Adverse Effects Of Bcg
Common adverse effects include cystitis, dysuria, malaise, fatigue, and a low fever . These can be managed by NSAIDS, phenazopyridine, and anticholinergics. If symptoms become intense or last longer than 24 hours, consider either delaying additional instillations until symptoms improve or reducing the dose.
In a review including 2602 patients treated with intravesical BCG instillation , the most common side effects were fever > 103ºF, hematuria, granulomatous prostatitis, pneumonitis and/or hepatitis, arthralgia, epididymitis, sepsis, rash, ureteral obstruction, bladder contracture, renal abscess, and cytopenia.
Early-onset BCG infection often presents as systemic manifestations. In contrast, delayed-onset infection presents as localized disease. Manifestations are as follows:
- Systemic manifestations occur when BCG disseminates outside of the genitourinary tract. They include sepsis syndrome, pulmonary issues from dyspnea, granulomatous hepatitis, osteomyelitis, reactive arthritis, monoarthritis, psoas abscess, and vascular complications due to mycotic aneurysms.
- Localized manifestations include cystitis, bladder contracture, granulomatous prostatitis, prostate abscess, epididymo-orchitis, testicular abscess, pyelonephritis, renal abscess, urethral stricture, and balanitis.
The AUA has noted the following with regard to BCG2:
Contributor Information and Disclosures
Fellow in Urologic Oncology and Minimally Invasive Surgery, University of Chicago Medical Center
Other Treatments For Bladder Cancer
For many early-stage bladder cancers, BCG is the best option for treatment. Other treatments for bladder cancer include:
- Surgery to remove the tumor: Early cancers can be removed with TURBT surgery. More advanced cancers may require more extensive surgery, like removal of part or all of the bladder .
- Intravesical chemotherapy: This treats the inside of the bladder with chemotherapy drugs. Chemotherapy drugs commonly used for bladder cancer include Mutamycin , Gemzar , or Valstar .
- Radiation therapy
- Clinical trials
Q Can I Get Bcg Somewhere Else
A. Merck is the sole maker and supplier of BCG to the United States. While the FDA is exploring opportunities to approve additional strains and supplies of BCG, Merck is still the only approved supplier at this time.
There are companies in Japan, Canada, and Europe working to develop their own strains of BCG. If the FDA ultimately approves them, they might be able to alleviate future shortages of the drug.
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Treating Stage Iii Bladder Cancer
These cancers have reached the outside of the bladder and might have grown into nearby tissues or organs and/or lymph nodes . They have not spread to distant parts of the body.
Transurethral resection is often done first to find out how far the cancer has grown into the bladder wall. Chemotherapy followed by radical cystectomy is then the standard treatment.Partial cystectomy is rarely an option for stage III cancers.
Chemotherapy before surgery can shrink the tumor, which may make surgery easier. Chemo can also kill any cancer cells that could already have spread to other areas of the body and help people live longer. It can be especially useful for T4 tumors, which have spread outside the bladder. When chemo is given first, surgery to remove the bladder is delayed. The delay is not a problem if the chemo shrinks the cancer, but it can be harmful if it continues to grow during chemo. Sometimes the chemo shrinks the tumor enough that intravesical therapy or chemo with radiation is possible instead of surgery.
Some patients get chemo after surgery to kill any cancer cells left after surgery that are too small to see. Chemo given after cystectomy may help patients stay cancer-free longer, but so far its not clear if it helps them live longer. If cancer is found in nearby lymph nodes, radiation may be needed after surgery. Another option is chemo, but only if it wasn’t given before surgery.
What Can I Expect Following Treatment
You may be advised to drink plenty of fluid to flush the rest of the medication from your bladder.
For six hours after each treatment, youll have to be very careful when you urinate to avoid transmitting BCG to others. Men should urinate while seated to avoid splashing.
Disinfect the urine by adding 2 cups of bleach into the toilet. Let it stand for about 20 minutes before flushing. You should also wash your genital area very carefully after you urinate, so your skin doesnt become irritated from the BCG. Wash your hands thoroughly, too.
Men can pass BCG to their partner during sex. For that reason, you should avoid sex for 48 hours after each treatment. Use a condom between treatments and for six weeks following your final treatment.
Women should avoid getting pregnant or breastfeeding while on BCG therapy.
Treatment is usually given every week for six weeks. After that, you might need to do it once a month for six months to a year.
One benefit of BCG is that while it affects the cells in your bladder, it doesnt have a major effect on any other part of your body. But there can be a few side effects such as:
When comparing BCG to other bladder cancer treatments, its important to remember that treatment isnt the same for everybody. Some of the factors that determine your options are:
- type of bladder cancer
- your age and general health
- how well you tolerate certain treatments
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Mechanism Of Action Of Bcg
The mechanism of action of bacillus Calmette-Guérin therapy is incompletely understood. Some early studies purported that an immune response against 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.
The most likely mechanism of action of BCG immunotherapy involves a combination of its direct effect on tumor cells along with the patients immune response to the therapy. These effects are summarized by Kawai et al into three categories: infection of cancer cells, induction of immune response, and antitumor effects.
The infection of cancer cells is mediated by the glycoprotein fibronectin, which allows the internalization of BCG, breakdown of proteins, and cellular changes that trigger the immune system. This is similar to the immunologic reaction that occurs in patients with tuberculosis. This immune response comprises specific cellular changes including surface receptor changes and release of various cytokines. Interferon is considered to be an important part of this process and has been used in the past to determine appropriate response to treatment. The immune response crescendos to antitumor activity in which cells recognize the cancer cells, target them for destruction, and subsequently decrease cancer burden.
The overall response to BCG is limited if the patient is immunosuppressed.
What Is Bcg Treatment
Bacillus Calmette-Guerin treatment is a type of intravesical immunotherapy. This liquid drug is made from a strain of Mycobacterium bovis the same bacterium used to create the tuberculosis vaccine. When used in medicine, Mycobacterium bovis is weakened to reduce harm to your body.
BCG treatment is usually given after TURBT , which is a bladder surgery to remove any visible cancer.
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Bladder Cancer And Its Symptoms
Bladder cancer is an invasive type of cancer that develops within the bladder. It affects the cells in the bladder and progresses slowly. When the cancerous cells spread to other parts of the body, it is referred to as metastasized bladder cancer.
The symptoms of bladder cancer are often vague or non-existent and so it can be hard to detect or diagnose. The symptoms depend on where the cancer is in the bladder i.e., whether it is contained only in the bladder or it has spread to other parts of the body.
The signs you should look out for include frequent urination, blood in the urine, pressure in your bladder and pain when urinating.
When cancer spreads out of the bladder, it is called metastasis. The most common place for metastasis of bladder cancer is in the bones, lymph nodes, liver and lungs. The symptoms of bladder cancer from its initial stage to the advanced stage include dizziness, difficulty in breathing, rashes, joint pain and in rare cases fever.
Why Do Some People Have Maintenance Therapy
Healthcare providers may advise patients who have certain types of non-muscle invasive bladder cancer to have maintenance therapy to attempt to keep the bladder cancer cells from growing back after treatment, which is called recurrence. Maintenance therapy may be recommended for patients who have a type of bladder cancer that is linked to a higher risk of recurrence.
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Treating Bladder Cancer That Progresses Or Recurs
If cancer continues to grow during treatment or comes back after treatment , treatment options will depend on where and how much the cancer has spread, what treatments have already been used, and the patient’s overall health and desire for more treatment. Its important to understand the goal of any further treatment if its to try to cure the cancer, to slow its growth, or to help relieve symptoms as well as the likely benefits and risks.
For instance, non-invasive bladder cancer often comes back in the bladder. The new cancer may be found either in the same place as the original cancer or in other parts of the bladder. These tumors are often treated the same way as the first tumor. But if the cancer keeps coming back, a cystectomy may be needed. For some non-invasive tumors that keep growing even with BCG treatment, and where a cystectomy is not an option, immunotherapy with pembrolizumab might be recommended.
Cancers that recur in distant parts of the body can be harder to remove with surgery, so other treatments, such as chemotherapy, immunotherapy, targeted therapy, or radiation therapy, might be needed. For more on dealing with a recurrence, see Understanding Recurrence.
Is There A Risk Of Bladder Cancer After Bcg Treatment
Like most cancers, bladder cancer can potentially return after treatment. Statistically, cancer will recur in up to 40% of people who receive BCG treatment. Its important to note, however, that even if the cancer comes back, it may not progress.
Low-grade bladder cancer usually doesnt spread to other areas of your body. But people who have low-grade bladder cancer have a higher risk of developing other low-grade cancers throughout their lifetime.
Less often, aggressive bladder cancer can develop after BCG treatment. If this happens, cystectomy is usually recommended.
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Q: Why Is There A Shortage Of Bcg
A. Merck & Co., Inc. is the sole maker and supplier of BCG to the United States. They are also the only source of BCG to many other countries around the world.
Although Merck has boosted its production of BCG by more than 100 percent and is producing the drug to the fullest extent of their manufacturing capacity, they are not able to sustain the increasing global demand of this product. This has led to supply constraints and a BCG shortage.
Is Bcg Treatment Contagious To Others
Yes. The drugs used for BCG treatment contain live bacteria, which can be passed to other people. To reduce the risk of contamination, follow these instructions for six hours after every BCG treatment:
- Dont use public toilets.
- Drink lots of fluids to dilute your pee.
- Sit down on the toilet to avoid splashing.
- After you pee, add 2 cups of undiluted bleach to the toilet, close the lid, wait 15 to 20 minutes and then flush.
- If you have urinary incontinence , immediately wash your clothes in a washing machine. Dont wash them with other clothes.
- If you wear an incontinence pad, pour bleach on the pad, allow it to soak in, then place it in a plastic bag and discard it in the trash.
Typically, youll need to refrain from having sex for a few days after each BCG treatment session. In addition, use a condom any time you have sex throughout the entire course of treatment. Ask your healthcare provider about specific guidelines regarding sex.
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Treating Stage 0 Bladder Cancer
Stage 0 bladder cancer includes non-invasive papillary carcinoma and flat non-invasive carcinoma . In either case, the cancer is only in the inner lining layer of the bladder. It has not invaded the bladder wall.
This early stage of bladder cancer is most often treated with transurethral resection with fulguration followed by intravesical therapy within 24 hours.
Availability Of Data And Materials
The datasets supporting the conclusions of this article are available in the National Health Insurance Research Database, Taiwan .
Only citizens of the Republic of China who fulfill the requirements of conducting research projects are eligible to apply for the National Health Insurance Research Database . The use of NHIRD is limited to research purposes only. Applicants must follow the Computer-Processed Personal Data Protection Law and related regulations of National Health Insurance Administration and NHRI , and an agreement must be signed by the applicant and his/her supervisor upon application submission. All applications are reviewed for approval of data release.
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Treating Stage I Bladder Cancer
Stage I bladder cancers have grown into the connective tissue layer of the bladder wall , but have not reached the muscle layer.
Transurethral resection with fulguration is usually the first treatment for these cancers. But it’s done to help determine the extent of the cancer rather than to try to cure it. If no other treatment is given, many people will later get a new bladder cancer, which often will be more advanced. This is more likely to happen if the first cancer is high-grade .
Even if the cancer is found to be low grade , a second TURBT is often recommended several weeks later. If the doctor then feels that all of the cancer has been removed, intravesical BCG or intravesical chemo is usually given. If all of the cancer wasn’t removed, options are intravesical BCG or cystectomy .
If the cancer is high grade, if many tumors are present, or if the tumor is very large when it’s first found, radical cystectomy may be recommended.
For people who arent healthy enough for a cystectomy, radiation therapy might be an option, but the chances for cure are not as good.
What Is Bcg Maintenance Therapy
BCG maintenance therapy is an intravesical treatment, which means that it is delivered directly into the bladder. BCG treatment in bladder cancer is known as local immunotherapy. BCG is a liquid medicine that is administered through a catheter, which is a thin, flexible tube that is inserted into the bladder through the urethra, a tube that allows urine to flow out of the body from the bladder. The medicine is then held in the patients bladder for a specified amount of time before the patient urinates.
In addition to being used for bladder cancer maintenance therapy, BCG treatment can also be used as part of the initial treatment for certain types of early-stage non-muscle-invasive bladder cancer.
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Treating Stage Iv Bladder Cancer
These cancers have reached the pelvic or abdominal wall , may have spread to nearby lymph nodes , and/or have spread to distant parts of the body . Stage IV cancers are very hard to get rid of completely.
Chemotherapy is usually the first treatment if the cancer has not spread to distant parts of the body . The tumor is then rechecked. If it appears to be gone, chemo with or without radiation or cystectomy are options. If there are still signs of cancer in the bladder, chemo with or without radiation, changing to another kind of chemo, trying an immunotherapy drug, or cystectomy may be recommended.
Chemo is typically the first treatment when bladder cancer has spread to distant parts of the body . After this treatment the cancer is rechecked. If it looks like its gone, a boost of radiation to the bladder may be given or cystectomy might be done. If there are still signs of cancer, options might include chemo, radiation, both at the same time, or immunotherapy.
In most cases surgery cant remove all of the cancer, so treatment is usually aimed at slowing the cancers growth and spread to help people live longer and feel better. If surgery is a treatment option, its important to understand the goal of the operation whether its to try to cure the cancer, to help a person live longer, or to help prevent or relieve symptoms from the cancer.
Because treatment is unlikely to cure these cancers, many experts recommend taking part in a clinical trial.
When Do Doctors Use Bcg
Doctors most commonly use BCG to treat superficial bladder cancer. The vaccine stimulates the immune system to attack cancer cells in the bladder. It can be used with intravesical chemotherapy for advanced stages of bladder cancer.
It is not recommended for those who have weakened immune systems. While BCG treatment for bladder cancer can be effective, it is not a cure. It can help prevent cancer from recurring.
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Wide Variation In Use Of Bcg
The recent study by Dr. Steinberg and colleagues reveals wide variations in BCG treatment intensity. Many eligible patients did not receive BCG at all, and among those who did, it was often inadequate, stopping short of ongoing maintenance therapy. Conversely, some patients with low-risk disease received the treatment despite a lack of guideline support.
The retrospective analysis included 39,532 patients over age 65 with early-stage urothelial bladder carcinoma diagnosed between 2000 and 2012, according to findings published on July 24, 2020, in Urology. Of the 41 percent who received BCG treatment, only 28.4 percent received adequate therapy. However, at the 12-month point, adequate BCG treatment was associated with decreased risks of recurrence and of cancer-specific and all-cause mortality in patients with intermediate- and high-risk disease.
Although the analysis was not equipped to identify the reasons for such variation, investigators speculated that physicians might be reluctant to give BCG to patients with a high comorbidity burden or other, unknown contraindications. They observed that inadequately treated patients tended to be less healthy than those who received sufficient treatment.
There seems to be a mismatch in treatment intensity based on disease risk, with many patients receiving too much or too little care, says Dr. Steinberg. Overuse of BCG in patients with low-grade disease is also concerning, considering that BCG is in short supply worldwide.