Adjuvant intravesical therapy in intermediate-risk non-muscle-invasive bladder cancer.

OBJECTIVE: To evaluate the impact of adjuvant therapy on oncological outcomes in patients with intermediate-risk non-muscle-invasive bladder cancer (NMIBC), as due to the poorly-defined and overlapping diagnostic criteria optimal decision-making remains challenging in these patients. PATIENTS AND METHODS: In this multicentre study, patients treated with transurethral resection of bladder tumour for Ta disease were retrospectively analysed. All patients with low- or high-risk NMIBC were excluded from the analysis. Associations between adjuvant therapy administration with recurrence-free survival (RFS) and progression-free survival (PFS) rates were assessed in Cox regression models. RESULTS: A total of 2206 patients with intermediate-risk NMIBC were included in the analysis. Among them, 1427 patients underwent adjuvant therapy, such as bacille Calmette-Guérin (n = 168), or chemotherapeutic agents, such as mitomycin C or epirubicin (n = 1259), in different regimens up to 1 year. The median (interquartile range) follow-up was 73.3 (38.4-106.9) months. The RFS at 1 and 5 years in patients treated with adjuvant therapy and those without were 72.6% vs 69.5% and 50.8% vs 41.3%, respectively. Adjuvant therapy was associated with better RFS (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.70-0.89, P < 0.001), but not with PFS (P = 0.09). In the subgroup of patients aged ≤70 years with primary, single Ta Grade 2 <3 cm tumours (n = 328), adjuvant therapy was not associated with RFS (HR 0.71, 95% CI 0.50-1.02, P = 0.06). While in the subgroup of patients with at least one risk factor including patient age >70 years, tumour multiplicity, recurrent tumour and tumour size ≥3 cm (n = 1878), adjuvant intravesical therapy was associated with improved RFS (HR 0.78, 95% CI 0.68-0.88, P < 0.001). CONCLUSION: In our study, patients with intermediate-risk NMIBC benefit from adjuvant intravesical therapy in terms of RFS. However, in patients without risk factors, adjuvant intravesical therapy did not result in a clear reduction in the recurrence rate.

Guía clínica del carcinoma urotelial no músculo invasivo de la Asociación Europea de Urología / EAU Guidelines on Non-Muscle-Carcinoma of the Bladder

Contexto y objetivos: Presentar una puesta al día de la versión del 2008 de la guía clínica de la Asociación Europea de Urología (EUA) sobre el cáncer vesical no músculo invasivo. Evidencia adquirida: Se ha realizado una revisión sistemática de la literatura reciente acerca del diagnóstico y tratamiento del cáncer vesical no músculo invasivo. Las guías clínicas fueron puestas al día y se asignó un nivel de evidencia así como un grado de recomendación. Evidencia sintetizada: El diagnóstico del cáncer vesical depende de la cistoscopia y de los hallazgos histológicos del tejido resecado. Una correcta y completa resección transuretral (RTU) es esencial en el pronóstico del paciente. Cuando la primera resección es incompleta o cuando se diagnostica un tumor de alto grado o T1, se debe realizar una segunda resección a las 2-6 semanas. El riesgo a corto y a largo plazo tanto de la recidiva como de la progresión serán calculados de manera individual a través de tablas de riesgo y sistemas de puntuación. La estratificación de los pacientes en grupos de bajo, intermedio y alto riesgo (separando la recidiva y la progresión), supone la piedra angular para indicar un tratamiento adyuvante. Es altamente recomendable en pacientes de bajo riesgo de recidiva y progresión, una instilación inmediata de quimioterapia. En aquellos que tienen riesgo intermedio o alto de recidiva y un riesgo intermedio de progresión, se debe administrar una instilación inmediata de quimioterapia seguido de instilaciones periódicas de quimioterapia o un mínimo de un año con Bacilo de Calmette-Guerin (BCG). En pacientes con alto riesgo de progresión tumoral, tras una administración inmediata de quimioterapia, está indicado BCG intravesical como mínimo durante un año. Una cistectomía inmediata debería ser ofrecida a pacientes de altísimo riesgo y en pacientes en los que ha fallado la BCG. La versión extensa de las guías clínicas está disponible en www.uroweb.org. Conclusiones: Esta guía clínica de la EUA presenta una información actualizada sobre el diagnóstico y tratamiento del cáncer vesical además de ofrecer recientes hallazgos con el fin de aplicarlos a la práctica clínica diaria (AU)

Context and objective: To present the updated version of 2008 European Association of Urology (EAU) guidelines on non-muscle-invasive bladder cancer. Evidence acquisition: A systematic review of the recent literature on the diagnosis and treatment of non-muscle-invasive bladder cancer was performed. The guidelines were updated and the level of evidence and grade of recommendation were assigned. Evidence synthesis: The diagnosis of bladder cancer depends on cystoscopy and histologic evaluation of the resected tissue. A complete and correct transurethral resection (TUR) is essential for the prognosis of the patient. When the initial resection is incomplete or when a high-grade or T1 tumour is detected, a second TUR within 2–6 wk should be performed. The short- and long-term risks of both recurrence and progression may be estimated for individual patients using the scoring system and risk tables. The stratification of patients to low, intermediate, and high-risk groups—separately for recurrence and progression—represents the cornerstone for indication of adjuvant treatment. In patients at low risk of tumour recurrence and progression, one immediate instillation of chemotherapy is strongly recommended. In those at an intermediate or high risk of recurrence and an intermediate risk of progression, one immediate instillation of chemotherapy should be followed by further instillations of chemotherapy or a minimum of 1 yr of bacillus Calmette-Guerin (BCG). In patients at high risk of tumour progression, after an immediate instillation of chemotherapy, intravesical BCG for at least 1 yr is indicated. Immediate cystectomy may be offered to the highest risk patients and in patients with BCG failure. The long version of the guidelines is available on www.uroweb.org. Conclusions: These EAU guidelines present the updated information about the diagnosis and treatment of non-muscle-invasive bladder cancer and offer the recent findings for the routine clinical application (AU)