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

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.

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

Objetivos: Este documento se ha desarrollado con el objetivo de establecer unas directrices para el seguimiento de los pacientes con carcinoma de células renales (CCR), basadas en la mejor evidencia científica disponible y en la opinión de expertos, que puedan facilitar a los urólogos la toma de decisiones, así como una normalización de criterios a nivel nacional. Material y métodos: La metodología utilizada se basó en el método RAND/UCLA. Un panel de 9 expertos en CCR participaron en el diseño de un índice temático, en la identificación y lectura de la evidencia disponible, y en la formulación de recomendaciones y redacción del contenido. Un grupo validador de 25 expertos, que no había participado en las fases previas, valoró las recomendaciones mediante una votación anónima en una reunión presencial de consenso. Las recomendaciones que alcanzaron el acuerdo del 75% o más de los participantes en dicha votación fueron aceptadas como consenso; las recomendaciones que obtuvieron un acuerdo inferior fueron rechazadas. Resultados: Un total de 25 recomendaciones fueron aceptadas como consenso. En ellas se recogen las pruebas analíticas, pruebas de evaluación clínica y de imagen que deben realizarse en los pacientes con CCR. Las recomendaciones presentadas han sido adaptadas dependiendo del riesgo de recaída. En el actual documento también se detalla la frecuencia y duración del seguimiento para cada perfil de paciente. Conclusiones: El documento actual permite estandarizar los criterios de seguimiento de los pacientes con CCR atendidos en el ámbito del sistema sanitario español, según su riesgo de recaída

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

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.

In vitro lithotripsy with the Alexandrite laser.

The Alexandrite laser system has proven to be an effective and safe method of ureteral lithotripsy. Some authors have recently reported the risk of interspersion of fiber splinters into tissue during lithotripsy, when short pulses and high power densities are employed. In vitro lithotripsy on renal calculi artificially placed in human ureters was realized under the parameters of a manufactured model (Alexantriptor, HMT). We have observed neither interspersion of fragments nor ureteral damage. These in vitro experiments and our clinical experience confirm that Alexandrite laser lithotripsy is reliable and safe.

Lithotripsy with the alexandrite laser: our initial 100 clinical cases.

The alexandrite laser system has proven to be an effective and safe method of treating ureteral stones. When the electromagnetic energy of a laser light pulse is selectively absorbed by the stone, a plasma forms at the surface. This plasma, which is composed of ions and electrons, continues to absorb laser energy, reaching very high pressure and generating a shock wave that fragments the stone. The degree of stone fragmentation is directly related to the composition and crystal lattice structure of the calculus. 112 calculi have been treated, and laser lithotripsy was successful in 87.5%. 6% of the stones were inadvertently flushed back into the kidney. No patient required an open ureterolithotomy. Guidance of the laser fiber onto the stone was performed by rigid ureteroscopy. There were no troublesome complications, and in a 3-month follow-up, no sequelae were reported.

[Genital brucellosis]. / Brucelosis genital.

Since this is a systemic disease, it is not uncommon to find brucella organisms in urine during acute infection however, it frequently presents with orchi-epididymitis (2-20%) and, rarely, with granulomas in the urinary tract. We report on two cases of acute epididymitis. The pathogenesis, diagnosis and treatment of this disease entity are briefly viewed highlighting the urological problem.

[Scrotal and perineal pain following coitus interruptus]. / Dolor escroto-perineal tras coitus interruptus.

A case of perineal-scrotal and hypogastric pain following coitus interruptus in a young male patient is described. The physiopathological mechanisms involved in this condition in normal subjects or those with neuropathic disorders are discussed.

PIP: A 27-year old male was treated in a hospital emergency room in Vizcaya, Spain, for perineal-scrotal and hypogastric pain following coitus interruptus. There were no other systemic alterations and the genital examination was normal. The patient was treated with analgesics and the physiopathologic mechanism was explained to him. THe complex mechanism of nervous and muscular coordination leading to ejaculation is sometimes disturbed by anomalous external stimuli, e.g., during masturbation or coitus interruptus, producing a constant pain in the entire genital and hypogastric area, even after ejaculation. Some authors suggest the possibility of an underlying psychopathology. It is possible that a delayed ejaculation factor also exists in these patients. Similar pains described in diabetes with neuropathy or in lesions of the sympathetic system are attributed to functional incompetence of the internal sphincter. It is recommended that men who frequently encounter this problem seek psychotherapy. Possible medical treatments include administration of analgesics and antispasmodic or muscle relaxants and tranquilizers.

[Usefulness of CAT in retroperitoneal fibrosis]. / Valor del TAC en la fibrosis retroperitoneal.

We report on six patients with with retroperitoneal fibrosis (RPF) who were evaluated preoperatively by CT. Patient scans disclosed a retroperitoneal fibrous layer localized between L4-S2, S3 in four of the six cases (65%). Similarly, varying degrees of uni-or bilateral utero-hydronephrosis were observed in five patients, and venous involvement with collateral abdominal circulation was observed in two. The surgical findings coincided with those of the CT scans, and disclosed that in the two patients with no evidence of a fibrous layer on the scan, this was due to the its being localized to an area in one or both sides of the pelvic cavity. The diagnosis was histologically confirmed as idiopathic retroperitoneal fibrosis in all six cases. We consider CT to be the preoperative method of choice in the diagnosis of RPF because it not only provides information on the status of the urinary system, the involvement of other retroperitoneal structures and the extent of the fibrous layer, it also provides orientation as to the possible etiology of the retroperitoneal fibrosis.