1) a study on efficacy 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 (they 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.htmlThe USA is ranked #36 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, so 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 SITESACROSS THE WORLD THAT HAVE THIS THERAPY FOR NET TUMORS!
Does it make sense for the US to not have this therapy??
Separately, 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 my experience, IN SOME CASES WITH INSURANCE, is that we have a simple hell of a system(s)-
>ne payer for older people where the government pays for everything (almost) but with the patient being able to buy relatively inexpensive additional insurance
>ne system for the low income and non citizen which generally use the hospitals
>ne system for the employed with insurance but with cavets.
IN this latter system one runs into lack of clear information, many systems and processes, agents and staff overworked, at times uncaring, misinformed, and finally, endless delays in appeals, which in my case have led to DENIALS which COULD BE VIEWED, to manage a patients health by denying or accepting treatments! This is currently managed by insurance companies, that are under pressure for bottom line profits.
I understand the need for profits and cost containment. But the 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..........does it?
Really I am confused and would welcome input?
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%PR, with some tough side effects and daily shots), Sudent, and others in that class and Somastatin. All of these drugs have side affects, as does PRRT. Most the the therapies need to be taken daily or monthly or weekly via oral, injection or IV, with most being forever as they typically PR or SD. With PRRT it is a 30 minute IV and then 3 days stay in the hosptial, with Iv hydrtation the first day and some side affects, usually caused by the hydration. The therapy is done every 4 months for up to 4 rds.
One issue with PRRT in the US, as a treatment choice may be need to work with radioactive material. But its done with other therapies such as hyperactive thyroid, prostrate pellets, etc..
Some MD's and pateints in the US are positive on this therapy and send or self referral to Europe, and undertake the therapy.
Some studies indicate PRRT therapy works better -- early in the disease course.
But since its not in the US, not a second round option or third round.....at times you may not talk this option, to see if its workable (do you have receptors, if your disease widespread?) unless one pushed it. Some MD's, look at this therapy as the" last option, however, and send patients when they are at the end of treatment options. Others are more aggressive and refer patients at earlier stage.
BTW, SURGERY IS ALWAYS the best way to go!
(I am not a MD, so please talk to your MD about the right therapy for you! If you don't like what he/she outlines, perhpas think about getting a 2nd or 3rd opinion....Remember, its 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:
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, in this country and supported by insurance, for this proven and inexpensive therapy and imaging!
Always find out how aggressive your disease is: find the KI Index or HPF, which determines the aggressiveness of the tumors and treatment path. That is a key indicator of survival. The higher the number, the worse survival options.
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 (decades) to become life threatening...but with good intervention, one can postpone the end point!
If there is an MD or clinic or Hospital that wants to take the risk/fund or invest to bring PRRT and or PET Gallium here to the USA, manage it, run it and service US patients, then we, as informed patients, with a TERMINAL stamp to our heads, should be allowed to decide what to do in this country and covered by our insurance.Today, we wait until its advanced, then we fly off to parts unknown, with cash in hand (some are fortunate to have insurance already, with companies wise enough to see the "cost benefit" of this treatment, versus what is available and the cost here), sicker than hell (ME) and hoping for a miracle from one of the advanced clinics in Europe.....
Cost Benefit
LETS GO THROUGH AN EXAMPLE OF COST of European pricing model- PRRT & PET w Gallium & CT vs Current US Systemic Options and O'scan/CT for Imaging . This is one option for ADVANCED TUMORS (non Pnets):1) USA- AVASTIN AND LAR30 MONTHLY--cost $16,000 TO $25,000 PER MONTH!
BEST RESULTS- PARTIAL REMISSION, DURATION ABOUT 12-16 MONTHS.
Side affects- various but avastin more harsh, LAR usually mild.
This is an option for late stage disease in the USA and was talked about for me after I had been through surgeries, and 2 clinical trials.
If I had not gone to Germany, I would have had Avastin w CT and Octrescans every 3, or 4 or 6 months -
Total cost for one year under this option:
ESTIMATED: $250,000 treatment & $50,000 for 3 scans=$300,000 for one year,
TYPICALLY THE DRUG STOPS WORKING AFTER 1 YEAR, ONE!
$300,000 hundred thousand...with potential insurance hell, since Avastin would be "off label",
and one needs approval.
2) Cost of Treatment, NOT IN USA- PRRT & Petw Gallium- $10,000-$15,000 EUROS (1.45), 3 treatments for the year. Before and after the therapy, the patient usually does not need LAR 30 injections, depending on level of symptoms. In one study it is 75% of the patients will be able to get off of somatastatin analog.
Total Cost for 3 treatments- $75,000 3 treatments which includes hosptial and scans. Add $5,000 for Travel for total cost of $81, 000. Restaging cost $5,000 each (every 6 months), total $20,000
Average duration ~ 40 months from first treatment-usually PR or SD. (as per Rotterdam study-on blog).
>USA Treatment $300,000 per year, every year
>Europe/PRRT Treatment $35,000 per year:
duration 40 months, total cost $100,000
(assuming 3 treatments only)
These are estimates, but I think close enough!
Is PRRT safe?...YES, by all indications, and YES due to many years of actual usage and study data, over a decade. 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 the other new drugs which have been approved by the FDA in the USA!
PRRT= 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 also but more manageable). 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! Some of the drugs such a Temedor Xeloda have been shown to work for many years and much less expensive than Avastin.
One takes a risk, to extend life, with potential risks along the way with anything. RIGHT? No matter what one uses.
So, PRRT &PETw/ Gallium 68 not available in this country? Why the hell not folks?
Current status in USA- PRRT "(Y90) technology technology has been purchased (leased) to a small pharmaceutical company. They are working in Europe on clinical trials for PRRT Y90 (MIPI Ticker symbol) to get it studied and approved.
With their issue of funding, lobbying power and influence, it MAY years, more or less, to make something happen in the USA, unless we can find a STAR PERSONALITY to help champion it!
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!
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.Always look for the best surgeons and carcinoid Md option FIRST when you deal with NET/Carcinoid.
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