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Studies Attribute Recent Increase in Multiple Myeloma Survival to Novel Therapies

Improved Survival in Multiple Myeloma and the Impact of Novel Therapies

Article Type: Myeloma Issues
Author: ASH
Source: american society of hematology
Source Type: online press release

WASHINGTON, November 1, 2007) – Multiple myeloma is one of the most common and devastating bone marrow cancers in the U.S., but survival rates have risen dramatically over the past decade. Recent analyses suggest that this trend may be attributed to new types of drugs and aggressive therapeutic interventions such as stem cell transplantation, according to the results of two studies prepublished online in Blood, the official journal of the American Society of Hematology.

Multiple myeloma (MM) is a neoplasm of plasma cells, a type of cell that resides in the bone marrow and produces antibody proteins. Survival rates for MM have traditionally been grim, with most patients dying within two to three years after diagnosis. However, within the last decade, a group of new therapies has been developed and approved for use in MM patients, including thalidomide (Thalidomid®), lenalidomide (Revlimid®), and bortezomib (Velcade®). Used alone or paired with traditional chemotherapy, these drugs have been shown to be highly effective in recently diagnosed and relapsed MM patients. Also, over the past decade high-dose chemotherapy and peripheral blood stem cell transplantation has been increasingly used for treatment of MM, especially in younger patients. Two recent studies analyzed outcomes in large populations of MM patients, comparing results with regard to diagnosis date, age, and gender.

Recent Major Improvement in Long-Term Survival of Younger Patients with Multiple Myeloma
In one study, a research team from the German Cancer Research Center and Weill Cornell Medical Center in New York analyzed trends in five- and 10-year survival of MM patients in the U.S. to understand how new therapies and innovative approaches have translated into better survival for patients. In this large epidemiologic study, 26,523 patients diagnosed with MM in the U.S. were studied from the 1990-1992 to 2002-2004 SEER (Surveillance, Epidemiology, and End Results) database.

The analyses found a definitive overall increase in the survival of MM patients over the past decade. In particular, five-year survival increased from 28.8 to 34.7 percent, and 10-year survival increased from 11.1 to 17.4 percent. Importantly, survival increased most dramatically in the youngest age group – more than half (56.7 percent) of patients younger than 50 survived at least five years, and more than 40 percent (41.3 percent) survived at least 10 years. In real years, the average relative survival increased from four years after diagnosis in 1990-1992 to almost seven years after diagnosis in 2002-2004.

Patients age 50-59 also fared well, with approximately half (48.2 percent) surviving at least five years, and nearly a third (28.6 percent) surviving at least 10 years. However, only modest increases were seen in the age group 60-69, and virtually no improvement was seen in patients older than 70. Since about half of MM patients are diagnosed when they are 60 or older, the lack of improvement in the eldest groups is a critical finding of the research.

“The rise in survival among MM patients in this study may be attributed to improvements in stem cell protocols, supportive care, and therapies with better efficacy and lower toxicity,” said Hermann Brenner, MD, of the Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, and lead author of the study. “However, the improvements among older patients in our analysis remained much more modest, suggesting a need to better understand the natural history and treatment options for multiple myeloma in this population.”

Improved Survival in Multiple Myeloma and the Impact of Novel Therapies
A second study conducted by researchers at the Mayo Clinic evaluated outcomes for a large group of MM patients by comparing survival among two date-specific analyses – one from time of diagnosis and one from time of relapse – to better understand trends in survival over time. “We wanted to understand if the new therapies available to these patients would translate directly into improved survival,” said lead author Shaji Kumar, MD, of the Mayo Clinic.

The first analysis studied 387 patient records to compare disease relapses before and after December 31, 2000, based on the availability of thalidomide and subsequent clinical trials of bortezomib and lenalidomide. The second analysis was conducted over a 36-year period (1971-2006) with a larger group of 2,981 patients with newly diagnosed MM. These patients were divided by date of diagnosis (before or after January 1, 1997) to understand the significance of the novel advances in MM therapies.

Study results illustrated a dramatic improvement in survival among patients diagnosed in recent years, both from the time of diagnosis and from relapse after stem cell transplantation. Among the patients in the relapse group, the researchers noted a significant improvement in overall survival for patients relapsing after 2000, compared with those relapsing before 2000 (24 vs. 12 months). Patients relapsing before 2000 were less likely to receive a prompt transplant and more likely to have relapsed disease at the time of transplant and to have had more treatment regimens prior to transplant, compared with the group who relapsed after 2000, but the improvement seen in the recent times was independent of these differences.

In the larger group of newly diagnosed MM patients, diagnosis within the last decade translated into a 50 percent improvement in overall survival (45 vs. 30 months). Though the team divided the groups into six-year intervals to understand trends throughout the 36 years, they found no significant changes in survival until the most recent six-year period. When the team examined the relative impact of age and gender, they found that patients younger than 65 benefited the most from the recent improvements and that female patients fared slightly better.

“These results demonstrate a clear improvement in survival among myeloma patients in the last decade, and while supportive care may have contributed to this trend, we believe that the introduction of novel drugs played a major role,” said Dr. Kumar. “This study also highlights the need to target the older patient population for innovative approaches to improve outcomes, considering these patients are more frail and more likely to have co-morbidities that may limit their treatment options. This progress reflects the effort of myeloma researchers worldwide, making myeloma a model for other cancers to follow.”

At what price ?  I'd like to see comparisons with far less expensive treatments such as the Budwig Diet, alkaline foods, Cesium and Sodium Bicarbonate IVs, and O2 Therapy.

Bruce-

"At what price ?  I'd like to see comparisons with far less expensive treatments such as the Budwig Diet, alkaline foods, Cesium and Sodium Bicarbonate IVs, and O2 Therapy."

I am cynical enough to believe that no one will pay for clinical trials for the BD, alkaline foods, etc.  But I do think that someone out there should study low doses of novel drugs (cheaper and fewer side effects) coupled with antioxidant support.  Studies clearly indicate the synergistic effect of velcade with curcumin.  Why not study the benefit of say 10mg daily of thalidomide, low dose dex, along with a range of anti-mm supplements like curcumin, green tea extract, grage seed extract, fish oil, resveritrol or some combination of these?

http://beating-myeloma.or...

David Emerson

 

My COBRA will be running out in December.  I have no job and am on long term disability and social security disability, what are my insurance options, if any?

Is it worth it to try and find private insurance?  Is there a health insurance company that will take on someone with myeloma?  I heard that you have to be on disability for two years before being eligible for Medicare and that's not the case for me. 

Has anyone gone through this?

Thanks for your insight.

 

 

According to a Democrat working on the health care issue, insurance companies have already agreed to the following.  They will insure everyone with preexisting conditions with the same rates as  people without preexisting conditions.  In exchange they want 3 things.

!) the 47 million people without health insurance would have to buy private health insurance.  Obviously this would increase the pool of buyers.  I have two stepson swithout any health insurance, but one is 28 and the other 33.  Although of course there are some people with mm at even these ages, most health problems start around the 40s.  At any rate, I am not sure how people can  pay into it with no money. Would the government have take the payments for those who cannot?  Is this  better plan than govt-run health care  (I suspect it is simply because the govt is NOT good at negotiating costs?

 

2) The insurance compnies are still allowed to base rates on age and location, just as they do with auto insurance.  i feel this is fair.

 

3) The govt stays out of tfhe health care business.

 

This Democrat has said he expected this plan to go through by August, but now mostly  I have been hearing about govt-run health care.

 

However, I do expect that they will get something accomplished in the next 19 months, which is when my Cobra will run out.

Finally, I do not know your treatments or what your medical  options will be at that point.  You can get thalidomide cheaply both from www.alanpharmaceuticals.c... in England and a similar pharmacy in India.  For the place in England, you need a doctor's prescription and you do have to sign a statement about the risks of taking thaiidomide. There is no STEPS program consisting of 3 questions to jack up the price to ridiculous levels since there is no patent on this drug (there is only  patent on the distribution)

 

Precision Pharmaceuticals has a very good patients'  assistance program for Revlimid,but you do have to apply for financial assistance first from Celgene.

Th financial program from Celgene supposedly "improved" is still terrible.

I have heard the financia lassistance program from Millenium Pharmaceuticals is much better, but I do not have any personal knowledge of this. CVS Caremark that sends me Revlimid and ex-jade (very expensive, causes diarrhea, and does not work very well eliminate iron from the blood--which I needed because of monthly blood transfusions I received from January 2008 to November 2008)can also send patients Velcade who have no insurance for the drug or have insurance that does not cover it very well.  I have found their "Specialty Pharmacy" is great to deal with, but the regular pharmacy can be very slow.  It was maddeningly difficult to get set up at CVS Caremark, but it hs been nothing but a pleasure dealing with the people who handle specialty drugs.

 

However my local oncologist told me the clinic where  I go will  not accept infusible drugs this way, as often as not they are sent at the wrong temperature. You would have to make sure that you could received Velcade this way.

I suppose CVS Caremark might also handle other infusible mm drugs this way, but I never asked about it.  These would be Doxil. maybe Trisenox (arsenic trioxide) and others I am not thinking about.

For something like dexamethasone or the generic equivalent of Biaxin XL, Costco has the best prices anywhere.

Finally there are lots of trials available that use Revlimid or Velcade in conjunction with a new drug.  The best of course are pill trials.

 

One is the pomalidomide trial (formerly known as Actimid) that is an analog or chemical cousin to thalidomide and Revlimid.  It is currently being tested at all 3 Mayo clinics, and I believe they are enrolling patients again.

 

However you do need to ask upfront about what will be be paid for in a trial when  the patient has no medical insurance.Usually the onologist wants a bone marrow biopsy, upfront, even though this  is rarely required by the pharmaaceutical companies

These can be very expensive for uninsured patients, especially when dealing with companies that do genetic testing associated withBMBS. I received a "Collection Notice" from Esoterish for 3300 dollars (everything else cost 2900 dollars).When a billing person heard this she told me the same company charged 400 dollars to per thtients with health insurance. This person must have called this compapny, as I never heard from them again.  I never received any bill before this collection notice.

 

If someone tells you everything in a trial will be paid for, please ask for specifics.  This is why I did not go through with Dr. Berenson's melphalan/LBH 589 trial as both he and his office told me everything would be paid for.

 

I was not in his office alone when he told me this, as my 87 yr old stepfather who  is also an MD who still practices medicine, alhe so heard the same thing.  In fact ,the only thing would be paid for at all was the new drug and the frequently required EKGs.  The bone marrow biopsy would not have beenpan paid for and neither was the echocardiogram (I did call the place that did it, and they told me the cost of that was only 500 dollars..the cost here os 1500 dollars so I did not believe it.).

 

Not even the melphalan would be paid for.   I was very worried about losing my insurance at the end of this month, so I though i would have to pay out of pocket for these things. Certainly Cobra at my share at 1200 month will be cheaper than than paying for 2 BMBS at thje time.

I had the same experience when I had no health insurance and inquired about a Doxi/Velcade trial given at Loma Linda in Riverside and also at the Mayo Clinic many years ago withthe Carfilozimab (PRI-0052) trial. Both places required the expensive BMBs because treating oncologist wanted to do them,  but the drug companies did not require them.

 

You can find a list of trials at clinicaltrials.gov.

 

I did think that the new HDAC inhibitor by Novatis named pobinostat looked promisiing from what I read, but I am not having my doubts.

 

I think that NPI-0052 is promising, but the trials are all  way away from me,as they are mostly back east. Strangely enough this is a pharmaceutical company here in San Diego, and despite my efforts to get them to start a trial here, they only say they are using already-established relationships.  I have talked to several oncologists here who run ciinical trials for mm.. including the person who is responsible for all clinical trials in CA done at Kaiser Hospitl.

Cephalon that makes Arsenic Trioxide, a cytoxan-like drug, has a new variant of Trisenox called Zio-101 that has a better safety profile (it has been shown not to work well as a single agent for mmers, and also makes Provigil/moModafinil, is supposedly going to put a new proteasome inhibitor in clinical trial next uear that not only attacks the mm cells but also the mm progenitor stem cell when given with Velcade.  It was supposed to be in trial  this year, but now the schedule date is next year.

There are a lot of other drugs in trial, including the antineoplaston  therapy specifically for mm patients.  There are some trial with various vaccines, immune system approaches and monoclonal antibodies,but I have absolutely no understanding of the latter.

 

I would probably be cheaper not to particpate in any trial that expects you to pay out of pocket for a BMB, and instead use the  drugs I mentioned from the places I mentioned.

 

Alex Maas

now failing Revlimid + Velcade + des on  the first round, when it has a 95% response rate among all mm patients--what a disappointment

bohso

I am currently one who lost their health insurance after leaving work, when the cost of Cobra became too high for me to pay. I will be getting medicare this June, after waiting for over a year since by disability was backdated to June of 07. You can find out alot about different insurance plans online, but it will be difficult to find one to accept someone with MM. You need to get into one before your cobra runs out, or you will have a lapse in insurance. I have been lucky that my numbers have risen slowly and have not needed treatment yet. Also, I was helped by a local organization to get bloodwork done to monitor the progression of my disease. There are many organizations out there that can help with this and other types of doctor care, you just have to talk to different groups, and do alot of homework yourself to find them. Get involved with a support group, and talk about your situation with them. Just like this list, there are alot more people affected by this disease than you realize, and they all have good information that can help you. Never stop trying and good luck.

I live in Canada renowned for its universal health insurance.  Well, I took a sabbatical in October and lost my work insurance - I researched private insurance - Blue Cross and one offered by Manulife - because I do not have mm but MGUS - I did not mention that - but I said I was taking HRT (hormone replacement therapy) because I am in menopause and also mentioned I use Synvisc for my osteoarthritis -  I was accepted for one insurance but they excluded anything that had to do with menopause (a new disease)??????? and arthritis.   Totally useless - I am 63 and 2 months - will be covered for prescription medicine at 65 through te Ontario Health plan -  in the meantime I hope and pray to stay healthy.

Marguerite in Ottawa

Is anyone on ss disability for myeloma? Have you had any trouble with medications or treatment being paid for? Does it cover out patient Revlamid? How much out of pocket have you had to pay? Is it worth going on dissability if you then loose your private insurance coverage? I can't seen to find out if expensive cancer drugs like Rev are covered by presciption drug plans, medicare or supplimental insurance.

I recently visited the doctor, and had many questions for my financial support person. Medicare will cover 20% of your IV and by mouth chemo drugs. The copays and deductibles that go with medicare can be covered by many different organizations that provide financial help for people with MM. There are local and national organizations you can apply to for help, such as Leukemia/Lymphoma society, Patient Advocate Organization, and if you go to a support group, ask if there are any local foundations available. Most of these will help you only if you have medicare. I dont qualify for AARP for supplemental ins., so I have had to look for other ways. Talk to your financial people where  you go for treatment.

I am on ssdi for mm.  I have been since 2000.  I am not on medicare because I am on my wife's health insurance from her job.

David

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