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Note: The comments under each article title are the opinion of our president, Al Musella, DPM, and do not reflect official policy of the Musella Foundation!

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08/15/19 DelMar Pharmaceuticals Reports Updated Results on Twenty Patients from the Phase 2 Clinical Trial of VAL-083 as First-Line Treatment in Newly-Diagnosed MGMT-Unmethylated Glioblastoma MultiForme (GBM)        

 Although this is a small study and very early, the results are impressive. This is an experimental chemotherapy that works in such a way that the MGMT repair system doesn't matter.  Temodar works best when MGMT is methylated (inactivated), and not so well when MGMT is unmethylated, so a huge unmet need is a new treatment that can help unmethylated MGMT GBM patients.   I will be keeping an eye on this.




08/15/19 Attend an Optune Open House        

 From our friends at Novocure.  These open houses are fun and informative!  Worth attending for anyone who has or knows someone with a gbm. Most are live but there are webinar versions in there for people not near a live site!




08/03/19 Young adults diagnosed with high grade gliomas: Patterns of care, outcomes, and impact on employment.        

 This is a very scary article. Most young adult patients did not continue to work after a high grade glioma diagnosis.  I feel that this should be one of the endpoints in all clinical trials:  is the patient able to work at the level they did before the diagnosis?  In the past, unfortunately, most patients did not return to work after the diagnosis.  Many who did were not able to work full time or in the same capacity as before.  2 years after diagnosis it was unheard of for patients to be working at a high level job.

So now as we are seeing more long term survivors with Optune and some experimental treatments, we now need to know their quality of life.  Being able to work is a very important quality of life marker.  I have come into contact with  a few patients recently who are able to work at high pressure jobs, just like before their diagnosis, over 5 years since diagnosis.   This was very rare before, so it is a significant finding for any trials.

 




08/03/19 Validation of an effective implantable pump-infusion system for chronic convection-enhanced delivery of intracerebral topotecan in a large animal model.        

 This is early - only in animals so far - but would be a major step forward int he fight against brain tumors. We have some effective treatments that have to be delivered by convection enhanced delivery, such as Toca 511 and PVSRIPO.  These experimental treatments showed some remarkable results after just one (or 2) course of treatment.  With this new technology, we could use these therapies on an ongoing basis and perhaps drastically increase their effectiveness!

 




07/29/19 Long-term survival in patients with recurrent glioblastoma treated with bevacizumab: a multicentric retrospective study.        

 This shows that a small % of patients go on to become long term survivors using Avastin.  The big trials for Avastin  "failed" just like some of the immunotherapy trials "failed" because they look at the median patient to determine how well the treatments do.  (Avastin showed an increase in the median progression free survival but not median overall survival).  These treatments do not help the majority of patients, but they do help a minority of patients.  The statistics we use does not recognize the importance of the tail of the long term survivors.

Even though each one alone only gives a small % of long term survivors, there is hope that the right combination of these could help the majority of patients become long term survivors.




07/29/19 Valerie Harper to stay out of hospice care, husband says        

I usually do not post personal stories like this but I need to clear up a huge misunderstanding of what Hospice is.  Hospice is an amazing service that helps not only patients but also the caregivers near the end of the battle.  It can be done in your home, or at a facility – whichever is easier for the patient and the family.  I used them 3 times for Hospice at home and they were amazing each time. I can not imagine how much worse these deaths would have been without Hospice.

For the patient, they make sure they are comfortable. They take care of managing pain and other symptoms (like constipation), preventing bed sores and so much more.  For the family, they provide guidance. NOBODY who has not gone through this knows how to handle the situation. The Hospice people are available by phone 24 hours a day for when questions or problems come up and they take so much of the pressure off of the family. They help guide the family through difficult decisions.

I can’t thank them enough.




07/29/19 Dramatic response of BRAF V600E-mutant epithelioid glioblastoma to combination therapy with BRAF and MEK inhibitor: establishment and xenograft of a cell line to predict clinical efficacy.        

 This is only in mice right now but if you happen to have these 3 mutations, which signify a pretty much hopeless situation, it might be worth trying this combination of drugs.




07/26/19 Musella Foundation Brain Tumor Copay Program has reopened!        

 I do not know how long it will remain open - so if you think you may need help with copayments for Temodar, Avastin and/or Optune, apply today!




07/20/19 A Randomized Double-Blind Placebo-Controlled Phase 2 Trial Of Dendritic Cell Vaccine ICT-107 In Newly Diagnosed Patients With Glioblastoma        

 This is the final report on the phase 2 trial of ICT-107 for newly diagnosed GBM.  It was declared a "failure" because the median survival did not improve enough.  However, digging into the details, there are many patients who responded very well, and there were no side effects.   As with the other immunotherapy trials, this had a long survival tail which does not get reflected in the mean survival statistics.  I still feel this is a worthy treatment to try. 

 I just heard (and reported in a recent news blast) that this vaccine is making a comeback - it was sold to a new company who hopefully will run another trial in the subgroups that benefitted!

 




07/19/19 Study hints at why an aggressive form of brain cancer is hard to treat        

 Very important article.     It points out how the tumor is usually made up of at least 2-4 different subtypes of GBM, and most importantly, that the cells are able to change from one type to another.  This may account for how easily a tumor evades treatments. It also opens up a lot of possibilities such as targeting the mechanism that the cells use to change back and forth - perhaps have them all change to an easier cell to kill, Or just target the four subtypes with 4 different treatments and the cells would have no place to hide!

 




07/19/19 A New Method for Ethical and Efficient Evidence Generation for Off-Label Medication Use in Oncology (A Case Study in Glioblastoma)        

 They report early results using a combination of 4 off label, easily available drugs for the treatment of GBM




07/18/19 Medicare Releases Final Local Coverage Determination Providing Coverage of Optune® for Newly Diagnosed Glioblastoma        
Medicare published the final rule this morning.  This is the one that we have been battling for the last few months, trying to get them to remove the proposed restrictions.   Medicare listened to every comment  we sent. (Their point by point  response is in the link on the article below), and removed the worst ones.  We can live with it the way it is. Not perfect, but much better than the proposed rule. I call our campaign a win!  The brain tumor community came together on this one.  There were 301 comments submitted, 5 from advocacy groups (including the Musella Foundation), and 209 from patients or caregivers, 80 from doctors!  Very impressive. Thanks!
 
They removed the big restriction on where you had to go for treatment. 
 
As for surgery, we commented that some people can't get "maximal debulking surgery". So they did not remove that requirement, but did add the words "where feasible". which effectively removes that one!
 
They did keep the need to start within 7 weeks of the end of concomitant chemotherapy, but did change from "Temodar" to "chemotherapy",  so those that are use a different chemotherapy are still covered. 
 
They kept the restriction on using Optune for 18 hours a day but added an exclusion for those days that you have to limit or interrupt treatment,
 
They did not change the need to have no evidence of progression but in their comments they mentioned the RANO criteria considers pseudoprogression. Reading the RANO criteria closely, for the time period in which the decision needs to be made, it is hard to claim it is progression even if the MRI is 
worse - so I do not think this will be much of a problem.
They did not remove the karnofsky score of 70., and the need for it to be a GBM.
They also added a way for people who were already on Optune and then switch to Medicare can continue if they are using the device and show it is helping.
 
And they opened the door to appeals if you do not meet any of the criteria!
 
Overall, much better than I thought we would get, and it was much faster than I thought!  Thanks to Medicare for conducting the process in the right way.
 

 




07/17/19 Electricity helps control man’s brain tumor        

 The doctor mentioned, Dr Peereboom, is one of the best neuro-oncologists in the world, and one of my favorites.  However, I disagree with what he says in the article. He talks about the average benefit is living 5 months longer with Optune than without.  That is true but I look at it in a different way. I would probably not choose something that only adds 5 months to the average survival (if there were any other choices).  I look at it as your chances of being alive in 5 years goes from about 4% without Optune, to 29% if you use Optune with at least a 90% compliance rate.  That is definitely worth choosing.




07/17/19 ImmunoCellular Therapeutics Announces Asset Purchase Agreement with Private Biotechnology Company        

 This is great news.   ICT-107 is an off the shelf vaccine for GBM.  The early clinical trials looked very good, but the final clinical trial "failed" and they stopped development of it.  However, there were quite a few responses and long term survivors from that trial.  There were probably some mistakes made in that trial design.  Patients that had certain biomarkers did well enough (adding over a year  to median time to progression compared to those without the biomarker)  get FDA approval but patients without those biomarkers had no benefit. Hopefully this new company will run the correct trial and make this vaccine available.  This is literally a shot in the arm (or leg) with the same side effects profile as the flu shot, and there are a few long term survivors out over 7 years who are not only alive, but in good shape, happy and still working.




07/16/19 GBM Awareness Day This Wednesday July 17th!        

 Please look for the hashtag #GBMDay on social media on Wednesday and retweet it so we can get it trending!




07/16/19 Attend an Optune Open House.        

 From our friends at Novocure!   




07/16/19 Neoadjuvant Anti-PD-1 Immunotherapy Leads to Survival Benefit in Recurrent Glioblastoma        

 This is the second publication which conforms that if you are going to have a surgery, it pays to start taking pembrolizumab before the surgery and continue after, instead of starting after.




07/15/19 Phase II study of Dovitinib in recurrent glioblastoma.        

 Unfortunately this treatment did not work.




07/06/19 Insurance type impacts the economic burden and survival of patients with newly diagnosed glioblastoma.        

 As expected, the better insurance you have the better you will do.  This is very significant when we start talking about Medicare for all.  The most popular "medicare for all" plan really is Medicaid for all. It sounds good with no copayments or deductibles, but when you try to limit costs especially for complex cases like a brain tumor, quality has to suffer.

One fault in the article- it says Medicare patients do not live as long as private insurance payments, but they did not correct for age.  Medicare patients are usually older than private insurance patients, especially at the time of the first surgery.  Older people in general do not do as well as younger people.

 

 




07/01/19 Defeat DIPG Executive Director Jenny Mosier Speaks at FDA Public Hearing Regarding ONC201        

 This is one of the most moving speeches about how devastating pediatric brain tumors are and the need to speed up development of treatments.




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