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Non Muscle Invasive Bladder Cancer Lawrence Karsh, MD FACS CPI Director of Research Attending Urologist The Urology Center of Colorado Lawrence I Karsh MD FACS CPI Director of Research Bladder Cancer Most frequent malignant tumor of the urinary tract Male > female; ratio 3:1 4th most common cancer in men; 8th in Women 72,570 estimated new cases in USA 2013 15,210 estimated deaths in USA 2013 Ages: 50-70 most common; “any” age can get Most common type is Transitional Cell Natural History- at diagnosis 70-80% are non-muscle invasive at presentation 60% are low grade 40% are high grade 50%-70% will recur at 5 yr 10%-30% will progress to muscle invasive 5%-10% are metastatic Low grade ca can develop into high grade Bladder Cancer -Risks Smoking – 4x greater risk Aniline dyes/aromatic amines Phenacetin – non steroid-anti inflammatory pain reliever; not much used any longer (illegal); is used to cut cocaine Cyclophosphamide – chemotherapeutic agent – leukemia, lymphoma, severe lupus History of pelvic radiation Hairdressers, photo processing, painters, truck drivers, synthetic textiles Chemicals with leather goods, rubber Drugs Increases with number smoked ? If decreases after quit smoking (>25yr smoke free) Prostate, cervical Chronic irritation/catheters – Squamous cell Carcinoma in-situ “superficial” Bad Guy 25% high grade cancers have CIS 30-70% muscle invasive tumors have CIS 50% response to BCG Intravesical therapy BCG - FDA approved Thiotepa FDA approved Mitomycin - NOT FDA approved Doxorubicin - NOT FDA approved Valrubicin-FDA approved for recurrent CIS Intravesical Therapy- BCG (Mycobacterium bovis) Bacillus Calmette Guerin Albert Calmette From Britianica.com Cammile Guerin From today in science The Tuberculosis vaccine (invented 1921) Attenuated (weakened) form of Mycobacterium bovis bacterium Produces local inflammatory reaction which is suppose to rev up the T immune system to destroy cancer Most effective intravesical agent Superior for CIS From microbiologybytes.com BCG Approved for CIS and recurrent Ta/T1 60-80% cystitis- no pain no gain Most effective but most risks Decrease recurrence by 40% Decrease progression by 27% if use maintenance What is this clinical trial about and who will benefit? How does the therapy work? Side Effects Intravesical administration of rAd-IFN with Syn3 was well tolerated in the phase I trial Why should I enroll in this trial? 1. Cutting edge treatment 2. May possibly delay or prevent cystectomy if effective and approved by the FDA 3. Advance science 4. Help next generation of patients with similar problem Where can I find this information? • • • • • www.bcan.org www.suoctc.org www.clinicaltrials.gov www.nccn.org www.tucc.com INSTILADRINTM (RAD-IFN)