First BCG Maintenance Started: Half Dose 40Mg

3 weeks 6 days ago - 3 weeks 6 days ago #60765 by Bills
Hi All,

Brief History 
My father's Diagnosis:
12 Sep 2020 ---> Gross Hematuria 
12 Sep 2020----> USG revealed calcified focal plague like mass in UB
12 Sep 2020 ---> CT scan revealed 1.8mm x 0.6mm focal plague in UB
13 Sep 2020 ---> Cystoscopy revealed Papillary growth in UB posterior wall and BN and part of Trigone. 
14 Sep 2020 ---> TURBT for all Bladder Tumor and Uro report wrote Papillary growth near BN, Trigone and posterior wall. Took three sample during TURBT. Entire tumor, Deep Bladder muscles, and prostrate muscles. Uro wrote the size of tumor as 3-4 cm after surgery.
29 Sep 2020----> Pathology report said , 20-30% HG papillary carcinoma, lamina propria and deep muscles invasion not seen. Also no malignancy detected in prostrate. Pathology report measured 2.2x2x0.5cm tumor.
BCG Induction : Could take only 4 instillations 80mg and 2 doses discontinued due to side effects
23 March 2021: reTURBT and Biopsy Both Clear for malignancy. Uro recommended half dose 3 BCG after 6 weeks

22 May 2021: 1st BCG dose 40 Mg in 20 ml saline

Results: No fever, no pain, no blood in Urine, no tiredness, no mood swings.
Side Effect: Urine Urgency and frequent urination. The same side effect as induction course but its only the first day. I hope they will subside in 2 and 3 day.

I need some advise in BCG saline concentration: Can we increase the saline concentration from 20ml to 50 ml so as to make it less concentrated? 
I am really keen to subside the side effect on this maintenance course as its our first one as Uro suggested that BCG was really effective in our case as was evident in reTURBT and biopsy.


Please advise 

Thanks and God Bless
Special Thanks to Alan , Sara and Joea73 for your valuable feedbacks every time.
God Bless you all and Respect

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3 weeks 5 days ago #60766 by sara.anne
Replied by sara.anne on topic First BCG Maintenance Started: Half Dose 40Mg
So glad to hear that everything is going well!

Urinary frequency and urgency are normal side effects of BCG and are to be expected.  I don't know about how BCG is obtained where you are located, but it usually comes in an already-prepared preparation.  Diluting it  would probably only decrease the effectiveness.  Of course, this is something that you need to discuss with the urologist if the side effects become too much to bear.  So far this doesn't seem to be the case.

Sara Anne

Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
Forum Moderator
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3 weeks 4 days ago #60768 by Bills
Hi Sara,

Thanks for the reply. Yes I see some decrease in the urgency today (2nd day) in my father. I am in UAE and we get an Onco-BCG here imported from India ( serum Institute of India). It comes as 40mg vial and you have to add saline to make it eligible to put through the catheter. 
Nurse mixed 20 ml of saline before putting it to the bladder. In induction we put 50ml saline.  My father hold it till 1.5 hrs in bladder. Recommended was 1 hr from Uro.
I see some decrease in frequency and urgency today but also observed some weakness and loss of appetite in father. I know its from BCG and since he is being treated aggressive from last 5 6  months( Cystoscopy,TURBT, BCG induction, & reTURBT & BCG again) , it is evident. I am sure things will become normal again and God willing my father will have a good prognosis in future.

Thanks and God Bless.

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3 weeks 4 days ago #60769 by sara.anne
Replied by sara.anne on topic First BCG Maintenance Started: Half Dose 40Mg
I wouldn't worry about this.  BCG side effects (and the ones he is experiencing are normal) can last for a week or so.

Your father is fortunate to have you in his corner!!

Sara Anne

Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
Forum Moderator
The following user(s) said Thank You: Bills

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3 weeks 4 days ago #60776 by Bills
Hi Sara,

Thanks for  your reply and encouragements. Parents are building blocks of the their children. I remember all those instances when my father took me to doctors and hospitals when I was not well. He was always there with me along with my mother. 

Parents are pearls , MUST BE PRESERVED.

I thank you again and also Alan and Joea
U are the real Heros 
Respect 

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3 weeks 4 days ago - 3 weeks 4 days ago #60777 by joea73
Hi Bills,

I have always thought that reducing the dose to reduce the side effect  had meant the reducing the concentration rate of BCG.   I recall that it was 80mg of BCG mixed with 50 ml of saline was administered to your dad, and that caused severe side effects, which led to the shortening of the 6 weeks induction course to 4 weeks.   40mg of BCG mixed with 20 ml of saline does not change much the concertation rate of BCG.    We know that Dr. Lamm of University of Arizona, one of pioneer for BCG treatment had stated that It is also true that maintenance can cause side effects. That is why we always reduce the dose (1/3, 1/10, 1/100th even if needed) or hold treatment if increasing side effects are seen.  In the US, TICE strain by MERCK with 50mg in 50ml saline is used.  I could not find what volume of saline was used when Dr. Lamm mentioned about 1/100th dose.  But, It does not make sense to use 0.5ml of saline for 1/100th dose BCG. It will not cover the whole bladder.  So, we assume that Dr. Lamm had meant 1/100th of 50mg Tice BCG in 50 ml saline.   I believe 50ml of saline is enough to fill the bladder lumen in emptied condition, thus cover the entire surface of the bladder wall.   So, I think 40mg in 50ml makes more sense to reduce the concentration rate of BCG in the saline.   40mg in 20ml saline does not make sense to me.

Another case in point is that "Immunobladder" which is intravesical BCG manufactured by Japan BCG Lab is Tokyo-172 strain, Tokyo-172 strain BCG has been on clinical trail for 4-5 years now in the US.   Immunobladder BCG come in two different vials, 40mg and 80mg. The administration instruction for 40mg or 80mg says to mix with 50ml saline.  When I checked before Urologists in Japan some urologists  use 40mg when their patients have side effects with 80 mg.  

Consequently, I believe that 40mg BCG in 50ml saline is the correct administration if the new regimen is to reduce the side effect of the BCG, unless there is another reason why 40mg BCG in 20ml saline has been determined to be the right treatment for your dad.

Please note that 1/3 dose of BCG has shown equivalent efficacy compared to full dose BCG.  That is why AUA has  recommended 1/3 dose usage when the BCG is in shortage.    So, it is assumed that  1/2 dose (40mg of 80mg) of SII-ONCO BCG  should give similar efficacy 
as the full dose 80mg, and 1/2 dose should give less side effects to your dad.  That is the reason the reducing BCG dose was thought to be the suitable treatment.   My understanding of 1/2 dose is the reduction of BCG concentration into a half.

I would definitely clarify with the urologist before the 2nd instilment.    

best

Just for perspective, according to Merck product monograph. Merck Onco-Tice 50mg has approximately 1 to 8 x 108 colony forming units (CFU) or  1 to 8 x 10 bacteria in a 50mg via l.    SII ONCO-BCG 40mg  has  1-19.2 x 10 8Colony Forming Units (CFU) according to their product description.   Or it can be said that in average a 50mg Tice has 400 million BCG bacteria, and SII ONCO-BCG 40mg as 1 billion BCG bacteria.  40mg of SII ONCO-BCG contain the same or more number of BCG bacteria as 50mg Tice does.
One vial of BCG contain a mind blowing number of BCG bacteria.     The product monograph of MERCK Tice and the product description of SII ONCO-BCG are described in the links below.

www.merck.ca/static/pdf/ONCOTICE-PM_E.pdf
www.seruminstitute.com/product_uro_uncology.php
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