[chrisy]

Would love to be a fly on the wall in that session! Glad that you will be participating.

This study design seems to be aimed more at discovering if TDM1 is more effective than "plain vanilla" herceptin, particularly in the adjuvant setting. I fear this misses a big point - which you mention - and that is can TDM1 replace the more toxic chemo therapies. The trial design does not answer that question.

I was on TDM1 as single agent for 3 years, and I can tell you (now that I've had to go back to rougher chemos), it is a HUGE deal. People seem to disregard QOL as a worthy goal, but especially in the mets setting it is the difference between being in your life or sitting on the sidelines suffering. I was able to continue being a fully productive member of society and to be fully IN MY LIFE. With stage IV disease that is EVERYTHING. But even as adjuvant or neoadjuvant therapy, it's inexcusable to not seriously look at less toxic options. Why should we expect women to give up 6 months, or a year of their lives to get back the rest of them?

I think the strategy of adding to vs replacing therapies stems from wanting to make sure people get at least standard of care treatment. It may be more challenging to recruit into trials with TDM1 as a single agent in the adjuvant setting especially, many people want to do the most aggressive thing to prevent a recurrence. But I think there have been studies looking at say, lapatinib and herceptin without chemo, at least as neoadjuvant.

Anyway, if I were ever able to say anything in a concise fashion, it would be this:
We need to be able to answer the question can the use of harsh chemos be forgone in at least some cases. In my view, TDM1 is a great opportunity to explore this option and we should not squander that opportunity.