ALL POTENTIAL CLINICAL RISK FACTORS
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Andrea Gallina, Marco Bandini, Emanuele Zaffuto, Andrea Necchi, Francesco Montorsi, Filippo Pederzoli, Simone Scuderi, Giusy Burgio, Alberto Briganti, Andrea Salonia, Vincenzo Scattoni, Marco Moschini, Federico Dehò, Renzo Colombo, and Roberta Lucianò
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Cystectomy ,Oncology ,medicine.medical_specialty ,business.industry ,Urology ,medicine.medical_treatment ,Internal medicine ,medicine ,Identification (biology) ,business ,Clinical risk factor - Published
- 2020
40. MP55-15 SHOULD WE CONSIDER ALL AJCC STAGE IIIB BCA EQUAL? THE IMPACT OF LOCAL T STAGING IN N2 AND N3 PATIENTS AFTER RADICAL CYSTECTOMY
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Andrea Gallina, Giusy Burgio, Renzo Colombo, Marco Moschini, Nicola Fossati, Federico Dehò, Roberto Bertini, Emanuele Zaffuto, Marco Bandini, Vincenzo Scattoni, Andrea Necchi, Francesco Montorsi, Andrea Salonia, Alberto Briganti, Giorgio Gandaglia, and Simone Scuderi
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Cystectomy ,medicine.medical_specialty ,business.industry ,Urology ,medicine.medical_treatment ,medicine ,Ajcc stage ,business - Published
- 2020
41. MP55-19 IMPACT OF HISTOLOGICAL VARIANTS IN NODE POSITIVE PATIENTS TREATED WITH RADICAL CYSTECTOMY FOR BLADDER CANCER
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Andrea Gallina, Filippo Pederzoli, Burgio Giusy, Luca Afferi, Stefania Zamboni, Marco Bandini, Roberta Lucianò, Marco Moschini, Federico Dehò, Alberto Briganti, Emanuele Zaffuto, Renzo Colombo, Andrea Salonia, Simone Scuderi, Roberto Bertini, Andrea Necchi, and Francesco Montorsi
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Cystectomy ,medicine.medical_specialty ,Bladder cancer ,business.industry ,Urology ,Node (networking) ,medicine.medical_treatment ,medicine ,medicine.disease ,business - Published
- 2020
42. Sex-specific Alterations in the Urinary and Tissue Microbiome in Therapy-naïve Urothelial Bladder Cancer Patients
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Filippo Pederzoli, Manuela Nebuloni, Andrea Necchi, Francesco Montorsi, Andrea Gallina, Massimo Alfano, Alberto Briganti, Roberta Lucianò, Renzo Colombo, Massimo Clementi, Andrea Salonia, Roberto Ferrarese, Nicasio Mancini, Irene Locatelli, Virginia Amato, Elisa Alchera, Pederzoli, Filippo, Ferrarese, Roberto, Amato, Virginia, Locatelli, Irene, Alchera, Elisa, Lucianò, Roberta, Nebuloni, Manuela, Briganti, Alberto, Gallina, Andrea, Colombo, Renzo, Necchi, Andrea, Clementi, Massimo, Montorsi, Francesco, Mancini, Nicasio, Salonia, Andrea, and Alfano, Massimo
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DNA, Bacterial ,Male ,Burkholderia ,Urology ,Urinary system ,medicine.medical_treatment ,Urinary Bladder ,030232 urology & nephrology ,Physiology ,Urine ,medicine.disease_cause ,Cystectomy ,Bladder cancer ,Gender medicine ,Microbiome ,Therapy naive ,03 medical and health sciences ,0302 clinical medicine ,Sex Factors ,Klebsiella ,RNA, Ribosomal, 16S ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,skin and connective tissue diseases ,Aged ,Carcinoma, Transitional Cell ,business.industry ,Microbiota ,Middle Aged ,medicine.disease ,Sex specific ,Healthy Volunteers ,Oncology ,Urinary Bladder Neoplasms ,030220 oncology & carcinogenesis ,Case-Control Studies ,Surgery ,Female ,business ,Carcinogenesis - Abstract
Comprehensive characterization of the urinary and urothelium-bound microbiomes in bladder cancer (BCa) and healthy state is essential to understand how these local microbiomes may play a role in BCa tumorigenesis and response to therapy, as well as to explain sex-based differences in BCa pathobiology. Performing 16 s rDNA microbiome analysis on 166 samples (urine and paired bladder tissues) from therapy-naive BCa patients undergoing radical cystectomy and healthy controls, we defined (1) sex-specific microbiome differences in the urine and bladder tissue, and (2) representativeness of the tissue microenvironment by the voided urinary microbiome. The genus Klebsiella was more common in the urine of female BCa patients versus healthy controls, while no clinically relevant bacteria were found differently enriched in men. In tissues, the genus Burkholderia was more abundant in the neoplastic versus the non-neoplastic tissue in both sexes, suggesting a potential role in BCa pathobiology. Lastly, we found that the urinary microbiome shares >80% of the bacterial families present in the paired bladder tissue, making the urinary microbiome a fair proxy of the tissue bacterial environment. Patient summary We identified specific bacteria present in the urine and tissues of male and female bladder cancer patients. These novel data represent a first step toward understanding the influence of the bladder microbiome on the development of bladder cancer and on the response to intravesical and systemic therapies.
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- 2020
43. Comment on Hospital care in Departments defined as COVID-free: A proposal for a safe hospitalization protecting healthcare professionals and patients not affected by COVID-19
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Giuseppe Saitta, Luigi Broglia, Davide De Marchi, Guido Giusti, Silvia Proietti, Guglielmo Mantica, P. Bellinzoni, Giovanni Passaretti, Antonio Russo, Vincenzo Grasso, Salvatore Smelzo, Nazareno Suardi, Rosario Leonardi, Lorenzo Falcone, Franco Gaboardi, Renzo Colombo, Tafuri A., Minervini A., Celia A., Cindolo L., Schiavina R., Rocco B., Porreca A., and Antonelli A.
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Operating Rooms ,030232 urology & nephrology ,Air Microbiology ,lcsh:RC870-923 ,Infectious Disease Transmission, Professional-to-Patient ,0302 clinical medicine ,COVID-19 Testing ,Patient Admission ,Pandemic ,Health care ,Ambulatory Care ,Infection control ,Medicine ,Viral ,Everyday life ,Cross Infection ,030219 obstetrics & reproductive medicine ,Hospital care ,Hospitalization ,Italy ,Air Pollution, Indoor ,Surgical Procedures, Operative ,Medical emergency ,Coronavirus Infections ,Human ,Infectious Disease Transmission, Patient-to-Professional ,Coronavirus disease 2019 (COVID-19) ,Urology ,Pneumonia, Viral ,MEDLINE ,Hospital Departments ,Guidelines as Topic ,Phase (combat) ,03 medical and health sciences ,Betacoronavirus ,Ambulatory care ,Paper report ,Humans ,Hospital Design and Construction ,Personal protective equipment ,Personal Protective Equipment ,Pandemics ,Aerosols ,Surgical team ,Infection Control ,Betacoronaviru ,Health professionals ,Coronavirus Infection ,business.industry ,Clinical Laboratory Techniques ,SARS-CoV-2 ,Protective Devices ,COVID-19 ,Pneumonia ,lcsh:Diseases of the genitourinary system. Urology ,medicine.disease ,Ventilation ,Surgical mask ,Covid 19 ,Pandemy ,Surgery ,Endoscopy ,Filtration ,business - Abstract
The COVID-19 pandemic influenced the normal course of clinical practice leading to significant delays in the delivery of healthcare services for patients non affected by COVID-19. In the near future, it will be crucial to identify facilities capable of providing health care in compliance with the safety of healthcare professionals, administrative staff and patients. All the staff involved in the project of a Covid-free hospital should be subjected to a diagnostic swab for COVID-19 before the beginning of healthcare activity and then periodically in order to avoid the risk of contamination of patients during the process of care. The modifications of various activities involved in the process of care are described: outpatient care, reception of inpatients, inpatient ward and operating room. For outpatient care, modality of appointment procedure, characteristics of waiting room and personal protective equipment (PPE) for healthcare professionals and administrative staff are presented. Reception of inpatients shall be conditional on a negative swab for COVID-19 obtained with a drive-in procedure. The management of the operating room represents the most crucial step of the patient's care process. The surgical team should be restricted and monitored with periodic swabs; surgical procedures should be performed by experienced surgeons according to standard procedures; surgical training experimental treatments and research protocols should be suspended. Adequate personal protective equipment and measures to reduce aerosolization in the operating room (closed circuits, continuous cycle insufflators, fume extraction) should be adopted. Prevention of possible transmission of the virus during procedures in open, laparoscopic and endoscopic surgery is to use a multi-tactic approach, which includes correct filtration and ventilation of the operating room, the use of appropriate PPE (FFP3 plus surgical mask and protective visor for all the staff working in the operating room) and smoke evacuation devices with a suction and filter system. on behalf of the UrOP Executive CommitteeGiuseppe Ludovico, Angelo Cafarelli, Ottavio De Cobelli, Ferdinando De Marco, Giovanni Ferrari, Stefano Pecoraro, Angelo Porreca, Domenico Tuzzolo
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- 2020
44. The Value of Multiparametric Magnetic Resonance Imaging Sequences to Assist in the Decision Making of Muscle-invasive Bladder Cancer
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Maurizio Colecchia, Renzo Colombo, Andrea Gallina, Alberto Briganti, Giuseppina Calareso, Nicola Fossati, Patrizia Giannatempo, Antonella Messina, Francesco De Cobelli, Umberto Capitanio, Giorgio Gandaglia, Daniele Raggi, Laura Marandino, Marco Bandini, Andrea Necchi, Francesco Montorsi, Andrea Salonia, Filippo Pederzoli, Bandini, Marco, Calareso, Giuseppina, Raggi, Daniele, Marandino, Laura, Colecchia, Maurizio, Gallina, Andrea, Giannatempo, Patrizia, Pederzoli, Filippo, Gandaglia, Giorgio, Fossati, Nicola, Capitanio, Umberto, Colombo, Renzo, Salonia, Andrea, Briganti, Alberto, Montorsi, Francesco, De Cobelli, Francesco, Messina, Antonella, and Necchi, Andrea
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medicine.medical_specialty ,Biparametric magnetic resonance imaging ,Urology ,medicine.medical_treatment ,Population ,Decision Making ,030232 urology & nephrology ,Pembrolizumab ,Noninvasive response assessment ,Cystectomy ,03 medical and health sciences ,0302 clinical medicine ,Multiparametric magnetic resonance imaging ,Medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Multiparametric Magnetic Resonance Imaging ,education ,education.field_of_study ,Bladder cancer ,medicine.diagnostic_test ,business.industry ,Muscles ,Muscle invasive ,Area under the curve ,Dynamic contrast enhancement ,Reproducibility of Results ,Magnetic resonance imaging ,medicine.disease ,Oncology ,Urinary Bladder Neoplasms ,030220 oncology & carcinogenesis ,Surgery ,Bladder magnetic resonance imaging ,Radiology ,business ,Muscle-invasive bladder cancer - Abstract
Interim data from the PURE-01 study, using pembrolizumab before radical cystectomy in muscle-invasive bladder cancer (MIBC), suggested that multiparametric magnetic resonance imaging (mpMRI) was able to predict the pathologic response. Owing to the availability of novel effective therapies in MIBC, the possibility to assess tumor response easily has become exceedingly important. The primary objective of the present study was to evaluate the association between individual and combined MRI sequences, and the pathologic response in the final PURE-01 population. Images were internally evaluated and the diagnostic performance was analyzed for separate sequences, along with their combination. From February 2017 to December 2019, 143 patients were enrolled in PURE-01, and 123 with suitable paired imaging assessments before and after pembrolizumab tests (N = 246 mpMRI in total) were analyzed in relation to the pathologic response. The area under the curve (AUC) of the combination of all sequences to predict ypT0ypN0 response was 0.74. By excluding dynamic contrast enhancement (DCE) assessment, the AUC was 0.74. When looking at ypT1/a/is ypN0 response, the AUC was 0.87 in both cases. Without DCE, 95% of patients with no evidence of disease resulted in ypT1/a/is ypN0 and 65% ypT0ypN0 responders. In conclusion, the final results confirmed the reliability of mpMRI and suggested the opportunity to avoid intravenous gadolinium contrast to personalize bladder-sparing strategies in radiologically complete responders. Patient summary We evaluated the reliability of multiparametric bladder magnetic resonance imaging to predict the pathologic response to pembrolizumab administered before radical cystectomy in muscle-invasive bladder cancer. We observed that this radiologic examination is promising in the attempt to identify opportunities to spare the bladder in selected, radiologically defined complete responders. We also observed that the use of intravenous gadolinium contrast can be avoided in future studies. ClinicalTrials.gov, number NCT02736266.
- Published
- 2020
45. Predictive factors of the absence of residual disease at repeated transurethral resection of the bladder. Is there a possibility to avoid it in well-selected patients?
- Author
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Paolo Gontero, Shahrokh F. Shariat, Alberto Briganti, Simone Mazzoli, Giuseppe Pizzuto, David D'Andrea, Vincenzo Altieri, Andrea Giordano, Marco Moschini, Renzo Colombo, Rodolfo Hurle, Francesco Soria, Soria, F., D'Andrea, D., Moschini, M., Giordano, A., Mazzoli, S., Pizzuto, G., Hurle, R., Colombo, R., Briganti, A., Altieri, V., Shariat, S. F., and Gontero, P.
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Detrusor muscle ,Male ,medicine.medical_specialty ,Neoplasm, Residual ,Urology ,030232 urology & nephrology ,Cystectomy ,Nomogram ,Re-TURB ,T1HG bladder cancer ,03 medical and health sciences ,0302 clinical medicine ,Urethra ,Predictive Value of Tests ,Medicine ,Humans ,Prospective cohort study ,Aged ,Neoplasm Staging ,Retrospective Studies ,Bladder cancer ,business.industry ,Carcinoma in situ ,Patient Selection ,Retrospective cohort study ,Predictive factors ,Second look TURB ,Middle Aged ,medicine.disease ,medicine.anatomical_structure ,Oncology ,Urinary Bladder Neoplasms ,030220 oncology & carcinogenesis ,Concomitant ,Cohort ,Retreatment ,Female ,business - Abstract
Purpose To evaluate the predictive factors of pT0 at repeated transurethral resection of the bladder (re-TURB) in pT1 high-grade (HG) nonmuscle invasive bladder cancer in order to explore the possibility to avoid it in well-selected patients. Methods This multicenter retrospective study included patients with pT1HG nonmuscle invasive bladder cancer from 4 different centers who underwent a complete TURB. Re-TURB was defined as a second resection which involved the site of the first TURB performed within 2-6 weeks from the previous resection. A multivariable logistic-regression model was performed to evaluate the predictors of pT0 at re-TURB. A nomogram was built to calculate the probability of obtaining a negative histology at re-TURB. The performance of the nomogram and its net benefit were tested with the decision curve analysis. Results Overall, 321 patients were included in the study. On multivariable logistic regression, detrusor muscle in the specimen (HR 1.99, P = 0.02), concomitant carcinoma in situ (HR 0.29, P = 0.005) and resection performed with en-bloc technique (HR 7.71, P = 0.01) were independent predictors of pT0 at re-TURB. Decision curve analysis showed a net benefit for the nomogram for each probability over 0.35 compared to the strategy to perform a re-TURB in all pT1HG tumors. Conclusions The presence of detrusor muscle in TURB specimen, the absence of concomitant carcinoma in situ and the en-bloc resection were able to predict a negative histology at re-TURB, opening the door to the possibility to avoid it in an extremely well-selected cohort of patients. External validations and prospective studies are urgently needed.
- Published
- 2020
46. Clinical Lymphadenopathy in Urothelial Cancer: A Transatlantic Collaboration on Performance of Cross-sectional Imaging and Oncologic Outcomes in Patients Treated with Radical Cystectomy Without Neoadjuvant Chemotherapy
- Author
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Francesco Montorsi, Brian Hu, Alessandro Morlacco, Alberto Briganti, Siamak Daneshmand, R. Jeffrey Karnes, Renzo Colombo, Marco Moschini, Igor Frank, Moschini, Marco, Morlacco, Alessandro, Briganti, Alberto, Hu, Brian, Colombo, Renzo, Montorsi, Francesco, Frank, Igor, Daneshmand, Siamak, and Karnes, R. Jeffrey
- Subjects
Male ,medicine.medical_treatment ,030232 urology & nephrology ,Lymphadenopathy ,0302 clinical medicine ,Lymph node ,education.field_of_study ,Urinary bladder ,medicine.diagnostic_test ,Bladder cancer ,Hazard ratio ,Middle Aged ,Treatment Outcome ,medicine.anatomical_structure ,Lymphatic Metastasis ,030220 oncology & carcinogenesis ,Preoperative Period ,Female ,Lymph node invasion ,medicine.medical_specialty ,Urology ,Urinary Bladder ,Population ,Clinical lymph node ,Lymph node metastases ,Radical cystectomy ,Aged ,Carcinoma, Transitional Cell ,Cystectomy ,Disease-Free Survival ,Humans ,Lymph Nodes ,Neoplasm Invasiveness ,Pelvis ,Predictive Value of Tests ,Urinary Bladder Neoplasms ,03 medical and health sciences ,Lymph node metastase ,medicine ,education ,Proportional hazards model ,business.industry ,Carcinoma ,Magnetic resonance imaging ,medicine.disease ,Surgery ,Transitional Cell ,business - Abstract
Background: Data regarding clinical node metastases (cN+) in patients undergoing radical cystectomy (RC) are scarce. Objective: To evaluate the performance of conventional imaging in detecting cN+ and analyze the impact of cN+ on survival among patients treated with RC without neoadjuvant chemotherapy (NAC). Design, setting, and participants: Data from three independent centers of consecutive patients with bladder cancer treated with RC without NAC were analyzed. Outcome measurements and statistical analysis: cN+ was defined as pelvic nodes >8. mm or abdominal nodes >10. mm in maximum short-axis diameter as detected via preoperative computed tomography or magnetic resonance imaging. Performance characteristics were evaluated considering pN+ disease as the reference standard. Multivariable Cox regression analyses were performed for prediction of survival. Results and limitations: Overall, 196 patients (7.1%) had cN+ disease before RC and pN+ status was confirmed for 122 of them (62.2%). cN+ status in the overall population had sensitivity of 18% and specificity of 96% with a calculated area under the curve of 57%. The median follow-up was 108 mo. On multivariable analyses, cN+pN+ (hazard ratio [HR] 1.84, 95% confidence interval [CI] 1.26-2.68) and cN-pN+ (HR 2.36, 95% CI 1.90-2.92) were predictors of CSM (both . p . 0.2). Conclusions: Our study confirms the poor accuracy of conventional preoperative imaging in assessing nodal disease status. cN status had no independent impact on survival when all confounders were evaluated, and potentially curative treatments should not be withheld on the basis of clinical nodal status alone. Patient summary: The accuracy of conventional imaging techniques for detection of pathologic lymph node-positive disease before radical cystectomy for bladder cancer is suboptimal. The presence of clinical lymph node positivity on preoperative imaging is not an independent predictor of oncologic outcomes, and if the node invasion is not confirmed at radical cystectomy, these patients may have good long-term outcomes. Conventional imaging techniques are suboptimal in detecting preoperative node metastases. The presence of node metastases on preoperative imaging is not a predictor of poor oncologic outcomes if the node invasion is not confirmed pathologically after surgery.
- Published
- 2018
47. Surgical treatment for clinical node-positive bladder cancer patients treated with radical cystectomy without neoadjuvant chemotherapy
- Author
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Renzo Colombo, Andrea Gallina, Alberto Briganti, Andrea Salonia, Julian Cornelius, Paolo Dell'Oglio, Emanuele Zaffuto, Marco Moschini, Shahrokh F. Shariat, Francesco Montorsi, Agostino Mattei, Moschini, Marco, Mattei, Agostino, Cornelius, Julian, Shariat, Shahrokh F., Dell’Oglio, Paolo, Zaffuto, Emanuele, Salonia, Andrea, Montorsi, Francesco, Briganti, Alberto, Colombo, Renzo, and Gallina, Andrea
- Subjects
Male ,Nephrology ,Clinical metastase ,medicine.medical_specialty ,Survival ,Urology ,medicine.medical_treatment ,Urinary Bladder ,Metastase ,030232 urology & nephrology ,Kaplan-Meier Estimate ,Cystectomy ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Prospective Studies ,Lymph node ,Aged ,Neoplasm Staging ,Carcinoma, Transitional Cell ,Chemotherapy ,Bladder cancer ,Proportional hazards model ,business.industry ,Hazard ratio ,Multimodal therapy ,Middle Aged ,medicine.disease ,Radical cystectomy ,Treatment Outcome ,medicine.anatomical_structure ,Urinary Bladder Neoplasms ,Lymphatic Metastasis ,030220 oncology & carcinogenesis ,Lymph Node Excision ,Female ,Lymph Nodes ,business ,Clinical node positive - Abstract
Objective: Growing literature supports good survival expectancies in bladder cancer (BCa) patients affected by clinical node metastases (cN+) treated with multimodal therapy. We evaluated the role of adjuvant chemotherapy in cN+BCa patients treated with radical cystectomy (RC) and pelvic lymph node dissection (PLND) without neoadjuvant chemotherapy (NAC). Methods: We evaluated a total of 192 patients with BCa and cN+. All patients were treated with RC and PLND without NAC between 2001 and 2013. KaplanâMeier analyses and Cox regression analyses were used to assess the impact of adjuvant chemotherapy (ACT) on recurrence, cancer-specific mortality (CSM) and overall mortality (OM) after surgery. Results: Overall, 99 patients (51.6%) were found without node metastases at RC, while 18 (9.4%), 58 (30.2%) and 17 (8.9%) patients were found pN1, pN2 and pN3, respectively. With a median follow-up of 48 months, in cN+ patients we recorded 5-year recurrence, CSM and OM of 55, 53 and 51%, respectively. Overall, 36 (18.8%) patients were treated with adjuvant chemotherapy. At univariable analyses, ACT was associated with improved overall survival [Hazard ratio (HR): 0.42, confidence interval (CI) 0.20â0.86, p = 0.02) in pN+ subgroup only. These results were confirmed at multivariable analyses, where ACT was associated with improved CSS (HR: 0.45, CI 0.21â0.89, p = 0.03) and OS (HR: 0.37, CI 0.17â0.81, p = 0.01). Conclusions: We report good survival outcomes in cN+ patients treated with RC. The use of ACT after surgery increases survival expectancies, especially in those patients with pathological node disease. Our data need to be further evaluated in prospective setting.
- Published
- 2018
48. Identifying the most informative cut-off of psa to define biochemical recurrence after radical prostatectomy: A stage-by-stage analysis
- Author
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Carlo Andrea Bravi, Simone Scuderi, Giuseppe Rosiello, Elio Mazzone, G. Gandaglia, A. Briganti, Gabriele Sorce, F. Montorsi, Renzo Colombo, Luigi Nocera, Vito Cucchiara, Giuseppe Cirulli, N. Fossati, Armando Stabile, Francesco Pellegrino, and Francesco Barletta
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Biochemical recurrence ,medicine.medical_specialty ,business.industry ,Prostatectomy ,Urology ,medicine.medical_treatment ,Medicine ,Stage (cooking) ,business - Published
- 2021
49. 68Ga-PSMA PET/CT for Recurrent Prostate Cancer after Radical Prostatectomy: What’s next? Analysis from a single, high volume tertiary referral center
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Elio Mazzone, P.I. Karakiewicz, Daniele Robesti, Vito Cucchiara, Andrea Necchi, Renzo Colombo, A. Briganti, F. Montorsi, N. Fossati, Giuseppe Rosiello, Armando Stabile, G. Gandaglia, Riccardo Leni, Marco Moschini, and E. Camisassa
- Subjects
PET-CT ,medicine.medical_specialty ,business.industry ,Prostatectomy ,Urology ,medicine.medical_treatment ,68ga psma ,Referral center ,Medicine ,Recurrent prostate cancer ,Radiology ,business ,Volume (compression) - Published
- 2021
50. Incidence and effect of variant histology on oncological outcomes in patients with bladder cancer treated with radical cystectomy
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Rocco Damiano, Alberto Briganti, Paolo Dell'Oglio, Andrea Salonia, Renzo Colombo, Shahrokh F. Shariat, Agostino Mattei, Francesco Soria, Giorgio Gandaglia, Marco Moschini, Andrea Gallina, Tobias Klatte, Roberta Lucianò, Francesco Montorsi, Moschini, Marco, Dell'Oglio, Paolo, Luciano, Roberta, Gandaglia, Giorgio, Soria, Francesco, Mattei, Agostino, Klatte, Tobia, Damiano, Rocco, Shariat, Shahrokh F., Salonia, Andrea, Montorsi, Francesco, Briganti, Alberto, Colombo, Renzo, and Gallina, Andrea
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Male ,medicine.medical_specialty ,Urology ,medicine.medical_treatment ,030232 urology & nephrology ,Cystectomy ,Bladder cancer ,Histological variants ,Radical cystectomy ,Aged ,Female ,Humans ,Incidence ,Treatment Outcome ,Urinary Bladder Neoplasms ,03 medical and health sciences ,0302 clinical medicine ,Histological variant ,medicine ,In patient ,business.industry ,Proportional hazards model ,Incidence (epidemiology) ,Hazard ratio ,Confounding ,medicine.disease ,Oncology ,030220 oncology & carcinogenesis ,Variant histology ,business - Abstract
Introduction We sought to describe incidence of histological variants after radical cystectomy (RC) due to bladder cancer (BCa). Moreover, we investigated survival outcomes accounting for this parameter. Methods We retrospectively evaluated data from 1,067 patients with BCa treated with RC between 1990 and 2013 at a single tertiary care referral center. All specimen were evaluated by dedicated uropathologists. Univariable and multivariable Cox regression analyses tested the effect of different histopathological variant on recurrence, cancer-specific mortality (CSM), and overall mortality (OM) after accounting for all available confounders. Results Of 1,067 patients, 729 (68.3%) harbored pure urothelial BCa while 338 (31.7%) were found to have a variant. Considering uncommon variants, 21 (2.0%) were sarcomatoid, 10 (0.9%) lymphoepitelial, 19 (1.8%) small cell, 109 (10.2%) squamous, 89 (8.3%) micropapillary, 23 (2.2%) glandular, 34 (3.2%) mixed variants, and 33 (3.1%) were found with other types of variants. With a median follow-up of 6.2 years, 343 recurrence, 365 CSM, and 451 OM were recorded, respectively. At multivariable Cox regression analyses, the presence of small cell variant was associated with higher recurrence (hazard ratio [HR] = 3.47, P 0.1). Conclusion Our study confirms that histological variant is not an infrequent event at RC specimen. However, in our single-center series, only patients found with small cell variant were associated with a negative effect on survival after RC.
- Published
- 2017
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