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T-DM1: Adjuvant or neoadjuvant use
Hi all. I'd like to ask for your opinion and thoughts about the design of adjuvant and neoadjuvant trials of T-DM1. I've been asked by NBCC to talk a bit about the advocate perspective on this, in a pre-meeting Project LEAD session at SABCS this year.
NBCC's concern is that it looks like adjuvant/neoadjuvant trials of T-DM1 will look at adding T-DM1 to standard-of-care -- in other words, administering WITH a systemic chemo agent. Most of the metastatic trials have not done this. In addition, of course, to efficacy in controlling/stopping HER2+ cancer, the most hopeful benefit of T-DM1 looks to be the lower toxicities. For example, fewer or no reports of nausea, hair loss, neuropathies, etc. If the adjuvant trials do not have a T-DM1-only arm (or at least a T-DM1 without systemic chemo arm), we'll miss the opportunity to know the answer to this important question.
The broader trial design issue that this illustrates is that it is typical, in adjuvant/neoadjuvant trials, to add new drugs INTO older regimens, rather than taking the opportunity to reduce toxicities and overtreatment by trialing less-toxic but possibly equally-effective treatments on their own. An example of this is the question of Herceptin alone (with an endocrine tx when appropriate) for both very small HER+ tumors and for those at high risk of harm from a combination chemo/Herceptin tx. It seems like everyone wants to know the answer to this question but no one is willing to do a trial to find the answer(s).
Thanks in advance for any help you can provide. I would like to have a slide with comments from patients and advocates, representing all perspectives. So although I do have an opinion and will include that in what I say, I want to include everyone's opinion in order to get the most-balanced perspective.
Debbie Laxague
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