Angiomiolipoma renal y complejo esclerosis tuberosa: resultados a largo plazo en seguridad y eficacia de terapia con everolimus / Renal angiomyolipoma and tuberous sclerosis complex: long-term safety and efficacy outcomes of Everolimus therapy

Introducción: El angiomiolipoma renal (AMLr) es una manifestación frecuente del complejo de esclerosis tuberosa (CET), estableciéndose, recientemente, el tratamiento con everolimus, como opción terapeútica novedosa, alternativa y no invasiva; sin embargo, existen datos limitados en la vida real y a largo plazo, por ello, el análisis de nuestra experiencia, en materia de seguridad y eficacia, aporta un valor añadido.Material y métodosSe realiza un análisis descriptivo de nuestra experiencia en pacientes con AMLr bilaterales gigantes, en el contexto de CET, tratados con 10 mg por vía oral de everolimus diario, durante una mediana de 71,5 meses. Evaluamos los parámetros como: tasa y duración de la respuesta; reducción del volumen renal y las lesiones; prevención de complicaciones, toxicidad presentada y causa.ResultadosConfirmamos la efectividad del tratamiento en cuatro pacientes jóvenes, con AMLr renales bilaterales, múltiples, de 12 (5 a 19) cm de diámetro máximo como mediana, desde junio del 2013 hasta la actualidad, con una reducción continua del tamaño de las lesiones, descenso del 30% del volumen, en el 75% al sexto mes y del 50% en la mitad de los sujetos después dos años, permaneciendo aún en respuesta. No se presentaron complicaciones como sangrado o deterioro del filtrado glomerular a largo plazo, con un perfil de seguridad favorable, sin interrupciones y con efectos adversos no acumulativos leves a moderados, en su mayoría durante el primer año de tratamiento.ConclusiónEverolimus es una opción terapéutica segura y eficaz para el AMLr y para diversas manifestaciones del CET, que se reproduce en la vida real, con seis años de seguimiento. (AU)

Introduction: Renal angiomyolipoma is a frequent manifestation of Tuberous Sclerosis Complex (TSC), for which everolimus therapy has been recently established as a novel non-invasive therapeutic option. As there are limited real life and long-term data, the analysis of our experience provides added value in terms of safety and efficacy.Material and methodsDescriptive analysis of our experience in patients with giant bilateral renal angiomyolipomas, in the context of TSC, treated with 10 mg oral everolimus daily, during a median of 71.5 months. We evaluated the following parameters: response rate and duration, reduction of kidney size and lesions, prevention of complications and presentation of toxicity and its cause.ResultsWe confirm the effectiveness of treatment in 4 young patients, with multiple, bilateral angiomyolipomas of a median of 12 (5-19) cm maximum diameter, from June 2013 to date, after continuous reduction in lesion size, a decrease of 30% of the volume in 75% at six months and 50% in half of the subjects at two years, still showing drug response. Absence of complications such as bleeding or glomerular filtration rate decline in the long term, with a favorable safety profile, without interruptions and with mild-moderate, non-cumulative adverse effects, mostly within the first year of treatment.ConclusionEverolimus is a safe and effective therapeutic option for renal angiomyolipoma and various manifestations of TSC, which has been reproduced in real life with six years of follow-up. (AU)

Renal angiomyolipoma and tuberous sclerosis complex: long-term safety and efficacy outcomes of Everolimus therapy. / Angiomiolipoma renal y complejo esclerosis tuberosa: resultados a largo plazo en seguridad y eficacia de terapia con everolimus.

INTRODUCTION: Renal angiomyolipoma is a frequent manifestation of Tuberous Sclerosis Complex (TSC), for which everolimus therapy has been recently established as a novel non-invasive therapeutic option. As there are limited real life and long-term data, the analysis of our experience provides added value in terms of safety and efficacy. MATERIAL AND METHODS: Descriptive analysis of our experience in patients with giant bilateral renal angiomyolipomas, in the context of TSC, treated with 10 mg oral everolimus daily, during a median of 71.5 months. We evaluated the following parameters: response rate and duration, reduction of kidney size and lesions, prevention of complications and presentation of toxicity and its cause. RESULTS: We confirm the effectiveness of treatment in 4 young patients, with multiple, bilateral angiomyolipomas of a median of 12 (5-19) cm maximum diameter, from June 2013 to date, after continuous reduction in lesion size, a decrease of 30% of the volume in 75% at six months and 50% in half of the subjects at two years, still showing drug response. Absence of complications such as bleeding or glomerular filtration rate decline in the long term, with a favorable safety profile, without interruptions and with mild-moderate, non-cumulative adverse effects, mostly within the first year of treatment. CONCLUSION: Everolimus is a safe and effective therapeutic option for renal angiomyolipoma and various manifestations of TSC, which has been reproduced in real life with six years of follow-up.

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.

Initial experience with abiraterone acetate in patients with castration-resistant prostate cancer.

OBJECTIVE: To describe the results obtained in 25 males with metastatic castration-resistant prostate cancer (MCRPC) treated with abiraterone (AA). A comparative analysis of abiraterone effectiveness and safety between our results and data published in the literature was conducted. MATERIAL AND METHOD: Bi-institutional prospective analysis of 25 consecutive patients with MCRPC undergoing treatment with abiraterone, with a mean follow-up 7.9 (3-15) months was carried out. Treatment effectiveness and safety analyses regarding baseline characteristics of patients (age, prior treatments, basal PSA, performance status, pain, metastasis) were conducted. RESULTS: At 13.6 months of follow-up, the overall survival is 80% (CI 95%: 11.8-15.4). Clinical and radiological-free progression survival is 9.5 ± 1 months (CI 95%: 7.7-11.3) and biochemical response is 6.8 ± 1 months (CI 95%: 5-8.7). Only the treatment with chemotherapy impaired significantly the response time to AA [6.4 months for radiological-free progression survival (CI 95%: 4.2-8,6) and 4.3 months for biochemical-free progression survival (CI 95%: 2.6-6)]. The incidence of adverse drug events was 36%, all of them grade 1-2/4 and, in no case, suspension or reduction of the dose of AA was needed. CONCLUSIONS: The treatment with AA has been effective in our series, with a tolerability considerably higher than what other studies published.

Pre-chemotherapy abiraterone acetate. A proposal of a treatment algorithm in castration resistant prostate cancer.

CONTEXT: Prostate cancer treatment remains a challenge for the urologist. Medical control in locally advanced or metastatic prostate cancer is usually performed with LHRH analogues and/or antiandrogens. Different treatments have been proposed when there is biochemical and clinical progression of the disease and other new ones have changed the patients' perspective and life expectancy. OBJECTIVE: This review has aimed to establish the current role of Abiraterone Acetate in the treatment of castration-resistant prostate cancer and facilitate decision-making by the Urologist by means of a Treatment Algorithm. ACQUISITION OF THE EVIDENCE: A search of current evidence on Abiraterone treatment in patients with castration- resistant metastatic prostate cancer was performed in PubMed, mainly analyzing those studies designed as clinical trials. In addition, we reviewed and updated the role of hormone therapy and androgen receptors in prostate cancer. EVIDENCE SYNTHESIS: There are currently basically two clinical trials that demonstrate the effectiveness of Abiraterone in metastatic prostate cancer compared to placebo. The study COU-AA 302 shows a clear benefit with Abiraterone prior to chemotherapy in patients with castration-resistant prostate cancer, this making it possible to establish an algorithm for initial treatment that facilitates decision-making by the urologist. CONCLUSION: Abiraterone is a pre-chemotherapy treatment option in selected patients with castration resistant metastatic prostate cancer, although it is necessary to improve the cost and to design more multicenter clinical trials to optimize the cost/benefit ratio.

Cirugía de puerto único transumbilical con instrumentos laparoscópicos convencionales en riñón en herradura / Transumbilical Single Port Surgery With Conventional Laparoscopic Instruments in Horseshoe Kidney

Introducción: La cirugía laparoscópica está teniendo una evolución natural a disminuir la agresión quirúrgica sobre la pared abdominal, sin merma de los resultados curativos y funcionales. Aunque en desarrollo, la cirugía monopuerto ha supuesto un avance en este sentido. Material y métodos: Presentamos la primera cirugía de pielolitectomía laparoscópica por puerto único en riñón en herradura, usando instrumentos rígidos convencionales. Paciente de 18 años con IMC de 19 que en las pruebas de imagen (urograma y tomografía computarizada) presenta un riñón en herradura con litiasis coraliforme izquierda y discreta ectasia calicial. Se extrae la litiasis mediante acceso umbilical con artilugio monopuerto e instrumentos rígidos convencionales. Resultados: La cirugía se completó sin complicaciones. El tiempo quirúrgico fue 110 min y el sangrado 50 cc. Al abrir el sistema urinario hubo extravasación de orina purulenta que condicionó fiebre en el postoperatorio de 38 ◦C. Durante la intervención se colocó catéter doble J por abordaje percutáneo. Fue dada de alta al tercer día de estancia. Conclusión: El acceso laparoscópico monopuerto para la cirugía de pielolitectomía en un riñón en herradura es una alternativa razonable. El uso de instrumentos convencionales rígidos facilita el desarrollo de esta cirugía con una buena triangulación, sin conflicto de manos y seguridad para el paciente (AU)

Introduction: Laparoscopic surgery is following a natural course as it decreases surgical aggression on the abdominal wall without undermining the curative and functional results. Although it is still being developed, single port surgery has meant an advance in this sense. Material and methods: We present the first single port laparoscopic pyelolithectomy surgery in horseshoe kidney, using conventional rigid instruments. The case of an 18-year old patient with BMI of 19 in whom the imaging tests (urogram and computed tomography) showed a horseshoe kidney with left coralliform lithiasis and discrete calyceal ectasia is presented. The lithiasis was extracted using umbilical access with single port device and conventional rigid instruments. Results: The surgery was performed without complications. Surgery time was 110 minutes and bleeding 50 cc. On incision of the urinary system, there was purulent urine extravasation that conditioned fever of 38 ◦C in the post-operatory period. During the intervention, a double J stent was placed via percutaneous approach. The patient was discharged on the third day of hospitalization. Conclusion: Single port laparoscopic access for pyelolithectomy surgery in horseshoe kidney isa reasonable alterative. The use of conventional rigid instruments facilitates the performance of this surgery with good triangulation, without conflict regarding hands and safety for the patient (AU)

Transumbilical single port surgery with conventional laparoscopic instruments in horseshoe kidney.

INTRODUCTION: Laparoscopic surgery is following a natural course as it decreases surgical aggression on the abdominal wall without undermining the curative and functional results. Although it is still being developed, single port surgery has meant an advance in this sense. MATERIAL AND METHODS: We present the first single port laparoscopic pyelolithectomy surgery in horseshoe kidney, using conventional rigid instruments. The case of an 18-year old patient with BMI of 19 in whom the imaging tests (urogram and computed tomography) showed a horseshoe kidney with left coralliform lithiasis and discrete calyceal ectasia is presented. The lithiasis was extracted using umbilical access with single port device and conventional rigid instruments. RESULTS: The surgery was performed without complications. Surgery time was 110 minutes and bleeding 50 cc. On incision of the urinary system, there was purulent urine extravasation that conditioned fever of 38 °C in the post-operatory period. During the intervention, a double J stent was placed via percutaneous approach. The patient was discharged on the third day of hospitalization. CONCLUSION: Single port laparoscopic access for pyelolithectomy surgery in horseshoe kidney is a reasonable alterative. The use of conventional rigid instruments facilitates the performance of this surgery with good triangulation, without conflict regarding hands and safety for the patient.