Ask Dr. Lamm: August - September 2005

We've received several questions about Oncovite, which is on back order due to a manufacturing problem at Mission Pharmacal. The most recent batch ended up on testing with a higher than label Vitamin A content, so it has to be redone and retested. If this is an emergency, please contact us at (602) 493-6626 and we can send (for a small shipping and handling fee) a supply that will get you through until Oncovite is again available.

My situation is a little complicated. Thanks for your patience in advance. I'm writing to ask information for my Dad, who currently lives in China.

My Dad was diagnosed as superficial bladder cancer in March, 2005. And also the upper urine tract also seems affected. Sorry that I could not provide more details about it, as he did all the diagnose and treatment in China. He had UTR and followed with BCG. After the six weeks doses, the biopsy shows no cancer cells. My father still find blood in the urine although, and the doctor define it as bladder infection. And the doctor recommend maintainance BCG. I wonder if we should continue the BCG or convert to other treatment for the 'bladder infection'.

Secondly, my father had no symptom for the first 6 BCG, but start to develop fever around 38-39 degree for the next dose. The fever stays for less than 24 hours. I want to ask if this is normal, should he continue the BCG?

Thirdly, for the upper urine tract problem, is any special treatment necessary? Or the BCG is enough for both bladder and UUT? I really worried about my father's situation, as the health service in China is poor. Thanks for your time on my letter, and any of advice from you is highly appreciated.

Thank you for your question regarding your father in China. We have had questions from Iceland, the Ukraine, and now China. As you know I cannot comment specifically regarding your father's care without medical information, but I can make some general comments that I hope will be helpful.

I am a 76 yr old wm physician with an intraarterial heptic pump for the admin of chemo to my liver post resection hepatic met from colon CA. I could not tolerate the FUDR/Leucovorin which resulted in 3 bouts of "chemical" hepatitis. Currently all chemo has been stopped and I was restaged and am NED. The pump remains in place and is routinely filled with saline, heparin and dexamethasone. I believe my oncologist has not gotten around to requesting the pump removal.

In the meantime I have been diagnosed with Stage 0-1 TCC bladder and will start intravesicle BCG in 6 weeks. My question: Is there any contraindication to continue receiving the dexameth in my liver pump and getting the instillations of BCG?. I had a fellowship in TB back in '59 and TB plus steroids was a no no and I did see 2 cases of diss TB after reactivation and steroid use. I am hesitant to keep receiving the dexameth and would just as soon have the pump removed as I doubt any hepatic chemo will be given in the future.

It is good to hear that the treatment of your colon CA is working well and that you are in remission. Your question regarding BCG administration for superficial bladder cancer while taking dexamethasone is a good one. There is an increased risk of side effects with BCG in patients that are immunosuppressed with drugs such as dexamethasone. Whether the increased risk is worth it depends on the risk of bladder tumor progression. You did not mention your tumor grade, but high grade (or G3) tumors are generally best treated with BCG. If the tumor is definitely T1 (lamina-propria invasive) BCG would also be best, unless it is G1 with focal or questionable invasion.

I assume that you are on a very low dose of steroid, in which case the risk would be minimal. Surprisingly, animal studies have paradoxically found that steroid co-administration can actually enhance the efficacy of BCG. If you do receive BCG, you should have Cipro 500mg BID and Isoniazid 300mg/day very handy to take at the onset of any potentially serious reaction, and you should be cautioned that the reactions can be "covered up" by the steroids, making the diagnosis more difficult.

I would not hesitate to reduce the dose and start antibiotic treatment at the first sign of reaction to BCG.

from a Physcian: I am treating a patient who developed a systemic reaction after 4 instillations of immnocyst for early bladder ca. He developed a PUO. He was started on triple anti Tb therapy and after a3 weeks completely improved. His urine specimen was negative for AAFB. How long do you think i should carry on with anti TB treatment?

This is a very difficult question. Many patients that have a severe BCG reaction will have sufficient exposure to BCG and immune response that further BCG treatment is not required: they remain tumor free for long periods. If and when to retreat would depend on his tumor risk factors. If he has G3,T1 or CIS he will most likely require BCG in the future.

Generally a waiting period of at least 6 months would be appropriate. BCG should be resumed at very low dose, say 1/100th or 1/30th- certainly no more than 1/10th dose. Recent data now suggest that, while live BCG are required initially, once sensitized, as your patient most certainly is, heat-inactivated BCG can produce an effective antitumor response without the risk of infection.

I am reading that many of my fellow bladder cancer warriors are not having maintenance BCG treatments. They report that maintenance treatments are controversial and have not proven to be more effective at preventing reoccurance and progression than the intial treatment followed with surveillance. More BCG can also cause long term damage to the bladder.

I read in your literature that many BC patients have reoccurances at the one year mark and that it is extremely important to continue maint. to prevent this. Is there a changing view of maint. therapy? Have you modified your ideas about continuing a schedule for 10 years? I have been diagnosed with CIS 8/03. I've had 6 BCG's and three maint. treatments of 3 BCG's so far. I don't want to damage my bladder...but also want the best possible chance for a good outcome in years to come.

I am scheduled for a follow up with my doctor in a couple of weeks. I finished my last 3 BCG's in late July. I noticed that he did not schedule a cysto. I am anticipating that he will want to discontinue BCG and just monitor for a while. I need some good information to discuss my further schedule of treatments. I would appreciate your input.

Thank you for you question. Yes, maintenance BCG remains controversial. Do you remember how long it took for people to accept that smoking was associated with an increased risk of CANCER?? To some people, the use of seat belts is still controversial- but that does not mean we should not continue to educate and advocate.

To put it as clearly and bluntly as possible, the evidence supporting maintenance BCG immunotherapy is as good as it gets for medical science. It is confirmed by randomized clinical trials and meta-analysis. Maintenance BCG is superior to chemotherapy and induction BCG in the prevention of tumor recurrence, and only with maintenance BCG do we see statistically significant reduction in disease progression.

Does this mean that everyone should have maintenance BCG? No. If the risk of recurrence and progression are low, it is not necessary, and if increased side effects occur the treatment can be reduced, postponed, or stopped to prevent serious problems.

I have read from several reputable sources that doses of vitamin-A in excess of 2,500 IUs a day can actually have an oxidizing effect on tissues and result in DNA damage with an increase in lung cancer and antherosclerosis. I am currently talking Oncovite, 2-tablets/2-times/day which give me a daily intake of 36,000 IUs. I assume that this recommendation is based on a benefit vs risk assessment however are there any recommended laboratory tests, blood/urine, etc. that I should be doing on an ongoing basis to monitor any potential risks?

Vitamin C can at times have an oxidizing effect, and it is true that two studies have found that smokers taking very high doses of beta carotene/vitamin A had an increased incidence of lung cancer. Concern has been raised about vitamin E as well. With this background, I think our use of multiple antioxidants is extremely fortuitous. Our 40% reduction in bladder tumor recurrence, with no increase in the incidence of other tumors, is quite remarkable. We believe that a balanced approach is the way to go -- the thought is that one single agent can throw off this balance and even be counterproductive. This speaks also to the importance of fruits and vegetables in the diet--there are a lot of phytochemicals that are beneficial besides the vitamins they provide.

High doses of vitamin A can, rarely in our experience, cause liver function abnormality. The toxicity of A is reduced by vitamin E. Periodic liver function tests, say once a year, are very appropriate.

Is it OK to drink lots of fluids after your first void of BCG? Some say if you drink a lot it waters down the effectiveness. Since even a reduced dose, seems to be effective, is this something to consider? I have found that drinking water seems to help ease the symptoms sooner, but I certainly want BCG to do its job. I have had three clear scopes since starting BCG, so I think it is working.

We do not have specific data to answer your question, but I can give you an opinion based on my experience. Using the 3 week maintenance schedule and dose reduction, I don't believe fluid intake makes a significant difference. The argument against pushing fluids is that BCG induces cytokines that would be washed out with fluids. If you are having symptoms that are relieved by pushing fluids, I would say go for it.

I had a bladder tumor removed January 18th of this year and then began six weeks of BCG treatments and taking Oncovite daily (2 tablets a day). I have since had another three weeks of BCG following my cysto in March and another three weeks of BCG following my cysto in July.

Now my cardiologist wants me to begin taking Lipitor (40 mg) for high cholesterol. I showed him the ingredients listed in Oncovite and he said I should not be taking such a high dose of Vitamin E. I have not begun the Lipitor yet and wonder if I should stop Oncovite “cold turkey” or cut back to one tablet a day. Have you had other patients taking Oncovite who were also on a cholesterol lowing medication? What is your recommendation? I first was diagnosed with a bladder tumor in 2001 and they have reoccurred three more times (every 12 months). I want to be proactive in fighting their reoccurrence but, at the same time, I do not want to do anything harmful to my heart.

Yes, many patients who take Oncovite are also taking statin drugs. Both the cholesterol lowering drugs and Oncovite can cause liver problems, though to my knowledge it has never occurred with the dose of Oncovite you are taking. Unfortunately, there is not a clear answer to your question.

Vitamin E was for many years thought to reduce heart attacks. I am not aware of any evidence that 200 IU/day is associated with any problems at all. Vitamin E does appear to lower the risk of bladder and prostate cancer. This appears to be a matter of choice, what is better for your bladder vs your heart. While hearts would generally take top priority, I would question if there is a significant risk at 200 IU.

Your question is a good one. We have 659 patients randomized to RDA vs high dose vitamins and followed for 2-6 years. We will look to see if there is any evidence of increased cardiac risk.

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