Prospective study of diagnostic accuracy in the detection of high-grade prostate cancer in biopsy-naïve patients with clinical suspicion of prostate cancer who underwent the Select MDx test.

OBJECTIVES: This study aimed to externally validate the diagnostic accuracy of the Select MDx test for Significant prostate cancer (Sig PCa) (ISUP > 1), in a contemporaneous, prospective, multicenter cohort with a prostate-specific antigen (PSA) between 3 and 10 ng/ml and a non-suspicious digital rectal examination. METHODS AND PARTICIPANTS: For all enrolled patients, the Select Mdx test, the risk calculator ERSPC3 + DRE, and a prostatic magnetic resonance imaging (MRI) were carried out. Subsequently, a systematic 12-core trans-rectal biopsy and a targeted biopsy, in the case of a prostate imaging-reporting and data system (PIRADS) > 2 lesion (max three lesions), were performed. To assess the accuracy of the Select MDx test in the detection of clinically Sig PCa, the test sensitivity was evaluated. Secondary objectives were specificity, negative predictive value (NPV), positive predictive value (PPV), and area under the curve (AUC). A direct comparison with the ERSPC + DRE risk calculator and MRI were also performed. We also studied the predictive ability to diagnose Sig PCa from the combination of the Select MDx test with MRI using clinical decision-curve analysis. RESULTS: There were 163 patients enrolled after meeting the inclusion criteria and study protocol. The Select MDx test showed a sensitivity of 76.9% (95% CI, 63.2-87.5), 49.6% specificity (95% CI, 39.9-59.2), 82.09% (95% CI, 70.8-90.4) NPV, and 41.67% (95% CI, 31.7-52.2) PPV for the diagnosis of Sig PCa. COR analysis was also performed, which showed an AUC of 0.63 (95% CI, 0.56-0.71). There were no differences in the accuracy of Select MDx, ERSPC + DRE, or MRI. The combination of Select MDX + MRI showed the highest impact in the decision-curve analysis, with an NPV of 93%. CONCLUSION: Our study showed a worse performance for the SelectMdx test than previously reported, within a cohort of patients with a PSA 3-10 ng/ml and a normal DRE, with results similar to those from ERSPC + DRE RC and MRI, but with an improvement in the usual PSA pathway. A combination of the Select Mdx test and MRI could improve accuracy, but studies specifically evaluating this scenario with a cost-effective analysis are needed.

[Emergency surgery during COVID-19 pandemia.] / Cirugía de urgencia en urología durante la pandemia Covid-19.

INTRODUCTION: The crisis in the SARSCoV-2 coronavirus causing COVID-19 is putting health systems around the world to the test. In a great effort to standardize the management and treatment guidelines, the different health authorities and scientific associations have tried to issue recommendations on how to act in this new and complex scenario. OBJECTIVE: To synthesize the existing evidence and recommendations about urological emergency surgery during the COVID-19 pandemic situation. Furthermore, we propose a general action protocol for these patients. MATERIAL AND METHODS: The document is based ont he scarce evidence on SARS / Cov-2 and the experience of the authors in the management of COVID-19 in their institutions, including specialists from Andalusia, Cantabria, Madrid and the Basque Country. A web and PubMed search was performed using the keywords "SARS-CoV-2", "COVID19",  "COVID Urology", "COVID19 surgery" and "emergency care". A narrative review of the literature was carried out until April 30, 2020, including only articles and documents written in Spanish and English. After the nominal group technique modified due to the extraordinary restrictions, a first draft was made to unify criteria. Finally, a definitive version was made, agreed by all the authors on May 12, 2020. RESULTS: General principles of action are set out, as well as specific recommendations for the most frequent urgent urological procedures. CONCLUSIONS: Given the exceptional nature of the situation, there is a lack of evidence regarding the optimal management of the patient with urgent urological pathology. The information is changing, as the epidemiological knowledge of the disease advances. The establishment of multidisciplinary surgical committees that develop and implement action protocols appropriate to the different resources and particular situations of each center is recommended. Likewise, these committees must individually assess each possible urological surgical emergency situation and ensure compliance with protective measures for the patient and other healthcare personnel.

INTRODUCCIÓN: La crisis del coronavirus SARS-CoV-2 causante del COVID-19 está poniendoa prueba los sistemas sanitarios de todo el mundo. En un gran esfuerzo por estandarizar las pautas de manejo y tratamiento, las distintas autoridades sanitarias y asociaciones científicas han tratado de dictar unas recomendaciones sobre como actuar en este nuevo y complejo escenario.OBJETIVO: Sintetizar la evidencia y recomendaciones existentes acerca de la cirugía de urgencia urológica durante la situación de pandemia COVID-19. Además, proponemos un protocolo de actuación general para estos pacientes. MATERIAL Y MÉTODOS: El documento se basa en la escasa evidencia sobre SARS/Cov-2 y la experiencia de los autores en el manejo de COVID-19 en sus instituciones incluyendo especialistas de Andalucía, Cantabria, Madrid y País Vasco. Se realizó una búsqueda web y en PubMed utilizando las palabras clave "SARSCoV-2", "COVID19", "COVID Urology", "COVID19 surgery" y "emergency care". Se realizó una revisión narrativa de la literatura hasta el día 30 de Abril de2020 incluyendo solo artículos y documentos escritos en lengua española e inglesa. Tras técnica de grupo nominal modificada debido a las restricciones extraordinarias se realizó un primer borrador para unificar criterios. Finalmente, se realizó una versión definitiva, consensuada por todos los autores el 12 Mayo 2020. RESULTADOS: Se exponen unos principios generales de actuación, así como unas recomendaciones específicas para los procedimientos urológicos urgentes más frecuentes.CONCLUSIONES: Dado el carácter excepcional de la situación, existe un déficit de evidencia respecto al óptimo manejo del paciente con patología urológica urgente. La información es cambiante, según avanza el conocimiento epidemiológico de la enfermedad. Es recomendable el establecimiento de comités multidisciplinares quirúrgicos que desarrollen e implementen protocolos de actuación adecuados a los distintos recursos y situaciones particulares de cada centro. Del mismo modo, estos comités deben evaluar de forma individualizada cada posible situación de urgencia quirúrgica urológica y velar por el cumplimiento de las medidas de protección para el paciente y resto del personal sanitario.

Cirugía de urgencia en urología durante la pandemia Covid-19 / Emergency surgery during COVID-19 pandemia

INTRODUCCIÓN: La crisis del coronavirus SARS-CoV-2 causante del COVID-19 está poniendoa prueba los sistemas sanitarios de todo el mundo. En un gran esfuerzo por estandarizar las pautas de manejo y tratamiento, las distintas autoridades sanitarias y asociaciones científicas han tratado de dictar unas recomendaciones sobre como actuar en este nuevo y complejo escenario. OBJETIVO: Sintetizar la evidencia y recomendaciones existentes acerca de la cirugía de urgencia urológica durante la situación de pandemia COVID-19. Además, proponemos un protocolo de actuación general para estos pacientes. MATERIAL Y MÉTODOS: El documento se basa en la escasa evidencia sobre SARS/Cov-2 y la experiencia de los autores en el manejo de COVID-19 en sus instituciones incluyendo especialistas de Andalucía, Cantabria, Madrid y País Vasco. Se realizó una búsqueda web y en PubMed utilizando las palabras clave "SARSCoV-2", "COVID19", "COVID Urology", "COVID19 surgery" y "emergency care". Se realizó una revisión narrativa de la literatura hasta el día 30 de Abril de2020 incluyendo solo artículos y documentos escritos en lengua española e inglesa. Tras técnica de grupo nominal modificada debido a las restricciones extraordinarias se realizó un primer borrador para unificar criterios. Finalmente, se realizó una versión definitiva, consensuada por todos los autores el 12 Mayo 2020. RESULTADOS: Se exponen unos principios generales de actuación, así como unas recomendaciones específicas para los procedimientos urológicos urgentes más frecuentes. CONCLUSIONES: Dado el carácter excepcional de la situación, existe un déficit de evidencia respecto al óptimo manejo del paciente con patología urológica urgente. La información es cambiante, según avanza el conocimiento epidemiológico de la enfermedad. Es recomendable el establecimiento de comités multidisciplinares quirúrgicos que desarrollen e implementen protocolos de actuación adecuados a los distintos recursos y situaciones particulares de cada centro. Del mismo modo, estos comités deben evaluar de forma individualizada cada posible situación de urgencia quirúrgica urológica y velar por el cumplimiento de las medidas de protección para el paciente y resto del personal sanitario

INTRODUCTION: The crisis in the SARSCoV-2 coronavirus causing COVID-19 is putting health systems around the world to the test. In a great effort to standardize the management and treatment guidelines, the different health authorities and scientific associations have tried to issue recommendations on how to act in this new and complex scenario. OBJECTIVE: To synthesize the existing evidence and recommendations about urological emergency surgery during the COVID-19 pandemic situation. Furthermore, we propose a general action protocol for these patients. MATERIAL AND METHODS: The document is based on the scarce evidence on SARS/Cov-2 and the experience of the authors in the management of COVID-19 in their institutions, including specialists from Andalusia, Cantabria, Madrid and the Basque Country. A web and PubMed search was performed using the keywords "SARS-CoV-2", "COVID19", "COVID Urology", "COVID19 surgery" and "emergency care". A narrative review of the literature was carried out until April 30, 2020, including only articles and documents written in Spanish and English. After the nominal group technique modified due to the extraordinary restrictions, a first draft was made to unify criteria. Finally, a definitive version was made, agreed by all the authors on May 12, 2020. RESULTS: General principles of action are set out, as well as specific recommendations for the most frequent urgent urological procedures. CONCLUSIONS: Given the exceptional nature of the situation, there is a lack of evidence regarding the optimal management of the patient with urgent urological pathology. The information is changing, as the epidemiological knowledge of the disease advances. The establishment of multidisciplinary surgical committees that develop and implement action protocols appropriate to the different resources and particular situations of each center is recommended. Likewise, these committees must individually assess each possible urological surgical emergency situation and ensure compliance with rotective measures for the patient and other healthcare personnel

[New therapeutic schedules of Sunitinib: Current evidence regarding the 2:1 scheme.] / Nuevos esquemas terapéuticos con Sunitinib: evidencia actual en torno a la pauta 2:1.

INTRODUCTION: In 2006, sunitinib approval by the FDA was a real revolution for the treatment of metastatic renal cell carcinoma (mRCC). However, considerable rates of dose reductions and therapeutic suppressions with the standard regimen (4:2) have forced the search for new schedule proposals in order to optimize the balance between side effects and oncologic efficacy. Among these new proposals, the 2:1 scheme is the one that has generated more expectations. OBJECTIVE: The objective of this paper is to make a review and critical discussion of current evidence about the new schedules of treatment with sunitinib. METHODS: Unstructured review of the literature on the various therapeutic regimens with sunitinib, making a comparison in terms of progression-free survival (PFS), overall survival (OS) and toxicity. RESULTS: We summarize the data from all relevant studies published to date comparing the standard 4:2 schedule versus the new 2:1. Most patients treated with 2:1 scheme are grouped in three retrospective observational studies and mostly correspond to patients who were initially treated with a 4:2 scheme and then moved to 2:1. A phase II randomized clinical trial comparing 4:2 and 2:1 schemes from the beginning has also been conducted. None of these studies found significant differences between the two regimens in terms of PFS or OS. Regarding the toxicity profile, the 2:1 scheme has proved to be more advantageous than the 4:2. CONCLUSIONS: Despite the still limited amount of data, current evidence supports the use of a 2:1 schedule, as it provides patients substantial advantages because of its better tolerability profile, without a loss in oncological efficacy. Currently, the 2:1 scheme is an appropriate alternative therapeutic strategy, especially in patients with poor tolerance to the standard 4:2 regimen.

Nuevos esquemas terapéuticos con Sunitinib: evidencia actual en torno a la pauta 2:1 / New therapeutic schedules of Sunitinib: current evidence regarding the 2:1 scheme

INTRODUCCIÓN: En 2006, la aprobación de Sunitinib por la FDA supuso una auténtica revolución en el tratamiento del carcinoma de células renales metastásico (CCRm). No obstante, las considerables tasas de reducciones de dosis y supresiones terapéuticas con el esquema terapéutico estándar (pauta 4:2), han forzado la búsqueda de nuevas propuestas posológicas con el objetivo de optimizar el equilibrio entre los efectos adversos y la eficacia terapéutica. Entre estas nuevas propuestas, la pauta 2:1 es la que más expectativas ha generado. OBJETIVO: El objetivo de este trabajo es realizar una síntesis y discusión crítica de la evidencia actual acerca de los nuevos esquemas de tratamiento con Sunitinib. MÉTODOS: Revisión no estructurada de la literatura sobre los distintos esquemas terapéuticos con Sunitinib, realizando una comparativa en términos de supervivencia libre de progresión (SLP), supervivencia global (SG) y toxicidad. RESULTADOS: Se exponen los datos de todos los estudios de relevancia publicados hasta la fecha en los que se compara la pauta 4:2 frente a la pauta 2:1. La mayoría de los pacientes tratados con el esquema 2:1 se aglutinan en tres estudios observacionales retrospectivos y, en su mayoría, corresponden a pacientes que inicialmente estuvieron tratados con un esquema 4:2 y luego pasaron al 2:1. Además se ha realizado un ensayo clínico aleatorizado fase II que compara el esquema 4:2 con el esquema 2:1 desde el inicio. Ninguno de estos estudios ha encontrado diferencias significativas entre ambas pautas en términos de SLP o SG, llegando a ser éstas incluso superiores a las de los esquemas 4:2. En cuanto al perfil de toxicidad, el esquema 2:1 ha mostrado ser más ventajoso que el 4:2. CONCLUSIONES: A pesar de la todavía escasa cantidad de datos, la evidencia actual sustenta la utilización del esquema 2:1 pues ofrece ventajas sustanciales a los pacientes con CCRm debido a su mejor perfil de tolerabilidad, sin que ello implique una pérdida de eficacia oncológica. Actualmente, la pauta 2:1 constituye una estrategia terapéutica alternativa adecuada, especialmente en aquellos pacientes con mala tolerancia al régimen 4:2

INTRODUCTION: In 2006, Sunitinib approval by the FDA was a real revolution for the treatment of metastatic renal cell carcinoma (mRCC). However, considerable rates of dose reductions and therapeutic suppressions with the standard regimen (4:2) have forced the search for new schedule proposals in order to optimize the balance between side effects and oncologic efficacy. Among these new proposals, the 2:1 scheme is the one that has generated more expectations. OBJECTIVE: The objective of this paper is to make a review and critical discussion of current evidence about the new schedules of treatment with Sunitinib. METHODS: Unstructured review of the literature on the various therapeutic regimens with Sunitinib, making a comparison in terms of progression-free survival (PFS), overall survival (OS) and toxicity. RESULTS: We summarize the data from all relevant studies published to date comparing the standard 4:2 schedule versus the new 2:1. Most patients treated with 2:1 scheme are grouped in three retrospective observational studies and mostly correspond to patients who were initially treated with a 4:2 scheme and then moved to 2:1. A phase II randomized clinical trial comparing 4:2 and 2:1 schemes from the beginning has also been conducted. None of these studies found significant differences between the two regimens in terms of PFS or OS. Regarding the toxicity profile, the 2:1 scheme has proved to be more advantageous than the 4:2. CONCLUSIONS: Despite the still limited amount of data, current evidence supports the use of a 2:1 schedule, as it provides patients substantial advantages because of its better tolerability profile, without a loss in oncological efficacy. Currently, the 2:1 scheme is an appropriate alternative therapeutic strategy, especially in patients with poor tolerance to the standard 4:2 regimen