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Bcg For Bladder Cancer Side Effects

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Preventive Systemic Administration Of Tuberculostatic Drugs

When BCG for Bladder Cancer Goes Rogue and How It Impacts TB Clinicians

As BCG strains are sensitive for most tuberculostatic drugs, it was logic to explore if its use could diminish the side effects, with however possible less efficacy. EORTC study addressed this clinical question. Three days of 300 mg isoniazid , once daily at the occasion of the BCG instillation, could not reduce local or systemic toxicity29 and did not influence efficacy on recurrence and progression.30,31 However, INH provoked transient liver toxicity in several patients. So, the use of prophylactic INH is not recommended.

Another prospective, double-blind, placebo-controlled multicenter randomized clinical trial32 showed that two doses of 200 mg ofloxacin, which is a strong tuberculostatic agent, given shortly after BCG instillation, reduced moderate-to-severe side effects by 18.5%. Compliance to the therapy was also better. However, it concerned only 115 patients, divided in two groups, which makes definitive conclusions dangerous. As the median follow-up was only 1 year, long-term efficacy cannot be judged. To our knowledge, further reports on this method of prevention did not appear so far, and therefore, it cannot be advocated.

Who Can Use Bcg

BCG is a treatment for early-stage bladder cancer that has not yet invaded the muscle of the bladder wall. Called non-muscle invasive bladder cancers or in situ bladder cancers, these account for about half of all bladder cancers.

For 2021, it was estimated that about 83,730 new cases of bladder cancer would be diagnosed in the United States, and about 17,200 American bladder cancer patients would die from the disease.

Intravesical Therapy For Bladder Cancer

With intravesical therapy, the doctor puts a liquid drug right into your bladder rather than giving it by mouth or injecting it into your blood. The drug is put in through a soft catheter that’s put into your bladder through your urethra. The drug stays in your bladder for up to 2 hours. This way, the drug can affect the cells lining the inside of your bladder without having major effects on other parts of your body.

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Local Infections With Bcg

BCG can invade the prostate and the seminal vesicles up to the epididymis. These diseases require a triple tuberculostatic treatment. Often fluoroquinolone is one arm of it. The duration varies from one study to another from 3 to 6 months. Orchiepididymectomy may be a rapid solution for a severely symptomatic patient, but it does not replace the general tuberculostatic treatment that should be continued.13 In rare cases, transurethral resection of the prostate is necessary to solve obstruction. Asymptomatic granulomatous prostatitis, however, was found to be frequent after intravesical BCG therapy but does not require treatment.14

BCG balanitis or contact dermatitis has been described and can be handled with local steroids. Careful cleaning of hands and genital region after drug handling and voiding should prevent it.

Granulomatous balanitis, however, can present with multiple erythematous and painless nodules of the glans, which should be treated with systemic triple tuberculostatic drug therapy.13,40

Is Bcg Treatment Contagious

Figure 1

Because BCG contains live bacteria, precautions are necessary to prevent it from being passed to others.

Patients should go to the bathroom sitting down to reduce splashing and wash their hands thoroughly after urinating. Pouring bleach into the toilet after use may also prevent contamination.

Once home, a patient should drink plenty of liquids and avoid sexual contact with others for 24 hours.

Research has shown that BCG may also reduce the risk of contracting a respiratory tract infection, giving your immune system a boost. However, precautions are still necessary to stay healthy.

The care team will talk to the patient about what to expect and provide instructions to follow at home.

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Type Of Severe Side Effects

Severe side effects continue to be reported in the literature. BCG infection or immune reactions can appear wherever in the body, in any organ, with very unusual clinical manifestations in different medical specialties. A review on the subject was published in August 201413 and gives an extensive list of described severe complications: prostatitis, orchiepididymitis, balanitis, osteomyelitis, and acute infectious arthritis at different places in the skeleton, infected orthopedic and vascular prostheses, rheumatological complications, mycobacterial pneumonia, interstitial pneumonitis due to hypersensitivity, hepatitis, nephritis, vasculitis, mycotic aneurisms, disseminated BCG and septicemia, and finally the local complication of ureteral obstruction and bladder contracture. From June 2014 to May 2015, we found another ten reports on severe complications.1423 So the things that can happen are very rare but quite impressive and in any organ of the body.

Side Effects Requiring Immediate Medical Attention

Along with its needed effects, bcg may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking bcg:

More common

  • painful urination


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Differences In Adverse Events Among Different Bcg Strains

Side effects seem similar for all BCG strains used , but frequency differs from one study to another. No differences between strains in side effects have been noted in a meta-analysis25 and in a recent study comparing Tice versus Connaught strain.26 The dose and treatment schedules used differ among studies, and therefore, comparison among them is difficult. Ideally, the dose should be expressed on colony-forming units as there are strong variations of factors 14 among the commercial preparations. Many studies do not mention this information and express the dose in milligrams.

Another problem is that the side effects of BCG have not been evaluated in a standard way in many studies, resulting in large differences in the frequency of local side effects of BCG. A classification of these side effects, taking into account severity and duration, has been proposed and validated,7 but this was not commonly applied by the urologic community.

How You Have It

Bladder Cancer Treatment: Intravesical Therapy – Urology Care Foundation

BCG is a liquid. Your doctor or nurse puts the liquid into your bladder through a tube in the urethra . Usually, they then remove the catheter.

You must not pass urine for 2 hours. This gives the BCG time to be in contact with the lining of the bladder. Some hospitals may ask you to change position every now and again to make sure the drug reaches all parts of your bladder lining.

When you do pass urine, you need to be careful for 6 hours after the treatment because the vaccine contains bacteria. Men should sit down to pass urine to reduce the chance of splashing.

After you’ve been to the toilet, pour about half a pint of neat bleach into the toilet bowl and leave it for 15 minutes before flushing.

Wash your hands and genitals immediately with warm soapy water after you pass urine.

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From Bcg To Chemo Combos

Non-muscle-invasive bladder cancer is so called because the tumor resides strictly in the bladders interior lining, called the mucosa. Among other tasks, this mucosal lining operates as a barrier between the smooth muscle that encases the bladder and the urine within it.

About 70%75% of bladder cancer diagnoses are NMIBC and about 25% of these are at high risk of progressing to muscle-invasive bladder cancer.

A tumor is called high-risk when its size or other features suggest that its biologically aggressive. One form of high-risk NMIBC, for example, is called carcinoma in situ, in which the tumor spreads along the mucosa in a pancake-like shape. These tumors are not only aggressive, Dr. Packiam explained, but particularly resistant to treatment with BCG. And when they do come back, its often in a more invasive form.

The treatment course for high-risk NMIBC begins with removing the bladder tumors via a surgical procedure called TURBT. Surgery is followed by additional treatments, known as adjuvant therapy, to kill off any remaining cancer cells and reduce the risk of the cancer coming back.

For decades, adjuvant therapy with BCGa severely weakened form of a bacterium that was originally developed as a tuberculosis vaccinewas the gold standard for preventing progression and recurrence in high-risk NMIBC, he explained.

Lowering The Bcg Dose

Low-dose BCG has been tried in an attempt to decrease the frequency and severity of the side effects.34 In this study, one-third dose BCG was found as effective as a full dose in the prevention of recurrence and progression. However, patients with multifocal tumors fared better with the standard dose. In a later study, they confirmed similar efficacy of one-third dose versus full dose in high-grade and high-risk tumors,35 while overall side effects were significantly less. However, the number of patients who discontinued BCG for toxicity and the severe complications were similar in both arms. A third report of the same group found that one-sixth dose was significantly less effective than one-third dose,36 and therefore should not be used. The EORTC showed in a Phase II marker lesion study that a quarter dose was still effective.37 So, this is probably the lowest dose that can be advocated regarding efficacy.

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What Are Some Other Side Effects Of This Drug

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach.
  • Not hungry.
  • Many people using this drug have bladder irritation. It may start within a few hours after getting this drug and may last for 1 to 3 days. You may pass urine more often or feel the need to pass urine right away. Call your doctor if you have bladder irritation that bothers you or does not go away within 3 days.
  • It is common to have burning or pain when passing urine, chills, flu-like signs, mild fever, tiredness, or weakness. If any of these signs last more than 2 days or get worse, call your doctor.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to your national health agency.

You may report side effects to the FDA at 1-. You may also report side effects at .

What To Expect During Bcg Treatment

BCG Treatment

First, make sure you havent had any fluids for four hours before the treatment. Right before you go into the treatment room your doctor or nurse will have you empty your bladder.

Youll lie on your back, and the medical professional will insert a catheter into your urethra and into your bladder, likely using some local numbing, and use this tube to infuse the treatment.

Once the treatment is infused, your doctor or nurse will remove the catheter. Theyll have you lie on your back, each side, and your stomach for 15 minutes each. The BCG mycobacteria needs to touch the bladder cancer cells to activate the immune system. Youll then be free to go but will need to hold off on peeing for another hour.

Verywell / Alex Dos Diaz

For at least six hours after your infusion, youll need to disinfect your pee to ensure none of the mycobacteria spread to anyone else. Pour an equal amount of bleach into the toilet after you pee and let it sit for 15 minutes before flushing.

You will likely need multiple BCG treatments. They may be given weekly for a few weeks, then less often for months or years to prevent cancer from coming back.

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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.

Bcg Side Effects And Complications

I’d like some advice and info from anyone who can help. My father was diagnosed with Bladder Cancer in November. Lives in Holland so it’s difficult to get answers to my questions. First TURBT was in December all went okay, another 4 weeks later to check for scarring etc. Then the BCG Treatment started, 6 week course. The first 3 were fine and then he started getting really sick with the treatment. Vomitting, high fever, weakness, loss of appetite. He was given antibiotics but same thing happened on the 4th and 5th treatment. By the 6th treatment he was so sick he was not able to dress himself as his been so weak. He was taken to A& E and had a seizure in the waiting room, stayed one night was given more antibiotics and fluids and then sent home. They said they won’t be continuing with the BCG but won’t know the options until we get some results in a months time but his in such a bad way. Struggling to walk with joint pain, very down and depressed as he needs so much help and support with simple tasks. Is this normal after BCG? How long will he be feeling like this? Has anyone had a similar experience? What other treatments have you had and were they successful. Sorry for so many questions, I just don’t want him to suffer anymore.

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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.

Is Bcg Treatment A Form Of Chemotherapy

Bladder Cancer, BCG, and Covid-19 | Treatment Vaccine Update for Patients and Families

BCG is an immunotherapy that helps the bodys immune system fight off cancer cells. Chemotherapy, on the other hand, uses anti-cancer medications to directly kill the cancer cells.

For most patients, BCG treatment usually begins with two-hour sessions once a week for six weeks. If the body responds to the treatments, more sessions may be scheduled.

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What Are Some Things I Need To Know Or Do While I Take This Drug

  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have a latex allergy, talk with your doctor.
  • Take extra care with your urine for the first 6 hours after getting this drug. Use the same toilet each time you use the bathroom at home. Sit down to urinate so your urine does not splash or spray.
  • Before flushing, add an equal amount of bleach to the urine. Wait 15 minutes, then flush. Do this for the first 6 hours after BCG is given.
  • It is fine to be around close contacts like household members, friends, and caregivers. However, do not allow anyone to come into contact with your urine.
  • You may need a TB test before starting this drug.
  • This drug may affect certain lab tests. Be sure your doctor and lab workers know you use this drug.
  • Use birth control that you can trust to prevent pregnancy while taking this drug.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Is There Any Preparation Involved

Its important that you follow your doctors instructions for what to do before and after the procedure. Tell your doctor about all the medications you take. Certain immunosuppressants, antimicrobial therapies, and radiation therapies can interfere with BCG treatment.

Youll be advised to limit your fluid intake for four hours prior to the procedure. You might be told to avoid caffeine for a few hours longer than that, because its a diuretic and could make things more difficult.

Youll be asked to urinate just before the procedure so youll be able to hold the medication in your bladder for several hours.

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