Use of fluorescence in situ hybridization to predict response to bacillus Calmette-Guérin therapy for bladder cancer: results of a prospective trial.

PURPOSE: No reliable methods currently exist to predict patient response to intravesical immunotherapy with bacillus Calmette-Guérin given after transurethral resection for high risk nonmuscle invasive bladder cancer. We initiated a prospective clinical trial to determine whether fluorescence in situ hybridization results during bacillus Calmette-Guérin immunotherapy can predict therapy failure. MATERIALS AND METHODS: Candidates for standard of care bacillus Calmette-Guérin were offered participation in a clinical trial. Fluorescence in situ hybridization was performed before bacillus Calmette-Guérin, and at 6 weeks, 3 months and 6 months during bacillus Calmette-Guérin therapy with maintenance. Cox proportional hazards regression was used to assess the relationship between fluorescence in situ hybridization results and tumor recurrence or progression. The Kaplan-Meier product limit method was used to estimate recurrence-free and progression-free survival. RESULTS: A total of 126 patients participated in the study. At a median followup of 24 months 31% of patients had recurrent tumors and 14% experienced disease progression. Patients who had positive fluorescence in situ hybridization results during bacillus Calmette-Guérin therapy were 3 to 5 times more likely than those who had negative fluorescence in situ hybridization results to experience recurrent tumors and 5 to 13 times more likely to have disease progression (p <0.01). The timing of positive fluorescence in situ hybridization results also affected outcomes. For example, patients with a negative fluorescence in situ hybridization result at baseline, 6 weeks and 3 months demonstrated an 8.3% recurrence rate compared to 48.1% for those with a positive result at all 3 points. CONCLUSIONS: Fluorescence in situ hybridization results can identify patients at risk for tumor recurrence and progression during bacillus Calmette-Guérin immunotherapy. This information may be used to counsel patients about alternative treatment strategies.

Opções técnicas utilizadas no transplante pancreático em centros brasileiros / Technical options used in pancreatic transplants in brazilian centers

OBJETIVO: Analisar o perfil dos principais centros de transplantes do Brasil, quanto às opções técnicas no transplante de pâncreas. MÉTODO: Foi encaminhado um questionário por correio eletrônico (email) para um membro de cada equipe de 12 centros de transplante do Brasil, com casuística mínima de um transplante de pâncreas. O questionário continha 10 perguntas, abordando aspectos controversos e não padronizados. RESULTADOS: A maioria dos centros (90,9 por cento) utiliza incisão mediana. O órgão de escolha a ser implantado primeiro foi principalmente o rim, em 63 por cento dos centros. Em relação à drenagem venosa, 90,9 por cento utilizam a drenagem sistêmica. A ligadura da veia ilíaca interna é realizada em 54,5 por cento dos centros. A maioria dos centros (90,9 por cento) utiliza a drenagem entérica para transplante combinado pâncreas-rim. Para o transplante de pâncreas isolado, apenas cinco centros responderam, sendo que dois utilizam a drenagem entérica e três a vesical. A utilização de dreno na cavidade abdominal ocorre em 63 por cento dos centros. Em 72,7 por cento dos centros é realizada algum tipo de indução na imunossupressão para o transplante combinado pâncreas-rim, sendo a imunossupressão básica a associação de tacrolimus (FK506), micofenolato mofetil (MMF) e corticóide. A antibioticoprofilaxia é realizada por todos os centros e profilaxia para fungos é realizada por seis centros (54,5 por cento). Oito centros (72,7 por cento) utilizam algum tipo de profilaxia para trombose vascular, em esquemas diversos. CONCLUSÃO: Existem diversos caminhos técnicos na condução do transplante pancreático. A falta de padronização dificulta a análise e a comparação dos resultados. Apesar dessa heterogeneidade das equipes, observamos uma tendência para a realização de incisão mediana, drenagem venosa sistêmica e exócrina entérica, com a utilização de algum tipo de profilaxia para trombose vascular nos transplantes combinados pâncreas-rim.

BACKGROUND: To analyze the profile of the most important Brazilian Transplant Centers regarding technical options in the pancreas transplant. METHODS: A query was sent by electronic mail for the 12 Brazilian Transplant Centers with at least one pancreas transplant performed. The query included ten questions approaching controversial and non-standard technical aspects. RESULTS: Midline abdominal incision is used in 90.9 percent of the Centers. The first organ to be implanted is the kidney in 63 percent of the Centers. Regarding the venous drainage, 90.9 percent perform systemic drainage. In 54.5 percent of the Centers the internal iliac vein is ligated. For combined pancreas-kidney transplant 90.9 percent of the teams perform enteric drainage. Five Centers answered about isolated pancreas transplant, two of them use enteric drainage and the other three prefer to utilize the bladder. 63 percent of the surgical teams use abdominal drain. 72.7 percent of the Centers adopt immunosupression induction for the combined pancreas-kidney transplant. The basic immunosuppression was an association between tacrolimus (FK506), and mofetil microfenolato (MMF), and corticoids. While antibiotic prophylaxis is performed in all the 12 Centers, fungus prophylaxis is routinely made in six of them. Eight Centers (72.7 percent) adopt vascular thrombosis prophylaxis by several different protocols. CONCLUSION: There are various technical medical protocols on how to conduct a pancreas transplant patient. The lack of homogeneity in the protocols makes it more difficult to analyze and compare the results. Nevertheless we can conclude that in combined pancreas-kidney transplant there is a preference towards midline abdominal incision, and vein systemic and enteric drainage, and vascular thrombosis prophylaxis.