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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!
Displaying Stories 1 to 20 of 6,487
02/15/19 Statins, NSAIDS Have No Apparent Survival Benefit for Grade IV Glioma
There have been other trials that show statins and NSAIDS have helped brain tumors. This study says no (except Aspirin for grade 3 gliomas). It is hard to prove one way or another with such conflicting information. A randomized blinded trial would be the best way but that will never happen due to cost. The next best thing is for the registry to track these drugs - but record the dosage and length of time the drugs are used, then evaluate it over a large number of patients.
02/13/19 Race influences survival in glioblastoma patients with KPS =?80 and associates with genetic markers of retinoic acid metabolism.
This study shows a very large racial disparity - this time favoring African Americans. They identified a set of genes that differed between the two groups, which may be responsible. This difference is larger than most clinical trials would report as a successful treatment. It may be worth reporting clinical trial results by race and/or this group of genes now.
Historically, African Americans have been way underrepresented in clinical trials – as shown by this study. Out of almost 1,000 patients, only 6% were African American - while in the USA African Americans make up about 13% of the population. We are working to try to correct that – and other – disparities.
02/12/19 Treatment of Glioblastoma (GBM) with the Addition of Tumor-Treating Fields (TTF): A Review
This article intended to be a balanced article on the plusses and minuses of Optune. Unfortunately it is loaded with errors and bias. For example,
1. They say: They did a survey between January 2015 and July 2015 and found only 41% of doctors had access to the device. Optune was approved for newly diagnosed in July 2015. So they did the survey before the device was available for newly diagnosed. (The recurrent data was not great). This article was published in 2019. Optune is now available at just about every major medical center in the USA. Their website, optune.com says there are 700 certified treatment centers that offer Optune in the USA. They should have repeated the survey but instead used an old one that made Optune look bad.
2. They harp on the fact that there was no sham device in the control group. That would have been ridiculous. Imagine having to shave your head twice a week and carry around the old version of the device (which was twice as heavy and bulky as the current version), and risk getting skin problems without a chance to benefit from it? I would not want to do that. The endpoint was overall survival. Placebos cannot show such an increase in overall survival. The Temodar studies did not use a placebo and nobody faulted the study for that. The Avastin trials did use a placebo but the placebo group did not do better than the treatment group (which means placebos do not help glioblastomas). This is absolutely not an issue.
3. They say Optune is not covered by Medicare or many other insurance companies. The second part of that statement is not true. Over 90% of non-medicare insurance companies pay for Optune. They go on to say Medicare has now agreed to reconsider coverage – which only happened a few weeks ago so there is no reason to be so far behind on the statistics. That statement was true in 2015 but not in 2019. Hopefully by the end of this year all insurances including Medicare will be paying for it. In the meantime, Novocure has said they would not let a patient not get access to this treatment due to being unable to afford it. They very generously gave it for free or at a very reduced rate to those on Medicare or who did not have insurance that covered it.
4. They keep talking about patients being reluctant to wear the device and shave their heads. This is too subjective. Of course patients would prefer not to shave heads or have to wear a device that constantly reminds them of the disease. However, having to use a wheelchair, or being unable to speak, at a much sooner time are not great alternatives. It is a personal decision that the patient has to make.
5. Finally – they complain about the price. At least they do point out that other new treatments are way more expensive. I doubt we will ever see a new brain tumor treatment priced less than Optune. Optune is about half of the price of Avastin, and the trials showed a big increase in survival for Optune, and no increase in survival for Avastin (although they did show a nice improvement in progression free survival and patients feel better on it). I never heard the complaint that Avastin was too expensive. Hopefully we will have a few new treatments approved in the next year or 2. We have no idea what they will cost but to put it in perspective: The cheapest gene therapy on the market (for other diseases) is $373,000 for the one treatment. Most expensive now is over $1 million for the one treatment. A new one that is under review might be $4 million for the 1 dose. As for vaccines, the only one approved in the USA (for prostate cancer) cost about $93,000 for a 6 week course of treatment. The only way to bring these prices down to earth is a major change in regulatory policy – but that is for another day.
02/11/19 Ziopharm Oncology Completes Enrollment of Controlled IL-12 Monotherapy Expansion Substudy in Phase 1 Brain Cancer Trial
This is a fascinating gene therapy. Follow the link in the article to the video explaining how it works. They have the ability to insert a gene into the cancer cells which can be controlled by an oral drug - which turns on the production of IL-12 in the infected cells. Stopping the oral drug turns off the production of IL-12 and they can fine tune the amount of IL-12 produced by adjusting the oral dose of the drug. IL-12 turns on the immune system and helps your body fight the cancer. The next step is to add a checkpoint inhibitor, which have not worked that great with brain tumors but this gene therapy might be able to make the checkpoint inhibitors work for brain tumors!
01/26/19 Early clinical trials of Toca 511 and Toca FC show a promising novel treatment for recurrent malignant glioma.
This is another case where the median overall survival is meaningless and could hide impressive results. Toca 511 and TocaFC is an experimental gene therapy. Toca 511 is a virus that is injected one time. It infects only tumor cells (see https://tocagen.com/our-science/#platform_tech for information on how that magic happens. It is fascinating). When this virus infects a tumor cell, it inserts a gene that codes for a protein called CD. CD can break down the drug Toca FC into a chemotherapy drug 5FU, but only in cells that had the gene inserted. Toca FC is an oral drug which is a reformulation of an old drug approved for fungal infections. After injecting the virus, you wait a few weeks for the virus to spread to most of the tumor cells, then start a round of the oral TocaFC. This drug is harmless to the body except when it comes into contact with the CD protein, which converts the drug to 5FU which kills the nearby cells. This not only kills the tumor cells but exposes the insides of the tumor cells to the immune system to trigger an immune response. You then stop the TOCA FC for a few weeks to allow the virus to infect the remaining cells and repeat the process as long as is needed.
This article reports on the results. This is on 56 recurrent high grade glioma patients - which is medium sized - enough patients to see the trend. They used a comparison to historical controls. The Median overall survival only moved up 2.9 months compared to historical controls (that would be very significant if it was against randomized controls) and the response rate was only 11.3%. Just looking at those numbers, I would usually say it is interesting but needs more research before I would consider using it if I needed it. However, they then go on to say of those 11.3% responders, ALL had complete responses for an extended period of time. This is very impressive. It is rare to get a single complete response in a trial this size, and many times we see a complete response that only last a few months. Seeing about 6 patients our of 56 having a sustained complete response places this treatment among the best options for brain cancer patients.
Disclaimer: The Musella Foundation was an early supporter of this treatment via grants, and Tocagen is a sponsor of our organization
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