My Update on 09-093 Trial

[KDR]

Dear Friends,

Here's my update for the 09-093 trial:

The 09-093 trial I have been on for one year has concluded and I remain NED. It was a hard won NED, but no regimen is easy. This trial started with Taxol, T-DM1 and Perjeta. I tolerated it quite well, but the infusions were five hours long when the three drugs were given together, and ultimately, during month three, Taxol had to be dropped due to severe side effects: 1) an SMA, which is an intestinal aneurysm (and it contained a blood clot), 2) near total loss of vision in my right eye which was neuropathy of the optical nerve and, 3) general neuropathy of hands and feet. After the Taxol was dropped, we continued on with the T-DM1 and Perjeta for the next nine months. I needed to use blood thinners for a time and learned my blood was too thin when a nosebleed landed me in the hospital with my face packed for for four days. We stopped the blood thinners. My vision returned and to everyone's amazement, the SMA was gone as well. This is nothing short of a miracle. Arteries just don't dilate and un-dilate.

This trial also required weekly bloodwork and CT scans, sometimes combined with PETs every six weeks. The hardest part has been the hit blood platelets take with T-DM1. Also, I take a dose of 2.4 mg/kg weekly. Part of the study was to determine whether there's more efficacy in weekly or tri-weekly doses.

So, on Wednesday, I had a CT, brain MRI, bone scan and echo done, as you have to repeat the inclusion criteria to continue on the extended study. I had such jitters waiting for the results--we all know how that feels. But, all is clear and I must forge on. The hardest part is the neuropathy, which I have at Grade 2. T-DM1 contains agents that can cause taxane-like side effects. I'm just happy to have my sight back.

Now, I will have bloods done every three weeks and scans every four months. A welcome change indeed. By participating in this trial, I hope I laid some groundwork and have given scientists and doctors and co-patients much-needed information.

I, for one, have been overwhelmed in recent months by the friends I have lost, with special mention to those on our list. I remember Jackie's father's words (no rest for a soldier's daughter) and my own father's words (you are going to be good) in their honor. None of us should have to endure the pain, the interruption of our lives, the terror of scan and test results.

Sent with love for the holiday season and beyond,
Happy 2013,

Karen