RESUMEN
OBJECTIVE: To report on the surgical safety and quality of pelvic lymph node dissection (PLND) in patients treated with radical cystectomy (RC) and PLND for muscle-invasive bladder cancer (MIBC) after neoadjuvant chemo-immunotherapy. PATIENTS AND METHODS: The Swiss Group for Clinical Cancer Research (SAKK) 06/17 was an open-label single-arm phase II trial including 61 cisplatin-fit patients with clinical stage (c)T2-T4a cN0-1 operable urothelial MIBC or upper urinary tract cancer. Patients received neoadjuvant cisplatin/gemcitabine and durvalumab followed by surgery. Prospective quality assessment of surgeries was performed via central review of intraoperative photographs. Postoperative complications were assessed using the Clavien-Dindo Classification. Data were analysed descriptively. RESULTS: A total of 50 patients received RC and PLND. All patients received neoadjuvant chemo-immunotherapy. The median (interquartile range) number of lymph nodes removed was 29 (23-38). No intraoperative complications were registered. Grade ≥III postoperative complications were reported in 12 patients (24%). Complete nodal dissection (100%) was performed at the level of the obturator fossa (bilaterally) and of the left external iliac region; in 49 patients (98%) at the internal iliac region and at the right external iliac region; in 39 (78%) and 38 (76%) patients at the right and left presacral level, respectively. CONCLUSION: This study supports the surgical safety of RC and PLND following neoadjuvant chemo-immunotherapy in patients with MIBC. The extent and completeness of protocol-defined PLND varies between patients, highlighting the need to communicate and monitor the surgical template.
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Anticuerpos Monoclonales , Protocolos de Quimioterapia Combinada Antineoplásica , Cisplatino , Cistectomía , Desoxicitidina , Gemcitabina , Escisión del Ganglio Linfático , Terapia Neoadyuvante , Neoplasias de la Vejiga Urinaria , Humanos , Cistectomía/métodos , Escisión del Ganglio Linfático/métodos , Masculino , Neoplasias de la Vejiga Urinaria/cirugía , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/patología , Cisplatino/administración & dosificación , Cisplatino/uso terapéutico , Femenino , Anciano , Persona de Mediana Edad , Desoxicitidina/análogos & derivados , Desoxicitidina/administración & dosificación , Desoxicitidina/uso terapéutico , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Pelvis , Estudios ProspectivosRESUMEN
INTRODUCTION: Limitations in tumor staging and the heterogeneous natural evolution of pT1 urothelial bladder carcinoma (UBC) make the choice of treatment challenging. We evaluated if histopathological substaging (pT1a, pT1b, and pT1c) helps predict disease recurrence, progression, and overall survival following transurethral resection of the bladder (TURB). METHODS: We included 239 consecutive patients diagnosed with pT1 UBC at TURB in a single institution since 2001. Each sample was interpreted by our specialized uropathologists trained to subclassify pT1 stage. Three groups were distinguished according to the degree of invasion: T1a (up to the muscularis mucosae [MM]), T1b (into the MM), and T1c (beyond the MM). RESULTS: T1 substaging was possible in 217/239 (90%) patients. pT1a, b, and c occurred in 124 (57), 59 (27), and 34 (16%), respectively. The median follow-up was 3.1 years, with a cumulative recurrence rate of 52%, progression rate of 20%, and survival rate of 54%. Recurrence was not significantly associated with tumor substage (p = 0.61). However, the Kaplan-Meier survival analysis showed a significantly higher progression rate among T1b (31) and T1c (26%) tumors than T1a (13%) (log-rank test: p = 0.001) stages. In a multivariable model including gender, age, ASA score, smoking, tumor grade, and presence of carcinoma in situ, T1 substage was the single variable significantly associated with progression-free survival (HR 1.7, p = 0.005). Nineteen patients (9%) needed radical cystectomy; among them, 12/19 (63%) had an invasive tumor. Overall survival was significantly associated with tumor substaging (p = 0.001). CONCLUSION: Histopathological substaging of pT1 UBC is significantly associated with tumor progression and overall survival and therefore appears to be a useful prognostic tool to counsel patients about treatment options.
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Carcinoma de Células Transicionales/mortalidad , Carcinoma de Células Transicionales/patología , Neoplasias de la Vejiga Urinaria/mortalidad , Neoplasias de la Vejiga Urinaria/patología , Anciano , Anciano de 80 o más Años , Carcinoma de Células Transicionales/cirugía , Cistectomía , Progresión de la Enfermedad , Femenino , Humanos , Masculino , Recurrencia Local de Neoplasia/epidemiología , Estadificación de Neoplasias , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Tasa de Supervivencia , Neoplasias de la Vejiga Urinaria/cirugíaRESUMEN
Percutaneous nephrolithotomy (PCNL) was at first indicated for larger renal stones. Technological progress allowed a significant improvement of the available equipment, mostly to miniaturize the devices. However, this should not affect the stone clearance. Many different techniques arised aiming to reduce the complications of PCNL, in particular the risk of haemorrhage. As it becomes less invasive, the indications are greatly expanded, and a growing number of patients will benefit from it in the future. This explains the significance of knowing this procedure in continual development in greater detail.
La néphrolithotomie percutanée (NLPC) était initialement indiquée pour les calculs rénaux de grande taille. Les progrès technologiques ont permis une amélioration significative du matériel disponible, principalement dans le sens de la miniaturisation des instruments. Ceci ne doit cependant pas se faire au détriment de la plus grande clairance possible des calculs. Une multitude de techniques sont apparues sur le marché dans l'optique de diminuer les complications possibles des NLPC, en particulier le risque hémorragique. L'invasivité de cette intervention étant réduite, ses indications s'en trouvent considérablement élargies et un nombre croissant de patients vont en bénéficier à l'avenir. Ceci explique l'intérêt de connaître un peu mieux cette technique chirurgicale en constante évolution.
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Cálculos Renales/cirugía , Nefrolitotomía Percutánea , Humanos , Miniaturización , Resultado del TratamientoRESUMEN
Minimally invasive surgery has recently gained popularity. This paradigm shift involves a series of potential difficulties from the surgeon's perspective. With recent developments these obstacles are gradually being overcomed. Recent navigation systems offer major improvements in the way information is acquired, displayed, and integrated into the surgical workflow through augmented reality. Finally, the progress of robotics has helped to improve the minimally invasive dexterity and competence of the surgeon. This article sumarizes the main and most recent developments in the areas mentionned above, analyzes the current limits that still need to be addressed, and suggests possible future directions.
La réalité augmentée en urologie a gagné en popularité ces dernières années. Des systèmes de navigation récents offrent des améliorations majeures en termes d'information acquise, qui est affichée et intégrée dans le flux de travail chirurgical, grâce à la réalité augmentée. De même, le progrès de la robotique a contribué à améliorer la dextérité et la compétence mini-invasives du chirurgien. Cet article résume les principaux et les plus récents développements dans les domaines susmentionnés, analyse les limites actuelles qui doivent encore être abordées et suggère des orientations futures possibles.
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Procedimientos Quirúrgicos Mínimamente Invasivos , Cirugía Asistida por Computador , Procedimientos Quirúrgicos Urológicos , Predicción , Humanos , Procedimientos Quirúrgicos Robotizados , Procedimientos Quirúrgicos Urológicos/métodosRESUMEN
PURPOSE: The aim of our study was to evaluate the expression pattern of HER2 overexpression in patients with upper tract urothelial carcinoma (UTUC) and to evaluate its association with clinical outcomes. METHODS: This multicenter retrospective study included 732 patients treated with radical nephroureterectomy for UTUC. HER2 expression was assessed using immunohistochemistry and scored according to the HercepTest: Scores of 0 or 1 were considered negative and 2 or 3 as positive. To qualify for 2 scoring, complete membrane staining of more than 10 % of tumor cells at a moderate intensity had to be observed. RESULTS: HER2 was overexpressed in 262 (35.8 %) patients. It was associated with pathologic characteristics such as more advanced T stage (p < 0.001), presence of lymph node metastasis (p = 0.006), high-grade tumor (p < 0.001), tumor necrosis (p = 0.01) and lymphovascular invasion (p = 0.02). Patients with HER2 overexpression had a 1.66-fold increased risk of experiencing disease recurrence (95 % CI 1.24-2.24, p = 0.001), 1.55-fold increased risk of death (95 % CI 1.21-1.99, p = 0.001) and 1.81-fold increased risk of cancer-specific death (95 % CI 1.33-2.48, p < 0.001). On multivariable analysis that adjusted for the effects of standard clinicopathologic variables, HER2 overexpression remained associated with disease recurrence (p = 0.04), overall (p = 0.02) and cancer-specific mortality (p = 0.02). CONCLUSIONS: Approximately, one-third of UTUC patients overexpressed HER2. HER2 overexpression was associated with features of clinically and biologically aggressive disease as well as prognosis. HER2 may represent a good marker for therapeutic risk stratification and potentially a target for therapy in some UTUC tumors.
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Carcinoma de Células Transicionales/genética , Regulación Neoplásica de la Expresión Génica , Genes erbB-2/fisiología , Neoplasias Renales/genética , Neoplasias Ureterales/genética , Anciano , Carcinoma de Células Transicionales/mortalidad , Femenino , Humanos , Neoplasias Renales/mortalidad , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Neoplasias Ureterales/mortalidadRESUMEN
INTRODUCTION: The study aimed to evaluate 3 different modalities of transrectal ultrasound (TRUS)-guided prostate biopsies (PBs; 2D-, 3D- and targeted 3D-TRUS with fusion to MRI - T3D). Primary end point was the detection rate of prostate cancer (PC). Secondary end point was the detection rate of insignificant PC according to the Epstein criteria. PATIENTS AND METHODS: Inclusion of 284 subsequent patients who underwent 2D-, 3D- or T3D PB from 2011 to 2015. All patients having PB for initial PC detection with a serum prostate-specific antigen value ≤20 ng/ml were included. Patients with T4 and/or clinical and/or radiological metastatic disease, so as these under active surveillance were excluded. RESULTS: Patients with T3D PB had a significantly higher detection rate of PC (58 vs. 19% for 2D and 38% for 3D biopsies; p = 0.001), with no difference in Gleason score distribution (p = 0.644), as well as detection rate of low-risk cancers (p = 0.914). Main predictive factor for positive biopsies was the technique used, with respectively a 3- and 8-fold higher detection rate in the 3D- and T3D group. For T3D-PB, there was a significant correlation between radiological cancer suspicion (Prostate Imaging Reporting and Data System Score) and cancer detection rate (p = 0.02). CONCLUSIONS: T3D PB should be preferred over 2D PB and 3D PB in patients with suspected PC as it improves the cancer detection rate.
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Imagenología Tridimensional , Imagen por Resonancia Magnética , Próstata/diagnóstico por imagen , Próstata/patología , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Ultrasonografía Intervencional , Anciano , Humanos , Biopsia Guiada por Imagen/métodos , Masculino , Persona de Mediana Edad , Recto , Estudios RetrospectivosRESUMEN
Non-invasive urothelial carcinoma of the bladder is known for its significant rate of recurrence after transurethral resection (TURB) even after adjuvant intravesical chemotherapy or immunoprophylaxis. Therefore, new and more effective approaches for the management of non-invasive bladder tumors have been developed and are progressively introduced in clinical practice. Recently, the endovesical administration of a combined regimen using a cytostatic agent and microwave-induced hyperthermia appears to be highly efficient and possibly superior to intravesical chemotherapy alone for none invasive bladder cancer.
Le carcinome urothélial non invasif de la vessie (n'envahissant pas le détrusor) est grevé d'un risque de récidive significatif malgré les instillations endovésicales adjuvantes avec des agents chimio- ou immunothérapeutiques suite à la résection endoscopique de la tumeur vésicale. Dans ce contexte, de nouvelles approches thérapeutiques potentiellement plus efficaces ont été récemment développées et sont progressivement introduites dans la pratique clinique courante. L'une de ces dernières est la combinaison d'une hyperthermie endovésicale à l'instillation intravésicale d'agents chimiothérapeutiques classiquement administrés lors de la prise en charge des cancers non invasifs. Ce nouveau traitement apparaît être d'une efficacité supérieure à celle de l'instillation simple d'agents chimiothérapeutiques endovésicaux.
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Hipertermia Inducida , Microondas , Neoplasias de la Vejiga Urinaria , Administración Intravesical , Terapia Combinada , Humanos , Microondas/uso terapéutico , Recurrencia Local de Neoplasia , Neoplasias de la Vejiga Urinaria/terapiaRESUMEN
Known for its significant morbidity, radical cystectomy must improve minimally invasively. Rapidly but sporadically initiated at the beginning of the robotic era 15 years ago, laparoscopic cystectomy-urinary diversion has slowly progressed technically. It is actually optimally standardized to be entirely performed intra-corporealy. Its technical difficulty remaining high, robotic cystectomy should remain in expert hands with a significant recruitement to remain performant.
Connue pour sa morbidité significative, la cystectomie radicale se doit d'évoluer vers des techniques mini-invasives. Rapidement initiée sporadiquement, au début de l'ère robotique il y a 15 ans, la cystectomie-dérivation par laparoscopie sous assistance robotisée a lentement progressé dans sa mise au point technique, actuellement standardisée de manière optimale pour être réalisée intégralement intracorporellement. Sa difficulté technique restant élevée, la cystectomie robotisée doit donc rester en mains expertes disposant d'un recrutement suffisant pour demeurer performantes.
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Laparoscopía , Procedimientos Quirúrgicos Robotizados , Neoplasias de la Vejiga Urinaria , Derivación Urinaria , Cistectomía , Humanos , Resultado del Tratamiento , Neoplasias de la Vejiga Urinaria/cirugía , Derivación Urinaria/métodosRESUMEN
Acute urinary retention is one of the most frequent urologic emergencies. It occurs mostly in elderly males that suffer from prostate enlargement. Very rare in women, it is essentially caused by vaginal prolapse and neurologic disease. Patients with acute urinary retention suffer from lower abdominal pain and cannot void. Medical history is the cornerstone of diagnosis. Rarely palpable on abdominal examination, an overfilled bladder may be revealed by dullness on supra-pubic percussion. Acute urinary retention may lead to a decrease in kidney function, and on the long term to detrusor hypocontractility. The initial management is bladder drainage by urethral or suprapubic catheterization. Post obstructive diuresis and hematuria are possible complications. Subsequent evaluation is performed by the urologist on an ambulatory basis.
La rétention urinaire aiguë (RUA) est une des urgences urologiques les plus fréquentes. Il s'agit d'un problème essentiellement masculin, souvent dans un contexte d'hypertrophie prostatique. Elle est très rare chez la femme, le plus souvent en raison d'un prolapsus vaginal ou d'une maladie neurologique. En cas de RUA, une forte douleur pelvienne est associée à l'impossibilité d'uriner. Le diagnostic est basé sur l'anamnèse. Cliniquement, la région sus-pubienne est tendue et douloureuse, la vessie est rarement palpable mais une matité sus-pubienne est détectable. La RUA peut se compliquer d'une insuffisance rénale aiguë, ou à plus long terme, d'une hypocontractilité détrusorienne. La prise en charge repose sur le drainage vésical. Les possibles complications sont le syndrome de levée d'obstacle ou l'hématurie. Le bilan étiologique est réalisé à distance en consultation urologique ambulatoire.
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Dolor Abdominal/etiología , Cateterismo Urinario/métodos , Retención Urinaria/terapia , Enfermedad Aguda , Anciano , Urgencias Médicas , Femenino , Hematuria/etiología , Humanos , Masculino , Factores de Riesgo , Retención Urinaria/complicaciones , Retención Urinaria/fisiopatologíaRESUMEN
Each developed country faces an aging population. Increase of age rises the risk to develop urologic pathology especially in men. Routine investigation and diagnostic of urologic pathology important, however must take into account the patient in his globality (including age, comorbidities, drug medication as well as sociocultural environment). The aim of this article is to help the general practitioner in taking decisions with frequent uro-geriatric symptoms. Bladder catheterization remains an invasive treatment and indication should be regularly re-evaluated. Urinary infections must be distinguished from bacterial colonisations, with some exceptions, don't need any specific treatment. We will resume two algorithms on the management of hematuria and the management of prostate cancer suitable for the elderly.
Tout pays développé voit vieillir sa population et le risque de développer une pathologie urologique augmente avec l'âge, notamment chez les hommes. La prise en charge d'un symptôme urologique doit prendre en compte la personne âgée dans sa globalité. Cet article rappelle les éléments principaux de la gestion initiale d'un prostatisme : dépister les symptômes, débuter un traitement et surtout l'adapter au quotidien du patient. La sonde urinaire est un traitement invasif dont l'indication doit être remise en cause. Les infections urinaires sont à différencier des colonisations bactériennes qu'il ne faut pas traiter, sauf dans certaines situations. Nous reprendrons deux arbres décisionnels sur la prise en charge de l'hématurie et d'un cancer prostatique adaptés à la personne âgée.
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Infecciones Bacterianas/diagnóstico , Enfermedades Urogenitales Masculinas/diagnóstico , Cateterismo Urinario/métodos , Infecciones Urinarias/diagnóstico , Factores de Edad , Anciano , Envejecimiento , Algoritmos , Infecciones Bacterianas/terapia , Médicos Generales , Hematuria/terapia , Humanos , Masculino , Enfermedades Urogenitales Masculinas/terapia , Neoplasias de la Próstata/terapia , Factores de Riesgo , Infecciones Urinarias/terapiaRESUMEN
Extending up to the submucosa, superficial bladder tumours (pTis, pTa et pTi) are initially treated by transurethral resection. According to their risk of recurrence and progression, this frequent cancer subsequently benefits from intra-vesical instillations of cytotoxic agents and immunomodulators. Several new treatments are currently being evaluated, namely new genetically modified BCG strains, so as novel means to administrate intravesical chemotherapy, which seam to improve prognosis. Owing to the significant prevalence of superficial bladder cancer and its morbidity, these new therapeutic means will probably be increasingly used.
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Antineoplásicos/administración & dosificación , Vacuna BCG/administración & dosificación , Neoplasias de la Vejiga Urinaria/terapia , Administración Intravesical , Progresión de la Enfermedad , Humanos , Recurrencia Local de Neoplasia , Pronóstico , Neoplasias de la Vejiga Urinaria/epidemiología , Neoplasias de la Vejiga Urinaria/patologíaRESUMEN
BACKGROUND: The objective of this population-based study was to assess patient, physician and tumour determinants associated with positive surgical margins after prostatectomy, and to assess the effects of positive surgical margins on prostate cancer-specific survival. METHODS: We included 1'254 prostate cancer patients recorded at the Geneva Cancer Registry who had radical prostatectomy during 1990-2008. To assess factors associated with positive margins, we used logistic regression. We assessed the effects of positive margins on prostate cancer-specific survival by Cox proportional hazard models accounting for numerous other prognostics factors including prostate and tumour volume, the total percentage of tumour, radiotherapy, surgical approach and surgeon's caseload. RESULTS: Among men undergoing prostatectomy, 479 (38%) had positive margins. In the multivariate logistic regression analysis, period, clinical- and pathological T stage, Prostate Specific Antigen (PSA) level, Gleason score and percentage of tumour in the prostate were significantly associated to positive margins. Ten-year prostate cancer-specific survival was 96.6% for the negative margins group and 92.0% for the positive margins group (log rank p = 0.008). In the Cox survival analysis adjusted for tumour characteristics, surgical margin status per se was not an independent prognostic factor while age, pathological T, PSA level and Gleason score remained associated with prostate cancer-specific survival. CONCLUSIONS: More aggressive tumour characteristics were strong determinants for positive margins. Furthermore, surgical margin status per se was not an independent prognostic factor for prostate cancer-specific survival after adjusting by the gravity of the disease in the multivariate analysis.
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Prostatectomía , Neoplasias de la Próstata/mortalidad , Neoplasias de la Próstata/patología , Anciano , Estudios de Casos y Controles , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Estadificación de Neoplasias , Modelos de Riesgos Proporcionales , Próstata/patología , Próstata/cirugía , Antígeno Prostático Específico/sangre , Prostatectomía/estadística & datos numéricos , Neoplasias de la Próstata/cirugía , Estudios Retrospectivos , Factores Socioeconómicos , Análisis de Supervivencia , Carga TumoralRESUMEN
Focal therapy is a novel treatment strategy in prostate cancer aiming to treat only the area of the gland harbouring clinically significant disease. The overall objective is to maintain the oncological benefit of active treatment while minimising treatment-related morbidity. Leading centres are currently evaluating various minimally invasive technologies in a rigorous manner. Oncological and functional results in mid-term are encouraging with low rate of urinary incontinence and erectile dysfunction. However, the oncological outcome needs to be evaluated in the long-term in the light of the prolonged natural history of the disease.
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Prostatectomía/métodos , Neoplasias de la Próstata/terapia , Criocirugía , Humanos , Masculino , Selección de Paciente , Fototerapia , Neoplasias de la Próstata/epidemiología , Suiza/epidemiologíaRESUMEN
In 2014, Geneva University Hospital has opened the first certified prostate cancer Center of western Switzerland. It incorporates 29 entities implicated in the diagnosis and treatment of this disease, thereby assuring that all available ressources are made available to patients, regardless of the division to which they were initially referred. The main strength of the Center lies in the synergy generated by its multidisciplinary tumor board. Furthermore, regular conferences, staff meetings, propectively held registers and the yearly re-certification audit support its constant quality improvement.
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Instituciones Oncológicas/organización & administración , Hospitales Universitarios/organización & administración , Neoplasias de la Próstata/terapia , Certificación , Vías Clínicas/organización & administración , Humanos , Comunicación Interdisciplinaria , Masculino , Grupo de Atención al Paciente/organización & administración , SuizaRESUMEN
OBJECTIVE: To compare the midterm risks of biochemical recurrence (BCR) and salvage radiation therapy (SRT) after laparoscopic (LRP) and open retropubic radical prostatectomy (RRP). Strong evidence that these techniques are comparable to the 'gold standard' of open RRP is lacking, as most comparative studies are limited by short follow-up or rely on historical controls. PATIENTS AND METHODS: We studied 1000 consecutive patients concurrently treated by either LRP or RRP between 2001 and 2005. LRPs were performed by a single surgeon and RRP by four surgeons. Primary outcomes were BCR and SRT. Survival analysis included relevant clinical and pathological variables. RESULTS: Of 844 included patients, 244 underwent LRP and 600 RRP. Clinical and pathological characteristics were similar in both groups. Most patients had Gleason 6 tumours (68%) and pT2 disease (86%). The median follow-up was 6.1 years and median time to recurrence 3.4 years. Overall, BCR occurred in 14% of patients: 13.1% after LRP and 14.7% after RRP. SRT was performed in 10.7% of patients both after LRP and RRP. In uni- and multivariate Cox regression models, surgical technique was not a significant predictor of BCR or SRT. CONCLUSION: Our results suggest that in high-volume centres, LRP provides equivalent oncological control to RRP.
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Laparoscopía , Prostatectomía/métodos , Neoplasias de la Próstata/cirugía , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Neoplasias de la Próstata/mortalidad , Estudios Retrospectivos , Tasa de Supervivencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: The term close surgical margin refers to a tumor extending to the inked margin of the specimen without reaching it. Current guidelines state that a close surgical margin should simply be reported as negative. However, this recommendation remains controversial and relies on limited evidence. We evaluated the impact of close surgical margins on the long-term risk of biochemical recurrence after radical prostatectomy. MATERIALS AND METHODS: We identified 1,195 consecutive patients who underwent radical prostatectomy and lymphadenectomy for localized prostate cancer at our institution from 1993 to 1999. In 894 of these patients associations between margin status and location, Gleason score, pathological stage, preoperative prostate specific antigen, prostate weight and age with the risk of biochemical recurrence were examined. RESULTS: Of these 894 patients 644 (72%) had negative margins and of these patients 100 (15.5%) had close surgical margins. In the group with prostate specific antigen failure, median time to recurrence was 3.5 years. In the group without recurrence median followup was 9.9 years. Cumulative recurrence-free survival differed significantly among positive, negative and close surgical margins (p <0.001). On multivariate analysis a close surgical margin constituted a significant, independent predictor of recurrence (HR 2.1, 95% CI 1.04-4.33). Gleason score and positive margins were the strongest prognostic factors. CONCLUSIONS: In this cohort close surgical margins were independently associated with a twofold risk of postoperative biochemical recurrence. Further evaluation of the clinical significance of close surgical margins is indicated as they might be an indicator of local recurrence and of relevance when considering salvage therapy.
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Recurrencia Local de Neoplasia/diagnóstico , Estadificación de Neoplasias , Prostatectomía , Neoplasias de la Próstata/cirugía , Anciano , Supervivencia sin Enfermedad , Estudios de Seguimiento , Humanos , Incidencia , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Clasificación del Tumor , Recurrencia Local de Neoplasia/sangre , Recurrencia Local de Neoplasia/epidemiología , Pronóstico , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/mortalidad , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Factores de Tiempo , Estados Unidos/epidemiologíaAsunto(s)
Procedimientos de Cirugía Plástica/efectos adversos , Complicaciones Posoperatorias/epidemiología , Uretra/cirugía , Estrechez Uretral/cirugía , Procedimientos Quirúrgicos Urológicos Masculinos/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Anastomosis Quirúrgica/efectos adversos , Anastomosis Quirúrgica/instrumentación , Anastomosis Quirúrgica/métodos , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Procedimientos de Cirugía Plástica/instrumentación , Procedimientos de Cirugía Plástica/métodos , Resultado del Tratamiento , Procedimientos Quirúrgicos Urológicos Masculinos/instrumentación , Procedimientos Quirúrgicos Urológicos Masculinos/métodos , Adulto JovenRESUMEN
Prostate cancer is the most frequently non-dermatologic tumor diagnosed in Europe. The validity of its screening has been demonstrated by 2 prospective randomized studies including over 160000 patients. However, prostate cancer screening remains controversial because it may lead to overtreatment; moreover, some patients may experience significant functional side effects after surgery and radiotherapy. Integrating this with the individual health situation leads to invite patients to early diagnosis once substantial information has been provided. If cancer is diagnosed, its management is recommended in a multidisciplinary center whose recruitment volume is significant.
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Detección Precoz del Cáncer , Tamizaje Masivo , Neoplasias de la Próstata/prevención & control , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de RiesgoRESUMEN
BACKGROUND: VPM1002BC is a genetically modified Mycobacterium bovis bacillus Calmette-Guérin (BCG) strain with potentially improved immunogenicity and attenuation. OBJECTIVE: To report on the efficacy, safety, tolerability and quality of life of intravesical VPM1002BC for the treatment of non-muscle-invasive bladder cancer (NMIBC) recurrence after conventional BCG therapy. DESIGN, SETTING, AND PARTICIPANTS: We designed a phase 1/2 single-arm trial (NCT02371447). Patients with recurrent NMIBC after BCG induction ± BCG maintenance therapy and intermediate to high risk for cancer progression were eligible. INTERVENTION: Patients were scheduled for standard treatment of six weekly instillations with VPM1002BC followed by maintenance for 1 yr. Treatment was stopped in cases of recurrence. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was defined as the recurrence-free rate (RFR) in the bladder 60 wk after trial registration. The sample size was calculated based on the assumption that ≥30% of the patients would be without recurrence at 60 wk after registration. RESULTS AND LIMITATIONS: After exclusion of two ineligible patients, 40 patients remained in the full analysis set. All treated tumours were of high grade and 27 patients (67.5%) presented with carcinoma in situ. The recurrence-free rate in the bladder at 60 wk after trial registration was 49.3% (95% confidence interval [CI] 32.1-64.4%) and remained at 47.4% (95% CI 30.4-62.6%] at 2 yr and 43.7% (95% CI 26.9-59.4%) at 3 yr after trial registration. At the same time, progression to muscle-invasive disease had occurred in three patients and metastatic disease in four patients. Treatment-related grade 1, 2, and 3 adverse events (AEs) were observed in 14.3%, 54.8%, and 4.8% of the patients, respectively. No grade ≥4 AEs occurred. Two of the 42 patients did not tolerate five or more instillations during induction. Limitations include the single-arm trial design and the low number of patients for subgroup analysis. CONCLUSIONS: At 1 yr after treatment start, almost half of the patients remained recurrence-free after therapy with VPM100BC. The primary endpoint of the study was met and the therapy is safe and well tolerated. PATIENT SUMMARY: We conducted a trial of VPM100BC, a genetically modified bacillus Calmette-Guérin (BCG) strain for treatment of bladder cancer not invading the bladder muscle. At 1 year after the start of treatment, almost half of the patients with a recurrence after previous conventional BCG were free from non-muscle-invasive bladder cancer (NMIBC). The results are encouraging and VPM1002BC merits further evaluation in randomised studies for patients with NMIBC.
Asunto(s)
Mycobacterium bovis , Neoplasias de la Vejiga Urinaria , Administración Intravesical , Vacuna BCG/uso terapéutico , Femenino , Humanos , Inmunoterapia , Masculino , Calidad de Vida , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Neoplasias de la Vejiga Urinaria/patologíaRESUMEN
BACKGROUND: Various prediction tools have been developed to predict biochemical recurrence (BCR) after radical prostatectomy (RP); however, few of the previous prediction tools used serum prostate-specific antigen (PSA) nadir after RP and maximum tumor diameter (MTD) at the same time. In this study, a nomogram incorporating MTD and PSA nadir was developed to predict BCR-free survival (BCRFS). METHODS: A total of 337 patients who underwent RP between January 2010 and March 2017 were retrospectively enrolled in this study. The maximum diameter of the index lesion was measured on magnetic resonance imaging (MRI). Cox regression analysis was performed to evaluate independent predictors of BCR. A nomogram was subsequently developed for the prediction of BCRFS at 3 and 5 years after RP. Time-dependent receiver operating characteristic (ROC) curve and decision curve analyses were performed to identify the advantage of the new nomogram in comparison with the cancer of the prostate risk assessment post-surgical (CAPRA-S) score. RESULTS: A novel nomogram was developed to predict BCR by including PSA nadir, MTD, Gleason score, surgical margin (SM), and seminal vesicle invasion (SVI), considering these variables were significantly associated with BCR in both univariate and multivariate analyses (Pâ<â0.05). In addition, a basic model including Gleason score, SM, and SVI was developed and used as a control to assess the incremental predictive power of the new model. The concordance index of our model was slightly higher than CAPRA-S model (0.76 vs. 0.70, Pâ=â0.02) and it was significantly higher than that of the basic model (0.76 vs. 0.66, Pâ=â0.001). Time-dependent ROC curve and decision curve analyses also demonstrated the advantages of the new nomogram. CONCLUSIONS: PSA nadir after RP and MTD based on MRI before surgery are independent predictors of BCR. By incorporating PSA nadir and MTD into the conventional predictive model, our newly developed nomogram significantly improved the accuracy in predicting BCRFS after RP.