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Objective: To compare the differential therapeutic effects of Bacillus Calmette-Guérin (BCG) instillation and radical cystectomy (RC) for high-risk non-muscle-invasive urothelial cancer (NMIBC) classified as high-grade T1 in initial and repeat transurethral resection of bladder tumors (TURBT) and to construct a prediction model. Methods: We retrospectively analyzed the clinical data of patients with malignant bladder tumors treated at the First Affiliated Hospital of Soochow University from January 2016 to December 2017 and compared the differences in 1-year, 2-year, 3-year, 5-year, and comprehensive overall survival (OS) and progression-free survival (PFS) between BCG instillation treatment and RC treatment. Survival curves were drawn to show differences in OS and PFS between the two groups. Concurrently, univariate and multivariate COX analyses were performed to identify risk factors affecting OS and PFS, and a nomogram was created. Results: In total, 146 patients were included in the study, of whom 97 and 49 were in the BCG and RC groups, respectively. No statistical differences were observed in the 1- and 2-year OS and PFS between the two groups, whereas significant statistical differences were found in the 3-year, 5-year, and comprehensive OS and PFS. Survival curves also confirmed the statistical differences in OS and PFS between the BCG and RC groups. Multivariate COX analysis revealed that the treatment method, concomitant satellite lesions, and albumin-to-alkaline phosphatase ratio (AAPR) were independent risk factors affecting OS and PFS. The nomogram that was further plotted showed good predictive ability for OS and PFS. Conclusion: For patients who exhibit high-level T1 pathology after both initial and repeat TURBT, especially those with low AAPR, and concomitant satellite lesions, choosing RC as a treatment method offers a better prognosis.
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OBJECTIVE: Primary aortoenteric fistulas (PAEFs) are a rare entity with high morbidity, and their relationship with Bacillus Instillation of Calmette-Guérin is anecdotal. METHODS/RESULTS: We present a 68-year-old male with a primary aortoenteric fistula after instillation of Bacillus Calmette-Guérin (BCG) for a non-muscle-invasive bladder cancer. Diagnosis was made by CT angiography, subsequently confirmed by intraoperative findings and results of anatomopathological studies of aortic wall samples. We performed an in-situ reconstruction with a silver prosthesis impregnated in rifampicin with satisfactory evolution at one year. CONCLUSIONS: Primary aortoenteric fistula is an extremely rare complication, and although its relationship with intravesical BCG therapy is anecdotal, it should be considered in patients with gastrointestinal bleeding who have previously undergone this treatment. Its diagnosis requires clinical suspicion, and its treatment should be carried out without delay. Long-term targeted anti-biotherapeutic treatment is a fundamental pillar for its management. Reconstruction with an antibiotic-impregnated silver prosthesis is a valid option in cases of controlled infection.
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BACKGROUND: Intravesical bacillus Calmette-Guerin (BCG) therapy is the treatment of choice for patients with T1 or high-grade superficial bladder cancer or those with carcinoma in situ after transurethral resection. A personal history of tuberculosis infection has been viewed as a relative contraindication for BCG therapy, because it may increase the risk of complications or decrease the treatment effectiveness. We determined the safety and efficacy of intravesical BCG treatment for patients with prior tuberculosis infection by analyzing the data obtained from the National Health Insurance Research Database in Taiwan. METHODS: We included patients who were newly diagnosed with bladder cancer from 2000 to 2009 and who received adjuvant intravesical BCG therapy within 3 months after the surgery. We excluded those who developed upper urinary tract cancer during the study period. Disease recurrence, disease progression, and major adverse effects were compared between patients with and without a prior diagnosis of tuberculosis infection until December 31, 2011. RESULTS: Among the 3915 patients included, 187 (4.8%) had been previously diagnosed with tuberculosis infection. The proportion of men (84.0% versus 76.9%) and older patients was higher in the group with a prior tuberculosis infection than in those without a prior tuberculosis infection. Significant differences in disease recurrence (20.3% versus 22.8%; hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.63-1.21, p = 0.404) or disease progression (10.2% versus 12.8%, HR, 0.74; 95% CI, 0.46-1.17, p = 0.191) were not observed between the two groups. None of the patients with a prior tuberculosis infection had severe urinary tract infections, whereas four (0.1%) patients without such an infection developed severe urinary tract infections. CONCLUSION: A prior tuberculosis infection did not affect the treatment efficacy or safety of intravesical BCG treatment. The efficacy and safety of intravesical BCG therapy are comparable between bladder cancer patients with and without prior tuberculosis infections.
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Adyuvantes Inmunológicos/administración & dosificación , Vacuna BCG/administración & dosificación , Neoplasias de la Vejiga Urinaria/tratamiento farmacológico , Administración Intravesical , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Taiwán , Resultado del Tratamiento , TuberculosisRESUMEN
CONTEXT: Intravesical Bacillus Calmette-Guérin (BCG) is a cause of bladder and systemic toxicity that is difficult to prevent and is responsible for treatment drop out in bladder cancer patients. More recently, BCG shortage has become the main cause of incomplete treatment. AIMS: The aim of this study was to examine the impact on long-term prognosis of bladder cancer patients following discontinuation of BCG instillations. SETTINGS AND DESIGN: In this retrospective study, data were examined from 333 consecutive nonmuscle invasive bladder cancer patients treated from 2005 to 2015 by transurethral resection (TUR) and had undergone adjuvant BCG therapy after TUR. SUBJECTS AND METHODS: Rate of complete cure, the reason for the interruption, toxicity, and the associations between discontinuance of BCG therapy, tumor characteristics, association with carcinoma in situ and tumor recurrence or progression were analyzed. STATISTICAL ANALYSIS USED: Recurrence and progression-free survival rate curves were estimated using the Kaplan-Meier method and were compared using the log-rank test. Univariate and multivariate analyses were performed using the Cox proportional hazards model. Differences among groups were considered as statistically significant when P < 0.05. RESULTS: Overall, 303 patients were eligible for analysis. Median follow up was 36 (confidence interval: 7-120) months. A total of 55 (18.1%) had <6 installations (Group I); 87 (28.7%) completed induction and 1-year maintenance (Group III); and 161 (53.1%) completed the induction course, but not the 1-year maintenance (Group II). Grade III-IV toxicity rates were significantly higher in Group I than Group II and III. Interruption for BCG shortage was the main cause of interrupting BCG in Group II. Multivariate analysis showed that discontinuation of BCG induction therapy was an independent predictor for tumor recurrence (P < 0.001) and 1-year BCG maintenance therapy for tumor progression (P = 0.005). CONCLUSIONS: Discontinuation of BCG therapy has a significantly deleterious effect on tumor recurrence and progression rates. Although BCG toxicity is a major cause of drop out, BCG shortage became a major cause of discontinuation. All effort must be done today to restore normal production of BCG worldwide.
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OBJECTIVE: To validate two prediction models (European Organization for Research and Treatment of Cancer and Spanish Urological Club for Oncological Treatment) for recurrence and progression of non-muscle invasive bladder cancer in Japanese patients who underwent bacillus Calmette-Guérin instillation therapy. METHODS: From March 1985 to April 2007, data were analyzed from 366 patients who underwent transurethral resection of bladder tumor followed by bacillus Calmette-Guérin instillation therapy. The ability of two scoring models to predict recurrence and progression was assessed by concordance index. RESULTS: For recurrence probability, the concordance index of the European Organization for Research and Treatment of Cancer and Spanish Urological Club for Oncological Treatment models was 0.514 and 0.576, respectively, which was lower than that (0.604) of a selected single prognostic factor (age) by our multivariate analysis. For progression probability, the concordance index of European Organization for Research and Treatment of Cancer and Spanish Urological Club for Oncological Treatment models was 0.693 and 0.764, respectively, which was higher than that (0.633) of a selected single factor (T stage) by our multivariate analysis. The Spanish Urological Club for Oncological Treatment scoring system resulted in better stratification of tumor recurrence and progression when compared with the European Organization for Research and Treatment of Cancer model, probably because more patients underwent bacillus Calmette-Guérin treatment in the Spanish Urological Club for Oncological Treatment cohort than in the European Organization for Research and Treatment of Cancer cohort. CONCLUSIONS: The Spanish Urological Club for Oncological Treatment scoring system is a good predictor of tumor recurrence and progression in Japanese patients who underwent bacillus Calmette-Guérin immunotherapy. A large prospective study is warranted to confirm the efficacy of this system.