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Brief Q&A for Patients by the International Bladder Cancer Group on the BCG Shortage
In this Question and Answer presentation by Ashish M. Kamat and colleagues from the International Bladder Cancer Group the authors provide a patient resource on BCG treatment answering questions including: What is BCG, Who and how is it made, If there is a shortage of BCG what are my options?, Is a reduced dose of BCG as effective as a full dose?, and are there any ongoing trials involving new therapies?
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Setting the Stage for the BCG Unresponsive Population - Interview with Ashish Kamat
Ashish M. Kamat, MD
Ashish Kamat and Alicia Morgans discuss non-muscle invasive bladder cancer, where the field stands particularly for BCG refractory patients and the definition of the BCG unresponsive patient. Ashish overviews the efforts of the SUO-CTC Bladder Committee and important updates and trials in this disease state.
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High Grade Non-Muscle Invasive Bladder Cancer and BCG Refractory Patient
Joshua J Meeks, MD, Ph.D
Alicia Morgans and Josh Meeks highlight ongoing trials in non-muscle invasive bladder cancer. Review SWOG 1602 and 1605, and highlight the great work being done in the search for treatment options for patients with this disease with the ultimate hope for patients to retain their bladder and potentially be cancer-free.
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Socio-economic Impact of BCG Shortage
A Cochrane review assessing intravesical BCG for Ta and T1 bladder cancer found that BCG instillation after TURBT reduced disease recurrence at 12 months compared with TURBT alone. The review concluded that in people with medium- to high-risk Ta or T1 bladder cancer, intravesical BCG following TUR has a significant advantage over TUR alone in delaying tumor recurrence.
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BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry
The purpose of this guidance is to assist sponsors in the development of drugs, including biologics, for the treatment of patients who have BCG-unresponsive nonmuscle invasive bladder cancer. This guidance is intended for pharmaceutical sponsors, the academic community, and the public and provides a framework, based on current FDA thinking, to facilitate the development of drugs to treat this patient population.
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Switching of Bacillus Calmette-Guerin Strain at Second BCG Therapy May Reduce BCG-Related Side Effects in Patients with BCG-Relapsing Tumors
Currently, two strains of BCG (Tokyo-172 and Connaught) are used for the treatment of patients with high-risk non-muscle invasive bladder cancer. Recent studies have proposed that BCG resistance may be related to the type of strain used. Dr. Niwa, from Keio University in Tokyo Japan, presents a retrospectives study which evaluates the clinical efficacy and safety of switching of BCG strain at the second BCG therapy in patients with BCG-relapsing non-muscle-invasive bladder tumor, defined as recurrence after achieving a disease-free status for 6 months.
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What’s So Exciting About BCG and Bladder Cancer?
The 2018 David A. Swanson Distinguished Alumni lecturer for the Department of Urology, Dr. Robert Svatek described being impressed as a resident by the effectiveness of BCG therapy in treating bladder carcinoma and discussed the fact that there are several BCG strains, having evolved from in vitro passaging over time in different laboratory conditions worldwide.
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Optimizing BCG Therapy for NMIBC
Six myths were explained and discussed, in order to achieve a better understanding about the use of BCG and optimize its use. Dr. Ashish Kamat demonstrated that BCG reduces both recurrence and progression rates in NMIBC, but progression is only reduced when maintenance is used. BCG has a 32% advantage over mitomycin C when maintenance is used, instead of induction alone.
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Options for Patients Failing BCG Therapy
Dr. Ashish Kamat reviewed the emerging options that are currently under investigation for use in patients with non-muscle invasive bladder cancer who have failed BCG. Among these include novel formulations of mitomycin C. Immunotherapy agents, such as the anti-PD-1 antibody pembrolizumab and anti-PD-L1 atezolizumab are also being investigated in these patients with follow-up ongoing.
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From the Desk of Evan Yu: “How can I keep my bladder, doc? The BCG Refractory Non-Muscle Invasive Bladder Cancer Question.”
Although urothelial carcinoma of the bladder represents the fourth most common malignancy in men, 70% of these cases are non-muscle invasive. Most of these patients will have outstanding outcomes, however, up to 70% will recur after initial treatment and 10-20% will progress to muscle-invasive bladder cancer. Once a patient has MIBC, then treatment options become more intense, with discussions of definitive cystectomy, chemotherapy, and radiation, all of which carry greater morbidity and cost.
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BCG vs Chemohyperthermia with Mitomycin C for High-Risk Non-Muscle Invasive Bladder Carcinoma: Preliminary Results of HIVEC-HR Randomized Clinical Trial
The shortage of BCG intravesical instillations that occurred several years ago resulted in the expedited search for alternative therapeutic options for a patient with non-muscle invasive bladder cancer. The HIVEC-HR is a pilot study aiming to compare the efficacy and safety of BCG and chemohyperthermia with mitomycin C. In this poster, the authors presented their preliminary results.
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POTOMAC Study - Durvalumab and BCG versus BCG Alone in High-risk, BCG-Naïve Non Muscle-Invasive Bladder Cancer
Standard treatment for patients with high-risk tumors is transurethral resection (TURBT) followed by intravesical BCG. Despite the efficacy of BCG, recurrence rates are as high as 50% in the first three years of follow-up and can be even higher for aggressive histologic subtypes. This trial is an open-label randomized, multicenter, global study to determine the efficacy and safety of Durvalumab + BCG combination therapy, and durvalumab +BCG combination therapy vs. BCG in the treatment of patients with high risk non-muscle invasive urothelial carcinoma.
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