This is from our good friends at Roon.care   This is a new community for Glioblastoma patients and caregivers.  It is worth taking a look at roon.care  it is free to join. They are having a webinar on caregiving tomorrow.

 This article is not  about brain tumors directly but it says the FDA now wants to change the rules for accelerated approval. In the past, they required a confirmatory trial after accelerated approval was granted. Most drug companies obviously wanted to slow down the process because if the results were bad, they lose the approval. If it is good, they gain nothing. Duh.   Many of the trials never complete because why would you enter a randomized trial for a drug and have a chance at getting a placebo (or standard of care) OR the drug when you can just get the drug directly. The entire system is insane.  Anyway - the FDA is now telling this drug company (and it infers this will be the rules going forward) that the confirmatory trial not only has to start, but the FDA wants the trial to be fully enrolled before they can get acceslerated approval.    This will cut maybe a year off of the regular process of FDA approval, but would also add a few years and tens of millions of dollars to the accelerated approval process. Not only is it wasting time and lives, but the additional wait time and costs will drive the prices of the drug way higher.

An alternative is my promising pathway act.  If that is too radical for the FDA, then just adopt the most important part - the registry. Require all patients who take an accelerated approval drug to be followed in a registry. It may add $1,000 a year to the cost of the drug, which is way less than the added cost under the proposed plan.  By observing all patients who use the drug we quickly will learn how to use it best and if it is worthy of full approval.

  This is very early work, but it is an exciting idea - to treat Schwannomas (and maybe meningiomas) with a 2 drug cocktail instead of surgery or radiation.  These tumors used to be deadly but today can be cured most of the time. Unfortunately the cure sometimes has side effects - the surgery is long and has a long recovery, there is a chance at deafness, tinnitus, dizzyness and/ or loss of facial nerve function.  There has been very little work on drugs to treat this because the cure rate was so high, but now these researchers are trying! Will keep an eye on this.

 This one is a must to watch. I think Sonodynamic therapy is going to be a breakthrough in the treatment of brain tumors. It is a noninvasive, relatively easy and painless procedure, kills only tumor cells and can be repeated if needed. This is still considered experimental and is in clinical trials now.

 The Musella Foundation gave a brain tumor research grant back in 2013 to Dr Towner to investigate this new treatment, OKN-007.  A phase 1 trial was done in recurrent glioblastoma, where it was found to be safe to the point where they couldn't find a toxic dose!  Early results in the highest dosage group showed an average survival of 21 months. There were no controls since this was a phase 1 trial, but we know from experience that the average survival for recurrent Glioblastoma is around 8 months.   Clinical trials of OKN-007 are now ongoing for newly diagnosed and recurrent high grade glioma.    Mouse studies were done on DIPG models which resulted in a huge decrease in tumor volume, so we wanted  DIPG and DMG patients to get access. We helped get this expanded access program started, in a way that is really a virtual trial, in that xCures will be observing the outcomes and hopefully the real world data collected can help speed up the FDA Approval provess.   I think it is worth a try. 

 This is big!   For the first time, we are able to collect and distill a patient's medical records quickly and automatically.   This program is the heart of our patient navigation program. The hardest part used to be getting the patient medical records into our database, and creating the patient journey so we could figure out the best treatment options for the patient.   It used to be a process that was manual and took 1-2 weeks and a lot of time from a human.  This limited the number of patients we could help and in some cases, delaying our suggestions until it was too late to implement.  With malignant brain tumors, speed is of the essence.   Now with this new system, the patient journey is automatically created quickly, and the AI program figures out the preliminary treatment options report immediately.    We can then take that report and evaluate it with our medical experts and virtual tumor boards (which feeds back into the AI system to make future reports better), to produce a finished report in much less time.    For those that need to make decisions immediately, that preliminary report will be produced in time and is usually pretty good.

This system is free to use for patients and doctors. It is like getting a free second opinion from a group of experts. For doctors, it also saves a vast amount of time to have the records organized.   I participate in a few tumor boards, and a common problem is the person presenting the case is not completely familiar with the entire patient journey. When a question is asked, they have to flip through the electronic chart looking for date or procedures or tests.   This wastes the time of all of the participants who don't have time to waste.  With the patient journey, everything would be at their fingertips.

  Sonodynamic therapy is one of the most promising new treatments available for brain tumors.    Dr Agarwal recently opened a new clinical trial for a new device that can perform this non-invasive procedure.  I have high hopes for this treatment!

 Sonodynamic therapy is one of the most promising new treatments available for brain tumors.    Dr Agarwal recently opened a new clinical trial for a new device that can perform this non-invasive procedure.  I have high hopes for this treatment!

 The printed edition of our Brain Tumor Guide For The Newly Diagnosed is now available!

 PLEASE select our charity and donate the round up amount to our charity if you use Walmart.com or the Walmart app.     If we get enough participants, it may lead to more opportunities with Walmart!

 This is from our good friends at NeedyMeds.   NeedyMeds helps patients find copayment assistance programs for any cancer and most drugs.  They also have their own drug discount card (we have a customized version of their discount card on our website). They have a few interesting webinars coming up.  The one about RemidiChain is most important.  This is the only pharmacy in the country that can recycle unopened oral cancer medications such as Temozolomide.   You can donate your unussed, unopened medications to them, and if you have trouble affording drugs, you can sometimes get free Temozolomide or other drugs!  

 Novocure launched a new educational website about Optune. It is worth  checking out.Optune is currently the most effective approved treatment that we have for Glioblastoma and it is vastly underused.  A recent article in our News Blast talks about the experiences at one major brain tumor center with Optune. They offer it to all of the Glioblastoma patients.   About 1/3 refuse to try it (probably because at the time they are told about the treatment they are in denial and do not realize how serious a Glioblastoma is).  Of the 2/3 that do try it, half (or 1/3 of the all Glioblastoma patients at their hospital) do not use it correctly.   If you are not going to use it correctly. it is not worth trying and you just waste time.   Of those that use it correctly, they had very impressive results.   You need to strive for 90% or more compliance.  

 They looked at Avastin alone or combined with re-radiation for the treatment of recurrent Glioblastoma and found that adding radiation to Avastin at the time of recurrence did not make a difference in the overall survival, but did almost double the progression free survival.   However, median survival was only about 10 months which means we need to find better treatments.

 Very informative article.   This hospital's protocol is that Optune is part of their standard of care and is offered to every Glioblastoma patient.  However, they found that there are 3 groups of patients: Those that refuse to even try Optune, those that are ambivalent - they will start but usually quit early and have bad compliance, and those that are enthusiastic and use Otpune the correct way. They found no reason why some refused it and others embraced it.  The same doctors would discuss it the same way with all of the patients, and some just did not want to try it. The groups were pretty balanced as far as age and sex.

  The amazing results were shown in Figure 3.   The patients who refused Optune did much worse than those that embraced it.    At the 5 year point, 20% of the Optune patients were alive and 0% of the non Optune patients were alive. Median survival was about 14 months without Optune and about  28 months with Optune.

They did mention that most clinical trials do not allow use of Optune - so people in that first group were more likely to enter a clinical trial - and said that trials should not prevent patients from using Optune.    They should build upon the standard of care, not try to replace it - at least until they show as good results as Optune. Why enter a clinical trial when you have a better chance of survival with Optune?  However, it makes sense to add something to Optune.   Clinical trials that include Optune are the right way to proceed.

They also mention that they used 75% as the minimum compliance for the Optune users, while they know that the higher the compliance the better. They did not show results based on compliance, but the target should now be 90% instead of 75%.

 An excellent summary of IDH mutant gliomas.

 The concept behind this trial is to see if starting radiation therapy the same time as the initial surgery instead of a few weeks later will work much better.   Usually, you wait until the surgical incision heals before starting radiation. This gives the tumor a chance to start growing back.  Implanting GammaTile at the time of surgery starts the radiation immediately not giving the tumor that extra time to grow back. Makes sense. And since the radiation is only delivered where it is needed, it shouldn't interfere with the wound haling from the surgery.   

 It was very interesting. A new approach to targeted radiation therapy not only for metastatic tumors but also for primary brain tumors.

 We are hosting the webinar about Plus Therapeutics' targeted radiation therapy.  The focus is on leptomeningeal mets but applies to most brain tumor types.  The webinar is TODAY Sunday, Oct. 9, 2022 at 7PM Eastern time.  Go to https://virtualtrials.org/webinar a few minutes before the start time!

 Nimotuzumab is a monoclonal antibody against EGFR. It is considered experimental in the USA but is approved in a few other countries.   Adding Nimotuzumab to radiation and Temodar resulted in a big improvement. For all Glioblastoma patients, it resulted in a 11 month increase in survival.  For MGMT unmethylated patients the results were more remarkable:  overall survival was 6.7 months without Nimotuzumab and 19.3 months with it.     

As I keep saying, we need to change the regulations so we can get access to treatments like this here in the USA. 

 This test can not only tell if you have a brain tumor, but can also tell the difference between primary brain tumors and metastatic tumors, with 96% to 100% accuracy which is amazing.  Hopefully they can perfect the test so that it can tell if treatments are working, or if the tumor is recurring.    Perhaps early detection using this as a routine screening tool migh allow better treatments.