Predictors Of Response To Bcg
Markers of response to intravesical BCG fall into three broad categories: determination of response , use of surrogate endpoint biomarkers and prediction of response. BCG is most frequently used to treat high-grade disease and assessing the response of CIS specifically is challenging because it is often difficult to detect. A commonly used design is to determine response by cystoscopy, cytology and possibly bladder biopsy at 3 months and 6 months following a BCG induction regimen. However, the 3-month assessment is problematic because of the well documented conversion of positive cytology at 3 months to negative cytology at 6 months, particularly after maintenance BCG. Fluorescence cystoscopy can improve detection of both CIS and papillary bladder cancer, but fluorescence can also be induced by inflammation. It remains to be seen whether fluorescence cystoscopy can reliably improve the determination of BCG response.
Cytology is a subjective test with variable performance molecular tests that are more objective might yield better and more consistent performance in detecting visually occult bladder cancer. Patients who have abnormal results in the UroVysion assay in a urine sample obtained immediately before the last of the 6-week induction instillations have increased risk for tumour recurrence and progression.
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.
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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Radiation As An Option For Recurrent Disease
Cystectomy remains the standard for recurrent BCG-refractory, high-grade T1 bladder tumours. However, many patients are not undergoing surgery, possibly owing to comorbidities and/or a desire to avoid a large operation. Furthermore, the high rates of clinicopathological stage discordance noted after surgery might contribute to the poor long-term results of second-line intravesical agents following BCG failure.
Radiation therapy presents a non-surgical option for BCG failures. Early studies showed reasonable response rates ,, and one randomized trial in patients with high-grade T1 tumours comparing conservative treatment with radiation alone showed no difference between treatments in terms of recurrence.
Based on current evidence, the new 2015 NCCN bladder cancer guideline states that external-beam radiotherapy is rarely appropriate for patients with stage Ta, T1, or Tis disease. Radiochemotherapy might be a potentially curative alternative to cystectomy in patients with recurrent TaT1 disease . Currently, the North American multicentre, cooperative Radiation Therapy Oncology Group protocol RTOG 0926 is evaluating the role of radiochemotherapy after maximum TURBT for patients with high-risk T1 bladder cancer following BCG failure for whom the next therapy would have been radical cystectomy.
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.
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Are There Any Possible Effects From The Treatment
9out of 10 people having BCG will develop some side effects these usually beginwithin 3-4 hours after treatment and may last 1-3 days.
Commontreatment effects
You should tell your doctorat your next appointment if you have any of these symptoms.
- Somebladder discomfort – an irritation rather like a urine infection.
- Flu-likesymptoms which can last for 1-3 days after each treatment.
- Wantingto pass urine more often than usual or more urgently, which can last for two tothree days.
- Failureto complete the course of treatment due to discomfort in the bladder.
- Bloodor debris in the urine.
Drinking2 litres of fluid daily, unless advised otherwise, and avoiding tea/coffee for24 hours after treatment will help flush any remaining drug out of the bladderand may ease the above symptoms.
Occasional
- Narrowing of the urethra following repeated use of a catheter.
- Inflammationwhich can affect various parts of the body .
Rare
- Persistentor severe pain after treatment, sometimes leading to removal of the bladder.
- Generalisedand possibly serious infection with the BCG bacteria needing treatment inhospital with powerful antibiotics. This is not TB and there is no risk ofcatching TB from the treatment.
Veryrarely – less than 1 person in every 100 – may experience more serious treatmenteffects.
Contact your GP/Nurse immediately if you have anyof the following:
- Urineis cloudy/offensive smelling
- HighTemperature over 38°C for 48 hours
After Your Bcg Treatment
If thecatheter was left in the bladder during your treatment, the BCG will be drainedback into a bag before the catheter is removed.
If you wouldlike something to drink you can now do so.
Sex – youshould abstain from intercourse/oral sex for 2-3 days after each treatment. Theuse of condoms thereafter is advised and should continue to be used for severalweeks after your treatment has been completed.
Pregnancy -the effects on pregnancy are unknown. If you are planning to have children youshould discuss this with your doctor as female patients of child bearing ageare advised to use birth control during treatments and to wait at least 2 yearsbefore conceiving, longer if on maintenance treatment.
Breastfeeding is not advised when having BCG treatment
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Bcg Phone Script For Member Offices
May also be posted as a message on Member websites
Bacillus Calmette-Guérin, otherwise known as BCG, is a standard treatment option for non-muscle invasive bladder cancer.
Merck & Company is the only maker and supplier of BCG to the United States. They have informed us there is a global shortage of this product and they expect the shortage to continue through the end of 2020.
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. We will continue to keep you updated as more news becomes available.
Several national organizations, including the American Urological Association, are staying in close contact with the U.S. Food and Drug Administration who is working to identify and approve other sources of BCG.
For further information about BCG, please feel free to reach out to Mercks National Service Center at 1-800-444-2080.
Options After Bcg Failure
BCG treatment eventually fails in up to 50% of patients and in about half of those within the first 6 months. In tumours that do not respond to BCG anymore, conventional intravesical chemotherapy agents, such as doxorubicin, thiotepa and mitomycin, have limited activity. In addition, valrubicin, the only FDA-approved drug for BCG-refractory CIS, is only effective in < 10% of patients at 2 years and none with coincident stage T1 disease. Thus, the traditional approach after BCG treatment failure has been to advocate early cystectomy. However, several lines of evidence suggest a reasonably safe window of opportunity, probably up to 1.52 years after onset of the index high-grade tumour, in which other conservative, nonradical therapies might be tried without undue risk.,,,
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Box : Recommendations For Intravesical Bcg
RCTs and practice pattern research demonstrate that BCG immunotherapy in NMIBC reduces recurrences and progression, and affects mortality
3-week BCG maintenance is confirmed to reduce recurrence rates compared with induction alone, as well as metastasis and mortality compared with maintenance chemotherapy thus, it is the optimal regimen for current practice
BCG maintenance schedules other than the 3-week schedule show no significant benefit in RCTs
In the period of around 1.52 years after the identification of high-grade NMIBC, nonradical alternative treatments for patients experiencing BCG-failure can be explored
After the first BCG failure, patients have several treatment options, including repeated BCG , BCG plus interferon, single-agent intravesical chemotherapy , sequential chemotherapy or device-assisted chemotherapy
After the second BCG failure, or if the disease is BCG-refractory, radical cystectomy should be considered with alternatives considered a matter of investigation by clinical trials
Patients with BCG-refractory disease who are not candidates for cystectomy can be considered for chemoradiation
Abbreviations: NMIBC, non-muscle-invasive bladder cancer RCTs, randomized controlled trials.
Is Bcg Treatment Contagious
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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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.
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.
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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.
How Bcg Treatment Is Performed
BCG treatment is administered in a liquid form using a catheter inserted into the urethra so the BCG enters directly into the bladder.
Once the BCG has reached the bladder, the patient needs to avoid going to the bathroom for at least two hours in order for the BCG to have time to reach the cancer in the bladders lining.
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Effects Of Intravesical Bcg Maintenance Therapy Duration On Recurrence Rate In High
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Roles Data curation, Investigation, Writing original draft
Affiliation Department of Urology, Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea
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Roles Methodology, Writing review & editing
Affiliation Department of Urology, Gangnam Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea
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Roles Data curation, Investigation, Resources
Affiliation Department of Urology, Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea
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Roles Formal analysis, Software, Visualization
Affiliation Department of Urology, Inha University College of Medicine, Incheon, Korea
Intravesical Chemoablation And Neoadjuvant Treatment
Older marker lesion studies have shown that chemoablation with a single intravesical chemotherapy instillation can achieve a complete response in a proportion of patients . In addition, hypothesis-generating findings from an older RCT comparing immediate pre-operative device-assisted MMC with post-operative SI with MMC and TURB only, showed improved long-term RFS among patients treated prior to TURB , and thus even suggest a long-term effect after neoadjuvant instillations. While this has not been reproduced by other groups, additional neoadjuvant clinical trials were recently published. In recurrent low-risk and recurrent Ta tumours , 4 and 6 intravesical MMC instillations achieved complete response in 37% and 57% of the patients, respectively. The former study prematurely stopped recruitment as the anticipated 45% complete response after chemoablation was not achieved. Compared to TURB, less dysuria and incontinence occurred in the intervention arm of the trial. Before routine clinical application, additional high-level evidence with RFS as an outcome measure is required.
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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.
Q: How Is Merck Determining How Much Bcg Each Physician Office In The United States Will Receive During This Shortage
A. As the sole supplier of BCG to the United States, Merck is allocating the quantity of available supply across states based on historical demand.
To minimize disruption to patient care, in January, Merck announced an immediate change to their BCG distribution model, and began allocating BCG exclusively to wholesalers and distributors based on product supply and historical purchasing patterns of physicians and hospitals. Wholesalers and distributors in turn, began utilizing the same allocation model to fulfill physician and hospital orders directly.
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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.
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 it’s 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, it’s important to understand the goal of the operation whether it’s 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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