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Background & Objectives: We aimed to evaluate the risk of progression in high-grade T1 (HGT1) tumors using tumor budding (TB) and other standard clinical and histological features. TB is defined as an isolated cancer cell or a cluster composed of fewer than 5 cells scattered in the stroma and is usually used as a strong predictor of lymph node metastasis in T1 colorectal cancer. Methods: This is an observational longitudinal cohort study involving 168 consecutive patients with HGT1 between 2013 and 2016. Cox regression was performed to analyze the relationship between the clinical and histological features and progression. All slides were blindly assessed by 2 genitourinary pathologists. Budding was determined to be positive when the number of buds was equal to or greater than 6. Results: The median age was 75 years; 152 (90.5%) patients were men, and 49 (29.2%) were positive for TB. At a median follow-up time of 35 months, 33 patients (19.6%) showed progression. Progression was observed in 32.7% of the patients positive for TB and in only 14.3% of those who were negative (p = 0.006). TB was significantly associated with the endoscopic tumor pattern (TP) (papillary/solid) and lymphovascular invasion (LVI). Univariate analysis showed that TB, carcinoma in situ (CIS), TP, LVI, sub-staging, and BCG induction predict progression. The multivariate analysis showed that TB (p = 0.032, hazard ratio 2.1), CIS, TP, and lack of BCG induction were significant for progression. Conclusions: TB is a new and significant pathological variable for predicting progression in HGT1 tumors and can be easily introduced in clinical practice. Its inclusion in the TNM system should be carefully considered, as it may aid early cystectomy decisions.

Bladder cancer is thefifth most common tumor in the world. Moreover, it isone of the most expensive due to its high recurrencerate. Urinary biomarkers for surveillance of non muscleinvasive bladder cancer is a promising and growingfield due to the invasiveness of the actual methods, basedon cystoscopy and cytology. Although current EuropeanGuidelines only consider the use of biomarkersin the low risk scenario as an alternative to cystoscopywhen the patient declines invasive methods for the follow-up after surgery, there is increasing evidence oftheir safety in high risk tumors.We have performeda review of the main urinary biomarkers, includingFDA-approved ones, protein-based and genetic biomarkers.We have also described the different options to incorporatethe biomarkers in the clinical practice.There are not randomized control trialscomparing any biomarker with the gold standard follow-up. Most of the papers published so far are cohortstudies, limitating the evidence of the results. Biomarkerscan be used as an alternative of cystoscopy, in a noninvasive follow-up, or alternating both tests. There arefew economical studies comparing both options, but theevidence supports the efficiency of the main biomarkers.Cystoscopy and cytology are the goldstandard for non muscle invasive bladder cancer surveillance.2021 European Guidelines suggest, for the firsttime, an alternative use of biomarkers in a concrete lowgrade scenario to avoid invasive explorations to patientswith low risk of progression. Paradoxically, biomarkers(mainly genetic ones) have a very good profile of sensitivityand negative predictive value in the high risk scenario.Although there is increasing evidence to supporttheir implementation, the lack of fase IV trials hinderstheir daily use.INTRODUCCIÓN: El carcinoma vesicales el quinto tumor más frecuente en el mundo. Dehecho, es uno de los que más recursos económicosconsume debido a su alta tasa de recurrencia. Los biomarcadoresurinarios para el seguimiento del tumorvesical no músculo invasivo es un campo prometedory en pleno crecimiento debido a la invasividad de losactuales métodos de seguimiento, basados en la cistoscopiay la citología de orina. A pesar de que las actualesGuías Europeas sólo consideran el uso de biomarcadoresen el escenario del tumor vesical de bajoriesgo como alternativa a la cistoscopia cuando el pacienteno desee procedimientos invasivos para el seguimientotras la cirugía, existe creciente evidencia desu seguridad en los tumores de alto riesgo.MATERIAL Y MÉTODOS: Se ha realizado una revisiónnarrativa de los principales biomarcadores urinarios,incluyendo los aprobados por la FDA, los basados enproteínas y los marcadores genéticos. Se han descritoigualmente las diferentes opciones para la incorporaciónde los biomarcadores en la práctica clínica diaria.RESULTADOS: No existen ensayos clínicos randomizadosque comparen los biomarcadores urinariosfrente al gold estándar en el seguimiento. La mayoría delos artículos hasta la fecha son estudios de cohortes, limitandola evidencia de los resultados. Los biomarcadores pueden ser utilizados como alternativa a la cistoscopia,en un seguimiento no invasivo, o alternandoambas pruebas. Existen pocos estudios económicosque comparen ambas opciones, pero la evidencia parecesoportar la eficiencia de los principales biomarcadores.CONCLUSIONES: La cistoscopia y la citología son elgold estándar para el seguimiento del tumor vesicalno músculo infiltrante. Las Guías Europeas de 2021sugieren, por primera vez, el uso alternativo de losbiomarcadores urinarios en el escenario concreto delbajo grado con el fin de evitar exploraciones invasivasa pacientes con muy bajo riesgo de progresión. Paradójicamente,los biomarcadores (principalmente losgenéticos) presentan un mejor perfil de sensibilidad yvalor predictivo negativo en el escenario del alto riesgo.A pesar de que existe creciente evidencia para recomendarsu implementación, la ausencia de ensayosclínicos fase IV dificulta su aplicación en la práctica diaria.

To analyze the validity of the ratio between the second and fourth finger (digit ratio; 2D/4D) of the left hand as a predictor for prostate cancer (PCa) in a group of men undergoing prostate biopsy.We prospectively recruited 204 consecutive patients referred for transrectal prostate biopsy due to PSA elevation or abnormal digital rectal examination between January 2008 and June 2009. The same physician performed all clinical examinations, digit ratio measurements and transrectal biopsy in all cases. Digit ratio determination was done with a Vernier caliper in the left hand. Patients underwent determination of hormone profile (testosterone and sexual hormone binding globulin (SHBG)) between 7:00AM and 11:00AM. Age, digital rectal examination, PSA, free PSA, PSA density, testosterone and SHBG, pathological report and D2 and D4 measurements were recorded prospectively.Variables age and SHBG were directly related to PCa. Prostate volume was inversely related to neoplasia. 2D/4D ratio0,95 (OR (CI 95%) 4,4 (1,491-13,107) was related to neoplasia. No differences in PCa were seen regarding PSA, free PSA, PSA density, digital rectal examination and testosterone.High digit ratio predicts PCa in men undergoing prostate biopsy. Digit ratio0,95 has 4-fold risk of PCa compared to men with digit ratio ≤0.95.