MP56-17 ADJUVANT CANCER PEPTIDE VACCINE TREATMENT WITH INTRAVESICAL BCG THERAPY FOR NON-MUSCLE INVASIVE BLADDER CANCER

2014 ◽  
Vol 191 (4S) ◽  
Author(s):  
Wataru Obara ◽  
Isao Hara ◽  
Tsuneharu Miki ◽  
Hiromitsu Mimata ◽  
Taro Shuin ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Peptide Vaccine ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Vaccine Treatment ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Muscle Invasive ◽  
Intravesical Bcg Therapy

Adjuvant cancer peptide vaccine treatment with intravesical BCG therapy for non-muscle-invasive bladder cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15587-e15587
Author(s):  
Wataru Obara
Keyword(s):  
Clinical Trial ◽  
Bladder Cancer ◽  
Peptide Vaccine ◽  
Muscle Invasive Bladder Cancer ◽  
Ctl Response ◽  
Vaccine Treatment ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Muscle Invasive ◽  
Intravesical Bcg Therapy

e15587 Background: We previously reported safety and high immunogenicity of peptide vaccine treatment using two novel peptides derived from oncoantigens, M phase phosphoprotein 1 (MPHOSPH1) and DEP domain containing 1 (DEPDC1), for patients with advanced bladder cancer. We further conducted a multi-center phase II clinical trial using the same peptides to investigate the effectiveness to prevent recurrence after TURBt for patients with non-muscle invasive bladder cancer (NMIBC). Methods: The key eligibility criteria were patients with intermediate or high risk for NMIBC, with tumors having expression of MPHOSPH1 and/or DEPDC1, and with HLA class I expression on tumor cells. HLA-A24-restricted MPH and/or DEP derived peptide were subcutaneously administered in combination with intravesical BCG therapy after TUR-Bt. All enrolled patients had received the vaccination without knowing HLA-A status, and the HLA genotypes were used for a key-open marker. The primary endpoint was to examine effect on recurrence free survival (RFS) and secondary endpoint was induction of peptide-specific CTL response, injection site of reaction (ISR) and adverse effect. Results: A total of 133 patients were enrolled. RFS rates at 2 years in all patients were 74.4 %. Although the difference in RFS between the A24(+) and A24(-) groups (77.2% vs. 70.4%) was not statistically significant (p=0.24), that in the ISR-positive group was significantly better than that in the ISR-negative group (81.6% vs. 54.3%, p=0.0004). The peptide vaccine treatment was well-tolerated without any treatment- associated severe adverse events, while the bladder irritability caused by BCG treatment was observed in 64 cases (48.1%). The MPHOSPH1 and DEPDC1 peptide-specific CTL responses in the 24(+) group were observed in 82 % and 83 % of patients, respectively. Four (7.4%) cases in the 24(-) group revealed the peptide-specific CTL response, indicating some cross-reactivity against the vaccinated peptides on other HLA allele(s). Conclusions: Combination immunotherapy of intravesical BCG and cancer peptide vaccine demonstrated the promising clinical effect on recurrence prevention for NMIBC as well as good immunogenicity and safety. Clinical trial information: 00633204.

Is there a role for urine cytology following BCG therapy for non-muscle-invasive bladder cancer (NMIBC)?

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 404-404
Author(s):  
Sarah Prattley ◽  
Ruth Jarvis ◽  
Jon Featherstone ◽  
Krishna Narahari ◽  
Murali Varma ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Urine Cytology ◽  
Invasive Bladder Cancer ◽  
Positive Cytology ◽  
Muscle Invasive Bladder Cancer ◽  
Flexible Cystoscopy ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Muscle Invasive ◽  
Intravesical Bcg Therapy

404 Background: Voided urine cytology has been used as an adjunct in the diagnosis of non-muscle invasive bladder cancer (NMIBC), with a sensitivity and specificity ranging between 13-75% and 76-100% respectively. There is limited data on the accuracy and utility of cytology following BCG therapy. We reviewed the results of cytology in patients undergoing induction and maintenance BCG immunotherapy in our institution. Methods: Newly diagnosed patients who had received induction and maintenance intravesical BCG therapy from 2004 - 2019 were identified from a prospective database and their outcomes reviewed retrospectively. Histopathology results of biopsies / resected specimens and voided urine cytology results were examined for 273 patients. Results: A total of 2567 cytology results and 638 biopsy results were recorded. The average age was 73.2 years and median number of BCG treatments was four (induction followed by three maintenance courses). Median follow up was 38 months. 94 patients (34.4%) had recurrence following BCG therapy. Of those 33 patients (12.1%) had progression to muscle invasive disease. The number of cytology samples per patient after BCG therapy ranged from 1-23 (median 7), with several patients having repeated, potentially unnecessary negative urine cytology. Overall accuracy of cytology (n = 526) was sensitivity 44.2%, specificity 84.7%, PPV 38.9%, NPV 87.3%. Patients that had an erythematous bladder or red patch at flexible cystoscopy underwent subgroup analysis; this gave a very high NPV of 95.9%, with additional sensitivity being 65.5%, specificity 85.9% and PPV 33.3%. Number of positive cytology results (Chi2 = 44.30, P = 0.002), any positive cytology (Chi2 = 27.94, P < 0.001) and positive cytology after induction BCG therapy (Chi2 = 30.381, P < 0.001) were all strongly associated with recurrence. Conclusions: Positive urine cytology in patients undergoing intravesical BCG therapy predicts increased risk of recurrence and has good specificity. We would recommend using voided urine cytology in patients who have an erythematous bladder or red patch at flexible cystoscopy. If the cytology is positive then proceed to biopsy, however, if it is negative continue with surveillance. [Table: see text]

Intravesical BCG therapy for non-muscle-invasive bladder cancer: Effect of concurrent statin therapy

2008 ◽  
Vol 207 (3) ◽  
pp. S110-S111
Author(s):  
Ted A. Skolarus ◽  
Eugene Lee ◽  
Adam S. Kibel ◽  
M'Liss A. Hudson ◽  
Katherine S. Virgo ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Statin Therapy ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Muscle Invasive ◽  
Intravesical Bcg Therapy

scholarly journals Rapamycin enhances BCG-specific γδ T cells during intravesical BCG therapy for non-muscle invasive bladder cancer: a randomized, double-blind study

2021 ◽  
Vol 9 (3) ◽  
pp. e001941
Author(s):  
Niannian Ji ◽  
Neelam Mukherjee ◽  
Ryan M Reyes ◽  
Jonathan Gelfond ◽  
Martin Javors ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
T Cells ◽  
Γδ T Cells ◽  
Percentage Change ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Double Blind ◽  
Bcg Therapy ◽  
Intravesical Bcg ◽  
Muscle Invasive

BackgroundAlthough intravesical BCG is the standard treatment of high-grade non-muscle invasive bladder cancer (NMIBC), response rates remain unsatisfactory. In preclinical models, rapamycin enhances BCG vaccine efficacy against tuberculosis and the killing capacity of γδ T cells, which are critical for BCG’s antitumor effects. Here, we monitored immunity, safety, and tolerability of rapamycin combined with BCG in patients with NMIBC.MethodsA randomized double-blind trial of oral rapamycin (0.5 or 2.0 mg daily) versus placebo for 1 month was conducted in patients with NMIBC concurrently receiving 3 weekly BCG instillations (NCT02753309). The primary outcome was induction of BCG-specific γδ T cells, measured as a percentage change from baseline. Post-BCG urinary cytokines and immune cells were examined as surrogates for local immune response in the bladder. Secondary outcomes measured were adverse events (AEs) and tolerability using validated patient-reported questionnaires.ResultsThirty-one patients were randomized (11 placebo, 8 rapamycin 2.0 mg, and 12 rapamycin 0.5 mg). AEs were similar across groups and most were grade 1–2. One (12.5%) patient randomized to 2.0 mg rapamycin was taken off treatment due to stomatitis. No significant differences in urinary symptoms, bowel function, or bother were observed between groups. The median (IQR) percentage change in BCG-specific γδ T cells from baseline per group was as follows: −26% (−51% to 24%) for placebo, 9.6% (−59% to 117%) for rapamycin 0.5 mg (versus placebo, p=0.18), and 78.8% (−31% to 115%) for rapamycin 2.0 mg (versus placebo, p=0.03). BCG-induced cytokines showed a progressive increase in IL-8 (p=0.02) and TNF-α (p=0.04) over time for patients on rapamycin 2.0 mg, whereas patients receiving placebo had no significant change in urinary cytokines. Compared with placebo, patients receiving 2.0 mg rapamycin had increased urinary γδ T cells at the first week of BCG (p=0.02).ConclusionsFour weeks of 0.5 and 2.0 mg oral rapamycin daily is safe and tolerable in combination with BCG for patients with NMIBC. Rapamycin enhances BCG-specific γδ T cell immunity and boosts urinary cytokines during BCG treatment. Further study is needed to determine long-term rapamycin safety, tolerability and effects on BCG efficacy.

scholarly journals THE EFFECT OF TREATMENT ON CYTOKINE LEVELS IN NON MUSCLE INVASIVE BLADDER CANCER

2020 ◽  
Author(s):  
Oktay Ucer ◽  
Gokhan Temeltas ◽  
Talha Muezzinoglu ◽  
Zeki Ari ◽  
Funda Kosova
Keyword(s):  
Bladder Cancer ◽  
Invasive Bladder Cancer ◽  
Control Group ◽  
Muscle Invasive Bladder Cancer ◽  
Bcg Therapy ◽  
Cytokine Levels ◽  
Intravesical Bcg ◽  
Effect Of Treatment ◽  
The Mean ◽  
Muscle Invasive

Objectives The aim of the present study was to investigate the effect of treatment on IL-1, IL-6, IL-8 and neopterin levels in patients with non-muscle invasive bladder cancer (NMIBC). Methods Thirty patients with NMIBC and 30 age-matched controls were included in the study. Preoperative, postoperative first control (at two weeks after second transurethral resection of bladder tumor (TURBT)) and second control (at the end of intravesical immunotherapy) blood samples were analyzed by ELISA to determine IL-1, IL-6, IL-8 and neopterin levels. The mean cytokine levels of the patients were statistically compared as well as comparing the patients’ and controls’ levels. Results There were no statistically significant differences between the mean IL-1, IL-6, IL-8 and neopterin levels of the patient and control group before initial TURBT. In the patient group, there were no statistically significant differences in the IL-6 and IL-8 levels after both TURBT and intravesical BCG therapy. The mean of preoperative IL-1 and neopterin levels significantly decrease after TURBT (p<0.05=). However this reduction do not continue after intravesical BCG instillations. Conclusions The finding of this study showed that the IL-1, IL-6, IL-8 and neopterin levels of the patients with NMIBC were similar to the levels of healthy controls. The IL-1 and neopterin levels significantly decreased after TURBT. But this reductions did not continue after intravesical BCG instillation. These findings demonstrate that IL-1 and neopterin levels decrease after TURBT due to the reduction of tumor weight or tumor removal.

scholarly journals Renal Granulomatosis Post Intravesical Bacillus Calmette–Guerin Therapy for Non-muscle-invasive Bladder Cancer

2018 ◽  
Vol 8 ◽  
pp. 18
Author(s):  
Karen Tran-Harding ◽  
Rashmi T Nair ◽  
Halemane Ganesh
Keyword(s):  
Bladder Cancer ◽  
Invasive Bladder Cancer ◽  
Bacillus Calmette Guerin ◽  
Muscle Invasive Bladder Cancer ◽  
Contrast Enhanced ◽  
Bcg Therapy ◽  
Muscle Invasive ◽  
Intravesical Bcg Therapy ◽  
Enhanced Computed Tomography ◽  
Contrast Enhanced Computed Tomography

Intravesical Bacillus Calmette–Guerin (BCG) immunotherapy is a proven, effective treatment for intermediate- and high-risk non-muscle-invasive bladder cancer. Minor side effects are common and expected but systemic effects can occur in <5% of treated patients. We present a rare case of a 49-year-old male that presented with fever and chills after 3 weeks of intravesical BCG therapy post transurethral resection of bladder tumor. New renal lesions were present on contrast-enhanced computed tomography scan which was histologically proven to be necrotizing renal granulomatosis.

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