Race, ethnicity, and gender reporting in North American clinical trials for BCG-unresponsive non-muscle invasive bladder cancer

2021 ◽  
Author(s):  
Sean A. Fletcher ◽  
Trinity J. Bivalacqua ◽  
Otis W. Brawley ◽  
Max Kates
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
North American ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Race Ethnicity ◽  
And Gender ◽  
Muscle Invasive ◽  
Ethnicity And Gender

scholarly journals Neoadjuvant Immunotherapy for Muscle-Invasive Bladder Cancer

Medicina ◽  
2021 ◽  
Vol 57 (8) ◽  
pp. 769
Author(s):  
Arthur Peyrottes ◽  
Idir Ouzaid ◽  
Gianluigi Califano ◽  
Jean-Francois Hermieu ◽  
Evanguelos Xylinas
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitor ◽  
Response Rate ◽  
Checkpoint Inhibitor ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Neoadjuvant Immunotherapy ◽  
Muscle Invasive

Background and Objectives: Facing neoadjuvant chemotherapy followed by surgery, neoadjuvant immunotherapy is an innovative concept in localized muscle-invasive bladder cancer. Herein, we performed a review of the available and ongoing evidence supporting immune checkpoint inhibitor (ICI) administration in the early stages of bladder cancer treatment. Materials and Methods: A literature search was performed on Medline and clinical trials databases, using the terms: “bladder cancer” OR “urothelial carcinoma”, AND “neoadjuvant immunotherapy” OR “preoperative immunotherapy”. We restricted our investigations to prospective clinical trials evaluating anti-PD-(L)1 and anti-CTLA-4 monoclonal antibodies. Data on efficacy, toxicity and potential biomarkers of response were retrieved. Results: The search identified 6 ICIs that were tested in the neoadjuvant setting for localized bladder cancer—4 anti-PD-(L)1 inhibitors (Pembrolizumab, Atezolizumab, Nivolumab and Durvalumab) and 2 anti-CTLA-4 inhibitors (Ipilimumab and Tremelimumab). Most of the existing literature was based on single-arm phase 2 clinical trials that included from 23 to 143 patients. The pathological complete response rate (pCR) and pathological response rate (pRR) ranged from 31% to 46% and from 55.9% to 66%, respectively. Survival data were immature at this time. The safety profile was acceptable, with severe treatment-related adverse events ranging from 6% to 41%. Conclusions: The results of early phase trials are encouraging, and more investigations are needed to strengthen the rationale for immune checkpoint inhibitor administration in localized muscle-invasive bladder cancer.

scholarly journals Biomarkers in Bladder Cancer Surveillance

2021 ◽  
Vol 8 ◽  
Author(s):  
Sukumar S. Sugeeta ◽  
Anand Sharma ◽  
Kenrick Ng ◽  
Arvind Nayak ◽  
Nikhil Vasdev
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Prospective Studies ◽  
Urine Cytology ◽  
Cancer Surveillance ◽  
Invasive Bladder Cancer ◽  
Low Grade ◽  
Protein Biomarkers ◽  
Muscle Invasive Bladder Cancer ◽  
Muscle Invasive

Aim: This is a narrative review with an aim to summarise and describe urinary biomarkers in the surveillance of non-muscle-invasive bladder cancer (NMIBC). It provides a summary of FDA-approved protein biomarkers along with emerging ones which utilise genetic, epigenetic and exosomal markers. We discuss the current limitations of the available assays.Background: Current guidelines advice a combination of cystoscopy, imaging,and urine cytology in diagnosis and surveillance. Although cytology has a high specificity, it is limited by low sensitivity particularly in low grade tumours. There are six FDA-approved urinary assays for diagnosis and surveillance of bladder cancer. They have shown to improve sensitivity and specificity to be used alongside cytology and cystoscopy but have a lower specificity in comparison to cytology and false positives often occur in benign conditions. Recent developments in laboratory techniques has allowed for use of markers which are RNA-, DNA-based as well as extracellular vesicles in the past decade.Methods: Using the PubMed/Medline search engines as well as Google Scholar, we performed an online search using the terms “bladder cancer,” “non-muscle invasive bladder cancer,” and “urine biomarkers” with filter for articles in English published up to May 2021. Systematic reviews and original data of clinical trials or observational studies which contributed to the development of the biomarkers were collated.Results: Biomarkers identified were divided into FDA-approved molecular biomarkers, protein biomarkers and gene-related biomarker with a table summarising the findings of each marker with the most relevant studies. The studies conducted were mainly retrospective. Due to the early stages of development, only a few prospective studies have been done for more recently developed biomarkers and limited meta-analyses are available.Therefore a detailed evaluation of these markers are still required to decide on their clinical use.Conclusion: Advancements of analytical methods in BC has driven the research towards non-invasive liquid-based biomarkers in adjunct to urine cytology. Further large prospective studies are required to determine its feasibility in a clinical setting as they are not effective when used in isolation as they have their limitation. With the ongoing pandemic, other than reduction in costs and increased accuracy, the need for biomarkers to cope with delay in cystoscopies in diagnosis and surveillance is crucial. Thus clinical trials with direct comparison is required to improve patient care.

Bladder preservation therapy for muscle invasive bladder cancer: the past, present and future

2020 ◽  
Vol 50 (10) ◽  
pp. 1097-1107
Author(s):  
Tomokazu Kimura ◽  
Hitoshi Ishikawa ◽  
Takahiro Kojima ◽  
Shuya Kandori ◽  
Takashi Kawahara ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Bladder Preservation ◽  
The Past ◽  
Muscle Invasive

Abstract Radical cystectomy is the gold standard treatment for muscle invasive bladder cancer, but some patients have medically inoperable disease or refuse cystectomy to preserve their bladder function. Bladder preservation therapy with transurethral resection of the bladder tumor and concurrent chemoradiotherapy, known as trimodal treatment, is regarded to be a curative-intent alternative to radical cystectomy for patients with muscle invasive bladder cancer during the past decade. After the development of immune checkpoint inhibitors, a world-changing breakthrough occurred in the field of metastatic urothelial carcinoma and many clinical trials have been conducted against non-muscle invasive bladder cancer. Interestingly, preclinical and clinical studies against other malignancies have shown that immune checkpoint inhibitors interact with the radiation-induced immune reaction. As half of the patients with muscle invasive bladder cancer are elderly, and some have renal dysfunction, not only as comorbidity but also because of hydronephrosis caused by their tumors, immune checkpoint inhibitors are expected to become part of a new therapeutic approach for combination treatment with radiotherapy. Accordingly, clinical trials testing immune checkpoint inhibitors have been initiated to preserve bladder for muscle invasive bladder cancer patients using radiation and immune checkpoint inhibitors with/without chemotherapy. The objective of this review is to summarize the evidence of trimodal therapy for muscle invasive bladder cancer during the past decade and to discuss the future directions of bladder preservation therapy in immuno-oncology era.

scholarly journals Current Topics in the Management of Non–Muscle-Invasive Bladder Cancer

2020 ◽  
Vol 18 (7.5) ◽  
pp. 973-976
Author(s):  
Philippe E. Spiess
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
High Risk ◽  
Invasive Bladder Cancer ◽  
Evidence Based ◽  
Bacillus Calmette Guerin ◽  
Muscle Invasive Bladder Cancer ◽  
Nccn Guidelines ◽  
Muscle Invasive

The current NCCN Guidelines for Bladder Cancer reflect the most up-to-date, evidence-based data relating to the evaluation and management of non–muscle-invasive bladder cancer (NMIBC). The most notable revision to the guidelines this year is the addition of pembrolizumab for a high-risk subset of patients not responding to bacillus Calmette-Guérin (BCG). It is anticipated that current BCG shortages will offer unique opportunities to promote and enhance clinical trials for patients with bladder cancer. Recent efforts to more precisely define BCG-unresponsive disease (adopted by the FDA) have been critical to standardizing definitions and evaluating the efficacy of clinical trials in bladder cancer.

scholarly journals Age and sex do not affect first year recurrence in patients with non-muscle invasive bladder cancer

Folia Medica ◽  
2021 ◽  
Vol 63 (2) ◽  
pp. 242-246
Author(s):  
Huseyin Kocan ◽  
Mustafa Kadihasanoglu
Keyword(s):  
Bladder Cancer ◽  
Survival Time ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Age And Gender ◽  
Mean Survival Time ◽  
And Gender ◽  
Muscle Invasive ◽  
The Impact ◽  
Age And Sex

Introduction: Although demographic heterogeneity in the management of patients with non-muscle invasive bladder tumor (NMIBT) is an important factor, there are only minimal evidence-based recommendations that adjust for patient age and gender. The relationship and impact of age and gender on the recurrence in NBIMT is poorly investigated and understood. Aim: The aim of the study was to evaluate the impact of age and sex on the recurrence of non-muscle invasive bladder cancer. Materials and methods: Patients treated with transurethral resection (TUR) of primary NMIBT were included in the study. Risk calculation was made according to the European Organization for Research and Treatment of Cancer (EORTC) risk tables. Prognostic factors for predicting tumor recurrence up to 5 years including age and sex were analyzed. The Mann-Whitney U test was used for comparison of non-parametric variables in independent groups. Kaplan-Meier method, with log rank (Mantel-Cox) analyses applied for comparison of mean duration of remission by sex and age, was used to calculate mean duration of remission.&nbsp; Results: A total of 81 patients, 68 males (mean age 59.03 years) and 13 females (mean age 58.13 years) were eligible for final analysis. Mean survival time of patients <60 years old and older was 17.3&plusmn;2.1 months (13.2&ndash;21.3) and 17.9&plusmn;2.8 months (12.4&ndash;23.4), respectively (p=0.6). Mean survival time was 17.3&plusmn;2.1 months for females and 15.4&plusmn;2.1 months for males (p=0.08). However, 1-year tumor-free rate of female patients (53.8%) was not much different from that of males (31%) (p=0.11). Although considerable difference was observed between recurrence rates of patients according to sex, it failed to reach statistical significance. Conclusions: The results of the present study suggest that the recurrence of NMIBT is not associated with age or gender.&nbsp;

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