OBJECTIVE: To investigate the influence of statins on the survival outcomes of patients with non-muscle-invasive bladder cancer (NMIBC) treated with adjuvant intravesical bacille Calmette-Guérin (BCG) immunotherapy. PATIENTS AND METHODS: A retrospective cohort of consecutive patients with NMIBC who received intravesical BCG therapy from 2001 to 2020 and statins prescription were identified. Overall survival (OS), cancer-specific survival (CSS), recurrence-free survival (RFS), and progression-free survival (PFS) were analysed between the Statins Group vs No-Statins Group using Kaplan-Meier method and multivariable Cox regression. RESULTS: A total of 2602 patients with NMIBC who received intravesical BCG were identified. The median follow-up was 11.0 years. On Kaplan-Meier analysis, the Statins Group had significant better OS (P < 0.001), CSS (P < 0.001), and PFS (P < 0.001). Subgroup analysis indicated statins treatment started before BCG treatment had better CSS (P = 0.02) and PFS (P < 0.01). Upon multivariable Cox regression analysis, the 'statins before BCG' group was an independent protective factor for OS (hazard ratio [HR] 0.607, 95% confidence interval [CI] 0.514-0.716), and CSS (HR 0.571, 95% CI 0.376-0.868), but not RFS (HR 0.885, 95% CI 0.736-1.065), and PFS (HR 0.689, 95% CI 0.469-1.013). CONCLUSIONS: Statins treatment appears to offer protective effects on OS and CSS for patients with NMIBC receiving adjuvant intravesical BCG.
- MeSH
- adjuvancia imunologická terapeutické užití MeSH
- aplikace intravezikální MeSH
- BCG vakcína * terapeutické užití MeSH
- invazivní růst nádoru MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory močového měchýře neinvadující svalovinu MeSH
- nádory močového měchýře * farmakoterapie patologie mortalita MeSH
- retrospektivní studie MeSH
- senioři MeSH
- statiny * terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: High-level evidence supporting the role of repeat transurethral resection (reTUR) in non-muscle-invasive bladder cancer (NMIBC) is lacking. A randomized controlled trial (RCT) assessing whether immediate reTUR has an impact on patient prognosis is essential. However, since such a RCT will require enrollment of a high number of patients, a preliminary feasibility study is appropriate. OBJECTIVE: To assess the feasibility of an RCT investigating the impact of immediate reTUR + adjuvant bacillus Calmette-Guérin (BCG) versus upfront induction BCG after initial TUR in NMIBC. DESIGN, SETTING, AND PARTICIPANTS: Eligible patients were randomly assigned to receive either reTUR + adjuvant BCG or upfront induction BCG after TUR. Patients with macroscopically completely resected high-grade T1 NMIBC, with or without concomitant carcinoma in situ, and with detrusor muscle (DM) present in the initial TUR specimen were considered eligible for inclusion. Exclusion criteria included lymphovascular invasion (LVI), histological subtypes, hydronephrosis, concomitant upper tract urothelial carcinoma (UTUC), or urothelial carcinoma within the prostatic urethra. The aim was to enroll 30 patients in this feasibility study. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The patient recruitment rate was the primary outcome. Oncological outcomes (recurrence-free and progression-free survival) were secondary endpoints. RESULTS AND LIMITATIONS: Overall, 30 patients (15 per arm) were randomized over a period of 14 mo (August 2020-October 2021). Two eligible patients refused the randomization, resulting in a patient compliance rate of 93.3% for the study protocol. We excluded 49 ineligible patients before randomization because of histological subtypes (n = 16, 33%), LVI (n = 9, 18%), DM absence in the TUR specimen (n = 12, 24%), metastatic disease (n = 5, 10%), concomitant UTUC (n = 3, 6%), or hydronephrosis (n = 4, 8%). At reTUR, persistent disease was found in four patients (29%) and upstaging to muscle-invasive disease in one (7%). Over median follow-up of 17 mo, disease recurrence was detected in three patients (23%) in the reTUR arm and six patients (40%) in the upfront BCG arm. Progression to muscle-invasive disease was observed in one patient treated with upfront BCG. CONCLUSIONS: The feasibility of conducting an RCT comparing upfront BCG versus reTUR + BCG in high-grade T1 NMIBC has been demonstrated. Our results underline the need to screen a large number of patients owing to characteristics meeting the exclusion criteria in a high percentage of cases. PATIENT SUMMARY: We found that a clinical trial of the role of a repeat surgical procedure to remove bladder tumors through the urethra would be feasible among patients with high-grade non-muscle-invasive bladder cancer. These preliminary results may help in refining the role of this repeat procedure for patients in this category.
- MeSH
- adjuvancia imunologická * terapeutické užití MeSH
- BCG vakcína * terapeutické užití aplikace a dávkování MeSH
- cystektomie metody MeSH
- invazivní růst nádoru * MeSH
- kombinovaná terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory močového měchýře neinvadující svalovinu MeSH
- nádory močového měchýře * chirurgie patologie farmakoterapie MeSH
- reoperace MeSH
- senioři MeSH
- studie proveditelnosti * MeSH
- uretra MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Current European Association of Urology (EAU) guidelines support adjuvant intravesical Bacillus Calmette-Guérin (BCG) treatment after Transurethral Resection of Bladder Tumor (TURB) for intermediate- or high-risk Non-Muscle-Invasive Bladder Cancer (NMIBC) patients, aiming to reduce the risk of tumor recurrence. The quality of data, however, does not allow definitive conclusions on whether different strains and dosages of BCG have different efficacies on long-term survival outcomes. OBJECTIVE: To evaluate the long-term survival outcomes of different strains and dosages of BCG in patients with NMIBC. DESIGN, SETTING, AND PARTICIPANTS: All NMIBC patients treated with intravesical BCG therapy from 2001 to 2020 were identified using a territory-wide database in Hong Kong. INTERVENTION: BCG strains and dosages (Connaught strain 81 mg, Connaught strain 27 mg, Tokyo strain 80 mg, and Danish strain 30 mg) were retrieved from medical records. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Overall Survival (OS), Cancer-Specific Survival (CSS), Recurrence-Free Survival (RFS), and Progression-Free Survival (PFS) were analyzed using the Kaplan-Meier method. A multivariable Cox regression analysis was used to adjust potential confounding factors, and to estimate Hazard Ratio (HR) and 95% confidence interval (CI) of different BCG strains. A further subgroup analysis on adequate versus inadequate BCG treatment was performed. RESULTS AND LIMITATIONS: A total of 2602 NMIBC patients treated with intravesical BCG were identified. Among them, 1291 (49.6%) received Connaught strain 81 mg, 199 (7.6%) received Connaught strain 27 mg, 1014 (39.0%) received Tokyo strain, and 98 (3.8%) received Danish strain. The median follow-up was 11.0 years. No statistically significant differences in OS, CSS, RFS, and PFS were detected among the different groups. At the multivariable analysis, the Connaught strain 27 mg group was inferior to the Connaught strain 81 mg group in terms of OS (HR: 1.26, 95% CI: 1.05-1.51), CSS (HR: 1.69, 95% CI: 1.08-2.66), and PFS (HR: 1.86, 95% CI: 1.20-2.88). Adequate BCG treatment was associated with improved OS (HR: 0.82, 95% CI: 0.73-0.92), CSS (HR: 0.64, 95% CI: 0.47-0.86), RFS (HR: 0.80, 95% CI: 0.70-0.92), and PFS (HR: 0.52, 95% CI: 0.39-0.68). Among patients treated with adequate BCG, at the multivariable analysis the Connaught strain 27 mg group showed worse results than the Connaught strain 81 mg group in terms of CSS (HR: 1.93, 95% CI: 1.07-3.51). Compared with the Connaught strain 81 mg group, both Tokyo and Danish strains had similar survival outcomes in the whole cohort and the adequate BCG treatment subgroup. CONCLUSIONS: Our findings suggest that adequate BCG remains the most important factor in optimizing survival outcomes in patients with intermediate- and high-risk NMIBC. No significant differences in survival outcomes were observed between full-dose Connaught, Tokyo, and Danish strains. Reduced-dose Connaught strain was associated with the worst survival outcomes. PATIENT SUMMARY: We evaluated the efficacy of different strains and dosages of bacillus Calmette-Guérin (BCG) in patients with intermediate- or high-risk non-muscle-invasive bladder cancer in the past two decades in Hong Kong. We conclude no significant differences in long-term survival outcomes in terms of full-dose Connaught, Tokyo, and Danish strains, while reduced-dose Connaught strain was inferior to the full-dose group. Adequate BCG treatment benefits long-term survival.
- MeSH
- adjuvancia imunologická terapeutické užití aplikace a dávkování MeSH
- aplikace intravezikální MeSH
- BCG vakcína * terapeutické užití aplikace a dávkování MeSH
- invazivní růst nádoru MeSH
- lidé středního věku MeSH
- lidé MeSH
- míra přežití MeSH
- nádory močového měchýře neinvadující svalovinu * mortalita terapie MeSH
- nádory močového měchýře * mortalita terapie MeSH
- retrospektivní studie MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Hongkong MeSH
OBJECTIVE: To investigate the impact of ageing on survival outcomes in Bacillus Calmette-Guérin (BCG) treated non-muscle invasive bladder cancer (NMIBC) patients and its synergy with adequate BCG treatment. METHOD: Patients with NMIBC who received BCG treatment from 2001 to 2020 were divided into group 1 (< = 70 years) and group 2 (> 70 years). Overall Survival (OS), Cancer-Specific Survival (CSS), Recurrence-Free Survival (RFS), and Progression-Free Survival (PFS) were analyzed using the Kaplan-Meier method. Multivariable Cox regression analysis was used to adjust potential confounding factors and to estimate Hazard Ratio (HR) and 95% Confidence Interval (CI). Subgroup analysis was performed according to adequate versus inadequate BCG treatment. RESULTS: Overall, 2602 NMIBC patients were included: 1051 (40.4%) and 1551 (59.6%) in groups 1 and 2, respectively. At median follow-up of 11.0 years, group 1 (< = 70 years) was associated with better OS, CSS, and RFS, but not PFS as compared to group 2 (> 70 years). At subgroup analysis, patients in group 1 treated with adequate BCG showed better OS, CSS, RFS, and PFS as compared with inadequate BCG treatment in group 2, while patients in group 2 receiving adequate BCG treatment had 41% less progression than those treated with inadequate BCG from the same group. CONCLUSIONS: Being younger (< = 70 years) was associated with better OS, CSS, and RFS, but not PFS. Older patients (> 70 years) who received adequate BCG treatment had similar PFS as those younger with adequate BCG treatment.
- MeSH
- adjuvancia imunologická * terapeutické užití MeSH
- aplikace intravezikální MeSH
- BCG vakcína * terapeutické užití MeSH
- invazivní růst nádoru * MeSH
- lidé středního věku MeSH
- lidé MeSH
- míra přežití MeSH
- nádory močového měchýře neinvadující svalovinu MeSH
- nádory močového měchýře * farmakoterapie patologie terapie mortalita MeSH
- retrospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- věkové faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- MeSH
- bakteriální lyzáty * farmakologie klasifikace terapeutické užití MeSH
- BCG vakcína aplikace a dávkování farmakologie imunologie terapeutické užití MeSH
- glukany aplikace a dávkování farmakologie terapeutické užití MeSH
- imunologické faktory farmakologie klasifikace terapeutické užití MeSH
- imunomodulační látky * aplikace a dávkování farmakologie klasifikace terapeutické užití MeSH
- mikrobiota fyziologie imunologie MeSH
- probiotika farmakologie klasifikace terapeutické užití MeSH
- slizniční imunita imunologie účinky léků MeSH
- Publikační typ
- přehledy MeSH
Nová doporučení navazují na Standard léčebného plánu z roku 2012(1) a na vydání speciálního čísla Česko-slovenské pediatrie z roku 2016 věnovaného problematice tuberkulózy (TB).(2) V předkládaném dokumentu reflektujeme nová doporučení Světové zdravotnické organizace (WHO),(3) která dlouhodobě hledá nové strategie pro optimální léčbu dětských a dorostových pacientů, neboť celosvětově onemocní TB ročně více než 10 milionů lidí, z toho 1,2 milionu dětí.(4) V České republice zůstává TB vzácným onemocněním s incidencí 3,6 : 100 000 v roce 2022.(5) Dětská TB odráží trend dospělé TB. Mezi roky 2010–2020 byl trend klesající. Ani změna očkovací strategie v roce 2010 tento trend nezměnila.(6) Od roku 2021 pozorujeme mírný nárůst dětských pacientů s TB. V roce 2023 onemocnělo TB 29 dětí (obr. 1). Nárůst dětských případů TB, včetně forem rezistentních na léčbu, zvyšuje nárok na aktualizaci doporučení pro diagnostiku a léčbu v souladu se světovými trendy. Hlavní změny v doporučeném postupu se týkají zejména zkrácení léčby nekomplikované TB u dětí ve věku 3–16 let na 4 měsíce. Dále jsou zde nově definované skupiny TB rezistentní na léčbu (drug resistant – DR) a nové strategie její léčby, jejíž součástí je podávání bedaquilinu a delamanidu. Inovativní je také zavedení TB preventivní terapie u kontaktů s DR-TB.
The new recommendations are a follow-up to the 2012 Standard treatment guidelines(1) and the 2016 special issue of Czech-Slovak Paediatrics dedicated to tuberculosis (TB).(2) The present document reflects the new recommendations(3) of the World Health Organization (WHO), which has long been seeking new strategies for optimal treatment of paediatric and adolescent patients, as more than 10 million people worldwide develop TB annually, including 1.2 million children.(4) In the Czech Republic, TB remains a rare disease, with an incidence of 3.6/100,000 in 2022.(5) Childhood TB mirrors the trend of adult TB. Between 2010–2020, the trend was downward. Even the change in vaccination strategy in 2010 did not change this trend.(6) From 2021, we observe a slight increase in paediatric TB cases. In 2023, 29 children developed TB (Figure 1). The increase in paediatric TB cases, including treatment-resistant forms, makes it imperative to update recommendations for diagnosis and treatment in line with global trends. In particular, the main changes to the recommended approach relate to shortening treatment of uncomplicated TB in children aged 3-16 years to 4 months. There are also newly defined groups of drug-resistant (DR) TB and a new strategy for their treatment, which includes the administration of bedaquiline and delamanid. The introduction of TB preventive therapy for contacts of DR-TB is also innovative.
- MeSH
- antituberkulotika terapeutické užití MeSH
- BCG vakcína MeSH
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- multirezistentní tuberkulóza klasifikace terapie MeSH
- Mycobacterium tuberculosis imunologie izolace a purifikace patogenita MeSH
- tuberkulóza * diagnóza prevence a kontrola terapie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- Publikační typ
- směrnice pro lékařskou praxi MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND AND OBJECTIVE: There has been a recent surge in the development of agents for bacillus Calmette-Guérin-unresponsive (BCG-U) non-muscle-invasive bladder cancer (NMIBC). Critical assessment of these agents and practical recommendations for optimal selection of patients and therapies are urgently needed, especially in the absence of randomized trials on bladder-sparing treatment (BST) options. METHODS: A global committee of bladder cancer experts was assembled to develop recommendations on BST for BCG-U NMIBC. Working groups reviewed the literature and developed draft recommendations, which were then voted on by International Bladder Cancer Group (IBCG) members using a modified Delphi process. During a live meeting in August 2023, voting results and supporting evidence were presented, and recommendations were refined on the basis of meeting discussions. Final recommendations achieved >75% agreement during the meeting, and some were further refined via web conferences and e-mail discussions. KEY FINDINGS AND LIMITATIONS: There is currently no single optimal agent for patients with BCG-U disease who seek to avoid radical cystectomy (RC). BST selection should be personalized, taking into account individual patient characteristics and preferences, tumor attributes, and efficacy/toxicity data for the agents available. For patients with BCG-U carcinoma in situ (CIS), gemcitabine/docetaxel (GEM/DOCE), nadofaragene firadenovec (NFF), and nogapendekin alfa inbakicept-pmln (NAI) + BCG are recommended; because of its systemic toxicity, pembrolizumab should only be offered after other options are exhausted. For patients with BCG-U papillary-only tumors, GEM/DOCE, NFF, NAI + BCG, single-agent chemotherapy, hyperthermic mitomycin C, and pembrolizumab are recommended. Given the modest efficacy of available options, clinical trial participation is encouraged. For unapproved agents with reported data, IBCG recommendations await the final results of pivotal trials. CONCLUSIONS AND CLINICAL IMPLICATIONS: The IBCG consensus recommendations provide practical guidance on BST for BCG-U NMIBC.
- MeSH
- adjuvancia imunologická terapeutické užití MeSH
- BCG vakcína * terapeutické užití MeSH
- cystektomie MeSH
- invazivní růst nádoru * MeSH
- léčba šetřící orgány * MeSH
- lidé MeSH
- nádory močového měchýře neinvadující svalovinu MeSH
- nádory močového měchýře * farmakoterapie patologie MeSH
- výběr pacientů * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- směrnice pro lékařskou praxi MeSH
BACKGROUND: The molecular content of urine is defined by filtration in the kidneys and by local release from tissues lining the urinary tract. Pathological processes and different therapies change the molecular composition of urine and a variety of markers have been analyzed in patients with bladder cancer. The response to BCG immunotherapy and chemotherapy has been extensively studied and elevated urine concentrations of IL-1RA, IFN-α, IFN-γ TNF-α, and IL-17 have been associated with improved outcome. METHODS: In this study, the host response to intravesical alpha 1-oleate treatment was characterized in patients with non-muscle invasive bladder cancer by proteomic and transcriptomic analysis. RESULTS: Proteomic profiling detected a significant increase in multiple cytokines in the treatment group compared to placebo. The innate immune response was strongly activated, including IL-1RA and pro-inflammatory cytokines in the IL-1 family (IL-1α, IL-1β, IL-33), chemokines (MIP-1α, IL-8), and interferons (IFN-α2, IFN-γ). Adaptive immune mediators included IL-12, Granzyme B, CD40, PD-L1, and IL-17D, suggesting broad effects of alpha 1-oleate treatment on the tumor tissues. CONCLUSIONS: The cytokine response profile in alpha 1-oleate treated patients was similar to that reported in BCG treated patients, suggesting a significant overlap. A reduction in protein levels at the end of treatment coincided with inhibition of cancer-related gene expression in tissue biopsies, consistent with a positive treatment effect. Thus, in addition to killing tumor cells and inducing cell detachment, alpha 1-oleate is shown to activate a broad immune response with a protective potential.
- MeSH
- antagonista receptoru pro interleukin 1 terapeutické užití MeSH
- BCG vakcína * terapeutické užití MeSH
- cytokiny MeSH
- imunita MeSH
- interferon alfa farmakologie terapeutické užití MeSH
- kyselina olejová MeSH
- lidé MeSH
- nádory močového měchýře * patologie MeSH
- proteomika MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Cíl: Cílem této retrospektivní studie je ověřit, zda provedení vícečetné transuretrální resekce (reTUR) u pacientů s T1 uroteliálním karcinomem močového měchýře nevede ke zhoršení prognózy, dále zhodnotit význam jednotlivých prognostických faktorů při první a druhé reTUR. Metoda: Do retrospektivní studie bylo zařazeno celkem 363 pacientů s diagnózou T1 uroteliál- ního karcinomu v letech 2001 až 2022, z toho 260 pacientů podstoupilo aspoň jednu reTUR, u 103 pacientů nebyl reTUR proveden. Standartně v případě nálezu pT1 nádoru v TUR byla indikována reTUR až do doby, kdy byl výsledek histologie pT0, pTa, CIS nebo byl diagnostikován svalovinu infiltrující nádor (stadium pT2 a více). Ke srovnání jednotlivých skupin dle počtu reTUR jsme použili Kaplan-Meierovu metodu odhadu distribuční funkce přežití a Log-rank test. Vliv jednotlivých prognostických faktorů při vícečetné reTUR byl testován pomocí Coxova regresního modelu. Výsledky: Při srovnání skupin pacientů bez provedené reTUR se skupinou s jednou reTUR, se dvě- ma reTUR a se třemi a více reTUR nebyl v rámci celého souboru 363 pacientů zjištěn významný rozdíl v celkovém přežití (OS), pro nemoc specifickém přežití (DSS) a přežití bez progrese (PFS). Přežití bez recidivy (RFS) se významně prodlužovalo s počtem provedených výkonů (p = 0,02). Podání intravezikální léčby vakcínou BCG bylo v multivariantní analýze jediným z nezávislých prognostických faktorů ve vztahu k OS a PFS. U 147 pacientů s T1 uroteliálním karcinomem léčených intravezikální vakcínou BCG rovněž nebyl zjištěn významný rozdíl v OS (p = 0,72), DSS (p = 0,75), PFS (p = 0,76), ani RFS (p = 0,85) při srovnání odpovídajících skupin pacientů. Podání intravezikální léčby vakcínou BCG u pacientů s nálezem T0, Ta a CIS v reTUR významně souviselo s delším OS (p = 0,03) a PFS (p = 0,01). Nález karcinomu během první a druhé reTUR zvyšoval riziko budoucí recidivy. Závěr: Provedení další doby transuretrální resekce v případě opakovaného nálezu T1 karcinomu v reTUR je možné považovat za bezpečné. Dle našich dat, případné komplikace plynoucí z provedení další doby TUR či oddálení případné intravezikální terapie, nezhoršují OS. Nález nádoru při první a druhé reTUR je u pacientů s T1 karcinomem močového měchýře rizikem pro budoucí recidivu.
Aim: The aim of this retrospective study is to investigate whether multiple transurethral resection (reTUR) in patients with T1 urothelial carcinoma of the bladder leads to worse prognosis and to evaluate the significance of individual prognostic factors in the first and second reTUR. Methods: A total of 363 patients diagnosed with T1 urothelial carcinoma between 2001 and 2022 were included in this retrospective study, of whom 260 patients underwent at least one reTUR and 103 patients did not undergo reTUR. By default, if a pT1 tumor was found in TUR, reTUR was indicated until histology was pT0, pTa, CIS, or a muscle-infiltrating tumor was diagnosed (stage pT2 or more). We used the Kaplan-Meier survival distribution function estimation method and the log-rank test to compare each group according to the number of reTURs. The effect of individual prognostic factors in multiple reTUR was tested using Cox regression model. Results: When comparing the groups of patients without reTUR with the groups with one reTUR, two reTUR, and three or more reTUR, there was no significant difference in overall survival (OS), disease-specific survival (DSS), and progression-free survival (PFS) in the entire cohort of 363 patients. Recurrence-free survival (RFS) significantly increased with the number of procedures performed (p = 0.02). Administration of intravesical BCG vaccine was the only independent prognostic factor in multivariate analysis in relation to OS and PFS. In 147 patients with T1 urothelial carcinoma treated with intravesical BCG vaccine, there was also no significant difference in OS (p = 0.72), DSS (p = 0.75), PFS (p = 0.76), or RFS (p = 0.85) when comparing matched groups of patients. Administration of intravesical BCG vaccine in patients with T0, Ta and CIS findings in reTUR was significantly associated with longer OS (p = 0.03) and PFS (p = 0.01). Finding cancer during the first and second reTUR increased the risk of future recurrence. Conclusion: Performing an additional period of transurethral resection in case of recurrence of T1 carcinoma at reTUR can be considered safe. According to our data, potential complications resulting from performing an additional TUR period or delaying any intravesical therapy do not worsen OS. Tumor finding at first and second reTUR is a risk for future recurrence in patients with T1 bladder cancer.
- MeSH
- BCG vakcína MeSH
- karcinom z přechodných buněk chirurgie MeSH
- lidé MeSH
- miniinvazivní chirurgické výkony metody MeSH
- nádory močového měchýře * chirurgie MeSH
- prognóza MeSH
- reoperace MeSH
- retrospektivní studie MeSH
- staging nádorů MeSH
- transuretrální resekce močového měchýře * metody MeSH
- Check Tag
- lidé MeSH
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.
- MeSH
- adjuvantní chemoterapie MeSH
- aplikace intravezikální MeSH
- BCG vakcína terapeutické užití aplikace a dávkování MeSH
- cystektomie metody MeSH
- epirubicin aplikace a dávkování MeSH
- invazivní růst nádoru MeSH
- lidé středního věku MeSH
- lidé MeSH
- mitomycin aplikace a dávkování terapeutické užití MeSH
- nádory močového měchýře neinvadující svalovinu MeSH
- nádory močového měchýře * patologie terapie farmakoterapie mortalita MeSH
- přežití po terapii bez příznaků nemoci MeSH
- retrospektivní studie MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH