PSA levels in patients on hemodialysis treatment.

OBJECTIVES: Standardized prostate-specific antigen (PSA) levels are based upon the general population levels and, although a higher incidence of prostate cancer in patients on hemodialysis (HD)has not been demonstrated, some studies point at the possibility of observing higher PSA levels in this type of patients than in males with preserved renal function. The objective of the present study is to compare PSA levels in males on hemodialysis with those of the population with normal renal function. METHODS: Comparative, transversal study of the variables age, total PSA, free PSA and PSA index in 190 patients with chronic renal disease on hemodialysis treatment (group 1) and 237 subjects without renal disease ( group 2). We carried out a descriptive analysis and a comparative study of the above mentioned variables using the SPSS software. RESULTS: Median age of patients on HD was 55 in cases (47-61)and 59 in controls (54-63.5). Mean total PSA was 1.49 ng/mL [1.24-1.73] in cases and 1.62 ng/mL [1.29-1.95] in controls; mean free PSA was 1.40 ng/mL [0.89-1.91] in group 1 and 2.31 ng/mL [-0.83-5.45] in group 2; mean PSA index was 27.67% [19.91-35.63] in cases and 14.82%[12.79-16.85]] in controls. The comparative study showed differences between the two groups in free PSA (p ≤ 0.007), PSA index (p ≤ 0.000) and total PSA (p ≤ 0.000) in patients under 50 after an age-specific analysis. CONCLUSIONS: Total PSA is higher in patients on HD within the subgroup of patients under 50 with statistically significant but not clinically relevant difference. PSA index is remarkably higher in the group of patients on HD. These data could have clinical implications as far as indications for biopsy is concerned.

Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting. / Seguridad de nivolumab en pacientes con carcinoma de células renales metastásico: experiencia española en urología en la práctica clínica real.

INTRODUCTION AND OBJECTIVES: Nivolumab is an immunotherapy agent that has been an approved treatment for previously treated patients with advanced renal cell carcinoma (RCC). Experience in real-life settings, especially regarding immune- related adverse events, is scarce. We present our experience with reference to the safety of nivolumab in patients with metastatic RCC (mRCC) treated in 9 hospitals in Spain. MATERIAL AND METHODS: Retrospective, multicentre study of patients with mRCC treated with nivolumab between 2016 and 2018. Data on baseline socio-demographic and clinical characteristics and drug-related adverse events were collected. RESULTS: The mean age of the 26 patients included was 63.7±11.5 years; 96% were ECOG 0-1 and 78% had favourable or intermediate MSKCC risk scores; 73% had the clear cell histological subtype and 30% metastatic disease. Median follow-up was 9 months (range 1-14). All patients experienced an adverse event at different grades, with fatigue, fever and anaemia being the most common (27%). Grade 3 adverse events occurred in 23% of patients. Adverse reactions led to treatment suspension in 3 patients (11%). CONCLUSION: In the real-life clinical setting, nivolumab shows favourable outcomes, similar to those reported by other studies.

Low-dose-rate brachytherapy for prostate cancer in renal transplant recipients.

PURPOSE: Prostate cancer (PCa) is the most common malignancy among men and one of the most common neoplasms affecting renal transplant recipients (RTRs). The available treatments for localized PCa among the general population (GP), surgery and external beam radiotherapy, carry a risk of damage to the transplanted kidney, the ureters, and the bladder and therefore tend to be avoided by most groups. The objective of this study was to assess the efficacy and feasibility of low-dose-rate brachytherapy (LDR-BT) for PCa in RTRs. METHODS AND MATERIALS: We carried out a retrospective review on all RTRs diagnosed of PCa who had undergone LDR-BT at our institution between 2000 and 2015. Nine patients met these criteria, but 1 did not fulfill the followup. Hence, we analyzed 8 patients. We reviewed all clinical data for PCa and graft function in these patients and compared the results with the GP. RESULTS: Mean baseline prostate-specific antigen was 6.8 ± 1.9 ng/mL. All PCa had a Gleason score of 6 and were classified as low risk according the Europe Association of Urology guidelines. Mean followup after seed implantation was 48 ± 12.8 months. All 8 patients remain free of prostate-specific antigen failure. Five-year progression-free survival, cancer-specific survival, and overall survival rates were 100%, 100%, and 62.5%. There was no specific toxicity associated with LDR-BT, and there were no acute adverse events affecting the graft. CONCLUSIONS: LDR-BT is a feasible and acceptable treatment for localized PCa in RTRs. Oncological outcomes are similar to the GP, and there is minimal toxicity to the renal graft.

Learning curve for the management of tyrosine kinase inhibitors as the first line of treatment for patients with metastatic renal cancer. / Curva de aprendizaje en el manejo de los inhibidores de tirosina quinasa como primera línea de tratamiento en pacientes con cáncer renal metastásico.

OBJECTIVES: To analyse the learning curve for the management of tyrosine kinase inhibitors as the first line of treatment for patients with metastatic renal cancer. MATERIAL AND METHODS: We evaluated 32 consecutive patients treated in our department for metastatic renal cancer with tyrosine kinase inhibitors (pazopanib or sunitinib) as first-line treatment between September 2012 and November 2015. We retrospectively analysed this sample. We measured the time to the withdrawal of the first-line treatment, the time to progression and overall survival using Kaplan-Meier curves. The learning curve was analysed with the cumulative sum (CUSUM) methodology. RESULTS: In our series, the median time to the withdrawal of the first-line treatment was 11 months (95% CI 4.9-17.1). The mean time to progression was 30.4 months (95% CI 22.7-38.1), and the mean overall survival was 34.9 months (95% CI 27.8-42). By applying the CUSUM methodology, we obtained a graph for the CUSUM value of the time to withdrawal of the first-line treatment (CUSUM TW), observing 3 well-differentiated phases: phase 1 or initial learning phase (1-15), phase 2 (16-26) in which the management of the drug progressively improved and phase 3 (27-32) of maximum experience or mastery of the management of these drugs. The number of treated patients needed to achieve the proper management of these patients was estimated at 15. CONCLUSIONS: Despite the limitations of the sample size and follow-up time, we estimated (in 15 patients) the number needed to reach the necessary experience in the management of these patients with tyrosine kinase inhibitors. We observed no relationship between the time to the withdrawal of the first-line treatment for any cause and progression.

Pairs of kidneys transplanted from the same donor: is there any difference?

OBJECTIVES: The aim of this study was to compare the evolution of the first kidney in relation to the second kidney transplanted from the same donor, focusing on the impact that a longer cold ischemia time may have as an independent variable. MATERIAL AND METHODS: The study included 44 pairs of kidneys transplanted from the same donor between February 2008 and October 2010, divided into Groups 1 and 2 according to the graft placement order. The variables analyzed were age, sex, comorbidities, number of transfusions, length of hospital stay, maximum peak PRA, immunologic incompatibility, ischemia time, delayed graft function (DGF), presence of rejection, creatinine clearance at first week, at 3 months and at 1 year, and vascular and tract complications in each group. RESULTS: The mean cold ischemia time was 15.6 hours in Group 1 and 20.1 hours in Group 2 (P < .001). The average recipient age was 52.79 years in Group 1 and 54.52 years in Group 2, with an equal sex ratio in the two groups; an average of 2.06 PRC were transfused prior to transplantation in Group 1 and 0.93 PRC in Group 2; the average length of stay was similar in the two groups. Major DR incompatibility was only found in Group 2 (P < .03). Creatinine clearance at first week, DGF and acute rejection showed worse results in Group 2, but these differences were not significant. Vascular complications were present in 4.5% and 2.3% of Groups 1 and 2, respectively, and tract complications were 6.8% and 11.4%. CONCLUSIONS: A greater tendency to DGF, early rejection and tract complications were found in the group with longer ischemia time, although the difference was not statistically significant. Larger series will be necessary to confirm our results.

Seguridad de nivolumab en pacientes con carcinoma de células renales metastásico: experiencia española en urología en la práctica clínica real / Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting

Introducción y objetivo: Nivolumab es un agente inmunoterapéutico aprobado para el tratamiento de pacientes con carcinoma de células renales (CCR) avanzado tratados previamente. La experiencia en práctica clínica real, especialmente en lo referente a la aparición de reacciones adversas inmunorrelacionadas, es escasa. Presentamos la experiencia acerca de la seguridad de nivolumab en pacientes con CCR metastásico (CCRm) tratados en 9 hospitales de España. Material y métodos: Estudio retrospectivo, multicéntrico en pacientes con CCRm tratados con nivolumab entre 2016 y 2018. Se recogieron datos sociodemográficos y clínicos basales y las reacciones adversas relacionadas con el fármaco. Resultados: Los 26 pacientes incluidos presentaron una edad de 63,7 ± 11,5 años. El 96% presentaba ECOG 0-1 y el 78% un riesgo MKSCC favorable/intermedio. El 73% presentaba subtipo histológico de células claras y el 30%, metástasis de inicio. La mediana de seguimiento fue de 9 meses (rango: 1-14). El 100% de los pacientes presentó una reacción adversa de cualquier grado; las más frecuentes fueron la fatiga, la fiebre y la anemia (27%). El 23% presentó una reacción adversa de grado 3. Las reacciones adversas llevaron a la suspensión del tratamiento en 3 pacientes (11%). Conclusión: En la práctica clínica real, nivolumab presenta un perfil de seguridad favorable y manejable, similar al descrito en otros estudios

Introduction and objectives: Nivolumab is an immunotherapy agent that has been an approved treatment for previously treated patients with advanced renal cell carcinoma (RCC). Experience in real-life settings, especially regarding immune- related adverse events, is scarce. We present our experience with reference to the safety of nivolumab in patients with metastatic RCC (mRCC) treated in 9 hospitals in Spain. Material and methods: Retrospective, multicentre study of patients with mRCC treated with nivolumab between 2016 and 2018. Data on baseline socio-demographic and clinical characteristics and drug-related adverse events were collected. Results: The mean age of the 26 patients included was 63.7 ± 11.5 years; 96% were ECOG 0-1 and 78% had favourable or intermediate MSKCC risk scores; 73% had the clear cell histological subtype and 30% metastatic disease. Median follow-up was 9 months (range 1-14). All patients experienced an adverse event at different grades, with fatigue, fever and anaemia being the most common (27%). Grade 3 adverse events occurred in 23% of patients. Adverse reactions led to treatment suspension in 3 patients (11%). Conclusion: In the real-life clinical setting, nivolumab shows favourable outcomes, similar to those reported by other studies

Curva de aprendizaje en el manejo de los inhibidores de tirosina quinasa como primera línea de tratamiento en pacientes con cáncer renal metastásico / Learning curve for the management of tyrosine kinase inhibitors as the first line of treatment for patients with metastatic renal cancer

Objetivos: Analizar la curva de aprendizaje en el manejo de los inhibidores de la tirosina quinasa como primera línea en el tratamiento de los paciente con cáncer renal metastásico. Material y métodos: Evaluamos 32 pacientes consecutivos tratados en nuestro servicio de cáncer renal metastásico con inhibidores de la tirosina quinasa (pazopanib o sunitinib) en primera línea entre septiembre de 2012 y noviembre de 2015. Analizamos retrospectivamente dicha muestra. Medimos tiempo hasta retirada de primera línea, tiempo hasta progresión y supervivencia global mediante curvas de Kaplan Meier. La curva de aprendizaje fue analizada con "cumulative sum (CUSUM) methodology". Resultados: En nuestra serie la mediana hasta la retirada de primera línea fue de 11 meses (IC 95% 4,9-17,1). El tiempo medio hasta progresión 30,4 meses (IC 95% 22,7-38,1) y la media de la supervivencia global 34,9 meses (IC 95% 27,8-42). Al aplicar la metodología CUSUM obtenemos una gráfica para el valor CUSUM tiempo hasta retirada de la primera línea (CUSUM TR) observando 3 fases bien diferenciadas: fase 1 o fase de aprendizaje inicial (1-15), fase 2 (16-26) en el que se mejora progresivamente el manejo del fármaco y una tercera fase (27-32) de máxima experiencia o maestría en el manejo de estos fármacos. Estimamos en 15 el número necesario de pacientes tratados para conseguir el manejo adecuado de estos pacientes. Conclusiones: Pese a la limitación del tamaño muestral y el tiempo de seguimiento estimamos en 15 pacientes el número necesario para alcanzar el nivel de experiencia óptimo de madurez en el manejo con inhibidores de la tirosina quinasa de estos pacientes. No observamos relación entre el tiempo hasta retirada de primera línea por cualquier causa y la progresión

Objectives: To analyse the learning curve for the management of tyrosine kinase inhibitors as the first line of treatment for patients with metastatic renal cancer. Material and methods: We evaluated 32 consecutive patients treated in our department for metastatic renal cancer with tyrosine kinase inhibitors (pazopanib or sunitinib) as first-line treatment between September 2012 and November 2015. We retrospectively analysed this sample. We measured the time to the withdrawal of the first-line treatment, the time to progression and overall survival using Kaplan-Meier curves. The learning curve was analysed with the cumulative sum (CUSUM) methodology. Results: In our series, the median time to the withdrawal of the first-line treatment was 11 months (95% CI 4.9-17.1). The mean time to progression was 30.4 months (95% CI 22.7-38.1), and the mean overall survival was 34.9 months (95% CI 27.8-42). By applying the CUSUM methodology, we obtained a graph for the CUSUM value of the time to withdrawal of the first-line treatment (CUSUM TW), observing 3 well-differentiated phases: phase 1 or initial learning phase (1-15), phase 2 (16-26) in which the management of the drug progressively improved and phase 3 (27-32) of maximum experience or mastery of the management of these drugs. The number of treated patients needed to achieve the proper management of these patients was estimated at 15. Conclusions: Despite the limitations of the sample size and follow-up time, we estimated (in 15 patients) the number needed to reach the necessary experience in the management of these patients with tyrosine kinase inhibitors. We observed no relationship between the time to the withdrawal of the first-line treatment for any cause and progression

Niveles de PSA de los pacientes en hemodiálisis / PSA levels in patients on hemodialysis treatment

OBJETIVO: Los niveles de PSA por los que nos regimos actualmente están basados en la población general, y aunque no se ha demostrado una mayor incidencia de cáncer de próstata en los pacientes en hemodiálisis (HD), algunos estudios señalan la posibilidad de encontrar niveles de PSA más elevados en estos pacientes que en los varones con función renal conservada. El objetivo de este estudio es medir y comparar los niveles de PSA de los varones en diálisis con los de la población con función renal normal. MÉTODO: Estudio transversal comparativo de las variables edad, PSA total, PSA libre e índice de PSA en 190 pacientes con enfermedad renal crónica en tratamiento sustitutivo en hemodiálisis (grupo 1) frente a 237 pacientes sanos desde el punto de vista renal (grupo 2). Realizamos análisis descriptivo y estudio comparativo de las variables referidas con el paquete informático SPSS. RESULTADOS: La mediana de edad de los pacientes en HD fue 55 años en los casos (47-61) y de 59 años (54-63,5) en los controles. El PSA total medio fue de 1,49 ng/ml [1,24-1,73] en los casos y 1,62 ng/ml [1,29-1,95] en los controles; el PSA libre medio 1,40ng/ml [0,89- 1,91] en grupo 1 y 2,31ng/ml [-0,83- 5,45] en grupo 2; el índice de PSA medio 27,67 % [19,91-35,63] en los casos y 14,82 % [12,79-16,85] en los controles. En el estudio comparativo encontramos diferencias entre los 2 grupos con respecto al PSA libre (p ≤0,007) y el índice (p ≤0,000) así como en el PSA total (p ≤0,000) en menores de 50 años tras un análisis por rangos de edad. CONCLUSIONES: El PSA total es más elevado en pacientes en HD en el subgrupo de edad de menos de 50 años con diferencia estadísticamente significativa aunque no clínicamente relevante. El índice de PSA es significativamente más alto en el grupo de pacientes en HD. Estos datos podrían tener implicación clínica en cuanto a la indicación de biopsia (AU)

OBJECTIVES: Standardized prostate-specific antigen (PSA) levels are based upon the general population levels and, although a higher incidence of prostate cancer in patients on hemodialysis (HD) has not been demonstrated, some studies point at the possibility of observing higher PSA levels in this type of patients than in males with preserved renal function. The objective of the present study is to compare PSA levels in males on hemodialysis with those of the population with normal renal function. METHODS: Comparative, transversal study of the variables age, total PSA, free PSA and PSA index in 190 patients with chronic renal disease on hemodialysis treatment (group 1) and 237 subjects without renal disease (group 2). We carried out a descriptive analysis and a comparative study of the above mentioned variables using the SPSS software. RESULTS: Median age of patients on HD was 55 in cases (47-61) and 59 in controls (54-63.5). Mean total PSA was 1.49ng/mL [1.24-1.73] in cases and 1.62 ng/mL [1.29-1.95] in controls; mean free PSA was 1.40ng/mL [0.89-1.91] in group 1 and 2.31ng/mL [-0.83- 5.45] in group 2; mean PSA index was 27.67% [19.91-35.63] in cases and 14.82% [12.79-16.85] in controls. The comparative study showed differences between the two groups in free PSA (p ≤ 0.007), PSA index (p ≤ 0.000) and total PSA (p ≤ 0.000) in patients under 50 after an age-specific analysis. CONCLUSIONS: Total PSA is higher in patients on HD within the subgroup of patients under 50 with statistically significant but not clinically relevant difference. PSA index is remarkably higher in the group of patients on HD. These data could have clinical implications as far as indications for biopsy is concerned (AU)