Patient Instructions for BCG Immunotherapy
In the 1970's doctors reported success with BCG treatment in lung cancer, skin cancer and others, but rigid scientific studies failed to prove that BCG was effective. BCG was about to be abandoned as a cancer treatment when Dr. Alvaro Morales, who had worked with BCG at the National Cancer Institute (NCI), reported in 1976 that BCG instilled in the bladder markedly reduced bladder tumor recurrence in 9 patients. In 1978 the NCI asked for research proposals to study BCG in bladder cancer. Since Dr. Lamm had experience with BCG in bladder cancer (showing it to be effective in animal bladder cancer) he was awarded a contract to do the research.
In 1980, while at the University of Texas in San Antonio, Dr. Lamm published the first controlled study showing that BCG reduced bladder cancer recurrence. It was not until 1990, however, when BCG gained FDA approval. Approval was based on Dr. Lamm's study in the Southwest Oncology Group where BCG was compared with a highly effective (though unapproved) chemotherapy, Adriamycin (doxorubicin). Subsequent research under Dr. Lamm's direction has demonstrated that BCG is superior to the most popular (and expensive) bladder cancer chemotherapy, Mitomycin C (also not FDA approved) and that maintenance BCG (continued treatment) is better than standard 6 week treatment. Further research and statistical review of published trials (meta-analysis) has shown that BCG, unlike chemotherapy, reduces not only tumor recurrence, but more importantly, progression (increasing stage). This reduction in progression, however, occurs only when maintenance BCG is used.
When tumors recur despite chemotherapy, when they are not low grade, and when they have superficial invasion or associated carcinoma in situ, BCG is generally indicated.
The living bacterial vaccine, BCG, is placed in the bladder by inserting a small tube (catheter). Treatments are generally not given within two weeks of tumor resection, and if placing the catheter in the bladder is difficult and results in bleeding (this is unusual), BCG should not be given. Since it is a living organism it can grow outside the bladder and produce all sorts of trouble if it is not recognized and treated (see BCG Complications). You will be asked to retain the BCG for two hours, so don't drink fluids for a few hours before treatment so you can hold it. You will be asked to lie on your abdomen for 15 minutes of the two hours, but can leave the office with the medication.
Treatments are given once a week for 6 weeks. After the second or third treatment we would expect you to have mild burning with urination, increased urinary frequency, and occasionally some aching or low grade fever- symptoms similar to an infuenza vaccine. These symptoms are actually good- they indicate that the medication is doing what it is supposed to do- stimulate your immune system. These symptoms should be mild and last for only one or two days. You will be given a prescription for specific antibiotics (isoniazid and a fluorquinolone) to take should symptoms increase or not resolve. Do not hesitate to take the antibiotics: too much is worse than too little BCG- we can always give you more. Symptoms typically increase with each treatment, so we adjust the dose to lower the risk of a side effect or complication.
It is my practice to do a skin test for tuberculosis before starting BCG and to give BCG inoculations percutaneously (through the skin) as well as intravesically. We and others have done controlled studies that failed to show that skin inoculation significantly improved the results of BCG, but in each study those who got skin inoculation did slightly better.
Six weeks after completing the 6 weekly BCG instillations we would normally inspect the bladder (cystoscopy) to be sure it is working and the tumor is responding. Maintenance BCG is generally given using up to three instillations at 3, 6, 12, 18, 24 and 36 months, and in high risk disease, at years 4, 5, 6, 8, 10 and 12.
Fever actually is associated with an improved response to BCG, but it can herald a BCG infection. Fever and chills should be treated promptly with combination antibiotics that are effective against BCG. On rare occasion serious, even life threatening infection can occur. BCG can infect the lungs, liver, bone, and even circulatory system (heart and arteries). Inflammation of the eyes can occur. Systemic (blood stream) infection with BCG can produce shock, with low blood pressure, respiratory, renal, and liver failure. In these cases in addition to antibiotics and intensive support, steroids (prednisone) has been found to be life saving.
Update: 8/15/2007