The program might not be open too long so if you think you can use it - apply now!
I love this kind of research - shows they are thinking through the problem and looking for new avenues of attack. This is way too early to say if it will help people, as they only tried it in mice. Will keep an eye on it as they move into humans!
They do not give many details except to say they doubled the survival compared to matched control group. That is a major advance!
In this study, they found that shortening the radiation duration from the usual 6 weeks to 3 weeks and using Temodar during and after radiation was the best option for elderly patients with a Glioblastoma. Unfortunately they did not look at adding Optune so from this article we can not tell where Optune would fit in. This is from India and I do not know if Optune is available in India.
This report says it may now be possible to safely surgically remove high grade brainstem gliomas. This could almost double the expected average survival, which buys time for other treatments to work!
This is the reason why we like to see prospective trials. In this retrospective study, they looked at people who used Temodar for 6 months or less versus people who received more than 6 months of Temodar. The progression free survival was a little better but the overall survival was more than double (47 vs 20 months) in the long term group vs. the short term group. That would be very impressive except they did not give one group 6 months of Temodar and the other group more than 6. They just looked back to see how long patients used it. It is possible that the patients who used it longer were the ones in good shape and who were responding to it and the ones who stopped at or before 6 months did so because they were having problems, in which case you would expect the group doing well to live longer than the group not doing well.
Very well written book describes what happens from the first symptoms of a brain tumor through the surgery, radiation, chemo and all of the problems that arise. Worth the read.
I love this type of research. They looked at how Temozolomide effects tumor cells over time. We already knew most GBM cells will become resistent to Temozolomide eventually, but they identified a stage that the cells go through where they change to slow growing and change shape. They identified a drug which interferes with the cell. Sounds like it is worth a try in clinical trials.
You can help. Follow the instructions in the article to ask your representatives to cosponsor and vote for this bill!
This is the 3rd of the 4 payments of $250K that we pledged toward this $1 million project. I still need help raising the final $250K! If anyone is interested in helping, contact me! (Al Musella, DPM firstname.lastname@example.org)
Congratulations to one of my favorite brain tumor centers!
This is a relatively small trial but shows a huge effect supporting the use of Optune for Glioblastoma.
In the big EF-14 phase 3 trial for newly diagnosed glioblastoma, the trial was stopped at the first interim analysis because it was obvious the Optune arm was doing so much better than the control group that it was unethical to continue withholding Optune from newly diagnosed patients. The people running this study did not do that - they allowed it to go on for 5 years - knowing that they were withholding the best treatment. Doesn't sound fair to me.
Very interesting question. The clinical trial for Regorafenib in recurrent gbm showed a small benefit over Lomustine. However, the control group of Lomustine did terrible compared to the large trial testing Lomustine. In the Regorafenib trial, the control group of Lomustine had 5.6 months of overall survival. In the Lomustine trial, the same type of patients had a median overall survival of 8.6–9.8 months. The Regorafenin group had 7.4 months. So although Regorafenib did better than the randomized control group it did not do as well as the Lomustine in the Lomustine trial.
However, reports from real world use of the drug came in that said almost all patients get severe side effects and they did not see the benefit seen in the trial. So what do you do?
Obviously more research needs to be done hopefully to find if there are biomarkers that would push you toward Lomustine, Regorafenib or the combination. Perhaps the best way would be for having all patients be followed in a registry so we can see how it works in the real world and correlate with biomarkers. As in our brain tumor virtual trial project or our new Excelsior registry https://clinicaltrials.gov/ct2/show/NCT03793088?term=musella&draw=2&rank=4
This is one of the biggest problems we have - the high cost of treatments. This analysis found a small benefit to adding bevacizumab (Avastin) to Temodar for people with inoperable Glioblastomas. However, because of the high cost of the drug, it was determined that is not cost effective. They set the acceptability bar at $26,500 to add 1 year of life. This treatment worked out to $171,638 for each year of life added. Not even close.
This is a societal problem. I do not blame the drug companies, as the cost to develop a drug under our system is so high that to recoup their investment, the prices have to be high. Without high prices, there would not be new drugs getting approved. We need to change the system so that any researcher with a good idea could afford to bring a drug through the system to get approval - which not only will drastically lower the cost of new drugs but gives us a wider range of treatments to use.
VB-111 is an experimental gene therapy. Two papers came out at the same time with conflicting results. This phase 1/2 study had very good results but was not as large or well designed as the phase 3 trial. mentioned in the next article. They used the treatment in a few different ways with the best being using the VB-111 alone until progression, then continue VB-111 and add Avastin. My thoughts are that most of the immunotherapy trials fail because they stop the treatment too soon. These treatments take time to work, and sometimes the tumor looks worse before it gets better.
VB-111 is an experimental gene therapy being tested for use in recurrent Glioblastoma. As I mentioned in the previous article, the results for the phase 1/2 trial came out on the same day as the results of the phase 3 trial. I do not think I ever saw that happen before. The Phase 1/2 trial came out very good however, this failed to show any improvement of VB-111 plus Avastin randomized against Avastin alone in recurrent GBM. If they had the results of the phase1/2 trial before they designed this phase 3 trial, they might have designed it differently as the phase 1/2 trial showed that using VB-111 alone until recurrence, then continuing vb-111 and adding avastin did much better than starting with VB-111 and Avastin at the same time. This shows that adding combinations doesn't always improve the outcome. Everything needs to be tested and timing is very important.
I am still a fan of VB-111 but think it needs more work to find the optimal way to use it.
This says that the dose of Avastin (high vs low) doesn't make much difference in outcome. This is important not only for cost but I would assume cutting the dose in half would also decrease side effects. May be worth asking your doctor about this if you are on Avastin.
There was a high chance of toxcicity - but the results look pretty good. Might be worth trying to add lomustine to the standard of temodar and optune.
This is our #givingTuesday appeal! The bottom line is that we have helped a lot of brain tumor patients directly - not only with our compassionate use program and copay assistance program, but by offering treatment suggestions, referrals to major centers and clinical trials, offering education via our online forums and our Brain Tumor Guide For The Newly Diagnosed, helped speed up approvals and funded a lot of quality research. Our programs are critical to speeding up the search for the cure and to help patients deal with a diagnosis of brain tumor. We offer all of this at no cost to the patient, so we need YOUR help. We are only limited by funding. We have projects on the back burner just waiting for funding. We need $250,000 by the end of this year just to cover our compassionate use grant. We have plans that require a few million dollars in funding, but every dollar helps and even small donations are appreciated. Check to see if your employer has a matching grants program!
This is the most exciting news for GBM treatments. It is a small trial but the results are unheard of. Unfortunately it is only available in Japan right now but we are working on trying to get access. We are discussing it in our forum: https://forum.virtualtrials.org/forum/brain-tumor-research/122-g47-delta-results-available-on-17thnovember