Una actualización en el protocolo en cáncer de próstata metastásico hormonosensible / Hormone sensitive protocol for metastatic prostate cancer, an update

Revisar y actualizar los últimos protocolos en cáncer de próstata metastásico hormonosensible para mejorar su manejo clínico en la práctica clínica. Realizar un análisis de los datos y los protocolos más recientes en el cáncer de próstata metastásico hormonosensible según paneles de expertos en este ámbito. Actualmente se necesita un grupo de consenso nominal para unificar y mejorar las recomendaciones para el manejo de pacientes sensibles con cáncer de próstata metastásico. Este documento unifica y mejora el manejo de los pacientes con cáncer de próstata metastásico hormonosensible, con una metodología que combina datos cuantitativos y cualitativos, y basada en la participación de un amplio comité científico designado por la Asociación Española de Urología (AU)

To review and update last protocols in hormone sensitive metastatic prostate cancer for improving clinical management in routine. Evidence analysis available about recent updates protocols in hormone sensitive metastatic prostate cancer according to expert panel of clinicians about this field. A nominal consensus group for unify and improve the recommendations to the management of sensitive metastatic prostate cancer patients is currently needed. This document unifies and improve the management of patients with hormone sensitive metastatic prostate cancer, with a methodology that combines data quantitative and qualitative and based on the participation of a broad scientific committee appointed by the Spanish Association of Urology (AU)

Consenso multidisciplinar sobre idoneidad farmacológica en cáncer de próstata hormono-sensible metastásico / A multidisciplinary consensus statement on the optimal pharmacological treatment for metastatic hormone-sensitive prostate cancer

La terapia de privación androgénica (TPA) es el pilar del tratamiento del cáncer de próstata hormono-sensible metastásico (CPHSm). La adición de docetaxel o de nuevas terapias hormonales (abiraterona, apalutamida o enzalutamida) mejora la supervivencia global (SG) y es en la actualidad el estándar de tratamiento. Sin embargo, la decisión sobre el régimen específico que acompañe a la TPA debe ser discutida con el paciente teniendo en cuenta factores como las posibles toxicidades asociadas, la duración del tratamiento, las comorbilidades o sus preferencias, pues no hay evidencia suficiente para recomendar un régimen sobre otro en la mayoría de los casos. En este trabajo se resume la evidencia sobre el manejo del CPHSm y se aportan recomendaciones consensuadas sobre el tratamiento óptimo para añadir a la TPA en pacientes con CPHSm con especial atención al perfil clínico del paciente (AU)

Androgen deprivation therapy (ADT) is the mainstay treatment for metastatic hormone-sensitive prostate cancer (mHSPC). The addition of docetaxel or new hormone therapies (abiraterone, apalutamide, or enzalutamide) improves overall survival and is currently the standard of care. However, the decision on the specific regimen to accompany ADT should be discussed with the patient, considering factors such as possible associated toxicities, duration of treatment, comorbidities, patient preferences, as there is no sufficient evidence to recommend one regimen over the other in most cases. This paper summarizes the evidence on the management of mHSPC and provides consensus recommendations on the optimal treatment in combination with ADT in mHSPC patients, with special attention to the patient's clinical profile (AU)

A multidisciplinary consensus statement on the optimal pharmacological treatment for metastatic hormone-sensitive prostate cancer.

Androgen deprivation therapy (ADT) is the mainstay treatment for metastatic hormone-sensitive prostate cancer (mHSPC). The addition of docetaxel or new hormone therapies (abiraterone, apalutamide, or enzalutamide) improves overall survival and is currently the standard of care. However, the decision on the specific regimen to accompany ADT should be discussed with the patient, considering factors such as possible associated toxicities, duration of treatment, comorbidities, patient preferences, as there is no sufficient evidence to recommend one regimen over the other in most cases. This paper summarizes the evidence on the management of mHSPC and provides consensus recommendations on the optimal treatment in combination with ADT in mHSPC patients, with special attention to the patient's clinical profile.

Hormone sensitive protocol for metastatic prostate cancer, an update.

To review and update last protocols in hormone sensitive metastatic prostate cancer for improving clinical management in routine. Evidence analysis available about recent updates protocols in hormone sensitive metastatic prostate cancer according to expert panel of clinicians about this field. A nominal consensus group for unify and improve the recommendations to the management of sensitive metastatic prostate cancer patients is currently needed. This document unifies and improve the management of patients with hormone sensitive metastatic prostate cancer, with a methodology that combines data quantitative and qualitative and based on the participation of a broad scientific committee appointed by the Spanish Association of Urology.

Cáncer de próstata resistente a la castración no metastásico: recomendaciones de manejo / Non-metastatic castration-resistant prostate cancer: management recommendations

Introducción y objetivo: La supervivencia y calidad de vida (QoL) de los pacientes con cáncer de próstata resistente a la castración no metastásico (CPRCnm) se deteriora de forma muy significativa cuando llegan a desarrollar metástasis. Los antiandrógenos de nueva generación (apalutamida, enzalutamida y darolutamida) pueden prolongar la supervivencia libre de metástasis (SLM) y la supervivencia global (SG) en estos pacientes, manteniendo su QoL.Material y método: Tras una revisión sistemática de la literatura, un comité científico alcanzó un consenso sobre recomendaciones sencillas y prácticas que unifiquen y mejoren el manejo de los pacientes con CPRCnm en las consultas de urología.Resultados: Se dan recomendaciones sobre la frecuencia de determinación de antígeno prostático específico (PSA) y pruebas de imagen en pacientes con CPRCnm. También se destaca la importancia de las comorbilidades en el paciente con CPRCnm y se ofrecen recomendaciones sobre la valoración funcional y de la QoL que se pueden llevar a cabo en la consulta de urología. Se revisa la eficacia, seguridad y efectos sobre la QoL de los antiandrógenos de nueva generación.Conclusiones: Para la evaluación del tratamiento de pacientes con CPRCnm, es necesario tener en cuenta no solo la edad, sino también las comorbilidades y la QoL. Los antiandrógenos de nueva generación son una opción de tratamiento segura y eficaz en los pacientes con CPRCnm. Las recomendaciones de trabajo pueden servir de ayuda para optimizar su manejo de los pacientes con CPRCnm en las consultas de urología. (AU)

Introduction and objective: Survival and quality of life (QoL) of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) deteriorate significantly when they develop metastases. New generation antiandrogens (apalutamide, enzalutamide and darolutamide) can prolong metastasis-free survival (MFS) and overall survival (OS) in these patients, maintaining their QoL.Material and methods: After the performance of a systematic review of the literature, a scientific committee reached a consensus on simple and practical recommendations to consolidate and improve the management of patients with nmCRPC in urology consultations.Results: Recommendations are made on the frequency of PSA determination and imaging tests in patients with nmCRPC. The importance of co-morbidities in patients with nmCRPC is also highlighted, and recommendations are also made on functional and QoL assessment that can be carried out during urology consultations. The efficacy, safety, and effects on QoL of new generation antiandrogens are reviewed.Conclusions: To evaluate treatment of patients with nmCRPC, it is necessary to consider co-morbidities and QoL, in addition to age. New generation antiandrogens are a safe and effective treatment option for patients with nmCRPC. The recommendations of this review can be helpful in optimizing the management of nmCRPC patients in urology consultations. (AU)

Optimización del tratamiento del cáncer de vejiga no músculo invasivo mediante una app / Optimizing treatment for non muscle-invasive bladder cancer with an app

Objetivos: Evaluar la concordancia global y ajustada por tasa de recidiva-progresión de la prescripción del tratamiento en el cáncer de vejiga no músculo-invasivo (NMIBC) de una app basada en la mejor evidencia científica disponible y la opinión del urólogo.Métodos: Desarrollo de una app específica para el tratamiento y seguimiento del NMIBC (APPv) y validación de la variable de salida propuesta de tratamiento mediante un estudio de concordancia observacional prospectivo de muestras relacionadas a doble ciego en 100 pacientes con primer o sucesivo diagnóstico histológico de NMIBC.Resultados: El tratamiento prescrito por el urólogo coincide con el propuesto por la APPv en el 64% de los casos (índice kappa 0,55; p<0,0001). La coincidencia para el bajo riesgo es del 77% (kappa 0,55; p=0,002), 63% (kappa 0,52; p<0,0001) para el riesgo intermedio, 17% (kappa 0,143; p=0,014) en alto riesgo y 66% (kappa 0,71; p=0,01) para muy alto riesgo. El 89,1% de los pacientes que reciben el tratamiento complementario intravesical acorde con la APPv continúan libres de recidiva, frente al 61,1% en que no hay acuerdo (p=0,0004), con un RR de 0,46 (IC 95%: 0,25-0,86) vs. RR de 2,4 (IC 95%: 1,5-3,8; p=0,001). El 100% de los pacientes están libres de progresión en el grupo de acuerdo y el 88,9% en el grupo sin acuerdo (p=0,004) con un RR de 1 vs. RR de 1,125 (IC 95%: 1-1,26; p=0,004).Conclusiones: La APPv puede mejorar la adherencia a las recomendaciones de tratamiento según las guías de práctica clínica y los resultados en salud en el NMIBC. (AU)

Objectives: To evaluate overall and recurrence-progression rate-adjusted concordance of treatment prescription in non-muscle-invasive bladder cancer (NMIBC) of an app based on the best available scientific evidence and the urologist's opinion.Methods: Development of an app (APPv) specifically designed for the treatment and follow-up of NMIBC and validation of the proposed APPv treatment endpoint by means of a prospective double-blind observational concordance study of related samples in 100 patients with initial or successive histological diagnosis of NMIBC.Results: The treatment prescribed by the urologist agrees with that proposed by the APPv in 64% of cases (kappa index 0.55, P<0.0001). Regarding low risk, the agreement is 77% (kappa 0.55, P=0.002), 63% (kappa 0.52, P<0.0001) for intermediate risk, 17% (kappa 0.143, P=0.014) in high risk and 66% (kappa 0.71, P=0.01) for very high risk. Of patients receiving adjuvant intravesical treatment according to APPv, 89.1% remain free of recurrence vs. 61.1% of those with disagreement (P=0.0004), with a RR 0.46 (95%CI: 0.25-0.86) vs. RR 2.4 (95%CI: 1.5-3.8, P=0.001). In the APPv-urologist agreement group, 100% of patients are free of progression and 88.9% in the disagreement group (P=0.004) with a RR 1 vs. RR 1.125 (95%CI: 1-1.26, P=0.004).Conclusions: APPv can improve adherence to treatment recommendations according to clinical practice guidelines and health outcomes at NMIBC. (AU)

Reacción anafilactoide a látex tras colocación de malla transvaginal para corrección de cistocele / Anaphylactoid latex reaction after transvaginal mesh placement for cystocele correction

La incidencia de alergia al látex en la población general es del 1-2%, siendo las reacciones más frecuentemente descritas de hipersensibilidad inmediata o tipo i y tardía o tipo iv, aunque también han sido descritas reacciones de hipersensibilidad no mediadas por IgE.Presentamos el caso de una mujer de 71 años con factores de riesgo cardiovascular (HTA y DLP) e intervenida previamente de colecistectomía y cistocele que ingresa de forma programada para intervención de recidiva de cistocele grado iv tras 4 años de la primera intervención.En el postoperatorio inmediato presenta fracaso renal agudo, por lo que se retira la malla a las 24h, persistiendo deterioro progresivo del estado general con dificultad respiratoria, disminución del nivel de conciencia y empeoramiento de la función renal. Tras una exploración exhaustiva se visualiza eritema en región vulvar e inguinal, por lo que se sospecha reacción anafiláctica a sonda de látex, que se recambia por una sonda de silicona, iniciándose tratamiento con metilprednisolona intravenosa y se consulta con el servicio de Alergología, que establece finalmente el diagnóstico.La paciente requirió ingreso en la unidad de cuidados intensivos durante 10 días por insuficiencia renal aguda e insuficiencia respiratoria aguda asociadas a íleo paralítico y coagulopatía.La anafilaxia es una reacción sistémica aguda que resulta en la liberación brusca de mediadores de los mastocitos y basófilos, mediada o no por IgE. Se admite que es una reacción de hipersensibilidad sistémica grave, de inicio repentino y potencialmente mortal. Clínicamente se asocia a la aparición de manifestaciones cutáneas relacionadas con alteraciones cardiovasculares, respiratorias o gastrointestinales.

Allergy to latex in the general population is 1-2%, the most frequent reactions described being immediate or type i and late or type iv hypersensitivity, although non-IgE-mediated hypersensitivity reactions have also been described.We present the case of a 71-year-old woman with cardiovascular risk factors (HTN and PLD) and previously operated on for cholecystectomy and cystocele who was admitted on a scheduled basis for intervention for grade iv cystocele recurrence, 4 years after the first intervention.In the immediate postoperative period, she presented acute renal failure, for which the mesh was removed after 24h, her general condition progressively deteriorated with respiratory distress, decreased level of consciousness, and worsening of renal function. After an exhaustive examination, erythema was visualized in the vulvar and inguinal region, hence the suspicion of an anaphylactic reaction to a latex catheter, which was replaced by a silicone catheter. Treatment was started with intravenous methylprednisolone, and the Allergology service was consulted who finally established the diagnosis.The patient required admission to the intensive care unit for 10 days due to acute renal failure and acute respiratory failure, associated with paralytic ileus and coagulopathy.Anaphylaxis is an acute systemic reaction that results in the abrupt release of mediators from mast cells and basophils, mediated or not by IgE. It is recognized to be a severe, sudden onset, and life-threatening systemic hypersensitivity reaction. Clinically, it is associated with the appearance of skin manifestations related to cardiovascular, respiratory, or gastrointestinal disorders.

Non-metastatic castration-resistant prostate cancer: management recommendations.

INTRODUCTION AND OBJECTIVE: Survival and quality of life (QoL) of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) deteriorate significantly when they develop metastases. New generation antiandrogens (apalutamide, enzalutamide and darolutamide) can prolong metastasis-free survival (MFS) and overall survival (OS) in these patients, maintaining their QoL. MATERIAL AND METHODS: After the performance of a systematic review of the literature, a scientific committee reached a consensus on simple and practical recommendations to consolidate and improve the management of patients with nmCRPC in urology consultations. RESULTS: Recommendations are made on the frequency of PSA determination and imaging tests in patients with nmCRPC. The importance of co-morbidities in patients with nmCRPC is also highlighted, and recommendations are also made on functional and QoL assessment that can be carried out during urology consultations. The efficacy, safety, and effects on QoL of new generation antiandrogens are reviewed. CONCLUSIONS: To evaluate treatment of patients with nmCRPC, it is necessary to consider co-morbidities and QoL, in addition to age. New generation antiandrogens are a safe and effective treatment option for patients with nmCRPC. The recommendations of this review can be helpful in optimizing the management of nmCRPC patients in urology consultations.

Optimizing treatment for non muscle-invasive bladder cancer with an app.

OBJECTIVES: To evaluate overall and recurrence-progression rate-adjusted concordance of treatment prescription in non-muscle-invasive bladder cancer (NMIBC) of an app based on the best available scientific evidence and the urologist's opinion. METHODS: Development of an app (APPv) specifically designed for the treatment and follow-up of NMIBC and validation of the proposed APPv treatment endpoint by means of a prospective double-blind observational concordance study of related samples in 100 patients with initial or successive histological diagnosis of NMIBC. RESULTS: The treatment prescribed by the urologist agrees with that proposed by the APPv in 64% of cases (kappa index 0.55, P < 0.0001). Regarding low risk, the agreement is 77% (kappa 0.55, P = 0.002), 63% (kappa 0.52, P < 0.0001) for intermediate risk, 17% (kappa 0.143, P = 0.014) in high risk and 66% (kappa 0.71, P = 0.01) for very high risk. Of patients receiving adjuvant intravesical treatment according to APPv, 89.1% remain free of recurrence vs. 61.1% of those with disagreement (P = 0.0004), with a RR 0.46 (95%CI: 0.25-0.86) vs. RR 2.4 (95%CI: 1.5-3.8, P = 0.001). In the APPv-urologist agreement group, 100% of patients are free of progression and 88.9% in the disagreement group (P = 0.004) with a RR 1 vs. RR 1.125 (95%CI: 1-1.26, P = 0.004). CONCLUSIONS: APPv can improve adherence to treatment recommendations according to clinical practice guidelines and health outcomes at NMIBC.

Incidence of upper tract urothelial carcinoma in Spain. / Incidencia del carcinoma transicional del tracto urinario superior en España.

INTRODUCTION AND OBJECTIVES: The incidence of upper urinary tract tumors is currently unknown. The aim of this study is to determine the real incidence of upper tract urothelial carcinoma (UTUC) in Spain. MATERIAL AND METHODS: A descriptive, prospective and multicenter epidemiological study was conducted in 31 Spanish facilities by means of the Platform for Multicenter Studies of the Spanish Association of Urology. Recruitment was opened from May 1st, 2017 to April 30th, 2018. The original database was exported directly from the electronic Data Collection Logbook on December 15th, 2018, with a total of 404 cases registered (402 valid cases after depuration). Statistical analysis was performed using IBM SPSS software v 23 and EPIDAT v 3.4. RESULTS: The incidence adjusted to Spanish population from raw data was 3.27 cases per 100.000 inhabitants per year (2.93 - 3.61 95% CI) and 3,3 cases per 100.000 inhabitants per year (2.96-3.66 95%CI) when adjusted to European population by age. The mean age at diagnosis was 70 years, and 77% of patients were male. Thirty-four percent of patients had an incidental diagnosis. Tumors were most commonly located in the pyelocalyceal system (54%), followed by the distal ureter (22%). Prior ureteroscopy was performed in 114 patients: this technique modified the subsequent treatment indication in 58% of cases. Radical nephroureterectomy was performed in 311 patients. Kidney-sparing surgery was the elected treatment in 76 patients (20%). Complications were found in 69% of cases, most of them classified as Clavien 1 and 2 (86% of all complications). Postoperative mortality rate was 1.7%. CONCLUSIONS: UTUC adjusted incidence rate in Spain is 3.27 and 3.3 in Europe. Prior URS modified the treatment indication in 18% of patients. We found a 69% complication rate and a 1.7% mortality rate.

Empiric therapy for idiopathic oligoasthenoteratozoospermia. / Tratamiento empírico de la oligoastenoteratozoospermia idiopática.

Male infertility accounts for 50% of the causes of infertile couples, being more than 30% of unknown etiology. In these cases, empiric treatment can be an option prior to the application of assisted reproduction techniques. Empiric treatment can be categorized as hormonal, such as gonadotropins, antiestrogens and aromatase inhibitors, and antioxidant, with vitamins, trace elements and carnitine, among others. Although scientifically acceptable evidence is limited due to the absence of large randomized and controlled clinical trials, recent systematic reviews and meta-analyses show that treatment with gonadotropins, antiestrogens and antioxidants increases pregnancy and live birth rates and improves seminal parameters. Empiric medical treatment for idiopathic infertility can be considered in specific cases in order to improve semen quality and spontaneous fertility.

Postoperative pain and cosmetic results of minilaparoscopic nephrectomy compared to the conventional technique. / Dolor postoperatorio y resultados cosméticos de la nefrectomía minilaparoscópica frente a la técnica convencional.

INTRODUCTION: In recent years urology has been focussing on less invasive forms of laparoscopy with less impact on the abdominal wall. The minilaparoscopy (ML) is promising in this regard. Our objective is to compare the results of a series of patients who underwent minilaparoscopic nephrectomy with another series who underwent conventional laparoscopy (CL). MATERIAL AND METHODS: We chose 8 nephrectomies performed by mini-laparoscopy in a single hospital (NmL group) from a total of 110 patients included in multiple centres and compared them retrospectively with a contemporary series of 16 patients who underwent CL (NL group). From 1 to 3 3mm and 5mm trocars were used for the NmL and the NL, respectively, one 10mm trocar in the pararectal edge of a Pfannenstiel incision and another 11mm paraumbilical trocar for the optics. Age, BMI, ASA, complications, analgesic requirements in the postoperative period and cosmetic satisfaction were recorded using the Patient Scar Assessment Questionnaire (PSAQ), one month after the intervention. RESULTS: Both groups were comparable and there were no differences in terms of surgery time, number of ports used, hospital stay or intra-and postoperative complications. In only one patient from the NmL group, a 3mm trocar had to be replaced by a 5mm trocar and one patient in the NL group was converted to hand-assisted surgery due to severe adherences. The patients in the NmL group had less postoperative pain on the VAS (±0 vs. 4±25, P=.05) and were more satisfied with their appearance on the PSAQ (8.5±1.4 vs. 16.6±3.1, P=.05) compared to the NL group. CONCLUSIONS: The results obtained with the ML instrument were similar to those obtained by CL, but with the advantages of less postoperative pain and better cosmetic results.

Radium-223 for the treatment of metastatic castration-resistant prostate cancer: A window of opportunity. / Radio-223 en el tratamiento del cáncer de próstata resistente a la castración metastásico: una ventana de oportunidad.

CONTEXT: The elimination of bone metastases, restoration and/or preservation of bone morphology and prevention and/or delay of skeletal events are a fundamental objective in the management of metastatic castration-resistant prostate cancer (mCRPC). Radium-223 is the first targeted alpha therapy with effects on bone that has been shown to increase survival in these patients, besides providing other bone-related benefits. OBJECTIVE: To analyze the impact of bone metastasis on mCRPC, and the benefits and the window of opportunity provided by radium-223 in the treatment of patients with mCRPC in the current treatment era. EVIDENCE ACQUISITION: A bibliographic search of PubMed and Spanish and international congresses on radium-223 and other first-line treatments for mCRPC was performed. Recent guidelines and recommendations by experts were also consulted. SUMMARY OF THE EVIDENCE: Evidence for the mechanism of action of radium-223 widen its effects to the tumor bone environment. Survival of patients treated with radium-223 is higher in those with mild symptoms as opposed to those with moderate-severe symptoms. The presence of visceral metastases even in the early stages of mCRPC supports starting radium-223 therapy before the symptoms become clinically relevant. A 3-year study has confirmed its good safety profile. Changes in tALP and LDH may be useful markers for monitoring the treatment with radium-223, but they are not predictors of overall survival. CONCLUSION: Radium-223 is a valuable therapeutic alternative in the treatment of patients with mCRPC in early stages of the disease, with a good safety profile. Its benefits extend to the bone environment.

National recommendations document on the follow-up of patients with renal cell carcinoma. / Documento nacional de recomendaciones sobre el seguimiento del paciente con carcinoma de células renales.

OBJECTIVES: This document was developed to establish directives for the follow-up of patients with renal cell carcinoma (RCC) based on the best available scientific evidence and on expert opinions, which can help urologists in the decision-making process and standardise the criteria at the national level. MATERIAL AND METHODS: The methodology is based on the RAND/UCLA method. A panel of 9 experts on RCC participated in designing a thematic index, identifying and reading the available evidence, formulating recommendations and drafting the content. A validating group of 25 experts, who did not participate in the previous phases, assessed the recommendations through anonymous voting in a face-to-face consensus meeting. The recommendations that were agreed upon by 75% or more of the participants in this vote were accepted as consensus. The recommendations that did not achieve this consensus were rejected. RESULTS: A total of 25 recommendations were accepted as consensus. These recommendations cover the laboratory tests, clinical assessment tests and imaging tests that should be performed for patients with RCC. The presented recommendations have been adapted according to relapse risk. The current document also outlines the frequency and duration of follow-up for each patient profile. CONCLUSIONS: The current document enables standardisation of the follow-up criteria for patients with RCC treated in the Spanish healthcare setting, according to the patients' relapse risk.