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.

Consensus statement on definition, diagnosis, and management of high-risk prostate cancer patients on behalf of the Spanish Groups of Uro-Oncology Societies URONCOR, GUO, and SOGUG

Purpose. Prostate cancer (PCa) is the most prevalent malignancy in men and the second cause of mortality in industrialized countries. Methods. Based on Spanish Register of PCa, the incidence of high-risk PCa is 29%, approximately. In spite of the evidence-based beneficial effect of radiotherapy and androgen deprivation therapy in high-risk PCa, these patients (pts) are still a therapeutic challenge for all specialists involved, in part due to the absence of comparative studies to establish which of the present disposable treatments offer better results. Results. Nowadays, high-risk PCa definition is not well consensual through the published oncology guides. Clinical stage, tumour grade, and number of risk factors are relevant to be considered on PCa prognosis. However, these factors are susceptible to change depending on when surgical or radiation therapy is considered to be the treatment of choice. Other factors, such as reference pathologist, different diagnosis biopsy schedules, surgical or radiotherapy techniques, adjuvant treatments, biochemical failures, and follow-up, make it difficult to compare the results between different therapeutic options. Conclusions. This article reviews important issues concerning high-risk PCa. URONCOR, GUO, and SOGUG on behalf of the Spanish Groups of Uro-Oncology Societies have reached a consensus addressing a practical recommendation on definition, diagnosis, and management of high-risk PCa (AU)

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Consensus statement on definition, diagnosis, and management of high-risk prostate cancer patients on behalf of the Spanish Groups of Uro-Oncology Societies URONCOR, GUO, and SOGUG.

PURPOSE: Prostate cancer (PCa) is the most prevalent malignancy in men and the second cause of mortality in industrialized countries. METHODS: Based on Spanish Register of PCa, the incidence of high-risk PCa is 29%, approximately. In spite of the evidence-based beneficial effect of radiotherapy and androgen deprivation therapy in high-risk PCa, these patients (pts) are still a therapeutic challenge for all specialists involved, in part due to the absence of comparative studies to establish which of the present disposable treatments offer better results. RESULTS: Nowadays, high-risk PCa definition is not well consensual through the published oncology guides. Clinical stage, tumour grade, and number of risk factors are relevant to be considered on PCa prognosis. However, these factors are susceptible to change depending on when surgical or radiation therapy is considered to be the treatment of choice. Other factors, such as reference pathologist, different diagnosis biopsy schedules, surgical or radiotherapy techniques, adjuvant treatments, biochemical failures, and follow-up, make it difficult to compare the results between different therapeutic options. CONCLUSIONS: This article reviews important issues concerning high-risk PCa. URONCOR, GUO, and SOGUG on behalf of the Spanish Groups of Uro-Oncology Societies have reached a consensus addressing a practical recommendation on definition, diagnosis, and management of high-risk PCa.

Diagnóstico y tratamiento del cáncer de prostata clínicamente localizado. Adherencia a las guías clínicas en un estudio poblacional nacional - GESCAP / Diagnosis and treatment for clinically localized prostate cancer. Adherence to the European Association of Urology clinical guidelines in a nationwide population-based study - GESCAP group

Objetivos: Evaluar la adherencia a las guías de la Asociación Europea de Urología (EAU) en el manejo del cáncer de próstata (CaP) en España. Pacientes y métodos: Estudio epidemiológico poblacional que incluyó una muestra representativa a nivel nacional formada por 3.918 pacientes con diagnóstico nuevo y confirmación histopatológica durante el año 2010; de estos pacientes, al 95% se les realizó un seguimiento mínimo de un año. Se registró el diagnóstico junto con las variables relacionadas con el tratamiento (para el CaP localizado de riesgo bajo, intermedio, alto o localmente avanzado, según la estratificación de riesgo de D’Amico). Las diferencias entre los grupos se evaluaron mediante pruebas de Chi-cuadrado y Kruskal-Wallis. Resultados: La media (DE) de la edad de los pacientes con CaP fue de 68,48 (8,18) años. En relación con los procedimientos diagnósticos, en el 64,56% de los pacientes se disponía de 8-12 cilindros en la primera biopsia y se realizó biopsia al 46,5% de los pacientes mayores de 75 años con PSA < 10ng/ml. Se utilizó tomografía computarizada o gammagrafía ósea para determinar la extensión tumoral en el 60,09% de los casos de alto riesgo; estas técnicas se aplicaron diferencialmente en función de la edad de los pacientes; 3.293 pacientes (84,05%) recibieron tratamiento para el CaP localizado. Se realizó prostatectomía radical a 1.277 pacientes; de ellos, 206 fueron también sometidos a linfadenectomía, siendo el 4,64% de los pacientes de bajo riesgo, el 22,81% de riesgo intermedio y el 36,00% de alto riesgo. El 86,08% de los 1.082 pacientes que recibieron radioterapia fueron tratados con 3D o RTIM y el 35,77% recibieron una dosis ≥ 75Gy; 419 pacientes fueron tratados con braquiterapia (BT), el 54,81% fueron pacientes de bajo riesgo, el 22,84% de riesgo intermedio y el 12,98% de alto riesgo. La terapia hormonal (TH, n = 521) se utilizó como monoterapia en el 9,46% de los pacientes de bajo riesgo y en el 17,92% de los pacientes de riesgo intermedio. Además, la TH se combinó con RT en el 14,34% de los pacientes con bajo riesgo y en el 58,26% con alto riesgo; el 67,19% de los pacientes de riesgo intermedio con RT y/o BT recibieron TH neoadyuvante/concomitante/adyuvante. Por último, el 83,75% de los pacientes de alto riesgo que recibieron RT y/o BT también recibieron TH. Conclusiones: Aunque las guías EAU para el manejo del CaP están disponibles en Europa, la adherencia a sus recomendaciones es baja; las mayores discrepancias se refieren a la necesidad de las biopsias de próstata y a los métodos diagnósticos. Una mayor información y programas educacionales podrían mejorar la adherencia a las guías y reducir la variabilidad en la práctica diaria. (Controlled-trials.com: ISRCTN19893319)

Objective: To assess the adherence to European Association of Urology (EAU) guidelines in the management of prostate cancer (PCa) in Spain. Patients and methods: Epidemiological, population-based, study including a national representative sample of 3,918 incident patients with histopathological confirmation during 2010; 95% of the patient's sample was followed up for at least one year. Diagnosis along with treatment related variables (for localized PCa -low, intermediate, high and locally-advanced by D’Amico risk stratification) was recorded. Differences between groups were tested with Chi-squared and Kruskal-Wallis tests. Results: Mean (SD) age of PCa patients was 68.48 (8.18). Regarding diagnostic by biopsy procedures, 64.56% of all patients had 8-12 cores in first biopsy and 46.5% of the patients over 75 years, with PSA < 10ng/mL were biopsied. Staging by Computer Tomography (CT) or Bone Scan (BS) was used for determining tumor extension in 60.09% of high-risk cases and was applied differentially depending on patients’ age; 3,293 (84.05%) patients received a treatment for localized PCa. Radical prostatectomy was done in 1,277 patients and 206 out of these patients also had a lymphadenectomy, being 4.64% low-risk, 22.81% intermediate-risk and 36.00% high-risk patients; 86.08% of 1,082 patients who had radiotherapy were treated with 3D or IMRT and 35.77% received a dose ≥ 75 Gy; 419 patients were treated with brachytherapy (BT): 54.81% were low-risk patients, 22.84% intermediate-risk and 12.98% high-risk. Hormonotherapy (HT, n = 521) was applied as single therapy in 9.46% of low-risk and 17.92% of intermediate-risk patients. Additionally, HT was combined with RT in 14.34% of lower-risk patients and 58.26% of high-risk patients, and 67.19% low-intermediate risk with RT and/or BT received neoadjuvant/concomitant/adjuvant HT. Finally, 83.75% of high-risk patients undergoing RT and/or BT also received HT. Conclusions: Although EAU guidelines for PCa management are easily available in Europe; the adherence to their recommendations is low, finding the highest discrepancies in the need for a prostate biopsy and the diagnostic methods. Improve information and educational programs could allow a higher adherence to the guidelines and reduce the variability in daily practice. (Controlled-trials.com: ISRCTN19893319)

Diagnosis and treatment for clinically localized prostate cancer. Adherence to the European Association of Urology clinical guidelines in a nationwide population-based study - GESCAP group. / Diagnóstico y tratamiento del cáncer de prostata clínicamente localizado. Adherencia a las guías clínicas en un estudio poblacional nacional ­ GESCAP.

OBJECTIVE: To assess the adherence to European Association of Urology (EAU) guidelines in the management of prostate cancer (PCa) in Spain. PATIENTS AND METHODS: Epidemiological, population-based, study including a national representative sample of 3,918 incident patients with histopathological confirmation during 2010; 95% of the patient's sample was followed up for at least one year. Diagnosis along with treatment related variables (for localized PCa -low, intermediate, high and locally-advanced by D'Amico risk stratification) was recorded. Differences between groups were tested with Chi-squared and Kruskal-Wallis tests. RESULTS: Mean (SD) age of PCa patients was 68.48 (8.18). Regarding diagnostic by biopsy procedures, 64.56% of all patients had 8-12 cores in first biopsy and 46.5% of the patients over 75 years, with PSA<10ng/mL were biopsied. Staging by Computer Tomography (CT) or Bone Scan (BS) was used for determining tumor extension in 60.09% of high-risk cases and was applied differentially depending on patients' age; 3,293 (84.05%) patients received a treatment for localized PCa. Radical prostatectomy was done in 1,277 patients and 206 out of these patients also had a lymphadenectomy, being 4.64% low-risk, 22.81% intermediate-risk and 36.00% high-risk patients; 86.08% of 1,082 patients who had radiotherapy were treated with 3D or IMRT and 35.77% received a dose ≥75Gy; 419 patients were treated with brachytherapy (BT): 54.81% were low-risk patients, 22.84% intermediate-risk and 12.98% high-risk. Hormonotherapy (HT, n=521) was applied as single therapy in 9.46% of low-risk and 17.92% of intermediate-risk patients. Additionally, HT was combined with RT in 14.34% of lower-risk patients and 58.26% of high-risk patients, and 67.19% low-intermediate risk with RT and/or BT received neoadjuvant/concomitant/adjuvant HT. Finally, 83.75% of high-risk patients undergoing RT and/or BT also received HT. CONCLUSIONS: Although EAU guidelines for PCa management are easily available in Europe, the adherence to their recommendations is low, finding the highest discrepancies in the need for a prostate biopsy and the diagnostic methods. Improve information and educational programs could allow a higher adherence to the guidelines and reduce the variability in daily practice. (Controlled-trials.com: ISRCTN19893319).

Estudio retrospectivo de diferentes opciones de tratamiento conservador con Bacilo de Calmette-Guèrin en el carcinoma urotelial vesical T1G3: terapia de mantenimiento / Retrospective study of various conservative treatment options with bacille Calmette-Guérin in bladder urothelial carcinoma T1G3: Maintenance therapy

Objetivo: Comparar diferentes opciones de tratamiento conservador del tumor vesical no músculo-invasivo (TVNMI) T1 de grado alto. El bacilo de Calmette-Guérin (BCG) es el tratamiento intravesical preferido para los tumores T1 de grado alto; sin embargo, algunos expertos aún cuestionan la necesidad de la BCG de mantenimiento. Materiales y métodos: Se analizaron retrospectivamente los datos de 1.039 pacientes con TVNMI T1G3 primario y recurrente. Todos los pacientes fueron tratados mediante una resección transuretral del tumor vesical (RTUTV) completa, con músculo en la muestra y múltiples biopsias de la vejiga. Los pacientes fueron tratados con solo una RTUTV inicial (n = 108), re-RTUTV (n = 153), inducción con 27 mg de BCG (cepa Connaught) (n = 87), inducción con 81 mg de BCG (n = 489) o inducción con 81 mg de BCG + mantenimiento (n = 202). El tiempo hasta la primera recidiva, progresión (a T2 o mayor, o a enfermedad metastásica) y mortalidad específica de la enfermedad se evaluaron mediante la función de supervivencia de Kaplan-Meier y se compararon utilizando la prueba de logaritmo del rango (log-rank) y el modelo multivariado de regresión de Cox de riesgos proporcionales. Resultados: El seguimiento medio fue de 62 ± 39 meses. El riesgo de recurrencia fue significativamente menor en los pacientes tratados con terapia de mantenimiento con 81 mg de BCG que en los otros grupos de tratamiento (p < 0,001). El riesgo de progresión del tumor también fue significativamente más bajo en los pacientes tratados con mantenimiento con BCG que en los pacientes tratados solo con una RTUTV, re-RTUTV y con terapia de inducción con 27 mg de BCG (p = 0,0003). La mortalidad específica de la enfermedad fue significativamente más baja con el mantenimiento con BCG (9,4%) que con solo una RTUTV (27,8%; p = 0,003). Conclusiones: En el caso del TVNMI T1G3, la dosis completa de BCG con mantenimiento va asociada a mejores resultados de recurrencia que otras modalidades de tratamiento conservador. Los resultados de progresión y de supervivencia específica de la enfermedad también fueron mejores con la BCG de inducción, con o sin mantenimiento

Objective: To compare various conservative treatment options for high-grade T1 nonmuscle-invasive bladder cancer (NMIBC). Bacille Calmette-Guérin (BCG) is the preferred intravesical treatment for high-grade T1 tumours; however, a number of experts still question the need for maintenance BCG. Material and methods: We retrospectively analysed data from 1039 patients with primary and recurrent T1G3 NMIBC. All patients underwent complete transurethral resection of the bladder tumour (TURBT), with muscle in the sample and multiple bladder biopsies. The patients were treated with the following: only one initial TURBT (n = 108), re-TURBT (n = 153), induction with 27 mg of BCG (Connaught strain) (n = 87), induction with 81 mg of BCG (n = 489) or induction with 81 mg of BCG + maintenance (n = 202). The time to first recurrence, progression (to T2 or greater or to metastatic disease) and specific mortality of the disease was assessed using the Kaplan-Meier survival function and were compared using the log-rank test and the Cox multivariate regression model of proportional risks. Results: The mean follow-up was 62 ± 39 months. The risk of recurrence was significantly lower for the patients treated with maintenance therapy of 81 mg of BCG than in the other treatment groups (P<.001). The risk of tumour progression was also significantly lower for the patients treated with maintenance BCG than for the patients treated only with one TURBT, re-TURBT and with induction therapy with 27 mg of BCG (P=.0003). The specific disease mortality was significantly lower with BCG maintenance (9.4%) than with only one TURBT (27.8%; P=.003). Conclusions: In the case of T1G3 NMIBC, a complete dose of BCG with maintenance is associated with better recurrence results than are other conservative treatment modalities. The results of progression and survival specific to the disease were also better with induction BCG, with or without maintenance

Tendencias de tratamiento en el cáncer de próstata clínicamente localizado. Análisis poblacional a nivel nacional: grupo GESCAP / Treatment trends for clinically localised prostate cancer. National population analysis: GESCAP group

Objetivos: Describir las terapias establecidas para el cáncer de próstata (CaP) localizado en España y valorar el cumplimiento de las guías EAU 2010. Pacientes y métodos: Estudio epidemiológico, observacional, prospectivo y multicéntrico. De los 3.918 pacientes diagnosticados con CaP durante 2010, solo se incluyeron los pacientes con CaP localizado. Finalmente, se hizo el seguimiento durante un periodo mínimo de un año a partir del diagnóstico a 3.713 pacientes (94,77%). Los grupos de tratamiento evaluados fueron: prostatectomía radical, radioterapia, terapia hormonal, braquiterapia, vigilancia activa u observación y tratamiento local experimental (crioterapia u otro tratamiento). Se estudió el cumplimiento de las recomendaciones de las guías EAU describiendo los grupos de tratamiento según los criterios de estratificación de riesgo de D’Amico (localizado [bajo riesgo, riesgo intermedio y alto riesgo] y localmente avanzado), edad, PSA y puntuación Gleason. Resultados: Considerando los criterios D’Amico, se incluyó a 3.641 (92,93%) pacientes. Según las recomendaciones EAU: 1) se hizo prostatectomía radical al 68,87% de los pacientes de riesgo bajo-intermedio de ≤ 65 años; 2) se administró radioterapia y terapia hormonal al 34,51% de los pacientes con riesgo alto-enfermedad localmente avanzada > 65 años; 3) se trató solo con terapia hormonal al 30,36% de los pacientes con riesgo alto-enfermedad localmente avanzada; 4) recibieron solo braquiterapia el 15,20% de los pacientes con riesgo bajo; 5) se eligió la vigilancia activa u observación en el 2,44% de los pacientes ≤ 65 años y en el 10,63% de los pacientes de riesgo bajo-intermedio > 65 años. Por último, el 86,5% de los pacientes de bajo riesgo recibió un único tratamiento y el 43,62% de los pacientes con riesgo alto-enfermedad localmente avanzada recibió tratamientos combinados. Conclusiones: Este es el primer estudio europeo de ámbito nacional que evalúa el manejo terapéutico para el CaP localizado en función del grupo de riesgo al que pertenece el paciente. La mayor parte de los pacientes jóvenes (≤ 65 años) con CaP localizado de riesgo bajo e intermedio fueron tratados con cirugía, lo cual se adapta a las recomendaciones de las guías de la EAU de 2010. En los pacientes con tumores localizados de alto riesgo y localmente avanzados se han empleado distintas combinaciones terapéuticas, poniendo de manifiesto la necesidad de un abordaje multidisciplinar (número de Controlled-trials.com ISRCTN19893319)

Objectives: To describe the established therapies for localised prostate cancer (PC) in Spain and to assess compliance with the 2010 UAE guidelines. Patients and methods: This was an epidemiological, observational, prospective and multicentre study. Of the 3,918 patients diagnosed with PC during 2010, only those patients with localised PC were included. Follow-up was ultimately conducted for a minimum of one year from the diagnosis for 3,713 patients (94.77%). The treatment groups assessed were as follows: radical prostatectomy, radiation therapy, hormone therapy, brachytherapy, active surveillance or observation and experimental local treatment (cryotherapy or other treatment). Compliance with the recommendations of the EAU guidelines was studied, describing the treatment groups according to D’Amico risk stratification criteria (localised [low, intermediate and high risk] and locally advanced), age, PSA and Gleason score. Results: By applying the D’Amico criteria, we included 3,641 (92.93%) patients. Based on the UAE recommendations: 1) 68.87% of the patients at low-intermediate risk aged ≤ 65 years underwent radical prostatectomy; 2) 34.51% of the patients > 65 years at high risk with locally advanced disease were administered radiation therapy and hormone therapy; 3) 30.36% of the patients at high risk with locally advanced disease were only treated with hormone therapy; 4) 15.20% of the patients at low risk were only treated with brachytherapy; 5) active surveillance or observation was selected for 2.44% of the patients aged ≤ 65 years and for 10.63% of the patients at low-intermediate risk who were > 65 years. Lastly, 86.5% of the patients at low risk underwent a single treatment, and 43.62% of the patients at high risk with locally advanced disease underwent combined treatments. Conclusions: This is the first national European study to evaluate the therapeutic management of localised PC based on the risk group to which the patient belonged. Most young patients (≤ 65 years) with low-intermediate risk localised PC were treated with surgery, which adheres to the recommendations of the 2010 UAE guidelines. Various therapeutic combinations have been employed for patients with high-risk, locally advanced localised tumours, revealing the need for a multidisciplinary approach (Controlled-trials.com number: ISRCTN19893319)

Retrospective study of various conservative treatment options with bacille Calmette-Guérin in bladder urothelial carcinoma T1G3: Maintenance therapy. / Estudio retrospectivo de diferentes opciones de tratamiento conservador con Bacilo de Calmette-Guèrin en el carcinoma urotelial vesical T1G3: terapia de mantenimiento.

OBJECTIVE: To compare various conservative treatment options for high-grade T1 nonmuscle-invasive bladder cancer (NMIBC). Bacille Calmette-Guérin (BCG) is the preferred intravesical treatment for high-grade T1 tumours; however, a number of experts still question the need for maintenance BCG. MATERIAL AND METHODS: We retrospectively analysed data from 1039 patients with primary and recurrent T1G3 NMIBC. All patients underwent complete transurethral resection of the bladder tumour (TURBT), with muscle in the sample and multiple bladder biopsies. The patients were treated with the following: only one initial TURBT (n=108), re-TURBT (n=153), induction with 27mg of BCG (Connaught strain) (n=87), induction with 81mg of BCG (n=489) or induction with 81mg of BCG+maintenance (n=202). The time to first recurrence, progression (to T2 or greater or to metastatic disease) and specific mortality of the disease was assessed using the Kaplan-Meier survival function and were compared using the log-rank test and the Cox multivariate regression model of proportional risks. RESULTS: The mean follow-up was 62±39 months. The risk of recurrence was significantly lower for the patients treated with maintenance therapy of 81mg of BCG than in the other treatment groups (P<.001). The risk of tumour progression was also significantly lower for the patients treated with maintenance BCG than for the patients treated only with one TURBT, re-TURBT and with induction therapy with 27mg of BCG (P=.0003). The specific disease mortality was significantly lower with BCG maintenance (9.4%) than with only one TURBT (27.8%; P=.003). CONCLUSIONS: In the case of T1G3 NMIBC, a complete dose of BCG with maintenance is associated with better recurrence results than are other conservative treatment modalities. The results of progression and survival specific to the disease were also better with induction BCG, with or without maintenance.

Treatment trends for clinically localised prostate cancer. National population analysis: GESCAP group. / Tendencias de tratamiento en el cáncer de próstata clínicamente localizado. Análisis poblacional a nivel nacional: grupo GESCAP.

OBJECTIVES: To describe the established therapies for localised prostate cancer (PC) in Spain and to assess compliance with the 2010 UAE guidelines. PATIENTS AND METHODS: This was an epidemiological, observational, prospective and multicentre study. Of the 3,918 patients diagnosed with PC during 2010, only those patients with localised PC were included. Follow-up was ultimately conducted for a minimum of one year from the diagnosis for 3,713 patients (94.77%). The treatment groups assessed were as follows: radical prostatectomy, radiation therapy, hormone therapy, brachytherapy, active surveillance or observation and experimental local treatment (cryotherapy or other treatment). Compliance with the recommendations of the EAU guidelines was studied, describing the treatment groups according to D'Amico risk stratification criteria (localised [low, intermediate and high risk] and locally advanced), age, PSA and Gleason score. RESULTS: By applying the D'Amico criteria, we included 3,641 (92.93%) patients. Based on the UAE recommendations: 1) 68.87% of the patients at low-intermediate risk aged≤65 years underwent radical prostatectomy; 2) 34.51% of the patients>65 years at high risk with locally advanced disease were administered radiation therapy and hormone therapy; 3) 30.36% of the patients at high risk with locally advanced disease were only treated with hormone therapy; 4) 15.20% of the patients at low risk were only treated with brachytherapy; 5) active surveillance or observation was selected for 2.44% of the patients aged≤65 years and for 10.63% of the patients at low-intermediate risk who were>65 years. Lastly, 86.5% of the patients at low risk underwent a single treatment, and 43.62% of the patients at high risk with locally advanced disease underwent combined treatments. CONCLUSIONS: This is the first national European study to evaluate the therapeutic management of localised PC based on the risk group to which the patient belonged. Most young patients (≤65 years) with low-intermediate risk localised PC were treated with surgery, which adheres to the recommendations of the 2010 UAE guidelines. Various therapeutic combinations have been employed for patients with high-risk, locally advanced localised tumours, revealing the need for a multidisciplinary approach (Controlled-trials.com number: ISRCTN19893319).

Influencia del número real de instilaciones de Bacilo de Calmette-Guérin aplicadas en el pronóstico de los tumores vesicales no músculo-infiltrantes / Influence of the true number of Bacillus Calmette-Guérin instillations on the prognosis of non-muscle invasive bladder tumors

Objetivos: Analizar si el número real de instilaciones de BCG aplicadas en los tumores vesicales no músculo-infiltrantes tiene alguna influencia en su pronóstico, así como otras variables clínicas y del tumor: edad, sexo, diferentes protocolos, dosis de BCG, primario o recurrente, G3 o Cis. Pacientes y métodos: De 1.491 pacientes incluidos en la base de datos del grupo CUETO se analizaron 324 tumores de alto grado (15 TaG3, 184 T1G3, 125 Cis). Tras la inducción de 6 instilaciones de BCG post-RTU fueron programados para recibir una instilación cada 2 semanas (3-6 veces), total 9-12 instilaciones. Un tercio de dosis (27 mg) en 112 casos y dosis total (81 mg) en 212 casos. Seguimiento medio: 59,6 meses. Análisis estadístico: Kaplan-Meier, regresión de Cox uni y multivariado. Resultados: Con el análisis de Kaplan-Meier y regresión de Cox multivariado se obtuvo mayor riesgo de recidiva (p = 0,032) y progresión (p = 0,013), y peor supervivencia cáncer-específica (p = 0,005) si < de 12 instilaciones. Dosis de 27 mg (p = 0,008) y el ser mujer (p < 0,001) fueron factores independientes predictivos de mayor recidiva, pero no de mayor progresión ni de peor supervivencia cáncer-específica. El resto de las características estudiadas no fueron estadísticamente significativas. Conclusiones: Con los resultados obtenidos parece que el número de instilaciones aplicadas tiene alguna influencia sobre el pronóstico, quedando por determinar cuál es el mínimo de instilaciones a partir del cual el paciente se puede beneficiar y su tiempo de aplicación. Dosis de 27 mg y el ser mujer son factores predictivos para mayor recidiva

Objectives: To analyze if the true number of BCG instillations applied in non-muscle invasive bladder tumors has any influence on their prognosis as well as other tumor and clinical characteristics: age, sex, different protocols, BCG dose, whether primary or recurrent, solitary or multiple, tumor size G3 or Cis. Patients and methods: A total of 324 high grade NMIBC (15 TaG3, 184 T1G3, 125 Cis) out of 1491 cases included in the CUETO database were analyzed. Following 6 post transurethral resection (RTU) BCG instillations, the patients were scheduled to receive one instillation every two weeks (3-6 times), for a total of 9-12 instillations. One third of the dose (27 mg) (112 cases) or total dose of 81 mg (212 cases). Mean follow-up was 59.6 months. Statistical Analysis: Kaplan-Meier, Cox-regression (uni-multivariate). Results: A higher level of recurrence (p = 0.032) and progression (p = 0.013) risk as well as worse Ca-specific survival (p = 0.005) were obtained if there were fewer than 12 instillations with the Kaplan-Meier and Cox-regression multivariate analysis. A 27 mg (p = 0.008) dosage and being a female (p < 0.001) were independent factors for a higher recurrence risk, but not for progression or Ca-specific survival. The remaining characteristics studied were not statistically significant. Conclusions: In accordance with the results obtained, we can conclude that the number of BCG instillations applied has some influence on the outcome of high grade NMIBC. The optimum number of instillations as well as their time of application must still be determined. A dose of 27 mg and being a female are predictive factors of recurrence

Factores que predicen el desarrollo de metástasis óseas por cáncer de próstata: recomendaciones de seguimiento y opciones terapéuticas / Factors that predict the development of bone metastases due to prostate cancer: Recommendations for follow-up and therapeutic options

Contexto: El cáncer de próstata representa un problema de salud pública en España y en el mundo occidental. En las fases avanzadas de la enfermedad la afectación ósea es prácticamente constante, asociada a una notable morbilidad. El objetivo de este trabajo es realizar una revisión de los factores pronósticos utilizados en la práctica clínica habitual que predicen el desarrollo de metástasis óseas y analizar las opciones de seguimiento y tratamiento en estos perfiles de pacientes. Adquisición de evidencia: Realizamos una revisión de la literatura sobre los factores útiles en el contexto de terapia de intención curativa; incluimos los valores clínicos clásicos al diagnóstico (PSA, estadio clínico, Gleason de la biopsia) factores patológicos (estadio pT, márgenes, invasión de vesículas, volumen tumoral, afectación ganglionar) y la cinética de PSA en sus diferentes contextos, así como parámetros histológicos y moleculares. Síntesis de evidencia: El grado de diferenciación tumoral «Gleason» y el PSA son los factores predictivos más importantes en la predicción de metástasis óseas en pacientes con intención curativa. Factores cinéticos como TDPSA < 8 meses o PSA > 10 ng/ml en la situación de CPRC son factores predictivos de desarrollo de metástasis. El ácido zoledrónico y el denosumab han demostrado su efectividad para el tratamiento de la enfermedad ósea en estudios aleatorizados. Conclusiones: Existen factores predictivos dentro de la práctica clínica habitual que permiten reconocer el «paciente riesgo» para el desarrollo de enfermedad metastásica ósea. Los tratamientos actualmente disponibles, ácido zoledrónico o denosumab, pueden ayudarnos en el manejo de paciente con riesgo de desarrollo de metástasis o metastásico, aumentando la calidad de vida y disminuyendo los eventos esqueléticos

Context: Prostate cancer is a public health problem in Spain and in the Western world. Bone involvement, associated to significant morbidity, is practically constant in the advanced stages of the disease. This work aims to review the prognostic factors used in the usual clinical practice that predict the development of bone metastases and to analyze the follow-up and treatment option in these patient profiles. Acquiring of evidence: We performed a review of the literature on the useful factors in the context of therapy with intention to cure. We included the classical clinical values in the diagnosis (PSA, clinical stage, Gleason score on the biopsy) pathological factors (pT stage, margins, bladder invasion, tumor volume, lymph node involvement) and PSA kinetics in their different contexts and the histological and molecular parameters. Synthesis of evidence: The tumor differentiation «Gleason» score and PSA are the most important predictive factors in the prediction of bone metastases in patients with intention to cure. Kinetic factors such as PSA doubling time (TDPSA) < 8 months or PSA > 10 ng/ml in the case of castration-resistant prostate cancer (CPRC), are predictive factors for the development of metastasis. Zoledronic acid and denosumab have demonstrated their effectiveness for the treatment of bone disease in randomized studies. Conclusions: There are predictive factors within the usual clinical practice that make it possible to recognize the «patient at risk» to develop bone metastatic disease. The currently available treatments, zoledronic acid or denosumab, can help us in the management of the patient at risk of developing metastasis or metastatic patient, increasing the quality of life and decreasing skeletal events

Influence of the true number of Bacillus Calmette-Guérin instillations on the prognosis of non-muscle invasive bladder tumors.

OBJECTIVES: To analyze if the true number of BCG instillations applied in non-muscle invasive bladder tumors has any influence on their prognosis as well as other tumor and clinical characteristics: age, sex, different protocols, BCG dose, whether primary or recurrent, solitary or multiple, tumor size G3 or Cis. PATIENTS AND METHODS: A total of 324 high grade NMIBC (15 TaG3, 184 T1G3, 125 Cis) out of 1491 cases included in the CUETO database were analyzed. Following 6 post transurethral resection (RTU) BCG instillations, the patients were scheduled to receive one instillation every two weeks (3-6 times), for a total of 9-12 instillations. One third of the dose (27 mg) (112 cases) or total dose of 81 mg (212 cases). Mean follow-up was 59.6 months. Statistical Analysis: Kaplan-Meier, Cox-regression (uni-multivariate). RESULTS: A higher level of recurrence (p = 0.032) and progression (P = .013) risk as well as worse Ca-specific survival (P = .005) were obtained if there were fewer than 12 instillations with the Kaplan-Meier and Cox-regression multivariate analysis. A 27 mg (P = .008) dosage and being a female (P < .001) were independent factors for a higher recurrence risk, but not for progression or Ca-specific survival. The remaining characteristics studied were not statistically significant. CONCLUSIONS: In accordance with the results obtained, we can conclude that the number of BCG instillations applied has some influence on the outcome of high grade NMIBC. The optimum number of instillations as well as their time of application must still be determined. A dose of 27 mg and being a female are predictive factors of recurrence.

Factors that predict the development of bone metastases due to prostate cancer: Recommendations for follow-up and therapeutic options.

CONTEXT: Prostate cancer is a public health problem in Spain and in the Western world. Bone involvement, associated to significant morbidity, is practically constant in the advanced stages of the disease. This work aims to review the prognostic factors used in the usual clinical practice that predict the development of bone metastases and to analyze the follow-up and treatment option in these patient profiles. ACQUIRING OF EVIDENCE: We performed a review of the literature on the useful factors in the context of therapy with intention to cure. We included the classical clinical values in the diagnosis (PSA, clinical stage, Gleason score on the biopsy) pathological factors (pT stage, margins, bladder invasion, tumor volume, lymph node involvement) and PSA kinetics in their different contexts and the histological and molecular parameters. SYNTHESIS OF EVIDENCE: The tumor differentiation "Gleason" score and PSA are the most important predictive factors in the prediction of bone metastases in patients with intention to cure. Kinetic factors such as PSA doubling time (TDPSA) < 8 months or PSA > 10 ng/ml in the case of castration-resistant prostate cancer (CPRC), are predictive factors for the development of metastasis. Zoledronic acid and denosumab have demonstrated their effectiveness for the treatment of bone disease in randomized studies. CONCLUSIONS: There are predictive factors within the usual clinical practice that make it possible to recognize the "patient at risk" to develop bone metastatic disease. The currently available treatments, zoledronic acid or denosumab, can help us in the management of the patient at risk of developing metastasis or metastatic patient, increasing the quality of life and decreasing skeletal events.