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.
How Does It Work
BCG is a vaccine which is used to prevent tuberculosis . But its also a helpful treatment for some early bladder cancers. Like chemotherapy it is inserted into the bladder via a catheter.
BCG is a type of immunotherapy which stimulates the bodys immune system to destroy cancer cells. BCG makes the bladder react in a way that triggers the bodys immune system to get rid of cancer cells in the bladder.
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:
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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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.
What To Expect During 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.
Also, people with a penis who undergo BCG treatment should avoid sex for 48 hours to ensure they dont pass the mycobacteria to their partners.
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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Treatment Of Cis Or Residual Papillary Tumours
Treatment of CIS
BCG is first line treatment for CIS. It has been shown by Akaza et al in 1995 that with BCG 84.4% of his 32 cases with CIS showed a complete response. These results were better than the previously reported figures by Harland et al, which revealed a complete response in only 53% of their 53 patients. Although it should be noted that the Harland group used a lower dose of BCG.
Merz et al, in 1995 looked at 115 patients with CIS, 25 of these had primary CIS and 90 had secondary CIS . They found that 88% of those with primary CIS had responded completely, with negative cytology and cystoscopic findings . Of those with secondary CIS, 78% had a complete response after treatment with BCG . These results are summarised in table 1.
Summary of results for CIS and papillary tumours treated with BCG
Treatment of papillary tumours
As an indication for BCG treatment, this is less common and is usually utilised when endoscopic control is not possible, either because the sheer volume of bladder tumour makes complete resection difficult or because the patient is not medically fit for an operative procedure. Akaza et al used BCG as a primary treatment for 125 cases of Ta or T1 tumours, and they were able to achieve a 66.4% complete response. A partial response was achieved in a further 20.8% of their patients.
How Bcg Therapy Is Done
BCG as an immunotherapy for cancer is given through a catheter into the bladder, never intravenously or as an injection. This is usually done in an outpatient setting. The professionals there will assemble the BCG so that it can be safely administered.
Your clinician will give you specific instructions about how you need to prepare ahead of time. You may need to limit your fluid intake before the procedure. Just before it, youll need to empty out your bladder.
The urinary catheter is inserted through the urethra . The solution containing the BCG is injected into the catheter. The catheter is clamped to help the BCG remain inside the bladder, where it can start to work. You may be asked to roll around a bit to help the medication reach all parts of the bladder. After a couple of hours or so, the catheter is unclamped. The fluid drains away, and someone removes the catheter.
Because BCG therapy includes an active, live bacteria, youll need to take certain precautions. For about six hours after the treatment, you should urinate while seated . During this time, you should also add bleach to the toilet for 15 minutes before flushing. This will help disinfect the toilet. You should also wash your genital region and your hands carefully. After the treatment, you should increase your fluids to better help flush out the bladder.
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When You Go Home
Some hospitals allow you to go home with the medicine in your bladder if you live close by and are okay with the treatment. Your team will let you know if you can do this. You should follow the advice on what to do when you pass urine.
You need to drink lots of fluid after this treatment for 24 hours. It helps clear your system of the BCG.
You should not have sex for 24 hours after each treatment. During your course of treatment and for a week afterwards, you should wear a condom during sex.
Having bladder cancer and its treatment can be difficult to cope with. Tell your doctor or nurse about any problems or side effects that you have. The nurse will give you telephone numbers to call if you have any problems at home.
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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What Is The Success Rate Of Bcg Treatment For Bladder Cancer
Bladder cancer is a relatively common cancer that affects the urinary system. If not treated early, it can spread to other parts of the body and become fatal.
Bladder cancer is most commonly diagnosed in older adults. It grows slowly and usually does not cause symptoms until it is large and spreads to other organs.
Bladder cancer treatment options include chemotherapy and radiation therapy. Patients who are diagnosed with this kind of cancer are usually given BCG treatment to help fight cancer. Lets have a look at the success rate of BCG treatment for bladder cancer.
Current Alternatives To Bcg
Research on improving NMIBC therapy has mainly focused on rescue patients who do not respond to BCG therapy, since BCG is truly efficacious in the majority of patients for avoiding recurrence and progression episodes. The alternative treatment options include virus and other bacteria different from BCG as vehicles for specific tumor growth inhibition agents or immunostimulatory components, chemotherapeutic agents, new delivery options for current therapies, and systemic immunotherapies that have to be demonstrated to be efficacious in other types of cancers .
Figure 1 Current alternative research for nonmuscle invasive bladder cancer treatment.
Chemotherapeutic Treatments and Improved Delivery
Different strategies can improve the use of chemotherapy for treating NMIBC. The appearance of new agents, the combination of different chemotherapeutic agents, the use of hyperthermia for improving intravesical instillation, or other strategies have been considered for improving the treatment of intermediate- and high-risk NMIBC patients.
The efficacy of intravesical therapies can also be improved through delivery adaptations such as hyperthermia, electromotive drug administration or new devices.
Checkpoint Inhibitors in Nonmuscle-Invasive BC
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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.
Who Can Have This Treatment
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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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.
When Is Bcg Treatment Used
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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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.
Q: Who Can I Call With More Questions About The Bcg Shortage
A. We understand this situation may be stressful to those who rely on this drug, and we are sorry. Please understand that we are working with suppliers in order to provide the best possible care for our patients. We encourage you to talk to your provider about alternative treatment options to BCG while this shortage continues.
For further information about BCG, please feel free to reach out to Mercks National Service Center at 1-800-444-2080.
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How Should I Prepare For Bcg Treatment For Bladder Cancer
Prior to BCG treatment, your healthcare provider will give you a list of specific guidelines to help you prepare. In general, you should avoid caffeinated beverages and diuretics for four hours before your appointment. When you arrive for your procedure, you should pee to ensure that your bladder is empty.
Treatment Of Superficial Bladder Cancer
The treatment of bladder cancer in general depends on numerous factors, including stage and grade of the disease, patient age, and their co-morbidity. The standard treatment of superficial bladder cancer is a transurethral resection, this initial resection usually removes the tumour but it is known that they have a great propensity to recur. It is important to realise that some tumours progress, and in those which do it is vital that they are recognised so that further treatment can be instigated. A significant breakthrough in the last decade has been the clear definition of prognostic factors, which determine later recurrence. Using these factors it is possible to identify different patient subgroups and tailor their treatment and subsequent follow up accordingly. The most important factors are easily assessed at transurethral resection and are listed in box 1.
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Whats Old Is New Again
Bacterial therapies for cancer are not new. They go back more than a hundred years to William Coley, whose eponymously named toxins were some of the first cancer immunotherapies ever developed. Dr. Coley was a surgeon at Memorial Hospital who noticed that people with cancer who got severe infections sometimes saw their cancers regress. He began administering a vaccine of heat-killed bacteria to patients in the hopes of spurring their immune systems to attack cancer. Dr. Coley had some success with his approach, but the results proved unpredictable and hard to replicate, so his toxins eventually faded from use.
Inspired by Dr. Coleys work, scientists at MSK continued to research immune-based treatments for cancer. This sustained research effort eventually led to the development of modern forms of immunotherapy, including immune checkpoint inhibitors. These drugs take the brakes off T cells and allow them to find and fight cancer cells that display unique neoantigens .
We show that BCG is similar to checkpoint inhibitors in that it works by eliciting an immune response against cancer neoantigens, says Gil Redelman-Sidi, a physician-scientist who collaborates with Dr. Glickman and is the co-corresponding author on the PNAS paper. These results bring BCG into the modern world of immunology.