Lutetium Lu 177 dotatate (Lutathera®) – PRRT

prrt update

Background

There’s a lot of questions doing the rounds on forums and messages about the approval of Lutathera (PRRT) in USA, Europe and other places.  This is not a place just for one particular country, I want a place to review what is happening globally given my following.  In many countries, however, I’m dependent on feedback from patients in those countries. Please note this is not intended to be a 100% complete breakdown on everything about PRRT or PRRT centres – it’s a summary.  It should be clear from below but please bear that in mind when reading.

Short PRRT Primer

What is PRRT?

For those who are still not sure what it’s all about.  This is a non-surgical treatment which is normally administered intravenously.  It’s based on the use of somatostatin receptors to attract a ‘radiopeptide’.  The radiopeptide is a combination of a somatostatin analogue and a radioactive material. As we already know, somatostatin analogues (i.e. Lanreotide/Octreotide) are a NET cell targeting drug, so when combined radioactivity, it binds with the NET cells and delivers a high dose of targeted radiation to the cancer while preserving healthy tissue.  In general, patients tend to receive up to 4 sessions spaced apart by at least 2 months. 

PRRT will not work on all NETs and not everyone will suited to this treatment. In general, for this treatment to be more successful, you must have somatostatin receptors in your tumors. Success rates are not 100% – it should not be considered a cure or ‘magic bullet’. However, the results are said to be pretty good.  The NETTER-1 trial data which has led to formal approval in Europe, USA and other areas, can be found here.

THERANOSTICS

Understanding the terminology is half the battle in understanding the latest developments. I’ve included Ga-68 PET scans within this section (or in more general terms Somatostatin Receptor PET (SSTR PET)) as the term ‘Theranostics‘ is becoming a commonly used theme.  Theranostics is a joining of the words diagnostics and therapy.

LUTATHERA is the radionuclide ‘mix’ for use in Peptide Radio Therapy Treatment (PRRT).  You may also see this drug called ‘Lutetium’ or ‘Lu-177 dotatate’, or just ‘Lu-177’ on its own. Yttrium 90 (Y-90) is a  radionuclide also used in PRRT. 

NETSPOT (USA) or SOMAKIT TOC (Europe) is not PRRT but it is the commercial names for the radiopeptide used in Gallium 68 (Ga-68) PET diagnostic scans.

Together they form a ‘theranostic pair’. Theranostics is apt as together (NETSPOT / SOMAKIT TOC and Lutathera), both target NETs expressing the same somatostatin receptor, with Lutathera intended to kill tumor cells by emitting a different kind of low-energy, short-range radiation than that of the diagnostic version.

Moreover, thanks to the theranostic approach that nuclear medicine allows, Novartis/AAA’s NETSPOT/SomaKit TOC products will be able to determine when Lutathera is the appropriate treatment.

Read more about Theranostics by clicking here.

LATEST HEADLINE – UK

20 July 2018National Institute for Health Care Excellence (NICE) has recommended Lutetium (177Lu) oxodotreotide, within its marketing authorisation, as an option for treating unresectable or metastatic, progressive, well-differentiated (grade 1 or grade 2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (NETs) in adults. There is a short interim period where until formal publication takes place. Final appraisal determination covers the period 20 July to 3 Aug 2018 but PRRT is now effectively approved in England. CLICK HERE to read the NICE statements

9 July 2018. The Scottish Medicines Consortium (NICE equivalent) has approved lutetium 177Lu (Lutathera) for patients in NHS Scotland. Good news for Scotland once their hospitals have the capability to deliver. Scottish patients would then not need to travel to England for the NHS Scotland funded treatment. Read more here

Hasn’t the therapy has been in use for some time?

Of course, this therapy has been in use in Europe and some other places for some time but to be honest, they have been on a limited scale and never formally approved by national drug agencies.  Despite its extensive use, the EU approval in 2017 was actually the very first approval of PRRT anywhere in the world. For example, in UK, it was used for some time for those in need but was removed from routine availability through a ‘slush fund’ formally known as the Cancer Drugs Fund – to cut a long story short, the funding source was cut off, although there are still ways of obtaining the treatment pending formal acceptance by the NHS (certain criteria apply).

In the meantime, I constantly see stories of patients travelling to Switzerland, Germany, Netherlands, Sweden, Great Britain and others; mostly at their own cost.   However, it does indicate one thing, there is a huge unmet need in that many patients do not have access to the best treatments in their own country. I see this daily through many private messages.

What about Grade 3 (High Grade) Neoplasms?  

The main treatment for Grade 3 is chemotherapy, particularly poorly differentiated.  PRRT tends to work better with efficient somatostatin receptors (i.e. somatostatin receptor-positive tumors).  The European approval wording only covers Grades 1 and 2. The US FDA approval indicates “somatostatin receptor-positive tumors”.  It’s also worth noting that with Grade 3, are more likely to exist in Grade 3 well differentiated NETs, particularly in the lower Ki-67 readings. However, there’s an interesting study from Australia which might be useful to read – check out the abstract here (note the full version is not available free).

What about Pheochromoctyoma/Paraganglioma?

There’s actually still a trial for Pheochromocytoma/Paraganglioma (Pheo/Para).  It is known that Pheo/Para can have somatostatin receptor tumors so a useful trial. The aim of the trial is to assess the safety and tolerability.  You can read about the trial here.

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Where can I get PRRT?

Regional Updates

The aim of this section is to update on a regional basis in order to inform an international community of followers and readers.

This section of this article will cover each region, indicating where PRRT can be obtained (as far as I know). It is not designed to indicate whether this is through public or private facilities (this will depend to too many factors beyond the reach of this article). Please note this is not intended to be a 100% complete breakdown on everything single PRRT centre – it’s a summary.  It should be clear from below but please bear that in mind when reading.

UNITED KINGDOM

On 20th July 2018National Institute for Health Care Excellence (NICE) has recommended Lutetium (177Lu) oxodotreotide, within its marketing authorisation, as an option for treating unresectable or metastatic, progressive, well-differentiated (grade 1 or grade 2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (NETs) in adults.  PRRT is also approved and funded in Scotland. It is funded in Wales and Northern Ireland but is currently administered in England with inter NHS budget transfers.

USA

PRRT was approved in USA on 26 Jan 2018. The approval is for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. CLICK HERE.

The extended access program (trial) is no longer offered but these locations should be ahead of the game in terms of provision, notwithstanding insurance and provision of sufficient nuclear material.

In the meantime, known USA sites offering routine “live site” insurance based PRRT treatment are as follows – please note information has been gleaned from US patients due to no other consolidated source of this information being readily available. It’s possible some patients got mixed up between trial locations and live locations so let me know of any omissions or additions/corrections – thanks in advance.

DRAFT – NOT YET COMPLETE – (as at 28 July 2018)

STATE LOCATION Due in Service? CONTACT DETAILS
Arizona Banner Now Dr Boris Naraev
California UCSF Medical Center Now tbc
California Palo Alto VA Summer 2018 tbc
California Cedars Sinai Medical Center now tbc
California Stanford Medical Center Now tbc
California Kaiser Permanente Los Angeles Medical Center Now tbc
California Hoag Hospital Newport Beach Now tbc
California UCLA Health Now tbc
California Kaiser Santa Clara Medical Center Now tbc
California City of Hope LA Now tbc
California Kaiser San Francisco Summer 2018 tbc
California UC San Diego Summer 2018 tbc
Colorado Rocky Mountain Cancer Center Denver Now Dr Eric Liu
Colorado University of Colorado UC Health Denver Now tbc
Florida Moffat Tampa Now Dr Strosberg
Florida Miami Cancer Center Summer 2018 tbc
Florida Mayo Jacksonville Now tbc
Georgia Emory Atlanta Estimated June 2018 tbc
Georgia CCTA Newnan, Atlanta Now Dr. Phan
Illinois Rush University Chicago Now Xavier M. Keutgen, MD
Illinois Northwestern Chicago now tbc
Illinois The University of Chicago Medicine now tbc
Iowa University of Iowa now Dr T O’Dorisio
Massachusetts Dana Farber Boston Now tbc
Massachusetts Massachusetts General Hospital Now tbc
Michigan Ann Arbor Now tbc
Minnesota Mayo Rochester 26 Apr 2018 Dr. Thor Halfdanarson
Minnesota University of Minnesota Health Now tbc
Missouri Sara Canon Cancer Center Kansas City Now tbc
Missouri Siteman Cancer Center St. Louis Now tbc
Missouri Barnes Jewish Hospital St. Louis Now tbc
Nebraska CHI Bergan Now Dr Samuel Mehr
New York Lenox Hill NYC Now tbc
New York Roswell Park Buffalo Now Dr Iyer
New York Mount Sinai Now tbc
New York NYU Langone Now tbc
Ohio The James, Columbus Now Dr Shah
Oregon Kaiser Portland Estimated Aug 2018 tbc
Pennsylvania UPMC Pittsburgh Now tbc
Pennsylvania Fox Chase Philadelphia Now Dr Paul Engstrom
Tennessee Vanderbilt Nashville Apr 2018 tbc
Texas MD Anderson Houston Summer 2018 tbc
Texas Excel Diagnostics Houston Now tbc
Texas CHI St Lukes Houston Now tbc
Utah Huntsman Cancer Institute, Salt Lake City 10 May tbc
Virginia Carilion Clinic Roanoke now tbc
Washington (State) Virginia Mason Seattle Now Dr. Hagen Kennecke
Wisconsin UW Health Madison, Carbone Cancer Center Now Noelle K. LoConte, MD Specialty: Medical Oncology Primary Location: UW Carbone Cancer Center (608) 265-1700 (800) 323-8942
 Wisconsin  Froedtert Milwaukee  Now  Dr Thomas

Canada

PRRT is only available at a few cancer centres in Canada. It can only be used with special approval from Health Canada or by taking part in a clinical trial

Europe (EU affiliated countries)

The European Medicines Agency (EMA) “market authorisation” received a positive indication on 20th July followed by EC approval on 29 Sep 2017.   The positive indication reads “Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults”. Of Course, the decision to fund the drug will be with national approval organisations.  Whilst I’m sure there are many more, these well-known centres have been making PRRT available for some years (but please note there are others):

Netherlands – Rotterdam Treatment Centre – click here

Sweden – Department of Endocrine Oncology Uppsala University Hospital – click here

Switzerland – University Hospital Basel, Radiology & Nuclear Medicine Clinicclick here

Germany – Zentralklinik Bade Berkaclick here

Denmark – ‘Rigshospitalet’ since 2009. They have treated around 250 patients- and given 800 treatments.

UK – Royal Free Hospitalclick here

I’d be interested to hear from countries in Europe with their full list of centres or a link to it.

Australia

Australia seems to be ahead of the game or that is what I sense when I read output from there.  There’s a good section on the Australian effort – click here.

New Zealand

These guys have had to fight to get some progress on the provision of PRRT.  Currently New Zealanders have to go to Melbourne Australia for treatment – almost 50 New Zealanders with NETs are currently raising tens of thousands of dollars to pay for treatment in Australia because the life-prolonging treatment isn’t available locally. But this could change in 2018.  Unicorn Foundation New Zealand announced that Pharmac, the New Zealand government agency that decides which pharmaceuticals, have said that PRRT will be funded for patients with medium priority for the treatment of unresectable or metastatic, well-differentiated NETs (irrespective of primary site) that express somatostatin receptors.

Africa

South Africa:

Middle East, Asia and the Far East

Turkey – Istanbul, Dr.Levent Kabasakal.

IsraelHadassah Medical Center, Jerusalem – click to read

Lebanon – The American Hospital of Beirut – Dr Ali Shamseddine “We have started using Lu-177 here in Lebanon. So far, we have treated 3 patients, with good response. The operational cost is much less than in Europe”.  

Ali Shamseddine, MD, CHB Professor and Head of Division as04@aub.edu.lb

India – Mahatma Gandhi Cancer Hospital, Visakhapatnam. Recently started radionuclide therapy. Although only currently available privately, some patients have been sponsored by the companies that they work for. Point of contact is Dr. K. Raghava Kashyap. I’ve been assured by CNETS India that many locations have PRRT capability – contact them direct please.

Malaysia

Sunway medical Centre

Beacon hospital

Pakistan – check out this article – click here

Singapore – Singapore General Hospital and National University Hospital.  

Philippines – St. Luke’s Medical Center, Global City, Taguig, Metro Manila.

South America

Chile – Instituto Oncológico Fundación Arturo López Pérez, Santiago

——————————————–

What’s next for NETs PRRT?

  • two radiopeptides together;
  • radiopeptides in conjunction with other chemotherapies (check out my article PRCRT);
  • repeated administrations of the radiotherapies;
  • other radionuclide-peptide combinations.
  • increasing the number of indications for this therapy, including other disease targets;

See this great summary from NET Research Foundtion of what might be next plus basic facts about PRRT – click here

Thanks for reading

Ronny

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32 thoughts on “Lutetium Lu 177 dotatate (Lutathera®) – PRRT”

  1. I have been feeling extremely exhausted this last couple of weeks, not wanting to get out of bed just sleeping all day. My consultant wants me to have PRRT in August and says it will shrink my tumours. I am interested to know if this will then give me energy. I don’t want to get out of bed, showering is a huge effort and I don’t want to go out although friends ask me for a quiet lunch, which I always use to enjoy. I have neuroendocrine tumours in my pancreas, liver mid gut, lymph nodes. I had an operation last July, one year ago, when they took out my bowel and cancerous masses. I am desperate to have some energy.

    1. there’s no easy answer to that – many many factors involved. You would think that less tumour would help but you can never be certain with NETs. I would look at vitamin and mineral deficiencies. Start here and use the links inside. Get tested asap for Vit B12 and Vit D, those are the main culprits. Also get a thyroid panel done as many NET patients have hypothyroidism issues. Get T3, T4 and TSH as a starter. https://ronnyallan.net/2015/06/30/neuroendocrine-cancer-nutrition-vitamin-and-mineral-challenges/

  2. Northwestern University In Chicago, IL also have Lutathera. When I initially called them and asked for Lu-177 Dotatate, they were clueless, but when I mentioned Lutathera, they new exactly what I was talking about. This is still NEW treatment for a lot of health providers. My Mom is waiting for her first session to be scheduled. The insurance approval took 4 weeks.

  3. Hi Ronny,

    Do you know, has any hospital offer Lu-177 Dotatate (hospital labels the Lu177 and peptide Dotatate in the hospital). Does it have to be Lutathera?

  4. Hi Ronny,
    Please let me know if this treatment is availble in Romania – I can’t find anything about it expect for a document on Lutatheras website that it’s translated in Romanian.
    Thank you so much
    Nela

  5. Just wanted to let you know that The James Cancer Hospital at Ohio State University Medical Center ran 5 people through a clinical trial of PRRT in December. They mixed their own amino acid compound up because the normal source, Puerto Rico, can’t currently produce it. They felt that their own amino acid mix causes less nausea and vomiting. Since PRRT was finally approved by the FDA, The James has set up their first group to go through the first round of treatment on March 13-14. I am in that group. They had to go through an appeals process just to get the Gallium PET scan approved. It was approved immediately once my oncology team spoke with a radiation oncologist at Aetna. I find it difficult to believe that they would pay for the PET scan they have denied for over a year if they weren’t going to cover the costs of the PRRT. I honestly thought I was going to die before this was approved in the USA. I have been stage 4 PNETS for over 4 years and I have been off all treatments since I had such an adverse reaction to the chemo drugs in August. They did start Lanreotide shots back up but only because the Carcinoid Syndrome was getting out of control. It has done little to nothing to slow the growth and spread of the cancer. So, I am hoping that March 13-14 will bring me good luck and shrinkage of the tumors because I am in horrible pain 24 hours a day. I have found nothing that controls the pain and allows me to sleep for more than 2 hours. I am putting all my eggs in the only basket left and hoping for a great response to the Gallium PET scan and the PRRT.


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  6. We are in the U.S. and waiting for 177 Lu-Dotatate to finally become available for patients here. Unfortunately, nobody could tell us when it would happen even though the physicians are aware of the FDA approval. This is very frustrating. I wish I knew who to contact with regards to the length of the wait. I fear the bureaucracy is going to prolong the time for this drug to get to patients.

    1. I’m hearing this a lot. It was anticipated that there would be a gap between approval and deployment. This happens a lot with different drugs and in many countries. I think the approval on 26 Jan 2018 was very well publicized and everyone was 99% positive it would happen. It seems that many establishments have not done some very low risk planning by putting in some resources to make sure the gap was as small as possible. There may also be some issues with supply of the drug but not heard that formally. I feel for people who really need this treatment and the clock ticks on. In UK, people would write to their Member of Parliament, I suspect that’s either your Congressman or Senator – not sure how that works.

      1. Hi Ronny,

        I am happy to share the good news: Northwestern Hospital in Chicago, IL has Luthera! My Mom had an initial appointment with the oncologist there and we were told that the only delay we could expect would be the insurance approval. Apparently, Northwestern was running a trial for Luthera and they have retained a qualified nurse who can administer the drug. UIC (University of Chicago) and American Cancer Center in Zion, IL do not have Luthera. After waiting for UIC to provide any timeline for the implementation of the drug, I called other hospitals in the area. I feel lucky that NW has it! I was told that Luthera is being imported to the U.S. from Europe. Along with training for medical personnel, it takes about 12 months for a medical institution to make it ready for patients. This is ridiculously long for cancer patients. Taking into an account the fact that this treatment has very minimal side effects, imagine the demand!

    1. reading about PRRT. NET small intestine, metastisis to liver. Not pancreas. Ga-68 scan with uptake in May, surgery in June. Ocreotide (Sandostatin) 30-mg since May (9 injections to date). Follow-up Ga-68 scan in September shows no progression. Serotonin (serum) now well within normal levels. What now? Is there a checklist for PRRT candidates to consider? Need to continue Sando, hope for future tumor shrinkage, reduction in Serotonin discharge?

      1. I don’t think there is a “checklist” other than the wording of the approval. If “stable”, then perhaps keep it in reserve for signs of progression. Does your doctor have a view?

  7. I was diagnosed with Neuroendicrine cancer in May 2015. I was then treated with Sandostatin LAR every 4 weeks but the cancer kept on spreading. I had my second Lutathera treatment last week. The PET-scan, however, showed that the tumors “looks slightly more intense but with no significant increase in size.” Is this normal? What is the maximum number of treatments that can be done safely? My white cell- and blood platelet count is very low.


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    1. As I understand it, the max Lutathera (PRRT) is 4. However, i know people in Europe who have done more including a lady on 11! Personalised dosing is being looked at and is already in place in certain European centres. I have no idea what they mean by ‘intense’, perhaps ‘hypervascular’. As for white cell and platelets, unsure of this, better to ask your doctors. Good luck for your treatment.

    1. In UK you won’t get it unless you other treatment isn’t working or tumors are progressing. Some people are suggesting it could be a first line treatment. I suspect private providers might hope so he said cynically 😃 I’m with you, I hope it’s there when I actually need it

  8. Thank you, Ronny, as always.
    I travel to Singapore for PRRT and the PET dotascan. I’m grateful it is only around 3 hours away by airplane from my country. For now, only one hospital there does PRRT, but by the latter part of the year, another hospital will have it as well.
    I’ve had 1 session so far. Do any of you know if it’s too early to tell through a PET dota or some other scan if PRRT is actually working for me? I have PNET Glucagonoma with liver mets. Thanks.


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      1. Hi Ronny,

        Here is an update. I was diagnosed with PNET in May 2016. I am living in Hong Kong.
        I received 2 PRRT treatments in a private hospital in Hong Kong In the same year after my debulking surgery. Then I started lanreotide injections.
        My condition has improved a lot.

        It is always my pleAsure to read your website. Keep up the good work and stay well.

  9. I had my 8th Lutetium (Lutathera) treatment last week. It has been available in Canada since 2010, though only used in two locations that I know of. I am fortunate to live a 2 hour drive from one of them. I’m waiting for the results of the latest post-treatment scan, but up to this point, there there has been no spread of disease since diagnosis and my existing tumours have been shrinking. I feel 100% well and I’m able to lead a pretty normal life. It frustrates me that this treatment isn’t readily available to NETS patients everywhere.


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    1. Lutathera – is a brand name of Lu177 Dotatate – NETSPOT and Somakit are brand names as well. NETSPOT and SOMAKIT are different drugs (one is Dotatate and one is dotatoc) Other companies make other version of PRRT drugs (Lutate for instance)

      1. NETSPOT and SOMAKIT are diagnostic equivalents to Lutathera – isotope is switched from Gallium-68 for PET scan in NETSPOT and SOMAKIT to Lu-177 (Lutathera) for therapy

    2. Hello hi i would love to hear your results with this treatment i live in usa and it is really frustrating that this is not available here, if it works i might as well travel to Canada to get this treatment i have the same disease now im doing fine with the sandostatin every four weeks but is just to control the symptoms so if you don’t mind please let us know if this worked for you, thank you and good luck…

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      1. I’ll have my next CT scan on August 30 and as long as that goes well, another treatment around the beginning of November. By all means, check my blog for updates around those dates. If there’s any other information I can help you with, please let me know!

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