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

2020 ◽  
Vol 16 (3) ◽  
pp. 126-134
Author(s):  
A. V. Zamyatin ◽  
V. O. Mager ◽  
A. S. Orlov ◽  
K. A. Il'in ◽  
S. E. Zavatskiy ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Treatment Group ◽  
High Risk ◽  
Recurrence Rate ◽  
Control Group ◽  
Recurrence Free Survival ◽  
Free Survival ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Intravesical Bcg Therapy

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 <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 >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.

A phase II, randomized study of nivolumab (nivo) or nivo plus BMS-986205 with or without intravesical Bacillus Calmette-Guerin (BCG) in BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC): CheckMate 9UT.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. TPS493-TPS493 ◽  
Author(s):  
Noah M. Hahn ◽  
Sam S. Chang ◽  
Maxwell Meng ◽  
Neal D. Shore ◽  
Badrinath R. Konety ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Locally Advanced ◽  
Unmet Need ◽  
Clinical Activity ◽  
Free Survival ◽  
Bcg Therapy ◽  
Intravesical Bcg

TPS493 Background: Immune checkpoint inhibitors, including nivo (anti–PD-1), have demonstrated favorable tolerability and efficacy profiles, ushering in a new treatment (tx) paradigm for advanced bladder cancer (advBC). However, an unmet need exists for new effective tx options in earlier stages of disease, specifically for patients (pts) with BCG-unresponsive, high-risk NMIBC. Increased IDO and PD-L1 expression in NMIBC tumors (Inman, et al. Cancer 2007; Hudolin, et al. Anticancer Res 2017), support the combination of anti–PD-1 and IDO1 inhibition in NMIBC. BMS-986205, a selective, potent, once-daily IDO1 inhibitor that works early in the IDO1 pathway, has demonstrated clinical activity in combination with nivo in pts with immunotherapy-naive advBC who received ≥ 1 prior line of therapy (objective response rate, 37%; Tabernero, et al. J Clin Oncol 2018;36(suppl) [abstr 4512]). These findings provide a rationale for investigation of nivo + BMS-986205 ± intravesical BCG therapy in BCG-unresponsive high-risk NMIBC. Here we describe a phase 2, randomized, open-label study assessing the safety and efficacy of nivo ± BMS-986205 ± intravesical BCG in pts with BCG-unresponsive, high-risk NMIBC. Methods: Pts aged ≥ 18 years with BCG-unresponsive (per February 2018 FDA guidance), high-risk NMIBC, defined as carcinoma-in-situ (CIS) with or without papillary component, any T1, or Ta high-grade lesions, will be enrolled. Pts must have urothelial carcinoma as the predominant histological component (>50%). Key exclusion criteria include locally advanced or metastatic BC, upper urinary tract disease within 2 years, prostatic urethral disease within 1 year, and prior immunotherapy. Using a novel adaptive-type design, pts will be randomized to 1 of 4 tx arms with nivo ± BMS-986205 ± BCG. Primary endpoints include proportion of pts with CIS with complete response (CR), duration of CR in pts with CIS, and event-free survival for all pts without CIS. Secondary endpoints are progression-free survival and safety. This global study in 13 countries is underway, with a target enrollment of 436 pts. ( Clinical trial information: NCT03519256.

scholarly journals A retrospective analysis of patients treated with intravesical BCG for high-risk nonmuscle invasive bladder cancer

2019 ◽  
Vol 11 ◽  
pp. 175628721983305 ◽  
Author(s):  
Julie Mariam Joshua ◽  
Meenu Vijayan ◽  
Ginil Kumar Pooleri
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Disease Free Survival ◽  
Invasive Bladder Cancer ◽  
Progression Rate ◽  
Therapeutic Effects ◽  
Free Survival ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Nonmuscle Invasive Bladder Cancer

Background: Adjuvant intravesical immunotherapy with Bacillus Calmette–Guerin (BCG) is considered as the first-line agent in patients with high-risk nonmuscle invasive bladder cancer (NMIBC) after surgery. There are no data in India where there is a high prevalence of tubercle bacillus and inherent immunity against Bacillus sp. The present study aims to evaluate the outcomes of intravesical BCG in the Indian population. Methods: A retrospective study of 101 patients who underwent intravesical BCG for high-risk NMIBC between January 2006 and December 2015 was carried out in a single centre. We compared the recurrence-free rate and progression rate of patients who received induction alone and induction with maintenance BCG therapy. The safety profile of intravesical BCG therapy was also assessed in the study. Results: After a median follow up of 2 years, the disease-free survival (DFS) rates of the induction group and maintenance group were 82% and 88% respectively ( p = 0.233). There was no difference in progression-free survival (PFS) rates at 2 years in those who receive maintenance BCG (95%) and those with induction BCG (94.7%; p = 0.721). A total of 69.36% of our patients had local adverse events. Conclusion: Our results suggest that maintenance therapy does not enhance the therapeutic effects of BCG in patients who respond favourably to 6 weeks of induction. Additional prospective studies are warranted in those countries where tuberculosis exposure is prevalent.

scholarly journals Association Between Antibiotic Treatment and the Efficacy of Intravesical BCG Therapy in Patients With High-Risk Non-Muscle Invasive Bladder Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Sahyun Pak ◽  
Sun-Young Kim ◽  
Sung Han Kim ◽  
Jae Young Joung ◽  
Weon Seo Park ◽  
...  
Keyword(s):  
High Risk ◽  
Antibiotic Therapy ◽  
Antibiotic Treatment ◽  
Progression Free Survival ◽  
Free Survival ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Muscle Invasive ◽  
Long Course ◽  
Intravesical Bcg Therapy

ObjectiveTo investigate the association between antibiotic therapy and the efficacy of intravesical BCG therapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC).MethodsThis study involved the retrospective review of medical records of patients who underwent transurethral resection of bladder tumors for high-risk NMIBC followed by intravesical BCG therapy between 2008 and 2017. Patients were categorized as none, short- (2-6 days), and long-course use (≥7 days) based on the duration of antibiotic treatment concurrent with or initiated ≤30 days before BCG therapy. Oncologic outcomes, including recurrence-free survival and progression-free survival, were analyzed.ResultsOf the 276 patients enrolled in the study, 162 (58.7%) had pathologic T1 disease and 206 (80.2%) had high-grade disease. Concurrently with or prior to BCG therapy, 114 patients had (41.3%) received short-course antibiotic therapy, and 96 (34.8%) patients had received long-course antibiotics. The 5-year recurrence-free survival (62.2% vs 26.9%; log rank, p &lt;0.001) and progression-free survival (79.6% vs. 53.3%; log rank, p=0.001) rates were significantly higher in patients who did not receive antibiotic therapy than in those treated with long-course antibiotics. Multivariable analysis revealed that antibiotic treatment for more than 7 days was independently associated with increased risks of recurrence (hazard ratio [HR], 2.45; 95% confidence interval [CI], 1.49-4.05; p &lt; 0.001) and progression (HR, 3.68; 95% CI, 1.65-8.22 p = 0.001).ConclusionLong-course antibiotic treatment concurrently with or prior to intravesical BCG adversely influenced disease recurrence and progression outcomes in patients with high-risk NMIBC. Careful use of antibiotics may be required to enhance the efficacy of intravesical BCG therapy. Further mechanistic and prospective studies are warranted.

scholarly journals Complications of intravesical BCG therapy in non-muscle invasive bladder cancer: our tertiary care centre experience

2020 ◽  
Vol 26 (1) ◽  
Author(s):  
Vivek Sharma ◽  
Avinash P. S. Thakur ◽  
Vasantharaja Ramasamy ◽  
Pushpendra Kumar Shukla ◽  
Fanindra Singh Solanki ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Adverse Effects ◽  
Bladder Carcinoma ◽  
Bladder Tumour ◽  
The Body ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Urothelial Bladder ◽  
Muscle Invasive ◽  
Intravesical Bcg Therapy

Abstract Background Urothelial bladder carcinoma accounts for around 3.9% cases of all the male cancers in India. Non-muscle-invasive bladder carcinoma (NMIBC) is predominant group which constitute approximately three fourth of the urothelial bladder cancer. Intravesical BCG immunotherapy is the corner stone of today’s NMIBC management. However, as with any other therapy it has its own complications and its interruption due to these adverse effects is a major cause of suboptimal efficacy. The aim of this study was to assess the complications of intravesical BCG therapy and their management in NMIBC patients. Methods This was a retrospective descriptive study conducted between October 2016 and November 2019; a backward review of 149 patients with diagnosis of NMIBC that undergone intravesicle BCG therapy was performed. Patient’s demographical, clinical, diagnostic and procedural data regarding bladder tumour, BCG therapy, its complications and management were collected and analysed. Results Total 149 patients were analysed, comprising 116 males and 33 females. The mean age was of 57.2 ± 6.7 years. Total 85.23% were primary and 14.76% were recurrent tumours. Total 96 patients (64.42%) completed the planned course, while 53 (35.57%) interrupted. The reasons for BCG interruption includes adverse effects (15.4%), progression of disease (6.7%), disease refractory to BCG (4.6%) and disease recurrence during BCG (3.3%). Most of the adverse events occurred in first 6 months and most interruptions occurred after the induction period. Cystitis was the most common observed adverse effect seen in 39.6% patients. Frequency, urgency, haematuria were common presentation. Radical cystectomy was the most common (16.10%) further treatment with patients whose treatment was interrupted. Conclusion BCG is an indispensable therapy available for NMIBC, but it is associated with array of adverse effects and complications, which are the main reasons for poor compliance to BCG therapy. Although BCG-related complications can affect any organ in the body, potentially life-threatening systemic BCG-related infections are encountered in only < 5% of patients. There are some difficulties in diagnosis of the BCG complications because acid-fast staining, culture and PCR test are not always positive; tissue biopsies should be indicated sometimes to evaluate histopathology and presence of M. bovis. A persistently monitored multidisciplinary approach with high index of suspicion and prompt anti-TB therapy can help to derive the maximum benefits while keeping the complications at check.

scholarly journals Management of hepatic granulomatous tuberculosis complicating intravesical BCG for superficial bladder cancer

2012 ◽  
Vol 1 (3) ◽  
Author(s):  
Vincent Fradet ◽  
Christiane Gaudreau ◽  
Paul Perrotte ◽  
Jean Côté ◽  
Jean-Marie Paquin
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Mycobacterium Bovis ◽  
Superficial Bladder Cancer ◽  
Granulomatous Hepatitis ◽  
Bacille Calmette Guerin ◽  
Systemic Complications ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Management Alternatives

Intravesical bacille Calmette-Guérin (BCG) therapy is the most effective treatmentfor high-risk superficial bladder cancer. Severe systemic complications are rare, but may occur in approximately 1% of cases. We report a severe complicationof intravesical BCG: a disseminated Mycobacterium bovis infectionwith biopsy-proven granulomatous hepatitis in a patient with bladder cancer. We also elaborate on the different management alternatives.

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