Sunday, February 18, 2024

Bcg Treatment For Bladder Cancer

Mechanism Of Action Of Bcg

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

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 To Know About Bcg For Bladder Cancer

Did you know May is Bladder Cancer Awareness Month? Itâs a time to raise extra awareness and promote facts about this disease. Education and raising awareness about bladder cancer is an important part of moving closer to a cure.

If you or a loved one is diagnosed with bladder cancer it can be frightening. However, your doctor and medical team are there to help you.

Talk with your healthcare team about all the available forms of treatment. They will tell you about possible risks and the side effects of treatment on your quality of life.

Your options for treatment will depend on how much your cancer has grown. Your urologist will stage and grade your cancer and assess the best way to manage your care considering your risk. Treatment also depends on your general health and age. Visit our condition article to learn more about treatment options for bladder cancer.

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Bcg Failure And Subclassification

About 40% of patients of NMIBC will fail intravesical BCG treatment. Although many factors might lead to BCG failure, the dose of BCG and type of T helper response may lead to dramatically diverging outcomes. Low-dose BCG might not trigger enough TH1-type immune response, which is the main response to BCG activity. Too high doses of BCG may paradoxically activate mixed TH1/TH2 responses which will counterbalance the TH1 response . Other factors of BCG failure include occult micrometastatic disease prior to BCG therapy .

Patients who fail intravesical BCG treatment are usually sub-classified into three categories based on the type of failure:

BCG refractory, which is the persistence of disease after induction or maintenance BCG treatment.

BCG relapse, the recurrence of disease after a disease-free period post BCG treatment.

BCG intolerance when the patient is not tolerating the completion of BCG induction .

The definitions, endpoints and clinical trial designs for NMIBC as recommended by the International Bladder Cancer Group might serve as an excellent current state-of-the-art resource . The type of failure should be clearly defined. Because stakes are very high for these patients, for whom BCG has failed, and options are limited, single-arm designs may be relevant for the BCG-unresponsive population. The consensus for a clinically meaningful initial complete response rate or recurrence-free rate is of at least 50% at 6 months, 30% at 12 months and 25% at 18 months.

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What Happens During Bcg Cancer Treatment

Before beginning BCG treatment, local anesthesia is given to numb the area and keep you comfortable. Next, your healthcare provider will place a catheter into your urethra and inject the liquid BCG solution into your bladder.

The BCG solution needs to come in contact with cancer cells to kill them. So, once the medication is injected, your healthcare provider will remove the catheter and ask you to lie on your back, stomach and both sides for 15 minutes each.

When the process is complete, youre free to leave your appointment. However, you should avoid peeing for at least one more hour.

How long do you hold BCG in your bladder?

Once the BCG solution is injected into your bladder, youll hold it for a total of two hours. After this point, youll be able to pee.

What does BCG do to the bladder?

When the BCG solution enters your bladder, your immune system cells begin to attack the cancer cells in your bladder.

BCG treatment schedule

The initial BCG cancer treatment occurs weekly for six weeks. This is called induction therapy.

If the treatment is working, your doctor may prescribe BCG maintenance therapy. Maintenance therapy is given once a week for three weeks at the three-, six- and 12-month marks. For some people, this may be continued up to three years.

Who Can Have This Treatment

Intravesical Therapy

BCG is appropriate for noninvasive and minimally invasive bladder cancers. It usually follows a procedure called transurethral resection of bladder tumor . Its intended to help prevent recurrence.

This treatment only affects cells inside the bladder. Its not useful for later stage bladder cancer that has spread into or beyond the bladder lining, or to other tissues and organs.

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How You Have It

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.

What Is The Maximum Number Of Bcg Treatments That May Be Given For Bladder Cancer

To administer BCG, a catheter is inserted into the bladder and a liquid solution is administered. For the next two hours, the subject must retain the solution in the bladder before letting go and eliminating it. In most cases, the therapy is administered once a week for six weeks, beginning two to three weeks after the previous TURBT was performed.

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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.

Who Can Use Bcg

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

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.

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Failure Of Bcg Contact With The Target

Gradual waning of the immune response. Intravesical BCG instillations induce a transient peripheral immune activation against BCG antigens. Reactivation is observed in most cases after additional BCG courses. The absence of long-lasting immune activation after a single 6-week course of BCG could be related to the increased clinical efficacy observed with BCG maintenance instillations.12,13,14

Inadequate immune response. There is strong evidence that the success of BCG therapy might be due to a preferential induction of a TH-1 response .15,16 Although somewhat controversial, TH-2 responses detected either in the peripheral circulation or locally in the bladder are associated with poorer outcomes and might explain failure to respond to BCG therapy.17

Natural resistance-associated macrophage protein gene polymorphisms. The NRAMP1 gene has been implicated in susceptibility to infectious diseases and in response to BCG. Data suggest implication of the NRAMP1 gene in bladder cancer recurrence and response to BCG.18

Unresponsive tumour. Many recent investigations have determined whether biological markers might predict disease progression and/or response to treatment.19 An excellent review was provided a couple of years ago by Saint and colleagues.20

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Q: Why Can’t Merck Make More Bcg

A. While Merck has many years of experience producing BCG, this medicine has a lengthy and complex manufacturing process. Merck continues to produce BCG at full capacity, but the demand for the drug is greater than what can be produced. Merck understands this is a challenge for patients and is working hard to improve production so they are able to get this medicine to patients as quickly as possible. On October 4, 2020, Merck announced plans to construct a new TICE BCG manufacturing facility in the United States. Merck expects to break ground in 2021 and anticipates the build to take up to six years to complete. Once fully operational, the company expects to triple its current manufacturing capacity, which is expected to support the anticipated demand for TICE BCG for the forseeable future.

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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

When Is Bcg Treatment Used

BCG immunotherapy of bladder cancer: 20 years on

You may have BCG directly into your bladder after surgery to remove non-muscle-invasive bladder cancer. This type of surgery is called a transurethral resection of a bladder tumour .

This treatment helps prevent the cancer from coming back in the bladder lining. It also reduces the risk of the cancer becoming muscle-invasive. Doctors usually suggest this treatment if you have a high-risk bladder cancer, or sometimes if you have an intermediate-risk bladder cancer.

There is usually at least 2 weeks between the surgery to remove the cancer and the start of BCG treatment. This is to give your bladder enough time to heal from the surgery.

You usually have BCG treatment once a week for 6 weeks. This is sometimes called the induction course. You may be offered more BCG treatments. This is usually called maintenance treatment.

Treatment times vary. Your doctor will explain what is best for you.

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Aftereffects Of Bcg Bladder Treatment

Just trying to see if anyone else has had the same experience. Recently finished my second âmaintenanceâ treatment after being passed âclearâ following the main 6 treatments. So really good news but the aftereffects seem to be lasting much longer than previously. The bladder irritation after treatment usually went after two or three days but with this last treatment l still have a constant ache in the bladder/scrotum area three weeks after treatment? Pain is controlled by Paracetamol so not that severe but would like to hear from other sufferers to see if this eventually goes away?

Welcome to Cancer Chat Dave.

Itâs great to read that youâve finished the second maintenance treatment after being passed clear following the main 6 treatments although Iâm sorry the after-effects youâre experiencing are lasting longer than usual.

I know you said the paracetemol is controlling the pain but do let your medical team or GP know about this as they may be able to help. Iâve had a quick look around the forum and thought you may like to connect with @Sharonna as sheâs having some difficulty managing the pain from her BCG treatment at the moment and you may be able to help each other.

You can chat with our cancer nurses about your situation as well if you like. Theyâre available Monday â Friday between 9a.m â 5p.m on 0808 800 4040.

I hope this helps and that the after-effects disappear soon Dave.

All the best,

Box : Prognostic Factors For Recurrence

  • Number of tumours more tumours mean more frequent recurrences.

  • Previous recurrence rate* or a recurrence at three months.

  • Size of the tumour those > 3 cm carry a worse prognosis.

  • Grade of anaplasia.

  • Presence of CIS.

*The recurrence rate being the number of positive cystoscopies per year over the number of cystoscopies performed per year.

For progression, tumour grade is the most important factor. It is also known that T1 tumours have a worse prognosis than Ta tumours. Using these factors patients with superficial bladder cancer can be divided into three groups: the lowest risk group with a single less than 3 cm Ta G1 tumour, and a recurrence rate of less than one tumour per year a high risk tumour of T1 G3, multifocal, large, highly recurrent, and CIS and other tumours of intermediate risk. Recent studies further confirm these criteria.

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Important Message About The Bcg Shortage

Bacillus Calmette-Guérin is a standard treatment option for non-muscle invasive bladder cancer. Last year, Merck & Co., the only maker and supplier of BCG to the United States, informed the AUA they were experiencing a global shortage of BCG due the growing use and need for this product around the world.

While Merck has raised their production of BCG, they expect this shortage to carry through 2020.

Please read the message below from the AUA concerning the shortage.

Treating Stage Iv Bladder Cancer

Bladder Cancer Treatment: Intravesical Therapy – Urology Care Foundation

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 casessurgery 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.

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When To See A Doctor

There are a few side effects that can be especially dangerous, so make sure to talk to your doctor if you notice that you:

  • Have a severe skin rash
  • Are wheezing or having difficulty breathing
  • Are finding swallowing to be difficult
  • Have a high fever that isnt lowered with Tylenol or other over-the-counter fever reducers

When You Have It

You usually have BCG into the bladder once a week for 6 weeks. This is called the induction course.

You may then have BCG into the bladder every few weeks or months for the next 1 to 3 years. This will depend on your risk of developing invasive bladder cancer. This is called maintenance BCG therapy.

You usually have treatment at the cancer day clinic.

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Bcg Treatment For Bladder Cancer

BCG is the standard treatment used for early-stage bladder cancer, and is used specifically on a cancer type known as high-risk non-muscle invasive bladder cancer .

For high-risk stage 0a bladder cancers, BCG is often given shortly after surgery. BCG is also used for stage 0is and stage 1 cancers, which have only spread into the lining of the bladder and not into deeper layers of tissue, muscle or to other parts of the body. BCG isnt typically appropriate for cancer cells that have spread outside the bladders lining.

Adverse Effects Of Bcg

BCG Treatment for Bladder Cancer Illustration by ATLAS Studios ...

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

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