Stages
TA and T1 tumors and CIS are Early-stage Bladder Cancers
A staging system has been developed to determine the extent to which cancer may have spread into the bladder wall, nearby tissues, or distant organs.1
Non-Muscle Invasive (Superficial) Bladder Cancer
Non-muscle invasive (superficial) bladder cancer is an early-stage cancer. Tumors are found only on the inner lining of the bladder. There are different types of non-invasive bladder cancer, including Ta or T1 papillary tumors and/or CIS.
Ta and T1 papillary tumors are mushroom-shaped tumors with stems attached to the lining of the bladder. Ta and T1 tumors are early stages of cancer and are identified based on how deep into the bladder lining they have grown. They usually grow into the bladder cavity and can spread outward as well as inward. There may be one or several tumors occurring at once, and they may be as small as a pea or large enough to almost fill the cavity.
Bladder CIS is also an early-stage cancer, but it does not form a mushroom-shaped tumor. Rather, it spreads across the inner lining of the bladder. It may occur with or without papillary tumors.
Fortunately, Ta and T1 tumors and CIS tend to be slow-growing. They can generally be controlled, especially when diagnosed early. To help prevent these cancers from returning, treatment often includes weekly therapy for 6-12 weeks and then maintenance therapy -- treatment at about monthly intervals for at least 6 to 12 months.
Reference:
- How is bladder cancer staged? http://www.cancer.org. Accessed June 26, 2007.
TICE® BCG is indicated for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). TICE® BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.
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TICE® BCG is not indicated for papillary tumors of stages higher than T1. |
WARNING
TICE® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material.
BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG.
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TICE® BCG is contraindicated in immunocompromised patients. Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization. TICE® BCG should not be administered to persons with active tuberculosis.
BCG LIVE (TICE® BCG) is not a vaccine for the prevention of cancer.
TICE® BCG is an infectious agent. Physicians using it should be familiar with the prevention and treatment of BCG-related complications. Deaths have been reported as a result of BCG infection and sepsis.
There is a ≤1% incidence of life-threatening reactions such as BCG sepsis, coagulopathy, leukopenia, thrombocytopenia, hepatic granuloma, hepatitis, disseminated sepsis with associated mortality, and M. bovis infections of several organs.
Many patients (60%) experience symptoms of bladder irritability beginning 4 to 6 hours after instillation and lasting for 24 to 72 hours. Adverse reactions tend to progress in frequency and severity with subsequent instillations.
Adverse reactions (frequency ≥5%) reported during clinical trials in patients with superficial bladder cancer, including carcinoma in situ, were dysuria (60%), urinary frequency (40%), flu-like syndrome (33%), hematuria (26%), fever (20%), malaise/fatigue (7%), cystitis (6%), urgency (6%), and nocturia (5%).
Adverse reactions (frequency ≥5%) reported during clinical trials in patients with TaT1 bladder cancer following transurethral resection were dysuria (52%), urgency/frequency (50%), hematuria (38%), flu-like symptoms (24%), fever (17%), pain (17%), hemorrhagic cystitis (9%), chills (9%), bladder cramps (8%), and nausea (7%).
You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
For additional important product information please click the “Prescribing Info” link below.
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