Hi. My husband is in his late 40's and was diagnosed with non-muscle invasive (high grade) bladder cancer about a month ago. He had a second TURBT this week and the results confirmed the initial report. The plan was to treat the cancer with BCG, but we were told this week that because of the BCG shortage, they would try to get the initial 6 weekly doses of treatment but that it would be unlikely that they could get any doses for a maintenance regimen.
A few days later. the doctor's office called to ask my husband if he would be interested in participating in the clinical trial comparing TICE BCG to Toyko-172 BCG. When reviewing the information sent by the doctor's office, it looks like my husband would be guaranteed a maintenance regimen but that it could be the BCG made here in the States by Merck or a different strain used in Japan. (The study is to compare the effectiveness of the Japanese strain to Merck's). So as I understand it, he'd either be able to get 6 doses of the Merck BCG - which we know should be effective in treating his cancer - but would be unlikely to do any maintenance doses or he can sign up for a clinical trial where he'd be given a drug for both the induction and maintenance phases but it may not be effective.
This has been a bit of whirlwind, particularly given the current climate with the Covid-19 virus. Our only appointment to date with the doctor was the initial consultation following an abnormal ultrasound after my husband had found blood in his urine. We've been trying to read here on the forum and other sources to at least get the lay of the land but wondered if you may have valuable insight for what our options might be. Thanks so much for any feedback you may have.
Welcome. I was under the impression that the BCG shortage had receded somewhat. Perhaps another poster can update on this.
I am not sure either manufacturer will make much difference as both I am certain have guidelines being a live bacterium. If one would be concerned that one may be better than the other, consider that every patient is a little different and reacts differently to each situation. I really would guess BOTH are OK. There are many different protocols people have used on this board from 6 installations each week followed by 3 stretched out over decreasing intervals for 3 to more 5 years. Or, a well respected but longtime retired URO named Dr. Herr from either Sloan/Kettering or John Hopkins stated he believed 6 was all he normally did. Some in other countries are once a month for 12 months. In my case I had 6 over 6 weeks, 6 weeks off then another 6 and that was it it. The important key is be sure to get the 6 done and go from there. Even if there is a shortage, nothing says you can't start another round later than what your URO says
DX 5/6/2008 TAG3 papillary tumor .5 CM in size. 2 TURBS followed by 6 instillations of BCG weekly with a second round of 6 after a 6 week wait.
I am currently on a similar path as your husband. High grade, flat tumor, late 40s. I have been battling this for ~3 years. My urologist also cannot get enough BCG to cover maintenance treatments for anyone not currently having cancer at the moment. When my cancer returned, I was given the option to try another round of 6 BCG treatments or to try Gemcitabine (Gemzar) chemotherapy. After discussion with my doctor, we opted to go back to BCG (Merck) since we had previous positive results with it. If it doesn't work out this time for me, the Gemzar would still be another option if we want to pursue it.
I agree with Alan's rationale on the treatment. It is important to get the first 6 done and then see where it takes you. I wish you all the best on this fight.
I am in the same situation myself. I start my first round of 6 weeks BCG next Wednesday. Plan is right now to wait 6 weeks after first round and do 3 weeks. Will have to wait and see what options are available for the second round of treatments.
For what my opinion is worth, I would go with the Toyko strain at this time. Shortages have become the norm after one maker left the market. The Toyko strain has been available out side the US for some time; it is working to pass FDA required testing. Toyko is in Phase 3 Testing which means:
" A phase III clinical trial tests a treatment that worked well for volunteers in a phase II clinical trial. Doctors use phase III to compare the new treatment with the standard treatment. They want to know if the new treatment is better, has fewer side effects, or both. So they put volunteers in different groups. The volunteers in each group get a different treatment.
Phase III clinical trials can take many years. They may have several thousand volunteers. These must include men, women, and people of different ages and ethnic groups, if possible. This helps doctors learn how the treatment works in different people.
If a phase III clinical trial shows the treatment works well, doctors might begin using it with people outside the clinical trial. For example, if they learn that a certain amount of exercise lowers your cancer risk, they publish a report. This shares the information with other doctors. If the researchers or sponsor learn a new medicine is safe and effective, they can ask the government to approve it for people to use. In the United States, they ask the Food and Drug Administration (FDA). The FDA looks at the results of the clinical trial's phases. They approve the treatment if the results meet their standards."
6/2015 HG Papillary & CIS
3 Years and 30 BCG/BCG+Inf
Tis CIS comes back.
BC clear as of 5/17 !
RCC found in my one & only kidney 10/17
Begin Chemo; Cisplatin and Gemzar
8/18 begin Chemo# 3
Begin year 4 with cis
2/19 Chemo #4
9/19 NED again
1/2020 CIS is back
Tried Keytruda, stopped by side effects
Workin on a new plan for 2021
The following user(s) said Thank You: Alan, VinceD
Thanks so much for all of your responses and valuable insight - it is so helpful to hear about your experiences. We are leaning toward my husband participating in the study to help insure the amount of doses and are hoping that there is no significant difference between strains. Thank you again and best wishes to each of you.