What are the side effects of BCG treatment for bladder cancer. How is intravesical therapy used in treating bladder cancer. When is intravesical therapy most effective for bladder cancer patients. What types of intravesical therapy are available for bladder cancer treatment. How does BCG immunotherapy work against bladder cancer cells. What are the potential risks and benefits of intravesical BCG treatment. How does nadofaragene firadenovec differ from traditional BCG therapy.

Understanding Intravesical Therapy for Bladder Cancer

Intravesical therapy is a crucial treatment option for certain types of bladder cancer. This approach involves directly administering medication into the bladder through a urinary catheter, allowing for targeted treatment of cancer cells lining the bladder wall. By delivering drugs directly to the affected area, intravesical therapy aims to maximize effectiveness while minimizing systemic side effects.

How Does Intravesical Therapy Work?

The medication used in intravesical therapy is introduced into the bladder as a liquid through a catheter inserted via the urethra. This method ensures that the drug comes into direct contact with the bladder lining, where most bladder cancers originate. The localized nature of this treatment means that it primarily affects cells within the bladder, with minimal impact on other parts of the body.

When Is Intravesical Therapy Most Effective?

Intravesical therapy is primarily used for early-stage bladder cancers that have not penetrated deeply into the bladder wall. These cancers are classified as non-muscle invasive bladder cancer (NMIBC) and include:

• Carcinoma in situ (CIS) or stage 0 cancer, which is confined to the inner lining of the bladder
• Stage I bladder cancer, which has grown into the layer beneath the lining but has not reached the muscle layer

In these cases, intravesical therapy can be highly effective in treating the cancer and preventing its recurrence or progression.

Types of Intravesical Therapy for Bladder Cancer

There are two main types of intravesical therapy used in the treatment of bladder cancer: immunotherapy and chemotherapy. Each type works differently to combat cancer cells and may be recommended based on the specific characteristics of the patient’s cancer.

Intravesical Immunotherapy

Immunotherapy stimulates the body’s immune system to recognize and attack cancer cells. The most common form of intravesical immunotherapy for bladder cancer is Bacillus Calmette-Guerin (BCG) treatment.

BCG Treatment: Mechanism of Action

BCG is a bacterium related to the one that causes tuberculosis. When introduced into the bladder, it activates immune system cells, prompting them to target and destroy bladder cancer cells. This treatment is particularly effective for early-stage bladder cancers and is often used after transurethral resection of bladder tumor (TURBT) to prevent cancer recurrence.

Nadofaragene Firadenovec (Adstiladrin)

A newer form of intravesical immunotherapy, nadofaragene firadenovec, uses a virus to deliver a gene that produces interferon alfa-2b, an immune system protein. This gene therapy approach enhances the body’s natural defense mechanisms against cancer cells.

Intravesical Chemotherapy

Intravesical chemotherapy involves the direct application of cancer-killing drugs to the bladder lining. This method is often used immediately after TURBT and may be continued on a regular schedule for several weeks or months, depending on the cancer’s risk level.

BCG Treatment Side Effects: What to Expect

While BCG treatment is generally well-tolerated, it can cause a range of side effects. Understanding these potential reactions can help patients prepare for treatment and know when to seek medical attention.

Common Side Effects of BCG Treatment

• Flu-like symptoms (fever, aches, chills, fatigue)
• Burning sensation in the bladder
• Increased urinary frequency and urgency
• Blood in urine (hematuria)

These symptoms typically last for 2 to 3 days after treatment and are generally manageable with over-the-counter pain relievers and plenty of fluids.

Serious Side Effects and Complications

While rare, more serious complications can occur with BCG treatment. These may include:

• Severe, persistent fever
• Systemic BCG infection
• Allergic reactions

Patients with weakened immune systems are at higher risk for serious complications and may not be suitable candidates for BCG therapy.

Treatment Schedules and Duration

The frequency and duration of intravesical therapy vary depending on several factors, including the cancer’s risk level, the specific treatment used, and the patient’s response to therapy.

Typical Treatment Protocols

• Initial treatment: Often given within 24 hours of TURBT
• Maintenance therapy: May continue weekly or less frequently for up to 3 years
• Low-risk cancers: May require no further treatment after initial dose
• Higher-risk cancers: More intensive and prolonged treatment schedules

Oncologists tailor treatment plans to each patient’s specific situation, adjusting as needed based on cancer response and tolerance to therapy.

Intravesical Therapy for Advanced Bladder Cancer

While intravesical therapy is most effective for early-stage bladder cancers, it may sometimes play a role in the management of more advanced cases.

Use in Higher-Stage Cancers

For bladder cancers that have invaded the muscle layer (stage II or higher), intravesical therapy is generally not the primary treatment. However, in certain situations, it may be used:

• As part of a multimodal treatment approach
• When surgery is not an option
• Following chemotherapy and radiation therapy, if the cancer has responded well

In these cases, intravesical therapy may help control local disease and prevent recurrence, though its effectiveness is limited compared to its use in early-stage cancers.

Comparing BCG and Nadofaragene Firadenovec

As newer treatments emerge, it’s important to understand how they compare to established therapies like BCG. Nadofaragene firadenovec represents an innovative approach to intravesical immunotherapy.

Key Differences

• Mechanism: BCG activates the immune system directly, while nadofaragene firadenovec uses gene therapy to enhance immune response
• Administration: Both are administered intravesically, but treatment schedules may differ
• Side effect profile: May vary, with potential for fewer systemic effects with nadofaragene firadenovec
• Efficacy: Comparative studies are ongoing to determine relative effectiveness

The choice between these treatments depends on factors such as cancer characteristics, patient health status, and treatment availability.

Monitoring and Follow-up Care

Regular monitoring is crucial for patients undergoing intravesical therapy for bladder cancer. This ongoing care helps assess treatment effectiveness and detect any recurrence or progression early.

Follow-up Protocol

• Cystoscopy: Regular examinations of the bladder lining
• Urine cytology: Tests to detect cancer cells in urine
• Imaging studies: As needed to evaluate the upper urinary tract and check for metastases
• Side effect management: Ongoing assessment and treatment of therapy-related symptoms

The frequency of follow-up visits and tests is determined by the cancer’s risk level and the patient’s response to treatment. Open communication between patients and their healthcare team is essential for optimal care and early detection of any issues.

Future Directions in Intravesical Therapy

Research in intravesical therapy for bladder cancer continues to evolve, with ongoing efforts to improve treatment efficacy and patient outcomes.

Emerging Trends and Research

• Combination therapies: Exploring synergistic effects of different intravesical agents
• Novel delivery systems: Developing methods to enhance drug absorption and retention in the bladder
• Personalized medicine approaches: Tailoring treatments based on genetic and molecular profiles of individual cancers
• Immunotherapy innovations: Investigating new immune-modulating agents for intravesical use

These advancements aim to expand treatment options, reduce side effects, and improve long-term outcomes for patients with bladder cancer.

As research progresses, patients and healthcare providers can look forward to more targeted and effective intravesical therapies. The ongoing development of new treatments and refinement of existing protocols offer hope for improved management of bladder cancer at all stages.

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 given through a tube (urinary catheter) that’s been put into your bladder through your urethra.

When is intravesical therapy used?

Intravesical therapy is used mainly for some early-stage bladder cancers that are still only in (or very close to) the inner lining of the bladder (where almost all bladder cancers start). Drugs given directly into the bladder affect the cells lining the inside of the bladder and have little to no effect on cells elsewhere. This means that any cancer cells outside of the bladder lining, including those that have grown deeply into the bladder wall, aren’t treated by intravesical therapy. Drugs put into the bladder also can’t reach any cancer cells in other parts of the body.

To treat non-muscle invasive bladder cancer (NMIBC)

These early-stage cancers have not grown deep enough to reach the muscle layer of the bladder wall (nor have they spread to other parts of the body). They are:

• Only in the inner lining of the bladder (called carcinoma in situ (CIS) or stage 0 cancer), or 
• Have grown only into the layer below the lining (stage I bladder cancer) 

Most often, intravesical therapy is used after transurethral resection of bladder tumor (TURBT). A dose of intravesical chemotherapy (see below) is usually given within 24 hours of the procedure. 

If further intravesical treatments (immunotherapy or chemotherapy) are needed, they’re usually started a few weeks later. Treatment schedules vary, depending on the risk of the bladder cancer coming back after treatment, which treatment is used, how well the cancer responds to the treatment, and other factors. For some low-risk cancers, no further treatment might be needed. For higher-risk cancers, intravesical therapy might be given weekly (or less often) for up to 3 years. Your doctor will talk with you about the best plan based on the details of your bladder cancer and how it responds to treatment.

To treat higher-stage, invasive bladder cancers

These cancers have reached the muscle layer of the bladder wall. If a transurethral resection of bladder tumor (TURBT) is done as the initial surgery (which isn’t often), a dose of intravesical chemotherapy is often given within 24 hours. But intravesical therapy isn’t likely to be helpful for most stage II or higher bladder cancers because they have already spread beyond the inner lining of the bladder wall.

Sometimes if surgery can’t be done for a stage II or III bladder cancer for some reason, chemotherapy (given into the blood) and radiation therapy might be the first treatments, after which intravesical immunotherapy might be used if the cancer has shrunk enough. More advanced bladder cancers are rarely treated with intravesical therapy.

Types of intravesical therapy

There are 2 main types of intravesical therapy:

• Immunotherapy
• Chemotherapy

Intravesical immunotherapy

Immunotherapy causes the body’s own immune system to attack the cancer cells.

Bacillus Calmette-Guerin (BCG)

BCG is the most common intravesical immunotherapy for treating early-stage bladder cancer.

BCG is a germ that’s related to the one that causes tuberculosis (TB), but it doesn’t usually cause serious disease. When BCG is put into the bladder as a liquid through a catheter, it helps “turn on” the immune system cells there, which then attack the bladder cancer cells.

Side effects of BCG: Treatment with BCG can cause a wide range of symptoms. It’s common to have flu-like symptoms, such as fever, aches, chills, and fatigue, which can last for 2 to 3 days after treatment. It also commonly causes a burning feeling in the bladder, the need to urinate often, and even blood in the urine.

While getting BCG doesn’t usually make people very sick, serious BCG infections are more likely in people who have a weakened immune system, so this treatment typically isn’t recommended for these people.

If a serious infection does happen, one sign of this can be a high fever that doesn’t go away. If this happens, call your doctor right away.

You might want to ask about other serious side effects you should watch for and call your doctor about.

Nadofaragene firadenovec (Adstiladrin)

This treatment is made up of a virus that contains the gene to make interferon alfa-2b, an important immune system protein. When the virus is put into the bladder as part of a liquid, it delivers the gene into the cells lining the bladder wall. The cells then start making extra interferon alfa-2b, which helps the body’s immune system attack the cancer cells. Because this treatment involves adding a gene to some cells in the body, it can be thought of as a type of gene therapy. 

Adstiladrin can be used to treat NMIBC that is at high risk of returning and that isn’t being helped by treatment with BCG. It is typically given once every 3 months.

Side effects of Adstiladrin: Some people getting this treatment might have side effects such as feeling tired, having bladder spasms, feeling the need to urinate often, or having blood in the urine.

The virus used in this treatment doesn’t usually cause disease in people with normally functioning immune systems – it’s just a way to get the gene inside the cells. Still, this is a live virus that might cause more serious infections in people who have weakened immune systems. Because of this, this treatment typically isn’t recommended for people with a weakened immune system. 

Intravesical chemotherapy

For this treatment, chemotherapy (chemo) drugs are put right into the bladder through a catheter. These drugs kill actively growing cancer cells. Many of these same drugs can also be given systemically (usually into a vein) to treat more advanced stages of bladder cancer. Intravesical chemotherapy is most often used when intravesical immunotherapy doesn’t work.

The chemotherapy solution might be heated up before it’s put into the bladder. Some experts believe that this makes the drug work better and helps it get into the cancer cells. When the chemo is heated, it might be called hyperthermic intravesical therapy.

Mitomycin and gemcitabine are the drugs used most often for intravesical chemotherapy. Delivery of mitomycin into the bladder along with heating the inside of the bladder, a treatment called electromotive mitomycin therapy, may work even better than giving intravesical mitomycin the usual way.

Valrubicin or other chemo drugs might also be options in some situations.

Side effects of intravesical chemo: The main side effects of intravesical chemo are irritation and a burning feeling in the bladder, and blood in the urine.

A major advantage of giving chemo right into the bladder instead of injecting it into the bloodstream is that the drugs usually do not reach and affect other parts of the body. This helps people avoid many of the side effects linked to chemo.

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Bladder cancer treatment. BCG therapy• Russian Doctor

The treatment of bladder cancer with the BCG vaccine has been known for 30 years. Today, rich experience has been accumulated in the use of immunotherapy in patients with superficial bladder cancer. A narrow list of indications, recommendations on the expediency of using this method and contraindications have been formed. But it is still impossible to say with confidence that the method has been fully studied. The mechanism of action of the vaccine on cancer cells is not fully known.

History of the method

Long-term observations of the health of tuberculosis patients formed the basis of BCG therapy for bladder cancer. It turned out that they were less likely to suffer from malignant neoplasms. This moment served as the basis for an in-depth study of the effectiveness of BCG in tumors. In 1976, A. Morales and co-authors shared the positive results of using the vaccine in patients with superficial bladder cancer. Since then, the method has gained popularity and scientific research has continued.

Modern view of BCG therapy

BCG is a vaccine against tuberculosis. Its name comes from the abbreviation of the words: Bacille Calmette – Guerin, fr. Bacillus Calmette-Guérin, BCG. Vaccination with this drug is included in the national calendar of preventive vaccinations. But for several decades, the BCG vaccine has been successfully used by oncologists for intravesical therapy of non-muscle-invasive bladder cancer.

Why is the vaccine useful for cancer?

BCG is an immunotherapy drug. Upon contact with the cells of the bladder, the immune system is strengthened and the fight against pathological cells begins.

This reduces the likelihood of recurrence of the disease and tumor growth into adjacent tissues.

Indications for BCG therapy

With a high probability of recurrence of the disease and transition to an invasive form, BCG vaccine is administered into the bladder cavity. These can be the following cases:

• Papillary cancer (T1) of the second degree and above, with a tumor size of more than 3 cm, or in the presence of several formations.
• Papillary cancer (Ta and T1) of the third degree.
• Carcinoma in situ – it has a number of features. Firstly, it is flat, which makes it difficult to remove it surgically. Secondly, it often grows into the mucous membrane of the bladder.

Specialists of our partner clinics will definitely explain to the patient why BCG therapy in this case is justified and appropriate and is the most appropriate treatment. For those who have undergone surgery, a break of more than two weeks is taken to recover.

Contraindications

Below is a short list of them. The list of contraindications for a particular patient is determined by the doctor at an internal appointment.

• Elderly patient, over 80;
• poor tolerability of the procedure;
• tuberculosis;
• redness at the Mantoux skin test site;
• diseases of the immune system;
• serious condition of the patient;
• other cases where the risk of the procedure outweighs the potential benefit.

Method description

Treatment with the vaccine takes six weeks. After that, it is recommended to take a break for a month and a half and start repeating the course again. Now once a week, one to three weeks.

Maintenance therapy is also possible with good results. It is allowed to be held for three years. The schedule for administering the drug is once a week. Within 1-3 weeks with a break of six months.

In each case, the doctor will give detailed explanations and warn you about all possible complications and adverse reactions.

How is the treatment going?

Treatment available on an outpatient basis. One session takes about 3 hours. After that, the patient can return to his home.

Before the session, the patient is advised to limit fluid intake so that the concentration of the drug introduced into the bladder does not decrease. The doctor will tell you in more detail about the preparation and correction of the therapy taken before BCG therapy.

The patient is in a comfortable position during the examination. The nurse gently inserts the catheter through which the drug is delivered. The first quarter of an hour will need to be spent lying on your stomach, and after that you can get up and even move around. The therapeutic effect of the drug depends on the amount of time it is in the bladder cavity. Usually this is two hours. If necessary and other indications, the exposure time can be reduced, strictly in agreement with the attending physician.

Do not urinate during the procedure. This may cause some difficulty. Sometimes the catheter is left in the bladder, blocking the exit. This allows the drug not to leak out during the procedure.

At the end of the session, the patient is allowed to urinate into the toilet or the opening of the catheter is opened, allowing the drug to flow out.

At home and in public places, the patient is advised to take precautions. Since BCG is a live vaccine, other people should not be exposed to the TB pathogen (even as it is contained in the vaccine). To do this, for the next six hours, you need to ensure that urine is not splashed on the toilet or hands. After urinating, the toilet bowl should be treated with an undiluted agent to destroy vaccine residues and left for 15 minutes. The water comes down with the toilet lid down. The patient will be told about all this before and after the procedure.

Side effects

The first thing the drug affects is the bladder. Therefore, most complications relate to local reactions. Below we list the main possible complications.

• Various unpleasant or painful sensations in the bladder area can last up to two days. To reduce them, it is recommended to increase fluid intake and, if necessary, take the help of an anesthetic drug.
• Less disturbing fever , cough and joint pain . The first symptoms of such an ailment should be reported to the doctor immediately. This may be a sign of an infection and require emergency treatment. In the event of such complications, anti-tuberculosis drugs may be required.
• Allergic reactions in the form of skin rash and arthralgia are possible.
• To avoid serious complications, therapy is not given to people over 80 years of age. And it is carried out with caution to persons over 70 years of age.

Important information for BCG therapy

A condom must be used during sex for a week. This will protect your partner. The vaccine can be contained in both semen (for men) and vaginal fluid (for women).

Contraception is required for the entire period of treatment. Since the effect of the vaccine on the unborn child has not been studied and may have consequences.

Perspectives of BCG therapy

The method is being further studied. Experts are considering the advisability of combining BCG with interferon. Some studies even show that the use of interferon will reduce the dose of BCG. However, such a solution requires serious clinical trials and is still under development.

Russian Doctor takes care of its patients and offers the best in medicine today. Call us or leave a request on the website for a consultation with outstanding doctors.

With best wishes,

Your “Russian Doctor”.

BCG therapy as a method of preventing the recurrence of bladder cancer

Bladder cancer is a cancer that affects the wall of the bladder.

Bladder cancer most often occurs between the ages of 40 and 60 years. It should be noted that in recent years, cancer has become younger, which leads to the need for early screening.

The main and most common form is transitional cell carcinoma (92%). Further, in descending order – squamous cell carcinoma and adenocarcinoma (6%). Tumors such as sarcomas are the most rare (2%). The incidence of bladder cancer is 40% more common in men than in women.

There is a gradation of damage to the bladder wall by a malignant tumor.

In general, we can say that there is a superficial lesion of the mucosa and submucosal layer of the bladder wall and a deep one with spread to the muscle and connective tissue. The method of treatment of bladder cancer depends on the degree of invasion. With a superficial lesion, endoscopic removal of the tumor is performed. With a deep lesion, a radical removal of the entire organ is carried out with the formation of a different type of new bladder, most often from the intestine.

The main clinical manifestation of bladder cancer at an early stage is the presence of blood in the urine. In this case, we recommend that you immediately contact a urologist! Also, a tumor of the bladder can be accompanied by pain in the lower abdomen and frequent urge to urinate.

Diagnosis

The main methods for diagnosing bladder cancer include:

1. diagnostic cystoscopy (in the presence of blood in the urine)
2. bladder ultrasound
3. urine cytology
4. magnetic resonance imaging of the pelvic organs

If a tumor is detected, its primary biopsy or complete removal of the tumor is performed with further histological examination of the tissue.

Treatment

Depending on the stage of the disease, either endoscopic removal of the tumor (at stage l) or complete removal of the bladder with further reconstruction of the urinary tract is performed.

With the most favorable stage I, the survival rate reaches 95%, especially in combination with intravesical BCG chemotherapy. The BCG vaccine is a suspension (suspension) of weakened viable Calmette-Guerin bacilli.

The BCG treatment of bladder cancer involves the intravesical administration of a vaccine. The reaction to the vaccine stimulates the activity of immune factors aimed at destroying the emerging new atypical cells; in addition, the actual antitumor effect has been proven, i.e. the ability of BCG to “orient” the immune system to the destruction of cells of an already existing and growing tumor.

In our Yourmed clinic you can take a complete course of diagnostics of the urinary system.

In case of bladder cancer, we can offer all types of treatment followed by intravesical BCG chemotherapy of the bladder.