Eficacia y seguridad de distintas cepas de BCG en el tratamiento del tumor vesical en práctica clínica habitual / Safety and efficacy of various strains of bacille Calmette-Guérin in the treatment of bladder tumours in standard clinical practice

Introducción: La evolución natural del tumor vesical no músculo infiltrante (TVNMI) es la recidiva con elevado porcentaje de progresión. La BCG se ha demostrado eficaz para disminuir estos porcentajes, pero hay pocos estudios comparativos entre cepas. Material y métodos: Registro observacional, prospectivo y multicéntrico, estudiándose 433 pacientes con visita de seguimiento a 12 meses de 961 registrados y evaluado supervivencia libre de enfermedad (SLE), de progresión (SLP) cáncer-específica (SE) y efectos adversos. Se estudiaron las cepas Tice, Russian, Tokyo, Connaught y RIVM. Resultados: Los datos sociodemográficos, antecedentes de TVNMI, comorbilidades, tamaño, número, estadio, grado, CIS asociado y Re-RTU, están bien balanceados. SLE: 85 recidivas (19,6%). La mediana del tiempo de SLE fue 20 meses. Al comparar las diferentes cepas, no se detectaron diferencias estadísticamente significativas (Log-rank test, p = 0,93). SLP: 33 progresiones (7,62%). Al comparar las diferentes cepas, no se detectaron diferencias estadísticamente significativas (Log-rank test, p = 0,69). SE: fallecieron 7 pacientes (1,68%). Al comparar la SE entre las diferentes cepas, no se detectaron diferencias (Log-rank test, p = 0,93). En seguridad, el 33,3% habían presentado algún tipo de efecto adverso, mayoritariamente clínica urinaria baja no ITU < 48h, > 48h y hematuria. Según los Common Toxicity Criteria de la European Organisation for Research and Treatment of Cancer, el 92,7% eran grado 1. No se obtuvieron diferencias estadísticamente significativas relevantes entre cepas. Conclusiones: En este análisis intermedio, el riesgo de recidiva, progresión, muerte específica y seguridad es independiente de la cepa de BCG utilizada

Background: The natural progression of bladder tumours (nonmuscle-invasive bladder cancer [NMIBC]) is recurrence with a high rate of progression. Bacille Calmette-Guérin (BCG) has been shown effective in reducing these rates, but there are few comparative studies between strains. Material and methods: An observational, prospective and multicentre registry studied 433 patients with a 12-month follow-up visit from 961 registered patients, assessing disease-free survival (DFS), progression-free survival (PFS) cancer-specific survival (CSS) and adverse effects. We studied the Tice, Russian, Tokyo, Connaught and RIVM strains. Results: The sociodemographic data, NMIBC history, comorbidities, size, number, stage, grade, associated carcinoma in situ and transurethral resection were well balanced. DFS: There were 85 relapses (19.6%). The median DFS time was 20months. When comparing the various strains, we detected no statistically significant differences (log-rank test; P =.93). LPS: There were 33 cases of progression (7.62%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P = .69). CSS: Seven patients died (1.68%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P = .93). In terms of safety, 33.3% of the patients presented some type of adverse effect, mostly lower urinary symptoms (no urinary tract infections) < 48 h, > 48 h and haematuria. According to the Common Toxicity Criteria of the European Organisation for Research and Treatment of Cancer, 92.7% of the patients were grade 1. There were no statistically significant differences between the strains. Conclusions: In this intermediate analysis, the risk of recurrence, progression, specific death and safety were independent of the BCG strain employed

Safety and efficacy of various strains of bacille Calmette-Guérin in the treatment of bladder tumours in standard clinical practice. / Eficacia y seguridad de distintas cepas de BCG en el tratamiento del tumor vesical en práctica clínica habitual.

BACKGROUND: The natural progression of bladder tumours (nonmuscle-invasive bladder cancer [NMIBC]) is recurrence with a high rate of progression. Bacille Calmette-Guérin (BCG) has been shown effective in reducing these rates, but there are few comparative studies between strains. MATERIAL AND METHODS: An observational, prospective and multicentre registry studied 433 patients with a 12-month follow-up visit from 961 registered patients, assessing disease-free survival (DFS), progression-free survival (PFS) cancer-specific survival (CSS) and adverse effects. We studied the Tice, Russian, Tokyo, Connaught and RIVM strains. RESULTS: The sociodemographic data, NMIBC history, comorbidities, size, number, stage, grade, associated carcinoma in situ and transurethral resection were well balanced. DFS: There were 85 relapses (19.6%). The median DFS time was 20months. When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.93). LPS: There were 33 cases of progression (7.62%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.69). CSS: Seven patients died (1.68%). When comparing the various strains, we detected no statistically significant differences (log-rank test; P=.93). In terms of safety, 33.3% of the patients presented some type of adverse effect, mostly lower urinary symptoms (no urinary tract infections) <48h, >48h and haematuria. According to the Common Toxicity Criteria of the European Organisation for Research and Treatment of Cancer, 92.7% of the patients were grade1. There were no statistically significant differences between the strains. CONCLUSIONS: In this intermediate analysis, the risk of recurrence, progression, specific death and safety were independent of the BCG strain employed.

Nefrolitectomía percutánea de calibre reducido (NLP-CR). Algoritmo de decisión terapéutica / Small-calibre percutaneous nephrolithotomy (SC-PCNL). Therapeutic decision algorithm

Introducción: La progresiva reducción del calibre del tracto en cirugía percutánea renal, hasta alcanzar la miniaturización, ha expandido su utilización a litiasis de menor tamaño que hasta ahora se trataban mediante litotricia extracorpórea por ondas de choque (LEOCH) y cirugía retrógrada intrarrenal (CRIR). Objetivo: Realizar una puesta al día de las diferentes técnicas de nefrolitectomía de calibre reducido (NLP-CR) analizando su eficacia, seguridad e indicaciones, así como su grado de implantación en la actualidad. Material y métodos: Realizamos una revisión en PubMed de la literatura en castellano e inglés sobre las diferentes técnicas de NLP-CR. Resultados. La NLP-CR ha disminuido la morbilidad asociada a la NLP estándar, particularmente el sangrado, y ha posibilitado la nefrolitectomía tubeless con mayor seguridad. Existen diferentes técnicas con confusa terminología (miniperc, microperc, mini-microperc, ultraminiperc) que se diferencian en el calibre que emplean y en determinados aspectos técnicos que hacen que sus indicaciones deban ser precisadas. Actualmente, la NLPCR compite con técnicas menos invasoras que la NLP estándar, como la LEOCH y la CRIR en el tratamiento de las litiasis de pequeño tamaño, pero todavía su papel no está suficientemente esclarecido y es aún motivo de debate. Conclusiones. Las indicaciones de la NLP se están expandiendo a tamaños litiásicos más pequeños debido a la miniaturización de la técnica, compitiendo en este campo con LEOCH y CRIR. Precisamos mayores estudios para establecer sus indicaciones precisas en el tratamiento de la litiasis renal

Introduction: The progressive reduction in the calibre of the tract in percutaneous kidney surgery to the point of miniaturisation has expanded its use to smaller stones that until now have been treated with extracorporeal shock wave lithotripsy (ESWL) and retrograde intrarenal surgery (RIRS). Objective: To provide an update on the various techniques of small-calibre nephrolithotomy (SC-PCNL) analyse their efficacy, safety and indications and determine their degree of implantation at this time. Material and methods: We performed a review in PubMed of Spanish and English medical literature on the various techniques of SC-PCNL. Results: The use of SC-PCNL has reduced the morbidity associated with standard PCNL, particularly bleeding, and has enabled tubeless nephrolithotomy with greater safety. There are various techniques with blurred terminology (Miniperc, Microperc, Mini-microperc, Ultraminiperc), which differ in terms of gauge employed and in certain technical aspects that require their indications be specified. Currently, SC-PCNL competes with techniques that are less invasive than standard PCNL such as ESWL and the RIRS in treating small stones, but the role of SC-PCNL is still not sufficiently understood and continues to be the subject of debate. Conclusions: The indications for PCNL are expanding to small stone sizes due to the miniaturisation of the technique. PCNL competes in this field with ESWL and RIRS. Larder studies are needed to establish the specific indications for PCNL in treating nephrolithiasis

Small-calibre percutaneous nephrolithotomy (SC-PCNL). Therapeutic decision algorithm. / Nefrolitectomía percutánea de calibre reducido (NLP-CR). Algoritmo de decisión terapéutica.

INTRODUCTION: The progressive reduction in the calibre of the tract in percutaneous kidney surgery to the point of miniaturisation has expanded its use to smaller stones that until now have been treated with extracorporeal shock wave lithotripsy (ESWL) and retrograde intrarenal surgery (RIRS). OBJECTIVE: To provide an update on the various techniques of small-calibre nephrolithotomy (SC-PCNL) analyse their efficacy, safety and indications and determine their degree of implantation at this time. MATERIAL AND METHODS: We performed a review in PubMed of Spanish and English medical literature on the various techniques of SC-PCNL. RESULTS: The use of SC-PCNL has reduced the morbidity associated with standard PCNL, particularly bleeding, and has enabled tubeless nephrolithotomy with greater safety. There are various techniques with blurred terminology (Miniperc, Microperc, Mini-microperc, Ultraminiperc), which differ in terms of gauge employed and in certain technical aspects that require their indications be specified. Currently, SC-PCNL competes with techniques that are less invasive than standard PCNL such as ESWL and the RIRS in treating small stones, but the role of SC-PCNL is still not sufficiently understood and continues to be the subject of debate. CONCLUSIONS: The indications for PCNL are expanding to small stone sizes due to the miniaturisation of the technique. PCNL competes in this field with ESWL and RIRS. Larder studies are needed to establish the specific indications for PCNL in treating nephrolithiasis.

Predicción de resultados de cistoscopias en la práctica / Predicting Results of Daily-practice Cystoscopies

Objetivo: Elaborar un modelo predictivo de cáncer de vejiga en una población clínica no seleccionada derivada a cistoscopia. Materiales y métodos: Pacientes consecutivos sometidos a cistoscopia debida a sospecha o seguimiento de un cáncer de vejiga previamente diagnosticado. Todos los pacientes fueron sometidos a citología urinaria y un BTA-stat®-test (BTA). Para evitar sesgos de evaluación, BTA, citologías y cistoscopias fueron realizados de forma ciega. Usamos regresión logística para predecir los resultados de la cistoscopia a partir de citología, BTA y variables clínicas. Resultados: Entre agosto de 2011 y julio de 2012 seleccionamos 244 pacientes y 237 fueron válidos para el análisis. Un 13% fueron de nuevo diagnóstico y un 87% de seguimiento. Las sensibilidades de la citología y el BTA fueron 57,9% (IC 95%: 42,2-72,1) y 63,2% (IC 95%: 47,3-76,6) con especificidades de 84,4% (IC 95%: 78,7- 88,8) y 82,9% (IC 95%: 77,1-87,5). El modelo predictivo incluyó BTA, citología, tiempo transcurrido desde el diagnóstico del tumor previo y tratamiento con mitomicina o BGC en los últimos 3 meses. La precisión del modelo (AUC) fue 0,85 (0,78-0,92), y bajó a 0,79 al excluir el BTA (p = 0,026). En los casos de seguimiento, un umbral de 10% en las probabilidades predichas por el modelo resultó en un valor predictivo negativo de 95,7%, y 95,0% en los tumores de bajo grado. Conclusión: En un contexto de contención de costes nuestro modelo puede usarse para espaciar las cistoscopias en pacientes con tumores de bajo grado previos, resultando en un uso más eficiente de recursos del sistema de salud

Objective: Our objective was to elaborate a predictive model of bladder cancer, in an unselected clinical population submitted to cystoscopy. Materials and methods: We recruited consecutive patients who underwent cystoscopy due to suspicion of bladder cancer or surveillance of a previously diagnosed bladder cancer. Urine cytology and a BTA-stat® (BTA) test were carried out for all patients. To avoid an assessment bias, the BTA-tests, cytologies and cystoscopies were conducted in a blinded fashion. We used logistic regression to predict cystoscopy results from cytology, BTA-test and clinical variables. Results: From August 2011 to July 2012, we recruited 244 patients and 237 were valid for analysis. Newly diagnosed and surveillance cases were 13% and 87% respectively. Cytology and BTA-test sensitivities were 57.9% (CI 95: 42.2-72.1) and 63.2% (CI 95: 47.3-76.6) with specificities of 84.4% (CI 95: 78.7-88.8) and 82.9% (CI 95: 77.1-87.5). The predictive model included the BTA-test, cytology, time since previous tumor, and treatment with mitomicin or BGC during the last three months. The model predictive accuracy (AUC) was 0.85 (0.78-0.92), and dropped to 0.79 when excluding the BTA-test (p = 0.026). For the surveillance of bladder cancer, a 10% threshold on the model predicted probabilities resulted in an overall negative predictive value of 95.7%, and 95.0% in low grade tumors. Conclusion: In a cost containment environment, our prediction model could be used to space out cystoscopies in patients with previous, low grade tumors, resulting in a more efficient use of resources in the healthcare system

Predicting results of daily-practice cystoscopies.

OBJECTIVE: Our objective was to elaborate a predictive model of bladder cancer, in an unselected clinical population submitted to cystoscopy. MATERIALS AND METHODS: We recruited consecutive patients that underwent cystoscopy due to suspicion of bladder cancer or surveillance of a previously diagnosed bladder cancer. Urine cytology and a BTA-stat® (BTA) test were carried out for all patients. To avoid an assessment bias, the BTA-tests, cytologies and cystoscopies were conducted in a blinded fashion. We used logistic regression to predict cystoscopy results from cytology, BTA-test and clinical variables. RESULTS: From August 2011 to July 2012, we recruited 244 patients and 237 were valid for analysis. Newly diagnosed and surveillance cases were 13% and 87% respectively. Cytology and BTA-test sensitivities were 57.9% (CI 95: 42.2-72.1) and 63.2% (CI 95: 47.3-76.6) with specificities of 84.4% (CI 95: 78.7-88.8) and 82.9% (CI 95: 77.1-87.5). The predictive model included the BTA-test, cytology, time since previous tumour, and treatment with mitomicin or BGC during the last three months. The model predictive accuracy (AUC) was .85 (.78-.92), and dropped to 0.79 when excluding the BTA-test (P=.026). For the surveillance of bladder cancer, a 10% threshold on the model predicted probabilities resulted in an overall negative predictive value of 95.7%, and 95.0% in low grade tumours. CONCLUSION: In a cost containment environment, our prediction model could be used to space out cystoscopies in patients with previous, low grade tumours, resulting in a more efficient use of resources in the healthcare system.