1) a study on efficay of prrt
2) why prrt is not in this country and options for systemic therapies
This is an article from JOURNEY OF NUCLEAR MEDICINE relative to :
Survival benefits and efficacy of peptide receptor radionuclide therapy (PRRT) using Y-90/Lu-177 DOTA-TATE in pancreatic neuroendocrine tumor (pNET)
The link to this site is :http://jnumedmtg.snmjournals.org/cgi/search?andorexactfulltext=and&resourcetype=1&disp_type=&sortspec=relevance&author1=&fulltext=prrt&pubdate_year=2009&volume=&firstpage=
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I entered 2009 and found the following abstract from Bad Berka (ther are many other studies from different sites also) on results for pancreatic NETs. The numbers are astonishing relative to survival benefits! An example of the results:
"Median duration of survival from FIRST DIAGNOSIS- Please note, it is from first time diagnosed, not when PRRT treatment was started- so the data is a bit twisted but still interesting!:
was 189 months. Median survival in patients with pNET in head (132 months) was less than that in body/cauda/tail (256 months). Mean survival in nonfunctional pNET was 148 months as compared to 341 months for functional pNET. Mean survival in patients with Ki 67 < 20% was 183 months vs 73 months for Ki 67 > 20%."
Patients with Pnets, these numbers are MONTHS! And if you do the math, let me see, get a calculator out and divide 183 months, and that equals 15.25 YEARS!!! FIFTH TEEN, ONE-FIVE, Y-E-A-R-S! Now at the low end (my Ki index has a range of 10% to 20-30% so I am not that good) its much less....KIEL INDEX IS THE OPERATIVE WORD FOR SURVIVAL! Obviously, its from FD so it skews it some, but it does let you know two things, Pnets can be a long term disease, with good quality of life, and PRRT can extend that life!
But even at that low end, AND MY TUMOR IS NOT PANCREATIC IN ORIGIN, MY IS RENAL CARCINOID, so this is not an apples to apples for me (its tumor to tumor), but for those with Pnets, it IS!, at the low end, its 73 months from FD, which equal 6+ YEARS!
These numbers are encouraging and should lead one, with this disease, to find out more about this mysterious and unavailable SYSTEMIC treatments. http://www.photius.com/rankings/healthranks.html
The USA is ranked #39 in the world, right below Costa Rica, Morocco and UAE in overall health care!!??? That does not make sense to me? Really, it does not. I have lived in CR. However, I lived in Canada under ONE PAYER system...ITS THE BEST friends.....as Tony would say "forget bout it"...it is good, inexpensive and everybody pays. No more 10x billing in hospital b/c 25% of the patients have no insurance and do not pay there for patients with $ and insurance make it up! No?
One reason, I think, or an example of the issue- not having PRRT treatment and scanning/imaging (gallium 68) in this country!
How in the world, could a therapy and Imaging, with such excellent and long term results, studied and tired on patients for over a decade, IN EUROPE, IS NOT BE AVAILABLE IN THIS COUNTRY?This forces terminally ill patients, to make a decision to go outside the country, pay in cash, and fight in INSURANCE HELL for coverage (TO BE CLEAR , THANK GOD FOR OPTIONS AND PROGRESSIVE CENTERS LIKE ROTTERDAM, BAD BERKA, BASEL, UPPSALA, AND MANY, MANY OTHER SITES IN ACROSS THE WORLD THAT HAVE THIS THERAPY FRO NET TUMORS! THANK YOU, DANKA, GRACIAS, AND THANKS CHAP!)
Does it make sense for the US to not have this therapy??
For those screaming and yelling they want their "private plans' in tact and pointing to Canada or other places as evidence of issues- I tell them "NO ONE IN CANADA HAS GONE BANKRUPT DUE TO MEDICAL ISSUES, NOBODY...and the quality of medical care, which I used for 2 years was excellent!....
Yes, there are faults, as in ANY SYSTEM, but from some of the experience IN SOME CASES WITH INSURANCE, is that we have a simple hell of a system- AT TIMES ONE CAN FIND PEOPLE THAT ARE overworked, uncaring, misinformed, and finally, endless delays in appeals and in the end, DENIALS which COULD BE VIEWED, to manage a patients health plan by denying treatment.....! This is currently, under the current system, managed by insurance companies, clerks, and managers, and CEOs that are under pressure for bottom line profits.
Benefits, I have paid for decades into a LTC plan and when I need it, I was denied, when I am in my advanced stage of cancer for LTC! Net be careful with LTC insurance. I finally got the denial support which is plain, bull.....read Lauire Todd's book on Insuance Warrior and how to fight the ins company (DENIAL INC's) and how to uderstand who really the "Medical Directors" are and "Experts" in the business....recall, you have a very rare tumor with specific symptoms and issues and limited treatments.....how many Insurance company Medical Experts understand this, I am not sure? But they are not in the business to protect your interests. They are in the business to make a profit, sometimes, on the backs of the dying patient which needs the drug. So learn to FIGHT- (attorney will not work as they dont understand and you will end up losing you money).
What is needed is a company that does this for a living...a lot of money and people if they set themselves up, however, it is not easy!
I understand the need for profits and cost containment. But PRRT therapy and GA 68 imaging have built in cost advantages and EVIDENCE OF SUCCESS dating back decade or more.
It does not make sense that it is not available in the #36 medical country in the world..........dos it?
Really I am confused and would welcome input? Remember, whatever you come up with, its MONEY and PROFIT that drive decision making in the USA!
THERAPY OPTIONS AND COST
More information below as fyi, and then tell me what you would do, if you were smart and running this as a business?
In the US, for PNet, the SYSTEMIC options are drugs such as RAD, Temedor/Xeloda, Interferon (the cheapest, but not very effective~ 15%, and some real bad side effects), Sudent, LAR and others in that class. All of these drugs have pronounced side affects, which are nowhere near the side effects of PRRT (although kidney and bone marrow are serious in PRRT and also some people have no receptors so the therapy will NOT WORK for them). Other drugs need to be taken daily or monthly or weekly via oral, injection or IV.
One issue with PRRT in the US, as a treatment choice is , and there is nothing wrong other than need to work with radioactive material. But its done with other therapies.
Some people in the US are finally becoming more empowered and aggressive, and do their own research, and find in Europe PRRT is used, at times, as a second line therapy. So they work with their US physician, if the disease timing is right, and they get in at the early part of the disease.
Some studies indicate this therapy works better -- early in the disease course-- PRRT.
But since its not in the US, not a second round option or third round.....you will this option, even to see if its workable, unless you push it. Most MD's in the USA look at this therapy as the" last resort", however, and send patients when they are at the end of treatment options.
Question? Why not do RAD or VEGF (treatments that last 50 weeks or so) as the "last bullet" instead, and use PRRT earlier? Give people a good quality of life for a while to enjoy life prior to taking the harsh drugs noted above?
BTW, SURGERY IS ALWAYS the best way to go!
(I am not a MD and repeating what I have read prior, so talk to your MD. If you don;t like what he/she says, get a 2nd opinion....it YOUR LIFE AND YOUR DISEASE....!)"I am mad as hell and I am not going to take it anymore"....remember the movie "The Network"?.....well, here is the address to write your President Obama to complain why this therapy is not available,,,,and oh yea, control insurance companies for us please (OVERSIGHT!):
Here is the address of the WHITE HOUSE
http://www.whitehouse.gov/contact/
Find out the address of your Senator and your congressperson and send them this information and DEMAND ("what do we want?" "when do we want it?" ....sort of thing).
PLEASE!
My opinion, patients should have a CHOICE, a SOLID CHOICE, in this country and supported by insurance, for this therapy and imaging! IT makes sense from aAlways look for the best surgeons and that option FIRST with NET/Carcinoid. Then after the operation, find the KI Index or HPF to determine the aggressiveness of the tumors. That is a key indicator of survival. The higher the number, the worse survival options. But, I have 20-30% KI index and have lived 8 years with this disease. Some people have 0-2% which is typical....consider yourself very fortunate as your tumors will take year and years to become life threatening...USUALLY
- quality of life
- cost
- survival
- less side effects
Cost Benefit
LETS GO THROUGH AN EXAMPLE OF COST of PRRT Gallium vs Current US and O'scan-
1) USA- AVASTIN AND LAR30 MONTHLY--cost $16,000 TO $25,000 PER MONTH!
BEST RESULTS, PARTIAL REMISSION, DURATION ABOUT 12-16 MONTHS (I will find the study data). Side affects- very hard, except RAD (for me)! This is an option for late stage disease in the USA and was talked about with me....I did not do it but without out right LUCK, I would be with an IV today or dead. Also, Octrescans every 3, or 4 or 6 months - I would venture to say the cost is $10-$15,000 per. A CAT scan would have to be fused to the scan so whatever that would cost, $10,000?
Total cost for one year: ESTIMATED: $250,000 treatment, $50,000 scans=$300,000 for one year, TYPICALLY THE DRUG STOPS WORKING AFTER 1 YEAR, ONE!
$300,000 hundred thousand...and insurance hell, since avastin would be "off label" and one needs approval from DENIAL INC.2) Cost of Treatment, NOT IN USA- PRRT & Gallium- $10,000-$15,000 EUROS (1.45), 2-4 treatments. Usually, afterward, NO MORE LAR 30 injections, ALTHOUGH THAT IS NOT THE CASE IN ALL SITUATIONS!
PET/CAT same timing, probably 50% to 25% less but sometimes is included in the initial fee!
Total Cost for entire treatments- $75,000 4 treatments, scans $37500 (IF SEPARATE)=$112,500 for treatments, which may last up to 40 months (complete remission, partial stable disease) (as per Rotterdam study-on blog).
To be clear there would be scans in out years but that would be the same for option #1) and continued savings.
Net: USA Treatment $300,000 per year, every year (not included scans per year, same for both), probale outcome stable disease.Probale outcome, partial or stable disease(cost includes scans built into treatment in Europe!),
Europe/PRRT Treatment $80,000 for treatment- duration 40 months, so cost per year- ~$24,000 per yr (40 month duration)-(assuming 3-4 treatments only)
These are estimates, but I think close enough!
note- one will need scans on same basis as with USA therapy going forward.
Assuming Oscan/Cat scan in USA versus Pet Gallium w/Cat scan, it would still be much cheaper in Europe (~33% cheaper) for these scans than in USA.
Is PRRT safe?...YES, more or less, by all indications, and YES due to many years of studies, ACTUAL TREATMENT, over a decade. Overall yes! its safe.
To be clear, there are known side affects and long term safety of kidneys is still a concern, however, compared to what we have as options, it is fairly tolerable. Also, there is more data on this therapy, than on RAD, NEXEVAR and other new drugs which have been approved by the FDA in the USA!
NOTE: Lutetium 177 (Lu177) is very safe compared to the other option which is Y90 (much stronger)
The APPROVED DRUGS in the USA such as sudent, nexavar and others in that class, have some side affects (RAD HAD NONE FOR ME BTW!). But there are studies these drugs MAY possibly have issues (not yet proven, but animal studies are not promising) with increased metastasis to other parts of the body. THIS IS NOT PROVEN, AND THE BENEFITS OUTWEIGH THE RISKS, SO PLEASE WORK WITH YOUR MD WHEN GIVEN AN OPTION.
These new drugs are available today in the USA. They were developed for other types of cancer, and are used OFF LABEL (insurance hell again!) for NET tumors. If lucky, enroll in a clinical trial and get the drug for free! LOOK FOR PHASE II STUDIES AS IT AVOIDS PLACEBOS!
NET, one takes a risk, to extend life, with potential risks along the way with anything.RIGHT? No matter what one uses? (the side affects of most of the drugs available in the US are more harsh as compared to PRRT btw, except SANDO).
Cost SummaryThey cost a bundle (Avastin price- $10K a month, every month until it stops working) I believe the other drugs are ~50% less but still EXPENSIVE (Interferon being the cheapest but the worse on side effects).
The plus side, most are taken orally, except for LAR, Avastin, Interferon, which is most expensive.......but taken monthly and on and on! (BTW, Temedor Xeloda is best used for Pnets and rather inexpensive also)
So, PRRT & Gallium 68 not available in this country? Why the hell not folks?
I can see it being a cost versus revenue thing.
Question- who owns the rights to PRRT technology in the USA and why aren't they fighting with Government for approval, presenting the European data ( decades ) to try to orphan stage or "fast track" approval in the US?
If its not profitable, they can make fairy compeling by pricing it as such (I know of one hospital that charges $15,500 for one LAR30 injection!). Its a "FREE FOR ALL" RELATIVE TO PRICING IN TERMINAL DISEASE, RARE DIEASE, DRUG PRICING IN THE USA!
Profit and Loss
Current status in USA- PRRT technology technology has been purchased (leased) to two small pharmaceutical companies, they are working in Europe to work for clinical trials for PRRT Y90 (MIPI Ticker symbol IS ONE OF THE COMPANIES) to get it studied and approved.
With their issue of funding, lobbying power and influence, it MAY 5 TO 10 years, more or less, to make something happen in the USA, unless we can find a STAR PERSONALITY!
To make this happen, a heavy weight INC. has to get behind it...NOW, and show it can make money, a lot of it, 10x more than anywhere in the world because, well because, the USA pays more than anywhere in the world....we have a better printing presses!
Why not get into the FDA/Government and present European data, that dates back 10 to 15 years? That is a hell of a lot of information, no? And request orphan status, fast track approval and then let capitalism take it course, and see where it TAKES US?
Or better, why not get the US government involved, as they are for auto and banks, and invest in this thing as it saves money and lives! That would be interesting......no?
Pet/Gallium68
The Gallium Imaging issue is beyond comprehension, something more mysterious than "AREA 57" or something.....why is it not here??
Convinced something is not right here?
To be clear , it could be money, not enough OF IT and too much testing and government red tape needed to get it approved.
It would seem; however, the therapy has worked in Europe for decades, and proven to be effective, relatively safe (as safe as the newer drugs and the questions they bring).
Seems like there could be a "fast track" solution to the issue ...perhaps too simple, or me in "dream land"!
But, so far, it's not approved in country #36 country for health care!
Rumor: I have heard they are trying to get it in Y90 that is, but the above is only my speculation.....
SIDE NOTE: Remember the 80's and AIDS and people dying? Well those people with HIV made things happened FAST by getting "mad, loud, aggressive and organized" (they all had money, star power and lobby power), in the 80's. They went into it and pressured the government, and companies, to move FAST on testing and approvals for therapies.
Today, people with HIV are alive, living with excellent quality of life (have you seen Magic on TV recently? looks great!)
They succeeded by getting aggressive with Government and having the backing of lobbyist, Hollywood types, and money, behind them.
Net, when is the last time you have heard of someone dying of AIDS in the USA? Its now a non killer, with a lot of medicine daily, but it's been stabilized, in the USA and EUROPE, more or less!
Please, as a place to start, write your representatives in Government, that is one step.Also, very important, start working on your insurance company to COVER this treatment via insurance payments now for treatment outside the country. It is the best investment they could make! Also, Medicare!
I think the latter would the quickest,"fast track" method to get these modalities into this country! Money drives medicines and therapies in the USA!
As soon as the insurance companies start to see the savings with these treatments, and start to regularly pay for this cheaper and effective NET treatments, with long survival rates, then US companies (or drug or medical companies doing business in the USA, hospital and doctors, etc) will have to act (get in the PRRT business), or lose a lot of patients/business....
BADDA BING- Y90 and Lu177- in the US here in no time, I think---(but at five or ten times the cost of Europe of course...lawyers, paperwork, OH, more profits, lack of insurance patients, etc.... but at least its here and approved and WE PATIENTS HAVE A US BASED CHOICE!)
Capitalism/FREE MARKET will drive it, BUT WE NEED YOUR HELP.....
IT WOULD BE GREAT TO HAVE A MAJOR HOLLYWOOD TYPE OR FAMOUS CEO TYPE TO HELP OUT. BUT THERE ARE NONE THAT WANT TO HELP HERE! NOT ONE!
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Here is the article -there are plenty more from other centers which by going to the web site and search you will find them. Remember, the study is for first diagnosis so keep that in mind...its not first therapy. But still impressive information to think about...remember the emails above to write!
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Survival benefits and efficacy of peptide receptor radionuclide therapy (PRRT) using Y-90/Lu-177 DOTA-TATE in pancreatic neuroendocrine tumor (pNET)
1 Zentralklinik Bad Berka, Dept. of Nuclear Medicine and Centre for PET/CT, Bad Berka, Germany 2 Zentralklinik Bad Berka, Dept. of Internal Medicine, Bad Berka, Germany 3 Zentralklinik Bad Berka, Dept. of General and Visceral Surgery, Bad Berka, Germany
Objectives: To evaluate the response to PRRT, using Y-90 or Lu-177 DOTA-TATE) and assess overall survival in patients with pNET.
Methods: 107 patients (mean age 60 yrs) of progressive pNET were treated with 1-7 cycles of PRRT using Y-90/Lu-177 DOTA-TATE. Response assessment (using Ga-68 DOTA-NOC PET/CT) was done in 54 patients receiving more than 3 cycles of PRRT and followed up for > 3 months.
Results: Mean/ Median duration of follow-up after first diagnosis (FD) was 107/58.5 months. 29/107 (27%) died. 26/107 (24%) had nonfunctional, 84/107 (76%) had functional pNET. Tumor localisation: head -31, body- 16, tail and cauda -41, total pancreas -4, body and tail -9 , head and body-. 11 patients had gastrinoma, 7 glucagonoma and 2 insulinoma. Metastases in liver was present in 99/107 (92.5%), lymph node 58/107 (54%) and in bone 38/107 (36.4%). The patients were pretreated with chemotherapy-44/107 (41%), surgery 52/107 (48.6%) and biotherapy (octreotide) 46/107 (43%). Objective response was seen in 52% of the patients, 39% had SD and 9% had PD. Median duration of survival from FD was 189 months. Median survival in patients with pNET in head (132 months) was less than that in body/cauda/tail (256 months). Mean survival in nonfunctional pNET was 148 months as compared to 341 months for functional pNET. Mean survival in patients with Ki 67 < 20% was 183 months vs 73 months for Ki 67 > 20%.
Conclusions: PRRT is an effective therapy option for pNET. Patients with pNET in head of pancreas and high grade tumor (Ki67 > 20%) have the worst prognosis.
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