Blog Posts

Where Would Most Myeloma Patients Be Without Revlimid, Velcade, Kyprolis, and Pomalyst? Without The Clinical Trials That Obtained FDA Approval, Probably DEAD!

8/4/2016

FRD - Franklin Delano Roosevelt

I am sorry if I was so blunt, however look at the history of myeloma. With the standard treatment of 15 years ago VAD(Vincristine, Doxorubicin and Dexamethasone) and Stem Cell Transplant the average life expectancy was just 3 years. With the development of these newer drugs the National Cancer Institute will report the average has doubled to 6 years, and myeloma specialists will quote 10 years or more. In 2015 we had 4 new drugs developed including Daratumumab, Ninlaro, and Elotuzumab. This did not happen by itself, but has been the result of synergistic efforts of myeloma specialists and researchers, IMF, MMRF, NCI, Pharmaceutical companies and of course my personal heroes, the men and women who sign up for these clinical trials. I know without their intelligent evaluation of the treatment options, understanding of the outstanding care afforded by clinical trials, and the outstanding cooperative efforts of the entire multiple myeloma community, I would not be here to write this blog today. How did myeloma achieve this outstanding drug development and survival improvement? We have had trouble accruing for trials but have managed to overcome some of the myths surrounding clinical trials through commitment and education. I think Myeloma Crowd TV has explained this better than most. Jenny Alhstrom provides a great explanation, and I believe it will put most of your fears to rest. As FDR said on a much bigger stage, "The only thing we have to fear is fear itself—nameless, unreasoning, unjustified terror which paralyzes needed efforts..."

My hats off to all the people who have worked so hard to get these new drugs approved, without which the survival would not have doubled and with all the new drugs likely to double again. It just amazes me that a disease which represent just 1% or all cancers can represent 21% of all new cancer drug development. Now, however, we have a new challenge and that is what I think will be the silver bullet that finally cures myeloma, and that is the new immunotherapies. We need expanded participation by the myeloma patient community to FINALLY bring this disease to an end. I hope and pray new clinical trials WILL result in the CURE.

Good luck and may God Bless your Cancer Journey. For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Finally The Promise Of Big Data Can Provide Myeloma Treatment INSIGHT!

7/12/2016

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We have 25,000 new myeloma patients each year in the USA and more than 100,000 living with myeloma, yet the nearest thing we have to Big Data is the COMPASS study by the MMRF. This is a great first step, and it will follow 1000 newly diagnosed patients through their myeloma journey. Prior to this initiative we had no data other than clinical trial data to compare how a patient's personal myeloma profile might be affected by different treatment regimens. So this study is and will continue to be, a Big Data breakthrough for the myeloma community. But like the cell phone commercial, "We Want More!", and now we get more. Celgene has a 3000 patient study called ConnectMM. Jim Omel has been part of a team sponsored by Takeda Pharmaceuticals on a new myeloma Big Data initiative to follow 5000 patients called INSIGHT-MM. In Jim's own words:

INSIGHT-MM An Observational Study

Treatment for multiple myeloma (MM) has changed significantly in the last few years. Four new drugs were approved by FDA in 2015 alone and we are quite fortunate to have so many therapeutic options. Along with these successful treatments come many questions regarding outcome results and quality of life. How will newly approved monoclonal antibodies change practice patterns and outcomes? How will all-oral therapies affect patient’s quality of life, and will there be any effect on treatment efficacy? How will quality of life and treatment outcomes for USA patients differ from patients in other countries where several of our MM drugs are not currently available? When exciting checkpoint inhibitors become more available, how will their single or combined use improve results? It is imperative that we have new treatment outcome data to guide both patients and doctors with therapeutic decisions. What we knew as recently as only two years ago will soon be ‘old news’ in myeloma.

“Interventional” studies offer patients active therapeutic approaches leading to better outcomes. “Observational” studies unobtrusively observe patients for treatment effects without intervening or directing their treatment in any way.

There have been several helpful observational studies in the past few years, studies which have accrued their required number of patients and are currently “maturing” data. Some of these include CoMMpass, an MMRF study for 1000 patients, Preamble, a BMS study for 1000 patients, and ConnectMM, a Celgene study for 3000 patients. None of them will have relevant data for Elotuzumab, Ixazomib, or Daratumumab approved in November, 2015 or checkpoint inhibitor therapy, all of which represent the future of successful myeloma treatment. It is vitally important to learn how incorporating these new agents will help MM patients.

INSIGHT is a multiple myeloma outcome observational study for 5000 patients officially added to ClinicalTrials.gov in May, 2016 (NCT02761187). It follows contemporary, real-world presentations, therapies, and clinical outcomes in participants with MM. Patients will not change their clinical treatment based on any INSIGHT guidelines whatsoever. To evaluate their quality of life they will be asked to complete a patient self-reported outcome (PRO) survey at home or during routine visits. INSIGHT is fully IRB-approved, open at several sites, and has already accrued its first patients!

This multi-center study will be conducted worldwide. In addition to participants from the United States INSIGHT will accrue MM patients from Germany, United Kingdom, France, Italy, Greece, Belgium, Brazil, Mexico, China, Israel, Spain Taiwan, Colombia, and Turkey. Participants will be evaluated and followed for a period of at least 5 years, until death, or the end of the study, whichever comes first.

The goal of this ambitious undertaking is to accrue 5000 patients over 3 years and follow their various treatments and outcomes for 5 years (an 8 year study estimated to be complete in July, 2024). It will be open to (1) participants who have newly diagnosed multiple myeloma, and (2) participants who have relapsed/refractory multiple myeloma. The overall inclusion goal is 50% for each sub-type of patient. USA will open 50 accrual sites comprised of 40% academic centers and 60% community centers. Outside the USA global enrollment for 3000 patients is planned with 5-10 sites in each participating country. INSIGHT is truly global is scope!

Electronic case report forms will be filed quarterly by health care providers. MM patients will complete Health Related QOL and PRO (Patient-Reported Outcomes) every 6 months and at any significant change in ongoing treatment.
None of the care of these patients will be impacted by INSIGHT, because treatment decisions will be made totally independent of the study. Every effort has been made to avoid treatment bias by patients or their doctors. Poorly designed observational studies can cause surprising treatment bias if release of early trial findings influences ongoing treatment decisions by patients or doctors.

Those of us at Myeloma Crowd strongly encourage participation in this important study. Please enroll if you are asked and you are eligible, and please encourage other MM patients to support this non-interventional clinical trial as well. The more information we share, and the more new outcome data we accumulate, the faster we will control and cure multiple myeloma.

Thank you,
Jim Omel MD

Click below to learn more about this important study:
INSIGHT Trial

Good luck and may God Bless your Cancer Journey. For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Myeloma End Game - Improved myeloma prognosis, life expectancy, and CURE!

7/4/2016

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I HAVE A MYELOMA DREAM! That all myeloma patients are screened and found before any end organ damage, that all high risk patients are found at MGUS or smoldering and treated and cured before the clones become untreatable, that all low risk smoldering patients are followed treated and cured before CRAB symptoms or end organ damage can develop. I HAVE THIS MYELOMA DREAM!

We are all excited about the myeloma moonshot, however it is the moon landing which we all want to see. What is the myeloma moon landing? It is my MYELOMA DREAM and it takes me back to a Cure Talk by Dr. Irene Ghorbrial of Dana Farber Cancer Institute in February of 2015. In it she states:

We specialists are coming to the conclusion that screening, early diagnosis, and early treatment is the future of myeloma treatment. There are a number of steps that must be taken to reach this goal. These steps are as follows:

Step 1 - We need to determine which MGUS and smoldering patients will progress to active myeloma and are candidates for early treatment. Genetic testing may be the key to this step. For example just 10% of smoldering patients will progress to full blown myeloma, whereas 50% of high risk smoldering patients will progress.

Step 2 - We need to prove early treatment will result in improved Overall Survival.

Step 3 - We have simple blood tests for the measurement of M protein and a more sophisticated test called the light chain test. Both of these tests together cost less than a mammogram or colonoscopy. However, these tests are not conducted during a normal physical and blood panel.

Where are we now? An emphasis on high risk smoldering myeloma seems to be the answer to the first step. It has been found that high risk disease is by far the most challenging of all forms of myeloma. Life expectancy for high risk myeloma is just 2 years vs 5 years for all myeloma. The end game for most myeloma patients is when the patient has high risk disease to begin with, or when standard risk disease eventually morphs into high risk myeloma. Therefore, it is felt if you can cure high risk myeloma you can cure all myeloma. Recently it has been shown that high risk smoldering myeloma has far fewer clones than high risk active myeloma, and as a result may be more likely to be treatable the earlier it can be identified.

We will be discussing the last two steps in a three part series of Cure Talks.

July Cure Talks - Dr. Shaji Kumar of Mayo Clinic Rochester will be the featured speaker on July 26th @5:00 PM EST, and he will be discussing the ASCENT high risk smoldering clinical trial with a goal of curing 30 to 50% of high risk smoldering patients. CLICK HERE to find out more about the broadcast and to enter questions for Dr. Kumar to answer during his broadcast.

August Cure Talks- I think it is fair to say the Spanish group headed by Dr. Jesus San Miguel has been instrumental in proving high risk smoldering disease treatment will improve HRSMM overall survival. Dr. San Miguel will be the featured speaker on August 18th @10:30AM EST (details to follow). He will be discussing, "The Road to Discovering High Risk Smoldering Survival Rate Improvement".

September Cure Talks - On Sept.14th at 11:00AM EST(details to follow), Dr Sigurdur Kristinsson from the University of Iceland will discuss the ground-breaking iStopMM (Iceland Screens Treats or Prevents Multiple Myeloma) study. The trial will test blood samples from all adults over the age of 40 in Iceland, almost one third of the country’s population, for the earliest signs of Myeloma.

This is a great opportunity to see the future of multiple myeloma unfold before your eyes. With the success of this initiative, myeloma may one day be as treatable as the early stages of breast cancer. The devastation and agony of the CRAB symptoms may become a fading memory. We can only dream!

Good luck and may God Bless your Cancer Journey. For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Multiple Myeloma Is A PAIN!

6/25/2016

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I previously had researched and found 25% or myeloma patients experience shoulder pain. This is in addition to the pain from bone damage which many myeloma patients already experience. Patients with arthritis often take nsaids for relief, but with many myeloma patients who have kidney insufficiency, what do they do? We are not to take nsaids like ibuprofen because they can cause additional kidney damage. From personal experience, I have been trying to answer this question for some time.

I have not had the debilitating bone pain or painful neuropathy as have some patients. However, like the 20% of patients with kidney insufficiency, I was told never to take nsaids for pain, because nsaids can cause kidney damage. I know of many myeloma patients who have been on nsaids and opioids for this bone pain, and so my lack of pain was fortuitous. My story of pain really began after my treatment was completed and I began an extended drug holiday. Soon after I came off of my VTd maintenance, I noticed pain in my left shoulder. This was odd because I did have a bad shoulder, but it was my right shoulder which I dislocated on a fall off of my bicycle. The right shoulder had a rotator cuff tear which I chose not to repair because I would have had to stop treatment for a period before and after surgery to get it repaired. I had decided I would rather be a one- armed man and alive rather than a two- armed man with regrets.

The pain in my left shoulder had gotten so great that I would often say it was so painful I wanted to gnaw my own arm off. I consulted the doctors at Mayo and an MRI showed I had a shoulder impingement which is pain and often weakness when you raise your arm, caused by a muscle tendon "catching" in your shoulder. Mayo suggested I go to a physical therapist and see if that would help, and if not the doctor could conduct arthroscopic surgery to remove some bone. The doctor also told me that my VTd maintenance may have masked the pain, because dexamethosone is an anti inflammatory. I went to a rheumatologist who gave me a topical nsaid, which he felt would not hurt my kidneys, but it also did not help the pain much either. I had several steroid injections in my left shoulder with little to just temporary relief. My daughter had used deep tissue massage physical therapy for an issue she had, and suggested I do the same. I went to John Goetze Physical Therapy in Jacksonville Beach, Fl. It was remarkable and I wrote the following on their web site: I had shoulder pain that was a 10+, the kind of pain where you want to gnaw your own arm off. I had been to doctors, and rheumatologists, with no relief. My daughter who is an editor on the health desk of the Wall Street Journal, told me I needed to go to a Physical Therapist but only one that does deep tissue massage. She found Aaron Robles Sr. and his team, and they have been remarkable. In just 14 short sessions my pain which was a 10+ is now nearly non existent. Thank You Aaron and your wonderful team. You have surrounded yourself with a remarkable, kind and talented staff. If I break again, I'll be back for another guaranteed fix. Gary Petersen

I graduated pain free, but was sent home with a list of the exercises to do at home. As time went on I got lax with the exercises and the pain would return and I would look to go back to JGPT for a tune up. I would call up to schedule an appointment and Kimberly the scheduler would answer, and the first question she would ask is did I do my exercises? I would say no, and she would say "WELL?" I would do the exercises at home and the pain would go away again. This went on for a few years, and most recently the exercises no longer seemed to work, and I was just about ready for my JGPT tuneup when I ran across an article on how Turmeric had proved to be as effective as nsaids for the relief of arthritic pain. You can see a lot of data on this on the web CLICK HERE for one New York Times article. I have been on three 400mg pills a day and it seems to be working. The active ingredient in Turmeric is Curcumin and Curcumin has been studied for anti myeloma activity. What a great possible side benefit.

This may provide some hope for the 20% of patients with kidney damage who do not want to risk more damage to their kidney which can result from the use of nsaids. I will update this post in the future with my read on this if it has been helpful in my quest to be pain free without opioids or surgery.

Good luck and may God Bless your Cancer Journey. For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Cancer Patients Forgive ICER, For They Know Not What They Do!

5/23/2016

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Let me call this PETERSEN's HYPOTHESIS! Who supports new drug development in the world? I would argue it is the country that pays the most for all of the drugs! What country might that be? It is the USA! The global pharmaceutical's market is worth US$937 billion a year. CLICK HERE for their report. And without private insurance included the US Medicare part B and D drug spending is $143 billion. Total US yearly drug sales are $374 billion.   We are 5% of the world's population, but with private insurance 40% of global drug spending. So historically, we have been the new drug development engine for the world. What has been the benefit from this effort and use of our treasure? We have had first access to most of the new drugs because we do not have limits by government on what we can or can not prescribe for use.   And insurance companies have always had the opportunity to raise rates to maintain their profit margins while still allowing the use of these drugs. We insured patients, then had the benefits of the first use of these drugs. Other major countries (with national heath care) usually would follow if the USA had shown adequate benefit from the use of these drugs over time. What is the cost of this to the USA? We spend 19% of GDP for health care while Europe spends less than 9%, and the rest of the world spends less than that.   What is the major difference in the two systems? Europe has nationalized health care and no one has to pay out of pocket for premiums or copays, but it comes at a cost. They have much less to spend on health care so they must find a way to allocate the limited money they have. They use allocation methods like the UK's NICE (National Institute for Health and Clinical Excellence), this is a special mechanism the UK created in 1999 during a period of budget cuts to enforce the reduction in medical treatment provided to Britons through its National Health Service (NHS), which was established in 1948.

NICE developed a mechanism which valued a quality year of life(QALY) at about $50,000, and would approve drugs which met this threshold, and decline those that cost more than this. So why does this have anything to do with the pay for service system we have in the USA? Well, new and old drug prices have had an explosion in prices, and this has put great pressure on insurance companies and the Medicare system. They looked to find ways to limit their exposure to these price increases. Therefore they looked to the European system as a way to do this. An independently funded program(money from insurance companies) called ICER(Insitute for Clinical Economic Review) was developed in the US to provide similar computations for the US that NICE has provided for the UK. A recent program has been completed for Relapsed Refractory Myeloma, and Blue Cross Blue Shield of California made the following statement about this preliminary report. BC BS of California plans to use the ICER research to determine which drugs to pay for.

Another very important consideration of using a system like ICER in the USA to limit drug use is the mere fact we pay twice as much for drugs in the USA than in Europe. This is because by law(via the drug lobby) Medicare cannot negotiate prices with drug companies like European countries can. So we pay twice as much for our drugs as does the UK. What this means if the (Quality Adjusted LIfe Year) QALY in Europe for Revlimid was $50,000 and approved for use, it would be $100,000 in the USA because drugs cost twice as much in the USA vs. in the UK. This would mean that unlike today without ICER, Europe would have drug approvals well before we ever get them, If we ever get them.

If this becomes the norm, we will have the cost of a market driven health care system (19%) without the only benefit we get from our system, which is the first use of these new drugs.    We would lose the benefit without the advantages of the low cost health care system of the Europeans. Given a system with no advantages over a nationalized health care system which costs twice as much, this would surely make a USA nationalized heath care system a rational outcome. We could at least save the 9% of GDP. However, without the US market to pay for the first use of new drugs, drug development would not only suffer, it may just disappear. Let me call this PETERSEN's PROPHECY!

Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Did You Know?? Major Changes Are Coming To Medicare For All Cancer Patients!

5/12/2016

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Most people are unaware of what is happening with the payment system for Medicare Part B, or the new ICER report which may limit your cancer treatment options, but they are just on the horizon. These changes have been initiated to confront the out of control price increases for existing cancer drugs and the outrageous prices for the newly developed drugs. World renowned hematologist oncologist Dr. Vincent Rajkumar of Mayo Clinic will be featured on Cure Talks to help to explain these proposed changes, along with his ideas on how to help control the high cost of cancer care. This is a can not miss opportunity to find out about these proposed changes. This broadcast will be on May 19th, at 6:00PM EST, and you can learn more about it and sign up to listen if you CLICK HERE.

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Will The ICER Report Leave Cancer Patients Out In The COLD?

5/1/2016

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Don't Be Left Out In The COLD!

I have never seen such a viral negative patient response like the one I see centered around the new ICER myeloma report. ICER(Institute for Clinical and Economic Review) put out a 138 page report intended to place a value on various treatment regimens for relapsed, refractory multiple myeloma. It was an attempt to compare different treatment options and find one which fits into their framework of a cost preferably less than $50,000 but no more than $150,000 per year of added life.    Sounds like a noble effort, but the devil is always in the details. I have looked at the analysis and will provide you with my patient centered evaluation of this ICER report.

The genesis of the ICER project or the elephant in the room is that some companies use patent protection to exercise monopoly pricing, and our government will not hold them to account. Like utilities, drug prices should be reviewed by a pricing review board. Those companies which have not acted in the public interest should be broken up into smaller units, just like the oil and railroad monopolies were. This resulted in the anti trust laws which could be used to control drug company greed. But I am so naive to really think our government would ever "Bite the Lobbyist that feeds them".

The ICER report looks like a lot of work and brainpower went into this effort, but unfortunately it is like reading a 5 year old newspaper.   A lot a great names in the stakeholder and list of sources pages, and I congratulate all who attempted to wrestle this elephant to the ground. The reason this is happening is because some drug companies have used their patent protection and monopolist position to exploit the current system. Some companies are making 25 to 50% net income after taxes, which is monopolistic and criminal in my opinion, and increasing prices on existing drugs by 20 to 100 times inflation(700 to 5000% in 5years), or in other words with no justification at all other than they can. Instead of taking on the core problem, the ICER report seems to focus on saving the insurance companies money at the expense of the patient population. My evaluation of the report is as follows:

Major Flaws which skew the outcomes are as follow:

Probably the most outrageous assumption in the analysis is the concept of QALY(quality-adjusted life year), where the value of a year of life is reduced to a fraction of a year the sicker the patient . For example in the extreme case of a person who is bedridden and unable to care for themselves, the value of a year of life is actually negative. Does this then suggest euthanasia? That is just plain SICK! For me and most cancer patients, each year of life becomes far more valued than when we were not sick. If I just have 5 years to live, like most myeloma patients, and my life expectancy if well is 20 years, I can argue my year of life has 4 times more value than that of a person who is perfectly healthy.

LD or Lenolidamide and high dose Dexamethasone would almost never be used as a 2nd or 3rd line of therapy. In general a patient would be refractory to Lenolidamide during their first line treatment, so the use of this as a 2nd therapy seems outrageous.

I see the base treatment is LD for all 2nd and 3rd lines of therapy, but this is not even a first treatment for many. Mayo Clinic's mSmart treatment recommends VRd for first line treatment. If VRd replaces LD in the analysis the difference in cost between regimens would be much less.

Also VRd vs LD has in early treatment shown a 1 year better OS(overall survival), but only 4 months in the secondary setting. If VRd was substituted for LD as the base case it would have a yearly cost in the $500,000 range with one year increase in OS, so there is nearly no major difference in the cost between all regimens and the study results would have no major differences in cost or outcomes. The logic collapses if we use real world recommended treatment regimens.

My take on it is that given the current cost of drugs the incremental benefit in the 2nd and 3rd line of treatments is not really good, but not much different to the cost of VRd. This would tend to support the hit it hard up front strategy, and to find and treat myeloma early before it morphs into more aggressive clones.

During my first job I worked with product costing and cost analysis in a very competitive industry. You set your price based on the fixed and variable costs and the competitive environment, and not based on monopoly pricing of whatever the traffic will bear. With higher volume the fixed and overhead costs per unit go down due to the economies of scale. This would result in the cost and therefore price of drugs for high volume diseases like breast, lung and colon cancer, to be far less expensive than drugs for orphan diseases. Prices of 25 to 50% less should be possible. If the pricing of a drug is totally inelastic, and usage is unaffected by the laws of supply and demand then it is monopolistic (made by the government patent protection) and there are laws for that. If drug pricing was market driven, then the cost of drugs for the major cancers should be significantly lower.

Also if a drug's price is set correctly the first time based on a good costing model, the price should change yearly by the inflation rate, or if indexed more than once the costing professional who set the price should be looking for another job.

My last point is that Medicare, and Private Insurance are there to spread the risk.   We pay in for years hoping we will not have to use the benefits, but when we do have a heart attack or cancer we know that we should have this protection, and should never think we are just not worth the cost of saving our life. We paid for this protection and we deserve to get what we have paid for. As the insured we all pay in so that some of us who are less fortunate who become really ill, can obtain the expensive life saving heath care we insured have paid for in full.

Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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A Tsunami Of Change Is Descending On Myeloma and Cancer - What Is ICER, Medicare Part B Changes, And Monopoly Drug Pricing

4/27/2016

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Mark your calendar for May 19th. Unless you have been living under a rock, you can not help but hear about how some companies have acted irresponsibly and raised drug prices by 5000 percent. Many cancer drugs cost upwards of $100,000 per year and more, and continue to increase at outrageous rates. Our government has discussed this but has done nothing to bring these monopolistic pricing practices into check, so Medicare and private insurance companies have looked to reign in these run away drug prices. Medicare has proposed major changes to Medicare Part B in an attempt to slow the explosion in health care expenditures. Today, Medicare Part B generally pays physicians and hospital outpatient departments the average sales price of a drug, plus a 6 percent add-on. The proposed model would test whether changing the add-on payment to 2.5 percent plus a flat fee payment of $16.80 per drug per day changes prescribing incentives and leads to improved quality and value. Most of all it would promote the use of cheaper drugs.

Others would like to have the insurance companies take on the doctors treatment decision process and deny coverage based on a FORMULA. An independent (funded in large part by insurance companies) ICER (Institute for Clinical and Economic Review) following in footsteps of NICE (the UK's National Institute for Health and Care Excellence) has looked to develop a formula which will value a year of life at between $50,000 to $100,000. In addition, they use a gauge of life which devalues a year of a patient's life to a fraction of a year the sicker the patient is. They actually go negative for someone who is bedridden and can not care for themselves.

This is a very complex subject, and luckily Dr. Rajkumar of Mayo Clinic, a respected and world renowned myeloma specialist, has been kind enough to be part of a Cure Talks broadcast to help to educate the doctors, patients, and the general public on what these programs are and how they might affect the doctor patient relationship. I can tell you that there has been a tidal wave of criticism of the ICER program. One view of the program comes from Dr. Durie, the head of the International Myeloma Foundation. You can read his evaluation of the ICER program if you CLICK HERE.

The Cure Talks broadcast will be on May 19th at 6:00PM EST. I will provide the details of the program in a later post.

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Is Screening Myeloma's New Frontier? - The Entire Country Of Iceland Will Screen For Myeloma And Could Double Their Myeloma Life Expectancy

4/21/2016

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It has taken myeloma almost 30 years to double life expectancy from 2 years to 4 years, but what if you could double it to 10 years from the current 5 years by doing one thing? In 2014, Dr. Gareth Morgan of UAMS stated, "On the subject of awareness and delayed diagnosis, I believe the fact that it takes 3 to 6 months and more often 6 months from first symptoms to diagnosis, is a bit of a scandal.   To make real inroads into improved myeloma survival we need to get it diagnosed early before we have organ involvement." In 2015 Dr. Irene Ghobrial of Dana Farber outlined a game plan to achieve this goal. She stated, "Multiple Myeloma is the only cancer where we wait for it to metastasize and show organ, bone damage, or anemia before we begin treatment."

She and many other specialists are coming to the conclusion that screening, early diagnosis, and early treatment is the future of myeloma treatment. There are a number of steps that must be taken to reach this goal. Those steps are as follows:

Step 1 - We need to determine which MGUS and smoldering patients will progress to active myeloma and are candidates for early treatment. Genetic testing may be the key to this step. For example just 10% of smoldering patients will progress to full blown myeloma, whereas 50% of high risk smoldering patients will progress. In MGUS only 1% of patients will progress, but some may have a genetic profile which indicates a higher likelihood of progression.

Step 2 - We need to prove early treatment will result in improved Overall Survival. A trial by Dr. San Miguel of the Spanish group was conducted for high risk smoldering myeloma.

Step 3 - We have simple blood tests for the measurement of M protein and a more sophisticated test called the light chain test. Both of these tests together cost less than a mammogram or colonoscopy. However, these tests are not conducted during a normal physical and blood panel. Dana Farber will be establishing a clinical trial to conduct screening on a large scale to determine if screening, genetic testing, and early treatment can be a game changer like it has with breast and colon cancer.

All of the steps have now been completed, or are in motion. The last step is being implemented in Iceland by Professor Sigurdur Kristinsson of the University of Iceland, in his pivotal MGUS screening study for the forthcoming iStopMM (Iceland Screens, Treats or Prevents Multiple Myeloma) trial. The study will examine blood samples from approximately 140,000 adults over age 40 in Iceland for the earliest signs of myeloma. A cancer of the blood plasma cells that affects approximately 90,000 in the US, and more than 200,000 around the world, myeloma can go undiagnosed until the disease begins to seriously damage health. To read an IMF article which explains the project CLICK HERE.

Why then if implemented will this double myeloma life expectancy? We can assume if this is an ongoing program, as people turn 40 they are also tested, few patients will ever go undetected as they often do now. When you have end organ damage you are already at ISS stage 2 or 3.   Most everybody if tested will be found in the MGUS, Smoldering, or in ISS stage1. Why is this important? If you are found in stage 1 your life expectancy is twice that of a stage 3 patient. Because of delayed diagnosis the UK has noted that 20% of patients die within the first 2 months of diagnosis, and the National Cancer Institutes SEER data base shows 30% of patients die in the first 2 years. So how would one estimate what life expectancy would be under the new program. Because we do not know with certainly the outcome of the trial, we can only make estimates based on assumptions.

One assumption might be that there will be far fewer of the 20% who die in the first 2 months. Lets say that goes to 5% which would bring the 2 year deaths to 15% from 30%. If you do the math this represents a 10 year life expectancy or 50% survival rate at 10 years.

Another assumption might be the death rate in first 2 years will be more like the third year is now. That is 6.8% and the two year rate of 13.6%. Or the life expectancy is a little over 10 years.

Or the best case, like in breast cancer, if found in the early stage like DCIS, 5 year survival is 100%, and if this is the case with myeloma, well then the sky is the limit. We all die from something else, like old age, but without ever having end organ damage. Now that would be a Myeloma Miracle!

Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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Multiple Myeloma Survival Finally Improved To 5 Years! Yeah!!! And In Two More Years It Will Reach 6 Years, BUT

4/17/2016

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If you are a myeloma patient, you have to love this news. When I was diagnosed there was little data available, but I do remember a Mayo publication which said the average life expectancy was 33 months and had not changed in a decade. The new patients can now look at the new data represented in the graph below, and it looks as though the sky is the limit for survival. And if you are lucky enough to make it through the first 2 years after diagnosis, the sky IS the limit. We unfortunately still lose 30% of patients in the first 2 years, and this has not changed much in the last 10 years. This has everything to do with late diagnosis, inadequate treatment for the newly diagnosed patients. I will leave further discussion on this subject to another post. But now let us celebrate some outstanding news. For the new SEER data published on 4/15/16 CLICK HERE.

On a blog post last year I predicted this would be the year life expectancy reached 5 years, and you can view my prior prediction if you CLICK HERE. My new prediction is that in two more years life expectancy will increase by another year to 6 years.

Below is a look at the history of the survival for myeloma in the USA and my prediction.

year                          survival milestones        years between milestones

1975              2 years                               -

1998                        3 years                             23

2004                        4 years                               6

2008         5 years                             4

2010 (prediction)       6 years                             2

As you can note in the graph and list above, the pace of change has increased significantly to where we are improving life expectancy by one year, in just two years. Whereas, it took 23 years to improve survival by just one year in 1975. And if you have not noticed, the drastic increase in the rate of improvement started in the early 2000's which coincides with the development of IMID,s (Thalamid, Revlimid) and the PI (Velcade).

With 4 new drugs approved for myeloma in 2015, and two of them representing a new class of drugs (checkpoint inhibitor and monoclonal antibody), we can expect continued improvement for the patients who are fortunate enough to be diagnosed in a timely fashion. The 30% who do not make it 2 years will not share in this because of late diagnosis, wrong diagnosis, and poor first line treatment. More on this subject later.

Good luck and may God Bless your Cancer Journey.   For more information on multiple myeloma survival rates and treatments CLICK HERE and you can follow me on twitter at: https://twitter.com/grpetersen1

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