Why neoadjuvant clinical trials like ispy-2 is the future?

jenrio

I never heard about preoperative chemo or neoadjuvant chemo, much less ispy-2 before I had my surgery.    

I was at a local hospital in a metropolitan area (so there was a few trials available). I did not qualify for any at the time diagnosis because of my circumstances. I was very overwhemed anyways and made some questionable treatment decisions.   Now I feel I missed out on a very important piece of information about my cancer and think that general population and newly dxed patient would need some education on neoadjuvant/preoperative chemo and clinical trials.

Here is what I missed out by not doing preoperative (neoadjuvant) chemo:

a. whether chemo worked at all: In future, if we have recurrence, I may have to go back to chemos that failed and waste 3 months to rediscover that the chemos with worst side effect did not work.   If the preoperative chemotherapy does not work, then neoadjuvant chemo is usually stopped or course changed, so that your treatment is better tailored to your cancer than an adjuvant chemotherapy which just runs on and on in the hope it works.

b. Chemo works, but we need to know how well it works. Say AC4+ T12 shrunk my primary tumor by 1/2, before my surgery. Hypothetically there is a remote metastatic cancer elsewhere, assume it's smaller say 1/4 size of my primary tumor, it is probably shrunk by 1/2 too, now 1/8 of the original primary tumor. But given the aggressiveness of tumor, it might take only 2 months to double again. Then I may be getting 2cm mass about 6 months after end of chemo.

Say alternatively preoperative chemo shrunk my tumor to 1/16 or even nothing! Then, I have a good inkling that I won't get recurrence for maybe 5-6 years. This is a great information to have for an almost worry free 5-6 years.   Of course, I'm assuming a lot about 1+ unseen metastatic sites, but it's just crude guesswork.

I think this is compelling reason for choose neoadjuvant chemo. As to ispy-2 clinical trials, whichever arm you randomize to, you will get the standard chemo with/without experimental drug that passed preclinical evidence and safety test. So the patient is contributing to faster development of drugs without sacrificing much.

Best news is, FDA is considering accelerating drug approval based on tests like ispy-2 and allow ispy-2 to try out 12 drugs instead of just 1. That should cut down the drug development time (currently at 15 years) and drug development cost (currently at 100s M even 1 billion dollars).

I think patients need to spread the word to general population, high risk population and newly diagnosed patients about the importance of faster/cheaper clinical trials and ispy-2.