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Arkansas Rebuttal – Part Three

Posted on November 29 2009 by Pat Killingsworth | 810 views

Here is the third and final installment of this series. Well, maybe not the final installment. One of the perks associated with writing your own blog is that you always get the last word! So, since this third part is so long, I will post a short commentary tomorrow:

Third, what type of patient most obviously benefits.

I believe patients of all types benefit from Arkansas’ approach, but there is clearly room for debate on the subject. The one group of patients that I think the debate is largely settled on (or should be) are newly-diagnosed patients with low-risk disease. Or about 85% of newly-diagnosed patients. For these people, the 74% projected cure rate and 15-year median survival rate achieved by Arkansas are in striking contrast to how the disease is normally thought about. These results are, quite simply, extroardinary. However, good results can be achieved for those with minimally previously treated disease as well. For those that are newly diagnosed, I personally strongly encourage them to at least visit Arkansas, have the extensive gene analysis done so they know what “flavor” of the disease they are dealing with, and use this information to make an informed decision. On high risk disease, it then becomes a discussion of whether the transplant approach works better in the long run than Velcade and other even more recently emerging drugs. This is an open question. For people with previously treated disease, it becomes a question of how resistant that disease has become.

So…where does this leave us?

Well, in respect to Pat’s email, we have the following:

But the unsubstantiated claims promising “double survival rates,” etc by using tandem transplants got me all worked up again. It took me two minutes to find credible research dissing tandems. But I can’t find positive research papers supporting it, except marginally. Do these guys publish? Will they be presenting at ASH? I don’t know, just seems a little strange/fishy. Think you can find me some stronger, published results supporting the tandem transplant/total therapy thing?

Hopefully, I demonstrated why the double survival rate is a very legitimate statistic for the newly-diagnosed patient. The median survival rate in Total Therapy 3 is projected to be fifteen years. The median survival rate for the disease overall, inclusive of Velcade treatment, is currently at 7 years. This is, in fact, a doubling. I believe I provided information on where Arkansas’ data is published and presented, and how it is compiled. I also pointed out how the “credible research dissing tandems” may or may not be using comparable situations and that makes any comparison difficult, if not invalid.” Lastly, I provided sources and references on their published data.

Then, Pat wrote the following:

In a new world where myeloma can be slowed or controlled by taking a pill, tandem transplantation seems very aggressive to me!

It remains the most aggressive therapy for Myeloma, that much is true. However, while I agree that Myeloma can be slowed by taking pills and infusions (I do not believe it can really be slowed, much less controlled, simply by taking Thal / Rev plus a steroid), the risk in this approach is that the disease will eventually become resistant to this therapy and relapse in a more serious form. What then? At that point, a transplant is not curative…it is merely another stalling tactic. Obviously, science moves forward and there are many promising drugs on the horizon. The patient who goes for the transplant simply wants to roll the dice at being cured NOW, rather than waiting for a cure (or a long-term controlling pill like Gleevec is for Chronic Myelogenous Leukemia) to be developed. If the Arkansas protocol doesn’t work for that person, they have certainly bought several years of prolonged life (hopefully in remission) while waiting for science to advance in these other areas. Obviously, given the potential for the transplant to kill you, it’s not something to be chosen lightly. But one needs to really weigh those odds against the odds of being left at some point in the future with drug resistant disease and with no more new agents to try. This, of course, depends on a person’s age at diagnosis, the rate at which their disease is increasing, general health, and other factors.

On Pat’s blog, we have the following:

Monday I was critical of claims made on the University of Arkansas Myeloma Research Center Website, touting “tandem stem cell transplants double the rate of both event-free and overall survival.” The site goes on to explain that “Event-free survival means there is no relapse.” Does this means those myeloma patients are considered cured?

Yes, provided event-free survival last a period of at least five years. After that point, the likelihood of recurrence is extremely low. The ability to lengthen EFS through tanden transplantation and maintenance therapy is a key element of the Arkansas protocol.

Pat’s blog continues:

Check-out this conclusion about the efficacy of tandem stem cell transplants from the National Cancer Institutes’s Website this past January:

The addition of a second (tandem) hematopoietic stem cell transplant (HSCT) procedure using one’s own (autologous) blood cells does not appear to improve either event-free or overall survival in multiple myeloma, according to a meta-analysis of trials comparing single versus tandem transplants head-to-head published in the January 21, 2009, Journal of the National Cancer Institute (see the journal abstract). Researchers led by Dr. Ambuj Kumar at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., concluded that “the routine use of tandem transplant in its current form is not justified.”
This conclusion reflects another finding in their review: While the response rate improved 21 percent in patients receiving tandem treatments, the risk of treatment-related mortality (TRM) increased by 71 percent in this group. The data were drawn from six randomized controlled trials published or presented at meetings since 2003, in which a total of 1,803 patients were enrolled.

As I noted above, unless they are looking at tandem transplants performed in the way that Arkansas performs them, these comparisons are not valid.

Tandem transplants can be beneficial when treating myeloma patients who relapse quickly after their first transplant. But there is very little data supporting the use of tandem transplantation on a wide-spread basis. And they are certainly not the “standard of care” for typical myeloma patients. By the way, a 21% improved response rate is far different from using terms like “overall and event-free survival.”

And again, if these tandem transplants are not part of a protocol following Arkansas direction, including the type of drugs used in induction, the type of “bridging therapy” (thalidomide and dex, generally) used in between transplants, the consolidation chemotherapy after transplantation and maintenance, the full benefits of this approach will not be seen. The 21% improved response rate is a red herring.

I hear positive testimonials from myeloma patients who have been, or are currently being treated at the UAMS all of the time! These patients use terms like “compassionate” and “thorough” and “positive.” It’s just too bad that some persons and patients associated with the University of Arkansas Myeloma Research Center end up, in effect, tainting and minimizing the positive aspects of the research and care done there by over-reaching and making unsubstantiated survival claims in support of a therapy style which is, at best, risky and controversial.

This one, I do think, is a miss. Their claims are factual, backed up with robust data which they share with any patient that requests it, and which tracks a large body of patients longitudinally over a period of twenty years.

This remains a very healthy dialogue and debate to have. As I have noted consistently, the Arkansas approach is not the only one, and it doesn’t have nearly the striking difference in outcome for some patients than it does for others. But newly-diagnosed patients should consider it is a path to cure that exists TODAY, whereas other paths show promise but are not there yet.

My final thoughts tomorrow. Feel good and keep smiling! Pat

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