Adjuvant BCG Research Articles

A single-center retrospective comparison of pT1 substaging methods in bladder cancer.

Substaging of T1 urothelial cancer is associated with tumor progression and its reporting is recommended by international guidelines. However, it has not been integrated in risk stratification tools and there is no agreement on the best method to use for its reporting. We aimed to investigate the applicability, interobserver variability, and prognostic value of histological landmark based and micrometric (aggregate linear length of invasive carcinoma (ALLICA), microscopic vs. extensive system, Rete Oncologica Lombarda (ROL) system) substaging methods. A total of 79 patients with the primary diagnosis of T1 urothelial cancer treated with conventional transurethral resection and adjuvant BCG therapy between 2000 and 2020 at the Medical University of Vienna were included. The anatomical and metrical substaging systems were evaluated using agreement rate, Cohen's kappa, Kendall's tau, and Spearman rank correlation. Prognostic value for high-grade recurrence or T2 progression was evaluated in uni- and multivariable analysis. Applicability and reproducibility were good to moderate and varied between substaging methods. Obstacles are mainly due to fragmentation of samples. Anatomical substaging was associated with progression in univariable and multivariable analysis. In our cohort, we could only identify anatomical landmark-based substaging to be prognostic for T2 progression. A major obstacle for proper pathological assessment is fragmentation of samples due to operational procedure. Avoiding such fragmentation might improve reproducibility and significance of pathological T1 substaging of urothelial cancer.

Prognostic significance of residual tumor at restaging transurethral bladder resection in high-risk non-muscle-invasive bladder cancer.

To assess prognostic significance of residual tumor at repeat transurethral resection (reTUR) in contemporary non-muscle-invasive bladder cancer (NMIBC) patients. Patients were identified retrospectively from eight referral centers in France, Italy and Spain. The cohort included consecutive patients with high or very-high risk NMIBC who underwent reTUR and subsequent adjuvant BCG therapy. A total of 440 high-risk NMIBC patients were screened, 29 (6%) were upstaged ≥ T2 at reTUR and 411 were analyzed (T1 stage: n = 275, 67%). Residual tumor was found in 191 cases (46%). In patients with T1 tumor on initial TURBT, persistent T1 tumor was found in 18% of reTUR (n = 49/275). In patients with high-grade Ta tumor on initial TURBT, T1 tumor was found in 6% of reTUR (n = 9/136). In multivariable logistic regression analysis, we found no statistical association between the use of photodynamic diagnosis (PDD, p = 0.4) or type of resection (conventional vs. en bloc, p = 0.6) and the risk of residual tumor. The estimated 5-yr recurrence and progression-free survival were 56% and 94%, respectively. Residual tumor was significantly associated with a higher risk of recurrence (p < 0.001) but not progression (p = 0.11). Only residual T1 tumor was associated with a higher risk of progression (p < 0.001) with an estimated 5-yr progression-free survival rate of 76%. ReTUR should remain a standard for T1 tumors, irrespective of the use of en bloc resection or PDD and could be safely omitted in high-grade Ta tumors. Persistent T1 tumor at reTUR should not exclude these patients from conservative management, and further studies are needed to explore the benefit of a third resection in this subgroup.

The impact of purified protein derivative prior to intravesical bacillus Calmette-Guérin for the treatment of patients with non-muscle invasive bladder cancer.

The aim of this study is to investigate the impact of the intradermal injection of purified protein derivative (PPD) and PPD skin test reactions on the oncological outcomes of patients with non-muscle invasive bladder cancer (NMIBC) treated by trans-urethral resection of bladder tumor (TURBT) and adjuvant intravesical BCG. The study included 100 consecutive patients with NMIBC prospectively given intradermal PPD 1-2 weeks before starting BCG therapy. Another 100 patients with NMIBC not given intradermal PPD before starting BCG were chosen as a historical control. The control group was chosen to be matching with the study group regarding baseline characteristics. The study group was divided into 2 subgroups with positive and negative reaction to PPD skin test. Oncological outcomes, immunological markers (TNF-α and IL-6) changes and BCG side effects were evaluated. There were no significant differences between patients who received PPD or not regarding the 2-year recurrence free survival (RFS) rates and progression-free survival (PFS) rates and immunological markers changes. The 2-year RFS and PFS rates were significantly higher in patients with positive reactions. Post-induction values of immunological markers increased in all patients with a significant increase in patients with positive reactions. BCG side effects were significantly higher in patients with positive reactions. The intradermal injection of PPD before intravesical BCG has no impact on oncological outcomes of patients with NMIBC treated with TURBT and intravesical BCG. However, the PPD skin test reactions before BCG therapy can predict the oncological outcomes, BCG side effects and the immunological outcomes of patients.

Carcinoma arising in ileal conduit or orthotopic ileal neobladder reconstruction: A 20-year single institute experience.

Carcinomas found in urinary diversion specimens are uncommon, particularly new primary tumours. New primary tumours primarily occur when the large intestine is utilised, whereas the occurrence is infrequent with the use of the ileum. These tumours include both the recurrence of primary malignancy or the development of a new primary malignancy originating from the small intestine. A search was performed within the pathology laboratory system to identify cases of malignancies involving ileal conduit/reconstruction from 2002 to 2022. Data on demographics, clinical details, pathology and management was recorded. A total of 13 male patients, with a mean age of 67 years (range = 49-81 years) were included in the study. The initial procedure performed included cystoprostatectomy (n = 10, including one case with right nephroureterectomy) and cystectomy (n = 3, including one case for bladder exstrophy) for initial diagnoses including urothelial carcinoma (n = 11; conventional, 6; sarcomatoid, 1; glandular 1; plasmacytoid, 1; micropapillary, 2) and adenocarcinoma (n = 1). The initial management included radical surgery with neoadjuvant chemotherapy/immunotherapy (n = 1), adjuvant chemotherapy (n = 3), intravesical adjuvant BCG (n = 2) and intravesical adjuvant chemotherapy (n = 1). Malignancies in ileal conduit or orthotopic ileal neobladder included recurrent urothelial carcinoma (n = 10) and new secondary adenocarcinomas (n = 3), which developed as early as 3 months (usually recurrence) and up to 13, 33 and 45 years (new primary malignancy) following primary resection. Utilising the ileum as conduit/neobladder presents a viable alternative for urinary diversion with a reduced malignancy risk compared to using a segment of the large intestine. However, there remains a potential for malignancy, either tumour recurrence or a new primary malignancy. In our study, tumour recurrence occurred up to 4 years following the initial diagnosis and the development of a new primary malignancy occurred up to 45 years after the initial diagnosis. Consequently, it is crucial to prioritise long-term follow-up for these patients undergoing this procedure.

Empyema Necessitans Following Bacille Calmette-Guérin Administration for Urothelial Carcinoma

Background Bacille Calmette-Guérin wash for urothelial carcinoma is a very common adjuvant treatment with a low potential for serious systemic adverse events. We present a case of a rare serious complication, empyema necessitans, following treatment with BCG. Case Presentation A 77-year-old patient with urothelial cancer treated with adjuvant BCG wash developed empyema due to Mycobacterium bovis related to his previous BCG exposure, which progressed to empyema necessitans treated with antituberculosis medications in conjugant with multiple thoracic drainages. Despite treatment, the patient's condition deteriorated slowly leading to death. Conclusion Rare adverse events of common treatments should be considered when evaluating a patient, as BCG wash could potentially lead to empyema necessitans.

Positive Predictive Values of Procedure Codes on the Treatment of Non-Muscle Invasive Bladder Cancer in the Danish National Patient Registry.

Globally non-muscle invasive bladder cancer (NMIBC) is a high-incidence disease. There is a large heterogeneity within NMIBC regarding recurrence- and progression risks, and large-scale studies of treatment patterns and prognoses in an everyday setting could result in NMIBC-subgroup treatment optimization, benefiting both patients and the economy. The Danish national registries provide such an opportunity if the registered procedure codes are valid. Therefore, the aim of the study was to validate the International Classification of Diseases, 10th Edition (ICD-10) codes of NMIBC treatment used in the Danish National Patient Registry (DNPR). From the DNPR, we randomly selected 200 NMIBC treatment courses identified by the dates of the course and the codes of transurethral resection of the bladder ((TURB), n = 125), photodynamic diagnosis ((PDD), n = 25), bladder instillation with Bacillus Calmette vaccine ((BCG), n = 25), or bladder instillation with chemotherapy/Mitomycin C ((MMC), n = 25). We used medical record reviews as the reference standard and estimated positive predictive values (PPVs) of all procedure codes and negative predictive values (NPVs) of PDD- and the perioperative single-shot MMC codes. We identified the medical records in 150 (75%) of the 200 treatment courses (149 individual patients). The overall PPVs were TURB: 98.9% (95% confidence interval: 93.8; 100.0%), PDD: 95.8% (78.9; 99.9%), adjuvant BCG: 90.0% (68.3; 98.8%), perioperative single-shot MMC 1/5, and adjuvant MMC: 69.2% (38.6; 90.9%). The overall NPVs were PDD: 64.8% (54.4; 73.9%) and perioperative single-shot MMC: 97.7% (92.1; 99.4%). The ICD-10 NMIBC procedure codes recorded in the DNPR are generally valid with high PPVs. The NPV of the PPD code is acceptable. However, the code for perioperative single-shot MMC is uncertain with low PPV, but a high NPV.

Intravesical therapy with the trifunctional anti-EpCAM/CD3 bsAb Catumaxomab is well tolerated and shows encouraging preliminary efficacy in patients with high-risk NMIBC (CATUNIBLA phase I trial).

e16555 Background: Tx of high-risk NMIBC is challenging due to a high risk of recurrence. Novel therapeutic options are highly anticipated to avoid cystectomy and disease progression. Malignant transitional cells express EpCAM. The trifunctional anti-EpCAM/CD3 bsAb Catumaxomab (CAT) mediates cell killing against human BC. This dose escalating Phase I trial (NCT04819399) investigates the safety of intravesical CAT in high-risk NMIBC. Methods: Following first TUR-B, pts with newly diagnosed high-risk NMIBC were enrolled and received 6 x weekly intravesical CAT instillations, each of 2h duration) at a dose of 50 or 70μg. Subsequently, 2nd TUR-B and adjuvant instillation therapy (tx) was performed as SoC. Here, we report the safety and preliminary efficacy of dose cohorts 1 and 2. Results: 7 Pts are included, 5 with pTa, 2 with pT1 disease. There were 5 concomitant pTis. 6/7 pts received the planned 6 x weekly CAT instillations. 1 pt discontinued after 1 instillation due to recurrent UTI. No DLTs occurred. 28 AEs were observed in 6/7 pts, all of gr 1-2 except two unrelated gr 3 AEs . 2/7 pts had an unrelated SAE each (1 hydronephrosis, 1 recurrent fever after BCG). For 6/7 pts cytokines were below LLQ. In one pt of cohort 2 low amounts of IL-6 and IL-8 were detectable. Weak HAMA responses in 5/6 pts transiently occurred at days 29 and 43. CAT instillations led to transient increases of urinary leukocytes. During and after CAT treatment, there was a strong trend towards reduction of EpCAM+ cells in urine. At 2nd TUR-B tumour persistency was observed in two patients only. Remarkably, 3/5 pTis were no longer detected at 2nd TUR-B. So far, 5/7 pts received adjuvant BCG, 2 pts declined. 7/7 pts achieved CR as best response. While 2/3 pts in the 50 μg cohort had a recurrence, no recurrence was observed in the 70 μg cohort. Conclusions: Intravesical instillations with the trifunctional, anti-EpCAM/anti-CD3 bsAb Catumaxomab are well tolerated in pts with high risk NMIBC. CAT does not enter systemic circulation and elicits only low and transient immunogenicity. The MTD is not reached and dose escalation is still ongoing with cohort 3 (100 μg)(updated results will be presented at meeting). The reduction in EpCAM+ urine cells indicates potential activity of this novel immunotherapy and the high CR rate of Tis at the end of CAT therapy is promising. Clinical trial information: NCT04819399. [Table: see text]

PD26-09 PRIMARY TA HIGH GRADE BLADDER TUMORS: DETERMINATION OF THE RISK OF PROGRESSION

You have accessJournal of UrologyCME1 May 2022PD26-09 PRIMARY TA HIGH GRADE BLADDER TUMORS: DETERMINATION OF THE RISK OF PROGRESSION Fahad Quhal, Keiichiro Mori, Ekaterina Laukhtina, Benjamin Pradere, Francesco Soria, Marco Moschini, Alberto Briganti, Pierre I. Karakiewicz, and Shahrokh F. Shariat Fahad QuhalFahad Quhal More articles by this author , Keiichiro MoriKeiichiro Mori More articles by this author , Ekaterina LaukhtinaEkaterina Laukhtina More articles by this author , Benjamin PradereBenjamin Pradere More articles by this author , Francesco SoriaFrancesco Soria More articles by this author , Marco MoschiniMarco Moschini More articles by this author , Alberto BrigantiAlberto Briganti More articles by this author , Pierre I. KarakiewiczPierre I. Karakiewicz More articles by this author , and Shahrokh F. ShariatShahrokh F. Shariat More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002574.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: TaG3 bladder cancer is an under-investigated disease and because of its rarity it is commonly studies together with T1G3 disease. We sought to exclusively study TaG3 disease and to determine the factors associated with disease progression. METHODS: Of 3505 patients with NMIBC, 285 patients had primary TaG3 and with no concomitant carcinoma in-situ. The median follow-up was 43 months; 70% of the patients received adjuvant BCG. RESULTS: Progression to ≥pT1 occurred in 21 patients (7.4%). In a multivariable competing-risk regression analysis, intravesical BCG was significantly associated with a lower risk of progression to ≥pT1 (HR 0.23, 95%CI 0.08-0.64, p=0.005). Recurrence in the first year of diagnosis was significantly associated with an increased risk of stage progression to ≥pT1 (HR 7.81, 95%CI 2.50-24.44, p<0.001). Progression to ≥T2 was observed in 9 patients (3.2%). In univariable competing-risk regression analyses, intravesical BCG was significantly associated with a lower risk of progression to ≥pT2 (HR 0.11, 95%CI 0.04-0.47, p=0.003). On the other hand, recurrence in the first year of diagnosis was significantly associated with an increased risk of stage progression to ≥T2 (HR 7.12, 95%CI 1.50-33.77, p=0.013). In a subgroup of 199 patients who were treated with BCG, there was no statistically significant association between tumor recurrence in the 1st year of diagnosis and stage progression to ≥pT1 (p=0.14) or ≥pT2 (p=0.19). CONCLUSIONS: Patients with TaG3 bladder cancer are considered high risk but if appropriately treated with BCG that risk is considerably mitigated. Our data support that TaG3 without concomitant CIS should not be considered as aggressive as T1G3 as it has a lower risk of progression to muscle-invasive bladder cancer (MIBC). Recurrence in the first year after diagnosis is the strongest predictor of progression to MIBC. Source of Funding: No funding © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e491 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Fahad Quhal More articles by this author Keiichiro Mori More articles by this author Ekaterina Laukhtina More articles by this author Benjamin Pradere More articles by this author Francesco Soria More articles by this author Marco Moschini More articles by this author Alberto Briganti More articles by this author Pierre I. Karakiewicz More articles by this author Shahrokh F. Shariat More articles by this author Expand All Advertisement PDF DownloadLoading ...

A0163 - Compared Efficacy of Adjuvant Intravesical BCG TICE vs. RIVM for High-risk Non-muscle Invasive Bladder Cancer: A Multicenter Propensity Score Matched Analysis

A0163 - Compared Efficacy of Adjuvant Intravesical BCG TICE vs. RIVM for High-risk Non-muscle Invasive Bladder Cancer: A Multicenter Propensity Score Matched Analysis

SC14 - Skeletal muscle loss predicts oncological outcomes in T1HG patients treated with adjuvant intravesical BCG: implications for decision-making?

SC14 - Skeletal muscle loss predicts oncological outcomes in T1HG patients treated with adjuvant intravesical BCG: implications for decision-making?

MP38-19 THE GLEASON PROGNOSTIC PERSPECTIVE APPLIED TO THE pT1 UROTHELIAL CARCINOMA HETEROGENEITY

You have accessJournal of UrologyBladder Cancer: Epidemiology & Evaluation I (MP38)1 Sep 2021MP38-19 THE GLEASON PROGNOSTIC PERSPECTIVE APPLIED TO THE pT1 UROTHELIAL CARCINOMA HETEROGENEITY Gustavo Mendonça, Karen Ferrari, Athanase Billis, and Leonardo Reis Gustavo MendonçaGustavo Mendonça More articles by this author , Karen FerrariKaren Ferrari More articles by this author , Athanase BillisAthanase Billis More articles by this author , and Leonardo ReisLeonardo Reis More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002053.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Current bipolar high/low grade World Health Organization/International Society of Urological Pathology (WHO/ISUP) bladder urothelial carcinoma grading relies on the highest pathologic specimen, not reflecting its inherent heterogeneity. METHODS: We studied 312 consecutive pT1 non-muscle invasive bladder carcinomas (NMIBC) submitted to transurethral resections (TURB) and adjuvant BCG until 2015 to propose and validate a prognostic clustering of a grading system that considers the primary (most common) and secondary (second most common or higher even focal) grades as 1, 2 or 3 according to the 1973 World Health Organization system. A final score was obtained which ranged from 2 (1+1) to 6 (3+3). RESULTS: Recurrence was diagnosed in 115 (36.9%), progression in 83 (26.6%) and cancer-specific death in 50 patients (16%). Mean time to recurrence, progression, and death of disease was 31.7±35.9, 44.5±47.6 and 50.4±51.2 months, respectively. Grade 3 presence (cluster 2+3, 3+2 or 3+3); independently predicted progression, p<0.001, HR 3.11, 95%CI 1.88-5.14; and grade 3 predominance (cluster 3+2 or 3+3); independently predicted death of disease, p<0.001, HR 3.39, 95%CI 1.88-5.10. CONCLUSIONS: Utilizing the established grading system WHO 1973 engenders a significantly better stratification of bladder cancer patients with clinical implication. Grade 3 presence and predominance are independent predictors of progression and death of disease, respectively. Source of Funding: none © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e702-e702 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Gustavo Mendonça More articles by this author Karen Ferrari More articles by this author Athanase Billis More articles by this author Leonardo Reis More articles by this author Expand All Advertisement Loading ...

P0731 - Skeletal muscle loss predicts oncological outcomes in T1HG patients treated with adjuvant intravesical BCG: Implications for decision-making?

P0731 - Skeletal muscle loss predicts oncological outcomes in T1HG patients treated with adjuvant intravesical BCG: Implications for decision-making?

Prospects for the use of the method of intravesical hyperthermic chemotherapy in the treatment of patients with non-muscle invasive bladder cancer

The aim: to compare disease-free survival time (DFS) in high-risk non-muscle-invasive bladder cancer patients treated with adjuvant hyperthermic intravesical chemotherapy and standard BCG therapy.&#x0D; Materials and methods: patients were divided into 2 groups. Group 1 (control) included patients who received adjuvant therapy after TURB with BCG vaccine (BCG therapy group; n=50), group 2 (study group) included patients (HIVEC® therapy group; n=46 ), who received adjuvant intravesical chemotherapy using a Combat BRS HIVEC® device for local hyperthermia.&#x0D; Results: median follow-up was 23 months (range 4 - 36). Tumor recurrence was reported in 19 patients receiving intravesical BCG therapy and in 8 patients receiving intravesical hyperthermic chemotherapy. The incidence of DFS in patients receiving chemohyperthermy was statistically higher than in patients receiving BCG therapy (log-rank test result: p=0.029).&#x0D; Conclusions: The method of hyperthermic intravesical chemotherapy significantly increased the 2-year disease-free survival rate - 82.6 % versus 62 % BCG therapy group (p=0.025). Its use in the future will allow increasing the frequency of organ-preserving treatment of patients with primary and recurrent muscular-non-invasive bladder tumors

Association of patients\u2019 sex with treatment outcomes after intravesical bacillus Calmette\u2013Gu\xe9rin immunotherapy for T1G3/HG bladder cancer

PurposeTo investigate the association of patients’ sex with recurrence and disease progression in patients treated with intravesical bacillus Calmette–Guérin (BCG) for T1G3/HG urinary bladder cancer (UBC).Materials and methodsWe analyzed the data of 2635 patients treated with adjuvant intravesical BCG for T1 UBC between 1984 and 2019. We accounted for missing data using multiple imputations and adjusted for covariate imbalance between males and females using inverse probability weighting (IPW). Crude and IPW-adjusted Cox regression analyses were used to estimate the hazard ratios (HR) with their 95% confidence intervals (CI) for the association of patients’ sex with HG-recurrence and disease progression.ResultsA total of 2170 (82%) males and 465 (18%) females were available for analysis. Overall, 1090 (50%) males and 244 (52%) females experienced recurrence, and 391 (18%) males and 104 (22%) females experienced disease progression. On IPW-adjusted Cox regression analyses, female sex was associated with disease progression (HR 1.25, 95%CI 1.01–1.56, p = 0.04) but not with recurrence (HR 1.06, 95%CI 0.92–1.22, p = 0.41). A total of 1056 patients were treated with adequate BCG. In these patients, on IPW-adjusted Cox regression analyses, patients’ sex was not associated with recurrence (HR 0.99, 95%CI 0.80–1.24, p = 0.96), HG-recurrence (HR 1.00, 95%CI 0.78–1.29, p = 0.99) or disease progression (HR 1.12, 95%CI 0.78–1.60, p = 0.55).ConclusionOur analysis generates the hypothesis of a differential response to BCG between males and females if not adequately treated. Further studies should focus on sex-based differences in innate and adaptive immune system and their association with BCG response.

A Chimera of Th1 Stimulatory Proteins of Leishmania donovani Offers Moderate Immunotherapeutic Efficacy with a Th1-Inclined Immune Response against Visceral Leishmaniasis.

Immunotherapy, a treatment based on host immune system activation, has been shown to provide a substitute for marginally effective conventional chemotherapy in controlling visceral leishmaniasis (VL), the deadliest form of leishmaniasis. As the majority of endemic inhabitants exhibit either subclinical or asymptomatic infection which often develops into the active disease state, therapeutic intervention seems to be an important avenue for combating infections by stimulating the natural defense system of infected individuals. With this perspective, the present study focuses on two immunodominant Leishmania (L.) donovani antigens (triosephosphate isomerase and enolase) previously proved to be potent prophylactic VL vaccine candidates, for generating a recombinant chimeric antigen. This is based on the premise that in a heterogeneous population, a multivalent antigen vaccine would be required for an effective response against leishmaniasis (a complex parasitic disease). The resulting molecule rLdT-E chimeric protein was evaluated for its immunogenicity and immunotherapeutic efficacy. A Th1 stimulating adjuvant BCG was employed with the protein which showed a remarkable 70% inhibition of splenic parasitic multiplication positively correlated with boosted Th1 dominant immune response against lethal L. donovani challenge in hamsters as evidenced by high IFN-γ and TNF-α and low IL-10. In addition, immunological analysis of antibody subclass presented IgG2-based humoral response besides considerable delayed-type hypersensitivity and lymphocyte proliferative responses in rLdT-E/BCG-treated animals. Our observations indicate the potential of the chimera towards its candidature for an effective vaccine against Leishmania donovani infection.

Adjuvant intravesical chemotherapy with titanium glycerosolvate aquacomplex versus BCG therapy in patients with high risk nonmuscle-invasive bladder cancer

Objective: to compare recurrence rate, progression rate and recurrence-free survival in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after adjuvant intravesical chemotherapy (IVCT) with titanium glycerosolvate aquacomplex (TGA) versus intravesical BCG therapy.Material and methods. In a retrospective multicenter clinical study initially were included 126 patients with NMIBC. Of all 126 patients, 94 patients with high-risk NMIBC were selected and divided into 2 groups using a pseudo randomization with propensity score matching to minimize systematic differences in the process of forming groups. The treatment group (n = 55) consisted of patients with high-risk NMIBC who received a 6-week course of adjuvant IVCT with TGA. In the control group (n = 39) patients received an induction 6-week course of adjuvant intravesical BCG therapy, 19 (49 %) of 39 patients received maintenance therapy. Both methods were compared according to recurrence rate, progression rate and recurrence-free survival. Significance of difference was set at p &lt;0.05.Results. The compared groups of patients were well balanced in terms of clinical and morphological characteristics and the main risk factors for recurrence and progression of non-muscle-invasive bladder cancer, no significant differences were found between the groups (p &gt;0.5). The recurrence rate in treatment and control groups was 33 % and 23 %, respectively (p = 0.31). The disease progression was observed in 1 (2 %) patient in the treatment group and in 4 (13 %) patients in the control group (p = 0.08). The median disease-free survival in both groups of patients was not reached at the time of analysis. Three- and five-year recurrence-free survival in the treatment group of patients were 71 % and 62 %, respectively; in the control group — 76 % and 72 %, respectively. There were no significant differences between recurrence-free-survival curves of the treatment and control groups (p = 0.58).Conclusion. Adjuvant IVCT with TGA has demonstrated a clinical effectiveness comparable to intravesical BCG therapy and it can be used as an alternative method of treatment in patients with high-risk NMIBC.

ROLE OF AGE, GENDER, AND TOBACCO IN CAUSING BLADDER CANCER AND PATHOLOGICAL STUDY OF BLADDER CANCER IN KPK.

Objective:&#x0D; To determine assocation of age, gender &amp; tabbaco in causing bladder carcinoma and its causative factors. &#x0D; Materials and Methods:&#x0D; This was a retrospective audit on individuals suffering from bladder carcinoma. All the enrolled individuals in our research study were diagnosed and treated in our set up under strict criteria.&#x0D; Results:&#x0D; Total 156 affected individuals suffering from bladder cancer were diagnosed and treated in our setup. Out of 156 patients, 111 were characterized by isolated painless total hematuria. Bladder carcinoma is associated with age so in 70 patients (age &gt; 60 year) were characterized by high grade cancer with a p = 0.04, while the remaining patients (age &lt;60 years), were characterized by both high and low-grade cancers. The risk of tumor relapse is considerably less in those individuals who take adjuvant BCG therapy or mitomycin C therapy, and the difference between the two groups is statistically significant, with a P &lt; 0.0001.&#x0D; Conclusion:&#x0D; The incidence rate of bladder carcinoma is increasing. Tobacco is one of the most common causative factors for bladder carcinoma in kpk.

946 - Skeletal muscle loss predicts oncological outcomes in T1HG patients treated with adjuvant intravesical BCG: Implications for decision-making?

946 - Skeletal muscle loss predicts oncological outcomes in T1HG patients treated with adjuvant intravesical BCG: Implications for decision-making?

Selected protein expression in a new prognostic model for patients with non-muscle-invasive bladder cancer

IntroductionAfter transurethral resection of a bladder tumor, patients frequently have a recurrence of the disease, thereby requiring adjuvant therapy.PurposeThe study aimed to determine the prognostic value of expression levels of p53, Ki-67, and survivin, and to develop a new prognostic model for patients with non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of a bladder tumor.MethodsThe study group consisted of 101 patients with primary NMIBC. Univariate followed by multivariate Cox proportional hazard regression analysis was performed to obtain a model including the smallest possible number of descriptive variables with the highest statistical significance and impact on risk.ResultsThe RECINT model (RECurrence In Not Treated) including factors independently associated with cancer recurrence (tumor size [HR 1.148; p = 0.034], intensity of the color reaction for p53 [HR 1.716; p = 0.008], Ki-67 [HR 3.001; p = 0.022], and survivin [HR 1.461; p = 0.021]) adequately stratified recurrence free-survival (R2 = 0.341, p < 0.001) in patients with primary NMIBC. Patients with the lowest RECINT score (0–6) had the lowest probability of cancer recurrence (1- and 5-year recurrence of 16%) in comparison with other groups (p < 0.001).ConclusionsThe RECINT model may be useful for stratifying the risk of recurrence in patients with non-muscle-invasive bladder cancer and may allow for identification of those who may benefit the most from adjuvant BCG immunotherapy.

Intensity of Nuclear Staining for Ki-67, p53 and Survivin as a New Prognostic Factor in Non-muscle Invasive Bladder Cancer

The aim of the study was to determine the prognostic value of expression levels of biomarkers selected on the basis of the literature: p53, Ki-67, survivin, β-catenin, E-cadherin and N-cadherin in patients with non-muscle invasive bladder cancer. Immunohistochemistry was performed on sections of primary papillary carcinoma of the bladder removed during transurethral resection of the tumor in 134 patients. The expression of β-catenin and E-cadherin was found in all analyzed cases and N-cadherin expression was demonstrated in 3.73% of the tissues examined. The expression of the p53 protein was confirmed in 96.27% of tissues examined. The expression of the Ki-67 protein was demonstrated in all analyzed cases. Survivin expression was found in 95.52% of the study group. Multivariate analysis confirmed the relationship between the recurrence-free survival (RFS) and the intensity of the nuclear reaction for p53 (HR 1417, 95% CI 1.001–2.007, p = 0.049) and survivin (HR 1.451; 95% CI 1.078–1.955; p = 0.014), the expression level of the Ki-67 protein expressed by the TS index (HR 1.146, 95% CI 1.116–1.823, p = 0.005) and the use of adjuvant BCG therapy (HR 0.218, 95% CI 0.097–0.489, p = 0.0002). The evaluation of Ki-67 expression and the intensity of nuclear staining for survivin and p53 may provide additional information that will allow more accurate stratification of the risk of NMIBC recurrence after TURBT.