What is BCG?

•Bacillus Calmette-Guerin (BCG)•Derived from a weakened strain of the tuberculosis bacteria.•The most commonly prescribed immunotherapy used in bladder cancer treatments.•It is thought to trigger an immune response in the bladder and work directly on the tumors.

•It was first approved by the FDA in 1990 to treat bladder cancer•The most effective non-surgical treatment for CIS (carcinoma in situ) and high grade, non muscle invasive cancer.

Indication

•Bladder cancer is the only cancer in which BCG is commonly used.•Carcinoma in situ, which is cancer that is localized to the urinary bladder.

Description•Therapy is given through a urinary catheter directly into the empty bladder, called intravesical placement•It uses a live vaccine called Bacillus calmette-Guerin (BCG), which is also used to inoculate against Tuberculosis.

Preparation•The BCG solution is prepared by initially dissolving the freeze-dried powder with the diluent that comes with the preparation.•This solution is diluted further with saline, so that the total volume is approximately 30 mL.•BCG solution should be used within 2-3 hours

Mechanism of Action of BCG•Substance placed into the bladder to stimulate an immune response•Bacillus Calmette-Guérin (BCG) surface antigens cross-reacted with putative bladder tumor antigens•When it is placed inside the bladder a local inflammatory reaction is created which kills cancer cells.

It is not clear how Bacillus Calmette-Guerin (BCG) works to treat bladder cancer. It may stimulate an immune response or cause inflammation of the bladder wall that destroys cancer cells within the bladder. BCG may be used to treat early-stage cancer, but it is used most commonly to prevent the return (recurrence) of noninvasive bladder cancer.

Once in the bladder, the live organisms enter macrophages, where they induce the same type of histologic and immunologic reaction as found in patients with tuberculosis.BCG vaccine also has a predilection for entering bladder cancer cells, where the proteins are broken down and fragments are combined with histocompatibility antigens and displayed on the cell surface.This induces a cytokine and direct cell-to-cell cytotoxicity response, which targets these cells for destruction.

AdvantagesIn the United States, bladder cancer is the fourth most common human malignancy. In the past decade, the incidence of bladder cancer has increased by 36%. However, mortality has declined by 8%. Intravesical chemotherapy was considered to be partially responsible for this improvement in survival, but a recent review of clinical studies shows no reduction in disease progression with intravesical chemotherapy.

Fortunately, the results of immunotherapy with bacille Calmette-Guérin (BCG) are quite different, and it is expected that patients treated with optimal BCG treatment regimens will have a long-term reduction in tumor recurrence, tumor progression, and cancer mortality.

The administration of Bacillus Calmette-Guérin (BCG) immunotherapy has become the standard of care for high-grade non-muscle invasive bladder cancer (NMIBC) and carcinoma in-situ (CIS) in terms of prevention of recurrence and progression.

Immunotherapy with intravesical BCG provides an effective alternative approach to chemotherapy in the management of superficial bladder cancer. BCG has been shown to eradicate residual tumor in 60% of patients with papillary disease and 70% in patients with carcinoma in situ.

Controlled trials suggest that BCG immunotherapy reduces disease progression, decreases the need for cystectomy, and prolongs survival.

Some early studies purported that an immune response against bacillus Calmette-Guérin (BCG) surface antigens cross-reacted with putative bladder tumor antigens, and this was proposed as the mechanism for the therapeutic effect of BCG; however, multiple subsequent studies refute this claim.

Adverse Effects After the third instillation, patients usually begin

experiencing irritative bladder symptoms and/or flulike symptoms that last 24-72 hours.

These symptoms are usually mild and can be controlled with bladder sedatives and antihistamines, and they are often perceived as favorable immunological responses to the therapy.

Severe reactions to BCG vaccine, including high-grade fevers (ie, temperature >40°C [104°F]), hepatotoxicity, respiratory distress, chills, hemodynamic instability, and mental status changes, suggest life-threatening septicemia. These are emergencies, and patients should be hospitalized.

A urine culture should be obtained because many cases of septicemia following BCG vaccine instillation are caused by more common uropathogens, rather than the organisms in the BCG vaccine. Tuberculosis organisms from the urine or tissues are usually difficult to culture.

•Treatment should be initiated without waiting for culture results.•Broad-spectrum antibiotics should be administered intravenously, and the patient should be started on antituberculosis therapy, including rifampin, isoniazid, and cycloserine, which is the only antituberculosis drug to reach bactericidal levels within 24 hours of administration.•Corticosteroids are also recommended in some patients

Induction phase

• Considered complete when the immunologic reaction has occurred

• Evident when the patient has irritative bladder symptoms, the urine contains WBCs without evidence of infection, and microscopic hematuria is present

Treatments are normally given once a week for 6 consecutive weeks. 

Another 6-week course may be administered if a repeat cystoscopy , reveals tumor persistence or recurrence.

Maintenance Therapy:

•This is one dose per week for 3 consecutive weeks. •3 week maintenance may then be repeated at 6, 12, 18 and 24 months depending on the type of tumour being treated and response to the treatment.

Patients should not be given antibiotics at the time of the instillation. These medications can kill the live organisms and negate the effect of the treatment.

The patient should wash out the toilet with bleach following the next 3 urinations to avoid exposing other family members to the vaccine.

Nursing ResponsibilitiesBeforeBefore the first treatment ask client about any previous illnesses, operations, or medicines that the client is taking.

If the clients have had the Influenza (Flu) or Pneumococcal injection you will not be able to start treatment until 6 weeks afterwards. Client should not have either of these injections until 6 weeks after the client have finished the course of treatments.

Client should not drink fluids for 2 hours before treatment, so that the bladder will be empty. If the client takes diuretic medicine (water tablets) they should not take them at least 6 hours before treatmentor after the treatment.

Ask client to produce a urine sample at the clients visit and each time the client come for treatment. The sample would be tested to make sure there is no infection present. lf there is an infection, the treatment would be postpone and prescribe some antibiotics, as infection makes complications more likely.

DuringAt client’s first appointment for BCG treatment, a list of further appointments will be given. The treatments are also given as an outpatient at Hospital in the Urology Outpatients department.

Ask the client to lie on an examination couch, because the genital area will be cleaned and a catheter (thin tube) will be inserted into your bladder, via the urethra (water pipe).

AfterAfter the therapy, client will be reminded that they must not use a public toilet on their way home.Remind client not to pass urine for at least the next hour.

They should not hold urine for more than 2 hours.

After one hour empty your bladder and continue to empty your bladder frequently.

For the first 6 hours of emptying your bladder, remind the client to sit down when urinating. This reduces the risk of spillage onto skin or outside the toilet. Remind client to wash their hands with soap and water every time they finish urination.

Remind client to drink plenty of fluids (2-3litres) for the first 24 hours after each treatment. Avoid caffeine drinks (coffee, cola). Drink decaffeinated drinks, cranberry juice and barley waters. Avoid drinking excessive amounts of alcohol (no more than I glass of wine or /, pint of beer). 

Stop smoking.