This information is based on guidance produced by the Oncology Section of the British Association of Urological Surgeons, July 2012, for patients receiving, or due to receive, BCG therapy for bladder cancer.
Due to difficulties at the manufacturing plant, production of BCG (ImmuCyst) has been suspended by the company Sanofi Pasteur. It has not, so far, been made clear what the production difficulties are, but the company do not think that ImmuCyst production will recommence until the end of 2013. This clearly presents a problem for urological teams and their patients. Another type of BCG called ‘OncoTICE’ (manufactured by MSD) is an alternative choice but, currently, their supplies are very limited. MSD is confident that some supplies of OncoTICE will be available at the end of August 2012 but not in sufficient amounts to meet the full requirements for BCG in the UK.
Urological teams are very aware of the potential worry and distress this will cause patients. To this end, The British Association of Urological Surgeons (BAUS) have produced some guidance for urologists so that patients can be looked after safely and to a consistent standard across the country. This guidance can be read by clicking here and this link also provides access to the Department of Health website, for information provided by the National Clinical Director for Cancer, Sir Mike Richards.
The lack of BCG does mean that patients will need to consider alternative strategies for looking after their bladders.
For patients with newly-diagnosed, high-risk, non-muscle invasive bladder cancer who have not yet started any treatment after an initial transurethral resection of the bladder tumour (TURBT)
These cancers are called T1 G3, Ta G3 and CIS cancers.
Some patients with this type of bladder cancer already receive a recommendation to undergo radical cystectomy (bladder removal) as this is undoubtedly the best curative treatment; better even than BCG. All patients considered fit and strong enough to undergo major surgery will have this option discussed with them.
Radical cystectomy is not suitable for everyone, for a number of reasons, and, if this is the case, the Bladder Cancer Team will discuss alternatives. For many patients, the best alternative will probably be intravesical chemotherapy. Intravesical (into the bladder) chemotherapy in these situations is not thought to be as effective as BCG but can work to reduce the risk of cancer recurrence. Chemotherapy is delivered via a catheter placed in the bladder and is usually administered weekly for 6 weeks.
There are a number of different methods of administering the chemotherapy. The exact one recommended by bladder cancer teams will differ according to local availability:
- Mitomycin or other chemotherapy drugs ( e.g. epirubicin /gemcitabine) given weekly over 6 consecutive weeks
- EMDA (Electromotive drug administration) Mitomycin given weekly over 6 consecutive weeks
- Hyperthermic Mitomycin (Synergo) given weekly over 6 consecutive weeks
Patients should be aware that data on the effectiveness of EMDA and Synergo in this setting is limited.
Urologists will recommend a "second look" cystoscopy for many patients, prior to them starting any intravesical treatment. This is to be as certain as possible that the bladder is clear of cancer before starting the intravesical chemotherapy.
Approximately 6 weeks after a course of chemotherapy, patients would undergo a check cystoscopy to determine if there has been a complete response to treatment.
If the bladder cancer has not fully cleared, then radical cystectomy should be considered if the patient is considered fit and strong enough to undergo major surgery.
For patients still undergoing their first course of BCG, whose treatment has been interrupted by lack of supplies of BCG
Patients who have started BCG induction will not be able to complete the full induction course of six doses due to lack of supplies. Clearly this is a difficult situation.
For many patients who have received the majority of the doses (4 or more), the simplest solution may be to undergo their planned check cystoscopy to see if the bladder is clear of disease. For other patients, who have only just started their course of treatment, alternative treatment may need to be offered. This alternative treatment could be with major surgery (radical cystectomy) to remove the bladder or with intravesical chemotherapy. If chemotherapy is chosen, the number of doses will be dependent on how much of the induction course was completed.
The chemotherapy options below may be offered according to local availability:
- Mitomycin or other chemotherapy drugs (e.g. epirubicin /gemcitabine) given weekly over 6 consecutive weeks
- EMDA Mitomycin given weekly over 6 consecutive weeks
- Hyperthermic Mitomycin (Synergo) given weekly over 6 consecutive weeks
For patients who have completed an induction (first course) but have not completed the first year of treatment
Many patients who have undergone their first 6 dose treatment with BCG, and who have been found to be clear of disease at their first check cystoscopy, will be offered further treatment with intravesical chemotherapy. The treatment schedule will involve treatment once a month, for up to one year, with regular check cystoscopies and urine testing for cancer. Chemotherapy is not a tried and tested treatment in this setting but probably offers the best chance of keeping the bladder free of disease until more BCG becomes available.
If the bladder cancer has not fully cleared then radical cystectomy should be considered, if the patient is considered fit and strong enough to undergo major surgery.
For patients who are currently receiving maintenance BCG courses beyond the first year of treatment
BCG maintenance therapy for these patients will need to be discontinued. The risk from discontinuing treatment is small. For those patients who never had carcinoma in situ in their bladder, recent research suggests that the risk from discontinuing treatment may be negligible. Given the low risk of problems, alternative treatment with chemotherapy is probably not required and the best policy will almost certainly be one of careful surveillance.
The surveillance would be with 6-monthly check cystoscopies and urine tests for bladder cancer (urine cytology tests).
If surveillance is performed diligently, we think the risk to patients in this situation is small. Once BCG supplies are restored, there is no reason, of course, why a patient could not re-start their maintenance BCG schedule.
We do understand that the situation is a worrying one. However, we believe that the situation is one in which risk can be minimised by sensible decision making. We encourage all patients to discuss matters with their bladder cancer team. As we receive further information on the supplies of BCG, we will issue updates, and you can monitor the situation here on the BAUS website.
