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Dr. Orlowski, let’s begin with you, a headline.  How do you feel about this year’s ASH when it comes to what’s significant for people living with the illness? 

And a couple of developments I thought that were interesting, one was a randomized study for patients with relapsed myeloma comparing two different ways of giving bortezomib.  One was the standard intravenous approach, and the other one was using the same dose and the same schedule but instead of using IV patients were given a subcutaneous injection.  And it turned out that very interestingly the approach was quite similar in terms of the response rate, the survival at one year and also the time to progression, but very importantly patients who got the subcutaneous injection had fewer episodes of neuropathy and also a trend toward fewer problems with blood count drops.  And overall this suggests that it’s safe to give bortezomib with injections under the skin.  It may get people in and out of the clinic or the office more quickly, and any time you can reduce side effects like neuropathy that’s always a positive development. 

Another I think important study looked at using carfilzomib, and this is one of the second generation proteasome inhibitors which is irreversible, unlike bortezomib, and the data that were presented showed a nice overall response rate with 24 percent of patients having at least a partial response or better, and if you counted patients with stable disease or better the response rate was almost 70 percent.  The duration of response was about 8.3 months.  Progression-free survival was quite nice as well.  Overall survival was one year.  And hopefully these data will be used to support a filing early next year in order to try to get carfilzomib approved by the Food and Drug Administration, which hopefully would get it out there pretty quickly to patients in the community. 

There also was one poster presented about carfilzomib that showed if you gave it over a longer IV period of about 30 minutes patients could tolerate higher doses and maybe even have a much better response rate.

I think that there are a number of themes that are emerging around which patients perhaps should receive some form of maintenance therapy versus those who perhaps can wait until their disease comes back and be retreated at that time point.  So I think it’s not a one-size-fits-all kind of an approach.  I think that what is making this more difficult and more challenging is that if you had 10 different patients with myeloma you have at least 10 different kinds of myeloma in those 10 patients, and so trying to say that every patient should get maintenance or that no patient should get maintenance is probably a little too black and white, and there are subtleties to clinical practice that I think make a decision an individual one, one that a patient certainly participates in but one where the physician who is treating and working with that patient probably needs to take lots of different factors into account when they make a recommendation regarding maintenance therapy.

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