25% of bladder cancer presents as muscle-invasive disease or greater1
17,630 patients (expected)
Approximately 25% of non-muscle-invasive bladder cancer presents as high-grade T1 disease2
13,222 patients (expected)
400 Million Suffer from Bladder Dz
Many Require Bladder Replacement
In 2010, there were an estimated 70,520 new cases of bladder cancer1 of which approximately 13,000 cases were diagnosed as clinical high-grade T1 bladder cancer.2 One of the key components of the evaluation of patients with high-grade T1 bladder cancer is the role of a re-resection or second TUR of the tumor bed 4-6 weeks after the initial diagnosis.
The transurethral resection of bladder tumors (TURBT) is truly one of the earliest minimally invasive surgical techniques. Although most urologist and urology residents are very adept at the technique, it has been little over 70 years since the instrumentation was developed to excise bladder tumors transurethrally. Prior to this era, large bladder tumor were excised via open incisions and often associated with multiple complications. Today, open tumor resections are rarely, if ever, performed.
BCG, an attenuated mycobacterium developed as a vaccine for tuberculosis, has been shown to have significant anti-tumor activity in patients with non-muscle invasive bladder cancer, and is the most effective intravesical agent at reducing recurrence and disease progression for patients with non-muscle invasive bladder cancer with high risk features (high grade disease, lamina propria involvement, carcinoma in situ)1-5. BCG is stored in refrigeration and reconstituted from a lyophilized powder.
It has been estimated that in 2010, there were more than 70,000 new cases of bladder cancer diagnosed in the United State, with more than 14,000 cancer specific deaths1. While approximately 70-80% present with non muscle invasive disease, 20% of these patients will be refractory or intolerant to intravesical therapies and another 10-30% of these patients will ultimately progress to muscle invasive disease2.
Although BCG is the reference standard for high risk non-muscle invasive bladder cancer (NMIBC), up to one third of patients recur, and a substantial number of patients progress to muscle invasive disease1. In addition, use of BCG is limited due to local or systemic toxicity in approximately 20% of patients. As a result, use of alternative intravesical agents has sparked significant interest in patients that are intolerant to BCG or not candidates for cystectomy due to competing risks.