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(1) Background: Intravesical mitomycin-C (MMC) combined with hyperthermia is increasingly used in non-muscle invasive bladder cancer (NMIBC), especially in the context of a relative BCG shortage. We aim to determine real-world data on the long-term treatment outcomes of adjunct hyperthermic intravesical chemotherapy (HIVEC) with MMC and a COMBAT® bladder recirculation system (BRS); (2) Methods: A prospective observational trial was performed on patients with NMIBC treated with HIVEC using BRS in nine academic institutions in Spain between 2012-2020 (HIVEC-E). Treatment effectiveness (recurrence, progression and overall mortality) was evaluated in patients treated with HIVEC MMC 40mg in the adjuvant setting, with baseline data and a clinical follow-up, that comprise the Full Analysis Set (FAS). Safety, according to the number and severity of adverse effects (AEs), was evaluated in the safety (SAF) population, composed by patients with at least one adjunct HIVEC MMC instillation; (3) Results: The FAS population (n = 502) received a median number of 8.78 ± 3.28 (range 1-20) HIVEC MMC instillations. The median follow-up duration was 24.5 ± 16.5 (range 1-81) months. Its distribution, based on EAU risk stratification, was 297 (59.2%) for intermediate and 205 (40.8%) for high-risk. The figures for five-year recurrence-free and progression-free survival were 50.37% (53.3% for intermediate and 47.14% for high-risk) and 89.83% (94.02% for intermediate and 84.23% for high-risk), respectively. A multivariate analysis identified recurrent tumors (HR 1.83), the duration of adjuvant HIVEC therapy <4 months (HR 1.72) and that high-risk group (HR 1.47) were at an increased risk of recurrence. Independent factors of progression were high-risk (HR 3.89), recurrent tumors (HR 3.32) and the induction of HIVEC therapy without maintenance (HR 2.37). The overall survival was determined by patient age at diagnosis (HR 3.36) and the treatment duration (HR 1.82). The SAF population (n = 592) revealed 406 (68.58%) patients without AEs and 186 (31.42%) with at least one AE: 170 (28.72%) of grade 1-2 and 16 (2.7%) of grade 3-4. The most frequent AEs were dysuria (10%), pain (7.1%), urgency (5.7%), skin rash (4.9%), spasms (3.7%) and hematuria (3.6%); (4) Conclusions: HIVEC using BRS is efficacious and well tolerated. A longer treatment duration, its use in naïve patients and the intermediate-risk disease are independent determinants of success. Furthermore, a monthly maintenance of adjunct MMC HIVEC diminishes the progression rate of NMIBC.
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OBJECTIVES: To evaluate the current clinical practice for patients with Prostate Cancer (CP) in the Health Areas of Castilla y León (CyL) in 2014. METHODS: A retrospective multicenter study was designed to provide data on the diagnosis and treatment of PC in CyL: 87.8% of patients were screened. Descriptive statistics on variables related to characteristics of the patient, the tumor and the treatment modality of the first line to which it was submitted are provided. RESULTS: A total of 1156 new cases of PC were analyzed with a mean age of 68.2 years and a mean PSA of 8.40 ng/ml. The Gleason score (GS) showed 538 (46.2%), 418 (35.9 %) and 200 (17.1%) patients for GS ≤ 6, 7 and ≥ 8 respectively. 91% of patients (1053 patients) are diagnosed at a localized stage. 56 (4.8%) patients received treatment with active surveillance/ watchful waiting, 423 (36.6%) radical prostatectomy (PR), 348 (30.1%) radiotherapy (RT), 98 (8.4%) brachytherapy (BT) and 170 (14.7%) hormone therapy (HT) respectively. CONCLUSIONS: Differed strategies still accounted for a small percentage of treatments. PR and RT/BT were of choice in patients with localized stages of the disease and younger than 70 years. More advanced stages and older patients were treated with HT mainly. Age is postulated as the main factor involved in therapeutic decision making.
OBJETIVO: Conocer la práctica clínica real en pacientes con Cáncer de Próstata (CP) en las Áreas Sanitarias de Castilla y León (CyL) en el año 2014. MATERIAL Y MÉTODOS: Se diseña un estudio multicéntrico con carácter retrospectivo para disponer de datos sobre el diagnóstico y tratamiento del CP en CyL: se logra una cobertura del 87,8% de los pacientes comunitarios. Se aporta estadística descriptiva sobre las variables referentes a características del paciente, del tumor y de la modalidad de tratamiento de primera línea a la que fue sometido. RESULTADOS: Se analizan 1.156 nuevos casos de CP con una edad media de 68,2 años y una mediana de PSA de 8,4 ng/ml. La puntuación de Gleason (PG) muestra 538 (46,2%), 418 (35,9%) y 200 (17,1%) pacientes para PG ≤ 6, 7 y ≥ 8 respectivamente. El 91,0% de los pacientes (1.053 pacientes) son diagnosticados en estadio localizado. 56 pacientes (4,8%) son tratados con estrategias diferidas (EDs), vigilancia activa/ observación, 423 (36,6%) con prostatectomia radical (PR), 348 (30,1%) con radioterapia, 98 (8,4%) con braquiterapia (BT) y 170 (14,7%) con hormonoterapia (HT). CONCLUSIONES: Las EDs aún supusieron un porcentaje pequeño de los tratamientos. PR y RT/BT fueron de elección en pacientes con estadios localizados de la enfermedad y menores de 70 años. Estadios más avanzados y pacientes mayores fueron tratados con HT principalmente. La edad se postula como el principal factor implicado en la toma de decisiones terapéuticas.
Asunto(s)
Antígeno Prostático Específico , Neoplasias de la Próstata , Anciano , Humanos , Masculino , Clasificación del Tumor , Prostatectomía , Neoplasias de la Próstata/diagnóstico , Neoplasias de la Próstata/cirugía , Estudios RetrospectivosRESUMEN
OBJECTIVES: To report the case of a female patient with ultrasound diagnosis of great left retroperitoneal hematoma admitted to the hospital for diagnostic workup and treatment. METHODS: 39-year-old patient presenting with intense epigastric pain irradiated to both flanks. Hematuria was not present. CT scan and arteriography led to the diagnosis of angiomyolipoma with arteriovenous fistula and subcapsular hematoma. Selective embolization was carried out. CONCLUSIONS: Hamartomas account for 3% of kidney tumors in adults; they are composed of 3 mesodermal tissues, including blood vessels. The lack of elastic membrane in their arteries favours aneurysm development.