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Thursday, December 8, 2011

To Transplant or Not To Transplant?

I have been giving some thought to the question of whether I should volunteer for the clinical trial that Dr. Richardson recommends to perform an ASCT in the next few months followed by Revlimid consolidation/maintenance, or to continue with the current MLN9708 clinical trial indefinitely.  Based on the limited amount of research I have done to date, I can make a case for either option.  So, here is a debate I am having with myself over the efficacy of these two approaches.

Case for entering the ASCT clinical trial at this time:

Opting to enter the ASCT clinical trial is the only option that makes sense. To do anything else would be really stupid, and here's why. Standard therapy for patients under the age of 70 is to do initial induction therapy followed by ASCT. Studies have shown that patients who received ASCT early have better Overall Survival (OS) than those who received ASCT after relapse (Ref. 1). The most important predictor for a good outcome is to be in Complete Response (CR) at the time of ASCT, resulting in Progression Free Survival (PFS) of 47 months and OS of 91 months (Ref. 2). I am already nearly at CR. If I wait until relapse to do the ASCT, I may not be in as favorable disease status as I am now, and ASCT may not work as well. Furthermore, recent trials have shown that Revlimid is an excellent maintenance therapy after ASCT, trumping even tandem transplants (Ref. 3). Since Revlimid is not FDA approved for this purpose, the only way to get the benefits of Revlimid maintenance is to be a part of this trial. Since I am close to 70 now, my age is another reason to opt for an early transplant.

Case for continuing MLN9708 trial and postpone ASCT until relapse:

Opting to continue with the MLN9708 clinical trial and postpone ASCT until first relapse is the only option that makes sense. To do anything else would be really stupid, and here's why. This MLN9708/Rev/dex trial is doing extremely well, with 100% Overall Response Rate (ORR) to date (Ref. 4), which indicates it may even be a better induction therapy than Velcade/Rev/dex, which is the current gold standard. The fact that I am almost in CR already augers well for a long-term benefit. The planned maintenance therapy is to continue with MLN9708. While this is unproven, Velcade has been shown to be a excellent maintenance therapy drug, and MLN9708, which is similar but more powerful, may work even better. If not, Velcade is always available. Many patients opt for early ASCT for quality-of-life reasons due to peripheral neuropathy (PN) associated with Velcade. I have no such issues, with minimal side effects from my treatment. In fact, ASCT is a serious invasive procedure, requiring weeks of hospitalization and months of restricted activity. Furthermore, there is a 4-5% mortality risk from the procedure itself. Recent research has also shown that with the new induction therapies, delaying ASCT until first relapse won't affect OS (Ref. 5). What about the risk of waiting until after age 70 for ASCT? Not so much. Recent tests (Ref. 1) have shown that patients over 70 without co-morbidities (heart, lung, kidney, liver problems) respond as well to ASCT as younger patients, even with lower levels of the chemotherapy melphalin (140 mg vs. 200 mg) that Richardson said he would use for me. Other than the MM, I'm as healthy as the proverbial horse, so keeping ASCT in reserve until first relapse makes sense. 

OK, readers, what do you think?  Did I make the better argument, or did I?  I welcome your comments.  Not that I plan to make my decision on the basis of a straw poll, mind you.  The only votes that count are mine, Gretchen's, and Dr. Richardson's, not necessarily in that order.  However, I'd like to be knowledgeable enough to be really comfortable with whatever the final decision is.  I plan to continue reading and learning so as to either further confirm or refute some of the arguments above.

1 comment:

  1. What a decision to have to make! I think you both have very good points, but clearly you were more convincing and you should shoul go with your choice :-)