Phil,
I would agree that the clinical trial system has to come out of the Dark Ages, and I think we'll be seeing more neoadjuvant trials, which will help shorten the process. The FDA recently issued draft guidance on using pCR as an endpoint in such trials, in order to accelerate approval.
As to t-dm1 and EMILIA, I have a lot of concerns. The capecitabine and lapatinib combo is the pip-squeak on the block. They couldn't have picked a better weakling for comparison. For several years now, oncs have known that patients who stay on herceptin even after they've progressed do better than those taken off of it. When my cancer progressed to my lung, my onc offered to give me capecitabine and lapatinib to ADD to herceptin, not in place of herceptin. And that was in spring 2007, almost 6 YEARS AGO. So, is it any wonder that T-DM1 beat out capecitabine and lapatinib?
OS, or overall survival, is very important to me. PFS is nice ... but what I want to know is whether a drug is going to make me LIVE LONGER. Often PFS doesn't pan out, and patients end up not surviving longer. Twenty years after doing bone marrow transplants, it's now known that there was no survival difference between the women who got them and those that didn't. Yet in the early days of this elixir women were suing their insurance companies for denying coverage!
Here's a very interesting piece written in September. It clearly spells out the problem.
http://www.clinicaloncology.com/View...887&a_id=21703
Please don't misunderstand me. I have metastatic disease and speak from the heart. I just wish that the trial design had been more compelling. It worries me. What a waste of money … and time. Yes, Paul, precious time. I cry over it. It's very upsetting to me.
And now I worry about adjuvant and neoadjuvant trials of t-dm1 going forward, and the suggestions that the NBBC made about trial design that are being ignored.
Joan